FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report

Selection Criteria:

Active Ingredient: Product Name: FDA Received Date: MedDRA® Version* : Total Cases**: Number of Pages:

. .;YAZ From: 01-JAN-2009 To: 15.1 18,053 7,840 04-FEB-2013

Disclaimer: Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events. *. “MedDRA® Version” refers to the name and version of the dictionary in use at the time the cases were retrieved from the FDA Adverse Event Reporting System (FAERS). MedDRA Medical Dictionary for Regulatory Activities (MedDRA®) is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of medical products. A MedDRA® Preferred Term (PT) is used to standardize a “medical concept” in a report. For example, a report of “heart attack” or “myocardial infarct” are standardized to the same Preferred Term, “Myocardial Infarction”. MedDRA is updated twice a year. **. “Total Cases” reflects the number of individual patient case reports associated with the product of interest that were submitted to FDA within the specified time period. A case consists of an initial report and any follow-up reports submitted to FDA. Because FDA may receive reports on the same patient from more than one source, some of these cases may be duplicate patient reports.

Date - Time: 02-04-2013 9:57:10 AM EST

Page: 1 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report
The information in this report is generated from the FDA Adverse Event Reporting System (FAERS) by using a report query where suspect product(s) or active ingredients are selected from a standardized dictionary and a date range is specified as search criteria. The table below provides the definitions for field headings that are listed on the report.

FAERS data have limitations, including the following. There is no certainty that the reported event was actually due to the product. Reports are often incomplete - a blank field means that no data were provided. FDA does not receive reports on all adverse events that occur with a product. Many factors can influence whether or not an event will be reported, therefore, FAERS data cannot be used to compare products or calculate how frequently an event occurs in the U.S. population.

Field Heading Definition FDA Received Date The date that FDA received the most recent information regarding a case, either as an initial report or follow-up report. The FDA Received Date may not be the same as the date that the event occurred. The event may have occurred days or even months (or years) before the report was sent to (and received by) FDA. Note the displayed date on the report may be later than the query date range if FDA received follow-up information for a case. FDA provides the most current case information available. Case # A unique number assigned by FDA that identifies a FAERS case. A case includes the information received in the initial report plus any additional information received in follow-up reports. Case Type There are three case types in FAERS: Expedited (15-Day): submitted to FDA by manufacturers; these are reports containing serious, unexpected adverse events Nonexpedited: submitted periodically to FDA by manufacturers; these are reports containing adverse events other than those qualifying for expedited (15-day) reporting Direct: submitted “directly” to FDA by healthcare professionals, patients and other consumers Indicates whether the initial source who provided information about the event is a health professional (HP). Possible values are; Y - Yes, N – No or the field is blank if it was not reported Based on FDA regulations, the reported outcome(s) determines whether a case is serious. The outcome categories include congenital anomaly/birth defect (CA), death (DE), disability (DS), hospitalization (HO), life-threatening (LT), other serious important medical event (OT), and required intervention to prevent permanent impairment/damage (RI). A case can have more than one outcome. The Manufacturer Control Number is the manufacturer’s unique identifier associated with the case. Also referred to as the Company Report Number. The patient's age, with age unit, based on information provided in the report. Patient sex (Male, Female, Unknown). The country where the event occurred. If not reported, then the country of the reporter. The International Organization for Standardization (ISO) 3166-1 alpha-3 country code is used as an abbreviation for the country.

Health Professional Outcomes

Manufacturer Control # Age Sex Country

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 2 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report
Field Heading Preferred Term Definition A Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Term (PT) is used to standardize a “medical concept” in a report. For example, a report of “heart attack” or “myocardial infarct” are standardized to the same Preferred Term, “Myocardial Infarction”. MedDRA is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to “code” adverse events, medication errors and other information associated with the use of medical products Name of a drug or therapeutic biologic in the case report. A product name can appear as either a brand name (trade name) or an active ingredient name, depending on what was reported. There are two roles for products listed on the cases. Suspect (S) identifies the product(s) that the initial reporter deemed most likely to be associated with the event. Concomitant (C) identifies products taken at the same time as the suspect product, but not deemed by the initial reporter as being associated with the event. Reported route of product administration (e.g., oral, topical, injection, sublingual, inhalation). Refers to the amount of the product that was taken or given to a patient, and the frequency of administration. For example, 20 mg twice daily. The length of time the product was used. For example, if someone reported taking Drug A from January 1 to January 30, the duration would be 30 days. The manufacturer of the product, as indicated in the report.

Product Role

Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 3 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6641594 Date FDA Received
02-Jan-2009 Case # 6641594 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200821873NA Role Route S C Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200837143NA Dosage Text Age 16 YR Sex Female Country USA ORAL Dosage Text Age 37 YR Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ SYNTHROID

Duration

Manufacturer BAYER

6801004 Date FDA Received
02-Jan-2009

Case # 6801004

Case Type EXPEDITED (15-DAY)

Preferred Term DIARRHOEA ABDOMINAL PAIN APPENDICECTOMY CONSTIPATION IRRITABLE BOWEL SYNDROME

Product YAZ NORDETTE

Role Route S C ORAL

Duration

Manufacturer BAYER

6825657 Date FDA Received
02-Jan-2009

Case # 6825657

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200837196NA

Age 14 YR

Sex Female

Country USA

Preferred Term UTERINE SPASM NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6872625 Date FDA Received
05-Jan-2009

Case # 6872625

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200840441NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ UNSPECIFIED INGREDIENT

Role Route S C ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 4 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6880209 Date FDA Received
05-Jan-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 6880209 Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ Case # 6870362 Case Type EXPEDITED (15-DAY) Health Professional N Health Professional Y Health Professional N Outcomes HO,LT Role Route S ORAL Dosage Text 1 PILL ONCE A DAY PO Manufacturer Control # Age 31 YR Dosage Text 3MG/0.02MG DAILY PO Manufacturer Control # USBAYER-200841442NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200910148NA Dosage Text Duration Dosage Text Duration 6 MTH Age Sex Female Age Sex Female Duration Sex Female Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer BAYER Country USA

6880264 Date FDA Received
05-Jan-2009 Preferred Term LIBIDO DECREASED

Case # 6880264

Outcomes OT Role Route S ORAL

Manufacturer BAYER Country USA

6870362 Date FDA Received
06-Jan-2009

Outcomes

Preferred Term GENITAL HAEMORRHAGE

Product YAZ Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

6873710 Date FDA Received
06-Jan-2009

Case # 6873710

Outcomes OT

Preferred Term ENDODONTIC PROCEDURE

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Manufacturer BAYER

6878825 Date FDA Received
06-Jan-2009 Preferred Term

Case # 6878825

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 1 TABLET ONCE A DAY PO

Duration

Manufacturer BERLEX

ABDOMINAL PAIN UPPER DIARRHOEA

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 5 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6874700 Date FDA Received
07-Jan-2009 Case # 6874700 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910197NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200910196NA Role Route S Health Professional N Product YAZ ORAL Manufacturer Control # Age 31 YR Dosage Text 1 PILL DAILY PO Duration Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ PLAN B

Manufacturer BAYER

6874702 Date FDA Received
07-Jan-2009

Case # 6874702

Case Type NON-EXPEDITED

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type DIRECT

Manufacturer BAYER Country USA

6882858 Date FDA Received
07-Jan-2009 Preferred Term DYSPNOEA

Case # 6882858

Outcomes HO,LT Role Route S ORAL

Manufacturer

INTRACARDIAC THROMBUS PULMONARY EMBOLISM

6882859 Date FDA Received
07-Jan-2009 Preferred Term CHEST PAIN DYSPNOEA

Case # 6882859

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 1 QD PO

Duration 2 MTH

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 6 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6885834 Date FDA Received
08-Jan-2009 Preferred Term COLITIS COLITIS ULCERATIVE Case # 6885834 Case Type DIRECT Product YAZ Health Professional Y Outcomes OT Role Route S ORAL Dosage Text ONE TAB DAILY PO Manufacturer Control # Age 36 YR Duration 1 MTH Sex Female Country USA

Manufacturer

6681011 Date FDA Received
09-Jan-2009

Case # 6681011

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200815173LA Dosage Text

Age

Sex Female

Country BRA

Preferred Term DIPLOPIA HEADACHE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6784560 Date FDA Received
09-Jan-2009

Case # 6784560

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200835150NA Dosage Text

Age

Sex Female

Country USA

Preferred Term TONSILLECTOMY AMENORRHOEA

Product YAZ

Role Route S

Duration

Manufacturer BAYER

6885566 Date FDA Received
09-Jan-2009 Preferred Term

Case # 6885566

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 7 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6784558 Date FDA Received
11-Jan-2009 Case # 6784558 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # BRBAYER-200818819LA Dosage Text Duration Age Sex Female Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION SPONTANEOUS NAUSEA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6853912 Date FDA Received
12-Jan-2009

Case # 6853912

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200839527NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ ACNE MEDICATIONS NOS

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

6891963 Date FDA Received
12-Jan-2009 Preferred Term

Case # 6891963

Case Type DIRECT Product YAZ

Health Professional N

Manufacturer Control #

Age

Sex Female

Country USA

Role Route S ORAL

Dosage Text 1 -ACTIVE- DAILY/24 DAYS PO 1 -INACTIVEDAILY/4 DAYS PO

Duration 1 YEAR

Manufacturer BAYER

BLOOD CHOLESTEROL INCREASED

BLOOD TRIGLYCERIDES INCREASED

6889206 Date FDA Received
13-Jan-2009 Preferred Term DEPRESSION ANXIETY FEELING ABNORMAL PANIC ATTACK

Case # 6889206

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text

Duration 4 MTH

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 8 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6889853 Date FDA Received
14-Jan-2009 Preferred Term BLOOD POTASSIUM INCREASED Case # 6889853 Case Type DIRECT Product YAZ DETROL LA MULTI-VITAMIN CALCIUM/VITAMIN D Health Professional Y Outcomes OT Role Route S C C C Outcomes Manufacturer Control # USBAYER-200840902NA Role Route S ORAL Dosage Text Age 16 YR Sex Female Country USA ORAL Dosage Text 1 DAILY PO Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer BAYER

6858578 Date FDA Received
15-Jan-2009

Case # 6858578

Case Type NON-EXPEDITED

Health Professional N

Preferred Term URINARY TRACT INFECTION NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6881709 Date FDA Received
15-Jan-2009

Case # 6881709

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # BRBAYER-200810461LA Dosage Text

Age 23 YR

Sex Female

Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE PREMENSTRUAL SYNDROME DIARRHOEA

Product YAZ OMEPRAZOLE ASCORBIC ACID\HESPERIDIN \PIPERIDOLATE HYDROCHLORIDE UNSPECIFIED INGREDIENT

Role Route S C C ORAL ORAL UNKNOWN

Duration

Manufacturer BAYER

ABDOMINAL PAIN BACK PAIN UTERINE CONTRACTIONS DURING PREGNANCY

C

UNKNOWN

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 9 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6891553 Date FDA Received
15-Jan-2009 Preferred Term CEREBROVASCULAR ACCIDENT Case # 6891553 Case Type DIRECT Product YAZ Case Type EXPEDITED (15-DAY) Health Professional Y Health Professional N Outcomes HO Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # USBAYER-200833142NA Dosage Text Unit dose: 1 DF Duration Age Sex Female Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer BAYER Country USA

6758889 Date FDA Received
16-Jan-2009

Case # 6758889

Outcomes DE

Preferred Term THROMBOSIS INTENTIONAL OVERDOSE

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6802423 Date FDA Received
16-Jan-2009

Case # 6802423

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200836845NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6883083 Date FDA Received
16-Jan-2009

Case # 6883083

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200841135NA

Age 24 YR

Sex Female

Country USA

Preferred Term INSOMNIA NO ADVERSE EVENT RESTLESSNESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 10 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6883085 Date FDA Received
16-Jan-2009 Case # 6883085 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841235NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA

Preferred Term MYALGIA NO ADVERSE EVENT POLLAKIURIA

Product YAZ

Duration

Manufacturer BAYER

6883087 Date FDA Received
16-Jan-2009

Case # 6883087

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841221NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6836060 Date FDA Received
19-Jan-2009

Case # 6836060

Outcomes

Manufacturer Control # USBAYER-200838340NA

Age

Sex Female

Country USA

Preferred Term OVARIAN CYST

Product YAZ Case # 6836070 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6836070 Date FDA Received
19-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200838342NA

Age

Sex Female

Country USA

Preferred Term OVARIAN CYST

Product YAZ Case # 6842003 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6842003 Date FDA Received
19-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200838518NA

Age 17 YR

Sex Female

Country USA

Preferred Term DYSPNOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 11 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6853857 Date FDA Received
19-Jan-2009 Case # 6853857 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200838709NA Role Route S ORAL Dosage Text Age 15 YR Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding ACNE CRYING

Product YAZ

Duration

Manufacturer BAYER

6883060 Date FDA Received
19-Jan-2009

Case # 6883060

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200813838LA Dosage Text

Age 23 YR

Sex Female

Country BRA

Preferred Term SOMNOLENCE

Product YAZ PHARMATON VITAMIN E

Role Route S C C Health Professional N ORAL ORAL ORAL

Duration

Manufacturer BAYER

6885978 Date FDA Received
19-Jan-2009

Case # 6885978

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200841280NA

Age 22 YR

Sex Female

Country USA

Preferred Term COUGH

Product YAZ Case # 6885984 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6885984 Date FDA Received
19-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200841381NA

Age 29 YR

Sex Female

Country USA

Preferred Term LIBIDO DECREASED NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 12 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6885986 Date FDA Received
19-Jan-2009 Case # 6885986 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841378NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VOMITING INFLUENZA

Product YAZ

Manufacturer BAYER

6885993 Date FDA Received
19-Jan-2009

Case # 6885993

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841266NA

Age 18 YR

Sex Female

Country USA

Preferred Term DEPRESSION CRYING

Product YAZ FLINTSTONES MULTIPLE VITAMINS Case # 6886000 Case Type NON-EXPEDITED Health Professional N

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

6886000 Date FDA Received
19-Jan-2009

Manufacturer Control # USBAYER-200841392NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6886003 Date FDA Received
19-Jan-2009

Case # 6886003

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841467NA

Age 32 YR

Sex Female

Country USA

Preferred Term OESTRADIOL DECREASED BLOOD FOLLICLE STIMULATING HORMONE DECREASED LIBIDO DECREASED METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 13 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6886012 Date FDA Received
19-Jan-2009 Case # 6886012 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841436NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200841519NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200841517NA Role Route S S C C C C Outcomes Manufacturer Control # USBAYER-200841521NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL ORAL ORAL ORAL ORAL Dosage Text Age 39 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 22 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6886017 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6886017 Date FDA Received
19-Jan-2009

Outcomes

Preferred Term URINARY TRACT INFECTION

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6886023 Date FDA Received
19-Jan-2009

Case # 6886023

Outcomes

Preferred Term ANXIETY INSOMNIA NO ADVERSE EVENT

Product YAZ YAZ CELEBREX ADDRELL XR MULTI-VITAMIN DROSPIRENONE

Duration

Manufacturer BAYER BAYER

6886029 Date FDA Received
19-Jan-2009

Case # 6886029

Case Type NON-EXPEDITED

Health Professional N

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 14 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6886030 Date FDA Received
19-Jan-2009 Case # 6886030 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841535NA Role Route S ORAL Dosage Text Age 17 YR Sex Female Country USA

Preferred Term VOMITING INFLUENZA

Product YAZ

Duration

Manufacturer BAYER

6886031 Date FDA Received
19-Jan-2009

Case # 6886031

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841522NA

Age

Sex Female

Country USA

Preferred Term RASH

Product YAZ Case # 6886035 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6886035 Date FDA Received
19-Jan-2009

Outcomes

Manufacturer Control # US-BAYERUS-2007-013040

Age 17 YR

Sex Female

Country USA

Preferred Term GENITAL HAEMORRHAGE Abnormal withdrawal bleeding METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6887462 Date FDA Received
21-Jan-2009

Case # 6887462

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200910785NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 15 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6887469 Date FDA Received
21-Jan-2009 Case # 6887469 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841516NA Role Route S C ORAL Dosage Text Age 46 YR Sex Female Country USA

Preferred Term WEIGHT INCREASED MENOMETRORRHAGIA NO ADVERSE EVENT

Product YAZ COPPER IUD NOS

Duration

Manufacturer BAYER

6887559 Date FDA Received
21-Jan-2009

Case # 6887559

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200911169NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type DIRECT Product YAZ COUMADIN ACTIVASE HEPPARIN Health Professional Y

Role Route S ORAL

Duration

Manufacturer BAYER

6894412 Date FDA Received
21-Jan-2009 Preferred Term

Case # 6894412

Outcomes HO,DS,LT,OT Role Route S C C C ORAL

Manufacturer Control #

Age 31 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM

6897770 Date FDA Received
21-Jan-2009 Preferred Term

Case # 6897770

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,DS,LT Role Route S ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 16 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6897942 Date FDA Received
21-Jan-2009 Preferred Term PULMONARY EMBOLISM ILL-DEFINED DISORDER Case # 6897942 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO,LT Role Route S ORAL Dosage Text 1 TAB DAILY PO APPROX.5 MOS. Manufacturer Control # Age 28 YR Duration Sex Female Country USA

Manufacturer BAYER

6792228 Date FDA Received
22-Jan-2009

Case # 6792228

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200834249NA

Age

Sex Female

Country USA

Preferred Term VERTIGO INFLUENZA LIKE ILLNESS NAUSEA VOMITING WEIGHT DECREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6823029 Date FDA Received
22-Jan-2009

Case # 6823029

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200839046NA

Age

Sex Female

Country USA

Preferred Term ORTHOSTATIC HYPOTENSION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration 3 MTH

Manufacturer BAYER Sex Female Country USA

6853894 Date FDA Received
22-Jan-2009

Case # 6853894

Outcomes

Manufacturer Control # USBAYER-200838912NA

Age 22 YR

Preferred Term ANAEMIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 17 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6855330 Date FDA Received
22-Jan-2009 Case # 6855330 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200840079NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200841606NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200841511NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200841624NA Role Route S S ORAL INTRAUTERINE Dosage Text Duration Age Sex Female Dosage Text Age 20 YR Sex Female Dosage Text Age 39 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term PAIN IN EXTREMITY

Product YAZ Case # 6888806 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6888806 Date FDA Received
22-Jan-2009

Outcomes

Preferred Term METRORRHAGIA COITAL BLEEDING

Product YAZ YAZ Case # 6888807 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER BAYER Country USA

6888807 Date FDA Received
22-Jan-2009

Outcomes

Preferred Term COITAL BLEEDING

Product YAZ Case # 6888814 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6888814 Date FDA Received
22-Jan-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding POST PROCEDURAL HAEMORRHAGE

Product YAZ MIRENA

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 18 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6888818 Date FDA Received
22-Jan-2009 Case # 6888818 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841404NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6888826 Date FDA Received
22-Jan-2009

Case # 6888826

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841648NA

Age 21 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6888831 Date FDA Received
22-Jan-2009

Case # 6888831

Outcomes

Manufacturer Control # USBAYER-200841622NA

Age 28 YR

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA NO ADVERSE EVENT

Product YAZ YAZ Case # 6888837 Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

6888837 Date FDA Received
22-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200841645NA

Age 17 YR

Sex Female

Country USA

Preferred Term ACNE

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration 7 MTH

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 19 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6836099 Date FDA Received
23-Jan-2009 Case # 6836099 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200838370NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA

Preferred Term ASTHENIA DYSPNOEA NAUSEA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6890112 Date FDA Received
23-Jan-2009

Case # 6890112

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841619NA

Age 19 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 6890118 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6890118 Date FDA Received
23-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200841626NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6890119 Date FDA Received
23-Jan-2009

Case # 6890119

Outcomes

Manufacturer Control # USBAYER-200841631NA

Age 31 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6890120 Date FDA Received
23-Jan-2009

Case # 6890120

Outcomes

Manufacturer Control # USBAYER-200841639NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 20 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6607304 Date FDA Received
26-Jan-2009 Case # 6607304 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200816044NA Role Route S C Outcomes Manufacturer Control # USBAYER-200841699NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA Dosage Text Age 30 YR Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE MENSTRUATION DELAYED

Product YAZ INSULIN NOS Case Type NON-EXPEDITED Health Professional N

Duration 3 MTH

Manufacturer BAYER

6891534 Date FDA Received
26-Jan-2009

Case # 6891534

Preferred Term MENORRHAGIA ABDOMINAL PAIN Abnormal withdrawal bleeding

Product YAZ

Manufacturer BAYER

6891545 Date FDA Received
26-Jan-2009

Case # 6891545

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841689NA

Age 31 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6900009 Date FDA Received
26-Jan-2009 Preferred Term

Case # 6900009

Case Type DIRECT Product YAZ

Health Professional N

Outcomes DE Role Route S

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer BAYER

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 21 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6901379 Date FDA Received
27-Jan-2009 Preferred Term PALPITATIONS ACTIVITIES OF DAILY LIVING IMPAIRED ADRENAL INSUFFICIENCY ANXIETY APPARENT DEATH BLOOD PRESSURE INADEQUATELY CONTROLLED CARDIAC DISORDER DYSPNOEA ECONOMIC PROBLEM GAIT DISTURBANCE HYPERTENSION IMPAIRED SELF-CARE POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME UNEMPLOYMENT Case # 6901379 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO,DS,LT Role Route S Dosage Text ONE PILL PER DAY ONE TIME PER DAY Manufacturer Control # Age 37 YR Duration 6 WEEK Sex Female Country USA

Manufacturer

6902299 Date FDA Received
27-Jan-2009 Preferred Term

Case # 6902299

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text 1 PILL -3MG/0.2MG- 1 TIME PER DAY PO Manufacturer Control # USBAYER-200840973NA

Duration

Manufacturer BAYER

PULMONARY THROMBOSIS

6858579 Date FDA Received
28-Jan-2009

Case # 6858579

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Age 20 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 22 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6791151 Date FDA Received
29-Jan-2009 Case # 6791151 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200835397NA Dosage Text Age 19 YR Sex Female Country USA

Preferred Term ALOPECIA EFFLUVIUM

Product YAZ Case # 6800997 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Duration

Manufacturer BAYER

6800997 Date FDA Received
29-Jan-2009

Outcomes OT

Manufacturer Control # USBAYER-200836431NA Dosage Text

Age 22 YR

Sex Female

Country USA

Preferred Term SYSTEMIC LUPUS ERYTHEMATOSUS ANTINUCLEAR ANTIBODY POSITIVE ARTHRALGIA

Product YAZ

Role Route S ORAL

Duration 1.75 YEAR

Manufacturer BAYER

6825649 Date FDA Received
29-Jan-2009

Case # 6825649

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200839528NA Dosage Text Total daily dose: 1 DF

Age 22 YR

Sex Female

Country USA

Preferred Term CROHN'S DISEASE

Product YAZ PENTASA

Role Route S C Health Professional N ORAL ORAL

Duration 5 MTH

Manufacturer BAYER

6895291 Date FDA Received
29-Jan-2009

Case # 6895291

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200841762NA

Age

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED

Product YAZ Case # 6895302 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6895302 Date FDA Received
29-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200841822NA

Age

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 23 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6895305 Date FDA Received
29-Jan-2009 Case # 6895305 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841803NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200841813NA Role Route S ORAL Dosage Text Age 17 YR Sex Female Dosage Text Age 23 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6895307 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6895307 Date FDA Received
29-Jan-2009

Outcomes

Preferred Term METRORRHAGIA Abnormal withdrawal bleeding

Product YAZ

Duration

Manufacturer BAYER

6895312 Date FDA Received
29-Jan-2009

Case # 6895312

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200841823NA

Age 18 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6905690 Date FDA Received
29-Jan-2009 Preferred Term PAIN IN EXTREMITY PELVIC PAIN

Case # 6905690

Outcomes

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 1 PILL ONCE A DAY PO

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 24 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6819356 Date FDA Received
30-Jan-2009 Case # 6819356 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200836858NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DEPRESSION ACNE ANXIETY BREAST PAIN NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6855270 Date FDA Received
30-Jan-2009

Case # 6855270

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200839112NA Dosage Text

Age 45 YR

Sex Female

Country USA

Preferred Term ALOPECIA TOTALIS HEADACHE RASH SWELLING VISUAL IMPAIRMENT WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6896624 Date FDA Received
30-Jan-2009

Case # 6896624

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910079NA

Age 18 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA WITHDRAWAL BLEED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 25 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6896629 Date FDA Received
30-Jan-2009 Case # 6896629 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910010NA Role Route S ORAL Dosage Text Age 18 YR Sex Female Country USA

Preferred Term MENOMETRORRHAGIA GENITAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

6896638 Date FDA Received
30-Jan-2009

Case # 6896638

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910038NA

Age 28 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6896639 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6896639 Date FDA Received
30-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200910033NA

Age 24 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6896642 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6896642 Date FDA Received
30-Jan-2009

Outcomes

Manufacturer Control # USBAYER-200910076NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6905562 Date FDA Received
30-Jan-2009 Preferred Term

Case # 6905562

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 31 YR

Sex Female

Country USA

Dosage Text 1 PILL EVERYDAY PO

Duration

Manufacturer BERLEX

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 26 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6898216 Date FDA Received
02-Feb-2009 Case # 6898216 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910047NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200910016NA Role Route S S ORAL ORAL Dosage Text Age 19 YR Sex Female Dosage Text Age 29 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 6898217 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6898217 Date FDA Received
02-Feb-2009

Outcomes

Preferred Term ACNE Abnormal withdrawal bleeding DIZZINESS NAUSEA NO ADVERSE EVENT

Product YAZ YASMIN

Duration

Manufacturer BAYER BAYER

6898226 Date FDA Received
02-Feb-2009

Case # 6898226

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910055NA

Age 15 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6898228 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6898228 Date FDA Received
02-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200910098NA

Age 24 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 27 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6898233 Date FDA Received
02-Feb-2009 Case # 6898233 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910163NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA

Preferred Term MENORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6898240 Date FDA Received
02-Feb-2009

Case # 6898240

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911099NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ YASMIN

Role Route S C Health Professional N ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER

6898241 Date FDA Received
02-Feb-2009

Case # 6898241

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200910058NA

Age

Sex Female

Country USA

Preferred Term Product quality issue NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6898242 Date FDA Received
02-Feb-2009

Case # 6898242

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910095NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 28 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6898257 Date FDA Received
03-Feb-2009 Case # 6898257 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DS Manufacturer Control # BRBAYER-200813245LA Dosage Text Age 25 YR Sex Female Country BRA

Preferred Term PREMENSTRUAL SYNDROME PAIN ARTHRALGIA CRYING DEPRESSED MOOD HEADACHE HUNGER IMPAIRED WORK ABILITY NERVOUSNESS PAIN IN EXTREMITY PHYSICAL DISABILITY SENSATION OF HEAVINESS

Product YASMIN YAZ

Role Route S S ORAL ORAL

Duration 2 YEAR

Manufacturer BAYER BAYER

6908673 Date FDA Received
03-Feb-2009 Preferred Term

Case # 6908673

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT,OT Role Route S ORAL

Manufacturer Control #

Age 37 YR

Sex Female

Country USA

Dosage Text 1 PILL ONCE A DAY PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM CARDIO-RESPIRATORY ARREST

6641592 Date FDA Received
04-Feb-2009

Case # 6641592

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200821872NA

Age 21 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 29 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6801005 Date FDA Received
04-Feb-2009 Case # 6801005 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # USBAYER-200836650NA Dosage Text Age 37 YR Sex Female Country USA

Preferred Term THROMBOTIC THROMBOCYTOPENIC PURPURA HAEMOLYTIC ANAEMIA CHROMATURIA HAEMATURIA HYPERTENSION HYPOAESTHESIA PROTEINURIA

Product YASMIN YAZ

Role Route S S ORAL ORAL

Duration 8 YEAR 10 DAY

Manufacturer BAYER BAYER

6855301 Date FDA Received
05-Feb-2009

Case # 6855301

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200839817NA

Age 28 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding LETHARGY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6901657 Date FDA Received
05-Feb-2009

Case # 6901657

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910335NA

Age 20 YR

Sex Female

Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 6901662 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6901662 Date FDA Received
05-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200910330NA

Age 19 YR

Sex Female

Country USA

Preferred Term NAUSEA DECREASED APPETITE HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 30 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6901670 Date FDA Received
05-Feb-2009 Case # 6901670 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910267NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200910249NA Role Route S S ORAL ORAL Dosage Text Age 20 YR Sex Female Country USA ORAL Dosage Text Age 48 YR Sex Female Country USA

Preferred Term MIGRAINE NO ADVERSE EVENT

Product YAZ LAMICTAL Case # 6901673 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER

6901673 Date FDA Received
05-Feb-2009

Preferred Term DEPRESSION MOOD SWINGS Abnormal withdrawal bleeding

Product YAZ YAZ

Duration

Manufacturer BAYER BAYER

6901688 Date FDA Received
05-Feb-2009

Case # 6901688

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910389NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 6801002 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6801002 Date FDA Received
06-Feb-2009

Outcomes OT

Manufacturer Control # USBAYER-200836999NA Dosage Text

Age 30 YR

Sex Female

Country USA

Preferred Term CHEST PAIN BLOOD PRESSURE DECREASED DISORIENTATION DIZZINESS HEART RATE DECREASED

Product YAZ

Role Route S ORAL

Duration 4 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 31 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6809416 Date FDA Received
06-Feb-2009 Case # 6809416 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200837328NA Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT WRIST FRACTURE

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6903017 Date FDA Received
06-Feb-2009

Case # 6903017

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910416NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6903026 Date FDA Received
06-Feb-2009

Case # 6903026

Outcomes

Manufacturer Control # USBAYER-200910348NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding ABDOMINAL DISTENSION ALOPECIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6903027 Date FDA Received
06-Feb-2009

Case # 6903027

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200910409NA

Age 33 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6912643 Date FDA Received
06-Feb-2009 Preferred Term OPTIC NEURITIS

Case # 6912643

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 15 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 32 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6855327 Date FDA Received
09-Feb-2009 Case # 6855327 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200839982NA Role Route S ORAL Dosage Text Age 28 YR Sex Female Country USA

Preferred Term INCREASED APPETITE Abnormal withdrawal bleeding FATIGUE NAUSEA NO ADVERSE EVENT TREMOR

Product YAZ

Duration

Manufacturer BAYER

6904450 Date FDA Received
09-Feb-2009

Case # 6904450

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910529NA

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6904457 Date FDA Received
09-Feb-2009

Case # 6904457

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910633NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6904467 Date FDA Received
09-Feb-2009

Case # 6904467

Outcomes

Manufacturer Control # USBAYER-200910564NA

Age 27 YR

Sex Female

Country USA

Preferred Term PELVIC PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 33 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6904470 Date FDA Received
09-Feb-2009 Case # 6904470 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910538NA Role Route S C Outcomes Manufacturer Control # USBAYER-200910553NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 24 YR Sex Female Country USA

Preferred Term MENSTRUATION DELAYED OLIGOMENORRHOEA

Product YAZ LACTASE ENZYMES NOS Case # 6904480 Case Type NON-EXPEDITED Health Professional N

Duration

Manufacturer BAYER

6904480 Date FDA Received
09-Feb-2009

Preferred Term ABDOMINAL DISTENSION DYSPEPSIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6904481 Date FDA Received
09-Feb-2009

Case # 6904481

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910651NA

Age 25 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ VALIUM ALBUTEROL

Role Route S C C Health Professional N Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

6904482 Date FDA Received
09-Feb-2009

Case # 6904482

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200910555NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 34 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6904489 Date FDA Received
09-Feb-2009 Case # 6904489 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910768NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200910810NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6904491 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6904491 Date FDA Received
09-Feb-2009

Outcomes

Preferred Term WITHDRAWAL BLEED Abnormal withdrawal bleeding NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6904493 Date FDA Received
09-Feb-2009

Case # 6904493

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910747NA

Age 26 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6904495 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6904495 Date FDA Received
09-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200910662NA

Age 27 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6904497 Date FDA Received
09-Feb-2009

Case # 6904497

Outcomes

Manufacturer Control # USBAYER-200910764NA

Age 30 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding STAPHYLOCOCCAL INFECTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 35 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6914405 Date FDA Received
09-Feb-2009 Preferred Term NERVOUSNESS BLOOD PRESSURE INCREASED FEAR PALPITATIONS PANIC REACTION Case # 6914405 Case Type DIRECT Product YAZ Health Professional Y Outcomes OT Role Route S ORAL Dosage Text 1 TAB DAILY PO Manufacturer Control # Age 41 YR Duration 4 DAY Sex Female Country USA

Manufacturer

6914507 Date FDA Received
09-Feb-2009 Preferred Term SLEEP DISORDER ANXIETY CHEST PAIN DEPRESSION HEADACHE IRRITABILITY LIBIDO DECREASED MOOD SWINGS SUICIDAL IDEATION VISUAL IMPAIRMENT

Case # 6914507

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 42 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration

Manufacturer BAYER

6794420 Date FDA Received
10-Feb-2009

Case # 6794420

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200834355NA

Age

Sex Female

Country USA

Preferred Term IRRITABILITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 36 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6905681 Date FDA Received
10-Feb-2009 Case # 6905681 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910772NA Role Route S Health Professional N Product YAZ Outcomes LT Role Route S ORAL Dosage Text ONE TABLET PER DAY DAILY PO Manufacturer Control # Age 17 YR Duration Sex Female Dosage Text Age 1 YR Sex Male Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6916466 Case Type DIRECT

Duration

Manufacturer BAYER Country USA

6916466 Date FDA Received
11-Feb-2009 Preferred Term PANIC ATTACK ANGER ANHEDONIA CRYING DEPRESSION DIZZINESS

Manufacturer

EMOTIONAL DISORDER FEAR HALLUCINATION, AUDITORY NAUSEA PALPITATIONS SCHIZOPHRENIFORM DISORDER THINKING ABNORMAL VISUAL IMPAIRMENT

6815533 Date FDA Received
12-Feb-2009

Case # 6815533

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200838692NA Dosage Text

Age 26 YR

Sex Female

Country USA

Preferred Term SUICIDAL IDEATION MOOD SWINGS

Product YAZ

Role Route S ORAL

Duration 4 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 37 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6840738 Date FDA Received
12-Feb-2009 Case # 6840738 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200838245NA Role Route S ORAL Dosage Text Age 47 YR Sex Female Country USA

Preferred Term PREGNANCY SINUSITIS

Product YAZ

Duration

Manufacturer BAYER

6904509 Date FDA Received
12-Feb-2009

Case # 6904509

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200912636NA Dosage Text Total daily dose: 1 DF Total daily dose: 1 DF Manufacturer Control # USBAYER-200910852NA

Age 27 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION SPONTANEOUS

Product YAZ MAXALT MULTI-VITAMIN

Role Route S C C ORAL ORAL ORAL

Duration

Manufacturer BAYER

6907803 Date FDA Received
12-Feb-2009

Case # 6907803

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Age

Sex Female

Country USA

Preferred Term NIGHT SWEATS FLUID RETENTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6907810 Date FDA Received
12-Feb-2009

Case # 6907810

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910849NA

Age

Sex Female

Country USA

Preferred Term RASH

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 38 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6907813 Date FDA Received
12-Feb-2009 Case # 6907813 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910845NA Role Route S ORAL Dosage Text Age 36 YR Sex Female Country USA

Preferred Term HYPOMENORRHOEA Abnormal withdrawal bleeding

Product YAZ

Duration

Manufacturer BAYER

6907820 Date FDA Received
12-Feb-2009

Case # 6907820

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910938NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6907827 Date FDA Received
12-Feb-2009

Case # 6907827

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910851NA

Age 26 YR

Sex Female

Country USA

Preferred Term MADAROSIS

Product YAZ Case # 6907828 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6907828 Date FDA Received
12-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200910930NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA ACNE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6907833 Date FDA Received
12-Feb-2009

Case # 6907833

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912827NA

Age

Sex Female

Country USA

Preferred Term ADVERSE REACTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 39 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6907835 Date FDA Received
12-Feb-2009 Case # 6907835 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912452NA Role Route S Health Professional N Product YAZ Role Route S ORAL Dosage Text DAILY PO Duration ORAL Dosage Text As used: 1 DF Manufacturer Control # Age Sex Female Age 21 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type DIRECT

Duration

Manufacturer BAYER Country USA

6918903 Date FDA Received
12-Feb-2009 Preferred Term HEADACHE BACK PAIN DYSMENORRHOEA HAEMORRHAGE

Case # 6918903

Outcomes

Manufacturer

6605169 Date FDA Received
13-Feb-2009

Case # 6605169

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200818382NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration 12 WEEK

Manufacturer BAYER Sex Female Country USA

6909105 Date FDA Received
13-Feb-2009

Case # 6909105

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200910953NA

Age

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6909124 Date FDA Received
13-Feb-2009

Case # 6909124

Outcomes

Manufacturer Control # USBAYER-200910950NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 40 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6909127 Date FDA Received
13-Feb-2009 Case # 6909127 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910943NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200911186NA Role Route S Health Professional Y Product YAZ DEPAKOTE PROZAC ASPIRIN MULTI-VITAMIN CALCIUM ORAL Manufacturer Control # Age 54 YR Dosage Text 1 TAB ONCE DAILY PO Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term OESTRADIOL DECREASED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6909139 Date FDA Received
13-Feb-2009

Case # 6909139

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type DIRECT

Manufacturer BAYER Country USA

6920861 Date FDA Received
13-Feb-2009 Preferred Term COLITIS ISCHAEMIC HYPERCOAGULATION

Case # 6920861

Outcomes HO Role Route S C C C C C ORAL

Manufacturer

LOWER GASTROINTESTINAL HAEMORRHAGE

6920954 Date FDA Received
13-Feb-2009 Preferred Term

Case # 6920954

Case Type DIRECT Product YAZ RISPERDAL LYRICA EFFEXOR ATIVAN

Health Professional Y

Outcomes HO Role Route S C C C C ORAL

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text 1 TAB ONCE DAILY PO

Duration 4 MTH

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 41 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6855323 Date FDA Received
16-Feb-2009 Case # 6855323 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200840239NA Role Route S ORAL Dosage Text Age 20 YR Sex Female Country USA

Preferred Term MOOD ALTERED CRYING DRUG WITHDRAWAL HEADACHE PALPITATIONS

Product YAZ

Duration

Manufacturer BAYER

6855356 Date FDA Received
16-Feb-2009

Case # 6855356

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200840590NA

Age 35 YR

Sex Female

Country USA

Preferred Term FATIGUE Abnormal withdrawal bleeding MENTAL STATUS CHANGES

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration 10 DAY

Manufacturer BAYER

6855366 Date FDA Received
16-Feb-2009

Case # 6855366

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200840766NA

Age 50 YR

Sex Female

Country USA

Preferred Term PAIN IN EXTREMITY

Product YAZ LEVOXYL CYTOMEL

Role Route S C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 42 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6885980 Date FDA Received
16-Feb-2009 Case # 6885980 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841245NA Role Route S ORAL Dosage Text Age 41 YR Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding ABDOMINAL PAIN ANGER ENDOMETRIOSIS IRRITABILITY MOOD ALTERED PREMENSTRUAL SYNDROME

Product YAZ

Duration 3 MTH

Manufacturer BAYER

6910314 Date FDA Received
16-Feb-2009

Case # 6910314

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910960NA

Age

Sex Female

Country USA

Preferred Term GASTROENTERITIS VIRAL DIARRHOEA MALAISE METRORRHAGIA NO ADVERSE EVENT VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6910321 Date FDA Received
16-Feb-2009

Case # 6910321

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911262NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 43 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6910329 Date FDA Received
16-Feb-2009 Case # 6910329 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200911222NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term FATIGUE NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6910330 Date FDA Received
16-Feb-2009

Case # 6910330

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911215NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6910353 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6910353 Date FDA Received
16-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200911386NA

Age 17 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6910362 Date FDA Received
16-Feb-2009

Case # 6910362

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911310NA

Age

Sex Female

Country USA

Preferred Term MALAISE NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 44 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6910364 Date FDA Received
16-Feb-2009 Case # 6910364 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200911383NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA MENORRHAGIA

Product YAZ

Manufacturer BAYER

6910365 Date FDA Received
16-Feb-2009

Case # 6910365

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911390NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6649393 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6649393 Date FDA Received
17-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200823015NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6800998 Date FDA Received
17-Feb-2009

Case # 6800998

Case Type EXPEDITED (15-DAY)

Outcomes HO,OT

Manufacturer Control # USBAYER-200836980NA Dosage Text Total daily dose: 1 DF Total daily dose: 1 DF

Age 49 YR

Sex Female

Country USA

Preferred Term UTERINE LEIOMYOMA VAGINAL HAEMORRHAGE

Product YAZ YAZ

Role Route S S ORAL ORAL

Duration 1.92 YEAR

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 45 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6910862 Date FDA Received
17-Feb-2009 Case # 6910862 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # BRBAYER-200912185LA Dosage Text Age 30 YR Sex Female Country BRA

Preferred Term NAUSEA HEADACHE PHOTOPHOBIA BREAST SWELLING MALAISE SOMNOLENCE WEIGHT INCREASED

Product YASMIN YASMIN YAZ

Role Route S S S ORAL ORAL ORAL

Duration 3 YEAR 1 YEAR

Manufacturer BAYER BAYER BAYER

6920831 Date FDA Received
17-Feb-2009 Preferred Term

Case # 6920831

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text I PILL DAILY PO

Duration

Manufacturer

DEAFNESS NEUROSENSORY DYSPHONIA EAR DISCOMFORT TINNITUS

6921444 Date FDA Received
17-Feb-2009 Preferred Term ANXIETY

Case # 6921444

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 32 YR

Sex Female

Country USA

Dosage Text 24 ACTIVE 4 NON ACTIVE PILLS 1 A DAY FOR 28 DAY PO

Duration 6 MTH

Manufacturer BAYER

DEPRESSION IMPAIRED WORK ABILITY

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 46 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6923882 Date FDA Received
18-Feb-2009 Preferred Term PALPITATIONS Case # 6923882 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 28 DAY PACK DAILY PO 3/08 EKG 3/08 ULTRA SOUND Manufacturer Control # Age 33 YR Duration Sex Female Country USA

Manufacturer

FEAR ADVERSE DRUG REACTION EXTRASYSTOLES SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE

6913273 Date FDA Received
19-Feb-2009

Case # 6913273

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911498NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6913276 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6913276 Date FDA Received
19-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200911377NA

Age 19 YR

Sex Female

Country USA

Preferred Term DEPRESSION NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6765537 Date FDA Received
20-Feb-2009

Case # 6765537

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200832032NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 47 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6876973 Date FDA Received
20-Feb-2009 Case # 6876973 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # USBAYER-200910264NA Dosage Text Age 28 YR Sex Female Country USA

Preferred Term ECTOPIC PREGNANCY PAIN VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6914378 Date FDA Received
20-Feb-2009

Case # 6914378

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911369NA

Age 19 YR

Sex Female

Country USA

Preferred Term ACNE NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6914385 Date FDA Received
20-Feb-2009

Case # 6914385

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911366NA

Age 30 YR

Sex Female

Country USA

Preferred Term PALPITATIONS

Product YAZ Case # 6914397 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6914397 Date FDA Received
20-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200911371NA

Age 33 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA MENSTRUATION DELAYED NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 48 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924472 Date FDA Received
20-Feb-2009 Preferred Term WEIGHT DECREASED ANXIETY APATHY BLOOD PRESSURE INCREASED BLOOD THYROID STIMULATING HORMONE INCREASED DIZZINESS DRUG LEVEL DECREASED HEADACHE INSOMNIA Case # 6924472 Case Type DIRECT Product YAZ Health Professional Y Outcomes OT Role Route S ORAL Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer BAYER

6926851 Date FDA Received
23-Feb-2009 Preferred Term DIZZINESS EPISTAXIS HEADACHE

Case # 6926851

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 28 TABLETS 1X/DAY PO

Duration

Manufacturer

LOSS OF CONSCIOUSNESS MOUTH HAEMORRHAGE NECK PAIN PREMENSTRUAL SYNDROME TOOTH DISORDER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 49 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6928537 Date FDA Received
23-Feb-2009 Preferred Term FUNGAL INFECTION HEADACHE HERPES VIRUS INFECTION METRORRHAGIA MOOD SWINGS NAUSEA STRESS Case # 6928537 Case Type DIRECT Product YAZ Health Professional N Role Route S ORAL Dosage Text 3MG / 0.02 MG 1X DIALY PO Outcomes Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer BAYER

6930550 Date FDA Received
23-Feb-2009 Preferred Term WEIGHT DECREASED

Case # 6930550

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text ONE TABLET DAILY PO

Duration

Manufacturer BAYER

VITAMIN B12 DEFICIENCY

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 50 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6930580 Date FDA Received
23-Feb-2009 Preferred Term PANIC ATTACK Case # 6930580 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 3MG DROSPIRENONE 20MCG ETHINYL 1 PER DAY PO Manufacturer Control # Age 29 YR Duration Sex Female Country USA

Manufacturer

ANXIETY DECREASED APPETITE DEPRESSION EAR DISORDER FEAR IMPAIRED WORK ABILITY INSOMNIA NERVOUSNESS TACHYCARDIA

6916573 Date FDA Received
24-Feb-2009

Case # 6916573

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911600NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ YAZ

Role Route S S Health Professional N ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

6916575 Date FDA Received
24-Feb-2009

Case # 6916575

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200911429NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 51 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6916576 Date FDA Received
24-Feb-2009 Case # 6916576 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200911607NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200911608NA Role Route S C Outcomes Manufacturer Control # USBAYER-200911602NA Role Route S ORAL Dosage Text Age 18 YR Sex Female Country USA ORAL Dosage Text Age 25 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6916577 Date FDA Received
24-Feb-2009

Case # 6916577

Outcomes

Preferred Term BREAST DISCHARGE

Product YAZ SLIMQUICK (DIET SUPPLEMENT)

Duration

Manufacturer BAYER

6916578 Date FDA Received
24-Feb-2009

Case # 6916578

Case Type NON-EXPEDITED

Health Professional N

Preferred Term Abnormal withdrawal bleeding NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6916579 Date FDA Received
24-Feb-2009

Case # 6916579

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911610NA

Age 17 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6916580 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6916580 Date FDA Received
24-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200911601NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 52 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6916581 Date FDA Received
24-Feb-2009 Case # 6916581 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200911605NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200911589NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term WEIGHT DECREASED

Product YAZ Case # 6916583 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6916583 Date FDA Received
24-Feb-2009

Outcomes

Preferred Term METRORRHAGIA MENSTRUAL DISORDER

Product YAZ

Manufacturer BAYER

6916589 Date FDA Received
24-Feb-2009

Case # 6916589

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911426NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ YAZ

Role Route S S Health Professional N ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

6916598 Date FDA Received
24-Feb-2009

Case # 6916598

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200911777NA

Age 28 YR

Sex Female

Country USA

Preferred Term BREAST ENLARGEMENT BREAST PAIN WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 53 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6916614 Date FDA Received
24-Feb-2009 Case # 6916614 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200911835NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200911822NA Role Route S S ORAL ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6916617 Date FDA Received
24-Feb-2009

Case # 6916617

Outcomes

Preferred Term AMENORRHOEA METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ YAZ

Manufacturer BAYER BAYER

6916639 Date FDA Received
24-Feb-2009

Case # 6916639

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911832NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6916653 Date FDA Received
24-Feb-2009

Case # 6916653

Outcomes

Manufacturer Control # USBAYER-200912052NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED MENORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 54 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6916664 Date FDA Received
24-Feb-2009 Case # 6916664 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913258NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term BREAST TENDERNESS ABDOMINAL PAIN LOWER Abnormal withdrawal bleeding

Product YAZ

Manufacturer BAYER

6930605 Date FDA Received
24-Feb-2009 Preferred Term

Case # 6930605

Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO, SEVERAL YEARS Manufacturer Control #

Duration

Manufacturer

PULMONARY EMBOLISM

6930956 Date FDA Received
24-Feb-2009 Preferred Term PAIN IN EXTREMITY OEDEMA PERIPHERAL

Case # 6930956

Health Professional Y

Outcomes OT Role Route S ORAL

Age 29 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration

Manufacturer BAYER

6859042 Date FDA Received
25-Feb-2009

Case # 6859042

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200840961NA Dosage Text

Age 22 YR

Sex Female

Country USA

Preferred Term APHASIA FATIGUE HEADACHE VISION BLURRED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 55 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6919563 Date FDA Received
25-Feb-2009 Preferred Term URTICARIA Case # 6919563 Case Type NON-EXPEDITED Product VALTREX YAZ Health Professional N Role Route S S Health Professional N Product YAZ ORAL ORAL Manufacturer Control # Age 15 YR Dosage Text 1 A DAY Duration Sex Female Country USA Outcomes Manufacturer Control # A0757440A Dosage Text 1G Per day Age 16 YR Duration 3 DAY Sex Female Country USA

Manufacturer GLAXOSMITHKLINE

6931349 Date FDA Received
25-Feb-2009 Preferred Term

Case # 6931349

Case Type DIRECT

Outcomes OT Role Route S

Manufacturer

ABDOMINAL DISTENSION DEPRESSION SUICIDAL IDEATION WEIGHT INCREASED

6935032 Date FDA Received
25-Feb-2009 Preferred Term

Case # 6935032

Case Type DIRECT Product YAZ Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text DAILY PO Manufacturer Control # USBAYER-200912088NA

Duration

Manufacturer BERLEX

PULMONARY EMBOLISM

6920737 Date FDA Received
26-Feb-2009

Case # 6920737

Health Professional N

Outcomes

Age 31 YR

Sex Female

Country USA

Preferred Term DEPRESSION MOOD ALTERED NERVOUSNESS

Product YAZ EFFEXOR

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 56 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6920746 Date FDA Received
26-Feb-2009 Case # 6920746 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200912072NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913247NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913250NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term HYPERSENSITIVITY

Product YAZ Case # 6920756 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6920756 Date FDA Received
26-Feb-2009

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 6920758 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6920758 Date FDA Received
26-Feb-2009

Outcomes

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION Abnormal withdrawal bleeding

Product YAZ

Manufacturer BAYER

6920759 Date FDA Received
26-Feb-2009

Case # 6920759

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913253NA

Age

Sex Female

Country USA

Preferred Term VISUAL IMPAIRMENT

Product YAZ Case # 6920760 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6920760 Date FDA Received
26-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200913246NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 57 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6932196 Date FDA Received
26-Feb-2009 Preferred Term THROMBOSIS Case # 6932196 Case Type DIRECT Product YAZ Case # 6700957 Case Type NON-EXPEDITED Health Professional N Health Professional N Outcomes HO,LT Role Route S Outcomes Manufacturer Control # USBAYER-200827283NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200834101NA Dosage Text Dosage Text Duration 5 MTH Age 27 YR Sex Female Dosage Text Manufacturer Control # Age 40 YR Duration 11 MTH Age Sex Female Country USA Sex Female Country USA

Manufacturer

6700957 Date FDA Received
27-Feb-2009

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Manufacturer BAYER Country USA

6791275 Date FDA Received
27-Feb-2009

Case # 6791275

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term MENORRHAGIA CRYING DEPRESSED MOOD DEPRESSION FATIGUE INSOMNIA IRRITABILITY MALAISE MIGRAINE SUICIDAL IDEATION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 58 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6922561 Date FDA Received
27-Feb-2009 Preferred Term MENSTRUATION IRREGULAR MOOD SWINGS PAIN IN EXTREMITY Case # 6922561 Case Type NON-EXPEDITED Product LAMICTAL YAZ EFFEXOR XR Case # 6923171 Case Type EXPEDITED (15-DAY) Health Professional Y Health Professional N Role Route S S C Outcomes HO,OT Manufacturer Control # RSBAYER-200914455GPV Dosage Text Age 33 YR Sex Female Country RS ORAL ORAL Outcomes Manufacturer Control # A0737956A Dosage Text 100MG Per day 1TAB Per day Age 36 YR Duration Sex Female Country USA

Manufacturer GLAXOSMITHKLINE

6923171 Date FDA Received
27-Feb-2009

Preferred Term METRORRHAGIA

Product YAZ Case # 6923222 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration 1 MTH

Manufacturer BAYER Sex Female Country USA

6923222 Date FDA Received
27-Feb-2009

Outcomes

Manufacturer Control # USBAYER-200912116NA

Age 16 YR

Preferred Term HEADACHE ABDOMINAL PAIN UPPER FATIGUE HYPOPHAGIA NAUSEA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6923229 Date FDA Received
27-Feb-2009

Case # 6923229

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912122NA

Age 29 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA MENSTRUATION IRREGULAR

Product YAZ ORTHO TRI CYCLEN

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 59 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6923241 Date FDA Received
27-Feb-2009 Case # 6923241 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913318NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913270NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913301NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term CRYING

Product YAZ Case # 6923245 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6923245 Date FDA Received
27-Feb-2009

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 6923250 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6923250 Date FDA Received
27-Feb-2009

Outcomes

Preferred Term WITHDRAWAL BLEED INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Manufacturer BAYER

6836077 Date FDA Received
02-Mar-2009

Case # 6836077

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200838327NA

Age 31 YR

Sex Female

Country USA

Preferred Term DEPRESSION AMENORRHOEA BREAST PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration 2 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 60 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6869132 Date FDA Received
02-Mar-2009 Case # 6869132 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200841556NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200841478NA Role Route S ORAL Dosage Text Dosage Text Age 37 YR Sex Female Country USA

Preferred Term C-REACTIVE PROTEIN INCREASED

Product YAZ Case Type NON-EXPEDITED

Duration 4 YEAR Age 29 YR Sex

Manufacturer BAYER Country USA

6886006 Date FDA Received
02-Mar-2009

Case # 6886006

Outcomes

Female

Preferred Term PAIN IN EXTREMITY CONTUSION NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6924671 Date FDA Received
02-Mar-2009

Case # 6924671

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912256NA

Age

Sex Female

Country USA

Preferred Term BREAST ENGORGEMENT Abnormal withdrawal bleeding METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6924686 Date FDA Received
02-Mar-2009

Case # 6924686

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912347NA

Age 23 YR

Sex Female

Country USA

Preferred Term MOOD ALTERED ACNE ANGER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 61 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924688 Date FDA Received
02-Mar-2009 Case # 6924688 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912259NA Role Route S S ORAL ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term INFLUENZA VOMITING DIARRHOEA

Product YAZ YAZ

Manufacturer BAYER BAYER

6924690 Date FDA Received
02-Mar-2009

Case # 6924690

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912320NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6924693 Date FDA Received
02-Mar-2009

Case # 6924693

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912342NA

Age 22 YR

Sex Female

Country USA

Preferred Term MOOD SWINGS

Product YAZ Case # 6924696 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6924696 Date FDA Received
02-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200912291NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6924697 Date FDA Received
02-Mar-2009

Case # 6924697

Outcomes

Manufacturer Control # USBAYER-200912298NA

Age 43 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 62 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924699 Date FDA Received
02-Mar-2009 Case # 6924699 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912263NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912293NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912334NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912261NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912309NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6924700 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924700 Date FDA Received
02-Mar-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6924701 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924701 Date FDA Received
02-Mar-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6924702 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924702 Date FDA Received
02-Mar-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6924709 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924709 Date FDA Received
02-Mar-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 63 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924729 Date FDA Received
02-Mar-2009 Case # 6924729 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912491NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912492NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913261NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913263NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913278NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL PAIN LOWER

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924733 Date FDA Received
02-Mar-2009

Case # 6924733

Outcomes

Preferred Term ABDOMINAL PAIN LOWER

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924740 Date FDA Received
02-Mar-2009

Case # 6924740

Outcomes

Preferred Term HOT FLUSH

Product YAZ Case # 6924741 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924741 Date FDA Received
02-Mar-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6924743 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924743 Date FDA Received
02-Mar-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 64 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924751 Date FDA Received
02-Mar-2009 Case # 6924751 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913266NA Role Route S Health Professional N Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N ORAL Manufacturer Control # Age 14 YR Dosage Text 3 MG DAILY PO Manufacturer Control # USBAYER-200840959NA Dosage Text Duration 28 DAY Age 25 YR Sex Female Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ACNE

Product YAZ Case # 6933493 Case Type DIRECT

Manufacturer BAYER Country USA

6933493 Date FDA Received
02-Mar-2009 Preferred Term

Outcomes OT Role Route S ORAL

Manufacturer BAYER Country USA

PRODUCT QUALITY ISSUE

6859043 Date FDA Received
03-Mar-2009

Case # 6859043

Outcomes OT

Preferred Term ABASIA ARTHRALGIA MOBILITY DECREASED

Product YAZ LEVLITE LEVLITE Case # 6869219 Case Type NON-EXPEDITED Health Professional Y

Role Route S C C ORAL ORAL ORAL

Duration 7 DAY

Manufacturer BAYER

6869219 Date FDA Received
03-Mar-2009

Outcomes HO

Manufacturer Control # USBAYER-200841623NA Dosage Text

Age 32 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DYSPNOEA

Product YAZ ARMOUR THYROID LEXAPRO

Role Route S C C ORAL

Duration 86 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 65 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6934862 Date FDA Received
03-Mar-2009 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM Case # 6934862 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,LT Role Route S ORAL Dosage Text 1 PILL ONCE DAILY PO Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer

6935939 Date FDA Received
03-Mar-2009 Preferred Term

Case # 6935939

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S S C Outcomes ORAL ORAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text ONE PILL DAILY PO ONE PILL DAILT PO

Duration

Manufacturer WARNER CHILCOTT

PREMENSTRUAL SYNDROME ABNORMAL BEHAVIOUR CONDITION AGGRAVATED

LOESTRIN 24 FE LOESTRIN 24 FE Case Type DIRECT Product YAZ Health Professional Y

6936860 Date FDA Received
03-Mar-2009 Preferred Term

Case # 6936860

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 1 QD PO

Duration 8 MTH

Manufacturer

IRRITABLE BOWEL SYNDROME HYPERCHOLESTEROLAEMIA LYMPH NODE PAIN WEIGHT INCREASED

6941262 Date FDA Received
03-Mar-2009 Preferred Term

Case # 6941262

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,DS,LT,OT,RI Role Route S

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text PILL DAILY PO TWO AND A HALF MONTHS

Duration

Manufacturer

PELVIC VENOUS THROMBOSIS ACTIVITIES OF DAILY LIVING IMPAIRED

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 66 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924645 Date FDA Received
04-Mar-2009 Case # 6924645 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # AUBAYER-200914706GPV Dosage Text Age 23 YR Sex Female Country AUS

Preferred Term Syncope

Product YAZ Case # 6928263 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration 1 DAY

Manufacturer BAYER Sex Female Country USA

6928263 Date FDA Received
05-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200912265NA

Age

Preferred Term WEIGHT INCREASED

Product YAZ Case # 6928295 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6928295 Date FDA Received
05-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200912918NA

Age 33 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding OFF LABEL USE

Product YAZ ALEVE Case # 6942926 Case Type DIRECT Product YAZ Case Type NON-EXPEDITED Health Professional Y Health Professional N

Role Route S C Outcomes DS,LT,OT,RI Role Route S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER

6942926 Date FDA Received
05-Mar-2009 Preferred Term

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text 1 PILL Q DAY PO Manufacturer Control # USBAYER-200821796NA

Duration 6 MTH Age 25 YR Sex

Manufacturer BAYER Country USA

BREAST CANCER IN SITU

6640237 Date FDA Received
06-Mar-2009

Case # 6640237

Outcomes

Female

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE Chlamydia test positive Haemorrhage in pregnancy

Product YAZ

Role Route S ORAL

Dosage Text

Duration 264 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 67 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6673297 Date FDA Received
06-Mar-2009 Case # 6673297 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200823649NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200912820NA Role Route S C C Health Professional N Outcomes Manufacturer Control # USBAYER-200912778NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912785NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Dosage Text Age 27 YR Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration 2 YEAR Age 26 YR Sex

Manufacturer BAYER Country USA

6929348 Date FDA Received
06-Mar-2009

Case # 6929348

Case Type NON-EXPEDITED

Female

Preferred Term Abnormal withdrawal bleeding

Product YAZ BROGON VITAMINS

Duration

Manufacturer BAYER

6929351 Date FDA Received
06-Mar-2009

Case # 6929351

Case Type NON-EXPEDITED

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6929361 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6929361 Date FDA Received
06-Mar-2009

Outcomes

Preferred Term NAUSEA ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 68 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6765600 Date FDA Received
09-Mar-2009 Case # 6765600 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200832776NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA DIARRHOEA NASOPHARYNGITIS UPPER RESPIRATORY TRACT CONGESTION

Product YAZ

Manufacturer BAYER

6855325 Date FDA Received
09-Mar-2009

Case # 6855325

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200840448NA

Age 27 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ YAZ

Role Route S S Health Professional N ORAL ORAL

Dosage Text

Duration 5 WEEK

Manufacturer BAYER BAYER

6930794 Date FDA Received
09-Mar-2009

Case # 6930794

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200912982NA

Age 27 YR

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ Case # 6930795 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6930795 Date FDA Received
09-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200912971NA

Age 24 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA ACNE

Product YAZ CELEXA

Role Route S C ORAL

Dosage Text

Duration 2 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 69 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6930815 Date FDA Received
09-Mar-2009 Case # 6930815 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912866NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term MENORRHAGIA ACNE MOOD ALTERED

Product YAZ

Manufacturer BAYER

6930876 Date FDA Received
09-Mar-2009

Case # 6930876

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912972NA

Age 17 YR

Sex Female

Country USA

Preferred Term BREAST DISCHARGE

Product YAZ Case # 6942720 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6942720 Date FDA Received
09-Mar-2009 Preferred Term DEPRESSION IRRITABILITY MOOD SWINGS SUICIDAL IDEATION

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 48 YR

Sex Female

Country USA

Dosage Text DAILY PO

Duration

Manufacturer BAYER

6810355 Date FDA Received
10-Mar-2009

Case # 6810355

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200838060NA Dosage Text

Age 31 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT HEMIPARESIS MENSTRUATION IRREGULAR

Product YAZ PROVERA

Role Route S C ORAL ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 70 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6945743 Date FDA Received
10-Mar-2009 Preferred Term ABDOMINAL DISCOMFORT BREAST MASS BREAST PAIN CHILLS FATIGUE HEADACHE PAIN IN EXTREMITY THROMBOSIS Case # 6945743 Case Type DIRECT Product YAZ Health Professional N Outcomes LT,OT Role Route S ORAL Dosage Text 1 PILL DAILY PO WEEK Manufacturer Control # Age 28 YR Duration Sex Female Country USA

Manufacturer BAYER

6946569 Date FDA Received
10-Mar-2009 Preferred Term NAUSEA

Case # 6946569

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 1 TAB QD PO

Duration

Manufacturer BAYER

ABDOMINAL PAIN UPPER ARTHRALGIA BREAST PAIN BREAST SWELLING DISTURBANCE IN ATTENTION HEADACHE INCREASED APPETITE INSOMNIA MOOD SWINGS SINUS HEADACHE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 71 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6916678 Date FDA Received
11-Mar-2009 Case # 6916678 Case Type NON-EXPEDITED Health Professional N Outcomes HO Manufacturer Control # USBAYER-200913641NA Dosage Text Age 17 YR Sex Female Country USA

Preferred Term PULMONARY THROMBOSIS DYSPNOEA OVARIAN CYST DRUG INEFFECTIVE

Product YAZ DUAC ( CLINDAMYCIN/BENZOLY PEROXIDE TAZORAC MINOCYCLINE HYDROCHLORIDE Case # 6926103 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S C C C Outcomes OT ORAL

Duration

Manufacturer BAYER

Total daily dose: 200 MG Manufacturer Control # USBAYER-200913472NA Dosage Text Age 19 YR Sex Female Country USA

6926103 Date FDA Received
11-Mar-2009

Preferred Term SOMNOLENCE FATIGUE WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6933569 Date FDA Received
11-Mar-2009

Case # 6933569

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200914818NA Dosage Text

Age 33 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration 3 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 72 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6945473 Date FDA Received
11-Mar-2009 Preferred Term ASTHENIA ABDOMINAL DISCOMFORT AFFECT LABILITY ANGER ARTHRALGIA CHEST PAIN DEPRESSION DYSPEPSIA HAEMORRHAGE INFLUENZA INSOMNIA LACERATION METRORRHAGIA MOOD SWINGS MULTIPLE ALLERGIES NASOPHARYNGITIS NAUSEA NEGATIVISM NIGHT SWEATS PANIC ATTACK PERSONALITY CHANGE PHARYNGITIS STREPTOCOCCAL SELF INJURIOUS BEHAVIOUR SOCIAL AVOIDANT BEHAVIOUR SUICIDAL IDEATION THINKING ABNORMAL Case # 6945473 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S Dosage Text 1 TABLET DAILY 047 Manufacturer Control # Age 17 YR Duration Sex Female Country USA

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 73 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6876086 Date FDA Received
12-Mar-2009 Case # 6876086 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910049NA Role Route S ORAL Dosage Text Age 39 YR Sex Female Country USA

Preferred Term MOOD SWINGS ABDOMINAL DISTENSION ABDOMINAL PAIN LOWER ACNE BREAST PAIN DIZZINESS FATIGUE HEADACHE NAUSEA PAIN IN EXTREMITY VAGINAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

6933571 Date FDA Received
12-Mar-2009

Case # 6933571

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200814418LA Dosage Text

Age 31 YR

Sex Female

Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE PRE-ECLAMPSIA

Product YAZ CITALOPRAM HYDROBROMIDE BUPROPION LOSARTAN POTASSIUM PAROXETINE

Role Route S C C C C ORAL UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Duration 5 MTH

Manufacturer BAYER

6934948 Date FDA Received
12-Mar-2009

Case # 6934948

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913153NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 74 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6934956 Date FDA Received
12-Mar-2009 Case # 6934956 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913227NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913065NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200913229NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200913063NA Role Route S Health Professional Y Product YAZ ORAL Manufacturer Control # Age 26 YR Dosage Text Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 40 YR Sex Female Dosage Text Duration 2 YEAR Dosage Text Age 17 YR Sex Female Country USA

Preferred Term NAUSEA

Product YAZ Case # 6934959 Case Type NON-EXPEDITED

Duration 1 MTH Age Sex

Manufacturer BAYER Country USA

6934959 Date FDA Received
12-Mar-2009

Outcomes

Female

Preferred Term BREAST TENDERNESS ABDOMINAL DISTENSION

Product YAZ YAZ Case Type NON-EXPEDITED

Manufacturer BAYER BAYER Country USA

6934965 Date FDA Received
12-Mar-2009

Case # 6934965

Outcomes

Preferred Term BREAST TENDERNESS ABDOMINAL DISTENSION

Product YAZ YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER BAYER Country USA

6934966 Date FDA Received
12-Mar-2009

Case # 6934966

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6947706 Case Type DIRECT

Manufacturer BAYER Country USA

6947706 Date FDA Received
12-Mar-2009 Preferred Term DEPRESSION ANXIETY

Outcomes OT Role Route S

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 75 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6949532 Date FDA Received
12-Mar-2009 Preferred Term DYSPEPSIA ANXIETY DEFAECATION URGENCY DIARRHOEA ECONOMIC PROBLEM EMOTIONAL DISORDER IMPAIRED WORK ABILITY NAUSEA VOMITING WEIGHT DECREASED Case # 6949532 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text ONE PILL DAILY PO Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer

6795494 Date FDA Received
13-Mar-2009

Case # 6795494

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200834467NA

Age

Sex Female

Country USA

Preferred Term MUSCLE SPASMS BREAST PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6937106 Date FDA Received
13-Mar-2009

Case # 6937106

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913169NA

Age 23 YR

Sex Female

Country USA

Preferred Term HEADACHE Abnormal withdrawal bleeding WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 76 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6937112 Date FDA Received
13-Mar-2009 Case # 6937112 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913154NA Role Route S Health Professional N Product YAZ Case Type DIRECT Product YAZ Health Professional ORAL Manufacturer Control # Dosage Text Duration 5 WEEK Age 34 YR Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 32 YR Role Route S ORAL Dosage Text DAILY PO Duration Sex Female Country USA Duration Sex Female Age Sex Female Country USA

Preferred Term DEPRESSION

Product YAZ Case # 6946869 Case Type DIRECT

Manufacturer BAYER Country USA

6946869 Date FDA Received
13-Mar-2009 Preferred Term

Outcomes HO Role Route S ORAL

Manufacturer

PULMONARY THROMBOSIS

6947209 Date FDA Received
13-Mar-2009 Preferred Term HYPERTENSION

Case # 6947209

Outcomes LT

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 77 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6948639 Date FDA Received
13-Mar-2009 Preferred Term MUSCLE SPASMS ACTIVITIES OF DAILY LIVING IMPAIRED AGGRESSION ANXIETY CHEST PAIN CRYING DECREASED APPETITE DEPRESSION DISTURBANCE IN ATTENTION DIZZINESS DYSPEPSIA FEAR FEELINGS OF WORTHLESSNESS HEART RATE INCREASED IMPAIRED WORK ABILITY IRRITABILITY MEMORY IMPAIRMENT MOOD ALTERED PAIN SOCIAL AVOIDANT BEHAVIOUR SUICIDAL IDEATION Case # 6948639 Case Type DIRECT Product YAZ Health Professional N Role Route S BUCCAL Dosage Text 1 DAY BUCCAL CURRENT Outcomes Manufacturer Control # Age 33 YR Duration Sex Female Country USA

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 78 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6948653 Date FDA Received
13-Mar-2009 Preferred Term PANIC ATTACK HEART RATE IRREGULAR DIZZINESS HYPERHIDROSIS Case # 6948653 Case Type DIRECT Product YAZ PROPRANOLOL Health Professional N Outcomes LT,RI Role Route S C Dosage Text ONE PILL A DAY Manufacturer Control # Age 29 YR Duration Sex Female Country USA

Manufacturer BAYER

6949578 Date FDA Received
13-Mar-2009 Preferred Term IRRITABILITY ANGER MARITAL PROBLEM

Case # 6949578

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 22 YR

Sex Female

Country USA

Dosage Text ONE PILL DAILY PO

Duration

Manufacturer

6801001 Date FDA Received
16-Mar-2009

Case # 6801001

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200836744NA Dosage Text

Age 30 YR

Sex Female

Country USA

Preferred Term PANCREATITIS ABDOMINAL PAIN

Product YAZ

Role Route S ORAL

Duration 19 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 79 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6896636 Date FDA Received
16-Mar-2009 Case # 6896636 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200911940NA Role Route S ORAL Dosage Text Age 28 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER CHEST DISCOMFORT MALAISE RASH VOMITING

Product YAZ

Duration

Manufacturer BAYER

6902992 Date FDA Received
16-Mar-2009

Case # 6902992

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200912272NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PANCREATITIS

Product YAZ Case # 6941280 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

6941280 Date FDA Received
16-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200913221NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6941281 Date FDA Received
16-Mar-2009

Case # 6941281

Outcomes

Manufacturer Control # USBAYER-200913316NA

Age

Sex Female

Country USA

Preferred Term BREAST TENDERNESS ABDOMINAL PAIN LOWER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 80 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6941283 Date FDA Received
16-Mar-2009 Case # 6941283 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913189NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Duration Age Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE BREAST ENLARGEMENT

Product YAZ

Manufacturer BAYER

6941284 Date FDA Received
16-Mar-2009

Case # 6941284

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913225NA

Age 33 YR

Sex Female

Country USA

Preferred Term CONTACT LENS INTOLERANCE EYE IRRITATION OCULAR HYPERAEMIA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

6941286 Date FDA Received
16-Mar-2009

Case # 6941286

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913224NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration 8 MTH

Manufacturer BAYER Sex Female Country USA

6941287 Date FDA Received
16-Mar-2009

Case # 6941287

Outcomes

Manufacturer Control # USBAYER-200913348NA

Age

Preferred Term ACNE MALAISE NO ADVERSE EVENT STRESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 81 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6941288 Date FDA Received
16-Mar-2009 Case # 6941288 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913346NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term MYALGIA Abdominal discomfort ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

6941289 Date FDA Received
16-Mar-2009

Case # 6941289

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913344NA

Age 22 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6941291 Date FDA Received
16-Mar-2009

Case # 6941291

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913380NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ Case # 6941294 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6941294 Date FDA Received
16-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200913337NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 82 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6941296 Date FDA Received
16-Mar-2009 Case # 6941296 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913336NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

6941313 Date FDA Received
16-Mar-2009

Case # 6941313

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200913233LA Dosage Text

Age 40 YR

Sex Female

Country BRA

Preferred Term BLOOD PRESSURE INCREASED ABORTION SPONTANEOUS NO ADVERSE EVENT

Product YAZ YAZ

Role Route S S ORAL ORAL

Duration 10 DAY

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 83 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6942632 Date FDA Received
17-Mar-2009 Case # 6942632 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # BRBAYER-200815239LA Dosage Text Age 27 YR Sex Female Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE AMENORRHOEA CAESAREAN SECTION FATIGUE GASTRIC DISORDER GASTRITIS BACTERIAL HEADACHE HORMONE LEVEL ABNORMAL MATERNAL EXPOSURE DURING PREGNANCY MIGRAINE PAIN PRE-ECLAMPSIA PREMATURE LABOUR SWELLING VOMITING VOMITING IN PREGNANCY

Product YAZ

Role Route S ORAL

Duration 1 YEAR

Manufacturer BAYER

7603030 Date FDA Received
17-Mar-2009

Case # 7603030

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # JPBAYER-200910352BYL Dosage Text Total daily dose: 1 DF

Age 37 YR

Sex Female

Country JPN

Preferred Term VIIth nerve paralysis

Product YAZ

Role Route S ORAL

Duration 331 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 84 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6942643 Date FDA Received
18-Mar-2009 Case # 6942643 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # BRBAYER-200913123LA Dosage Text Age Sex Country BRA < 1 DAY Female

Preferred Term PREMATURE BABY SMALL FOR DATES BABY

Product YAZ

Role Route S TRANSPLACENTAL

Duration

Manufacturer BAYER

6945377 Date FDA Received
19-Mar-2009

Case # 6945377

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes DS,OT

Manufacturer Control # BRBAYER-200913413LA Dosage Text

Age

Sex Female

Country BRA

Preferred Term EYE HAEMORRHAGE BLINDNESS UNILATERAL

Product YASMIN YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S S ORAL ORAL

Duration

Manufacturer BAYER BAYER

6953655 Date FDA Received
19-Mar-2009 Preferred Term ANXIETY MIGRAINE WITH AURA SLEEP DISORDER VISUAL IMPAIRMENT

Case # 6953655

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer

6946678 Date FDA Received
20-Mar-2009

Case # 6946678

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913554NA

Age

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 85 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6946680 Date FDA Received
20-Mar-2009 Case # 6946680 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913555NA Role Route S C Outcomes Manufacturer Control # USBAYER-200913551NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913475NA Role Route S S ORAL ORAL Dosage Text Duration Age Sex Female Dosage Text Age 21 YR Sex Female Country USA ORAL Dosage Text Age 15 YR Sex Female Country USA

Preferred Term NAUSEA VOMITING

Product YAZ MINOCYCLINE HYDROCHLORIDE Case # 6946681 Case Type NON-EXPEDITED Health Professional N

Duration

Manufacturer BAYER

6946681 Date FDA Received
20-Mar-2009

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6946682 Date FDA Received
20-Mar-2009

Case # 6946682

Outcomes

Preferred Term NAUSEA VOMITING NO ADVERSE EVENT

Product YAZ YAZ

Manufacturer BAYER BAYER

6946684 Date FDA Received
20-Mar-2009

Case # 6946684

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913476NA

Age 28 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN UPPER NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 86 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6946685 Date FDA Received
20-Mar-2009 Case # 6946685 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913651NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913558NA Role Route S ORAL Dosage Text Age 41 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 6946686 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6946686 Date FDA Received
20-Mar-2009

Outcomes

Preferred Term METRORRHAGIA NAUSEA

Product YAZ

Duration

Manufacturer BAYER

6946687 Date FDA Received
20-Mar-2009

Case # 6946687

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913548NA

Age 22 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6946688 Date FDA Received
20-Mar-2009

Case # 6946688

Outcomes

Manufacturer Control # USBAYER-200913496NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6946690 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6946690 Date FDA Received
20-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200913440NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 87 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6946692 Date FDA Received
20-Mar-2009 Case # 6946692 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913442NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913484NA Role Route S C Outcomes Manufacturer Control # USBAYER-200913495NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913445NA Role Route S C Outcomes Manufacturer Control # USBAYER-200913439NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Dosage Text Age 36 YR Sex Female Country USA ORAL Dosage Text Age 19 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term HEADACHE

Product YAZ Case # 6946693 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6946693 Date FDA Received
20-Mar-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ AMOXICILLIN

Duration

Manufacturer BAYER

6946695 Date FDA Received
20-Mar-2009

Case # 6946695

Case Type NON-EXPEDITED

Health Professional N

Preferred Term METRORRHAGIA

Product YAZ Case # 6946696 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6946696 Date FDA Received
20-Mar-2009

Outcomes

Preferred Term WITHDRAWAL BLEED

Product YAZ UNSPECIFIED INGREDIENT

Manufacturer BAYER

6946697 Date FDA Received
20-Mar-2009

Case # 6946697

Case Type NON-EXPEDITED

Health Professional N

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 88 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6957347 Date FDA Received
20-Mar-2009 Preferred Term PULMONARY EMBOLISM Case # 6957347 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO Role Route S ORAL Dosage Text 24 ACTIVE TABLETS AND 4 INACTI 1 TABLET PER DAY PO Manufacturer Control # USBAYER-200913756NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913708NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913686NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer BERLEX

6948314 Date FDA Received
23-Mar-2009

Case # 6948314

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6948316 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6948316 Date FDA Received
23-Mar-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6948317 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6948317 Date FDA Received
23-Mar-2009

Outcomes

Preferred Term MENORRHAGIA DECREASED APPETITE

Product YAZ

Manufacturer BAYER

6948318 Date FDA Received
23-Mar-2009

Case # 6948318

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913839NA

Age 32 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 89 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6948320 Date FDA Received
23-Mar-2009 Case # 6948320 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913800NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913754NA Role Route S C C Health Professional N Outcomes Manufacturer Control # USBAYER-200913791NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913844NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 38 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term OLIGOMENORRHOEA

Product YAZ Case # 6948323 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6948323 Date FDA Received
23-Mar-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding NO ADVERSE EVENT

Product YAZ TYLENOL ALEVE

Duration

Manufacturer BAYER

6948327 Date FDA Received
23-Mar-2009

Case # 6948327

Case Type NON-EXPEDITED

Preferred Term METRORRHAGIA

Product YAZ Case # 6948328 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6948328 Date FDA Received
23-Mar-2009

Outcomes

Preferred Term DRUG DOSE OMISSION GASTROENTERITIS VIRAL

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 90 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6948329 Date FDA Received
23-Mar-2009 Case # 6948329 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913838NA Role Route S C Outcomes Manufacturer Control # USBAYER-200914158NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200913846NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 20 YR Sex Female Country USA

Preferred Term METRORRHAGIA VULVOVAGINAL MYCOTIC INFECTION

Product YAZ VITAMINS NOS Case Type NON-EXPEDITED Health Professional N

Duration

Manufacturer BAYER

6948330 Date FDA Received
23-Mar-2009

Case # 6948330

Preferred Term ADVERSE DRUG REACTION

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6948334 Date FDA Received
23-Mar-2009

Case # 6948334

Outcomes

Preferred Term HEADACHE ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 91 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6955722 Date FDA Received
23-Mar-2009 Preferred Term CHEST PAIN ANGER ANXIETY DEPRESSION DYSPNOEA FATIGUE IRRITABILITY LOSS OF LIBIDO MOOD ALTERED NAUSEA PALPITATIONS SUICIDAL IDEATION Case # 6955722 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,OT Role Route S ORAL Dosage Text 3MG/0.02MG 1 TABLET/DAY PO Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer BAYER

6955943 Date FDA Received
23-Mar-2009 Preferred Term MANIA PANIC ATTACK

Case # 6955943

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text 1 DAILY PO

Duration

Manufacturer BAYER

6950776 Date FDA Received
25-Mar-2009

Case # 6950776

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200913478LA Dosage Text

Age

Sex

Country BRA

< 1 DAY Male

Preferred Term ARRHYTHMIA

Product YAZ

Role Route S TRANSPLACENTAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 92 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6950777 Date FDA Received
25-Mar-2009 Case # 6950777 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200915855NA Dosage Text Age 18 YR Sex Female Country USA

Preferred Term DEPRESSION DECREASED APPETITE PARANOIA SUICIDAL IDEATION TREMOR

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6958090 Date FDA Received
25-Mar-2009 Preferred Term ABDOMINAL PAIN CRYING DEPRESSION EAR PAIN HEADACHE

Case # 6958090

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 28 TABLETS ONCE NIGHTLY PO

Duration

Manufacturer BAYER

INAPPROPRIATE AFFECT MUSCLE SPASMS PARAESTHESIA

6887558 Date FDA Received
26-Mar-2009

Case # 6887558

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200911133NA Dosage Text 1 TAB/DAY

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 93 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924679 Date FDA Received
26-Mar-2009 Case # 6924679 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912137NA Role Route S Health Professional Y ORAL Manufacturer Control # CABAYER-200915666NA Dosage Text Age 22 YR Sex Female Dosage Text Age 22 YR Sex Female Country USA

Preferred Term ACNE

Product YAZ Case # 6949392 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer BAYER Country CAN

6949392 Date FDA Received
26-Mar-2009

Outcomes HO,OT

Preferred Term SYNCOPE HEPATIC ENZYME INCREASED HEPATIC STEATOSIS MALAISE NASOPHARYNGITIS PALLOR

Product YAZ

Role Route S ORAL

Duration 30 DAY

Manufacturer BAYER

6952494 Date FDA Received
26-Mar-2009

Case # 6952494

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913588NA

Age 45 YR

Sex Female

Country USA

Preferred Term WEIGHT DECREASED HOT FLUSH MOOD SWINGS NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 94 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6952506 Date FDA Received
26-Mar-2009 Case # 6952506 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913760NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA BACK PAIN BREAST TENDERNESS

Product YAZ

Manufacturer BAYER

6952526 Date FDA Received
26-Mar-2009

Case # 6952526

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913594NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6952535 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6952535 Date FDA Received
26-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200913821NA

Age 18 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6952538 Date FDA Received
26-Mar-2009

Case # 6952538

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913928NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 95 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6952540 Date FDA Received
26-Mar-2009 Case # 6952540 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913836NA Role Route S ORAL Dosage Text Age 14 YR Sex Female Country USA

Preferred Term DIARRHOEA ABDOMINAL PAIN LOWER METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6952544 Date FDA Received
26-Mar-2009

Case # 6952544

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914002NA

Age 19 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA DIARRHOEA GASTROENTERITIS VIRAL VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6952551 Date FDA Received
26-Mar-2009

Case # 6952551

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914074NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6952556 Date FDA Received
26-Mar-2009

Case # 6952556

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914180NA

Age 21 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 96 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6952557 Date FDA Received
26-Mar-2009 Case # 6952557 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913999NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914098NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914100NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914094NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914176NA Role Route S ORAL Dosage Text Age 32 YR Sex Female Dosage Text Age 26 YR Sex Female Dosage Text Age 22 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6952561 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6952561 Date FDA Received
26-Mar-2009

Outcomes

Preferred Term INFECTION

Product YAZ Case # 6952564 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6952564 Date FDA Received
26-Mar-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6952570 Date FDA Received
26-Mar-2009

Case # 6952570

Outcomes

Preferred Term VULVOVAGINAL MYCOTIC INFECTION

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6952574 Date FDA Received
26-Mar-2009

Case # 6952574

Outcomes

Preferred Term MENORRHAGIA

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 97 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6952575 Date FDA Received
26-Mar-2009 Case # 6952575 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914075NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Manufacturer BAYER

6952761 Date FDA Received
26-Mar-2009

Case # 6952761

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # USBAYER-200910920NA Dosage Text DOUBLE BLIND STUDY

Age 46 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS PAIN IN EXTREMITY OEDEMA PERIPHERAL HIP FRACTURE

Product YAZ RAMIPRIL ALISKIREN

Role Route S S S ORAL ORAL ORAL

Duration 38 DAY 38 DAY

Manufacturer BAYER

6804771 Date FDA Received
27-Mar-2009

Case # 6804771

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200835432NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA VOMITING WITHDRAWAL BLEED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6895329 Date FDA Received
27-Mar-2009

Case # 6895329

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200911583NA Dosage Text

Age 33 YR

Sex Female

Country USA

Preferred Term PORTAL VEIN THROMBOSIS

Product YAZ

Role Route S ORAL

Duration 1 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 98 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6954356 Date FDA Received
27-Mar-2009 Case # 6954356 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914008NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914228NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914296NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914281NA Role Route S C Outcomes Manufacturer Control # USBAYER-200914300NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Dosage Text Age 20 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 6954388 Case Type NON-EXPEDITED

Duration 12 MTH Age 43 YR Sex

Manufacturer BAYER Country USA

6954388 Date FDA Received
27-Mar-2009

Outcomes

Female

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6954390 Date FDA Received
27-Mar-2009

Case # 6954390

Outcomes

Preferred Term BREAST TENDERNESS

Product YAZ Case # 6954392 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6954392 Date FDA Received
27-Mar-2009

Outcomes

Preferred Term ABDOMINAL PAIN LOWER METRORRHAGIA

Product YAZ ANTIEPILEPTIC NOS Case # 6954393 Case Type NON-EXPEDITED Health Professional N

Manufacturer BAYER

6954393 Date FDA Received
27-Mar-2009

Preferred Term CRYING

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 99 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6954404 Date FDA Received
27-Mar-2009 Case # 6954404 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914207NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

6954405 Date FDA Received
27-Mar-2009

Case # 6954405

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200914246NA

Age

Sex Female

Country USA

Preferred Term ACNE HIRSUTISM

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6954407 Date FDA Received
27-Mar-2009

Case # 6954407

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914076NA

Age 46 YR

Sex Female

Country USA

Preferred Term OLIGOMENORRHOEA MENSTRUAL DISORDER

Product YAZ SYNTHROID Case Type NON-EXPEDITED Health Professional N

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

6954408 Date FDA Received
27-Mar-2009

Case # 6954408

Manufacturer Control # USBAYER-200914151NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6961411 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6961411 Date FDA Received
27-Mar-2009 Preferred Term

Outcomes LT Role Route S ORAL

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 100 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6923246 Date FDA Received
30-Mar-2009 Case # 6923246 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913260NA Role Route S C ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term IRRITABILITY NERVOUSNESS ANGER MENTAL STATUS CHANGES NEGATIVE THOUGHTS

Product YAZ SULODEXIDE

Manufacturer BAYER

6924674 Date FDA Received
30-Mar-2009

Case # 6924674

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200912254NA

Age 35 YR

Sex Female

Country USA

Preferred Term ACNE Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6955337 Date FDA Received
30-Mar-2009

Case # 6955337

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914391NA

Age

Sex Female

Country USA

Preferred Term FOOD POISONING NO ADVERSE EVENT VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6955338 Date FDA Received
30-Mar-2009

Case # 6955338

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914248NA

Age 36 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA BRONCHITIS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 101 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6955340 Date FDA Received
30-Mar-2009 Case # 6955340 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914282NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914412NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914287NA Role Route S C Outcomes Manufacturer Control # USBAYER-200914616NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914253NA Role Route S C C ORAL Unit dose: 400 MG Unit dose: 50 MG Dosage Text Age 48 YR Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 19 YR Sex Female Dosage Text Age 35 YR Sex Female Dosage Text Age 22 YR Sex Female Country USA

Preferred Term ACNE

Product YAZ Case # 6955341 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6955341 Date FDA Received
30-Mar-2009

Outcomes

Preferred Term CHLOASMA

Product YAZ Case # 6955342 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6955342 Date FDA Received
30-Mar-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ WELLBUTRIN

Duration

Manufacturer BAYER

6955344 Date FDA Received
30-Mar-2009

Case # 6955344

Case Type NON-EXPEDITED

Health Professional N

Preferred Term ABDOMINAL PAIN LOWER

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6955345 Date FDA Received
30-Mar-2009

Case # 6955345

Outcomes

Preferred Term MUSCLE SPASMS

Product YAZ ASCORBIC ACID TOPROL XL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 102 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6955350 Date FDA Received
30-Mar-2009 Case # 6955350 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914565NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914459NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914613NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200914511NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914570NA Role Route S ORAL Dosage Text Age 21 YR Sex Female Dosage Text Age 22 YR Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NASOPHARYNGITIS

Product YAZ Case # 6955352 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6955352 Date FDA Received
30-Mar-2009

Outcomes

Preferred Term INJURY

Product YAZ Case # 6955354 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6955354 Date FDA Received
30-Mar-2009

Outcomes

Preferred Term ARTHRITIS

Product YAZ NAPROSYN

Manufacturer BAYER

6955355 Date FDA Received
30-Mar-2009

Case # 6955355

Case Type NON-EXPEDITED

Preferred Term METRORRHAGIA

Product YAZ Case # 6955358 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6955358 Date FDA Received
30-Mar-2009

Outcomes

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 103 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6955359 Date FDA Received
30-Mar-2009 Case # 6955359 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914610NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6955360 Date FDA Received
30-Mar-2009

Case # 6955360

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914543NA

Age 29 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding AMENORRHOEA

Product YAZ MIRENA ADVIL

Role Route S S C Health Professional N Outcomes ORAL INTRAUTERINE

Dosage Text CONTINUOUS DELIVERY

Duration

Manufacturer BAYER BAYER

6955361 Date FDA Received
30-Mar-2009

Case # 6955361

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200914608NA

Age

Sex Female

Country USA

Preferred Term TOOTHACHE

Product YAZ Case # 6955362 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6955362 Date FDA Received
30-Mar-2009

Outcomes

Manufacturer Control # USBAYER-200914458NA

Age

Sex Female

Country USA

Preferred Term INJURY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 104 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6955366 Date FDA Received
30-Mar-2009 Case # 6955366 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914572NA Role Route S S ORAL ORAL Dosage Text Age 21 YR Sex Female Country USA

Preferred Term WEIGHT INCREASED MENORRHAGIA ABDOMINAL PAIN LOWER

Product YAZ YAZ

Duration

Manufacturer BAYER BAYER

6895330 Date FDA Received
31-Mar-2009

Case # 6895330

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200911952NA Dosage Text As used: 1 DF Manufacturer Control # USBAYER-200914557NA

Age 15 YR

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 6956430 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration 5 MTH Age 36 YR Sex

Manufacturer BAYER Country USA

6956430 Date FDA Received
31-Mar-2009

Outcomes

Female

Preferred Term INFLUENZA LIKE ILLNESS NAUSEA DEPRESSED MOOD VOMITING

Product YAZ YASMIN

Role Route S S ORAL ORAL

Dosage Text Total daily dose: 1 DF

Duration 4 MTH

Manufacturer BAYER BAYER

6956432 Date FDA Received
31-Mar-2009

Case # 6956432

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914425NA

Age 42 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ YAZ CIPROFLOXACIN HYDROCHLORIDE

Role Route S S C ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

4 DAY

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 105 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6961555 Date FDA Received
31-Mar-2009 Preferred Term PARANOIA OBSESSIVE THOUGHTS ANXIETY CHEST DISCOMFORT CHEST PAIN DIZZINESS DYSPNOEA FEELING ABNORMAL FUNGAL INFECTION HEADACHE HYPOAESTHESIA POST-TRAUMATIC STRESS DISORDER RASH VULVOVAGINAL DISCOMFORT Case # 6961555 Case Type DIRECT Product YAZ ELAVIN Health Professional N Outcomes HO,OT Role Route S C ORAL Dosage Text 1/PILL 1 X DAILY PO Manufacturer Control # Age 29 YR Duration 6 MTH Sex Female Country USA

Manufacturer BAYER

6962027 Date FDA Received
31-Mar-2009 Preferred Term DEPRESSION ANXIETY CRYING SUICIDAL IDEATION

Case # 6962027

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 106 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6962762 Date FDA Received
31-Mar-2009 Preferred Term MIGRAINE BLOOD PRESSURE FLUCTUATION HYPERVENTILATION LOSS OF CONSCIOUSNESS Case # 6962762 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,OT Role Route S ORAL Dosage Text 1 ONCE A DAY PO Manufacturer Control # Age 17 YR Duration Sex Female Country USA

Manufacturer BAYER

6964037 Date FDA Received
31-Mar-2009 Preferred Term CHEST PAIN

Case # 6964037

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 41 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

ABDOMINAL PAIN UPPER CHILLS DIZZINESS NAUSEA PARAESTHESIA

6963102 Date FDA Received
01-Apr-2009 Preferred Term

Case # 6963102

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,DS,LT Role Route S ORAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text 28 TABLETS 1 DAILY PO

Duration

Manufacturer

PULMONARY EMBOLISM PULMONARY INFARCTION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 107 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6963550 Date FDA Received
01-Apr-2009 Preferred Term FEELING ABNORMAL DEPRESSION PANIC REACTION SUICIDAL IDEATION Case # 6963550 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 26 YR Duration Sex Female Country USA

Manufacturer

6963780 Date FDA Received
01-Apr-2009 Preferred Term PELVIC PAIN BREAST MASS BREAST PAIN FATIGUE HYPERSOMNIA UTERINE CYST

Case # 6963780

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S UNKNOWN

Manufacturer Control #

Age 33 YR

Sex Female

Country USA

Dosage Text DAILY UNK

Duration

Manufacturer

6923169 Date FDA Received
02-Apr-2009

Case # 6923169

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200913877NA Dosage Text

Age 24 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION SPONTANEOUS CERVICAL DYSPLASIA

Product YAZ

Role Route S ORAL

Duration 44 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 108 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6958661 Date FDA Received
02-Apr-2009 Case # 6958661 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914590NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA ABDOMINAL DISTENSION FOOD CRAVING PREMENSTRUAL SYNDROME

Product YAZ

Manufacturer BAYER

6958662 Date FDA Received
02-Apr-2009

Case # 6958662

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914662NA

Age

Sex Female

Country USA

Preferred Term JOINT INJURY

Product YAZ Case # 6958663 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6958663 Date FDA Received
02-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200914603NA

Age 40 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6958664 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6958664 Date FDA Received
02-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200914598NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 109 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6958666 Date FDA Received
02-Apr-2009 Case # 6958666 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914593NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914601NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914651NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914666NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914657NA Role Route S ORAL Dosage Text Age 20 YR Sex Female Dosage Text Age 17 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA

Product YAZ Case # 6958668 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6958668 Date FDA Received
02-Apr-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6958669 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6958669 Date FDA Received
02-Apr-2009

Outcomes

Preferred Term NAUSEA

Product YAZ Case # 6958671 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6958671 Date FDA Received
02-Apr-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6958693 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6958693 Date FDA Received
02-Apr-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 110 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6965391 Date FDA Received
02-Apr-2009 Preferred Term DEPRESSION PANIC ATTACK ANGER ANTISOCIAL BEHAVIOUR ANXIETY DISTURBANCE IN ATTENTION FEELING ABNORMAL FEELINGS OF WORTHLESSNESS IMPULSIVE BEHAVIOUR SUICIDAL IDEATION TEMPERATURE INTOLERANCE Case # 6965391 Case Type DIRECT Product YASMIN YAZ Health Professional Outcomes LT Role Route S S ORAL ORAL Dosage Text 3MG/0.03 MG ONE DAILY 21 DAYS PO 3MG/0.02MG ONE DAILY 21 DAYS PO Manufacturer Control # Age 27 YR Duration Sex Female Country USA

Manufacturer BAYER BAYER

6959760 Date FDA Received
03-Apr-2009

Case # 6959760

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914675NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ Case # 6959764 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6959764 Date FDA Received
03-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200914691NA

Age

Sex Female

Country USA

Preferred Term FATIGUE ABDOMINAL PAIN LOWER METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 111 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6959767 Date FDA Received
03-Apr-2009 Case # 6959767 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914683NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Manufacturer BAYER

6959775 Date FDA Received
03-Apr-2009

Case # 6959775

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914679NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6959812 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6959812 Date FDA Received
03-Apr-2009

Outcomes OT

Manufacturer Control # USBAYER-200916976NA Dosage Text

Age

Sex Female

Country USA

Preferred Term HORMONE LEVEL ABNORMAL MOOD ALTERED CONVERSION DISORDER

Product YAZ YASMIN

Role Route S S ORAL

Duration

Manufacturer BAYER BAYER

6959813 Date FDA Received
03-Apr-2009

Case # 6959813

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # USBAYER-200916964NA Dosage Text

Age

Sex Female

Country USA

Preferred Term ADVERSE DRUG REACTION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 112 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6959815 Date FDA Received
03-Apr-2009 Case # 6959815 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # USBAYER-200916961NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PREMENSTRUAL SYNDROME Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6959816 Date FDA Received
03-Apr-2009

Case # 6959816

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # USBAYER-200916958NA Dosage Text 1 TAB/DAY Manufacturer Control # USBAYER-200916956NA Dosage Text 1 TAB/DAY Manufacturer Control #

Age

Sex Female

Country USA

Preferred Term VULVOVAGINAL DRYNESS

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional

Role Route S ORAL

Duration

Manufacturer BAYER

6959830 Date FDA Received
03-Apr-2009

Case # 6959830

Outcomes OT

Age

Sex Female

Country USA

Preferred Term APHTHOUS STOMATITIS

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

6966825 Date FDA Received
03-Apr-2009 Preferred Term HEADACHE

Case # 6966825

Outcomes

Age 24 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 3 MG/0.02 MG DAILY PO

Duration

Manufacturer

NO THERAPEUTIC RESPONSE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 113 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6967958 Date FDA Received
03-Apr-2009 Preferred Term PULMONARY EMBOLISM WHEEZING IMPAIRED WORK ABILITY Case # 6967958 Case Type DIRECT Product YAZ COUMADIN LOVENOX Case Type NON-EXPEDITED Health Professional N Health Professional Outcomes HO,LT,OT Role Route S C C Outcomes Manufacturer Control # USBAYER-200839566NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text 1 PILL 1 X DAILY MOUTH Manufacturer Control # Age 36 YR Duration Sex Female Country USA

Manufacturer BAYER

6855288 Date FDA Received
06-Apr-2009

Case # 6855288

Preferred Term AMENORRHOEA METRORRHAGIA

Product YAZ

Manufacturer BAYER

6961115 Date FDA Received
06-Apr-2009

Case # 6961115

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # USBAYER-200916970NA Dosage Text

Age

Sex Female

Country USA

Preferred Term ANXIETY ABDOMINAL PAIN LOWER CONFUSIONAL STATE FEELING ABNORMAL FEELING OF DESPAIR LIBIDO DECREASED MOOD SWINGS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6961117 Date FDA Received
06-Apr-2009

Case # 6961117

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200916928NA Dosage Text Total daily dose: 1 DF

Age 38 YR

Sex Female

Country USA

Preferred Term DEPRESSION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 114 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6961192 Date FDA Received
06-Apr-2009 Case # 6961192 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914896NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

6961193 Date FDA Received
06-Apr-2009

Case # 6961193

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914874NA

Age 18 YR

Sex Female

Country USA

Preferred Term ABDOMINAL DISTENSION MIGRAINE ADVERSE EVENT

Product YAZ FOLIC ACID VITAMIN B6 VITAMIN B12

Role Route S C C C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

6961195 Date FDA Received
06-Apr-2009

Case # 6961195

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200914888NA

Age 28 YR

Sex Female

Country USA

Preferred Term PARAESTHESIA INSOMNIA WEIGHT DECREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6961196 Date FDA Received
06-Apr-2009

Case # 6961196

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914722NA

Age

Sex Female

Country USA

Preferred Term CHEST PAIN PALPITATIONS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 115 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6961199 Date FDA Received
06-Apr-2009 Case # 6961199 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914693NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914719NA Role Route S ORAL Dosage Text Age 36 YR Sex Female Dosage Text Age 14 YR Sex Female Country USA

Preferred Term MOOD ALTERED

Product YAZ Case # 6961201 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6961201 Date FDA Received
06-Apr-2009

Outcomes

Preferred Term TEMPOROMANDIBULAR JOINT SYNDROME ABDOMINAL DISTENSION SINUSITIS WEIGHT DECREASED

Product YAZ

Duration

Manufacturer BAYER

6961206 Date FDA Received
06-Apr-2009

Case # 6961206

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914876NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6961209 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6961209 Date FDA Received
06-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200914875NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 116 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6961214 Date FDA Received
06-Apr-2009 Case # 6961214 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914910NA Role Route S ORAL Dosage Text Age 19 YR Sex Female Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN LOWER

Product YAZ

Duration

Manufacturer BAYER

6961216 Date FDA Received
06-Apr-2009

Case # 6961216

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914904NA

Age 29 YR

Sex Female

Country USA

Preferred Term DYSMENORRHOEA

Product YAZ Case # 6961219 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6961219 Date FDA Received
06-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200914878NA

Age 27 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding AMENORRHOEA

Product YAZ MIRENA Case # 6961220 Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL INTRAUTERINE

Dosage Text CONTINUOUS DELIVERY Manufacturer Control # USBAYER-200914893NA

Duration

Manufacturer BAYER BAYER

6961220 Date FDA Received
06-Apr-2009

Outcomes

Age

Sex Female

Country USA

Preferred Term WEIGHT INCREASED AMENORRHOEA METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 117 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6961222 Date FDA Received
06-Apr-2009 Case # 6961222 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915251NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915254NA Role Route S Health Professional N Product YAZ ORAL Manufacturer Control # Age 20 YR Dosage Text 3 MG/0.02 MG 28 DAYS ORAL Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 32 YR Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6961223 Date FDA Received
06-Apr-2009

Case # 6961223

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type DIRECT

Manufacturer BAYER Country USA

6967671 Date FDA Received
06-Apr-2009 Preferred Term MOOD SWINGS DEPRESSION WEIGHT DECREASED

Case # 6967671

Outcomes HO Role Route S ORAL

Manufacturer

6968530 Date FDA Received
06-Apr-2009 Preferred Term ABDOMINAL PAIN PAIN IN EXTREMITY THROMBOSIS

Case # 6968530

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S OTHER

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY OTHER

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 118 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6968553 Date FDA Received
06-Apr-2009 Preferred Term PULMONARY EMBOLISM PULMONARY HYPERTENSION PULMONARY INFARCTION UNEVALUABLE EVENT Case # 6968553 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO Role Route S ORAL Dosage Text 1 DAILY PO Manufacturer Control # Age 36 YR Duration Sex Female Country USA

Manufacturer BAYER

6931969 Date FDA Received
07-Apr-2009

Case # 6931969

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200914647NA Dosage Text 1 TAB/DAY

Age 29 YR

Sex Female

Country USA

Preferred Term HYPERKALAEMIA ARTHRALGIA SKIN DISCOLOURATION

Product YAZ

Role Route S ORAL

Duration 1.9 YEAR

Manufacturer BAYER

6941324 Date FDA Received
07-Apr-2009

Case # 6941324

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200914892NA Dosage Text

Age 27 YR

Sex Female

Country USA

Preferred Term PSYCHOTIC DISORDER ANGER ANXIETY DEPRESSION LIBIDO DECREASED MOOD SWINGS PREMENSTRUAL SYNDROME VAGINAL HAEMORRHAGE WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 119 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6962180 Date FDA Received
07-Apr-2009 Case # 6962180 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915128NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA

Preferred Term INFLUENZA LIKE ILLNESS CHILLS HEADACHE MUSCLE TIGHTNESS NAUSEA VOMITING

Product YAZ

Duration

Manufacturer BAYER

6929367 Date FDA Received
08-Apr-2009

Case # 6929367

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913917NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6964862 Date FDA Received
09-Apr-2009

Case # 6964862

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200915121NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6967013 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6967013 Date FDA Received
13-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200915239NA

Age 22 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ PREDNISONE KEFLEX ANTIHISTAMINE NOS

Role Route S C C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 120 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6967017 Date FDA Received
13-Apr-2009 Case # 6967017 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915200NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915386NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 24 YR Sex Female Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 6967023 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6967023 Date FDA Received
13-Apr-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding MOOD SWINGS

Product YAZ

Manufacturer BAYER

6967024 Date FDA Received
13-Apr-2009

Case # 6967024

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915453NA

Age 30 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ YAZ

Role Route S S Health Professional N ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

6967027 Date FDA Received
13-Apr-2009

Case # 6967027

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200914303NA

Age

Sex Female

Country USA

Preferred Term HOT FLUSH NAUSEA HEADACHE

Product YAZ UNSPECIFIED INGREDIENT

Role Route S C ORAL

Dosage Text

Duration 2 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 121 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6967029 Date FDA Received
13-Apr-2009 Case # 6967029 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915369NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200915201NA Role Route S Health Professional Y ORAL Manufacturer Control # USBAYER-200916923NA Role Route S Health Professional N Product YAZ INTRAUTERINE Dosage Text CONTINUOUS Manufacturer Control # Age 31 YR Sex Female Dosage Text Age 37 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6967032 Date FDA Received
13-Apr-2009

Case # 6967032

Preferred Term NAUSEA

Product YAZ Case # 6967034 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6967034 Date FDA Received
13-Apr-2009

Outcomes

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration 9 MTH Age 29 YR Sex

Manufacturer BAYER Country USA

6973104 Date FDA Received
13-Apr-2009 Preferred Term

Case # 6973104

Case Type DIRECT

Outcomes OT Role Route S ORAL

Female

Dosage Text 1 PO

Duration

Manufacturer BERLEX

ARTHROSCOPIC SURGERY DEEP VEIN THROMBOSIS POSTOPERATIVE

6973351 Date FDA Received
13-Apr-2009 Preferred Term DIARRHOEA VOMITING

Case # 6973351

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Role Route S

Dosage Text 1 PILL DAILY

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 122 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6712534 Date FDA Received
15-Apr-2009 Case # 6712534 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # BRBAYER-200816276LA Dosage Text 24D/28D Age 30 YR Sex Female Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION THREATENED Haemorrhage in pregnancy POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Duration 5 MTH

Manufacturer BAYER

6754961 Date FDA Received
15-Apr-2009

Case # 6754961

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200833003NA Dosage Text

Age 18 YR

Sex Female

Country USA

Preferred Term PANCREATITIS ABDOMINAL PAIN NAUSEA VOMITING OFF LABEL USE ULCER

Product YAZ YAZ LOESTRIN FE 1/20 28 DAY TRILEPTAL

Role Route S S C C ORAL ORAL

Duration 2 MTH

Manufacturer BAYER BAYER

Unit dose: 150 MG

6615803 Date FDA Received
16-Apr-2009

Case # 6615803

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200819616NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

6970258 Date FDA Received
16-Apr-2009

Case # 6970258

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200915732NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 123 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6970259 Date FDA Received
16-Apr-2009 Case # 6970259 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200915723NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915746NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200830357NA Dosage Text ONE TABLET PER DAY Age 45 YR Sex Female Dosage Text Age 24 YR Sex Female Dosage Text Age 16 YR Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6970260 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6970260 Date FDA Received
16-Apr-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type EXPEDITED (15-DAY)

Duration

Manufacturer BAYER Country USA

6763982 Date FDA Received
17-Apr-2009

Case # 6763982

Outcomes OT

Preferred Term SUICIDAL IDEATION ABDOMINAL PAIN Abnormal withdrawal bleeding ANXIETY BEDRIDDEN Decreased appetite INSOMNIA METRORRHAGIA NO ADVERSE EVENT PALPITATIONS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6924739 Date FDA Received
17-Apr-2009

Case # 6924739

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913259NA

Age

Sex Female

Country USA

Preferred Term RAYNAUD'S PHENOMENON

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 124 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6969254 Date FDA Received
17-Apr-2009 Case # 6969254 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes LT,OT Manufacturer Control # USBAYER-200918041NA Dosage Text Age 35 YR Sex Female Country USA

Preferred Term CORONARY ARTERY OCCLUSION CARDIAC ARREST CHEST PAIN GASTRITIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6971256 Date FDA Received
17-Apr-2009

Case # 6971256

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915873NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN LOWER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6971257 Date FDA Received
17-Apr-2009

Case # 6971257

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916056NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6971294 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6971294 Date FDA Received
17-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200915985NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 125 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6978055 Date FDA Received
17-Apr-2009 Preferred Term WEIGHT DECREASED CONDITION AGGRAVATED DIARRHOEA FOOD ALLERGY HEPATIC PAIN Case # 6978055 Case Type DIRECT Product YAZ Health Professional N Outcomes LT Role Route S ORAL Dosage Text 1 TABLET ONCE DAILY MOUTH ORAL Manufacturer Control # Age 47 YR Duration Sex Female Country USA

Manufacturer BAYER

6972401 Date FDA Received
20-Apr-2009

Case # 6972401

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200916035NA

Age

Sex Female

Country USA

Preferred Term MOOD ALTERED ABDOMINAL DISTENSION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6972405 Date FDA Received
20-Apr-2009

Case # 6972405

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916319NA

Age 38 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6979064 Case Type DIRECT Product YAZ PROZAC L-LYSINE Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6979064 Date FDA Received
20-Apr-2009 Preferred Term

Outcomes OT Role Route S C C ORAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text ONE DAILY PO

Duration

Manufacturer

BLOOD PRESSURE INCREASED

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 126 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6711475 Date FDA Received
21-Apr-2009 Case # 6711475 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200828373NA Dosage Text DAILY CONTINUOUS Age 26 YR Sex Female Country USA

Preferred Term POLYCYSTIC OVARIES BACK PAIN ABDOMINAL PAIN LOWER Device expulsion GENITAL HAEMORRHAGE HAEMOGLOBIN DECREASED NAUSEA OVARIAN CYST PELVIC PAIN UTERINE HAEMORRHAGE UTERINE POLYP VAGINAL HAEMORRHAGE

Product MIRENA YAZ

Role Route S S INTRAUTERINE ORAL

Duration

Manufacturer BAYER BAYER

6914347 Date FDA Received
21-Apr-2009

Case # 6914347

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200913286NA Dosage Text Total daily dose: 1 DF Manufacturer Control # HUBAYER-200918297GPV Dosage Text Total daily dose: 1.5 MG Unit dose: 0.75 MG

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

6974796 Date FDA Received
22-Apr-2009

Case # 6974796

Outcomes OT

Age 31 YR

Sex Female

Country USA

Preferred Term ECTOPIC PREGNANCY VAGINAL HAEMORRHAGE

Product YAZ PLAN B

Role Route S S ORAL ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 127 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6941322 Date FDA Received
23-Apr-2009 Case # 6941322 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200914531NA Dosage Text Age 39 YR Sex Female Country USA

Preferred Term HYPERALDOSTERONISM BLOOD ALDOSTERONE INCREASED HYPERTENSION

Product YAZ VERELAN CATAPRES-TTS Case # 6976032 Case Type NON-EXPEDITED Health Professional N

Role Route S C C Outcomes ORAL ORAL

Duration

Manufacturer BAYER

6976032 Date FDA Received
23-Apr-2009

Manufacturer Control # USBAYER-200914917NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6976033 Date FDA Received
23-Apr-2009

Case # 6976033

Outcomes

Manufacturer Control # USBAYER-200914914NA

Age 42 YR

Sex Female

Country USA

Preferred Term DRUG WITHDRAWAL HEADACHE NO ADVERSE EVENT

Product YAZ WELLBUTRIN EFFEXOR ATENOLOL

Role Route S C C C Health Professional N ORAL ORAL ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER

6976042 Date FDA Received
23-Apr-2009

Case # 6976042

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200915154NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 128 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6976045 Date FDA Received
23-Apr-2009 Case # 6976045 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915146NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term BLOOD TRIGLYCERIDES INCREASED BLOOD POTASSIUM INCREASED GLUCOSE TOLERANCE IMPAIRED NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6976048 Date FDA Received
23-Apr-2009

Case # 6976048

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915123NA

Age 17 YR

Sex Female

Country USA

Preferred Term ASTHMA

Product YAZ Case # 6976051 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6976051 Date FDA Received
23-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200915052NA

Age 34 YR

Sex Female

Country USA

Preferred Term PALPITATIONS MIGRAINE NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration 8 DAY

Manufacturer BAYER

6976071 Date FDA Received
23-Apr-2009

Case # 6976071

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # CABAYER-200918671NA Dosage Text

Age

Sex Female

Country CAN

Preferred Term PSYCHOTIC DISORDER

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 129 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6869204 Date FDA Received
24-Apr-2009 Case # 6869204 Case Type NON-EXPEDITED Health Professional Y Outcomes HO,OT Manufacturer Control # USBAYER-200841545NA Dosage Text Age 48 YR Sex Female Country USA

Preferred Term DEEP VEIN THROMBOSIS ERYTHEMA HAEMATOMA OEDEMA PERIPHERAL PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration 1.5 YEAR

Manufacturer BAYER

6891480 Date FDA Received
24-Apr-2009

Case # 6891480

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # CHBAYER-200911458GPV Dosage Text

Age

Sex Female

Country CHE

Preferred Term ANGIOEDEMA

Product YAZ Case # 6959818 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

6959818 Date FDA Received
24-Apr-2009

Outcomes OT

Manufacturer Control # USBAYER-200916926NA Dosage Text

Age 42 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM ELECTROCARDIOGRAM ABNORMAL BACK PAIN BLOOD CHOLESTEROL INCREASED HYPERLIPIDAEMIA LOW DENSITY LIPOPROTEIN INCREASED

Product YAZ ZOLOFT ORTHO-NOVUM

Role Route S C C ORAL ORAL ORAL

Duration 161 DAY 1.2 YEAR

Manufacturer BAYER

1/35

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 130 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6977027 Date FDA Received
24-Apr-2009 Case # 6977027 Case Type NON-EXPEDITED Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200918890NA Dosage Text Duration Age Sex Female Country USA

Preferred Term DEEP VEIN THROMBOSIS EMBOLISM VENOUS

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6977029 Date FDA Received
24-Apr-2009

Case # 6977029

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200918887NA Dosage Text

Age

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS EMBOLISM VENOUS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6977031 Date FDA Received
24-Apr-2009

Case # 6977031

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200918892NA Dosage Text

Age

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS EMBOLISM VENOUS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6977068 Date FDA Received
24-Apr-2009

Case # 6977068

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915189NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6977070 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6977070 Date FDA Received
24-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200915236NA

Age 19 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 131 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924704 Date FDA Received
27-Apr-2009 Case # 6924704 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200912260NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200912438NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200912381NA Role Route S Health Professional N INTRAUTERINE Dosage Text CONTINUOUS Manufacturer Control # USBAYER-200912976NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Age 24 YR Sex Female Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6924707 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6924707 Date FDA Received
27-Apr-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6929350 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6929350 Date FDA Received
27-Apr-2009

Outcomes

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration

Manufacturer BAYER Country USA

6930872 Date FDA Received
27-Apr-2009

Case # 6930872

Case Type NON-EXPEDITED

Outcomes

Preferred Term DYSPNOEA AMENORRHOEA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6948333 Date FDA Received
27-Apr-2009

Case # 6948333

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913734NA

Age 20 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE MEDICATION ERROR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 132 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6955353 Date FDA Received
27-Apr-2009 Case # 6955353 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914566NA Role Route S C Outcomes Manufacturer Control # USBAYER-200915163NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ACNE

Product YAZ ACNE MEDICATIONS NOS

Manufacturer BAYER

6978417 Date FDA Received
27-Apr-2009

Case # 6978417

Case Type NON-EXPEDITED

Health Professional N

Preferred Term ALOPECIA DEPRESSION

Product YAZ

Manufacturer BAYER

6978434 Date FDA Received
27-Apr-2009

Case # 6978434

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917167NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6985583 Case Type DIRECT Product YAZ Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6985583 Date FDA Received
27-Apr-2009 Preferred Term

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text ONE PILL DAILY PO

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 133 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6578539 Date FDA Received
28-Apr-2009 Case # 6578539 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200815759NA Dosage Text Age 13 YR Sex Female Country USA

Preferred Term VON WILLEBRAND'S DISEASE CHEST PAIN DIZZINESS EPISTAXIS NAUSEA OEDEMA PERIPHERAL PELVIC PAIN POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6987089 Date FDA Received
28-Apr-2009 Preferred Term DIZZINESS BACK PAIN DYSPNOEA

Case # 6987089

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 DAILY PO

Duration

Manufacturer BAYER

LOSS OF CONSCIOUSNESS PULMONARY THROMBOSIS

6988571 Date FDA Received
28-Apr-2009 Preferred Term

Case # 6988571

Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer BAYER

DEEP VEIN THROMBOSIS

6988752 Date FDA Received
28-Apr-2009 Preferred Term

Case # 6988752

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control #

Age 32 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

RETINAL VEIN OCCLUSION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 134 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6992706 Date FDA Received
28-Apr-2009 Preferred Term SUICIDAL IDEATION Case # 6992706 Case Type DIRECT Product YAZ YASMIN Health Professional Y Outcomes LT Role Route S S Health Professional N ORAL ORAL Dosage Text 1 PILL DAILY PO 1 PILL DAILY PO Manufacturer Control # USBAYER-200918820NA Dosage Text Age 28 YR Sex Female Country USA Manufacturer Control # Age 40 YR Duration Sex Female Country USA

Manufacturer

6980509 Date FDA Received
29-Apr-2009

Case # 6980509

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term HYPERSENSITIVITY ALCOHOL INTOLERANCE EYE PRURITUS RASH THROAT TIGHTNESS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6980561 Date FDA Received
29-Apr-2009

Case # 6980561

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915157NA

Age 28 YR

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA

Product YAZ YAZ

Role Route S S Health Professional N Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

6980562 Date FDA Received
29-Apr-2009

Case # 6980562

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200915097NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 135 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6980563 Date FDA Received
29-Apr-2009 Case # 6980563 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915229NA Role Route S ORAL Dosage Text Age 18 YR Sex Female Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6980564 Date FDA Received
29-Apr-2009

Case # 6980564

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915196NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 6980565 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6980565 Date FDA Received
29-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200915096NA

Age

Sex Female

Country USA

Preferred Term FOOD POISONING DIARRHOEA VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6980572 Date FDA Received
29-Apr-2009

Case # 6980572

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915149NA

Age

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN UPPER HYPOMENORRHOEA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 136 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6980574 Date FDA Received
29-Apr-2009 Case # 6980574 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915243NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915159NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915242NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915373NA Role Route S C C C Outcomes Manufacturer Control # USBAYER-200915197NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA 3 YEAR ORAL Dosage Text Age 40 YR Sex Female Dosage Text Age 29 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6980576 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6980576 Date FDA Received
29-Apr-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 6980577 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6980577 Date FDA Received
29-Apr-2009

Outcomes

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6980579 Date FDA Received
29-Apr-2009

Case # 6980579

Outcomes

Preferred Term WEIGHT INCREASED PELVIC PAIN NO ADVERSE EVENT

Product YAZ SULODEXIDE MIRALAX ALLERGY MEDICATION NOS

Duration

Manufacturer BAYER

6980580 Date FDA Received
29-Apr-2009

Case # 6980580

Case Type NON-EXPEDITED

Health Professional N

Preferred Term AMENORRHOEA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 137 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6980582 Date FDA Received
29-Apr-2009 Case # 6980582 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915381NA Role Route S Dosage Text Age 20 YR Sex Female Country USA

Preferred Term WEIGHT INCREASED NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6980586 Date FDA Received
29-Apr-2009

Case # 6980586

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915237NA

Age 16 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED DEPRESSION ANXIETY DIARRHOEA INSOMNIA NO ADVERSE EVENT

Product YAZ METFORMIN HYDROCHLORIDE

Role Route S C

Dosage Text

Duration

Manufacturer BAYER

6980587 Date FDA Received
29-Apr-2009

Case # 6980587

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915360NA

Age 20 YR

Sex Female

Country USA

Preferred Term VAGINAL DISCHARGE VULVOVAGINAL MYCOTIC INFECTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6700902 Date FDA Received
30-Apr-2009

Case # 6700902

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200815836LA Dosage Text 21D/28D 24D/28D

Age 23 YR

Sex Female

Country BRA

Preferred Term UTERINE LEIOMYOMA MIGRAINE

Product YASMIN YAZ

Role Route S S ORAL ORAL

Duration 5 MTH

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 138 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6981640 Date FDA Received
30-Apr-2009 Case # 6981640 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200918905NA Dosage Text Duration Age Sex Female Country USA

Preferred Term COLITIS

Product YAZ Case # 6981657 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER

6981657 Date FDA Received
30-Apr-2009

Outcomes

Manufacturer Control # USBAYER-200919280NA

Age 36 YR

Sex Female

Country USA

Preferred Term SINUS TACHYCARDIA

Product YAZ Case # 6983024 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text 1 TAB/DAY Manufacturer Control # USASTRAZENECA-2008U W19451

Duration

Manufacturer BAYER

6983024 Date FDA Received
30-Apr-2009

Outcomes

Age 30 YR

Sex Female

Country USA

Preferred Term ECZEMA

Product NEXIUM YAZ

Role Route S S Health Professional N ORAL UNKNOWN

Dosage Text

Duration 9 DAY 15 DAY

Manufacturer

6844465 Date FDA Received
01-May-2009

Case # 6844465

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # BRBAYER-200822538LA

Age

Sex Female

Country USA

Preferred Term GENITAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 139 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6941301 Date FDA Received
01-May-2009 Case # 6941301 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200914564NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE DYSPAREUNIA GENITAL HAEMORRHAGE MEDICATION ERROR

Product YAZ

Manufacturer BAYER

6967030 Date FDA Received
01-May-2009

Case # 6967030

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200916924NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text 1 TABL / DAY Manufacturer Control # BRBAYER-200915509LA Dosage Text

Duration

Manufacturer BAYER

6983807 Date FDA Received
01-May-2009

Case # 6983807

Case Type EXPEDITED (15-DAY)

Outcomes OT

Age 14 YR

Sex Female

Country BRA

Preferred Term INCREASED APPETITE BREAST ENLARGEMENT FATIGUE SKIN STRIAE SOMNOLENCE WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6983825 Date FDA Received
01-May-2009

Case # 6983825

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915365NA

Age

Sex Female

Country USA

Preferred Term POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 140 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6983827 Date FDA Received
01-May-2009 Case # 6983827 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915364NA Role Route S ORAL Dosage Text Age 29 YR Sex Female Country USA

Preferred Term DIZZINESS EMOTIONAL DISORDER HEART RATE INCREASED PANIC ATTACK

Product YAZ

Duration

Manufacturer BAYER

6983830 Date FDA Received
01-May-2009

Case # 6983830

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917131NA

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6983836 Date FDA Received
01-May-2009

Case # 6983836

Outcomes

Manufacturer Control # USBAYER-200915310NA

Age 49 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6983838 Date FDA Received
01-May-2009

Case # 6983838

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915362NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 141 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6983839 Date FDA Received
01-May-2009 Case # 6983839 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915457NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915450NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200915379NA Role Route S ORAL Dosage Text Duration 1 WEEK Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA

Product YAZ Case # 6983846 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6983846 Date FDA Received
01-May-2009

Outcomes

Preferred Term WEIGHT INCREASED

Product YAZ Case # 6983850 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6983850 Date FDA Received
01-May-2009

Outcomes

Preferred Term DYSGEUSIA GASTROOESOPHAGEAL REFLUX DISEASE NO ADVERSE EVENT SINUS DISORDER

Product YAZ

Manufacturer BAYER

6983854 Date FDA Received
01-May-2009

Case # 6983854

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916431NA

Age 23 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN LOWER AFFECT LABILITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 142 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6989745 Date FDA Received
01-May-2009 Preferred Term NAUSEA ABDOMINAL DISCOMFORT BURNING SENSATION DIZZINESS GASTROINTESTINAL DISORDER HEART RATE INCREASED Case # 6989745 Case Type DIRECT Product YAZ Health Professional Outcomes OT Role Route S Dosage Text Duration Manufacturer Control # Age Sex Unknown Country PRI

Manufacturer BAYER

6869193 Date FDA Received
05-May-2009

Case # 6869193

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200841537NA Dosage Text

Age 41 YR

Sex Female

Country USA

Preferred Term SUICIDAL IDEATION DEPRESSION EMOTIONAL DISORDER

Product YAZ MULTI-VITAMIN LOVAZA Case Type NON-EXPEDITED Health Professional N

Role Route S C C Outcomes ORAL

Duration 3 WEEK

Manufacturer BAYER

6941279 Date FDA Received
05-May-2009

Case # 6941279

Manufacturer Control # USBAYER-200913332NA

Age 35 YR

Sex Female

Country USA

Preferred Term BLOOD CHOLESTEROL INCREASED BLOOD TRIGLYCERIDES INCREASED FATIGUE

Product YAZ WELLBUTRIN ABILIFY ATATLOL

Role Route S C C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 143 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6986619 Date FDA Received
05-May-2009 Case # 6986619 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915308NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6986630 Date FDA Received
05-May-2009

Case # 6986630

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915742NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 6986632 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6986632 Date FDA Received
05-May-2009

Outcomes

Manufacturer Control # USBAYER-200915756NA

Age

Sex Female

Country USA

Preferred Term SINUSITIS

Product YAZ Case # 6986633 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6986633 Date FDA Received
05-May-2009

Outcomes

Manufacturer Control # USBAYER-200915725NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA STRESS

Product YAZ VITAMINS SUPPLEMENTS NOS NSAIDS NOS

Role Route S C C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 144 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6986635 Date FDA Received
05-May-2009 Case # 6986635 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200915738NA Role Route S ORAL Dosage Text Age 45 YR Sex Female Country USA

Preferred Term HYPOMENORRHOEA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

6986637 Date FDA Received
05-May-2009

Case # 6986637

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915728NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 6986640 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6986640 Date FDA Received
05-May-2009

Outcomes

Manufacturer Control # USBAYER-200915752NA

Age 42 YR

Sex Female

Country USA

Preferred Term LIBIDO DECREASED

Product YAZ Case # 6986645 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6986645 Date FDA Received
05-May-2009

Outcomes

Manufacturer Control # USBAYER-200915726NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 145 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6986649 Date FDA Received
05-May-2009 Case # 6986649 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917556NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Duration 3 MTH Age Sex Female Country USA

Preferred Term HYPOAESTHESIA HEADACHE Hypoaesthesia PARAESTHESIA

Product YAZ

Manufacturer BAYER

6986654 Date FDA Received
05-May-2009

Case # 6986654

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915562NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6993504 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6993504 Date FDA Received
05-May-2009 Preferred Term PANIC ATTACK ACNE DYSPHAGIA DYSPNOEA

Outcomes

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 3MG DAILY PO

Duration

Manufacturer

HEART RATE IRREGULAR PALPITATIONS THROAT TIGHTNESS

6979380 Date FDA Received
06-May-2009

Case # 6979380

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918506NA

Age 24 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration 2.3 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 146 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6925428 Date FDA Received
07-May-2009 Case # 6925428 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,LT,OT Manufacturer Control # USBAYER-200913878NA Dosage Text Age 35 YR Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION INDUCED ABORTION INDUCED COMPLICATED HYSTERECTOMY POST ABORTION HAEMORRHAGE PYREXIA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6955351 Date FDA Received
07-May-2009

Case # 6955351

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914442NA

Age 17 YR

Sex Female

Country USA

Preferred Term BREAST MASS BREAST DISORDER DIZZINESS FOOD CRAVING HEADACHE PHOTOPHOBIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 147 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6974798 Date FDA Received
07-May-2009 Case # 6974798 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200918341NA Dosage Text Total daily dose: 1 DF Age 20 YR Sex Female Country USA

Preferred Term SYSTEMIC LUPUS ERYTHEMATOSUS BUTTERFLY RASH FATIGUE LUNG DISORDER PAIN POLYMYOSITIS PRODUCTIVE COUGH PYREXIA SCLERODERMA SJOGREN'S SYNDROME

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

6988717 Date FDA Received
07-May-2009

Case # 6988717

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917628NA

Age 35 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional Y Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6995894 Date FDA Received
08-May-2009 Preferred Term

Case # 6995894

Case Type DIRECT

Outcomes OT Role Route S

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 148 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342333 Date FDA Received
08-May-2009 Case # 8342333 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # USBAYER-200919936NA Dosage Text Age 21 YR Sex Female Country USA

Preferred Term CHOLECYSTITIS ACUTE ABDOMINAL PAIN LOWER

Product YAZ LASIX ULTRAM NAPROXEN

Role Route S C C C Health Professional N ORAL ORAL ORAL ORAL

Duration

Manufacturer BAYER

6928264 Date FDA Received
11-May-2009

Case # 6928264

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200912269NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA PARAESTHESIA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 149 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6933570 Date FDA Received
11-May-2009 Case # 6933570 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # BRBAYER-200815372LA Dosage Text RESTARTED A NEW PACKAGE ON 1ST DAY OF MENSTRUATION (5 OR 6 DAYS OF INTERVAL BETWEEN PACKAGES) Age 35 YR Sex Female Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Duration 5 MTH

Manufacturer BAYER

NAUSEA MALAISE AMENORRHOEA VAGINAL HAEMORRHAGE ABORTION SPONTANEOUS ABDOMINAL PAIN HEADACHE BONE PAIN BACK PAIN PYREXIA CERVIX DISORDER UTERINE INFLAMMATION

CAFFEINE\ORPHENADRINE CITRATE DACTIL VITAMINS NOS BUTYLSCOPOLAMINE BROMIDE LUFTAL CHLORAMPHENICOL ERGOTRATE ANESTHESIA DICLOFENAC SODIC DIPIRONA

C C C C C C C C C C

ORAL UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN

6991096 Date FDA Received
11-May-2009

Case # 6991096

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200918117NA

Age

Sex Female

Country USA

Preferred Term OVARIAN CYST

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 150 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6996687 Date FDA Received
11-May-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 6996687 Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ Case # 6998711 Case Type DIRECT Product YAZ Health Professional N Health Professional Y Health Professional N Outcomes LT,OT Role Route S Outcomes OT Role Route S Outcomes HO,LT,OT Role Route S ORAL Dosage Text 1 PILL FOR 28 DAYS 1 TIME A DAY PO Manufacturer Control # USBAYER-200914426NA Dosage Text 2 WEEKS BEFORE MENSES Age 38 YR Sex Female Manufacturer Control # Age 38 YR Duration Sex Female Country USA Dosage Text Manufacturer Control # Age 24 YR Duration Sex Female Country USA Dosage Text Manufacturer Control # Age 23 YR Duration Sex Female Country USA

Manufacturer

6998217 Date FDA Received
12-May-2009 Preferred Term URTICARIA

Case # 6998217

Manufacturer

6998711 Date FDA Received
12-May-2009 Preferred Term TACHYCARDIA

Manufacturer BAYER

6931958 Date FDA Received
13-May-2009

Case # 6931958

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Country USA

Preferred Term DEEP VEIN THROMBOSIS MALAISE MUSCLE TIGHTNESS ARTHRALGIA OEDEMA PERIPHERAL PULMONARY EMBOLISM SKIN DISCOLOURATION

Product YAZ SARAFEM ZOMIG

Role Route S C C ORAL ORAL ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 151 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6972368 Date FDA Received
13-May-2009 Case # 6972368 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,LT,OT Manufacturer Control # CRBAYER-200915174LA Dosage Text Age 20 YR Sex Female Country CRI

Preferred Term EMBOLISM VENOUS CONVULSION COR PULMONALE DYSPNOEA HAEMATOMA LOSS OF CONSCIOUSNESS PAIN IN EXTREMITY PHLEBITIS PULMONARY ARTERIAL HYPERTENSION PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration 7 MTH

Manufacturer BAYER

6999824 Date FDA Received
14-May-2009 Preferred Term PALPITATIONS CONSTIPATION DEHYDRATION FEELING ABNORMAL NAUSEA PRESYNCOPE SYNCOPE

Case # 6999824

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 152 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6995348 Date FDA Received
15-May-2009 Case # 6995348 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200920525NA Dosage Text Duration Age Sex Female Country USA

Preferred Term SYSTEMIC LUPUS ERYTHEMATOSUS ALOPECIA RASH

Product YAZ

Role Route S ORAL

Manufacturer BAYER

7001947 Date FDA Received
15-May-2009 Preferred Term MALAISE NAUSEA DEPRESSION FATIGUE

Case # 7001947

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S C C C C ORAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text 1 TABLET 1X/DAY PO

Duration

Manufacturer BAYER

ALLEGRA--D 24 HOUR RETIN-A CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION SERTRALINE HYDROCHLORIDE

DECREASED INTEREST FEELING ABNORMAL

6904479 Date FDA Received
18-May-2009

Case # 6904479

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910652NA

Age

Sex Female

Country USA

Preferred Term LABORATORY TEST ABNORMAL

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6983806 Date FDA Received
18-May-2009

Case # 6983806

Outcomes OT

Manufacturer Control # FRBAYER-200919430GPV Dosage Text

Age 19 YR

Sex Female

Country FRA

Preferred Term CONGENITAL CYSTIC KIDNEY DISEASE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 153 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7003492 Date FDA Received
18-May-2009 Preferred Term CHEST DISCOMFORT DYSPNOEA Case # 7003492 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text DAILY PO CURRENT Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer BAYER

6810362 Date FDA Received
20-May-2009

Case # 6810362

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # USBAYER-200837906NA Dosage Text ONCE DAILY

Age 23 YR

Sex Female

Country USA

Preferred Term CONVULSION

Product YAZ ALPRAZOLAM FOLIC ACID

Role Route S C C Health Professional N Outcomes OT ORAL

Duration 6 MTH

Manufacturer BAYER

6998358 Date FDA Received
20-May-2009

Case # 6998358

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200920979NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200920794NA

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

6998361 Date FDA Received
20-May-2009

Case # 6998361

Outcomes

Age

Sex Female

Country USA

Preferred Term CHEST PAIN NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 154 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7293342 Date FDA Received
20-May-2009 Preferred Term THROMBOSIS ECONOMIC PROBLEM Case # 7293342 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,DS,LT,OT Role Route S ORAL Dosage Text ONE TABLET DAILY PO Manufacturer Control # Age 34 YR Duration Sex Female Country USA

Manufacturer BAYER

6650377 Date FDA Received
21-May-2009

Case # 6650377

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200823595NA Dosage Text

Age 16 YR

Sex Female

Country USA

Preferred Term CHEST PAIN ABDOMINAL PAIN UPPER VISION BLURRED

Product YAZ

Role Route S ORAL

Duration 2 WEEK

Manufacturer BAYER

7007068 Date FDA Received
21-May-2009 Preferred Term

Case # 7007068

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT,OT,RI Role Route S

Manufacturer Control #

Age

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

CEREBRAL THROMBOSIS BRAIN OEDEMA CEREBROVASCULAR DISORDER

6986650 Date FDA Received
22-May-2009

Case # 6986650

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200918920NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 155 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6778168 Date FDA Received
26-May-2009 Case # 6778168 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200834276NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200914351NA Dosage Text 1 TAB/DAY PO Duration 4 MTH Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term PREGNANCY ON CONTRACEPTIVE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

6931968 Date FDA Received
26-May-2009

Case # 6931968

Outcomes HO

Preferred Term PULMONARY EMBOLISM HEART RATE INCREASED THROMBOSIS

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6969246 Date FDA Received
26-May-2009

Case # 6969246

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200917933NA Dosage Text

Age 19 YR

Sex Female

Country USA

Preferred Term ANAPHYLACTIC REACTION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 156 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6988720 Date FDA Received
26-May-2009 Case # 6988720 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # CABAYER-200919628NA Dosage Text 1 TAB/DAY Age 16 YR Sex Female Country CAN

Preferred Term NEPHROLITHIASIS BACK PAIN BURNING SENSATION CONSTIPATION DIZZINESS FEELING ABNORMAL HEADACHE HOT FLUSH MUSCULOSKELETAL CHEST PAIN NAUSEA WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7001990 Date FDA Received
26-May-2009

Case # 7001990

Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO

Manufacturer Control # USBAYER-200921414NA Dosage Text

Age 45 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS DISEASE COMPLICATION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7001997 Date FDA Received
26-May-2009

Case # 7001997

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200921283NA Dosage Text

Age

Sex Female

Country USA

Preferred Term SOMNOLENCE FEELING JITTERY

Product YAZ CYMBALTA

Role Route S S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 157 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7002002 Date FDA Received
26-May-2009 Case # 7002002 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200921286NA Dosage Text Age 22 YR Sex Female Country USA

Preferred Term CHEST PAIN HEADACHE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7008504 Date FDA Received
26-May-2009 Preferred Term RASH PRURITIC

Case # 7008504

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 3MG 1 BY MOUTH DAILY PO Manufacturer Control # USBAYER-200920988NA Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

7001986 Date FDA Received
27-May-2009

Case # 7001986

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Age

Sex Female

Country USA

Preferred Term ABORTION SPONTANEOUS ABDOMINAL PAIN LOWER BREAST ENLARGEMENT PREGNANCY ON ORAL CONTRACEPTIVE WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7001988 Date FDA Received
27-May-2009

Case # 7001988

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200921071NA Dosage Text

Age

Sex Female

Country USA

Preferred Term LUPUS-LIKE SYNDROME SYSTEMIC LUPUS ERYTHEMATOSUS RASH ARTHRALGIA INFLAMMATION

Product YAZ YAZ

Role Route S S ORAL ORAL

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 158 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7009358 Date FDA Received
27-May-2009 Preferred Term ABDOMINAL DISTENSION FATIGUE FLATULENCE HUNGER INSOMNIA IRRITABILITY MOOD ALTERED PARTNER STRESS THINKING ABNORMAL WEIGHT INCREASED Case # 7009358 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer

6952525 Date FDA Received
28-May-2009

Case # 6952525

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913591NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA ABNORMAL WITHDRAWAL BLEEDING DEPRESSION MOOD SWINGS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6952762 Date FDA Received
28-May-2009

Case # 6952762

Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO

Manufacturer Control # USBAYER-200916203NA Dosage Text

Age 40 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 159 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6961205 Date FDA Received
28-May-2009 Case # 6961205 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200914869NA Role Route S Health Professional Y Product YAZ YAZ FEXOFENADINE ORAL Manufacturer Control # Age 28 YR Dosage Text 1 TABLET DAILY PO Duration 1 MTH Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term EPISTAXIS

Product YAZ Case # 7010208 Case Type DIRECT

Manufacturer BAYER Country USA

7010208 Date FDA Received
29-May-2009 Preferred Term IRRITABILITY

Outcomes OT Role Route S C C ORAL

Manufacturer BAYER

EMOTIONAL DISORDER SUICIDAL IDEATION VIOLENCE-RELATED SYMPTOM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 160 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7010251 Date FDA Received
29-May-2009 Preferred Term CRYING AGGRESSION ANGER ANXIETY CHILLS DECREASED APPETITE DEPRESSION DYSPNOEA FEELING ABNORMAL MIGRAINE MOOD SWINGS NAUSEA NEGLECT OF PERSONAL APPEARANCE SOCIAL AVOIDANT BEHAVIOUR UNEVALUABLE EVENT Case # 7010251 Case Type DIRECT Product YAZ Health Professional N Role Route S Dosage Text 1 PILL DAILY Outcomes Manufacturer Control # Age 19 YR Duration 3 WEEK Sex Female Country USA

Manufacturer BAYER

7007694 Date FDA Received
01-Jun-2009

Case # 7007694

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917814NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7007697 Date FDA Received
01-Jun-2009

Case # 7007697

Outcomes

Manufacturer Control # USBAYER-200918934NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 161 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7007698 Date FDA Received
01-Jun-2009 Case # 7007698 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918133NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919370NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917825NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919529NA Role Route S ORAL Dosage Text Age 26 YR Sex Female Dosage Text Age 24 YR Sex Female Dosage Text Age 19 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7007700 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7007700 Date FDA Received
01-Jun-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7007702 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7007702 Date FDA Received
01-Jun-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7007707 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7007707 Date FDA Received
01-Jun-2009

Outcomes

Preferred Term HEADACHE SKIN DISCOLOURATION

Product YAZ

Duration

Manufacturer BAYER

7007714 Date FDA Received
01-Jun-2009

Case # 7007714

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919654NA

Age 17 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 162 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7012032 Date FDA Received
01-Jun-2009 Preferred Term DIZZINESS ABNORMAL DREAMS BREAST PAIN BREAST SWELLING EAR DISCOMFORT FATIGUE JOINT CREPITATION MYALGIA NIGHT SWEATS POLLAKIURIA THIRST TREMOR VERTIGO Case # 7012032 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text ONE PILL DAILY PO Manufacturer Control # Age 40 YR Duration 8 DAY Sex Female Country USA

Manufacturer BAYER

6941323 Date FDA Received
03-Jun-2009

Case # 6941323

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200915028NA Dosage Text

Age 36 YR

Sex Female

Country USA

Preferred Term MENTAL DISORDER ANXIETY MOOD SWINGS ACNE FATIGUE HEADACHE SOCIAL PHOBIA

Product YAZ YAZ SYNTHROID

Role Route S S C ORAL ORAL ORAL

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 163 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6977032 Date FDA Received
03-Jun-2009 Case # 6977032 Case Type NON-EXPEDITED Health Professional Y Outcomes HO,OT Manufacturer Control # USBAYER-200918743NA Dosage Text Age 42 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration 228 DAY

Manufacturer BAYER Sex Female Country IRL

7007649 Date FDA Received
03-Jun-2009

Case # 7007649

Outcomes HO,OT

Manufacturer Control # IEBAYER-200911845BNE Dosage Text

Age

Preferred Term BURNING SENSATION CHEST PAIN PAIN IN EXTREMITY

Product YAZ PROPYLTHIOURACIL

Role Route S C ORAL

Duration 12 DAY

Manufacturer BAYER

7015999 Date FDA Received
03-Jun-2009 Preferred Term

Case # 7015999

Case Type DIRECT Product YAZ SYNTHROID

Health Professional Y

Outcomes HO,LT Role Route S C ORAL

Manufacturer Control #

Age 33 YR

Sex Female

Country USA

Dosage Text ONE PILL DAILY PO/ 047

Duration

Manufacturer BAYER

PULMONARY EMBOLISM HAEMOPTYSIS PNEUMONIA

6937103 Date FDA Received
04-Jun-2009

Case # 6937103

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200913212NA

Age 28 YR

Sex Female

Country USA

Preferred Term HEADACHE DEPRESSION NO ADVERSE EVENT

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 164 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6946689 Date FDA Received
04-Jun-2009 Case # 6946689 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913502NA Role Route S ORAL Dosage Text Age 21 YR Sex Female Country USA

Preferred Term HYPERSENSITIVITY ANXIETY CHEST DISCOMFORT CHEST PAIN DIARRHOEA NAUSEA VOMITING

Product YAZ

Duration

Manufacturer BAYER

6962197 Date FDA Received
04-Jun-2009

Case # 6962197

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917156NA

Age 16 YR

Sex Female

Country USA

Preferred Term CHOKING SENSATION

Product YAZ Case # 7010786 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200921734NA Dosage Text

Duration

Manufacturer BAYER

7010786 Date FDA Received
04-Jun-2009

Outcomes OT

Age 23 YR

Sex Female

Country USA

Preferred Term LIPOMA DIABETES MELLITUS HYPERTENSION NAUSEA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 165 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7010988 Date FDA Received
04-Jun-2009 Case # 7010988 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919878NA Role Route S Health Professional Y ORAL Manufacturer Control # USBAYER-200920163NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920947NA Dosage Text Total daily dose: 1 DF Age 38 YR Sex Female Dosage Text Age 27 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7012009 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7012009 Date FDA Received
05-Jun-2009

Outcomes

Preferred Term HEADACHE

Product YAZ Case # 7000426 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer BAYER Country USA

7000426 Date FDA Received
08-Jun-2009

Outcomes OT

Preferred Term OPTIC NEURITIS EYE PAIN ANAL HAEMORRHAGE CONJUNCTIVITIS INFECTIVE CONVERSION DISORDER EYE DISORDER

Product YAZ PARACETAMOL

Role Route S C ORAL

Duration

Manufacturer BAYER

7022656 Date FDA Received
08-Jun-2009 Preferred Term THROMBOTIC STROKE

Case # 7022656

Case Type DIRECT Product YAZ

Health Professional N

Outcomes RI Role Route S ORAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text DAILY PO

Duration 5 MTH

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 166 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7023870 Date FDA Received
08-Jun-2009 Preferred Term DEPRESSION AGGRESSION ANGER CRYING DELUSION DEPRESSED MOOD PARANOIA Case # 7023870 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,LT,OT,RI Role Route S Dosage Text Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer

7022625 Date FDA Received
09-Jun-2009 Preferred Term

Case # 7022625

Case Type DIRECT Product YAZ

Health Professional N

Outcomes CA Role Route S ORAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text 1 PISS DAILY PO Manufacturer Control # USBAYER-200913583NA

Duration 1 YEAR Age 19 YR Sex

Manufacturer

MATERNAL EXPOSURE BEFORE PREGNANCY

6924750 Date FDA Received
10-Jun-2009

Case # 6924750

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Country USA

Female

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200917378NA Dosage Text

Duration

Manufacturer BAYER

6962123 Date FDA Received
10-Jun-2009

Case # 6962123

Case Type EXPEDITED (15-DAY)

Outcomes OT

Age

Sex Female

Country USA

Preferred Term UTERINE LEIOMYOMA OVARIAN CYST

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 167 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6788902 Date FDA Received
11-Jun-2009 Case # 6788902 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # BRBAYER-200819073LA Dosage Text Age 26 YR Sex Female Country BRA

Preferred Term VOMITING FLUID RETENTION Haemorrhage in pregnancy MATERNAL EXPOSURE DURING PREGNANCY PRE-ECLAMPSIA PREGNANCY ON ORAL CONTRACEPTIVE

Product YASMIN YAZ

Role Route S S ORAL ORAL

Duration 2 YEAR 6 MTH

Manufacturer BAYER BAYER

7017243 Date FDA Received
11-Jun-2009

Case # 7017243

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200919743NA

Age

Sex Female

Country USA

Preferred Term DEPRESSED MOOD

Product YAZ Case # 7017255 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7017255 Date FDA Received
11-Jun-2009

Outcomes

Manufacturer Control # USBAYER-200919796NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7017256 Date FDA Received
11-Jun-2009

Case # 7017256

Outcomes

Manufacturer Control # USBAYER-200920270NA

Age

Sex Female

Country USA

Preferred Term BREAST ENLARGEMENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 168 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7021743 Date FDA Received
12-Jun-2009 Case # 7021743 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916330NA Role Route S C Outcomes Manufacturer Control # USBAYER-200919574NA Role Route S Health Professional Y ORAL Manufacturer Control # USBAYER-200919468NA Role Route S C Outcomes Manufacturer Control # USBAYER-200916334NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916325NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 29 YR Sex Female Dosage Text Age 23 YR Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ CIPROFLOXACIN EXTENDEDRELEASE

Manufacturer BAYER

7021745 Date FDA Received
12-Jun-2009

Case # 7021745

Case Type NON-EXPEDITED

Health Professional Y

Preferred Term RASH

Product YAZ Case # 7021746 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7021746 Date FDA Received
12-Jun-2009

Outcomes

Preferred Term AMENORRHOEA

Product YAZ LEVOTHYROXINE

Duration

Manufacturer BAYER

7021821 Date FDA Received
12-Jun-2009

Case # 7021821

Case Type NON-EXPEDITED

Health Professional N

Preferred Term TONGUE DISORDER

Product YAZ Case # 7021827 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7021827 Date FDA Received
12-Jun-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 169 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7021938 Date FDA Received
12-Jun-2009 Case # 7021938 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916328NA Role Route S Health Professional Y Product YAZ PRILOSEC CLARITIN ZOLOFT ORAL Manufacturer Control # Age 31 YR Dosage Text 1 TAB DAILY OTHER Duration Sex Female Dosage Text Age 20 YR Sex Female Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type DIRECT

Duration

Manufacturer BAYER Country USA

7026888 Date FDA Received
12-Jun-2009 Preferred Term

Case # 7026888

Outcomes HO Role Route S C C C

Manufacturer BAYER

PULMONARY EMBOLISM

6674094 Date FDA Received
15-Jun-2009

Case # 6674094

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200825669NA

Age 40 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED BLOOD TRIGLYCERIDES INCREASED

Product YAZ

Role Route S ORAL

Dosage Text ONE TABLET PER DAY

Duration

Manufacturer BAYER

7023084 Date FDA Received
15-Jun-2009

Case # 7023084

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916454NA

Age 28 YR

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED ABDOMINAL PAIN LOWER BREAST TENDERNESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 170 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7023088 Date FDA Received
15-Jun-2009 Case # 7023088 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916440NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916444NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916448NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 18 YR Sex Female Dosage Text Age 19 YR Sex Female Country USA

Preferred Term CHEST PAIN

Product YAZ Case # 7023094 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7023094 Date FDA Received
15-Jun-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7023108 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7023108 Date FDA Received
15-Jun-2009

Outcomes

Preferred Term HEADACHE ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

7024505 Date FDA Received
16-Jun-2009

Case # 7024505

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916487NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7024512 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7024512 Date FDA Received
16-Jun-2009

Outcomes

Manufacturer Control # USBAYER-200916178NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 171 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7024519 Date FDA Received
16-Jun-2009 Case # 7024519 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916179NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA DIZZINESS FEELING ABNORMAL NAUSEA

Product YAZ

Manufacturer BAYER

7024552 Date FDA Received
16-Jun-2009

Case # 7024552

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917444NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ YASMIN

Role Route S C Health Professional N Outcomes ORAL

Dosage Text FOR 3 MONTHS Manufacturer Control # USBAYER-200919363NA

Duration

Manufacturer BAYER

7024576 Date FDA Received
16-Jun-2009

Case # 7024576

Case Type NON-EXPEDITED

Age 35 YR

Sex Female

Country USA

Preferred Term MIGRAINE CONTACT LENS INTOLERANCE UNEVALUABLE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7024584 Date FDA Received
16-Jun-2009

Case # 7024584

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919236NA

Age 25 YR

Sex Female

Country USA

Preferred Term NAUSEA VOMITING NO ADVERSE EVENT

Product YAZ IBUPROFEN

Role Route S C ORAL

Dosage Text ON REGULAR BASIS

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 172 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7030845 Date FDA Received
16-Jun-2009 Preferred Term TACHYCARDIA PULMONARY EMBOLISM Case # 7030845 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO Role Route S ORAL Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 18 YR Duration Sex Female Country USA

Manufacturer

7031277 Date FDA Received
16-Jun-2009 Preferred Term FATIGUE

Case # 7031277

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Role Route S ORAL

Dosage Text 3 MG 1X DAILY PO

Duration

Manufacturer BAYER

BREAST ENLARGEMENT BREAST PAIN COGNITIVE DISORDER LIBIDO DECREASED

6910318 Date FDA Received
17-Jun-2009

Case # 6910318

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200910957NA

Age 46 YR

Sex Female

Country USA

Preferred Term IRRITABILITY OFF LABEL USE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7025639 Date FDA Received
17-Jun-2009

Case # 7025639

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916174NA

Age 46 YR

Sex Female

Country USA

Preferred Term GENITAL PAIN GENITAL BURNING SENSATION ADVERSE EVENT HEADACHE

Product YAZ ADVIL ALEVE

Role Route S C C ORAL ORAL ORAL

Dosage Text Total daily dose: 4 DF Unit dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 173 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7025666 Date FDA Received
17-Jun-2009 Case # 7025666 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916061NA Role Route S ORAL Dosage Text Age 43 YR Sex Female Country USA

Preferred Term HEADACHE ABDOMINAL PAIN LOWER

Product YAZ

Duration

Manufacturer BAYER

7032645 Date FDA Received
17-Jun-2009 Preferred Term DEPRESSION ALOPECIA

Case # 7032645

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Role Route S

Dosage Text 3MG DAILY

Duration

Manufacturer BAYER

DECREASED APPETITE DIZZINESS FEELING ABNORMAL FEELINGS OF WORTHLESSNESS HEADACHE LIBIDO DECREASED MOOD ALTERED SOCIAL AVOIDANT BEHAVIOUR

7032685 Date FDA Received
17-Jun-2009 Preferred Term

Case # 7032685

Case Type DIRECT Product YAZ

Health Professional N

Outcomes LT Role Route S C C ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text SINGLE PILL DAILU PO

Duration

Manufacturer

PULMONARY ARTERIAL HYPERTENSION HORMONE LEVEL ABNORMAL ACNE BREAST DISCHARGE IRRITABLE BOWEL SYNDROME WEIGHT INCREASED

ORTHO TRI CYCLEN CHANTIX

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 174 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7032768 Date FDA Received
17-Jun-2009 Preferred Term PALPITATIONS ANXIETY DECREASED APPETITE HYPOAESTHESIA INSOMNIA NAUSEA NERVOUSNESS PANIC ATTACK PARAESTHESIA SKIN BURNING SENSATION Case # 7032768 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO Role Route S ORAL Dosage Text 1 TAB DAILY PO Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer BAYER

7002000 Date FDA Received
18-Jun-2009

Case # 7002000

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200921487NA Dosage Text Total daily dose: 1 DF

Age 39 YR

Sex Female

Country USA

Preferred Term POLYURIA ABDOMINAL PAIN UPPER CHEST PAIN DIARRHOEA DYSPEPSIA FATIGUE FEELING ABNORMAL HOT FLUSH HYPERHIDROSIS MALAISE NAUSEA PHOBIA OF FLYING

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 175 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7026571 Date FDA Received
18-Jun-2009 Case # 7026571 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916059NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916054NA Role Route S ORAL Dosage Text Age 26 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term SPIDER VEIN

Product YAZ Case # 7026572 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7026572 Date FDA Received
18-Jun-2009

Outcomes

Preferred Term NAUSEA ABDOMINAL PAIN UPPER OFF LABEL USE

Product YAZ

Duration

Manufacturer BAYER

7027554 Date FDA Received
19-Jun-2009

Case # 7027554

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916038NA

Age

Sex Female

Country USA

Preferred Term BREAST TENDERNESS BREAST DISCHARGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7027556 Date FDA Received
19-Jun-2009

Case # 7027556

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916040NA

Age 21 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN ABDOMINAL DISCOMFORT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 176 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7027557 Date FDA Received
19-Jun-2009 Case # 7027557 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916052NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916053NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916046NA Role Route S ORAL Dosage Text Age 30 YR Sex Female Dosage Text Duration Dosage Text Duration 7 MTH Age Sex Female Age Sex Female Country USA

Preferred Term SINUSITIS

Product YAZ Case # 7027561 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7027561 Date FDA Received
19-Jun-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7027562 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7027562 Date FDA Received
19-Jun-2009

Outcomes

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7027563 Date FDA Received
19-Jun-2009

Case # 7027563

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916043NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7036600 Case Type DIRECT Product YAZ Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7036600 Date FDA Received
19-Jun-2009 Preferred Term

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM PULMONARY INFARCTION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 177 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6779379 Date FDA Received
22-Jun-2009 Case # 6779379 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200834176NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term HORMONE LEVEL ABNORMAL PREGNANCY TEST FALSE POSITIVE

Product YAZ

Manufacturer BAYER

7023102 Date FDA Received
22-Jun-2009

Case # 7023102

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916317NA

Age

Sex Female

Country USA

Preferred Term ANXIETY MUSCLE TIGHTNESS PALPITATIONS THROAT TIGHTNESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration 6 MTH

Manufacturer BAYER

7024423 Date FDA Received
22-Jun-2009

Case # 7024423

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200923201NA Dosage Text

Age 29 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT BLINDNESS UNILATERAL CEREBRAL ARTERY EMBOLISM CEREBRAL HAEMORRHAGE DEAFNESS UNILATERAL DIARRHOEA MIGRAINE NAUSEA PARALYSIS VOMITING

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 178 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7029299 Date FDA Received
22-Jun-2009 Case # 7029299 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # CABAYER-200923262NA Dosage Text Age 33 YR Sex Female Country CAN

Preferred Term SUICIDAL IDEATION MOOD ALTERED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7029411 Date FDA Received
22-Jun-2009

Case # 7029411

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923207NA

Age 20 YR

Sex Female

Country USA

Preferred Term BLOOD PROLACTIN INCREASED

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7029413 Date FDA Received
22-Jun-2009

Case # 7029413

Outcomes

Manufacturer Control # USBAYER-200923203NA

Age 16 YR

Sex Female

Country USA

Preferred Term HEART RATE IRREGULAR CHEST DISCOMFORT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7029419 Date FDA Received
22-Jun-2009

Case # 7029419

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921781NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7029432 Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7029432 Date FDA Received
22-Jun-2009

Manufacturer Control # USBAYER-200923235NA

Age 15 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 179 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7029434 Date FDA Received
22-Jun-2009 Case # 7029434 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923558NA Role Route S C ORAL Dosage Text 1 TAB/DAY Age 23 YR Sex Female Country USA

Preferred Term NEPHROLITHIASIS NAUSEA ABDOMINAL PAIN LOWER AMENORRHOEA VAGINAL HAEMORRHAGE VOMITING

Product YAZ OTHER MEDICATION

Duration

Manufacturer BAYER

6674104 Date FDA Received
23-Jun-2009

Case # 6674104

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200825377NA

Age 17 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA HYPOMENORRHOEA METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7030225 Date FDA Received
23-Jun-2009

Case # 7030225

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917185NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7039651 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7039651 Date FDA Received
23-Jun-2009 Preferred Term

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 PILL EACH NIGHT PO

Duration

Manufacturer BAYER

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 180 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7032020 Date FDA Received
24-Jun-2009 Case # 7032020 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DE Manufacturer Control # USBAYER-200924369NA Dosage Text 1 TAB / DAY Manufacturer Control # USBAYER-200924099NA Dosage Text Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term PULMONARY THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER Country USA

7032021 Date FDA Received
24-Jun-2009

Case # 7032021

Outcomes OT

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Manufacturer BAYER

7040370 Date FDA Received
24-Jun-2009 Preferred Term ANXIETY FEELING ABNORMAL FORMICATION

Case # 7040370

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text 1 PILL ONCE A DAY PO

Duration

Manufacturer BAYER

HORMONE LEVEL ABNORMAL HOT FLUSH NIGHT SWEATS PALPITATIONS PANIC ATTACK

7040890 Date FDA Received
24-Jun-2009 Preferred Term PALPITATIONS

Case # 7040890

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT,CA,OT,RI Role Route S BUCCAL

Manufacturer Control #

Age 46 YR

Sex Female

Country USA

Dosage Text DAILY BUCCAL

Duration

Manufacturer BAYER

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 181 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6903021 Date FDA Received
25-Jun-2009 Case # 6903021 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200910412NA Role Route S ORAL Dosage Text Age 16 YR Sex Female Country USA

Preferred Term METRORRHAGIA OLIGOMENORRHOEA

Product YAZ

Duration

Manufacturer BAYER

6929341 Date FDA Received
25-Jun-2009

Case # 6929341

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200912946LA Dosage Text

Age

Sex Female

Country BRA

Preferred Term SOMNOLENCE BREAST TENDERNESS METRORRHAGIA

Product YAZ

Role Route S ORAL

Duration 121 DAY

Manufacturer BAYER

6992058 Date FDA Received
25-Jun-2009

Case # 6992058

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # USBAYER-200919859NA Dosage Text

Age 43 YR

Sex Female

Country USA

Preferred Term MYOCARDIAL INFARCTION ANXIETY CHEST PAIN DYSPNOEA

Product YAZ YAZ

Role Route S S ORAL ORAL

Duration 6 MTH

Manufacturer BAYER BAYER

6995344 Date FDA Received
25-Jun-2009

Case # 6995344

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200920523NA Dosage Text

Age 47 YR

Sex Female

Country USA

Preferred Term BLOOD TRIGLYCERIDES INCREASED BLOOD CHOLESTEROL INCREASED CHEST PAIN

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 182 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6997387 Date FDA Received
25-Jun-2009 Case # 6997387 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # PLBAYER-200920929GPV Dosage Text Duration 10 DAY Age Sex Female Country POL

Preferred Term SCOTOMA LOSS OF CONSCIOUSNESS VERTIGO

Product YAZ

Role Route S ORAL

Manufacturer BAYER

6998356 Date FDA Received
25-Jun-2009

Case # 6998356

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200920590NA Dosage Text

Age 20 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT HYPOAESTHESIA DYSARTHRIA MIGRAINE VIIth nerve paralysis

Product YAZ ASPIRIN

Role Route S C ORAL

Duration

Manufacturer BAYER

7033042 Date FDA Received
25-Jun-2009

Case # 7033042

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915869NA

Age

Sex Female

Country USA

Preferred Term ANXIETY ABDOMINAL PAIN LOWER ABNORMAL BEHAVIOUR AFFECT LABILITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7033046 Date FDA Received
25-Jun-2009

Case # 7033046

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915878NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 183 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7033049 Date FDA Received
25-Jun-2009 Case # 7033049 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920591NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term BREAST TENDERNESS ABDOMINAL PAIN LOWER ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Manufacturer BAYER

7033053 Date FDA Received
25-Jun-2009

Case # 7033053

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920844NA

Age 22 YR

Sex Female

Country USA

Preferred Term OLIGOMENORRHOEA METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7033061 Date FDA Received
25-Jun-2009

Case # 7033061

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915984NA

Age 28 YR

Sex Female

Country USA

Preferred Term RASH

Product YAZ Case # 6652094 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

6652094 Date FDA Received
26-Jun-2009

Outcomes OT

Manufacturer Control # USBAYER-200817995NA Dosage Text ONE TABLET PER DAY

Age 39 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA BILIRUBINURIA CHEST DISCOMFORT DIZZINESS NAUSEA PALPITATIONS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 184 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6948332 Date FDA Received
26-Jun-2009 Case # 6948332 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200913924NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200914174NA Role Route S ORAL Dosage Text Age 21 YR Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term HYPERKALAEMIA

Product YAZ NSAIDS

Manufacturer BAYER

6952554 Date FDA Received
26-Jun-2009

Case # 6952554

Case Type NON-EXPEDITED

Preferred Term Gingivitis DYSGEUSIA

Product YAZ

Duration

Manufacturer BAYER

6977066 Date FDA Received
26-Jun-2009

Case # 6977066

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915170NA

Age

Sex Female

Country USA

Preferred Term DEPRESSION CRYING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7034306 Date FDA Received
26-Jun-2009

Case # 7034306

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916649NA

Age

Sex Female

Country USA

Preferred Term NAUSEA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration 3 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 185 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7034307 Date FDA Received
26-Jun-2009 Case # 7034307 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917720NA Role Route S C C C C C C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200916659NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916683NA Role Route S ORAL Dosage Text Age 37 YR Sex Female Dosage Text Age 40 YR Sex Female Country USA ORAL Dosage Text Age 39 YR Sex Female Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING WITHDRAWAL BLEED

Product YAZ LUXOX NOS CARBAMAZEPINE NEURONTIN KLONOPIN WELLBUTRIN SR LAMICTAL VITAMIN D ZANTAC

Duration

Manufacturer BAYER

7034308 Date FDA Received
26-Jun-2009

Case # 7034308

Case Type NON-EXPEDITED

Preferred Term AMENORRHOEA

Product YAZ Case # 7034312 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7034312 Date FDA Received
26-Jun-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING MENSTRUATION DELAYED

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 186 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7034315 Date FDA Received
26-Jun-2009 Case # 7034315 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916648NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term PREMENSTRUAL SYNDROME DEPRESSION WEIGHT INCREASED

Product YAZ

Manufacturer BAYER

7034316 Date FDA Received
26-Jun-2009

Case # 7034316

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916643NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7034318 Date FDA Received
26-Jun-2009

Case # 7034318

Outcomes

Manufacturer Control # USBAYER-200916645NA

Age 29 YR

Sex Female

Country USA

Preferred Term DYSGEUSIA

Product YAZ Case # 7034321 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7034321 Date FDA Received
26-Jun-2009

Outcomes

Manufacturer Control # USBAYER-200916646NA

Age

Sex Female

Country USA

Preferred Term DYSPEPSIA CHEST DISCOMFORT MUSCLE TIGHTNESS VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 187 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7034322 Date FDA Received
26-Jun-2009 Case # 7034322 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916647NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL DISTENSION HOT FLUSH MOOD SWINGS SENSATION OF HEAVINESS

Product YAZ

Manufacturer BAYER

7034330 Date FDA Received
26-Jun-2009

Case # 7034330

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921736NA

Age

Sex Female

Country USA

Preferred Term ADVERSE DRUG REACTION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7034337 Date FDA Received
26-Jun-2009

Case # 7034337

Outcomes

Manufacturer Control # USBAYER-200921880NA

Age

Sex Female

Country USA

Preferred Term COITAL BLEEDING VAGINAL DISCHARGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7044594 Date FDA Received
29-Jun-2009 Preferred Term THROMBOSIS

Case # 7044594

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text STANDARD DAILY PO

Duration 6 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 188 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7032015 Date FDA Received
30-Jun-2009 Case # 7032015 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes Manufacturer Control # CABAYER-200922600NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Age 32 YR Sex Female Country CAN

Preferred Term FEELING ABNORMAL CERVIX DISORDER FATIGUE FOOD CRAVING METRORRHAGIA NAUSEA

Product YAZ

Duration

Manufacturer BAYER

7036880 Date FDA Received
30-Jun-2009

Case # 7036880

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924173NA

Age 33 YR

Sex Female

Country USA

Preferred Term MIGRAINE WITH AURA

Product YAZ

Role Route S ORAL

Dosage Text DOSING SCHEDULE AS INDICATED IN PACKAGE INSERT ON CONTINUOUS BASIS Manufacturer Control #

Duration

Manufacturer BAYER

VAGINAL HAEMORRHAGE

YAZ Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ Health Professional N Health Professional N

S

ORAL

BAYER Age 48 YR Sex Female Country USA

7043844 Date FDA Received
30-Jun-2009 Preferred Term

Case # 7043844

Outcomes HO Role Route S ORAL

Dosage Text ONE PILL DAILY PO Manufacturer Control #

Duration

Manufacturer BAYER

PULMONARY EMBOLISM

7047768 Date FDA Received
30-Jun-2009 Preferred Term DIARRHOEA

Case # 7047768

Outcomes OT Role Route S ORAL

Age 38 YR

Sex Female

Country USA

Dosage Text REGULAR YAZ DOSE ONCE DAILY PO APPROX. SIX WEEKS OR SO

Duration 6 WEEK

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 189 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7047830 Date FDA Received
30-Jun-2009 Preferred Term FATIGUE ALOPECIA AMENORRHOEA CHOKING SENSATION MUSCLE SPASMS MUSCULAR WEAKNESS TINNITUS VERTIGO WEIGHT INCREASED Case # 7047830 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer BAYER

7038515 Date FDA Received
01-Jul-2009

Case # 7038515

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200917956LA Dosage Text

Age 22 YR

Sex Female

Country BRA

Preferred Term MICTURITION URGENCY BLADDER DISCOMFORT HEADACHE HYPOAESTHESIA LOSS OF CONSCIOUSNESS MUSCLE SPASTICITY

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7038518 Date FDA Received
01-Jul-2009

Case # 7038518

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200924438NA Dosage Text CONTINUOUS

Age 41 YR

Sex Female

Country USA

Preferred Term BLOOD ALDOSTERONE INCREASED BLOOD SODIUM DECREASED DIZZINESS ENDOMETRIOSIS ABLATION

Product MIRENA YAZ

Role Route S S INTRAUTERINE ORAL

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 190 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7039616 Date FDA Received
02-Jul-2009 Case # 7039616 Case Type NON-EXPEDITED Health Professional N Outcomes HO Manufacturer Control # USBAYER-200925043NA Dosage Text Age 39 YR Sex Female Country USA

Preferred Term THROMBOSIS OEDEMA PERIPHERAL PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7047809 Date FDA Received
02-Jul-2009 Preferred Term MUSCLE SPASMS

Case # 7047809

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 32 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration

Manufacturer BAYER

DEEP VEIN THROMBOSIS JOINT SWELLING PULMONARY EMBOLISM

7047835 Date FDA Received
02-Jul-2009 Preferred Term

Case # 7047835

Case Type DIRECT Product YAZ Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO Manufacturer Control # USBAYER-200825222NA

Duration

Manufacturer

PULMONARY EMBOLISM

6673301 Date FDA Received
06-Jul-2009

Case # 6673301

Health Professional N

Outcomes

Age 28 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration 6 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 191 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6719717 Date FDA Received
06-Jul-2009 Case # 6719717 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200828953NA Role Route S Health Professional N ORAL Dosage Text 1 TAB/DAILY Manufacturer Control # USBAYER-200914714NA Role Route S ORAL Dosage Text Age 19 YR Sex Female Age 34 YR Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration

Manufacturer BAYER Country USA

6961207 Date FDA Received
06-Jul-2009

Case # 6961207

Case Type NON-EXPEDITED

Outcomes

Preferred Term FEELING ABNORMAL ABNORMAL BEHAVIOUR CRYING NO ADVERSE EVENT SELF ESTEEM DECREASED

Product YAZ

Duration

Manufacturer BAYER

7041280 Date FDA Received
06-Jul-2009

Case # 7041280

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200925047NA Dosage Text

Age 22 YR

Sex Female

Country USA

Preferred Term ENTEROCOLITIS INFECTIOUS ABDOMINAL PAIN UPPER DIARRHOEA VOMITING

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 192 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7041284 Date FDA Received
06-Jul-2009 Case # 7041284 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200925207NA Dosage Text Age 25 YR Sex Female Country USA

Preferred Term CONVULSION EYE MOVEMENT DISORDER TREMOR VISUAL IMPAIRMENT

Product YAZ

Role Route S ORAL

Duration 2 YEAR

Manufacturer BAYER

7041378 Date FDA Received
06-Jul-2009

Case # 7041378

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922148NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE FATIGUE NAUSEA POLLAKIURIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7041394 Date FDA Received
06-Jul-2009

Case # 7041394

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922599NA

Age

Sex Female

Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7041423 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration 3 MTH

Manufacturer BAYER Sex Female Country USA

7041423 Date FDA Received
06-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200922922NA

Age 43 YR

Preferred Term SINUSITIS

Product YAZ

Role Route S ORAL

Dosage Text

Duration 1 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 193 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7041447 Date FDA Received
06-Jul-2009 Case # 7041447 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922854NA Role Route S ORAL Dosage Text Age 16 YR Sex Female Country USA

Preferred Term DEPRESSION CRYING NO ADVERSE EVENT SOCIAL AVOIDANT BEHAVIOUR

Product YAZ

Duration

Manufacturer BAYER

7049518 Date FDA Received
07-Jul-2009 Preferred Term IRRITABILITY DEPRESSION MIGRAINE MOOD SWINGS

Case # 7049518

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

7049551 Date FDA Received
07-Jul-2009 Preferred Term

Case # 7049551

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,DS,LT Role Route S ORAL

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 1 TAB DAILY PO

Duration

Manufacturer

SUPRAVENTRICULAR TACHYCARDIA IMPAIRED WORK ABILITY PULMONARY EMBOLISM

7049611 Date FDA Received
07-Jul-2009 Preferred Term CYSTITIS

Case # 7049611

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text 3MG TABLET ONCE A DAY PO

Duration

Manufacturer BAYER

CYSTITIS NONINFECTIVE PELVIC PAIN

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 194 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6976054 Date FDA Received
08-Jul-2009 Case # 6976054 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200916486NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term FATIGUE BLOOD POTASSIUM INCREASED

Product YAZ

Manufacturer BAYER

7017115 Date FDA Received
08-Jul-2009

Case # 7017115

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200922963NA Dosage Text

Age

Sex Female

Country USA

Preferred Term SYNCOPE DIZZINESS HEAD INJURY LOSS OF CONSCIOUSNESS RESPIRATORY ARREST

Product YAZ

Role Route S ORAL

Duration 8 MTH

Manufacturer BAYER

7044018 Date FDA Received
08-Jul-2009

Case # 7044018

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920852NA

Age 26 YR

Sex Female

Country USA

Preferred Term VAGINAL DISCHARGE ABDOMINAL PAIN LOWER METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7044031 Date FDA Received
08-Jul-2009

Case # 7044031

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920430NA

Age 23 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 195 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7044040 Date FDA Received
08-Jul-2009 Case # 7044040 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921302NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term MENORRHAGIA NO ADVERSE EVENT VAGINAL DISCHARGE

Product YAZ

Manufacturer BAYER

7044050 Date FDA Received
08-Jul-2009

Case # 7044050

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200925327NA Dosage Text

Age 45 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7045145 Date FDA Received
09-Jul-2009

Case # 7045145

Outcomes OT

Manufacturer Control # BRBAYER-200918626LA Dosage Text

Age 31 YR

Sex Female

Country BRA

Preferred Term SOMNOLENCE DEPRESSED MOOD MALAISE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7045216 Date FDA Received
09-Jul-2009

Case # 7045216

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916491NA

Age

Sex Female

Country USA

Preferred Term NAUSEA VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 196 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7045221 Date FDA Received
09-Jul-2009 Case # 7045221 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200916510NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916629NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916637NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921532NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922979NA Role Route S ORAL Dosage Text Duration 1.17 YEAR Age Sex Female Dosage Text Age 39 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 31 YR Sex Female Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7045226 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7045226 Date FDA Received
09-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7045227 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7045227 Date FDA Received
09-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7045229 Date FDA Received
09-Jul-2009

Case # 7045229

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7045232 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7045232 Date FDA Received
09-Jul-2009

Outcomes

Preferred Term MENORRHAGIA ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 197 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7045236 Date FDA Received
09-Jul-2009 Case # 7045236 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922935NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200916639NA Role Route S Health Professional ORAL Manufacturer Control # Age 24 YR Dosage Text 1 TABLET DAILY 3-4 MONTHS Manufacturer Control # USBAYER-200913012NA Role Route S S ORAL TOPICAL Dosage Text Total daily dose: 1 DF FACE CREAM Manufacturer Control # USBAYER-200913590NA Role Route S ORAL Dosage Text Age 33 YR Sex Female Country USA Duration 18 DAY Age Sex Female Country USA Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7045242 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7045242 Date FDA Received
09-Jul-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type DIRECT Product YAZ

Manufacturer BAYER Country USA

7053177 Date FDA Received
09-Jul-2009 Preferred Term

Case # 7053177

Outcomes HO,LT,OT,RI Role Route S

Manufacturer

PULMONARY EMBOLISM

6941278 Date FDA Received
10-Jul-2009

Case # 6941278

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Preferred Term ACNE

Product YAZ UNSPECIFIED INGREDIENT

Manufacturer BAYER

6952524 Date FDA Received
10-Jul-2009

Case # 6952524

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Preferred Term ACNE NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 198 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7046800 Date FDA Received
10-Jul-2009 Case # 7046800 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200925425NA Dosage Text Age 29 YR Sex Female Country USA

Preferred Term PITUITARY TUMOUR BLOOD FOLLICLE STIMULATING HORMONE ABNORMAL BLOOD OESTROGEN ABNORMAL BLOOD TESTOSTERONE ABNORMAL FATIGUE IRRITABILITY

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7046965 Date FDA Received
10-Jul-2009

Case # 7046965

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923165NA

Age

Sex Female

Country USA

Preferred Term MUSCLE SPASMS NO ADVERSE EVENT

Product YAZ YAZ Case # 7046970 Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

7046970 Date FDA Received
10-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200917113NA

Age 23 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 199 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7054731 Date FDA Received
10-Jul-2009 Preferred Term TREMOR DEPRESSION HYPOPHAGIA INSOMNIA MENTAL DISORDER TOOTH DISORDER Case # 7054731 Case Type DIRECT Product YAZ Health Professional N Outcomes LT Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # Age 38 YR Duration Sex Female Country USA

Manufacturer BAYER

7055102 Date FDA Received
10-Jul-2009 Preferred Term

Case # 7055102

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text 1 TAB -3 MG/0.02 MGDAILY PO

Duration

Manufacturer BAYER

ACUTE MYOCARDIAL INFARCTION CORONARY ARTERY OCCLUSION CORONARY ARTERY THROMBOSIS

6674077 Date FDA Received
13-Jul-2009

Case # 6674077

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200825353NA

Age 44 YR

Sex Female

Country USA

Preferred Term PREMENSTRUAL SYNDROME BREAST ENLARGEMENT DEPRESSION FATIGUE FEELING ABNORMAL FEELING COLD HEADACHE HYPOGLYCAEMIA IRRITABILITY MOOD ALTERED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 200 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7048377 Date FDA Received
13-Jul-2009 Case # 7048377 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918378NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918927NA Role Route S ORAL Dosage Text Age 16 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7048391 Date FDA Received
13-Jul-2009

Case # 7048391

Outcomes

Preferred Term MENSTRUATION DELAYED METRORRHAGIA

Product YAZ

Duration

Manufacturer BAYER

7048489 Date FDA Received
13-Jul-2009

Case # 7048489

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917188NA

Age 18 YR

Sex Female

Country USA

Preferred Term NASAL CONGESTION RESPIRATORY DISORDER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7048491 Date FDA Received
13-Jul-2009

Case # 7048491

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917127NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7048492 Date FDA Received
13-Jul-2009

Case # 7048492

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917166NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 201 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7048493 Date FDA Received
13-Jul-2009 Case # 7048493 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917170NA Role Route S C C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200917137NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917142NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 18 YR Sex Female Country USA ORAL Dosage Text Age 30 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ EFFEXOR IRON AMBIEN ATENOLOL

Duration

Manufacturer BAYER

7048497 Date FDA Received
13-Jul-2009

Case # 7048497

Case Type NON-EXPEDITED

Preferred Term COITAL BLEEDING

Product YAZ Case # 7048500 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7048500 Date FDA Received
13-Jul-2009

Outcomes

Preferred Term METRORRHAGIA AMENORRHOEA

Product YAZ

Manufacturer BAYER

7048502 Date FDA Received
13-Jul-2009

Case # 7048502

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917129NA

Age 18 YR

Sex Female

Country USA

Preferred Term AFFECT LABILITY ENDOCRINE DISORDER IRRITABILITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 202 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7048503 Date FDA Received
13-Jul-2009 Case # 7048503 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917139NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200917181NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917143NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917180NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 29 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ADVERSE EVENT

Product YAZ YAZ

Manufacturer BAYER BAYER Country USA

7048505 Date FDA Received
13-Jul-2009

Case # 7048505

Case Type NON-EXPEDITED

Outcomes

Preferred Term AMENORRHOEA

Product YAZ Case # 7048507 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7048507 Date FDA Received
13-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7048510 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7048510 Date FDA Received
13-Jul-2009

Outcomes

Preferred Term DEPRESSION ASTHENIA MOOD SWINGS

Product YAZ

Duration

Manufacturer BAYER

7048512 Date FDA Received
13-Jul-2009

Case # 7048512

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917141NA

Age

Sex Female

Country USA

Preferred Term BREAST DISCHARGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 203 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7048514 Date FDA Received
13-Jul-2009 Case # 7048514 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917135NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term FATIGUE METRORRHAGIA

Product YAZ

Manufacturer BAYER

6796721 Date FDA Received
14-Jul-2009

Case # 6796721

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200834943NA

Age 37 YR

Sex Female

Country USA

Preferred Term HEADACHE DYSSTASIA NAUSEA NO ADVERSE EVENT VULVOVAGINAL DISCOMFORT

Product YAZ

Role Route S ORAL

Dosage Text

Duration 3 WEEK

Manufacturer BAYER

6961211 Date FDA Received
14-Jul-2009

Case # 6961211

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200914877NA

Age 35 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ ASCORBIC ACID \ERGOCALCIFEROL\FOLIC ACID \RETINOL\TOCOPHEROL Case # 7049368 Case Type NON-EXPEDITED Health Professional N

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

7049368 Date FDA Received
14-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200917174NA

Age 24 YR

Sex Female

Country USA

Preferred Term VAGINAL DISCHARGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 204 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7049369 Date FDA Received
14-Jul-2009 Case # 7049369 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917169NA Role Route S C Outcomes Manufacturer Control # USBAYER-200917133NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term IRRITABILITY PREMENSTRUAL SYNDROME

Product YAZ ST. JOHNS WORT Case Type NON-EXPEDITED Health Professional N

Manufacturer BAYER

7049370 Date FDA Received
14-Jul-2009

Case # 7049370

Preferred Term NAUSEA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7049371 Date FDA Received
14-Jul-2009

Case # 7049371

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917292NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7049372 Date FDA Received
14-Jul-2009

Case # 7049372

Outcomes

Manufacturer Control # USBAYER-200917168NA

Age 20 YR

Sex Female

Country USA

Preferred Term FATIGUE ADNEXA UTERI PAIN BREAST PAIN NAUSEA NO ADVERSE EVENT SOMNOLENCE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 205 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7049373 Date FDA Received
14-Jul-2009 Case # 7049373 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917177NA Role Route S C ORAL Dosage Text Age 42 YR Sex Female Country USA

Preferred Term WITHDRAWAL BLEED BACK INJURY NO ADVERSE EVENT PAIN IN EXTREMITY

Product YAZ NSAIDS NOS

Duration

Manufacturer BAYER

7049374 Date FDA Received
14-Jul-2009

Case # 7049374

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917175NA

Age 26 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7049375 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7049375 Date FDA Received
14-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200917171NA

Age 26 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7049378 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7049378 Date FDA Received
14-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200917317NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 206 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7049385 Date FDA Received
14-Jul-2009 Case # 7049385 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917311NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term PAIN IN EXTREMITY HEADACHE NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7049386 Date FDA Received
14-Jul-2009

Case # 7049386

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917606NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ Case # 7056150 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7056150 Date FDA Received
14-Jul-2009 Preferred Term

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text ONE PILL ONE TIME A DAY PO

Duration

Manufacturer

VULVOVAGINAL PRURITUS GENITAL INFECTION BACTERIAL GENITAL INFECTION FUNGAL LIBIDO DECREASED VAGINAL DISCHARGE WEIGHT INCREASED

7050669 Date FDA Received
15-Jul-2009

Case # 7050669

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917961NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ ANTIBIOTICS

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 207 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050675 Date FDA Received
15-Jul-2009 Case # 7050675 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917725NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917603NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917716NA Role Route S C ORAL ORAL 3MG/0.02MG Dosage Text Age 46 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7050676 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050676 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050677 Date FDA Received
15-Jul-2009

Case # 7050677

Outcomes

Preferred Term MUSCLE SPASMS FATIGUE ABDOMINAL DISTENSION NO ADVERSE EVENT

Product YAZ CELEBREX

Duration

Manufacturer BAYER

7050679 Date FDA Received
15-Jul-2009

Case # 7050679

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917838NA

Age 18 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 208 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050681 Date FDA Received
15-Jul-2009 Case # 7050681 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917609NA Role Route S S C C Outcomes Unit dose: 50 MG Manufacturer Control # USBAYER-200917722NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL ORAL Dosage Text Age 32 YR Sex Female Country USA

Preferred Term ALOPECIA WEIGHT DECREASED ACNE

Product YAZ YAZ PAXIL DOXYCYCLINE

Duration

Manufacturer BAYER BAYER

7050682 Date FDA Received
15-Jul-2009

Case # 7050682

Case Type NON-EXPEDITED

Health Professional N

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7050684 Date FDA Received
15-Jul-2009

Case # 7050684

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200917680NA

Age

Sex Female

Country USA

Preferred Term RASH

Product YAZ Case # 7050685 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050685 Date FDA Received
15-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200917694NA

Age 22 YR

Sex Female

Country USA

Preferred Term BLOOD POTASSIUM INCREASED DIZZINESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 209 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050686 Date FDA Received
15-Jul-2009 Case # 7050686 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917611NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918023NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917590NA Role Route S ORAL Dosage Text Age 16 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 29 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7050694 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7050694 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050697 Date FDA Received
15-Jul-2009

Case # 7050697

Outcomes

Preferred Term ABDOMINAL PAIN UPPER NAUSEA

Product YAZ

Duration

Manufacturer BAYER

7050703 Date FDA Received
15-Jul-2009

Case # 7050703

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918241NA

Age 29 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7050710 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050710 Date FDA Received
15-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918031NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 210 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050715 Date FDA Received
15-Jul-2009 Case # 7050715 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918128NA Role Route S ORAL Dosage Text Age 19 YR Sex Female Country USA

Preferred Term IRRITABILITY NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7050717 Date FDA Received
15-Jul-2009

Case # 7050717

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918026NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7050720 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050720 Date FDA Received
15-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918011NA

Age 43 YR

Sex Female

Country USA

Preferred Term INSOMNIA

Product YAZ Case # 7050721 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050721 Date FDA Received
15-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918027NA

Age 17 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7050722 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050722 Date FDA Received
15-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200919807NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 211 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050723 Date FDA Received
15-Jul-2009 Case # 7050723 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918577NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term BREAST TENDERNESS DEPRESSION WEIGHT INCREASED

Product YAZ

Manufacturer BAYER

7050725 Date FDA Received
15-Jul-2009

Case # 7050725

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918382NA

Age

Sex Female

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050729 Date FDA Received
15-Jul-2009

Case # 7050729

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918587NA

Age

Sex Female

Country USA

Preferred Term BLOOD POTASSIUM INCREASED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7050730 Date FDA Received
15-Jul-2009

Case # 7050730

Outcomes

Manufacturer Control # USBAYER-200918967NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 212 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050733 Date FDA Received
15-Jul-2009 Case # 7050733 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918576NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919650NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919804NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918381NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920837NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 36 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7050739 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050739 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7050740 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7050740 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050741 Date FDA Received
15-Jul-2009

Case # 7050741

Outcomes

Preferred Term UPPER RESPIRATORY TRACT INFECTION

Product YAZ

Manufacturer BAYER Country USA

7050747 Date FDA Received
15-Jul-2009

Case # 7050747

Case Type NON-EXPEDITED

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 213 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050757 Date FDA Received
15-Jul-2009 Case # 7050757 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920141NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922945NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922355NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920745NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920741NA Role Route S ORAL Dosage Text Age 21 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 19 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7050759 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050759 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 7050760 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050760 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term WITHDRAWAL BLEED

Product YAZ Case # 7050765 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7050765 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050766 Date FDA Received
15-Jul-2009

Case # 7050766

Outcomes

Preferred Term METRORRHAGIA

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 214 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050768 Date FDA Received
15-Jul-2009 Case # 7050768 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920165NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921191NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922489NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920855NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921882NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Age 13 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7050769 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050769 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7050770 Case Type NON-EXPEDITED

Duration 3 MTH Age Sex

Manufacturer BAYER Country USA

7050770 Date FDA Received
15-Jul-2009

Outcomes

Female

Preferred Term ACNE

Product YAZ Case # 7050771 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050771 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050772 Date FDA Received
15-Jul-2009

Case # 7050772

Outcomes

Preferred Term METRORRHAGIA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 215 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050775 Date FDA Received
15-Jul-2009 Case # 7050775 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922620NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917447NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917446NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917591NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917449NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Duration 1 YEAR Age Sex Female Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7050784 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050784 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term HEADACHE

Product YAZ Case # 7050785 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050785 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050787 Date FDA Received
15-Jul-2009

Case # 7050787

Outcomes

Preferred Term PAIN IN EXTREMITY

Product YAZ Case # 7050790 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050790 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 216 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050792 Date FDA Received
15-Jul-2009 Case # 7050792 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917551NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200917445NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917310NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917600NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200917614NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 19 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MOOD SWINGS

Product YAZ Case # 7050793 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050793 Date FDA Received
15-Jul-2009

Preferred Term RASH

Product YAZ Case # 7050795 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050795 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7050801 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7050801 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7050805 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7050805 Date FDA Received
15-Jul-2009

Outcomes

Preferred Term AMENORRHOEA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 217 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7050806 Date FDA Received
15-Jul-2009 Case # 7050806 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200917602NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200822558NA Role Route S Health Professional N ORAL Dosage Text ONE TABLET PER DAY Manufacturer Control # USBAYER-200922657NA Dosage Text 1 TAB/DAY UNKNOWN UNKNOWN UNKNOWN 20 MG "TWICE A WEEK" Age 29 YR Sex Female Duration Age Sex Female Dosage Text Age 31 YR Sex Female Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 6673255 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6673255 Date FDA Received
16-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7017104 Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

7017104 Date FDA Received
16-Jul-2009

Outcomes HO

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE FUNGAL OESOPHAGITIS GASTRITIS FUNGAL BLOOD COUNT ABNORMAL

Product YAZ PREDNISONE PREDNISONE ANALGESICS PERCOCET

Role Route S S C C C Health Professional Y Outcomes

Duration 6 MTH

Manufacturer BAYER

7017257 Date FDA Received
16-Jul-2009

Case # 7017257

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200920479NA

Age 45 YR

Sex Female

Country USA

Preferred Term DYSMENORRHOEA MENOMETRORRHAGIA PREMENSTRUAL SYNDROME

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 218 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052074 Date FDA Received
16-Jul-2009 Case # 7052074 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918379NA Role Route S ORAL Dosage Text Age 28 YR Sex Female Country USA

Preferred Term AFFECT LABILITY CRYING EUPHORIC MOOD SCREAMING

Product YAZ

Duration

Manufacturer BAYER

7052075 Date FDA Received
16-Jul-2009

Case # 7052075

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918385NA

Age

Sex Female

Country USA

Preferred Term HEADACHE NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052082 Date FDA Received
16-Jul-2009

Case # 7052082

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918126NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7052083 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052083 Date FDA Received
16-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918116NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 219 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052086 Date FDA Received
16-Jul-2009 Case # 7052086 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918118NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA

Preferred Term NAUSEA HEADACHE

Product YAZ

Duration

Manufacturer BAYER

7052087 Date FDA Received
16-Jul-2009

Case # 7052087

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918380NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7052088 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052088 Date FDA Received
16-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918152NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052089 Date FDA Received
16-Jul-2009

Case # 7052089

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918384NA

Age

Sex Female

Country USA

Preferred Term HEADACHE NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 220 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052091 Date FDA Received
16-Jul-2009 Case # 7052091 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918144NA Role Route S ORAL Dosage Text Age 40 YR Sex Female Country USA

Preferred Term WEIGHT INCREASED ANXIETY BACK PAIN BREAST TENDERNESS MUSCLE SPASMS NO ADVERSE EVENT PAIN

Product YAZ

Duration

Manufacturer BAYER

7052095 Date FDA Received
16-Jul-2009

Case # 7052095

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918258NA

Age 29 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA ABDOMINAL PAIN LOWER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052097 Date FDA Received
16-Jul-2009

Case # 7052097

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918377NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 221 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052102 Date FDA Received
16-Jul-2009 Case # 7052102 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918134NA Role Route S C C C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200918592NA Role Route S ORAL Dosage Text Age 20 YR Sex Female Country USA ORAL Dosage Text Age 45 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ CYMBALTA QUETIAPINE FUMARATE IRON VITAMIN B COMPLEX LIBRIUM

Duration

Manufacturer BAYER

7052107 Date FDA Received
16-Jul-2009

Case # 7052107

Case Type NON-EXPEDITED

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7052110 Date FDA Received
16-Jul-2009

Case # 7052110

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918559NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7052112 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052112 Date FDA Received
16-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918590NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 222 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052113 Date FDA Received
16-Jul-2009 Case # 7052113 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200918574NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200918578NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918561NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918642NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918562NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7052116 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052116 Date FDA Received
16-Jul-2009

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7052117 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052117 Date FDA Received
16-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052118 Date FDA Received
16-Jul-2009

Case # 7052118

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7052119 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052119 Date FDA Received
16-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 223 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052120 Date FDA Received
16-Jul-2009 Case # 7052120 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918585NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918851NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918563NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918741NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7052125 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052125 Date FDA Received
16-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052127 Date FDA Received
16-Jul-2009

Case # 7052127

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7052128 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052128 Date FDA Received
16-Jul-2009

Outcomes

Preferred Term HYPOMENORRHOEA MENSTRUAL DISORDER

Product YAZ

Manufacturer BAYER

7052132 Date FDA Received
16-Jul-2009

Case # 7052132

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919366NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 224 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052134 Date FDA Received
16-Jul-2009 Case # 7052134 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921078NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term WITHDRAWAL BLEED WEIGHT INCREASED

Product YAZ

Manufacturer BAYER

7052139 Date FDA Received
16-Jul-2009

Case # 7052139

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921054NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ ANTIBIOTICS

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7052140 Date FDA Received
16-Jul-2009

Case # 7052140

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200918800NA

Age 26 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ YAZ

Role Route S S Health Professional N ORAL ORAL

Dosage Text

Duration 8 MTH

Manufacturer BAYER BAYER

7052154 Date FDA Received
16-Jul-2009

Case # 7052154

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200918821NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7052155 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7052155 Date FDA Received
16-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918828NA

Age 37 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 225 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7052165 Date FDA Received
16-Jul-2009 Case # 7052165 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923858NA Role Route S Health Professional N Outcomes Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Manufacturer Control # USBAYER-200922501NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922495NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200918794NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918773NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 44 YR Sex Female Dosage Text Duration Age Sex Female Age 17 YR Sex Female Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7052171 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7052171 Date FDA Received
16-Jul-2009

Preferred Term METRORRHAGIA

Product YAZ Case # 7052183 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7052183 Date FDA Received
16-Jul-2009

Outcomes

Preferred Term AMENORRHOEA

Product YAZ ACCUTANE

Duration

Manufacturer BAYER

7053448 Date FDA Received
17-Jul-2009

Case # 7053448

Case Type NON-EXPEDITED

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7053450 Date FDA Received
17-Jul-2009

Case # 7053450

Outcomes

Preferred Term METRORRHAGIA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 226 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7053452 Date FDA Received
17-Jul-2009 Case # 7053452 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918770NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918775NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918823NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 20 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term SENSATION OF HEAVINESS

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7053453 Date FDA Received
17-Jul-2009

Case # 7053453

Outcomes

Preferred Term SINUSITIS

Product YAZ Case # 7053454 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7053454 Date FDA Received
17-Jul-2009

Outcomes

Preferred Term MALAISE NAUSEA VOMITING

Product YAZ

Manufacturer BAYER

7053455 Date FDA Received
17-Jul-2009

Case # 7053455

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918853NA

Age

Sex Female

Country USA

Preferred Term ACNE CYSTIC

Product YAZ Case # 7053456 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7053456 Date FDA Received
17-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918776NA

Age

Sex Female

Country USA

Preferred Term DEPRESSION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 227 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7053458 Date FDA Received
17-Jul-2009 Case # 7053458 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918791NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200918930NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term BREAST PAIN

Product YAZ Case # 7053463 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7053463 Date FDA Received
17-Jul-2009

Outcomes

Preferred Term METRORRHAGIA HUNGER WEIGHT INCREASED

Product YAZ

Manufacturer BAYER

7053466 Date FDA Received
17-Jul-2009

Case # 7053466

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918913NA

Age

Sex Male

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7053469 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7053469 Date FDA Received
17-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918911NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT ABNORMAL WITHDRAWAL BLEEDING METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 228 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7053474 Date FDA Received
17-Jul-2009 Case # 7053474 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918991NA Role Route S ORAL Dosage Text Duration 5 DAY Age Sex Female Country USA

Preferred Term HEADACHE LIBIDO INCREASED NECK PAIN

Product YAZ

Manufacturer BAYER

7053475 Date FDA Received
17-Jul-2009

Case # 7053475

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200918969NA

Age 23 YR

Sex Female

Country USA

Preferred Term BRONCHITIS ACNE ABDOMINAL DISTENSION

Product YAZ VITAMINS FISH OIL VITAMIN B COMPLEX

Role Route S C C C Outcomes ORAL

Dosage Text Total daily dose: 1 DF

Duration 1.5 YEAR

Manufacturer BAYER

7053485 Date FDA Received
17-Jul-2009

Case # 7053485

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200918908NA

Age 24 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7053486 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7053486 Date FDA Received
17-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200918988NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 229 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7053487 Date FDA Received
17-Jul-2009 Case # 7053487 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200918986NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923839NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200840894NA Role Route S ORAL Dosage Text Age 27 YR Sex Female Dosage Text Age 33 YR Sex Female Dosage Text Age 39 YR Sex Female Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7053494 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7053494 Date FDA Received
17-Jul-2009

Outcomes

Preferred Term MEDICATION ERROR

Product YAZ Case # 6855339 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

6855339 Date FDA Received
20-Jul-2009

Outcomes

Preferred Term PREMENSTRUAL SYNDROME ANXIETY BREAST TENDERNESS DEPRESSED MOOD HEADACHE HYPOAESTHESIA MENSTRUATION IRREGULAR MUSCLE TWITCHING NERVOUSNESS NO ADVERSE EVENT PAIN PALPITATIONS RASH MACULAR TREMOR VULVOVAGINAL MYCOTIC INFECTION

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 230 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6971293 Date FDA Received
20-Jul-2009 Case # 6971293 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DE Manufacturer Control # USBAYER-200918424NA Dosage Text Duration Age Sex Female Country USA

Preferred Term DEATH

Product YAZ Case # 7001815 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Manufacturer BAYER

7001815 Date FDA Received
20-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200921247NA

Age 18 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ SINGULAIR

Role Route S C Health Professional N ORAL ORAL

Dosage Text Total daily dose: 1 DF

Duration 9 MTH

Manufacturer BAYER

7054814 Date FDA Received
20-Jul-2009

Case # 7054814

Case Type EXPEDITED (15-DAY)

Outcomes DE

Manufacturer Control # PLBAYER-200925706GPV Dosage Text

Age 22 YR

Sex Female

Country POL

Preferred Term Embolism arterial

Product YAZ Case # 7054818 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7054818 Date FDA Received
20-Jul-2009

Outcomes OT

Manufacturer Control # USBAYER-200926294NA Dosage Text

Age 15 YR

Sex Female

Country USA

Preferred Term HYPOKALAEMIA DYSPNOEA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7054867 Date FDA Received
20-Jul-2009

Case # 7054867

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919235NA

Age 41 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 231 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7054868 Date FDA Received
20-Jul-2009 Case # 7054868 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # CABAYER-200919251NA Role Route S ORAL Dosage Text Age 25 YR Sex Female Country USA

Preferred Term VAGINAL DISCHARGE METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7054872 Date FDA Received
20-Jul-2009

Case # 7054872

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919126NA

Age 14 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7054874 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7054874 Date FDA Received
20-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200919244NA

Age 32 YR

Sex Female

Country USA

Preferred Term MOOD SWINGS IRRITABILITY MENSTRUATION DELAYED NO ADVERSE EVENT

Product YAZ FLORINEF ACETATE PREVACID SINGULAIR Case # 7054876 Case Type NON-EXPEDITED Health Professional N

Role Route S C C C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7054876 Date FDA Received
20-Jul-2009

Manufacturer Control # USBAYER-200919123NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 232 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7054879 Date FDA Received
20-Jul-2009 Case # 7054879 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919084NA Role Route S S ORAL Dosage Text Age 21 YR Sex Female Country USA

Preferred Term OVARIAN CYST DYSPNOEA CHEST PAIN PAIN IN EXTREMITY

Product YAZ NUVARING

Duration

Manufacturer BAYER

7054885 Date FDA Received
20-Jul-2009

Case # 7054885

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919355NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7054894 Date FDA Received
20-Jul-2009

Case # 7054894

Outcomes

Manufacturer Control # USBAYER-200919442NA

Age 26 YR

Sex Female

Country USA

Preferred Term VOMITING HYPOMENORRHOEA MENSTRUATION DELAYED PRODUCT TASTE ABNORMAL

Product YAZ

Role Route S ORAL

Dosage Text

Duration 7 MTH

Manufacturer BAYER

7054895 Date FDA Received
20-Jul-2009

Case # 7054895

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919840NA

Age

Sex Female

Country USA

Preferred Term VAGINAL ABSCESS NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 233 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7054899 Date FDA Received
20-Jul-2009 Case # 7054899 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924303NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200924050NA Role Route S Health Professional Y ORAL Manufacturer Control # USBAYER-200924125NA Role Route S S ORAL Dosage Text 1 TAB/DAY Age 24 YR Sex Female Dosage Text Age 18 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7054909 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7054909 Date FDA Received
20-Jul-2009

Outcomes

Preferred Term ABDOMINAL PAIN UPPER

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7054911 Date FDA Received
20-Jul-2009

Case # 7054911

Outcomes

Preferred Term HERPES ZOSTER RASH RASH PAPULAR

Product YAZ HUMIRA

Duration 6 WEEK

Manufacturer BAYER

7054916 Date FDA Received
20-Jul-2009

Case # 7054916

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924297NA

Age

Sex Female

Country USA

Preferred Term CHLAMYDIAL INFECTION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7054936 Date FDA Received
20-Jul-2009

Case # 7054936

Outcomes

Manufacturer Control # USBAYER-200924485NA

Age 19 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 234 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7056121 Date FDA Received
21-Jul-2009 Case # 7056121 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # BRBAYER-200919017LA Dosage Text Duration Age Sex Female Country BRA

Preferred Term MENSTRUATION DELAYED SOMNOLENCE DIZZINESS METRORRHAGIA UTERINE INJURY UTERINE PAIN

Product YAZ TETRACYCLINE HYDROCHLORIDE

Role Route S C ORAL UNKNOWN

Manufacturer BAYER

6732563 Date FDA Received
22-Jul-2009

Case # 6732563

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200830983NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA VAGINAL HAEMORRHAGE ALOPECIA PAIN IN EXTREMITY PELVIC PAIN

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration 4 MTH

Manufacturer BAYER BAYER

7058203 Date FDA Received
22-Jul-2009

Case # 7058203

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919372NA

Age 39 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 235 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058206 Date FDA Received
22-Jul-2009 Case # 7058206 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919466NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919376NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919392NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919380NA Role Route S ORAL Dosage Text Duration Dosage Text Duration 6 DAY Age Sex Female Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7058210 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7058210 Date FDA Received
22-Jul-2009

Outcomes

Preferred Term BREAST TENDERNESS

Product YAZ Case # 7058213 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7058213 Date FDA Received
22-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7058215 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7058215 Date FDA Received
22-Jul-2009

Outcomes

Preferred Term MOOD SWINGS NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7058217 Date FDA Received
22-Jul-2009

Case # 7058217

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919349NA

Age 21 YR

Sex Female

Country USA

Preferred Term NASOPHARYNGITIS NERVOUSNESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 236 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058221 Date FDA Received
22-Jul-2009 Case # 7058221 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919452NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919992NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200919773NA Role Route S ORAL Dosage Text Age 19 YR Sex Female Dosage Text Age 36 YR Sex Female Dosage Text Age 19 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7058225 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7058225 Date FDA Received
22-Jul-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7058227 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7058227 Date FDA Received
22-Jul-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7058228 Date FDA Received
22-Jul-2009

Case # 7058228

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919351NA

Age

Sex Female

Country USA

Preferred Term INSOMNIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 237 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058229 Date FDA Received
22-Jul-2009 Case # 7058229 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919880NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA

Preferred Term NO ADVERSE EVENT ABNORMAL WITHDRAWAL BLEEDING HYPOMENORRHOEA INFLUENZA

Product YAZ

Duration

Manufacturer BAYER

7058231 Date FDA Received
22-Jul-2009

Case # 7058231

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920028NA

Age

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7058234 Date FDA Received
22-Jul-2009

Case # 7058234

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919671NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7058244 Date FDA Received
22-Jul-2009

Case # 7058244

Outcomes

Manufacturer Control # USBAYER-200919674NA

Age

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 238 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058246 Date FDA Received
22-Jul-2009 Case # 7058246 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919879NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920153NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 17 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7058250 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7058250 Date FDA Received
22-Jul-2009

Outcomes

Preferred Term AMENORRHOEA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7058251 Date FDA Received
22-Jul-2009

Case # 7058251

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920117NA

Age

Sex Female

Country USA

Preferred Term WISDOM TEETH REMOVAL

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7058262 Date FDA Received
22-Jul-2009

Case # 7058262

Outcomes

Manufacturer Control # USBAYER-200920166NA

Age 37 YR

Sex Female

Country USA

Preferred Term CHLOASMA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 239 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058265 Date FDA Received
22-Jul-2009 Case # 7058265 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920160NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Manufacturer BAYER

7065925 Date FDA Received
22-Jul-2009 Preferred Term ANXIETY DEPRESSION MALAISE NERVOUSNESS

Case # 7065925

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 1 PILL PER DAY 1 PER DAY PO

Duration

Manufacturer

7059450 Date FDA Received
23-Jul-2009

Case # 7059450

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924728NA

Age

Sex Female

Country USA

Preferred Term BREAST ENLARGEMENT Decreased appetite WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7059465 Date FDA Received
23-Jul-2009

Case # 7059465

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924718NA

Age 24 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration 3 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 240 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7059466 Date FDA Received
23-Jul-2009 Case # 7059466 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924754NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200924441NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200924731NA Role Route S Health Professional N INTRAUTERINE Dosage Text CONTINUOUS Manufacturer Control # USBAYER-200924398NA Role Route S Health Professional Y Product YAZ ORAL Manufacturer Control # Age 23 YR Role Route S ORAL Dosage Text 1 TABLET DAILY PO Duration 3 WEEK Sex Female Dosage Text Duration Age Sex Female Age 48 YR Sex Female Dosage Text Duration 1 DAY Age Sex Female Dosage Text Age 28 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7059467 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7059467 Date FDA Received
23-Jul-2009

Outcomes

Preferred Term NAUSEA

Product YAZ YAZ

Manufacturer BAYER BAYER Country USA

7059469 Date FDA Received
23-Jul-2009

Case # 7059469

Case Type NON-EXPEDITED

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7059477 Date FDA Received
23-Jul-2009

Case # 7059477

Outcomes

Preferred Term INFECTION SUSCEPTIBILITY INCREASED

Product YAZ

Manufacturer BAYER Country USA

7065972 Date FDA Received
23-Jul-2009 Preferred Term

Case # 7065972

Case Type DIRECT

Outcomes LT

Manufacturer BAYER

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 241 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7069856 Date FDA Received
23-Jul-2009 Preferred Term HEADACHE CEREBRAL THROMBOSIS HYPOAESTHESIA Case # 7069856 Case Type DIRECT Product YAZ Health Professional Y Outcomes LT Role Route S ORAL Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer BAYER

7062438 Date FDA Received
24-Jul-2009

Case # 7062438

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924602NA

Age

Sex Female

Country USA

Preferred Term SINUSITIS

Product YAZ Case # 7062442 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7062442 Date FDA Received
24-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200921888NA

Age 28 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA AMENORRHOEA LOWER EXTREMITY MASS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7062448 Date FDA Received
24-Jul-2009

Case # 7062448

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924617NA

Age

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 242 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7062450 Date FDA Received
24-Jul-2009 Case # 7062450 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922891NA Role Route S ORAL Dosage Text Age 34 YR Sex Female Country USA

Preferred Term CHLOASMA DEPRESSED MOOD

Product YAZ

Duration 2 MTH

Manufacturer BAYER

7062451 Date FDA Received
24-Jul-2009

Case # 7062451

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924615NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7062452 Date FDA Received
24-Jul-2009

Case # 7062452

Manufacturer Control # USBAYER-200924478NA

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA MENSTRUATION DELAYED

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7062458 Date FDA Received
24-Jul-2009

Case # 7062458

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924753NA

Age

Sex Female

Country USA

Preferred Term ASTHENIA DISSOCIATION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7062460 Date FDA Received
24-Jul-2009

Case # 7062460

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924764NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration 6 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 243 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7062464 Date FDA Received
24-Jul-2009 Case # 7062464 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924778NA Role Route S Health Professional N INTRAUTERINE Manufacturer Control # USBAYER-200924780NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920247NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 16 YR Sex Female Country USA

Preferred Term MENSTRUAL DISORDER

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7062472 Date FDA Received
24-Jul-2009

Case # 7062472

Outcomes

Preferred Term ABDOMINAL PAIN LOWER

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7064090 Date FDA Received
27-Jul-2009

Case # 7064090

Outcomes

Preferred Term NAUSEA ALOPECIA

Product YAZ

Manufacturer BAYER

7064093 Date FDA Received
27-Jul-2009

Case # 7064093

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920126NA

Age 35 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED BREAST ENLARGEMENT

Product YAZ AMITRIPTYLINE HYDROCHLORIDE

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 244 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7064100 Date FDA Received
27-Jul-2009 Case # 7064100 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920438NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7064102 Date FDA Received
27-Jul-2009

Case # 7064102

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920556NA

Age

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7064103 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7064103 Date FDA Received
27-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200920274NA

Age 23 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7064104 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7064104 Date FDA Received
27-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200920139NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ Case # 7064124 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7064124 Date FDA Received
27-Jul-2009

Outcomes

Manufacturer Control # USBAYER-200920562NA

Age 17 YR

Sex Female

Country USA

Preferred Term MEDICATION ERROR

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 245 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7064130 Date FDA Received
27-Jul-2009 Case # 7064130 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924903NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200924896NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200924915NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7064141 Date FDA Received
27-Jul-2009

Case # 7064141

Outcomes

Preferred Term ALOPECIA

Product YAZ Case # 7064147 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7064147 Date FDA Received
27-Jul-2009

Preferred Term MALAISE NAUSEA

Product YAZ

Manufacturer BAYER

7064155 Date FDA Received
27-Jul-2009

Case # 7064155

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925149NA

Age

Sex Female

Country USA

Preferred Term NAUSEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Role Route S ORAL

Dosage Text

Duration 2 WEEK

Manufacturer BAYER

7064164 Date FDA Received
27-Jul-2009

Case # 7064164

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925025NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 246 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7064165 Date FDA Received
27-Jul-2009 Case # 7064165 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925162NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925142NA Role Route S Health Professional N Product YAZ ORAL Manufacturer Control # Dosage Text Duration 1 YEAR Age 22 YR Dosage Text Duration Sex Female Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7064174 Date FDA Received
27-Jul-2009

Case # 7064174

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type DIRECT

Manufacturer BAYER Country USA

7070032 Date FDA Received
27-Jul-2009 Preferred Term DEPRESSION ALOPECIA ANXIETY FUNGAL INFECTION GASTRIC DISORDER

Case # 7070032

Outcomes OT Role Route S

Manufacturer

URINARY TRACT INFECTION VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 247 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7070936 Date FDA Received
27-Jul-2009 Preferred Term FATIGUE ABDOMINAL DISTENSION ANXIETY AUTONOMIC NEUROPATHY BACK PAIN CHEST DISCOMFORT COUGH HEADACHE HYPOAESTHESIA MUSCLE SPASMS MUSCLE TWITCHING MUSCULAR WEAKNESS PULMONARY THROMBOSIS SINUS TACHYCARDIA WEIGHT DECREASED Case # 7070936 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,DS,LT,RI Role Route S ORAL Dosage Text 1 TABLET, DAILY, ORAL Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 248 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7071477 Date FDA Received
27-Jul-2009 Preferred Term FATIGUE ANXIETY AUTONOMIC NEUROPATHY BACK PAIN CHEST DISCOMFORT COUGH FEELING ABNORMAL HEADACHE MUSCLE SPASMS MUSCULAR WEAKNESS PULMONARY THROMBOSIS SINUS TACHYCARDIA WEIGHT DECREASED Case # 7071477 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,DS,LT,RI Role Route S ORAL Dosage Text 1 TABLET, DAILY, PO Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer BAYER

7065095 Date FDA Received
28-Jul-2009

Case # 7065095

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924927NA

Age

Sex Female

Country USA

Preferred Term UNEVALUABLE EVENT

Product YAZ Case # 7076244 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7076244 Date FDA Received
28-Jul-2009 Preferred Term

Outcomes OT Role Route S

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

EMOTIONAL DISORDER FATIGUE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 249 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7067372 Date FDA Received
30-Jul-2009 Case # 7067372 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925309NA Role Route S ORAL Dosage Text Duration 1 MTH Age Sex Female Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN

Product YAZ

Manufacturer BAYER

7073768 Date FDA Received
30-Jul-2009 Preferred Term MOOD ALTERED IRRITABILITY WEIGHT INCREASED

Case # 7073768

Case Type DIRECT Product YAZ

Health Professional

Outcomes OT Role Route S

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY

Duration 3 MTH

Manufacturer

7068587 Date FDA Received
31-Jul-2009

Case # 7068587

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # BRBAYER-200913032LA Dosage Text

Age 28 YR

Sex Female

Country BRA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE Gestational hypertension

Product YAZ AEROLIN LORATADINE

Role Route S C C ORAL ORAL ORAL

Duration 1.33 YEAR

Manufacturer BAYER

ONE TABLET PER DAY / 15 DAYS Manufacturer Control # USBAYER-200928261NA Dosage Text Duration Age Sex Female Country USA

7068595 Date FDA Received
31-Jul-2009

Case # 7068595

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Preferred Term BLOOD PRESSURE INCREASED

Product YAZ

Role Route S

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 250 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7068662 Date FDA Received
31-Jul-2009 Case # 7068662 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925422NA Role Route S ORAL Dosage Text Age 25 YR Sex Female Country USA

Preferred Term MENSTRUATION DELAYED INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Duration

Manufacturer BAYER

7068674 Date FDA Received
31-Jul-2009

Case # 7068674

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925409NA

Age 22 YR

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED ABDOMINAL PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7069936 Date FDA Received
03-Aug-2009

Case # 7069936

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200928279NA Dosage Text Total daily dose: 1 DF Total daily dose: 400 MG Total daily dose: 25 MG Manufacturer Control # USBAYER-200924360NA

Age 25 YR

Sex Female

Country USA

Preferred Term HEADACHE DIZZINESS FALL

Product YAZ TEGRETOL TOPAMAX Case # 7070084 Case Type NON-EXPEDITED Health Professional N

Role Route S C C Outcomes ORAL

Duration 1 YEAR

Manufacturer BAYER

7070084 Date FDA Received
03-Aug-2009

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA MENSTRUATION IRREGULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration 1 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 251 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7070105 Date FDA Received
03-Aug-2009 Case # 7070105 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925477NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200925485NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925466NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925525NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925481NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 19 YR Sex Female Duration Age Sex Female Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7070111 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7070111 Date FDA Received
03-Aug-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7070112 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7070112 Date FDA Received
03-Aug-2009

Outcomes

Preferred Term ACNE

Product YAZ Case # 7070118 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7070118 Date FDA Received
03-Aug-2009

Outcomes

Preferred Term AMENORRHOEA

Product YAZ Case # 7070126 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7070126 Date FDA Received
03-Aug-2009

Outcomes

Preferred Term DRUG DOSE OMISSION VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 252 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7070131 Date FDA Received
03-Aug-2009 Case # 7070131 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925520NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200925648NA Role Route S Dosage Text SAMPLE Duration Dosage Text Age 23 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7070134 Case Type NON-EXPEDITED

Duration 6 MTH Age Sex

Manufacturer BAYER Country USA

7070134 Date FDA Received
03-Aug-2009

Female

Preferred Term HEADACHE ABDOMINAL PAIN

Product YAZ

Manufacturer BAYER

7070514 Date FDA Received
03-Aug-2009

Case # 7070514

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200926372NA

Age

Sex Female

Country USA

Preferred Term HYPERTHYROIDISM ALOPECIA CONSTIPATION SLUGGISHNESS WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7070515 Date FDA Received
03-Aug-2009

Case # 7070515

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925637NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 253 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7070526 Date FDA Received
03-Aug-2009 Case # 7070526 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200925571NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200926521NA Dosage Text Total daily dose: 1 DF Total daily dose: 1 DF Age 34 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7066335 Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

7066335 Date FDA Received
04-Aug-2009

Outcomes OT

Preferred Term OEDEMA PERIPHERAL RED BLOOD CELL SEDIMENTATION RATE INCREASED BLOOD URINE PRESENT C-REACTIVE PROTEIN INCREASED

Product YAZ PROTONIX

Role Route S C ORAL ORAL

Duration

Manufacturer BAYER

7071554 Date FDA Received
04-Aug-2009

Case # 7071554

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # BRBAYER-200919810LA Dosage Text

Age 26 YR

Sex Female

Country BRA

Preferred Term CYSTITIS CHOLELITHIASIS VOMITING DIARRHOEA AMENORRHOEA

Product YAZ CIPROFLOXACIN METRONIDAZOLE OMEPRAZOLE

Role Route S C C C ORAL ORAL ORAL ORAL

Duration 2 YEAR

Manufacturer BAYER

7071588 Date FDA Received
04-Aug-2009

Case # 7071588

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925016NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA COITAL BLEEDING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 254 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7071598 Date FDA Received
04-Aug-2009 Case # 7071598 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927449NA Role Route S ORAL Dosage Text Age 25 YR Sex Female Country USA

Preferred Term HYPERSENSITIVITY EYE SWELLING OEDEMA PERIPHERAL URTICARIA

Product YAZ

Duration 1 WEEK

Manufacturer BAYER

7071600 Date FDA Received
04-Aug-2009

Case # 7071600

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925487NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200925453NA

Duration

Manufacturer BAYER

7071601 Date FDA Received
04-Aug-2009

Case # 7071601

Outcomes

Age

Sex Female

Country USA

Preferred Term SKIN DISCOLOURATION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200925452NA

Duration 6 WEEK Age Sex

Manufacturer BAYER Country USA

7071605 Date FDA Received
04-Aug-2009

Case # 7071605

Outcomes

Female

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 255 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7071612 Date FDA Received
04-Aug-2009 Case # 7071612 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925020NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL DISCHARGE VULVOVAGINAL PRURITUS

Product YAZ

Manufacturer BAYER

7071615 Date FDA Received
04-Aug-2009

Case # 7071615

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925430NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7071619 Date FDA Received
04-Aug-2009

Case # 7071619

Outcomes

Manufacturer Control # USBAYER-200925264NA

Age 30 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA DIZZINESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7080195 Date FDA Received
04-Aug-2009 Preferred Term ACNE HEADACHE

Case # 7080195

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text ONCE DAILY PO

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 256 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7029348 Date FDA Received
05-Aug-2009 Case # 7029348 Case Type NON-EXPEDITED Health Professional N Outcomes HO Manufacturer Control # USBAYER-200923811NA Dosage Text Duration 3 MTH Age Sex Female Country USA

Preferred Term DEPRESSION ANXIETY FOOD INTOLERANCE HYPOPHAGIA INSOMNIA TREMOR

Product YAZ

Role Route S ORAL

Manufacturer BAYER

7073877 Date FDA Received
06-Aug-2009

Case # 7073877

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924354NA

Age 37 YR

Sex Female

Country USA

Preferred Term ABDOMINAL DISTENSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7073879 Date FDA Received
06-Aug-2009

Case # 7073879

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925566NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7073883 Date FDA Received
06-Aug-2009

Case # 7073883

Outcomes

Manufacturer Control # USBAYER-200925616NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 257 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7073887 Date FDA Received
06-Aug-2009 Case # 7073887 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925657NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925555NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200925744NA Role Route S ORAL Dosage Text Age 42 YR Sex Female Dosage Text Age 24 YR Sex Female Dosage Text Age 26 YR Sex Female Country USA

Preferred Term MOOD SWINGS

Product YAZ Case # 7073892 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7073892 Date FDA Received
06-Aug-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7073895 Date FDA Received
06-Aug-2009

Case # 7073895

Preferred Term HYPOMENORRHOEA MENSTRUATION DELAYED

Product YAZ

Duration

Manufacturer BAYER

7073898 Date FDA Received
06-Aug-2009

Case # 7073898

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925654NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7073901 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7073901 Date FDA Received
06-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200925645NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 258 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7073903 Date FDA Received
06-Aug-2009 Case # 7073903 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925641NA Role Route S Health Professional N Outcomes OT Manufacturer Control # USBAYER-200928696NA Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VOMITING

Product YAZ Case # 7074308 Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

7074308 Date FDA Received
06-Aug-2009

Preferred Term BENIGN INTRACRANIAL HYPERTENSION

Product YAZ Health Professional N

Role Route S Outcomes

Manufacturer BAYER

7075350 Date FDA Received
07-Aug-2009

Case # 7075350

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200925795NA

Age 18 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7075353 Date FDA Received
07-Aug-2009

Case # 7075353

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925775NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7075354 Date FDA Received
07-Aug-2009

Case # 7075354

Outcomes

Manufacturer Control # USBAYER-200925719NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 259 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7075362 Date FDA Received
07-Aug-2009 Case # 7075362 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925771NA Role Route S Health Professional Y Product YAZ Case # 7084390 Case Type DIRECT Product YAZ Health Professional N ORAL Manufacturer Control # Age 42 YR Role Route S ORAL Dosage Text 1 TABLET DAILY ORAL Manufacturer Control # Age Sex Female Dosage Text 1 A DAY 1 A DAY Duration Duration Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term CHEST PAIN

Product YAZ Case # 7082314 Case Type DIRECT

Manufacturer BAYER Country USA

7082314 Date FDA Received
07-Aug-2009 Preferred Term HYPERLIPIDAEMIA

Outcomes RI

Manufacturer BAYER Country USA

7084390 Date FDA Received
07-Aug-2009 Preferred Term TREMOR ABDOMINAL PAIN BREAST TENDERNESS BURNING SENSATION DYSPNOEA HEADACHE HYPERTENSION JOINT SWELLING MUSCLE TWITCHING PAIN IN EXTREMITY PELVIC PAIN RASH

Outcomes HO,DS,LT,RI Role Route S

Manufacturer

URINARY TRACT INFECTION VIBRATORY SENSE INCREASED

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 260 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7076425 Date FDA Received
10-Aug-2009 Case # 7076425 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200928701NA Dosage Text Duration Age Sex Female Country USA

Preferred Term LOSS OF CONSCIOUSNESS

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Manufacturer BAYER

7076427 Date FDA Received
10-Aug-2009

Case # 7076427

Manufacturer Control # USBAYER-200928731NA Dosage Text

Age 26 YR

Sex Female

Country USA

Preferred Term LOSS OF CONSCIOUSNESS CARDIAC FLUTTER HEART RATE INCREASED UNEVALUABLE EVENT

Product YAZ

Role Route S

Duration 3 MTH

Manufacturer BAYER

7076429 Date FDA Received
10-Aug-2009

Case # 7076429

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200928911NA Dosage Text

Age 26 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration

Manufacturer BAYER

7076603 Date FDA Received
10-Aug-2009

Case # 7076603

Manufacturer Control # USBAYER-200925924NA

Age 49 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 261 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7076616 Date FDA Received
10-Aug-2009 Case # 7076616 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926027NA Role Route S Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Age 16 YR Sex Female Country USA

Preferred Term POLYMENORRHOEA AFFECT LABILITY NERVOUSNESS

Product YAZ

Duration

Manufacturer BAYER

7076619 Date FDA Received
10-Aug-2009

Case # 7076619

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925996NA

Age 20 YR

Sex Female

Country USA

Preferred Term GASTROOESOPHAGEAL REFLUX DISEASE

Product YAZ Health Professional N

Role Route S Outcomes

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Manufacturer Control # USBAYER-200926265NA

Duration

Manufacturer BAYER

7076628 Date FDA Received
10-Aug-2009

Case # 7076628

Case Type NON-EXPEDITED

Age 39 YR

Sex Female

Country USA

Preferred Term SMEAR CERVIX ABNORMAL GASTROENTERITIS VIRAL MENORRHAGIA

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

7076629 Date FDA Received
10-Aug-2009

Case # 7076629

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200926258NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 262 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7076631 Date FDA Received
10-Aug-2009 Case # 7076631 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925957NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200925980NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925931NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200926029NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200926272NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA

Product YAZ Case # 7076634 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076634 Date FDA Received
10-Aug-2009

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076636 Date FDA Received
10-Aug-2009

Case # 7076636

Outcomes

Preferred Term VOMITING

Product YAZ Case # 7076637 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076637 Date FDA Received
10-Aug-2009

Preferred Term PREMENSTRUAL SYNDROME

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076638 Date FDA Received
10-Aug-2009

Case # 7076638

Preferred Term MENSTRUATION DELAYED

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 263 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7076646 Date FDA Received
10-Aug-2009 Case # 7076646 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926268NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200926269NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term SINUSITIS

Product YAZ Case # 7076652 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076652 Date FDA Received
10-Aug-2009

Outcomes

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION POLYMENORRHOEA

Product YAZ

Manufacturer BAYER

7076656 Date FDA Received
10-Aug-2009

Case # 7076656

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200926408NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7076661 Date FDA Received
10-Aug-2009

Case # 7076661

Outcomes

Manufacturer Control # USBAYER-200926271NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7076662 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7076662 Date FDA Received
10-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200926278NA

Age 32 YR

Sex Female

Country USA

Preferred Term HYPERTENSION

Product YAZ

Role Route S ORAL

Dosage Text

Duration 6 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 264 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7076668 Date FDA Received
10-Aug-2009 Case # 7076668 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926477NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200926270NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200926479NA Role Route S C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200926458NA Role Route S Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076670 Date FDA Received
10-Aug-2009

Case # 7076670

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7076682 Date FDA Received
10-Aug-2009

Case # 7076682

Preferred Term ERUCTATION FLATULENCE OFF LABEL USE

Product YAZ ZANTAC PEPCID AC NEXIUM

Manufacturer BAYER

7076692 Date FDA Received
10-Aug-2009

Case # 7076692

Case Type NON-EXPEDITED

Preferred Term HYPOMENORRHOEA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 265 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7082760 Date FDA Received
10-Aug-2009 Preferred Term DRY EYE CHALAZION EYE DISORDER Case # 7082760 Case Type DIRECT Product YAZ Health Professional Y Role Route S ORAL Dosage Text 1 TABLET DAILY PO Outcomes Manufacturer Control # Age 46 YR Duration 2 MTH Sex Female Country USA

Manufacturer BAYER

7082918 Date FDA Received
10-Aug-2009 Preferred Term MIGRAINE

Case # 7082918

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Role Route S Health Professional N ORAL

Dosage Text 1 PILL ONCE DAILY PO Manufacturer Control #

Duration

Manufacturer

7082935 Date FDA Received
10-Aug-2009 Preferred Term

Case # 7082935

Case Type DIRECT Product YAZ

Outcomes HO,LT Role Route S

Age 46 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7077931 Date FDA Received
11-Aug-2009

Case # 7077931

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924533NA

Age 22 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S Outcomes OT Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084130 Date FDA Received
11-Aug-2009 Preferred Term

Case # 7084130

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

CEREBROVASCULAR ACCIDENT THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 266 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7084524 Date FDA Received
11-Aug-2009 Preferred Term CHLOASMA Case # 7084524 Case Type DIRECT Product YAZ Case # 7084614 Case Type DIRECT Product YAZ YAZ Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S S ORAL ORAL Dosage Text 1-3 MG PILL DAILY FOR 24 DAYS PO 1- 0.02 MG PILL DAILY FOR 4 DAYS PO Dosage Text APPROXIMATELY 6 MONTHS Manufacturer Control # Manufacturer Control # Age 26 YR Duration 6 MTH Age 29 YR Duration Sex Female Country USA Sex Female Country USA

Manufacturer

7084614 Date FDA Received
11-Aug-2009 Preferred Term MALAISE CHEST PAIN ANXIETY DEPRESSION DYSPNOEA

Manufacturer BAYER

EMOTIONAL DISORDER EYE IRRITATION EYE PRURITUS FEELING ABNORMAL HEADACHE LETHARGY LOSS OF LIBIDO MIGRAINE MOOD SWINGS MUSCLE SPASMS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 267 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7085859 Date FDA Received
11-Aug-2009 Preferred Term VISUAL FIELD DEFECT BLINDNESS TRANSIENT MIGRAINE Case # 7085859 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 1 DAILY PO Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer

7085889 Date FDA Received
11-Aug-2009 Preferred Term ANAEMIA BLOOD DISORDER

Case # 7085889

Case Type DIRECT Product YAZ

Health Professional N

Outcomes LT Role Route S ORAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text 1 DAILY PO

Duration

Manufacturer BAYER

CHRONIC MYELOID LEUKAEMIA FATIGUE HEADACHE MUSCLE SPASMS PLATELET COUNT INCREASED SWELLING

7079100 Date FDA Received
12-Aug-2009

Case # 7079100

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200929421NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7079106 Date FDA Received
12-Aug-2009

Case # 7079106

Manufacturer Control # USBAYER-200929272NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLELITHIASIS

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 268 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7079129 Date FDA Received
12-Aug-2009 Case # 7079129 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925695NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200926196NA Role Route S Health Professional N Product YAZ Case # 6980583 Case Type NON-EXPEDITED Health Professional N Outcomes LT Role Route S Outcomes Manufacturer Control # USBAYER-200915761NA Role Route S ORAL Dosage Text Age 11 YR Sex Female Country USA Dosage Text Dosage Text Unit dose: 1 DF Manufacturer Control # Age 45 YR Duration Sex Female Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MIGRAINE

Product YAZ Case # 7079132 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7079132 Date FDA Received
12-Aug-2009

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7086086 Case Type DIRECT

Manufacturer BAYER Country USA

7086086 Date FDA Received
12-Aug-2009 Preferred Term THROMBOSIS

Manufacturer

6980583 Date FDA Received
13-Aug-2009

Preferred Term NAUSEA ABDOMINAL DISTENSION ABNORMAL WITHDRAWAL BLEEDING DYSMENORRHOEA INCREASED APPETITE MENOMETRORRHAGIA MENORRHAGIA

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 269 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7080471 Date FDA Received
13-Aug-2009 Case # 7080471 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920796NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200920569NA Role Route S ORAL Dosage Text Age 35 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7080472 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7080472 Date FDA Received
13-Aug-2009

Outcomes

Preferred Term DIZZINESS AMENORRHOEA METRORRHAGIA NAUSEA TREMOR WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7080473 Date FDA Received
13-Aug-2009

Case # 7080473

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920643NA

Age 25 YR

Sex Female

Country USA

Preferred Term ACNE

Product YAZ Case # 7080476 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7080476 Date FDA Received
13-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200920460NA

Age

Sex Female

Country USA

Preferred Term VISION BLURRED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 270 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7080479 Date FDA Received
13-Aug-2009 Case # 7080479 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920646NA Role Route S ORAL Dosage Text Age 23 YR Sex Female Country USA

Preferred Term SINUSITIS NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7080482 Date FDA Received
13-Aug-2009

Case # 7080482

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920452NA

Age 23 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7080483 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7080483 Date FDA Received
13-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200920707NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN LOWER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7080485 Date FDA Received
13-Aug-2009

Case # 7080485

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920546NA

Age

Sex Female

Country USA

Preferred Term RASH PAPULAR METRORRHAGIA

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 271 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7080488 Date FDA Received
13-Aug-2009 Case # 7080488 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920563NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200926614NA Role Route S Health Professional N ORAL Manufacturer Control # PRBAYER-200926531NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929201NA Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DEPRESSED MOOD AMENORRHOEA

Product YAZ LEVOXYL Case # 7080510 Case Type NON-EXPEDITED

Manufacturer BAYER

7080510 Date FDA Received
13-Aug-2009

Preferred Term METRORRHAGIA

Product YAZ Case # 7080512 Case Type NON-EXPEDITED

Manufacturer BAYER Country PRI

7080512 Date FDA Received
13-Aug-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7080515 Date FDA Received
13-Aug-2009

Case # 7080515

Outcomes HO,OT

Preferred Term DEPRESSED MOOD

Product YAZ Case # 7087142 Case Type DIRECT Product YAZ Health Professional N

Role Route S Outcomes HO,DS,LT Role Route S ORAL

Manufacturer BAYER

7087142 Date FDA Received
13-Aug-2009 Preferred Term MUSCLE SPASMS

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text 1 DAILY PO

Duration

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 272 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087151 Date FDA Received
13-Aug-2009 Preferred Term ABDOMINAL PAIN LOWER FACTOR II DEFICIENCY FACTOR V DEFICIENCY FLANK PAIN NEPHROLITHIASIS PELVIC VENOUS THROMBOSIS Case # 7087151 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO Role Route S ORAL Dosage Text 1 TAB DAILY PO Manufacturer Control # Age 25 YR Duration 4 MTH Sex Female Country USA

Manufacturer BAYER

6964871 Date FDA Received
14-Aug-2009

Case # 6964871

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915054NA

Age 32 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT OROPHARYNGEAL PAIN

Product YAZ ADVIL

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

7081856 Date FDA Received
14-Aug-2009

Case # 7081856

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921070NA

Age

Sex Female

Country USA

Preferred Term RASH

Product YAZ Case # 7081857 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7081857 Date FDA Received
14-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200921210NA

Age

Sex Female

Country USA

Preferred Term SKIN DISCOLOURATION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 273 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7081860 Date FDA Received
14-Aug-2009 Case # 7081860 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200920768NA Role Route S ORAL Dosage Text Age 14 YR Sex Female Country USA

Preferred Term SKIN DISCOLOURATION ERYTHEMA NO ADVERSE EVENT SWELLING FACE WITHDRAWAL BLEED

Product YAZ

Duration

Manufacturer BAYER

7081862 Date FDA Received
14-Aug-2009

Case # 7081862

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920780NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ Case # 7081866 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7081866 Date FDA Received
14-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200921052NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7081881 Date FDA Received
14-Aug-2009

Case # 7081881

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200920778NA

Age

Sex Female

Country USA

Preferred Term DIARRHOEA GASTROINTESTINAL DISORDER WEIGHT DECREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 274 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7081900 Date FDA Received
14-Aug-2009 Case # 7081900 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923877NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200923963NA Role Route S Health Professional N Role Route S S Health Professional N TRANSPLACENTAL TRANSPLACENTAL Manufacturer Control # USBAYER-200717111NA Role Route S C C C ORAL Dosage Text ONE TABLET PER DAY Age 42 YR Sex Female Country USA Outcomes Manufacturer Control # BR-ROCHE-648787 Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 20 YR Sex Female Country USA

Preferred Term NAUSEA

Product YAZ YAZ

Duration

Manufacturer BAYER BAYER Country USA

7081902 Date FDA Received
14-Aug-2009

Case # 7081902

Case Type NON-EXPEDITED

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Product ISOTRETINOIN YAZ Case # 6540577 Case Type NON-EXPEDITED

Manufacturer BAYER Country BRA

7082301 Date FDA Received
14-Aug-2009 Preferred Term TREMOR NORMAL NEWBORN

Case # 7082301

Manufacturer ROCHE

6540577 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE MENORRHAGIA METRORRHAGIA ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ ATENOLOL HYDROCHLOROTHIAZIDE IRON

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 275 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7083083 Date FDA Received
17-Aug-2009 Case # 7083083 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921020NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Manufacturer BAYER

7083091 Date FDA Received
17-Aug-2009

Case # 7083091

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921007NA

Age 42 YR

Sex Female

Country USA

Preferred Term FEELING ABNORMAL PREMENSTRUAL SYNDROME BACK PAIN MENSTRUAL DISORDER

Product YAZ SERTRALINE LOPERAMIDE HYDROCHLORIDE

Role Route S C C ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

7083100 Date FDA Received
17-Aug-2009

Case # 7083100

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921149NA

Age

Sex Female

Country USA

Preferred Term WEIGHT INCREASED JOINT SWELLING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7083101 Date FDA Received
17-Aug-2009

Case # 7083101

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921161NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 276 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7083102 Date FDA Received
17-Aug-2009 Case # 7083102 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921306NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921507NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VOMITING

Product YAZ Case # 7083103 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7083103 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term ACNE NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7083104 Date FDA Received
17-Aug-2009

Case # 7083104

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921200NA

Age 21 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7083106 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7083106 Date FDA Received
17-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200921276NA

Age

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7083107 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7083107 Date FDA Received
17-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200921404NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 277 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7083109 Date FDA Received
17-Aug-2009 Case # 7083109 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921454NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921287NA Role Route S ORAL Dosage Text Age 18 YR Sex Female Dosage Text Age 26 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7083111 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7083111 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term EYE PAIN HEADACHE NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7083112 Date FDA Received
17-Aug-2009

Case # 7083112

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921290NA

Age

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED ABDOMINAL PAIN LOWER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7083114 Date FDA Received
17-Aug-2009

Case # 7083114

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921457NA

Age 28 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7083115 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7083115 Date FDA Received
17-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200921298NA

Age

Sex Female

Country USA

Preferred Term URINARY TRACT INFECTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 278 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7083118 Date FDA Received
17-Aug-2009 Case # 7083118 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921277NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921683NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921614NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921653NA Role Route S C C Outcomes Manufacturer Control # USBAYER-200921394NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Dosage Text Age 25 YR Sex Female Dosage Text Age 27 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term DERMATITIS CONTACT

Product YAZ Case # 7083123 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7083123 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term RASH

Product YAZ Case # 7083124 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7083124 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term ABDOMINAL PAIN

Product YAZ Case # 7083127 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7083127 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term VULVOVAGINAL MYCOTIC INFECTION METRORRHAGIA

Product YAZ CREAM FOR ECZEMA NOS NOSTRIANCOLE ACETONE NOS

Manufacturer BAYER

7083130 Date FDA Received
17-Aug-2009

Case # 7083130

Case Type NON-EXPEDITED

Health Professional N

Preferred Term METRORRHAGIA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 279 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7083134 Date FDA Received
17-Aug-2009 Case # 7083134 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922697NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200921867NA Role Route S S Health Professional N INTRAUTERINE INTRAUTERINE Manufacturer Control # USBAYER-200922498NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921783NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921786NA Role Route S ORAL Dosage Text Age 27 YR Sex Female Dosage Text Age 17 YR Sex Female Dosage Text Duration Dosage Text CONTINUOUS Age 26 YR Sex Female Dosage Text Age 17 YR Sex Female Country USA

Preferred Term WITHDRAWAL BLEED

Product YAZ YAZ

Duration

Manufacturer BAYER BAYER Country USA

7083135 Date FDA Received
17-Aug-2009

Case # 7083135

Case Type NON-EXPEDITED

Outcomes

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN

Product MIRENA YAZ Case # 7083138 Case Type NON-EXPEDITED

Duration 6 WEEK 1 WEEK Age Sex

Manufacturer BAYER BAYER Country USA

7083138 Date FDA Received
17-Aug-2009

Outcomes

Female

Preferred Term ACNE

Product YAZ Case # 7083142 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7083142 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7083148 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7083148 Date FDA Received
17-Aug-2009

Outcomes

Preferred Term VAGINAL DISCHARGE METRORRHAGIA

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 280 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7083150 Date FDA Received
17-Aug-2009 Case # 7083150 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921774NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL DISCHARGE ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

7083157 Date FDA Received
17-Aug-2009

Case # 7083157

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927186NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7083160 Date FDA Received
17-Aug-2009

Case # 7083160

Manufacturer Control # USBAYER-200927184NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7083174 Date FDA Received
17-Aug-2009

Case # 7083174

Manufacturer Control # USBAYER-200927132NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7083176 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7083176 Date FDA Received
17-Aug-2009

Manufacturer Control # USBAYER-200927406NA

Age 19 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ

Role Route S

Dosage Text

Duration 8 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 281 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091029 Date FDA Received
17-Aug-2009 Preferred Term PLEURISY HYPOXIA PERICARDITIS PULMONARY THROMBOSIS Case # 7091029 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,LT Role Route S ORAL Dosage Text 3 MG/0.02 MG 1 TABLET A DAY PO Manufacturer Control # Age 22 YR Duration Sex Female Country USA

Manufacturer BAYER

7092852 Date FDA Received
17-Aug-2009 Preferred Term MOOD SWINGS DEPRESSION HOT FLUSH SUICIDAL IDEATION

Case # 7092852

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text ONCE DAILY PO

Duration

Manufacturer BERLEX

7095274 Date FDA Received
17-Aug-2009 Preferred Term THROMBOSIS

Case # 7095274

Case Type DIRECT Product YAZ

Health Professional N

Outcomes DE,HO,LT Role Route S

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text

Duration 2 YEAR

Manufacturer BAYER

PULMONARY EMBOLISM

7096768 Date FDA Received
17-Aug-2009 Preferred Term DYSPNOEA ANXIETY

Case # 7096768

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 46 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY ORAL

Duration

Manufacturer

EMOTIONAL DISORDER PALPITATIONS VENTRICULAR EXTRASYSTOLES

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 282 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7096771 Date FDA Received
17-Aug-2009 Preferred Term ANXIETY DEPRESSION Case # 7096771 Case Type DIRECT Product YAZ FORTAMET Case # 7013580 Case Type NON-EXPEDITED Health Professional N Health Professional N Outcomes OT Role Route S C Outcomes Manufacturer Control # USBAYER-200920240NA Role Route S Health Professional N ORAL Dosage Text 1 TAB/DAY Manufacturer Control # USBAYER-200921619NA Role Route S ORAL Dosage Text Age 23 YR Sex Female Duration Age Sex Female Country USA ORAL Dosage Text 1 PILL DAILY ORAL Manufacturer Control # Age 16 YR Duration Sex Female Country USA

Manufacturer

7013580 Date FDA Received
18-Aug-2009

Preferred Term THYROID FUNCTION TEST ABNORMAL

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7084220 Date FDA Received
18-Aug-2009

Case # 7084220

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING METRORRHAGIA

Product YAZ

Duration

Manufacturer BAYER

7084222 Date FDA Received
18-Aug-2009

Case # 7084222

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921777NA

Age 18 YR

Sex Female

Country USA

Preferred Term PHARYNGITIS STREPTOCOCCAL NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084225 Date FDA Received
18-Aug-2009

Case # 7084225

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921711NA

Age 46 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ ACYCLOVIR

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 283 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7084227 Date FDA Received
18-Aug-2009 Case # 7084227 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921763NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921714NA Role Route S C Outcomes Manufacturer Control # USBAYER-200921780NA Role Route S ORAL Dosage Text Age 39 YR Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Dosage Text Age 34 YR Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7084228 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7084228 Date FDA Received
18-Aug-2009

Outcomes

Preferred Term VOMITING

Product YAZ OTHER MEDICATIONS NOS

Manufacturer BAYER

7084233 Date FDA Received
18-Aug-2009

Case # 7084233

Case Type NON-EXPEDITED

Health Professional N

Preferred Term ACNE ABDOMINAL DISTENSION MENORRHAGIA NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 284 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7084234 Date FDA Received
18-Aug-2009 Case # 7084234 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921877NA Role Route S ORAL Dosage Text Age 28 YR Sex Female Country USA

Preferred Term GASTRIC DISORDER ABDOMINAL DISTENSION ABNORMAL WITHDRAWAL BLEEDING DIARRHOEA GASTRIC HYPERMOTILITY NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7084236 Date FDA Received
18-Aug-2009

Case # 7084236

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921723NA

Age 35 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084242 Date FDA Received
18-Aug-2009

Case # 7084242

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922136NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084244 Date FDA Received
18-Aug-2009

Case # 7084244

Outcomes

Manufacturer Control # USBAYER-200922947NA

Age

Sex Female

Country USA

Preferred Term MIGRAINE METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 285 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7084251 Date FDA Received
18-Aug-2009 Case # 7084251 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921749NA Role Route S ORAL Dosage Text Age 28 YR Sex Female Country USA

Preferred Term MENORRHAGIA MENSTRUATION IRREGULAR NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7084254 Date FDA Received
18-Aug-2009

Case # 7084254

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922037NA

Age 26 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084255 Date FDA Received
18-Aug-2009

Case # 7084255

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922143NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7084256 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084256 Date FDA Received
18-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200923905NA

Age

Sex Female

Country USA

Preferred Term HEADACHE

Product YAZ UNKNOWN DRUG FOR TREATMENT OF GALLBLADDER NOS

Role Route S C ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 286 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7084257 Date FDA Received
18-Aug-2009 Case # 7084257 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922133NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921878NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 28 YR Sex Female Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7084258 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7084258 Date FDA Received
18-Aug-2009

Outcomes

Preferred Term BREAST TENDERNESS BREAST SWELLING

Product YAZ

Manufacturer BAYER

7084259 Date FDA Received
18-Aug-2009

Case # 7084259

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923706NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7084260 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration 2 DAY

Manufacturer BAYER Sex Female Country USA

7084260 Date FDA Received
18-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200922000NA

Age 18 YR

Preferred Term SINUSITIS

Product YAZ Case # 7084262 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7084262 Date FDA Received
18-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200923717NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 287 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7084265 Date FDA Received
18-Aug-2009 Case # 7084265 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922044NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200924921NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921985NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200921995NA Role Route S C C ORAL Dosage Text Age 32 YR Sex Female Dosage Text Age 21 YR Sex Female Dosage Text Age 20 YR Sex Female Dosage Text Age 26 YR Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7044029 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7044029 Date FDA Received
19-Aug-2009

Outcomes

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration

Manufacturer BAYER Country USA

7085191 Date FDA Received
19-Aug-2009

Case # 7085191

Case Type NON-EXPEDITED

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7085194 Date FDA Received
19-Aug-2009

Case # 7085194

Outcomes

Preferred Term MENSTRUATION DELAYED AFFECT LABILITY ABDOMINAL PAIN LOWER FEELING ABNORMAL MOOD SWINGS

Product YAZ ASCORBIC ACID FOLIC ACID

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 288 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7085195 Date FDA Received
19-Aug-2009 Case # 7085195 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200921986NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922353NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200922137NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 35 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7085198 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7085198 Date FDA Received
19-Aug-2009

Outcomes

Preferred Term MENORRHAGIA NO ADVERSE EVENT

Product YAZ PROVERA Case # 7085199 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER

7085199 Date FDA Received
19-Aug-2009

Preferred Term VOMITING NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7085202 Date FDA Received
19-Aug-2009

Case # 7085202

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922247NA

Age

Sex Female

Country USA

Preferred Term HEADACHE

Product YAZ Case # 7085203 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7085203 Date FDA Received
19-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200927418NA

Age 16 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 289 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7085229 Date FDA Received
19-Aug-2009 Case # 7085229 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DS Manufacturer Control # RSBAYER-200927983GPV Dosage Text Age 28 YR Sex Female Country RS

Preferred Term DYSSTASIA ASTHENIA HEADACHE PAIN IN EXTREMITY VOMITING

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7096165 Date FDA Received
19-Aug-2009 Preferred Term CHOLELITHIASIS CHOLECYSTITIS

Case # 7096165

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text 3MG FOR 28 DAYS MONTHLY PO

Duration 2 YEAR

Manufacturer BAYER

POST PROCEDURAL INFECTION PROCEDURAL PAIN

7096639 Date FDA Received
19-Aug-2009 Preferred Term UNEVALUABLE EVENT

Case # 7096639

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT,OT,RI Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text ONE DAILY PO Manufacturer Control #

Duration

Manufacturer BAYER

7110023 Date FDA Received
19-Aug-2009 Preferred Term

Case # 7110023

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO Role Route S ORAL

Age 25 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration

Manufacturer BAYER

CEREBRAL VENOUS THROMBOSIS CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 290 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7086521 Date FDA Received
20-Aug-2009 Case # 7086521 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200929988NA Dosage Text Duration 1.17 YEAR Age Sex Female Country USA

Preferred Term OPTIC NEURITIS AMENORRHOEA BLINDNESS UNILATERAL

Product YAZ

Role Route S

Manufacturer BAYER

7086528 Date FDA Received
20-Aug-2009

Case # 7086528

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200930129NA Dosage Text

Age 43 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DYSPNOEA EXERTIONAL HEART RATE INCREASED WEIGHT DECREASED

Product YAZ LYRICA AMANTADINE MS MEDICATION NOS Case # 7086532 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S C C C Outcomes OT ORAL

Duration

Manufacturer BAYER

7086532 Date FDA Received
20-Aug-2009

Manufacturer Control # USBAYER-200930012NA Dosage Text

Age 17 YR

Sex Female

Country USA

Preferred Term CONVULSION

Product YAZ Case # 7006402 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7006402 Date FDA Received
21-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200918749NA

Age 26 YR

Sex Female

Country USA

Preferred Term ACNE MOOD ALTERED

Product YAZ

Role Route S ORAL

Dosage Text

Duration 3 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 291 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087504 Date FDA Received
21-Aug-2009 Case # 7087504 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922508NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7087505 Date FDA Received
21-Aug-2009

Case # 7087505

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922473NA

Age 14 YR

Sex Female

Country USA

Preferred Term SKIN DISCOLOURATION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7087508 Date FDA Received
21-Aug-2009

Case # 7087508

Outcomes

Manufacturer Control # USBAYER-200922259NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7087510 Date FDA Received
21-Aug-2009

Case # 7087510

Outcomes

Manufacturer Control # USBAYER-200922433NA

Age 16 YR

Sex Female

Country USA

Preferred Term COGNITIVE DISORDER METRORRHAGIA

Product YAZ ABILIFY ZOLOFT CENTRUM CALCIUM

Role Route S S C C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 292 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087512 Date FDA Received
21-Aug-2009 Case # 7087512 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922476NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922608NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922423NA Role Route S ORAL Dosage Text Age 17 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7087513 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087513 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7087516 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087516 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term DEPRESSION THYROXINE INCREASED

Product YAZ

Duration

Manufacturer BAYER

7087518 Date FDA Received
21-Aug-2009

Case # 7087518

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922250NA

Age

Sex Female

Country USA

Preferred Term OLIGOMENORRHOEA

Product YAZ Case # 7087530 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7087530 Date FDA Received
21-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200922485NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 293 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087533 Date FDA Received
21-Aug-2009 Case # 7087533 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922882NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922732NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922698NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7087534 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087534 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 7087535 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087535 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term BREAST ENLARGEMENT NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7087536 Date FDA Received
21-Aug-2009

Case # 7087536

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200922811NA

Age 39 YR

Sex Female

Country USA

Preferred Term MOOD SWINGS ACNE VAGINAL HAEMORRHAGE OFF LABEL USE

Product YAZ VICODIN IBUPROFEN SINGULAIR SKELAXIN

Role Route S C C C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 294 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087540 Date FDA Received
21-Aug-2009 Case # 7087540 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922849NA Role Route S C Outcomes Manufacturer Control # USBAYER-200922740NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922621NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922782NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 24 YR Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE NO ADVERSE EVENT

Product YAZ PROGESTERONE Case # 7087541 Case Type NON-EXPEDITED Health Professional N

Manufacturer BAYER

7087541 Date FDA Received
21-Aug-2009

Preferred Term DRY EYE

Product YAZ Case # 7087543 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7087543 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7087544 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087544 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 295 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087545 Date FDA Received
21-Aug-2009 Case # 7087545 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922630NA Role Route S C C C C Outcomes Manufacturer Control # USBAYER-200922682NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922614NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922868NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 33 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ OXYCODONE SODIUM CHLORIDE BENADRYL SUDAFED 12 HOUR

Duration

Manufacturer BAYER

7087546 Date FDA Received
21-Aug-2009

Case # 7087546

Case Type NON-EXPEDITED

Health Professional N

Preferred Term METRORRHAGIA

Product YAZ Case # 7087548 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087548 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term SKIN DISCOLOURATION

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087551 Date FDA Received
21-Aug-2009

Case # 7087551

Outcomes

Preferred Term HYPOMENORRHOEA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 296 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087552 Date FDA Received
21-Aug-2009 Case # 7087552 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923126NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200922734NA Role Route S ORAL Dosage Text Age 34 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ACNE

Product YAZ Case # 7087557 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7087557 Date FDA Received
21-Aug-2009

Outcomes

Preferred Term MOOD ALTERED ABDOMINAL DISTENSION

Product YAZ

Duration

Manufacturer BAYER

7087563 Date FDA Received
21-Aug-2009

Case # 7087563

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927613NA

Age

Sex Female

Country USA

Preferred Term NAUSEA HEADACHE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7087575 Date FDA Received
21-Aug-2009

Case # 7087575

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928099NA

Age

Sex Female

Country USA

Preferred Term ANTIBIOTIC THERAPY

Product YAZ PENICILLIN

Role Route S C Health Professional N Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7087579 Date FDA Received
21-Aug-2009

Case # 7087579

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200927784NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 297 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087580 Date FDA Received
21-Aug-2009 Case # 7087580 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927452NA Role Route S Health Professional N Product YAZ Outcomes HO,LT,OT Role Route S ORAL Dosage Text DAILY PO Manufacturer Control # Age 34 YR Duration Sex Female Dosage Text Age 19 YR Sex Female Country USA

Preferred Term FIBROCYSTIC BREAST DISEASE

Product YAZ Case Type DIRECT

Duration

Manufacturer BAYER Country USA

7098844 Date FDA Received
21-Aug-2009 Preferred Term

Case # 7098844

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7054869 Date FDA Received
24-Aug-2009

Case # 7054869

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919129NA

Age

Sex Female

Country USA

Preferred Term COITAL BLEEDING ASTHENIA HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091146 Date FDA Received
24-Aug-2009

Case # 7091146

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923116NA

Age

Sex Female

Country USA

Preferred Term CONTACT LENS INTOLERANCE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091147 Date FDA Received
24-Aug-2009

Case # 7091147

Outcomes

Manufacturer Control # USBAYER-200923114NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 298 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091148 Date FDA Received
24-Aug-2009 Case # 7091148 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922948NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923190NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923406NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923250NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923507NA Role Route S ORAL Dosage Text Age 25 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 18 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7091149 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7091149 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term CRYING

Product YAZ Case # 7091152 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7091152 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7091153 Date FDA Received
24-Aug-2009

Case # 7091153

Outcomes

Preferred Term ABDOMINAL PAIN

Product YAZ Case # 7091155 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7091155 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term Sunburn NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 299 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091156 Date FDA Received
24-Aug-2009 Case # 7091156 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923547NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term TONSILLAR HYPERTROPHY AMENORRHOEA OROPHARYNGEAL PAIN VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

7091157 Date FDA Received
24-Aug-2009

Case # 7091157

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923825NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ Case # 7091161 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091161 Date FDA Received
24-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200923723NA

Age

Sex Female

Country USA

Preferred Term VAGINAL DISCHARGE NASOPHARYNGITIS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091162 Date FDA Received
24-Aug-2009

Case # 7091162

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923850NA

Age

Sex Female

Country USA

Preferred Term ANXIETY

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration 7 MTH

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 300 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091163 Date FDA Received
24-Aug-2009 Case # 7091163 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923260NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923854NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7091165 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7091165 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term METRORRHAGIA STRESS

Product YAZ

Manufacturer BAYER

7091166 Date FDA Received
24-Aug-2009

Case # 7091166

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923415NA

Age 25 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091167 Date FDA Received
24-Aug-2009

Case # 7091167

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923728NA

Age 17 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA ABDOMINAL PAIN LOWER NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 301 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091168 Date FDA Received
24-Aug-2009 Case # 7091168 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923306NA Role Route S S C ORAL ORAL Dosage Text BEGAN THERAPY MID CYCLE 7 MTH Duration Age Sex Female Country USA

Preferred Term DEPRESSION ANXIETY NAUSEA FATIGUE FEELING ABNORMAL HYPOGLYCAEMIA

Product YAZ YAZ LEXAPRO

Manufacturer BAYER BAYER

7091170 Date FDA Received
24-Aug-2009

Case # 7091170

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923310NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ Case # 7091171 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091171 Date FDA Received
24-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200923505NA

Age 35 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7091181 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091181 Date FDA Received
24-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200923852NA

Age

Sex Female

Country USA

Preferred Term SWELLING

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 302 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091185 Date FDA Received
24-Aug-2009 Case # 7091185 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927788NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923909NA Role Route S ORAL Dosage Text Age 40 YR Sex Female Dosage Text Age 28 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7091189 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7091189 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term IRRITABILITY ABDOMINAL DISTENSION ABDOMINAL PAIN ACNE DEPRESSED MOOD FLUID RETENTION HYPOMENORRHOEA MENSTRUATION DELAYED OFF LABEL USE VAGINAL HAEMORRHAGE WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7091190 Date FDA Received
24-Aug-2009

Case # 7091190

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923898NA

Age 31 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA HYPOMENORRHOEA

Product YAZ CLONAZEPAM

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 303 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091196 Date FDA Received
24-Aug-2009 Case # 7091196 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200923906NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923880NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term HOT FLUSH

Product YAZ Case # 7091198 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7091198 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term METRORRHAGIA MENSTRUATION DELAYED NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7091200 Date FDA Received
24-Aug-2009

Case # 7091200

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923868NA

Age

Sex Female

Country USA

Preferred Term SKIN DISCOLOURATION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7091201 Date FDA Received
24-Aug-2009

Case # 7091201

Outcomes

Manufacturer Control # USBAYER-200923958NA

Age

Sex Female

Country USA

Preferred Term NAUSEA ABDOMINAL PAIN UPPER WEIGHT INCREASED

Product YAZ LISINOPRIL PHENTERMINE

Role Route S C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 304 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7091230 Date FDA Received
24-Aug-2009 Case # 7091230 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928105NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930245NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7091235 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7091235 Date FDA Received
24-Aug-2009

Outcomes

Preferred Term VAGINITIS BACTERIAL DEPRESSION INFECTION VARICOSE VEINS PELVIC VULVOVAGINAL MYCOTIC INFECTION

Product YAZ

Manufacturer BAYER

7091237 Date FDA Received
24-Aug-2009

Case # 7091237

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928122NA

Age 21 YR

Sex Female

Country USA

Preferred Term ACNE BREAST DISCOMFORT ABDOMINAL PAIN IRRITABILITY

Product YAZ SYNTHROID

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 305 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7099919 Date FDA Received
24-Aug-2009 Preferred Term INSOMNIA ANXIETY DEPRESSION HEPATIC CYST MENTAL DISORDER MOOD SWINGS OVARIAN CYST RUPTURED PANIC ATTACK VOMITING Case # 7099919 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text ONE PILL DAILY PO Manufacturer Control # Age 34 YR Duration Sex Female Country USA

Manufacturer BAYER

7099928 Date FDA Received
24-Aug-2009 Preferred Term

Case # 7099928

Case Type DIRECT Product

Health Professional N

Outcomes HO,LT,RI Role Route S S ORAL ORAL

Manufacturer Control #

Age 38 YR

Sex Female

Country USA

Dosage Text 28 DAILY PO 28 DAILY PO Manufacturer Control #

Duration

Manufacturer

GALLBLADDER DISORDER

DROSPIRENONE\ETHINYL ESTRADIOL YAZ

BAYER Age 54 YR Sex Female Country USA

7100008 Date FDA Received
24-Aug-2009 Preferred Term

Case # 7100008

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S ORAL

Dosage Text ONE DAILY PO

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 306 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7100221 Date FDA Received
24-Aug-2009 Preferred Term ABDOMINAL PAIN ABDOMINAL PAIN UPPER AGGRESSION ANXIETY ASTHENIA DEPRESSION FATIGUE HEADACHE IRRITABILITY NERVOUSNESS SOCIAL AVOIDANT BEHAVIOUR SUICIDAL IDEATION Case # 7100221 Case Type DIRECT Product YAZ Health Professional Outcomes LT Role Route S Dosage Text Manufacturer Control # Age 13 YR Duration Sex Female Country USA

Manufacturer

7095325 Date FDA Received
25-Aug-2009

Case # 7095325

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200930390NA Dosage Text

Age 20 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7095357 Date FDA Received
25-Aug-2009

Case # 7095357

Outcomes

Manufacturer Control # USBAYER-200921399NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 307 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7095359 Date FDA Received
25-Aug-2009 Case # 7095359 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924418NA Role Route S S C Outcomes Manufacturer Control # USBAYER-200924240NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200924067NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200923990NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL ORAL Dosage Text Age 25 YR Sex Female Country USA

Preferred Term ACNE DEPRESSED MOOD METRORRHAGIA

Product YAZ YASMIN HERBAL SUPPLEMENTS Case # 7095361 Case Type NON-EXPEDITED Health Professional N

Duration

Manufacturer BAYER BAYER

7095361 Date FDA Received
25-Aug-2009

Preferred Term ACNE

Product YAZ Case # 7095362 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7095362 Date FDA Received
25-Aug-2009

Outcomes

Preferred Term HEADACHE

Product YAZ Case # 7095363 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7095363 Date FDA Received
25-Aug-2009

Outcomes

Preferred Term FEELING COLD PILOERECTION

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 308 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7095364 Date FDA Received
25-Aug-2009 Case # 7095364 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924065NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VOMITING NASOPHARYNGITIS

Product YAZ

Manufacturer BAYER

7095365 Date FDA Received
25-Aug-2009

Case # 7095365

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924016NA

Age

Sex Female

Country USA

Preferred Term MUSCULAR WEAKNESS ARTHRALGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7095369 Date FDA Received
25-Aug-2009

Case # 7095369

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923991NA

Age 24 YR

Sex Female

Country USA

Preferred Term CONSTIPATION

Product YAZ Case # 7095371 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7095371 Date FDA Received
25-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200924708NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ Case # 7095372 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7095372 Date FDA Received
25-Aug-2009

Outcomes

Manufacturer Control # USBAYER-200923996NA

Age 25 YR

Sex Female

Country USA

Preferred Term POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 309 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7095374 Date FDA Received
25-Aug-2009 Case # 7095374 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924488NA Role Route S ORAL Dosage Text Age 19 YR Sex Female Country USA

Preferred Term METRORRHAGIA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7095377 Date FDA Received
25-Aug-2009

Case # 7095377

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928089NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 310 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7097017 Date FDA Received
26-Aug-2009 Case # 7097017 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200930249NA Dosage Text Age 21 YR Sex Female Country USA

Preferred Term GASTROINTESTINAL PAIN ABDOMINAL DISTENSION ABDOMINAL PAIN UPPER AFFECTIVE DISORDER BACK PAIN BREAST TENDERNESS CHEST PAIN DEPRESSION SUICIDAL DIARRHOEA GASTROOESOPHAGEAL REFLUX DISEASE HEPATIC LESION HEPATIC NEOPLASM HEPATIC PAIN MOOD SWINGS OESOPHAGITIS VOMITING WEIGHT DECREASED

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7097026 Date FDA Received
26-Aug-2009

Case # 7097026

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200930244NA Dosage Text Total daily dose: 1 DF

Age 18 YR

Sex Female

Country USA

Preferred Term PANIC ATTACK MIGRAINE MUSCLE TWITCHING MUSCULOSKELETAL STIFFNESS PALPITATIONS TREMOR

Product YAZ

Role Route S ORAL

Duration 4 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 311 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7097029 Date FDA Received
26-Aug-2009 Case # 7097029 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200930696NA Dosage Text Age 20 YR Sex Female Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ Case # 7097031 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7097031 Date FDA Received
26-Aug-2009

Outcomes OT

Manufacturer Control # USBAYER-200930492NA Dosage Text

Age

Sex Female

Country USA

Preferred Term METAMORPHOPSIA BLOOD PRESSURE INCREASED CHEST PAIN CHLOASMA CHROMATURIA IRRITABILITY MUSCULAR WEAKNESS PAIN IN EXTREMITY VISION BLURRED VISUAL IMPAIRMENT YELLOW SKIN

Product YAZ

Role Route S

Duration 2 MTH

Manufacturer BAYER

7097065 Date FDA Received
26-Aug-2009

Case # 7097065

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200927088NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 312 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7097066 Date FDA Received
26-Aug-2009 Case # 7097066 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925748NA Role Route S Dosage Text Duration 1 WEEK Age Sex Female Country USA

Preferred Term RASH GENERALISED VAGINAL DISCHARGE VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

7097073 Date FDA Received
26-Aug-2009

Case # 7097073

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927094NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7097074 Date FDA Received
26-Aug-2009

Case # 7097074

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923417NA

Age 50 YR

Sex Female

Country USA

Preferred Term BLOOD PRESSURE INCREASED HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration 5 DAY

Manufacturer BAYER

7097075 Date FDA Received
26-Aug-2009

Case # 7097075

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200925732NA

Age 16 YR

Sex Female

Country USA

Preferred Term BLOOD POTASSIUM INCREASED

Product YAZ

Role Route S

Dosage Text

Duration 5 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 313 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7097076 Date FDA Received
26-Aug-2009 Case # 7097076 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200927095NA Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

7097077 Date FDA Received
26-Aug-2009

Case # 7097077

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200927092NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7097078 Date FDA Received
26-Aug-2009

Case # 7097078

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200927093NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7097080 Date FDA Received
26-Aug-2009

Case # 7097080

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927096NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 314 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7097081 Date FDA Received
26-Aug-2009 Case # 7097081 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927091NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Manufacturer BAYER

6765606 Date FDA Received
27-Aug-2009

Case # 6765606

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200832639NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING MENORRHAGIA METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text ONE TABLET PER DAY

Duration

Manufacturer BAYER

6913263 Date FDA Received
27-Aug-2009

Case # 6913263

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911375NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING GASTROENTERITIS VIRAL HYPOMENORRHOEA METRORRHAGIA NASOPHARYNGITIS VIRAL INFECTION VOMITING

Product YAZ UNIDENTIFIED OTC COLD MEDICINE

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 315 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7098106 Date FDA Received
27-Aug-2009 Case # 7098106 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200930568NA Dosage Text Age 39 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM THROMBOPHLEBITIS SUPERFICIAL

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7098107 Date FDA Received
27-Aug-2009

Case # 7098107

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200930570NA Dosage Text

Age 33 YR

Sex Female

Country USA

Preferred Term VENTRICULAR TACHYCARDIA GASTROINTESTINAL DISORDER

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7098223 Date FDA Received
27-Aug-2009

Case # 7098223

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924034NA

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA MENORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7098224 Date FDA Received
27-Aug-2009

Case # 7098224

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924029NA

Age 45 YR

Sex Female

Country USA

Preferred Term ALOPECIA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 316 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7098242 Date FDA Received
27-Aug-2009 Case # 7098242 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924490NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200924475NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200924526NA Role Route S Dosage Text Age 35 YR Sex Female Dosage Text Duration Dosage Text Age 17 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration 37 DAY Age Sex

Manufacturer BAYER Country USA

7098246 Date FDA Received
27-Aug-2009

Case # 7098246

Female

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7098251 Date FDA Received
27-Aug-2009

Case # 7098251

Outcomes

Preferred Term METRORRHAGIA ACNE NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7098257 Date FDA Received
27-Aug-2009

Case # 7098257

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200930704NA

Age 43 YR

Sex Female

Country USA

Preferred Term DYSPNOEA ABDOMINAL DISTENSION DIZZINESS HEADACHE PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 317 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7099190 Date FDA Received
28-Aug-2009 Case # 7099190 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200922480NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200929083NA Role Route S Health Professional N Product YAZ Role Route S Dosage Text Duration ORAL Manufacturer Control # Age Sex Female Dosage Text Age 33 YR Sex Female Dosage Text Age 34 YR Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7099202 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7099202 Date FDA Received
28-Aug-2009

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type DIRECT

Duration

Manufacturer BAYER Country USA

7105005 Date FDA Received
28-Aug-2009 Preferred Term LICHEN PLANUS ALOPECIA

Case # 7105005

Outcomes

Manufacturer

7105521 Date FDA Received
28-Aug-2009 Preferred Term HYDROCEPHALUS

Case # 7105521

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO,DS,LT,RI Role Route S

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

CENTRAL NERVOUS SYSTEM NECROSIS CEREBRAL VENOUS THROMBOSIS CEREBROVASCULAR DISORDER INTRACRANIAL VENOUS SINUS THROMBOSIS OBSTRUCTION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 318 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7073884 Date FDA Received
31-Aug-2009 Case # 7073884 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925638NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA ABDOMINAL DISCOMFORT HYPOMENORRHOEA MEDICATION ERROR

Product YAZ

Manufacturer BAYER

7101242 Date FDA Received
31-Aug-2009

Case # 7101242

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929030NA

Age 23 YR

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ Case # 7101287 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Manufacturer Control # USBAYER-200929080NA

Duration

Manufacturer BAYER

7101287 Date FDA Received
31-Aug-2009

Age

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN DEPRESSED MOOD

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7101294 Date FDA Received
31-Aug-2009

Case # 7101294

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929136NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 319 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7101302 Date FDA Received
31-Aug-2009 Case # 7101302 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200929141NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929118NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200929077NA Role Route S Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Manufacturer Control # BRBAYER-200817696LA Dosage Text 24D/28D Age 29 YR Sex Female Age 15 YR Sex Female Dosage Text Age 37 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term PAIN IN EXTREMITY

Product YAZ Case # 7101303 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7101303 Date FDA Received
31-Aug-2009

Outcomes

Preferred Term AMENORRHOEA

Product YAZ Case # 7101310 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7101310 Date FDA Received
31-Aug-2009

Preferred Term RASH PAPULAR

Product YAZ

Duration

Manufacturer BAYER

6748903 Date FDA Received
01-Sep-2009

Case # 6748903

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Country BRA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING ABDOMINAL DISTENSION BREAST SWELLING HEADACHE IRRITABILITY PAIN SOMNOLENCE SWELLING

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 320 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7102096 Date FDA Received
01-Sep-2009 Case # 7102096 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200930971NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PALPITATIONS

Product YAZ Case # 7102103 Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes OT

Manufacturer BAYER

7102103 Date FDA Received
01-Sep-2009

Manufacturer Control # USBAYER-200931009NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 7102104 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7102104 Date FDA Received
01-Sep-2009

Manufacturer Control # USBAYER-200931012NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 7102107 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7102107 Date FDA Received
01-Sep-2009

Manufacturer Control # USBAYER-200931011NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 7106897 Case Type DIRECT Product YAZ Health Professional N

Role Route S Outcomes HO,LT,OT Role Route S ORAL

Duration

Manufacturer BAYER

7106897 Date FDA Received
01-Sep-2009 Preferred Term THROMBOSIS LUNG INFECTION PLEURISY

Manufacturer Control #

Age 37 YR

Sex Female

Country USA

Dosage Text 1 DAILY ORAL

Duration 2 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 321 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7109083 Date FDA Received
02-Sep-2009 Preferred Term FATIGUE ABDOMINAL DISTENSION ABDOMINAL PAIN AGGRESSION ANGER DIZZINESS DRY EYE HEADACHE MENORRHAGIA PHYSICAL ASSAULT VAGINAL HAEMORRHAGE Case # 7109083 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S Dosage Text 1 PILL ONCE DAILY Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer

7104142 Date FDA Received
03-Sep-2009

Case # 7104142

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925000NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA WITHDRAWAL BLEED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7104150 Date FDA Received
03-Sep-2009

Case # 7104150

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925173NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT ABDOMINAL PAIN MENORRHAGIA POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 322 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7104159 Date FDA Received
03-Sep-2009 Case # 7104159 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200929246NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929263NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7104169 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7104169 Date FDA Received
03-Sep-2009

Outcomes

Preferred Term NAUSEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product YAZ

Manufacturer BAYER

7104189 Date FDA Received
03-Sep-2009

Case # 7104189

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925167NA

Age 33 YR

Sex Female

Country USA

Preferred Term MALAISE FEELING ABNORMAL OFF LABEL USE VAGINAL DISCHARGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 323 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7110645 Date FDA Received
03-Sep-2009 Preferred Term SYNCOPE PANIC ATTACK ASTHENIA CHEST PAIN DIZZINESS DYSPNOEA ECONOMIC PROBLEM FATIGUE HEADACHE HYPOAESTHESIA PARAESTHESIA PARANOIA WEIGHT DECREASED Case # 7110645 Case Type DIRECT Product YAZ YASMIN Health Professional N Outcomes HO,OT,RI Role Route S S ORAL Dosage Text 28 PILLS TO TAKE 1 DAILY ORAL Manufacturer Control # Age 27 YR Duration Sex Female Country USA

Manufacturer BAYER

7105299 Date FDA Received
04-Sep-2009

Case # 7105299

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929402NA

Age 32 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type DIRECT Product YAZ NUVARING Health Professional Y

Role Route S Outcomes HO,LT,RI Role Route S C ORAL

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Manufacturer Control #

Duration

Manufacturer BAYER

7109835 Date FDA Received
04-Sep-2009 Preferred Term

Case # 7109835

Age 34 YR

Sex Female

Country USA

Dosage Text 1 TABLET EVERYDAY PO

Duration

Manufacturer BAYER

PULMONARY THROMBOSIS PRODUCT QUALITY ISSUE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 324 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7111282 Date FDA Received
04-Sep-2009 Preferred Term HEADACHE Case # 7111282 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,DS,LT Role Route S ORAL Dosage Text 1 PILL .02MG ESTROGEN 3MG PROGESTERN DAILY ORAL Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer BAYER

GAIT DEVIATION HYPOAESTHESIA HYPOAESTHESIA ORAL INTRACRANIAL VENOUS SINUS THROMBOSIS OEDEMA PERIPHERAL PAIN IN EXTREMITY SPEECH DISORDER VISION BLURRED

7046802 Date FDA Received
08-Sep-2009

Case # 7046802

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200925760NA Dosage Text

Age 37 YR

Sex Female

Country USA

Preferred Term SMALL INTESTINAL OBSTRUCTION ABDOMINAL PAIN COLITIS VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 325 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7062388 Date FDA Received
08-Sep-2009 Case # 7062388 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,LT Manufacturer Control # FRBAYER-200926029GPV Dosage Text Age 25 YR Sex Female Country FRA

Preferred Term IDIOPATHIC THROMBOCYTOPENIC PURPURA PETECHIAE SPONTANEOUS HAEMATOMA LEUKOPENIA NEUTROPENIA THROMBOCYTOPENIA

Product YAZ NOMEGESTROL ACETATE FERROUS SULFATE

Role Route S C C ORAL

Duration 22 DAY

Manufacturer BAYER

7086527 Date FDA Received
08-Sep-2009

Case # 7086527

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200930126NA Dosage Text Total daily dose: 1 DF

Age 22 YR

Sex Female

Country USA

Preferred Term AORTIC ANEURYSM SYNCOPE

Product YAZ PROZAC RISPERIDONE KLONOPIN ZOLOFT PROZAC COMPAZINE

Role Route S C C C C C C Health Professional N Outcomes OT ORAL

Duration 2.6 YEAR

Manufacturer BAYER

7105267 Date FDA Received
08-Sep-2009

Case # 7105267

Case Type EXPEDITED (15-DAY)

Manufacturer Control # USBAYER-200930982NA Dosage Text

Age

Sex Female

Country USA

Preferred Term BLOOD PRESSURE INCREASED SURGERY

Product YAZ HYDROCHLOROTHIAZIDE

Role Route S C

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 326 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7105269 Date FDA Received
08-Sep-2009 Case # 7105269 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200930985NA Dosage Text Age 19 YR Sex Female Country USA

Preferred Term THROMBOSIS ANAPHYLACTIC REACTION COUGH DRUG HYPERSENSITIVITY PYREXIA

Product YAZ YASMIN

Role Route S S

Duration

Manufacturer BAYER BAYER

7107181 Date FDA Received
08-Sep-2009

Case # 7107181

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200931338NA Dosage Text

Age 21 YR

Sex Female

Country USA

Preferred Term GALLBLADDER DISORDER

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes OT

Duration 6 MTH

Manufacturer BAYER Sex Female Country USA

7107183 Date FDA Received
08-Sep-2009

Case # 7107183

Manufacturer Control # USBAYER-200931386NA Dosage Text

Age

Preferred Term PANCREATITIS

Product YAZ Case # 7107184 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes HO

Duration

Manufacturer BAYER

7107184 Date FDA Received
08-Sep-2009

Manufacturer Control # USBAYER-200931469NA Dosage Text

Age 31 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 327 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7107196 Date FDA Received
08-Sep-2009 Case # 7107196 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DE,HO Manufacturer Control # USBAYER-200932100NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200929623NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200929622NA Role Route S Health Professional N Product YAZ Outcomes OT Role Route S ORAL Dosage Text NORMAL DOSE ONCE A DAY PO Manufacturer Control # Age 27 YR Duration Sex Female Dosage Text Duration Dosage Text Duration 6 MTH Age Sex Female Age Sex Female Duration Age Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER Country USA

7107378 Date FDA Received
08-Sep-2009

Case # 7107378

Outcomes

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7107382 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7107382 Date FDA Received
08-Sep-2009

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7113509 Case Type DIRECT

Manufacturer BAYER Country USA

7113509 Date FDA Received
08-Sep-2009 Preferred Term MADAROSIS HYPERTHYROIDISM

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 328 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114611 Date FDA Received
08-Sep-2009 Preferred Term ANXIETY INCREASED APPETITE MENORRHAGIA PANIC ATTACK WEIGHT INCREASED Case # 7114611 Case Type DIRECT Product YAZ Health Professional N Outcomes DS,OT Role Route S Dosage Text Manufacturer Control # Age 19 YR Duration 6 MTH Sex Female Country USA

Manufacturer BAYER

7114615 Date FDA Received
08-Sep-2009 Preferred Term ISCHAEMIC STROKE

Case # 7114615

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,DS,LT,OT,RI Role Route S ORAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 3MG AS PERSCRIBED PO

Duration

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS

7058279 Date FDA Received
09-Sep-2009

Case # 7058279

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200926247NA

Age 30 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7058280 Date FDA Received
09-Sep-2009

Case # 7058280

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200926244NA

Age 35 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 329 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7065089 Date FDA Received
09-Sep-2009 Case # 7065089 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926995NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200926993NA Role Route S Health Professional N Product YAZ Case # 7113849 Case Type DIRECT Product YAZ PAXIL ROPRINEROL VITAMINS NOS Health Professional N ORAL Manufacturer Control # Age 27 YR Dosage Text 1 DAILY PO Manufacturer Control # Age 51 YR Dosage Text ONE PILL DAILY PO Duration 3 WEEK Sex Female Country USA Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Manufacturer BAYER Country USA

7065091 Date FDA Received
09-Sep-2009

Case # 7065091

Case Type NON-EXPEDITED

Outcomes

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Manufacturer BAYER Country USA

7113532 Date FDA Received
09-Sep-2009 Preferred Term THROMBOSIS

Case # 7113532

Case Type DIRECT

Outcomes HO Role Route S ORAL

Manufacturer

7113849 Date FDA Received
09-Sep-2009 Preferred Term

Outcomes HO,DS,LT,OT Role Route S C C C Outcomes ORAL

Manufacturer BAYER

DEEP VEIN THROMBOSIS

7109691 Date FDA Received
10-Sep-2009

Case # 7109691

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200929895NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 330 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7129999 Date FDA Received
10-Sep-2009 Preferred Term CHEST PAIN Case # 7129999 Case Type DIRECT Product YAZ Case # 7056133 Case Type NON-EXPEDITED Health Professional N Health Professional Y Role Route S Outcomes OT Manufacturer Control # USBAYER-200926868NA Dosage Text Total daily dose: 1 DF INTERMITTENT USE Manufacturer Control # USBAYER-200929629NA Dosage Text Age 33 YR Sex Female Country USA Age 24 YR Sex Female Country USA Dosage Text Outcomes Manufacturer Control # Age 45 YR Duration Sex Female Country USA

Manufacturer

7056133 Date FDA Received
11-Sep-2009

Preferred Term DEEP VEIN THROMBOSIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE

Product YAZ ADIPEX-P Health Professional Y

Role Route S C ORAL ORAL

Duration 2 YEAR

Manufacturer BAYER

7085240 Date FDA Received
11-Sep-2009

Case # 7085240

Case Type NON-EXPEDITED

Outcomes HO,OT

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7111101 Date FDA Received
11-Sep-2009

Case # 7111101

Manufacturer Control # USBAYER-200932075NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY FACIAL PAIN

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7111113 Date FDA Received
11-Sep-2009

Case # 7111113

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # USBAYER-200932015NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS GALLBLADDER DISORDER PAIN

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 331 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7111114 Date FDA Received
11-Sep-2009 Case # 7111114 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200932183NA Dosage Text Duration Age Sex Female Country USA

Preferred Term BIPOLAR DISORDER

Product YAZ Case # 7111115 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Manufacturer BAYER

7111115 Date FDA Received
11-Sep-2009

Manufacturer Control # BRBAYER-200921418LA Dosage Text

Age 22 YR

Sex Female

Country BRA

Preferred Term Embolism arterial ISCHAEMIA VISION BLURRED

Product YAZ

Role Route S ORAL

Duration 151 DAY

Manufacturer BAYER

7111118 Date FDA Received
11-Sep-2009

Case # 7111118

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200932290NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7111121 Date FDA Received
11-Sep-2009

Case # 7111121

Outcomes OT

Manufacturer Control # USBAYER-200932292NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7111122 Date FDA Received
11-Sep-2009

Case # 7111122

Outcomes OT

Manufacturer Control # USBAYER-200932291NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 332 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7111128 Date FDA Received
11-Sep-2009 Case # 7111128 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200932294NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER

7111130 Date FDA Received
11-Sep-2009

Case # 7111130

Outcomes OT

Manufacturer Control # USBAYER-200932293NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7111220 Date FDA Received
11-Sep-2009

Case # 7111220

Outcomes

Manufacturer Control # USBAYER-200917822NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7111232 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7111232 Date FDA Received
11-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200925269NA

Age

Sex Female

Country USA

Preferred Term URINARY TRACT INFECTION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7111237 Date FDA Received
11-Sep-2009

Case # 7111237

Outcomes

Manufacturer Control # USBAYER-200928443NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 333 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7111242 Date FDA Received
11-Sep-2009 Case # 7111242 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925714NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200925497NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929635NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Age 21 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration 20 DAY Age Sex

Manufacturer BAYER Country USA

7111244 Date FDA Received
11-Sep-2009

Case # 7111244

Outcomes

Female

Preferred Term NAUSEA

Product YAZ Case # 7111251 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7111251 Date FDA Received
11-Sep-2009

Outcomes

Preferred Term WEIGHT INCREASED BREAST TENDERNESS

Product YAZ

Manufacturer BAYER

7111252 Date FDA Received
11-Sep-2009

Case # 7111252

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929639NA

Age

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN

Product YAZ

Role Route S

Dosage Text

Duration 2 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 334 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7111255 Date FDA Received
11-Sep-2009 Case # 7111255 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925182NA Role Route S S ORAL Dosage Text Age 17 YR Sex Female Country USA

Preferred Term IRRITABILITY UNEVALUABLE EVENT DEPRESSED MOOD NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ DAYTRANA

Duration

Manufacturer BAYER

7111267 Date FDA Received
11-Sep-2009

Case # 7111267

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929771NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7113697 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7113697 Date FDA Received
14-Sep-2009

Manufacturer Control # USBAYER-200929170NA

Age 25 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN DIARRHOEA

Product YAZ

Role Route S

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF

Duration

Manufacturer BAYER

7113733 Date FDA Received
14-Sep-2009

Case # 7113733

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200930277NA

Age

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 335 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7116964 Date FDA Received
14-Sep-2009 Preferred Term PULMONARY EMBOLISM Case # 7116964 Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ Health Professional N Health Professional N Health Professional N Outcomes DE Role Route S Outcomes HO,LT Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # Age 28 YR Dosage Text 1 PILL PER DAY PO TWO TO THREE YEARS Duration Sex Female Country USA Manufacturer Control # Age 31 YR Duration Sex Female Country USA Dosage Text Manufacturer Control # Age 44 YR Duration Sex Female Country USA

Manufacturer

7117056 Date FDA Received
14-Sep-2009 Preferred Term

Case # 7117056

Manufacturer

JUGULAR VEIN THROMBOSIS

7117761 Date FDA Received
14-Sep-2009 Preferred Term CHOLELITHIASIS

Case # 7117761

Outcomes HO Role Route S ORAL

Manufacturer

PAIN

6765505 Date FDA Received
15-Sep-2009

Case # 6765505

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200831761NA

Age 22 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA ABDOMINAL PAIN AMENORRHOEA NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text ONE TABLET PER DAY

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 336 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058219 Date FDA Received
15-Sep-2009 Case # 7058219 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919388NA Role Route S ORAL Dosage Text Duration 14 DAY Age Sex Female Country USA

Preferred Term ASTHENIA ABDOMINAL DISTENSION ACNE INCREASED APPETITE WEIGHT INCREASED

Product YAZ

Manufacturer BAYER

7058238 Date FDA Received
15-Sep-2009

Case # 7058238

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919568NA

Age 38 YR

Sex Female

Country USA

Preferred Term PAIN IN EXTREMITY HYPOAESTHESIA NO ADVERSE EVENT

Product YAZ THYROID, UNSPECIFIED

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

7114823 Date FDA Received
15-Sep-2009

Case # 7114823

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925705NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA DYSMENORRHOEA MENORRHAGIA MENSTRUAL DISORDER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7114824 Date FDA Received
15-Sep-2009

Case # 7114824

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200926802NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 337 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114826 Date FDA Received
15-Sep-2009 Case # 7114826 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925610NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUAL DISORDER AMENORRHOEA

Product YAZ

Manufacturer BAYER

7114830 Date FDA Received
15-Sep-2009

Case # 7114830

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925961NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7114832 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7114832 Date FDA Received
15-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200927425NA

Age

Sex Female

Country USA

Preferred Term RASH

Product YAZ Case # 7114833 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7114833 Date FDA Received
15-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200927601NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7114838 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7114838 Date FDA Received
15-Sep-2009

Manufacturer Control # USBAYER-200927295NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 338 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114849 Date FDA Received
15-Sep-2009 Case # 7114849 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927227NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL PAIN LOWER BREAST MASS MENSTRUATION IRREGULAR

Product YAZ

Manufacturer BAYER

7114851 Date FDA Received
15-Sep-2009

Case # 7114851

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927783NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ Case # 7114852 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7114852 Date FDA Received
15-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200927068NA

Age

Sex Male

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7114858 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7114858 Date FDA Received
15-Sep-2009

Manufacturer Control # USBAYER-200927469NA

Age

Sex Female

Country USA

Preferred Term SINUSITIS

Product YAZ Case # 7114861 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7114861 Date FDA Received
15-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200927514NA

Age 19 YR

Sex Female

Country USA

Preferred Term ACNE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 339 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114864 Date FDA Received
15-Sep-2009 Case # 7114864 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927948NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932473NA Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7114884 Date FDA Received
15-Sep-2009

Case # 7114884

Outcomes OT

Preferred Term PULMONARY EMBOLISM ATRIAL THROMBOSIS COUGH FATIGUE PLEURITIC PAIN PYREXIA

Product YAZ

Role Route S

Manufacturer BAYER

7068644 Date FDA Received
16-Sep-2009

Case # 7068644

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200925212NA

Age 26 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED FATIGUE NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7070103 Date FDA Received
16-Sep-2009

Case # 7070103

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924477NA

Age 26 YR

Sex Female

Country USA

Preferred Term HYPERSENSITIVITY URTICARIA

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 340 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7115960 Date FDA Received
16-Sep-2009 Case # 7115960 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927070NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200927318NA Role Route S ORAL Dosage Text Dosage Text Age 20 YR Sex Female Country USA

Preferred Term PEAU D'ORANGE

Product YAZ Case # 7115961 Case Type NON-EXPEDITED

Duration 2 YEAR Age 21 YR Sex

Manufacturer BAYER Country USA

7115961 Date FDA Received
16-Sep-2009

Female

Preferred Term VULVOVAGINAL DRYNESS VULVOVAGINAL PAIN

Product YAZ

Duration

Manufacturer BAYER

7115963 Date FDA Received
16-Sep-2009

Case # 7115963

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927066NA

Age 40 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA ABDOMINAL DISCOMFORT HEADACHE MALAISE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7115965 Date FDA Received
16-Sep-2009

Case # 7115965

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927975NA

Age

Sex Female

Country USA

Preferred Term INCORRECT DOSE ADMINISTERED MENSTRUATION IRREGULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 341 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7115967 Date FDA Received
16-Sep-2009 Case # 7115967 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927300NA Role Route S C ORAL Dosage Text Age 20 YR Sex Female Country USA

Preferred Term ABDOMINAL PAIN UPPER FATIGUE ABDOMINAL DISCOMFORT DIARRHOEA HYPERPHAGIA NAUSEA

Product YAZ ZYRTEC

Duration

Manufacturer BAYER

7115968 Date FDA Received
16-Sep-2009

Case # 7115968

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927313NA

Age 29 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7115972 Date FDA Received
16-Sep-2009

Case # 7115972

Outcomes

Manufacturer Control # USBAYER-200927336NA

Age 19 YR

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7116002 Date FDA Received
16-Sep-2009

Case # 7116002

Outcomes OT

Manufacturer Control # USBAYER-200932706NA Dosage Text Total daily dose: 1 DF

Age 35 YR

Sex Female

Country USA

Preferred Term RECTAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 342 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7116005 Date FDA Received
16-Sep-2009 Case # 7116005 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # USBAYER-200932814NA Dosage Text Duration Age Sex Female Country USA

Preferred Term BLOOD POTASSIUM INCREASED DIARRHOEA

Product YAZ

Role Route S

Manufacturer BAYER

7123656 Date FDA Received
16-Sep-2009 Preferred Term

Case # 7123656

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 33 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY (24+4) 047

Duration 6 MTH

Manufacturer BAYER

DEEP VEIN THROMBOSIS MUSCLE SPASMS

7123897 Date FDA Received
16-Sep-2009 Preferred Term

Case # 7123897

Case Type DIRECT Product YAZ

Health Professional

Outcomes DS Role Route S

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text 3MG/ 0.02MG ONCER EVERY DAY

Duration

Manufacturer

PIGMENTATION DISORDER EMOTIONAL DISTRESS

6913260 Date FDA Received
17-Sep-2009

Case # 6913260

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911373NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ TRI-SPRINTEC

Role Route S C ORAL

Dosage Text STOPS AFTER 3 MONTHS

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 343 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7117105 Date FDA Received
17-Sep-2009 Case # 7117105 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927480NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DERMATITIS PAIN RASH

Product YAZ

Manufacturer BAYER

7126995 Date FDA Received
17-Sep-2009 Preferred Term

Case # 7126995

Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT,OT Role Route S ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO A LITTLE OVER 2 YEARS Manufacturer Control #

Duration 2 YEAR Age 43 YR Sex

Manufacturer BAYER Country USA

CEREBROVASCULAR ACCIDENT

7130133 Date FDA Received
17-Sep-2009 Preferred Term DEPRESSION AGITATION ANXIETY

Case # 7130133

Health Professional N

Outcomes OT Role Route S ORAL

Female

Dosage Text ONE TABLET PER DAY PO

Duration

Manufacturer BAYER

7133008 Date FDA Received
17-Sep-2009 Preferred Term

Case # 7133008

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 50 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY BY MOUTH

Duration

Manufacturer BAYER

GALLBLADDER DISORDER ABDOMINAL PAIN

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 344 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7133117 Date FDA Received
17-Sep-2009 Preferred Term HAEMATOCHEZIA CHEST PAIN DEPRESSION HEART RATE INCREASED LUNG DISORDER NAUSEA Case # 7133117 Case Type DIRECT Product YAZ Health Professional N Outcomes HO Role Route S ORAL Dosage Text ONE A DAY PO NIGHTLY Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

7118308 Date FDA Received
18-Sep-2009

Case # 7118308

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928092NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7118309 Date FDA Received
18-Sep-2009

Case # 7118309

Outcomes

Manufacturer Control # USBAYER-200928355NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7118315 Date FDA Received
18-Sep-2009

Case # 7118315

Outcomes

Manufacturer Control # USBAYER-200928088NA

Age 21 YR

Sex Female

Country USA

Preferred Term URINARY TRACT INFECTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 345 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7118317 Date FDA Received
18-Sep-2009 Case # 7118317 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928101NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200928073NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 30 YR Sex Female Country USA

Preferred Term HEADACHE

Product YAZ Case # 7118319 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7118319 Date FDA Received
18-Sep-2009

Outcomes

Preferred Term BACK PAIN ABDOMINAL PAIN

Product YAZ

Manufacturer BAYER

7118324 Date FDA Received
18-Sep-2009

Case # 7118324

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200930312NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7118331 Date FDA Received
18-Sep-2009

Case # 7118331

Manufacturer Control # USBAYER-200931047NA

Age 29 YR

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA

Product YAZ Case # 7118332 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Manufacturer Control # USBAYER-200928417NA

Duration

Manufacturer BAYER

7118332 Date FDA Received
18-Sep-2009

Age

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 346 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7118333 Date FDA Received
18-Sep-2009 Case # 7118333 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928069NA Role Route S ORAL Dosage Text Age 17 YR Sex Female Country USA

Preferred Term ANXIETY DEPRESSION

Product YAZ

Duration

Manufacturer BAYER

7130768 Date FDA Received
18-Sep-2009 Preferred Term HEADACHE MEMORY IMPAIRMENT

Case # 7130768

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text 28 1 DAILY PO

Duration

Manufacturer BAYER

7130967 Date FDA Received
18-Sep-2009 Preferred Term CHOLELITHIASIS DYSPNOEA

Case # 7130967

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 1 PER DAY PO

Duration

Manufacturer BAYER

7133096 Date FDA Received
18-Sep-2009 Preferred Term

Case # 7133096

Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 22 YR

Sex Female

Country USA

Dosage Text DAILY PO Manufacturer Control #

Duration

Manufacturer

GALLBLADDER DISORDER

7140165 Date FDA Received
18-Sep-2009 Preferred Term

Case # 7140165

Health Professional N

Outcomes HO,LT Role Route S

Age 38 YR

Sex Female

Country USA

Dosage Text

Duration 1 YEAR

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 347 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7062457 Date FDA Received
21-Sep-2009 Case # 7062457 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200926519NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200926450NA Role Route S C ORAL Dosage Text Dosage Text Age 25 YR Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration 3 MTH Age 34 YR Sex

Manufacturer BAYER Country USA

7080491 Date FDA Received
21-Sep-2009

Case # 7080491

Case Type NON-EXPEDITED

Outcomes

Female

Preferred Term MENORRHAGIA METRORRHAGIA DECREASED APPETITE NIGHT SWEATS WEIGHT DECREASED

Product YAZ VITAMINS NOS

Duration

Manufacturer BAYER

7099177 Date FDA Received
21-Sep-2009

Case # 7099177

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # TRBAYER-200929531GPV Dosage Text

Age 34 YR

Sex Female

Country TUR

Preferred Term CRYING DEPRESSED MOOD DEPRESSION INSOMNIA

Product YAZ

Role Route S ORAL

Duration 1 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 348 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7123552 Date FDA Received
21-Sep-2009 Case # 7123552 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200932803NA Dosage Text 1 TAB/DAY Age 24 YR Sex Female Country USA

Preferred Term PULMONARY THROMBOSIS ANKLE FRACTURE MUSCLE SPASMS THROMBOSIS

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7123773 Date FDA Received
21-Sep-2009

Case # 7123773

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200926816NA

Age 17 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7123775 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7123775 Date FDA Received
21-Sep-2009

Manufacturer Control # USBAYER-200926809NA

Age 2 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7123790 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text Unit dose: 1 DF Manufacturer Control # USBAYER-200926836NA

Duration

Manufacturer BAYER

7123790 Date FDA Received
21-Sep-2009

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA ABDOMINAL PAIN

Product YAZ CYMBALTA

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 349 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7123795 Date FDA Received
21-Sep-2009 Case # 7123795 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926810NA Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUAL DISORDER VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

7123797 Date FDA Received
21-Sep-2009

Case # 7123797

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200926840NA

Age

Sex Female

Country USA

Preferred Term INSOMNIA SINUSITIS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7123803 Date FDA Received
21-Sep-2009

Case # 7123803

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200930851NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

7123804 Date FDA Received
21-Sep-2009

Case # 7123804

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200926681NA

Age 19 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA BACK PAIN BREAST TENDERNESS MENORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 350 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7123821 Date FDA Received
21-Sep-2009 Case # 7123821 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931206NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200931158NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200931165NA Role Route S Health Professional Y Outcomes Manufacturer Control # USBAYER-200931148NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200931161NA Role Route S S Dosage Text Unit dose: 1 DF Duration Age Sex Female Dosage Text Age 49 YR Sex Female Dosage Text Age 39 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7123826 Date FDA Received
21-Sep-2009

Case # 7123826

Preferred Term MIGRAINE

Product YAZ Case # 7123830 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7123830 Date FDA Received
21-Sep-2009

Preferred Term AMENORRHOEA

Product YAZ Case # 7123834 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7123834 Date FDA Received
21-Sep-2009

Preferred Term Upper-airway cough syndrome

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7123837 Date FDA Received
21-Sep-2009

Case # 7123837

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ YAZ

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 351 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7123841 Date FDA Received
21-Sep-2009 Case # 7123841 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931155NA Role Route S Dosage Text Duration 3 MTH Age Sex Female Country USA

Preferred Term MENSTRUATION IRREGULAR AMENORRHOEA VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

7123842 Date FDA Received
21-Sep-2009

Case # 7123842

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931208NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ YAZ

Role Route S S Health Professional N Outcomes

Dosage Text

Duration 4 MTH

Manufacturer BAYER BAYER

7123848 Date FDA Received
21-Sep-2009

Case # 7123848

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200931142NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7123858 Date FDA Received
21-Sep-2009

Case # 7123858

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200933065NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 352 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7123871 Date FDA Received
21-Sep-2009 Case # 7123871 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932908NA Role Route S Dosage Text Age 15 YR Sex Female Country USA

Preferred Term URINARY TRACT INFECTION ABDOMINAL PAIN ADVERSE EVENT Bacterial test positive CONSTIPATION DIARRHOEA DIZZINESS LYMPHOCYTE COUNT ABNORMAL NAUSEA URINARY TRACT INFECTION STAPHYLOCOCCAL WHITE BLOOD CELL COUNT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7124553 Date FDA Received
22-Sep-2009

Case # 7124553

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927961NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ BIAXIN

Role Route S C Health Professional N Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7124557 Date FDA Received
22-Sep-2009

Case # 7124557

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200927516NA

Age

Sex Female

Country USA

Preferred Term DRUG DOSE OMISSION MENSTRUATION IRREGULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 353 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7124559 Date FDA Received
22-Sep-2009 Case # 7124559 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927615NA Role Route S ORAL Dosage Text Age 45 YR Sex Female Country USA

Preferred Term VULVOVAGINAL MYCOTIC INFECTION BREAST TENDERNESS

Product YAZ

Duration

Manufacturer BAYER

7130826 Date FDA Received
22-Sep-2009 Preferred Term DEPRESSION

Case # 7130826

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text 1 TABLET 1X DAY PO

Duration

Manufacturer BAYER

ACTIVITIES OF DAILY LIVING IMPAIRED ANHEDONIA ANXIETY CHEST DISCOMFORT CRYING MORBID THOUGHTS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 354 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7133433 Date FDA Received
22-Sep-2009 Preferred Term ANXIETY Case # 7133433 Case Type DIRECT Product YASMIN Health Professional N Outcomes OT Role Route S BUCCAL Dosage Text 3.0MG DROSPIRENONE/ 0.030MG ONCE A DAY BUCCAL 3.0MG DROSPIRENONE/ 0.020MG ONCE A DAY BUCCAL Manufacturer Control # Age 23 YR Duration 4 YEAR Sex Female Country USA

Manufacturer BAYER

MOOD SWINGS

YAZ

S

BUCCAL

1 MTH

BAYER

ATRIAL FLUTTER BLOOD CHOLESTEROL INCREASED HEART VALVE INCOMPETENCE HYPERTENSION PRODUCT SUBSTITUTION ISSUE

7133893 Date FDA Received
22-Sep-2009 Preferred Term GUTTATE PSORIASIS

Case # 7133893

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S C C C ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 28 DAY CYCLE PO

Duration 2 YEAR

Manufacturer BAYER

PHARYNGITIS STREPTOCOCCAL LIVER DISORDER DRUG DOSE OMISSION

CLOBETAL PROPIANATE DOVONEX HYDROCORTIZONE VALLERATE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 355 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7134244 Date FDA Received
22-Sep-2009 Preferred Term NAUSEA CARDIAC DISORDER CONDITION AGGRAVATED DIARRHOEA DIZZINESS IMPAIRED WORK ABILITY INFECTION INFERTILITY FEMALE MENORRHAGIA VAGINITIS BACTERIAL Case # 7134244 Case Type DIRECT Product YAZ Health Professional Y Outcomes OT Role Route S ORAL Dosage Text 1 PILL EVERY DAY PO Manufacturer Control # Age 18 YR Duration Sex Female Country USA

Manufacturer

6641579 Date FDA Received
23-Sep-2009

Case # 6641579

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200820349NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING MOOD SWINGS POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text ONE TABLET PER DAY

Duration 2 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 356 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7054883 Date FDA Received
23-Sep-2009 Case # 7054883 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919361NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DYSPNOEA EXERTIONAL ABNORMAL WITHDRAWAL BLEEDING CRYING INSOMNIA MALAISE NO ADVERSE EVENT WEIGHT INCREASED

Product YAZ

Manufacturer BAYER

7054888 Date FDA Received
23-Sep-2009

Case # 7054888

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924030NA

Age

Sex Female

Country USA

Preferred Term VISUAL IMPAIRMENT

Product YAZ Case # 7125786 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7125786 Date FDA Received
23-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200917547NA

Age

Sex Female

Country USA

Preferred Term DEHYDROEPIANDROSTERONE INCREASED

Product YAZ Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200927831NA

Duration

Manufacturer BAYER

7125808 Date FDA Received
23-Sep-2009

Case # 7125808

Case Type NON-EXPEDITED

Outcomes

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 357 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7125815 Date FDA Received
23-Sep-2009 Case # 7125815 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926813NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200927973NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200929498NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200927956NA Role Route S Dosage Text Age 18 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUAL DISORDER

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125816 Date FDA Received
23-Sep-2009

Case # 7125816

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125824 Date FDA Received
23-Sep-2009

Case # 7125824

Preferred Term ABDOMINAL PAIN

Product YAZ Case # 7125826 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125826 Date FDA Received
23-Sep-2009

Preferred Term METRORRHAGIA MENSTRUATION DELAYED

Product YAZ

Duration

Manufacturer BAYER

7125828 Date FDA Received
23-Sep-2009

Case # 7125828

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929896NA

Age 19 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 358 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7125830 Date FDA Received
23-Sep-2009 Case # 7125830 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928352NA Role Route S C Outcomes Manufacturer Control # USBAYER-200929022NA Role Route S Dosage Text Unit dose: 1 DF Age 48 YR Sex Female Country USA ORAL Dosage Text Age 33 YR Sex Female Country USA

Preferred Term METRORRHAGIA AMENORRHOEA

Product YAZ LEVOTHROID Case # 7125832 Case Type NON-EXPEDITED Health Professional N

Duration

Manufacturer BAYER

7125832 Date FDA Received
23-Sep-2009

Preferred Term MENSTRUATION DELAYED FATIGUE HEADACHE NAUSEA WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7125835 Date FDA Received
23-Sep-2009

Case # 7125835

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929869NA

Age

Sex Female

Country USA

Preferred Term ADNEXA UTERI PAIN

Product YAZ Case # 7125841 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7125841 Date FDA Received
23-Sep-2009

Manufacturer Control # USBAYER-200929772NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 359 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7125847 Date FDA Received
23-Sep-2009 Case # 7125847 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928994NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929506NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200929780NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929245NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200928976NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 37 YR Sex Female Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7125849 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7125849 Date FDA Received
23-Sep-2009

Outcomes

Preferred Term PYREXIA

Product YAZ Case # 7125850 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125850 Date FDA Received
23-Sep-2009

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7125851 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125851 Date FDA Received
23-Sep-2009

Outcomes

Preferred Term BRONCHITIS

Product YAZ Case # 7125852 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125852 Date FDA Received
23-Sep-2009

Preferred Term MENSTRUATION IRREGULAR

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 360 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7125853 Date FDA Received
23-Sep-2009 Case # 7125853 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200929385NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929273NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7125857 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7125857 Date FDA Received
23-Sep-2009

Outcomes

Preferred Term NO ADVERSE EVENT MENORRHAGIA

Product YAZ

Manufacturer BAYER

7135761 Date FDA Received
23-Sep-2009 Preferred Term IRRITABILITY

Case # 7135761

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text 1 EVERY DAY PO

Duration

Manufacturer BAYER

ABDOMINAL DISCOMFORT ABDOMINAL DISTENSION ANXIETY HYPOMENORRHOEA MOOD SWINGS VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 361 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7135762 Date FDA Received
23-Sep-2009 Preferred Term DEPRESSION ASTHENIA CRYING DECREASED INTEREST EMOTIONAL DISORDER FATIGUE SUICIDAL IDEATION Case # 7135762 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 3 MG/0.02 MG 1 A DAY, Q8 DAYS PO Manufacturer Control # Age 22 YR Duration Sex Female Country USA

Manufacturer BAYER

7001993 Date FDA Received
24-Sep-2009

Case # 7001993

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # UABAYER-200921265GPV Dosage Text

Age 37 YR

Sex Female

Country UKR

Preferred Term CIRCULATORY COLLAPSE ASTHENIA VISUAL IMPAIRMENT

Product YAZ

Role Route S ORAL

Duration 17 DAY

Manufacturer BAYER

7109751 Date FDA Received
24-Sep-2009

Case # 7109751

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # PEBAYER-200921401LA Dosage Text

Age 47 YR

Sex Female

Country PER

Preferred Term CHEST PAIN OEDEMA PERIPHERAL PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Duration 6 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 362 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7129052 Date FDA Received
24-Sep-2009 Case # 7129052 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931199NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200931202NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200926807NA Role Route S Dosage Text Duration 8 YEAR Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7129059 Date FDA Received
24-Sep-2009

Case # 7129059

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7129062 Date FDA Received
24-Sep-2009

Case # 7129062

Preferred Term ABDOMINAL DISTENSION MENSTRUATION DELAYED

Product YAZ

Manufacturer BAYER

7134561 Date FDA Received
24-Sep-2009 Preferred Term PRURITUS

Case # 7134561

Case Type DIRECT Product YAZ BENADRYL

Health Professional N

Outcomes OT Role Route S C ORAL

Manufacturer Control #

Age 47 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration 2 MTH

Manufacturer BAYER

7041453 Date FDA Received
25-Sep-2009

Case # 7041453

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200924040NA

Age 17 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text 1 TAB / DAY

Duration 2 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 363 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7130847 Date FDA Received
25-Sep-2009 Case # 7130847 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200919243NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term BLOOD FOLLICLE STIMULATING HORMONE DECREASED BLOOD LUTEINISING HORMONE DECREASED OESTRADIOL DECREASED

Product YAZ

Manufacturer BAYER

7130907 Date FDA Received
25-Sep-2009

Case # 7130907

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200917616NA

Age

Sex Female

Country USA

Preferred Term INSOMNIA

Product YAZ Case # 7130913 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7130913 Date FDA Received
25-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200918824NA

Age 30 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7064094 Date FDA Received
28-Sep-2009

Case # 7064094

Outcomes

Manufacturer Control # USBAYER-200920195NA

Age 22 YR

Sex Female

Country USA

Preferred Term BACK PAIN ACNE BLOOD CREATININE INCREASED

Product YAZ YASMIN ZYRTEC

Role Route S S C

Dosage Text

Duration 1.17 YEAR

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 364 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7130714 Date FDA Received
28-Sep-2009 Case # 7130714 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # BRBAYER-200921790LA Dosage Text Age 43 YR Sex Female Country BRA

Preferred Term HEADACHE OTOSCLEROSIS HYPOACUSIS VAGINAL HAEMORRHAGE

Product YAZ YASMIN MIRENA

Role Route S S S ORAL ORAL INTRAUTERINE

Duration

Manufacturer BAYER BAYER

FREQUENCY: CONTINUOUS

BAYER

7132343 Date FDA Received
28-Sep-2009

Case # 7132343

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200933542NA Dosage Text

Age 33 YR

Sex Female

Country USA

Preferred Term BLINDNESS HEADACHE HYPERCHOLESTEROLAEMIA

Product YAZ

Role Route S ORAL

Duration 1.5 YEAR

Manufacturer BAYER

7132511 Date FDA Received
28-Sep-2009

Case # 7132511

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200923625NA

Age

Sex Female

Country USA

Preferred Term ADVERSE EVENT

Product YAZ Case # 7132516 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200922431NA

Duration

Manufacturer BAYER

7132516 Date FDA Received
28-Sep-2009

Outcomes

Age

Sex Female

Country USA

Preferred Term ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 365 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7132520 Date FDA Received
28-Sep-2009 Case # 7132520 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926817NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200924479NA Role Route S C Health Professional Y Outcomes ON AND OFF Manufacturer Control # USBAYER-200924546NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200928558NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA Dosage Text Age 45 YR Sex Female Dosage Text Age 47 YR Sex Female Country USA

Preferred Term PALPITATIONS

Product YAZ Case # 7132528 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7132528 Date FDA Received
28-Sep-2009

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN LOWER

Product YAZ IRON Case Type NON-EXPEDITED

Duration

Manufacturer BAYER

7132537 Date FDA Received
28-Sep-2009

Case # 7132537

Preferred Term AMENORRHOEA

Product YAZ Case # 7132545 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7132545 Date FDA Received
28-Sep-2009

Preferred Term ADVERSE EVENT

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 366 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7132546 Date FDA Received
28-Sep-2009 Case # 7132546 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200924755NA Role Route S ORAL Dosage Text Age 20 YR Sex Female Country USA

Preferred Term PANIC ATTACK ANXIETY HEART RATE INCREASED VOMITING

Product YAZ

Duration

Manufacturer BAYER

7132549 Date FDA Received
28-Sep-2009

Case # 7132549

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928838NA

Age 23 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration 1 YEAR

Manufacturer BAYER Sex Female Country USA

7132553 Date FDA Received
28-Sep-2009

Case # 7132553

Manufacturer Control # USBAYER-200928461NA

Age

Preferred Term AMENORRHOEA

Product YAZ Case # 7132554 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7132554 Date FDA Received
28-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200928781NA

Age 19 YR

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ Case # 7132556 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7132556 Date FDA Received
28-Sep-2009

Outcomes

Manufacturer Control # USBAYER-200928617NA

Age 33 YR

Sex Female

Country USA

Preferred Term AFFECT LABILITY

Product YAZ

Role Route S

Dosage Text

Duration 6 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 367 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7132561 Date FDA Received
28-Sep-2009 Case # 7132561 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928791NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200928842NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200928414NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Duration 3 MTH Age Sex Female Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7132569 Date FDA Received
28-Sep-2009

Case # 7132569

Preferred Term GINGIVAL INFECTION

Product YAZ Case # 7132570 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7132570 Date FDA Received
28-Sep-2009

Preferred Term CHEST PAIN ANGER DEPRESSED MOOD DIZZINESS IRRITABILITY MALAISE

Product YAZ

Manufacturer BAYER

7132573 Date FDA Received
28-Sep-2009

Case # 7132573

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928449NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 368 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7132579 Date FDA Received
28-Sep-2009 Case # 7132579 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200929085NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931398NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200928854NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929636NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 19 YR Sex Female Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7132591 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7132591 Date FDA Received
28-Sep-2009

Outcomes

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7132592 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7132592 Date FDA Received
28-Sep-2009

Preferred Term ADVERSE EVENT

Product YAZ Case # 7132593 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7132593 Date FDA Received
28-Sep-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE MENSTRUATION DELAYED

Product YAZ

Manufacturer BAYER

7132603 Date FDA Received
28-Sep-2009

Case # 7132603

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931399NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA VAGINAL HAEMORRHAGE

Product YAZ YAZ

Role Route S S

Dosage Text

Duration 8 MTH

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 369 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7139076 Date FDA Received
28-Sep-2009 Preferred Term NAUSEA CONVULSION DIZZINESS PRODUCT QUALITY ISSUE Case # 7139076 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,OT Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # Age 17 YR Duration 6 MTH Sex Female Country USA

Manufacturer BAYER

7139723 Date FDA Received
28-Sep-2009 Preferred Term THROMBOSIS

Case # 7139723

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 39 YR

Sex Female

Country USA

Dosage Text 28 DAIL ORALLY Manufacturer Control #

Duration 1 YEAR Age 30 YR Sex

Manufacturer BAYER Country USA

7139909 Date FDA Received
28-Sep-2009 Preferred Term CHOLECYSTECTOMY

Case # 7139909

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Female

Dosage Text 1 PILL DAILY PO Manufacturer Control #

Duration

Manufacturer

7147570 Date FDA Received
28-Sep-2009 Preferred Term

Case # 7147570

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Age 43 YR

Sex Female

Country USA

Dosage Text 1X DAILY PO

Duration 7 MTH

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 370 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6736969 Date FDA Received
29-Sep-2009 Case # 6736969 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes Manufacturer Control # BRBAYER-200817322LA Role Route S S S S ORAL ORAL ORAL ORAL Dosage Text Age 19 YR Sex Female Country BRA

Preferred Term PREMENSTRUAL SYNDROME REFRACTION DISORDER DIPLOPIA VISION BLURRED KERATITIS

Product YASMIN YASMIN YAZ YAZ

Duration 3 YEAR 3 MTH

Manufacturer BAYER BAYER BAYER BAYER

6972402 Date FDA Received
29-Sep-2009

Case # 6972402

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916051NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7125810 Date FDA Received
29-Sep-2009

Case # 7125810

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200927957NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE HYPOMENORRHOEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7133660 Date FDA Received
29-Sep-2009

Case # 7133660

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200932200NA Dosage Text

Age 32 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DYSPNOEA

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 371 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7133673 Date FDA Received
29-Sep-2009 Case # 7133673 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200933880NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200930479NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930350NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200930990NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200933544NA Role Route S ORAL Dosage Text Duration Age Sex Female Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term EMBOLISM VENOUS

Product YAZ Case # 7133795 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER Country USA

7133795 Date FDA Received
29-Sep-2009

Outcomes

Preferred Term ABDOMINAL PAIN UPPER

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7133798 Date FDA Received
29-Sep-2009

Case # 7133798

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7133810 Date FDA Received
29-Sep-2009

Case # 7133810

Preferred Term PURULENT DISCHARGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7133815 Date FDA Received
29-Sep-2009

Case # 7133815

Outcomes

Preferred Term AMENORRHOEA POLYMENORRHOEA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 372 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7133821 Date FDA Received
29-Sep-2009 Case # 7133821 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931138NA Role Route S C Health Professional Y Product YAZ Case Type DIRECT Product YAZ Health Professional N Outcomes HO,OT Role Route S Outcomes HO Role Route S Dosage Text Dosage Text CYCLE CONTROL & MOOD SWINGS Manufacturer Control # Age 23 YR Duration Sex Female Manufacturer Control # Age 54 YR Duration Sex Female Country USA Dosage Text Age 42 YR Sex Female Country USA

Preferred Term CRYING

Product YAZ ADVIL

Duration

Manufacturer BAYER

7138886 Date FDA Received
29-Sep-2009 Preferred Term

Case # 7138886

Case Type DIRECT

Manufacturer BAYER Country USA

Peripheral artery thrombosis

7143160 Date FDA Received
29-Sep-2009 Preferred Term

Case # 7143160

Manufacturer

GALLBLADDER DISORDER CHOLECYSTECTOMY

7101300 Date FDA Received
30-Sep-2009

Case # 7101300

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200930473NA

Age 22 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S Outcomes OT

Dosage Text

Duration

Manufacturer BAYER

7134850 Date FDA Received
30-Sep-2009

Case # 7134850

Case Type EXPEDITED (15-DAY)

Manufacturer Control # AUBAYER-200932650GPV Dosage Text

Age 42 YR

Sex Female

Country AUS

Preferred Term VULVOVAGINAL CANDIDIASIS ENDOMETRIAL HYPERPLASIA

Product MIRENA YAZ

Role Route S S INTRAUTERINE

Duration 4 YEAR

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 373 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144036 Date FDA Received
30-Sep-2009 Preferred Term NAUSEA ABDOMINAL PAIN LOWER ABNORMAL BEHAVIOUR ALOPECIA DECREASED APPETITE DEPRESSION DIZZINESS FATIGUE HEADACHE MOOD ALTERED VISUAL IMPAIRMENT VOMITING WEIGHT DECREASED Case # 7144036 Case Type DIRECT Product YAZ Health Professional N Outcomes DS,OT Role Route S ORAL Dosage Text 1 EVERY DAY PO Manufacturer Control # Age 22 YR Duration Sex Female Country USA

Manufacturer

7048490 Date FDA Received
01-Oct-2009

Case # 7048490

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200916433NA

Age 22 YR

Sex Female

Country USA

Preferred Term DEPRESSION MOOD SWINGS CRYING DYSMENORRHOEA NO ADVERSE EVENT

Product YAZ STEROIDS NOS

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 374 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7102097 Date FDA Received
01-Oct-2009 Case # 7102097 Case Type NON-EXPEDITED Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200930986NA Dosage Text Age 44 YR Sex Female Country USA

Preferred Term Peripheral artery thrombosis PAIN IN EXTREMITY OEDEMA PERIPHERAL DEEP VEIN THROMBOSIS

Product YAZ LEXAPRO COUMADIN

Role Route S C C ORAL ORAL

Duration

Manufacturer BAYER

7134849 Date FDA Received
01-Oct-2009

Case # 7134849

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes CA

Manufacturer Control # FRBAYER-200933522GPV Dosage Text

Age

Sex Unknown

Country FRA

Preferred Term FOETAL MALFORMATION MATERNAL DRUGS AFFECTING FOETUS

Product YAZ UNKNOWN CONCOMITANT TREATMENT (NOS) Health Professional N

Role Route S C TRANSPLACENTAL TRANSPLACENTAL

Duration

Manufacturer BAYER

7136068 Date FDA Received
01-Oct-2009

Case # 7136068

Case Type NON-EXPEDITED

Outcomes HO

Manufacturer Control # USBAYER-200934415NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type DIRECT Product YAZ Health Professional Y

Role Route S ORAL

Duration

Manufacturer BAYER

7143846 Date FDA Received
01-Oct-2009 Preferred Term

Case # 7143846

Outcomes HO,RI Role Route S ORAL

Manufacturer Control #

Age 37 YR

Sex Female

Country USA

Dosage Text DAILY PO

Duration

Manufacturer

CEREBRAL INFARCTION APHASIA HEMIPARESIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 375 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7145423 Date FDA Received
01-Oct-2009 Preferred Term BRADYCARDIA TACHYCARDIA ARRHYTHMIA ANGINA PECTORIS HEART RATE IRREGULAR AMENORRHOEA CARDIAC DISORDER MENSTRUAL DISORDER MENSTRUATION IRREGULAR METRORRHAGIA Case # 7145423 Case Type DIRECT Product YAZ TREXIMET YAZ DOLGIC PULS XYZAL Health Professional N Outcomes OT Role Route S C C C C ORAL Dosage Text DAILY PO Manufacturer Control # Age 19 YR Duration Sex Female Country USA

Manufacturer BAYER

7145717 Date FDA Received
01-Oct-2009 Preferred Term KIDNEY INFECTION CHOLELITHIASIS NEPHROLITHIASIS

Case # 7145717

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S

Manufacturer Control #

Age 31 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

7072861 Date FDA Received
02-Oct-2009

Case # 7072861

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924366NA

Age 30 YR

Sex Female

Country USA

Preferred Term ABDOMINAL DISTENSION MUSCULOSKELETAL PAIN NECK PAIN PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration 10 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 376 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7136875 Date FDA Received
02-Oct-2009 Case # 7136875 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # BRBAYER-200922238LA Dosage Text Age 17 YR Sex Female Country BRA

Preferred Term CONVULSION

Product YAZ Case # 7136883 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7136883 Date FDA Received
02-Oct-2009

Outcomes OT

Manufacturer Control # USBAYER-200934316NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLELITHIASIS

Product YAZ Case # 7136884 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7136884 Date FDA Received
02-Oct-2009

Outcomes OT

Manufacturer Control # USBAYER-200934453NA Dosage Text

Age 25 YR

Sex Female

Country USA

Preferred Term TRANSIENT ISCHAEMIC ATTACK DYSARTHRIA HYPOAESTHESIA VISION BLURRED

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7136928 Date FDA Received
02-Oct-2009

Case # 7136928

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928445NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 377 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7136932 Date FDA Received
02-Oct-2009 Case # 7136932 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928888NA Role Route S C Health Professional N Outcomes Manufacturer Control # USBAYER-200928444NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932248NA Role Route S Dosage Text Age 27 YR Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DEPRESSION

Product YAZ VITAMINS

Manufacturer BAYER

7136937 Date FDA Received
02-Oct-2009

Case # 7136937

Case Type NON-EXPEDITED

Preferred Term ABDOMINAL PAIN

Product YAZ Case # 7136944 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7136944 Date FDA Received
02-Oct-2009

Outcomes

Preferred Term MENSTRUATION DELAYED VAGINAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

7136952 Date FDA Received
02-Oct-2009

Case # 7136952

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932028NA

Age

Sex Female

Country USA

Preferred Term BREAST TENDERNESS

Product YAZ

Role Route S

Dosage Text

Duration 4 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 378 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7136960 Date FDA Received
02-Oct-2009 Case # 7136960 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932141NA Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term HEADACHE ACNE MIGRAINE VULVOVAGINAL MYCOTIC INFECTION

Product YAZ

Manufacturer BAYER

7145928 Date FDA Received
02-Oct-2009 Preferred Term MUSCLE SPASMS

Case # 7145928

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 50 YR

Sex Female

Country USA

Dosage Text 28 TABS 1 DAILY PO

Duration

Manufacturer BAYER

BLOOD PRESSURE INADEQUATELY CONTROLLED BLOOD PRESSURE INCREASED DIABETES MELLITUS INADEQUATE CONTROL VAGINAL HAEMORRHAGE

7139404 Date FDA Received
05-Oct-2009

Case # 7139404

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928757NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ MINOCYCLINE HYDROCHLORIDE

Role Route S C

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 379 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7145952 Date FDA Received
05-Oct-2009 Preferred Term GALLBLADDER DISORDER ECONOMIC PROBLEM IMPAIRED WORK ABILITY METRORRHAGIA PAIN POST PROCEDURAL COMPLICATION POST PROCEDURAL INFECTION Case # 7145952 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO,OT Role Route S ORAL Dosage Text 1 PILL 1 X DAY PO Manufacturer Control # Age 27 YR Duration Sex Female Country USA

Manufacturer BAYER

7140142 Date FDA Received
06-Oct-2009

Case # 7140142

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929667NA

Age

Sex Female

Country USA

Preferred Term URINARY TRACT INFECTION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7140144 Date FDA Received
06-Oct-2009

Case # 7140144

Outcomes

Manufacturer Control # USBAYER-200929634NA

Age 20 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN FLATULENCE HEADACHE URTICARIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration 3 MTH

Manufacturer BAYER

7140146 Date FDA Received
06-Oct-2009

Case # 7140146

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929546NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 380 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7140147 Date FDA Received
06-Oct-2009 Case # 7140147 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928454NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929997NA Role Route S Health Professional Y ORAL Manufacturer Control # USBAYER-200929511NA Role Route S Health Professional N Product YAZ ORAL Manufacturer Control # Age 18 YR Dosage Text Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7140149 Date FDA Received
06-Oct-2009

Case # 7140149

Outcomes

Preferred Term PREMENSTRUAL SYNDROME

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7140153 Date FDA Received
06-Oct-2009

Case # 7140153

Outcomes

Preferred Term PALPITATIONS

Product YAZ Case # 7149425 Case Type DIRECT

Manufacturer BAYER Country USA

7149425 Date FDA Received
06-Oct-2009 Preferred Term ACNE DIARRHOEA

Outcomes OT Role Route S

Manufacturer BAYER

7054870 Date FDA Received
07-Oct-2009

Case # 7054870

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919121NA

Age

Sex Female

Country USA

Preferred Term GASTROENTERITIS VIRAL FLUID RETENTION INCREASED APPETITE VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 381 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7107404 Date FDA Received
07-Oct-2009 Case # 7107404 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931271NA Role Route S Health Professional N ORAL Dosage Text 1 TAB/DAY Manufacturer Control # USBAYER-200929202NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200930170NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929234NA Role Route S C Outcomes Manufacturer Control # USBAYER-200930396NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Duration 3 WEEK Age Sex Female Age Sex Female Duration Age Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Manufacturer BAYER Country USA

7141930 Date FDA Received
07-Oct-2009

Case # 7141930

Case Type NON-EXPEDITED

Outcomes

Preferred Term DEPRESSED MOOD

Product YAZ Case # 7141942 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7141942 Date FDA Received
07-Oct-2009

Preferred Term WITHDRAWAL BLEED

Product YAZ Case # 7141943 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7141943 Date FDA Received
07-Oct-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ ANTIBIOTICS NOS

Manufacturer BAYER

7141951 Date FDA Received
07-Oct-2009

Case # 7141951

Case Type NON-EXPEDITED

Health Professional N

Preferred Term WITHDRAWAL BLEED

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 382 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7141955 Date FDA Received
07-Oct-2009 Case # 7141955 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930399NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL PAIN UPPER ASTHENIA DIZZINESS

Product YAZ

Manufacturer BAYER

7141964 Date FDA Received
07-Oct-2009

Case # 7141964

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929984NA

Age 39 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration 28 DAY

Manufacturer BAYER Sex Female Country USA

7141979 Date FDA Received
07-Oct-2009

Case # 7141979

Manufacturer Control # USBAYER-200930422NA

Age

Preferred Term MENORRHAGIA VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7141983 Date FDA Received
07-Oct-2009

Case # 7141983

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200930551NA

Age

Sex Female

Country USA

Preferred Term ADVERSE DRUG REACTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 383 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7141984 Date FDA Received
07-Oct-2009 Case # 7141984 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930430NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200930682NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200930619NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200930844NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930842NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term HYPOMENORRHOEA

Product YAZ YAZ

Manufacturer BAYER BAYER Country USA

7141998 Date FDA Received
07-Oct-2009

Case # 7141998

Case Type NON-EXPEDITED

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 7142004 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7142004 Date FDA Received
07-Oct-2009

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ YAZ

Manufacturer BAYER BAYER Country USA

7142019 Date FDA Received
07-Oct-2009

Case # 7142019

Case Type NON-EXPEDITED

Outcomes

Preferred Term DRY SKIN

Product YAZ Case # 7142022 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7142022 Date FDA Received
07-Oct-2009

Outcomes

Preferred Term FOOD POISONING ACNE

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 384 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7150416 Date FDA Received
07-Oct-2009 Preferred Term ASTIGMATISM CONDITION AGGRAVATED EYE DISORDER EYE PAIN MENOPAUSAL SYMPTOMS MUSCLE SPASMS Case # 7150416 Case Type DIRECT Product YAZ Health Professional Y Outcomes OT Role Route S ORAL Dosage Text 1 TABLET QD PO Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer

7150961 Date FDA Received
07-Oct-2009 Preferred Term

Case # 7150961

Case Type DIRECT Product YAZ ACCUTANE

Health Professional Y

Outcomes HO Role Route S S

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM CRYING

7151094 Date FDA Received
07-Oct-2009 Preferred Term

Case # 7151094

Case Type DIRECT Product YAZ Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 33 YR

Sex Female

Country CAN

Dosage Text

Duration 6 MTH

Manufacturer BAYER Sex Female Country USA

PULMONARY EMBOLISM

6899279 Date FDA Received
08-Oct-2009

Case # 6899279

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200911629NA

Age 18 YR

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 385 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7087581 Date FDA Received
08-Oct-2009 Case # 7087581 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200927451NA Role Route S Health Professional N ORAL Dosage Text IRREGULAR DOSING AND ADMINISTRATION Manufacturer Control # USBAYER-200928985NA Role Route S Dosage Text TAKES 3 WEEKS OF HORMONE PILLS AND SKIPS LAST WEEK OF PILLS AND THEN STARTS HORMONE PILLS AGAIN Age 45 YR Sex Female Duration Age Sex Female Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Manufacturer BAYER Country USA

7143484 Date FDA Received
08-Oct-2009

Case # 7143484

Case Type NON-EXPEDITED

Outcomes

Preferred Term PREMENSTRUAL SYNDROME

Product YAZ

Duration 6 MTH

Manufacturer BAYER

CRYING PSYCHOMOTOR HYPERACTIVITY THINKING ABNORMAL

7143487 Date FDA Received
08-Oct-2009

Case # 7143487

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931167NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7143490 Date FDA Received
08-Oct-2009

Case # 7143490

Outcomes

Manufacturer Control # USBAYER-200929547NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA ACNE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 386 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7143495 Date FDA Received
08-Oct-2009 Case # 7143495 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931163NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200928568NA Dosage Text Total daily dose: 300 MG Age 38 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

7074310 Date FDA Received
09-Oct-2009

Case # 7074310

Outcomes HO

Preferred Term ROAD TRAFFIC ACCIDENT MENSTRUATION IRREGULAR DYSFUNCTIONAL UTERINE BLEEDING

Product YAZ EFFEXOR XANAX SEROQUEL

Role Route S C C C Health Professional N Outcomes HO,OT ORAL ORAL

Duration

Manufacturer BAYER

7095324 Date FDA Received
09-Oct-2009

Case # 7095324

Case Type EXPEDITED (15-DAY)

Manufacturer Control # AUBAYER-200929008GPV Dosage Text

Age

Sex Female

Country AUS

Preferred Term ANXIETY DEPRESSION DIARRHOEA INSOMNIA NAUSEA VOMITING

Product YAZ

Role Route S ORAL

Duration 12 DAY

Manufacturer BAYER

7101220 Date FDA Received
09-Oct-2009

Case # 7101220

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200928727NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S

Dosage Text

Duration 6 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 387 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7109752 Date FDA Received
09-Oct-2009 Case # 7109752 Case Type NON-EXPEDITED Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200932172NA Dosage Text Age 43 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product YAZ

Role Route S ORAL

Duration 348 DAY

Manufacturer BAYER

7109757 Date FDA Received
09-Oct-2009

Case # 7109757

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,LT

Manufacturer Control # USBAYER-200932174NA Dosage Text

Age 40 YR

Sex Female

Country USA

Preferred Term PORTAL VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7111131 Date FDA Received
09-Oct-2009

Case # 7111131

Outcomes HO,OT

Manufacturer Control # USBAYER-200932283NA Dosage Text Unit dose: 1 DF Manufacturer Control # NZBAYER-200933090GPV Dosage Text

Age 46 YR

Sex Female

Country USA

Preferred Term TRANSIENT ISCHAEMIC ATTACK

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7132344 Date FDA Received
09-Oct-2009

Case # 7132344

Outcomes OT

Age 33 YR

Sex Female

Country NZL

Preferred Term ANXIETY DEPRESSION HEADACHE NAUSEA

Product YAZ LOXAMINE PAROXETINE

Role Route S C C ORAL

Duration 9 DAY 2 YEAR 2 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 388 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7132560 Date FDA Received
09-Oct-2009 Case # 7132560 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928620NA Role Route S Dosage Text Age 38 YR Sex Female Country USA

Preferred Term AMENORRHOEA MUSCLE SPASMS NAUSEA VAGINAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

7144537 Date FDA Received
09-Oct-2009

Case # 7144537

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200934668NA Dosage Text

Age 40 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DEHYDRATION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7144538 Date FDA Received
09-Oct-2009

Case # 7144538

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200934682NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7144545 Date FDA Received
09-Oct-2009

Case # 7144545

Outcomes OT

Manufacturer Control # USBAYER-200934562NA Dosage Text

Age 30 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 389 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144559 Date FDA Received
09-Oct-2009 Case # 7144559 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # DEBAYER-200934254GPV Dosage Text Duration Age Sex Female Country DEU

Preferred Term EPILEPSY

Product YAZ Case # 7144567 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Manufacturer BAYER

7144567 Date FDA Received
09-Oct-2009

Outcomes HO,OT

Manufacturer Control # USBAYER-200934687NA Dosage Text

Age 23 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DYSPNOEA LOSS OF CONSCIOUSNESS MALAISE SINUS OPERATION THROMBOSIS

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7144569 Date FDA Received
09-Oct-2009

Case # 7144569

Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO

Manufacturer Control # USBAYER-200934897NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7144572 Date FDA Received
09-Oct-2009

Case # 7144572

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200934791NA Dosage Text

Age

Sex Female

Country USA

Preferred Term SUICIDAL IDEATION BREAST TENDERNESS CONTACT LENS INTOLERANCE VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Duration 1 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 390 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144711 Date FDA Received
09-Oct-2009 Case # 7144711 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930026NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200929281NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200929985NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930077NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930120NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Duration 3 MTH Age Sex Female Age Sex Female Dosage Text Age 26 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7144712 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7144712 Date FDA Received
09-Oct-2009

Outcomes

Preferred Term MEDICATION ERROR

Product YAZ Case # 7144714 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7144714 Date FDA Received
09-Oct-2009

Preferred Term WEIGHT DECREASED

Product YAZ Case # 7144720 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7144720 Date FDA Received
09-Oct-2009

Outcomes

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7144725 Date FDA Received
09-Oct-2009

Case # 7144725

Outcomes

Preferred Term ADVERSE DRUG REACTION

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 391 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144727 Date FDA Received
09-Oct-2009 Case # 7144727 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200930904NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931173NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term BREAST ENLARGEMENT

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7144728 Date FDA Received
09-Oct-2009

Case # 7144728

Outcomes

Preferred Term VAGINAL HAEMORRHAGE NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7144730 Date FDA Received
09-Oct-2009

Case # 7144730

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200929991NA

Age 24 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7144745 Date FDA Received
09-Oct-2009

Case # 7144745

Outcomes

Manufacturer Control # USBAYER-200931135NA

Age 34 YR

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR VAGINAL HAEMORRHAGE WEIGHT DECREASED ANXIETY CRYING MOOD ALTERED MUSCULOSKELETAL DISCOMFORT

Product YAZ YAZ XANAX

Role Route S S C

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Unit dose: 1 DF

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 392 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144749 Date FDA Received
09-Oct-2009 Case # 7144749 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930676NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930908NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term DRUG DOSE OMISSION

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7144754 Date FDA Received
09-Oct-2009

Case # 7144754

Outcomes

Preferred Term MENSTRUATION DELAYED ABDOMINAL DISTENSION BREAST TENDERNESS FATIGUE

Product YAZ

Manufacturer BAYER

7144755 Date FDA Received
09-Oct-2009

Case # 7144755

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931181NA

Age 19 YR

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7144758 Date FDA Received
09-Oct-2009

Case # 7144758

Outcomes

Manufacturer Control # USBAYER-200930115NA

Age

Sex Female

Country USA

Preferred Term MALAISE DIARRHOEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 393 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144773 Date FDA Received
09-Oct-2009 Case # 7144773 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931379NA Role Route S Dosage Text Duration 4 DAY Age Sex Female Country USA

Preferred Term ABDOMINAL DISTENSION DYSURIA OVARIAN DISORDER

Product YAZ

Manufacturer BAYER

7144777 Date FDA Received
09-Oct-2009

Case # 7144777

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931421NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ UNSPECIFIED INGREDIENT ADDERALL

Role Route S S C Health Professional N Outcomes

Dosage Text

Duration

Manufacturer BAYER

7144778 Date FDA Received
09-Oct-2009

Case # 7144778

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200931380NA

Age

Sex Female

Country USA

Preferred Term MENSTRUAL DISORDER

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7144779 Date FDA Received
09-Oct-2009

Case # 7144779

Manufacturer Control # USBAYER-200931420NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE NAUSEA

Product YAZ

Role Route S

Dosage Text

Duration 1 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 394 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144781 Date FDA Received
09-Oct-2009 Case # 7144781 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931419NA Role Route S C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200935229NA Role Route S S Health Professional N Outcomes OT Manufacturer Control # USBAYER-200928699NA Dosage Text Age 15 YR Sex Female Dosage Text Duration Age Sex Female Country USA Dosage Text Age 29 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ CELEXA AMITRIPTYLINE NASACORT

Duration 8 DAY

Manufacturer BAYER

7144797 Date FDA Received
09-Oct-2009

Case # 7144797

Case Type NON-EXPEDITED

Preferred Term UNEVALUABLE EVENT

Product YASMIN YAZ

Manufacturer BAYER BAYER Country USA

7074309 Date FDA Received
12-Oct-2009

Case # 7074309

Case Type EXPEDITED (15-DAY)

Preferred Term LOSS OF CONSCIOUSNESS HYPERSOMNIA HEADACHE

Product YAZ ACCUTANE

Role Route S C ORAL

Duration

Manufacturer BAYER

7144543 Date FDA Received
12-Oct-2009

Case # 7144543

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200934566NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBRAL ARTERY EMBOLISM DEEP VEIN THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 395 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7146535 Date FDA Received
12-Oct-2009 Case # 7146535 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200928429NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DERMATITIS ACNEIFORM DIZZINESS

Product YAZ

Manufacturer BAYER

7146538 Date FDA Received
12-Oct-2009

Case # 7146538

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931340NA

Age 32 YR

Sex Female

Country USA

Preferred Term HYPERTENSION

Product YAZ Case # 7146539 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7146539 Date FDA Received
12-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200930080NA

Age 19 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN FREQUENT BOWEL MOVEMENTS

Product YAZ YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

7146543 Date FDA Received
12-Oct-2009

Case # 7146543

Outcomes

Manufacturer Control # USBAYER-200930457NA

Age

Sex Female

Country USA

Preferred Term MOOD SWINGS

Product YAZ TAKING "OTHER THINGS" NOS

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 396 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7146544 Date FDA Received
12-Oct-2009 Case # 7146544 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931050NA Role Route S Dosage Text Duration 6 WEEK Age Sex Female Country USA

Preferred Term TREMOR DYSPNOEA

Product YAZ

Manufacturer BAYER

7146545 Date FDA Received
12-Oct-2009

Case # 7146545

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200930433NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7146547 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7146547 Date FDA Received
12-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200932496NA

Age 17 YR

Sex Female

Country USA

Preferred Term MALAISE DEPRESSION HYPERNATRAEMIA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7146550 Date FDA Received
12-Oct-2009

Case # 7146550

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931383NA

Age 38 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ ANOTHER BIRTH CONTROL

Role Route S C

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 397 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7146570 Date FDA Received
12-Oct-2009 Case # 7146570 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932764NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Age 43 YR Sex Female Country USA

Preferred Term BLOOD PRESSURE INCREASED ABDOMINAL DISTENSION ANXIETY BACK PAIN DEPRESSED MOOD DRUG WITHDRAWAL HEADACHE IRRITABILITY VAGINAL HAEMORRHAGE WEIGHT INCREASED

Product YAZ

Duration 4 MTH

Manufacturer BAYER

7146624 Date FDA Received
12-Oct-2009

Case # 7146624

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200935121NA Dosage Text 1 DF/DAY

Age

Sex Female

Country USA

Preferred Term CONVULSION DEPRESSED LEVEL OF CONSCIOUSNESS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7146639 Date FDA Received
12-Oct-2009

Case # 7146639

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200935153NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY THROMBOSIS THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 398 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7030199 Date FDA Received
13-Oct-2009 Case # 7030199 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DE Manufacturer Control # USBAYER-200924087NA Dosage Text Total daily dose: 1 DF Age 23 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ VITAMINS NOS

Role Route S C Outcomes ORAL

Duration 114 DAY

Manufacturer BAYER

7147283 Date FDA Received
13-Oct-2009

Case # 7147283

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200929633NA

Age

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7147286 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7147286 Date FDA Received
13-Oct-2009

Manufacturer Control # USBAYER-200931541NA

Age

Sex Female

Country USA

Preferred Term CHLOASMA

Product YAZ Case # 7147294 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7147294 Date FDA Received
13-Oct-2009

Manufacturer Control # USBAYER-200931603NA

Age 2 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7147307 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7147307 Date FDA Received
13-Oct-2009

Manufacturer Control # USBAYER-200931584NA

Age 28 YR

Sex Female

Country USA

Preferred Term VISION BLURRED

Product YAZ NASONEX ZYRTEC GENERIC

Role Route S C C

Dosage Text

Duration 2 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 399 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7147334 Date FDA Received
13-Oct-2009 Case # 7147334 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200934906NA Dosage Text Duration Age Sex Female Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER

7147335 Date FDA Received
13-Oct-2009

Case # 7147335

Outcomes HO

Manufacturer Control # USBAYER-200935137NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY THROMBOSIS DYSPNOEA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7147341 Date FDA Received
13-Oct-2009

Case # 7147341

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200935505NA Dosage Text

Age 28 YR

Sex Female

Country USA

Preferred Term BLOOD UREA INCREASED

Product YAZ YAZ NORGESTIMATE

Role Route S S S Outcomes HO,LT Role Route S ORAL ORAL

Duration

Manufacturer BAYER BAYER

7152364 Date FDA Received
13-Oct-2009 Preferred Term

Case # 7152364

Case Type DIRECT Product YAZ

Health Professional Y

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer BAYER

CHOLECYSTITIS ACUTE CHOLELITHIASIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 400 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153517 Date FDA Received
13-Oct-2009 Preferred Term GALLBLADDER DISORDER CHOLELITHIASIS SPHINCTER OF ODDI DYSFUNCTION Case # 7153517 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,RI Role Route S ORAL Dosage Text STANDARD DAILY PO Manufacturer Control # Age 28 YR Duration Sex Female Country USA

Manufacturer BAYER

7157590 Date FDA Received
13-Oct-2009 Preferred Term CHOLECYSTITIS CHOLELITHIASIS CHOLECYSTECTOMY

Case # 7157590

Case Type DIRECT Product YAZ MAXOLT RELPAX

Health Professional N

Outcomes HO,OT Role Route S C C C C C ORAL

Manufacturer Control #

Age 22 YR

Sex Female

Country USA

Dosage Text MONTLY PILL PACK PO

Duration

Manufacturer BAYER

IMPAIRED WORK ABILITY EDUCATIONAL PROBLEM

ACETAMINOPHEN ASPIRIN IBUPROFEN

7006381 Date FDA Received
14-Oct-2009

Case # 7006381

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # BEBAYER-200921686GPV Dosage Text

Age 25 YR

Sex Female

Country BEL

Preferred Term MALAISE BLIGHTED OVUM PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S

Duration 4 MTH

Manufacturer BAYER

7148458 Date FDA Received
14-Oct-2009

Case # 7148458

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200931486NA

Age 15 YR

Sex Female

Country USA

Preferred Term HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 401 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7148471 Date FDA Received
14-Oct-2009 Case # 7148471 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931475NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931749NA Dosage Text Age 17 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7107173 Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

7107173 Date FDA Received
15-Oct-2009

Outcomes OT

Preferred Term CARDIAC DISORDER BLOOD PRESSURE INCREASED CHEST DISCOMFORT HEART RATE INCREASED KIDNEY INFECTION SMEAR CERVIX ABNORMAL URINARY TRACT INFECTION

Product YAZ

Role Route S

Duration 2 YEAR

Manufacturer BAYER

7149516 Date FDA Received
15-Oct-2009

Case # 7149516

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931473NA

Age

Sex Female

Country USA

Preferred Term HEADACHE VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7149517 Date FDA Received
15-Oct-2009

Case # 7149517

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931717NA

Age

Sex Female

Country USA

Preferred Term DYSURIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 402 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7149521 Date FDA Received
15-Oct-2009 Case # 7149521 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930705NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930876NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200933054NA Role Route S Health Professional N ORAL Manufacturer Control # CHBAYER-200912664GPV Dosage Text Duration 3 MTH Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 39 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term UNEVALUABLE EVENT

Product YAZ Case # 7149523 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7149523 Date FDA Received
15-Oct-2009

Outcomes

Preferred Term HYPOMENORRHOEA

Product YAZ YAZ

Duration

Manufacturer BAYER BAYER Country USA

7149542 Date FDA Received
15-Oct-2009

Case # 7149542

Case Type NON-EXPEDITED

Outcomes

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country CHE

7149586 Date FDA Received
15-Oct-2009

Case # 7149586

Outcomes OT

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION MISSED

Product YAZ

Role Route S ORAL

Manufacturer BAYER

7153895 Date FDA Received
15-Oct-2009 Preferred Term BACK PAIN CHEST PAIN

Case # 7153895

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 41 YR

Sex Female

Country USA

Dosage Text 1 DAY PO

Duration

Manufacturer

GALLBLADDER DISORDER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 403 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7154790 Date FDA Received
15-Oct-2009 Preferred Term BACK PAIN PULMONARY EMBOLISM Case # 7154790 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO,LT,RI Role Route S ORAL Dosage Text 1 TABLET DAILY ORAL Manufacturer Control # Age 45 YR Duration Sex Female Country USA

Manufacturer

7150891 Date FDA Received
16-Oct-2009

Case # 7150891

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932282NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7150892 Date FDA Received
16-Oct-2009

Case # 7150892

Outcomes

Manufacturer Control # USBAYER-200931045NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7150894 Date FDA Received
16-Oct-2009

Case # 7150894

Outcomes

Manufacturer Control # USBAYER-200931736NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7150895 Date FDA Received
16-Oct-2009

Case # 7150895

Manufacturer Control # USBAYER-200932332NA

Age 16 YR

Sex Female

Country USA

Preferred Term PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Dosage Text

Duration 1.5 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 404 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7150897 Date FDA Received
16-Oct-2009 Case # 7150897 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931552NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931984NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7150900 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7150900 Date FDA Received
16-Oct-2009

Outcomes

Preferred Term DEPRESSION NAUSEA

Product YAZ

Manufacturer BAYER

7150901 Date FDA Received
16-Oct-2009

Case # 7150901

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931986NA

Age

Sex Female

Country USA

Preferred Term MALAISE

Product YAZ Case # 7150903 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7150903 Date FDA Received
16-Oct-2009

Manufacturer Control # USBAYER-200932266NA

Age

Sex Female

Country USA

Preferred Term DYSPHAGIA

Product YAZ Case # 7150907 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7150907 Date FDA Received
16-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200932278NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 405 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7150911 Date FDA Received
16-Oct-2009 Case # 7150911 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933034NA Role Route S S Health Professional N Outcomes Manufacturer Control # USBAYER-200931549NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200935943NA Role Route S C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200934888NA Role Route S ORAL Dosage Text Age 31 YR Sex Female Country USA Dosage Text Age 31 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL DISTENSION

Product YAZ MIRENA

Manufacturer BAYER BAYER Country USA

7150917 Date FDA Received
16-Oct-2009

Case # 7150917

Case Type NON-EXPEDITED

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7150919 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7150919 Date FDA Received
16-Oct-2009

Outcomes

Preferred Term EUSTACHIAN TUBE PATULOUS DYSACUSIS MENORRHAGIA

Product YAZ MEDROXYPROGESTERONE ACETATE LEVOTHYROXINE SODIUM ALLEGRA

Duration 1 MTH

Manufacturer BAYER

7150920 Date FDA Received
16-Oct-2009

Case # 7150920

Case Type NON-EXPEDITED

Preferred Term BREAST MASS

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 406 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7150931 Date FDA Received
16-Oct-2009 Case # 7150931 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200935766NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200934476NA Role Route S S Health Professional N Outcomes OT Manufacturer Control # USBAYER-200935417NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200935713NA Dosage Text 1 TAB/DAY Manufacturer Control # USBAYER-200935716NA Dosage Text 1 TAB/DAY Duration Age Sex Female Duration Age Sex Female Duration Age Sex Female Dosage Text Age 19 YR Sex Female Dosage Text Age 18 YR Sex Female Country USA

Preferred Term KIDNEY INFECTION

Product YAZ Case # 7150932 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7150932 Date FDA Received
16-Oct-2009

Preferred Term ALOPECIA

Product YAZ YAZ

Duration

Manufacturer BAYER BAYER Country USA

7151029 Date FDA Received
16-Oct-2009

Case # 7151029

Case Type NON-EXPEDITED

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER Country USA

7151040 Date FDA Received
16-Oct-2009

Case # 7151040

Outcomes OT

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Manufacturer BAYER Country USA

7151048 Date FDA Received
16-Oct-2009

Case # 7151048

Outcomes OT

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 407 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7151050 Date FDA Received
16-Oct-2009 Case # 7151050 Case Type NON-EXPEDITED Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200935945NA Dosage Text Duration Age Sex Female Country USA

Preferred Term EMBOLISM VENOUS

Product YAZ Case # 7151051 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes HO

Manufacturer BAYER

7151051 Date FDA Received
16-Oct-2009

Manufacturer Control # USBAYER-200935937NA Dosage Text

Age 23 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7151061 Date FDA Received
16-Oct-2009

Case # 7151061

Outcomes OT

Manufacturer Control # USBAYER-200935715NA Dosage Text 1 TAB/DAY Manufacturer Control # USBAYER-200935941NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7151062 Date FDA Received
16-Oct-2009

Case # 7151062

Outcomes OT

Age 20 YR

Sex Female

Country USA

Preferred Term NEPHROLITHIASIS ABDOMINAL PAIN PAIN RASH

Product YAZ

Role Route S

Duration 45 DAY

Manufacturer BAYER

7151063 Date FDA Received
16-Oct-2009

Case # 7151063

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200936116NA Dosage Text

Age 22 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 408 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7151065 Date FDA Received
16-Oct-2009 Case # 7151065 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200936071NA Dosage Text Age 16 YR Sex Female Country USA

Preferred Term TOOTH LOSS BRUXISM UNEVALUABLE EVENT

Product YASMIN YAZ

Role Route S S ORAL ORAL

Duration

Manufacturer BAYER BAYER

7154716 Date FDA Received
16-Oct-2009 Preferred Term PALPITATIONS

Case # 7154716

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text 1 DAILY PO Manufacturer Control #

Duration

Manufacturer

7155095 Date FDA Received
16-Oct-2009 Preferred Term

Case # 7155095

Case Type DIRECT Product YAZ Case Type DIRECT Product YASMIN YAZ

Health Professional Y

Outcomes OT Role Route S ORAL

Age 32 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO Manufacturer Control #

Duration

Manufacturer BAYER

GALLBLADDER DISORDER

7155300 Date FDA Received
16-Oct-2009 Preferred Term OEDEMA PERIPHERAL

Case # 7155300

Health Professional Y

Outcomes OT,RI Role Route S S ORAL ORAL

Age 17 YR

Sex Female

Country USA

Dosage Text 28 DAY PACK ONE DAILY PO 28 DAY PACK ONE DAILY PO

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 409 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155306 Date FDA Received
16-Oct-2009 Preferred Term FALL CAROTID ARTERY DISEASE CEREBRAL HYPOPERFUSION CEREBRAL INFARCTION CEREBROVASCULAR DISORDER HEAD INJURY Case # 7155306 Case Type DIRECT Product YAZ Health Professional Y Outcomes DE Role Route S ORAL Dosage Text 1 TAB DAILY PO Manufacturer Control # Age 38 YR Duration 3 MTH Sex Female Country USA

Manufacturer BAYER

7155956 Date FDA Received
16-Oct-2009 Preferred Term CHOLELITHIASIS CHOLECYSTECTOMY CHOLECYSTITIS

Case # 7155956

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 1 TABLET/PILL DAILY X1 ORAL

Duration

Manufacturer BAYER

7152228 Date FDA Received
19-Oct-2009

Case # 7152228

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931647NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ LOW-OGESTREL

Role Route S S Outcomes ORAL

Dosage Text 0.3/30 - 28 Manufacturer Control # USBAYER-200931819NA

Duration

Manufacturer BAYER

7152229 Date FDA Received
19-Oct-2009

Case # 7152229

Case Type NON-EXPEDITED

Health Professional N

Age 23 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 410 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7152232 Date FDA Received
19-Oct-2009 Case # 7152232 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933359NA Role Route S ORAL Dosage Text Duration 1 YEAR Age Sex Female Country USA

Preferred Term MIGRAINE HOT FLUSH HYPERAESTHESIA MOOD ALTERED NAUSEA

Product YAZ

Manufacturer BAYER

7152234 Date FDA Received
19-Oct-2009

Case # 7152234

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933412NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED VAGINAL HAEMORRHAGE

Product YAZ ORTHO TRI CYCLEN Case Type NON-EXPEDITED Health Professional N

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7152236 Date FDA Received
19-Oct-2009

Case # 7152236

Manufacturer Control # USBAYER-200931551NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7152237 Date FDA Received
19-Oct-2009

Case # 7152237

Manufacturer Control # USBAYER-200933228NA

Age 29 YR

Sex Female

Country USA

Preferred Term PRESYNCOPE LETHARGY NERVOUSNESS

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 411 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7152238 Date FDA Received
19-Oct-2009 Case # 7152238 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933440NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200933758NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933749NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933391NA Role Route S ORAL Dosage Text Age 20 YR Sex Female Dosage Text Age 18 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term DYSPNOEA

Product YAZ Case # 7152244 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7152244 Date FDA Received
19-Oct-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7152245 Date FDA Received
19-Oct-2009

Case # 7152245

Preferred Term FEELING ABNORMAL

Product YAZ Case # 7152247 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7152247 Date FDA Received
19-Oct-2009

Preferred Term COITAL BLEEDING

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 412 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7152248 Date FDA Received
19-Oct-2009 Case # 7152248 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200933737NA Role Route S Dosage Text Age 35 YR Sex Female Country USA

Preferred Term CHEST PAIN CHEST DISCOMFORT CRYING DEPRESSED MOOD DEPRESSION DYSPNOEA

Product YAZ

Duration

Manufacturer BAYER

7152249 Date FDA Received
19-Oct-2009

Case # 7152249

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933767NA

Age 41 YR

Sex Female

Country USA

Preferred Term MENORRHAGIA POLYMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7152263 Date FDA Received
19-Oct-2009

Case # 7152263

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933732NA

Age

Sex Female

Country USA

Preferred Term CONTUSION

Product YAZ PROZAC FISH OIL

Role Route S C C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 413 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7152269 Date FDA Received
19-Oct-2009 Case # 7152269 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933466NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA ABDOMINAL PAIN DIARRHOEA VOMITING

Product YAZ

Manufacturer BAYER

7152271 Date FDA Received
19-Oct-2009

Case # 7152271

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933918NA

Age 20 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7152272 Date FDA Received
19-Oct-2009

Case # 7152272

Manufacturer Control # USBAYER-200933580NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7152285 Date FDA Received
19-Oct-2009

Case # 7152285

Outcomes

Manufacturer Control # USBAYER-200933913NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7157327 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7157327 Date FDA Received
19-Oct-2009 Preferred Term

Outcomes HO,LT,OT,RI Role Route S ORAL

Manufacturer Control #

Age 39 YR

Sex Female

Country USA

Dosage Text 1 DAILY X28DAYS PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM IMPAIRED WORK ABILITY

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 414 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7207099 Date FDA Received
19-Oct-2009 Preferred Term MALAISE HYPERPHAGIA MENORRHAGIA MENSTRUAL DISORDER THROMBOSIS Case # 7207099 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,DS,LT,CA,OT,RI Role Route S ORAL Dosage Text 1 TABLET 1XDAILY ORAL Manufacturer Control # Age 19 YR Duration Sex Female Country USA

Manufacturer

6797790 Date FDA Received
20-Oct-2009

Case # 6797790

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200836523NA

Age 28 YR

Sex Female

Country USA

Preferred Term INFLUENZA NAUSEA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7054908 Date FDA Received
20-Oct-2009

Case # 7054908

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200924265NA

Age 17 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7076613 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7076613 Date FDA Received
20-Oct-2009

Manufacturer Control # USBAYER-200926266NA

Age 16 YR

Sex Female

Country USA

Preferred Term BREAST DISCHARGE EMOTIONAL DISORDER MENSTRUATION DELAYED THINKING ABNORMAL

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 415 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7076665 Date FDA Received
20-Oct-2009 Case # 7076665 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200926472NA Role Route S ORAL Dosage Text Age 29 YR Sex Female Country USA

Preferred Term PREMENSTRUAL SYNDROME FATIGUE HEADACHE MUSCLE SPASMS WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7123820 Date FDA Received
20-Oct-2009

Case # 7123820

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931164NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7140125 Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S Outcomes HO,DS,LT

Dosage Text

Duration

Manufacturer BAYER

7140125 Date FDA Received
20-Oct-2009

Manufacturer Control # DKBAYER-200934101GPV Dosage Text

Age 20 YR

Sex Female

Country DNK

Preferred Term STEVENS-JOHNSON SYNDROME BLISTER LIP SWELLING SKIN NECROSIS

Product YAZ IBUPROFEN

Role Route S C ORAL

Duration

Manufacturer BAYER

7152168 Date FDA Received
20-Oct-2009

Case # 7152168

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # DEBAYER-200935637GPV Dosage Text

Age

Sex Female

Country DEU

Preferred Term NAUSEA CIRCULATORY COLLAPSE

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 416 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153337 Date FDA Received
20-Oct-2009 Case # 7153337 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930476NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200930694NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200930117NA Role Route S S Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200933601NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200933250NA Role Route S ORAL Dosage Text Age 31 YR Sex Female Dosage Text Age 14 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Dosage Text Duration 4 MTH Age 40 YR Sex Female Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7153338 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7153338 Date FDA Received
20-Oct-2009

Preferred Term BLOOD TRIGLYCERIDES INCREASED

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7153339 Date FDA Received
20-Oct-2009

Case # 7153339

Outcomes

Preferred Term MENSTRUATION DELAYED VAGINAL HAEMORRHAGE

Product YAZ YAZ Case Type NON-EXPEDITED

Manufacturer BAYER BAYER Country USA

7153340 Date FDA Received
20-Oct-2009

Case # 7153340

Outcomes

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7153346 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7153346 Date FDA Received
20-Oct-2009

Outcomes

Preferred Term OLIGOMENORRHOEA MENSTRUATION DELAYED

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 417 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153347 Date FDA Received
20-Oct-2009 Case # 7153347 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933184NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931467NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931803NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200932790NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200933736NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 23 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term IRRITABILITY

Product YAZ Case # 7153349 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7153349 Date FDA Received
20-Oct-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7153351 Date FDA Received
20-Oct-2009

Case # 7153351

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7153352 Date FDA Received
20-Oct-2009

Case # 7153352

Preferred Term VULVOVAGINAL MYCOTIC INFECTION

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7153353 Date FDA Received
20-Oct-2009

Case # 7153353

Outcomes

Preferred Term VAGINAL HAEMORRHAGE MENSTRUAL DISORDER

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 418 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153356 Date FDA Received
20-Oct-2009 Case # 7153356 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932370NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200933712NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200932788NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931545NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200933211NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 22 YR Sex Female Dosage Text Age 16 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 21 YR Sex Female Country USA

Preferred Term MUSCLE SPASMS

Product YAZ Case # 7153357 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7153357 Date FDA Received
20-Oct-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7153359 Date FDA Received
20-Oct-2009

Case # 7153359

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7153362 Date FDA Received
20-Oct-2009

Case # 7153362

Outcomes

Preferred Term AMENORRHOEA

Product YAZ Case # 7153363 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7153363 Date FDA Received
20-Oct-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 419 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157922 Date FDA Received
20-Oct-2009 Preferred Term BILIARY COLIC SPHINCTER OF ODDI DYSFUNCTION Case # 7157922 Case Type DIRECT Product YAZ Health Professional Y Outcomes HO,DS Role Route S ORAL Dosage Text YAZ 28 DAILY ORAL Manufacturer Control # Age 29 YR Duration Sex Female Country USA

Manufacturer BAYER

7079133 Date FDA Received
21-Oct-2009

Case # 7079133

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200929098NA Dosage Text

Age 19 YR

Sex Female

Country USA

Preferred Term MUSCLE SPASMS BLOOD POTASSIUM DECREASED

Product YAZ MOTRIN Case Type NON-EXPEDITED Health Professional N

Role Route S C ORAL

Duration 6 MTH

Manufacturer BAYER

7154180 Date FDA Received
21-Oct-2009

Case # 7154180

Outcomes OT

Manufacturer Control # USBAYER-200936392NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7154184 Date FDA Received
21-Oct-2009

Case # 7154184

Outcomes OT

Manufacturer Control # USBAYER-200936264NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Duration

Manufacturer BAYER

7154189 Date FDA Received
21-Oct-2009

Case # 7154189

Outcomes HO,OT

Manufacturer Control # USBAYER-200936214NA Dosage Text

Age 18 YR

Sex Female

Country USA

Preferred Term THROMBOSIS PULMONARY THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 420 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7154254 Date FDA Received
21-Oct-2009 Case # 7154254 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200930242NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200930678NA Role Route S ORAL Dosage Text Age 49 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7154267 Date FDA Received
21-Oct-2009

Case # 7154267

Preferred Term NAUSEA NO ADVERSE EVENT

Product YAZ

Duration

Manufacturer BAYER

7155309 Date FDA Received
22-Oct-2009

Case # 7155309

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931463NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7155311 Date FDA Received
22-Oct-2009

Case # 7155311

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200931737NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 421 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155317 Date FDA Received
22-Oct-2009 Case # 7155317 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932454NA Role Route S S ORAL ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VULVOVAGINAL MYCOTIC INFECTION CERVICITIS ABDOMINAL PAIN ACNE MENORRHAGIA VAGINAL INFECTION

Product YAZ YASMIN

Manufacturer BAYER BAYER

7155319 Date FDA Received
22-Oct-2009

Case # 7155319

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932481NA

Age

Sex Female

Country USA

Preferred Term GASTROINTESTINAL DISORDER DIARRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7155322 Date FDA Received
22-Oct-2009

Case # 7155322

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932510NA

Age

Sex Female

Country USA

Preferred Term MASS

Product YAZ Case # 7155323 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7155323 Date FDA Received
22-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200932508NA

Age 30 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 422 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155325 Date FDA Received
22-Oct-2009 Case # 7155325 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932515NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932595NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200931711NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200931822NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200931817NA Role Route S ORAL Dosage Text Age 27 YR Sex Female Dosage Text Duration Age Sex Female Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL PAIN

Product YAZ Case # 7155327 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155327 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term ANXIETY

Product YAZ Case # 7155328 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155328 Date FDA Received
22-Oct-2009

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7155330 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155330 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155331 Date FDA Received
22-Oct-2009

Case # 7155331

Outcomes

Preferred Term ABDOMINAL PAIN VAGINAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 423 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155332 Date FDA Received
22-Oct-2009 Case # 7155332 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931738NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200931735NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200932512NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932519NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932516NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7155333 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155333 Date FDA Received
22-Oct-2009

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155339 Date FDA Received
22-Oct-2009

Case # 7155339

Preferred Term NAUSEA

Product YAZ Case # 7155340 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155340 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7155341 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155341 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term ALLERGIC SINUSITIS

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 424 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155342 Date FDA Received
22-Oct-2009 Case # 7155342 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932029NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932666NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932646NA Role Route S Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Age 29 YR Sex Female Dosage Text Age 26 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term HAIR TEXTURE ABNORMAL

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155343 Date FDA Received
22-Oct-2009

Case # 7155343

Outcomes

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7155344 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7155344 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term BLOOD POTASSIUM ABNORMAL MUSCLE SPASMS PAIN IN EXTREMITY

Product YAZ

Duration 6 MTH

Manufacturer BAYER

7155346 Date FDA Received
22-Oct-2009

Case # 7155346

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933047NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE HEADACHE

Product YAZ DROSPIRENONE

Role Route S S

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 425 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155349 Date FDA Received
22-Oct-2009 Case # 7155349 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932917NA Role Route S ORAL Dosage Text Age 25 YR Sex Female Country USA

Preferred Term DRUG DOSE OMISSION POLYMENORRHOEA

Product YAZ

Duration

Manufacturer BAYER

7155350 Date FDA Received
22-Oct-2009

Case # 7155350

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932969NA

Age

Sex Female

Country USA

Preferred Term MALAISE HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7155351 Date FDA Received
22-Oct-2009

Case # 7155351

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933174NA

Age 31 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE MOOD SWINGS

Product YAZ YASMIN Case # 7155353 Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL ORAL

Dosage Text

Duration 3 MTH 1 MTH

Manufacturer BAYER BAYER Sex Female Country USA

7155353 Date FDA Received
22-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200932674NA

Age

Preferred Term MENORRHAGIA MENSTRUAL DISORDER SINUSITIS

Product YAZ ZITHROMAX

Role Route S C ORAL

Dosage Text

Duration 6 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 426 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155354 Date FDA Received
22-Oct-2009 Case # 7155354 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932596NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933144NA Role Route S Dosage Text Age 18 YR Sex Female Dosage Text Age 41 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7155355 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7155355 Date FDA Received
22-Oct-2009

Preferred Term HYPOMENORRHOEA NAUSEA VAGINAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

7155357 Date FDA Received
22-Oct-2009

Case # 7155357

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932641NA

Age 24 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED DERMATITIS CONTACT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7155358 Date FDA Received
22-Oct-2009

Case # 7155358

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933247NA

Age 19 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 427 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155359 Date FDA Received
22-Oct-2009 Case # 7155359 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932979NA Role Route S Dosage Text Duration 6 DAY Age Sex Female Country USA

Preferred Term DIZZINESS HEADACHE NAUSEA

Product YAZ

Manufacturer BAYER

7155360 Date FDA Received
22-Oct-2009

Case # 7155360

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932846NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7155367 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7155367 Date FDA Received
22-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200933206NA

Age 45 YR

Sex Female

Country USA

Preferred Term DIARRHOEA VULVOVAGINAL MYCOTIC INFECTION

Product YAZ MIRENA CLARITIN MICONAZOLE NITRATE

Role Route S S C C Outcomes ORAL INTRAUTERINE

Dosage Text

Duration 5 MTH

Manufacturer BAYER BAYER

7155368 Date FDA Received
22-Oct-2009

Case # 7155368

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200932643NA

Age 26 YR

Sex Female

Country USA

Preferred Term NAUSEA BREAST TENDERNESS SOMNOLENCE INCREASED APPETITE

Product YAZ YAZ KLONOPIN

Role Route S S C

Dosage Text

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 428 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155369 Date FDA Received
22-Oct-2009 Case # 7155369 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933157NA Role Route S C C C C Health Professional N Outcomes Manufacturer Control # USBAYER-200932825NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932959NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932819NA Role Route S ORAL Dosage Text Age 26 YR Sex Female Dosage Text Age 20 YR Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 23 YR Sex Female Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ LYRICA PREDNISONE ERYTHROMYCIN ALBUTEROL

Duration

Manufacturer BAYER

7155370 Date FDA Received
22-Oct-2009

Case # 7155370

Case Type NON-EXPEDITED

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155372 Date FDA Received
22-Oct-2009

Case # 7155372

Outcomes

Preferred Term FATIGUE

Product YAZ Case # 7155373 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7155373 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term AFFECTIVE DISORDER

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 429 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155374 Date FDA Received
22-Oct-2009 Case # 7155374 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933811NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200933800NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933954NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200933646NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933950NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Dosage Text Duration 11 MTH Age 20 YR Sex Female Age Sex Female Age 19 YR Sex Female Dosage Text Duration Age Sex Female Age 17 YR Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7155375 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7155375 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term WEIGHT INCREASED

Product YAZ Case # 7155376 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155376 Date FDA Received
22-Oct-2009

Preferred Term METRORRHAGIA

Product YAZ Case # 7155378 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7155378 Date FDA Received
22-Oct-2009

Outcomes

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155380 Date FDA Received
22-Oct-2009

Case # 7155380

Preferred Term POLYMENORRHOEA

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 430 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155383 Date FDA Received
22-Oct-2009 Case # 7155383 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933915NA Role Route S S Health Professional N Outcomes Manufacturer Control # USBAYER-200933905NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933793NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933803NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200933823NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Duration 6 MTH Age Sex Female Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term FEELING ABNORMAL ACNE

Product YAZ YAZ Case # 7155387 Case Type NON-EXPEDITED

Manufacturer BAYER BAYER Country USA

7155387 Date FDA Received
22-Oct-2009

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7155388 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155388 Date FDA Received
22-Oct-2009

Preferred Term AMENORRHOEA

Product YAZ Case # 7155389 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155389 Date FDA Received
22-Oct-2009

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7155392 Date FDA Received
22-Oct-2009

Case # 7155392

Preferred Term DIARRHOEA

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 431 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155393 Date FDA Received
22-Oct-2009 Case # 7155393 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933762NA Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term MIGRAINE NO ADVERSE EVENT

Product YAZ

Manufacturer BAYER

7155399 Date FDA Received
22-Oct-2009

Case # 7155399

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934053NA

Age

Sex Female

Country USA

Preferred Term GASTRIC DISORDER

Product YAZ CLIDINIUM

Role Route S C Health Professional N Outcomes ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

7155400 Date FDA Received
22-Oct-2009

Case # 7155400

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200934032NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED ABDOMINAL PAIN

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7155402 Date FDA Received
22-Oct-2009

Case # 7155402

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933919NA

Age

Sex Female

Country USA

Preferred Term DRUG DOSE OMISSION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200933798NA

Duration

Manufacturer BAYER

7155403 Date FDA Received
22-Oct-2009

Case # 7155403

Outcomes

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 432 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155407 Date FDA Received
22-Oct-2009 Case # 7155407 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933806NA Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term DIZZINESS HEADACHE NAUSEA

Product YAZ

Manufacturer BAYER

7155414 Date FDA Received
22-Oct-2009

Case # 7155414

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934018NA

Age

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7155427 Date FDA Received
22-Oct-2009

Case # 7155427

Manufacturer Control # USBAYER-200933962NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7160183 Date FDA Received
22-Oct-2009 Preferred Term SWELLING ENDOMETRIOSIS FLUID RETENTION NEPHROLITHIASIS

Case # 7160183

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 1 PILL BY MOUTH DAILY

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 433 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7068669 Date FDA Received
23-Oct-2009 Case # 7068669 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200925408NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200927193NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Age 24 YR Sex Female Dosage Text Age 30 YR Sex Female Country USA

Preferred Term MOOD SWINGS

Product YAZ Case # 7115964 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7115964 Date FDA Received
23-Oct-2009

Outcomes

Preferred Term DYSPNOEA DIZZINESS FATIGUE MENORRHAGIA MUSCLE SPASMS NAUSEA

Product YAZ

Duration 3 WEEK

Manufacturer BAYER

7155118 Date FDA Received
23-Oct-2009

Case # 7155118

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200931802NA Dosage Text

Age

Sex Female

Country USA

Preferred Term BIPOLAR DISORDER MOOD SWINGS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7156273 Date FDA Received
23-Oct-2009

Case # 7156273

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933942NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 434 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7156276 Date FDA Received
23-Oct-2009 Case # 7156276 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932593NA Role Route S Dosage Text Age 20 YR Sex Female Country USA

Preferred Term ANXIETY MENSTRUATION DELAYED

Product YAZ

Duration

Manufacturer BAYER

7156280 Date FDA Received
23-Oct-2009

Case # 7156280

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933148NA

Age

Sex Female

Country USA

Preferred Term TOOTH ABSCESS

Product YAZ Case # 7156303 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7156303 Date FDA Received
23-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200932583NA

Age 14 YR

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7156304 Date FDA Received
23-Oct-2009

Case # 7156304

Manufacturer Control # USBAYER-200934020NA

Age

Sex Female

Country USA

Preferred Term FATIGUE

Product YAZ Case # 7156306 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7156306 Date FDA Received
23-Oct-2009

Manufacturer Control # USBAYER-200934085NA

Age

Sex Female

Country USA

Preferred Term WEIGHT INCREASED ACNE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 435 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7156313 Date FDA Received
23-Oct-2009 Case # 7156313 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200933958NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200933945NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200934088NA Role Route S ORAL Dosage Text Duration Age Sex Female Age 32 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term DRUG DOSE OMISSION

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7156316 Date FDA Received
23-Oct-2009

Case # 7156316

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 7156319 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7156319 Date FDA Received
23-Oct-2009

Outcomes

Preferred Term HYPOMENORRHOEA METRORRHAGIA

Product YAZ

Manufacturer BAYER

7156341 Date FDA Received
23-Oct-2009

Case # 7156341

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934097NA

Age 20 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7160380 Case Type DIRECT Product YAZ Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7160380 Date FDA Received
23-Oct-2009 Preferred Term FLANK PAIN

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY OTHER

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 436 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7160693 Date FDA Received
23-Oct-2009 Preferred Term PULMONARY THROMBOSIS PAIN IN EXTREMITY Case # 7160693 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,LT Role Route S ORAL Dosage Text 1 TABLET 1 X DAILY ORAL Manufacturer Control # Age 43 YR Duration Sex Female Country USA

Manufacturer

7114867 Date FDA Received
26-Oct-2009

Case # 7114867

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200932709NA

Age

Sex Female

Country USA

Preferred Term GALLBLADDER DISORDER

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7118328 Date FDA Received
26-Oct-2009

Case # 7118328

Manufacturer Control # USBAYER-200932424NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY TEST POSITIVE AMENORRHOEA NAUSEA

Product YAZ

Role Route S

Dosage Text

Duration 1 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 437 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157931 Date FDA Received
26-Oct-2009 Case # 7157931 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200931686NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Age 38 YR Sex Female Country USA

Preferred Term PALPITATIONS ANXIETY CHEST PAIN DEPRESSION DRY EYE DYSMENORRHOEA HYPOAESTHESIA MENORRHAGIA MENSTRUATION DELAYED SLEEP DISORDER

Product YAZ

Duration 10 MTH

Manufacturer BAYER

7157935 Date FDA Received
26-Oct-2009

Case # 7157935

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200934252NA

Age

Sex Female

Country USA

Preferred Term PARAESTHESIA

Product YAZ Case # 7157937 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7157937 Date FDA Received
26-Oct-2009

Outcomes

Manufacturer Control # USBAYER-200934226NA

Age 21 YR

Sex Female

Country USA

Preferred Term ANXIETY DEPRESSION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 438 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157942 Date FDA Received
26-Oct-2009 Case # 7157942 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934234NA Role Route S ORAL Dosage Text Age 23 YR Sex Female Country USA

Preferred Term MUSCLE SPASMS FEELING ABNORMAL

Product YAZ

Duration 3 MTH

Manufacturer BAYER

7157949 Date FDA Received
26-Oct-2009

Case # 7157949

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934186NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7157951 Date FDA Received
26-Oct-2009

Case # 7157951

Outcomes

Manufacturer Control # USBAYER-200934245NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7157954 Date FDA Received
26-Oct-2009

Case # 7157954

Manufacturer Control # USBAYER-200934236NA

Age 17 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration 4 MTH

Manufacturer BAYER Sex Female Country USA

7157955 Date FDA Received
26-Oct-2009

Case # 7157955

Manufacturer Control # USBAYER-200934262NA

Age

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 439 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157956 Date FDA Received
26-Oct-2009 Case # 7157956 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934311NA Role Route S ORAL Dosage Text Age 23 YR Sex Female Country USA

Preferred Term ABDOMINAL PAIN UPPER BACK PAIN HEADACHE IRRITABILITY MENORRHAGIA SOMNOLENCE

Product YAZ

Duration

Manufacturer BAYER

7157960 Date FDA Received
26-Oct-2009

Case # 7157960

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934350NA

Age

Sex Female

Country USA

Preferred Term POLYMENORRHOEA ACNE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7157979 Date FDA Received
26-Oct-2009

Case # 7157979

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934346NA

Age 32 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN UPPER ABNORMAL WITHDRAWAL BLEEDING DIZZINESS HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration 3 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 440 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157981 Date FDA Received
26-Oct-2009 Case # 7157981 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934416NA Role Route S ORAL Dosage Text Age 24 YR Sex Female Country USA

Preferred Term DIZZINESS MOOD SWINGS

Product YAZ

Duration

Manufacturer BAYER

7157994 Date FDA Received
26-Oct-2009

Case # 7157994

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934386NA

Age

Sex Female

Country USA

Preferred Term MUSCLE SPASMS

Product YAZ VITAMINS

Role Route S C Health Professional N Outcomes

Dosage Text

Duration

Manufacturer BAYER

7158002 Date FDA Received
26-Oct-2009

Case # 7158002

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200934429NA

Age 47 YR

Sex Female

Country USA

Preferred Term MIGRAINE HYPERTENSION NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7158003 Date FDA Received
26-Oct-2009

Case # 7158003

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934380NA

Age 26 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 441 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7158009 Date FDA Received
26-Oct-2009 Case # 7158009 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934465NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200934551NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200934425NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200936977NA Role Route S S Health Professional N Product YAZ ORAL ORAL Manufacturer Control # Age 43 YR Dosage Text 1 TABLET DAILY PO Duration Sex Female Dosage Text Age 18 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7158016 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7158016 Date FDA Received
26-Oct-2009

Outcomes

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7158018 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7158018 Date FDA Received
26-Oct-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7158022 Date FDA Received
26-Oct-2009

Case # 7158022

Outcomes

Preferred Term MENORRHAGIA MUSCLE SPASMS

Product YAZ YAZ Case # 7161497 Case Type DIRECT

Duration

Manufacturer BAYER BAYER Country USA

7161497 Date FDA Received
26-Oct-2009 Preferred Term

Outcomes HO,LT,RI Role Route S ORAL

Manufacturer BAYER

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 442 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7098230 Date FDA Received
27-Oct-2009 Case # 7098230 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200924521NA Role Route S C C Health Professional N Outcomes Manufacturer Control # USBAYER-200924356NA Role Route S ORAL Dosage Text Age 22 YR Sex Female Country USA Dosage Text Age 37 YR Sex Female Country USA

Preferred Term HYPOAESTHESIA BLOOD POTASSIUM INCREASED

Product YAZ VITAMINS AMBIEN

Duration 6 MTH

Manufacturer BAYER

7098240 Date FDA Received
27-Oct-2009

Case # 7098240

Case Type NON-EXPEDITED

Preferred Term HYPERTHYROIDISM WEIGHT INCREASED

Product YAZ

Duration 2 YEAR

Manufacturer BAYER

7157782 Date FDA Received
27-Oct-2009

Case # 7157782

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes DE

Manufacturer Control # USBAYER-200937108NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200936513NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 7159018 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7159018 Date FDA Received
27-Oct-2009

Outcomes OT

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ YASMIN

Role Route S S

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 443 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7159051 Date FDA Received
27-Oct-2009 Case # 7159051 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934213NA Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term MOOD SWINGS DYSPNOEA

Product YAZ

Manufacturer BAYER

7164289 Date FDA Received
28-Oct-2009 Preferred Term

Case # 7164289

Case Type DIRECT Product YAZ Case Type NON-EXPEDITED

Health Professional N

Outcomes LT Role Route S ORAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO Manufacturer Control # USBAYER-200934494NA

Duration

Manufacturer

PULMONARY THROMBOSIS

7161639 Date FDA Received
29-Oct-2009

Case # 7161639

Health Professional N

Outcomes

Age

Sex Female

Country USA

Preferred Term CHEST PAIN DIZZINESS DYSPNOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7161647 Date FDA Received
29-Oct-2009

Case # 7161647

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934485NA

Age 15 YR

Sex Female

Country USA

Preferred Term VISUAL IMPAIRMENT HEADACHE PARAESTHESIA

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 444 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7161648 Date FDA Received
29-Oct-2009 Case # 7161648 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934495NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term CHEST PAIN DIZZINESS DYSPNOEA

Product YAZ

Manufacturer BAYER

7161659 Date FDA Received
29-Oct-2009

Case # 7161659

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934584NA

Age 31 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7161664 Date FDA Received
29-Oct-2009

Case # 7161664

Outcomes

Manufacturer Control # USBAYER-200934619NA

Age

Sex Female

Country USA

Preferred Term MALAISE DIZZINESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7161670 Date FDA Received
29-Oct-2009

Case # 7161670

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934653NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 445 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7161676 Date FDA Received
29-Oct-2009 Case # 7161676 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934642NA Role Route S ORAL Dosage Text Duration 2 YEAR Age Sex Female Country USA

Preferred Term PAIN IN EXTREMITY PARAESTHESIA RASH

Product YAZ

Manufacturer BAYER

7161677 Date FDA Received
29-Oct-2009

Case # 7161677

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934592NA

Age

Sex Female

Country USA

Preferred Term RETCHING MALAISE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7161678 Date FDA Received
29-Oct-2009

Case # 7161678

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934604NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type DIRECT Product VIVAGLOBIN YAZ Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7164847 Date FDA Received
29-Oct-2009 Preferred Term URTICARIA

Case # 7164847

Outcomes HO,DS,LT Role Route S S SUBCUTANEOUS ORAL

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text 5.28 G QWEEK SQ 1 TABLET DAILY PO

Duration 2 YEAR

Manufacturer

MUSCULAR WEAKNESS CEREBRAL HAEMORRHAGE FACIAL PARESIS SUPERIOR SAGITTAL SINUS THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 446 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7165967 Date FDA Received
29-Oct-2009 Preferred Term GALLBLADDER DISORDER MENSTRUAL DISORDER Case # 7165967 Case Type DIRECT Product YAZ Health Professional N Outcomes RI Role Route S ORAL Dosage Text 1 TABLET 1X DAILY ORAL Manufacturer Control # Age 19 YR Duration Sex Female Country USA

Manufacturer

7162879 Date FDA Received
30-Oct-2009

Case # 7162879

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200937039NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ Case # 7162888 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7162888 Date FDA Received
30-Oct-2009

Manufacturer Control # USBAYER-200937036NA Dosage Text

Age 40 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration 6 WEEK

Manufacturer BAYER Sex Female Country USA

7163103 Date FDA Received
30-Oct-2009

Case # 7163103

Manufacturer Control # USBAYER-200934702NA

Age

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7163115 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7163115 Date FDA Received
30-Oct-2009

Manufacturer Control # USBAYER-200934754NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 447 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7163118 Date FDA Received
30-Oct-2009 Case # 7163118 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200934698NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200934770NA Role Route S Health Professional N Product YAZ Case # 7076653 Case Type NON-EXPEDITED Health Professional N Outcomes HO Role Route S ORAL Dosage Text 1 DAILY PO Manufacturer Control # USBAYER-200926291NA Role Route S C C C ORAL Dosage Text Age 26 YR Sex Female Manufacturer Control # Age 33 YR Duration Sex Female Dosage Text Age 20 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7163125 Date FDA Received
30-Oct-2009

Case # 7163125

Outcomes

Preferred Term MENORRHAGIA

Product YAZ Case # 7169064 Case Type DIRECT

Duration

Manufacturer BAYER Country USA

7169064 Date FDA Received
30-Oct-2009 Preferred Term CHOLELITHIASIS

Manufacturer BAYER Country USA

7076653 Date FDA Received
02-Nov-2009

Outcomes

Preferred Term METRORRHAGIA MUSCLE SPASMS OEDEMA PERIPHERAL TOOTH DEPOSIT ABDOMINAL PAIN LOWER FUNGAL INFECTION HEADACHE

Product YAZ PRILOSEC ZYRTEC CLARITIN

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 448 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7139437 Date FDA Received
02-Nov-2009 Case # 7139437 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932244NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200937138NA Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ACNE

Product YAZ Case # 7164205 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7164205 Date FDA Received
02-Nov-2009

Outcomes OT

Preferred Term CEREBROVASCULAR ACCIDENT HYPOAESTHESIA VISUAL IMPAIRMENT

Product YAZ

Role Route S

Manufacturer BAYER

7164335 Date FDA Received
02-Nov-2009

Case # 7164335

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935138NA

Age

Sex Female

Country USA

Preferred Term IRRITABILITY

Product YAZ Case # 7164339 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7164339 Date FDA Received
02-Nov-2009

Manufacturer Control # USBAYER-200935119NA

Age

Sex Female

Country USA

Preferred Term MUSCLE SPASMS

Product YAZ Case # 7164346 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7164346 Date FDA Received
02-Nov-2009

Manufacturer Control # USBAYER-200935239NA

Age

Sex Female

Country USA

Preferred Term BREAST TENDERNESS MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 449 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7164354 Date FDA Received
02-Nov-2009 Case # 7164354 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935270NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA MENORRHAGIA

Product YAZ

Manufacturer BAYER

7164358 Date FDA Received
02-Nov-2009

Case # 7164358

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935296NA

Age

Sex Female

Country USA

Preferred Term FOOD POISONING

Product YAZ Case # 7164359 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7164359 Date FDA Received
02-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200935243NA

Age

Sex Female

Country USA

Preferred Term MUSCLE SPASMS

Product YAZ Case # 7164362 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7164362 Date FDA Received
02-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200935177NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ PLAN B

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 450 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7164368 Date FDA Received
02-Nov-2009 Case # 7164368 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935170NA Role Route S C ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term POLYMENORRHOEA

Product YAZ VICKS DAYQUIL SINUS PRESSURE & PAIN RELIEF W/ IBUPROFEN

Manufacturer BAYER

7164378 Date FDA Received
02-Nov-2009

Case # 7164378

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935437NA

Age

Sex Female

Country USA

Preferred Term OROPHARYNGEAL PAIN

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7164380 Date FDA Received
02-Nov-2009

Case # 7164380

Outcomes

Manufacturer Control # USBAYER-200935418NA

Age 18 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration 7 MTH

Manufacturer BAYER Sex Female Country USA

7164385 Date FDA Received
02-Nov-2009

Case # 7164385

Manufacturer Control # USBAYER-200936208NA

Age 19 YR

Preferred Term PLEURISY BACK PAIN DYSPNOEA PAIN

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 451 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7164391 Date FDA Received
02-Nov-2009 Case # 7164391 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935331NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term HEADACHE NAUSEA

Product YAZ

Manufacturer BAYER

7168515 Date FDA Received
03-Nov-2009 Preferred Term

Case # 7168515

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S S ORAL ORAL

Manufacturer Control #

Age 51 YR

Sex Female

Country USA

Dosage Text DAILY FOR 21 DAYS, PO DAILY FOR 21 DAYS, PO

Duration

Manufacturer

PREMENSTRUAL SYNDROME CONDITION AGGRAVATED PULMONARY THROMBOSIS

ETHINYL ESTRADIOL \LEVONORGESTREL

7077920 Date FDA Received
04-Nov-2009

Case # 7077920

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200929016NA Dosage Text DRUG NOT YET STARTED

Age

Sex Female

Country USA

Preferred Term SINUS OPERATION MALAISE

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7166397 Date FDA Received
04-Nov-2009

Case # 7166397

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935727NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 452 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7171450 Date FDA Received
04-Nov-2009 Preferred Term HEART RATE INCREASED BLOOD PRESSURE DECREASED CHEST PAIN DYSPNOEA FLUSHING HYPERHIDROSIS NAUSEA PRURITUS SYNCOPE URTICARIA VOMITING Case # 7171450 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer

7173150 Date FDA Received
04-Nov-2009 Preferred Term

Case # 7173150

Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ YASMIN

Health Professional Y

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 15 YR

Sex Female

Country USA

Dosage Text 1 PILL 1XDAILY PO Manufacturer Control #

Duration

Manufacturer

GALLBLADDER DISORDER

7173594 Date FDA Received
04-Nov-2009 Preferred Term

Case # 7173594

Health Professional N

Outcomes

Age 31 YR

Sex Female

Country USA

Role Route S S ORAL

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer

RESTLESS LEGS SYNDROME SCREAMING CARDIOVASCULAR DISORDER HYPERHIDROSIS HYPOAESTHESIA OEDEMA PERIPHERAL PAIN IN EXTREMITY PRODUCT SUBSTITUTION ISSUE

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 453 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7173595 Date FDA Received
04-Nov-2009 Preferred Term DEEP VEIN THROMBOSIS ECONOMIC PROBLEM PULMONARY EMBOLISM Case # 7173595 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,LT Role Route S ORAL Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 44 YR Duration Sex Female Country USA

Manufacturer BAYER

6977069 Date FDA Received
05-Nov-2009

Case # 6977069

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200915172NA

Age 19 YR

Sex Female

Country USA

Preferred Term DEPRESSION

Product YAZ Case # 7142006 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7142006 Date FDA Received
05-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200931466NA

Age 14 YR

Sex Female

Country USA

Preferred Term ACNE MENSTRUATION IRREGULAR

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration 1 MTH

Manufacturer BAYER

7167479 Date FDA Received
05-Nov-2009

Case # 7167479

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200937603NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration

Manufacturer BAYER

7167636 Date FDA Received
05-Nov-2009

Case # 7167636

Manufacturer Control # USBAYER-200935733NA

Age

Sex Female

Country USA

Preferred Term PHARYNGITIS STREPTOCOCCAL

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 454 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7167638 Date FDA Received
05-Nov-2009 Case # 7167638 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935638NA Role Route S C Outcomes Manufacturer Control # USBAYER-200936569NA Role Route S S S Outcomes Manufacturer Control # USBAYER-200935623NA Role Route S ORAL Dosage Text Age 29 YR Sex Female Country USA Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA AMENORRHOEA

Product YAZ ST. JOHN'S WORT Case # 7167640 Case Type NON-EXPEDITED Health Professional N

Manufacturer BAYER

7167640 Date FDA Received
05-Nov-2009

Preferred Term INJURY

Product YAZ YASMIN DROSPIRENONE

Manufacturer BAYER BAYER

7167641 Date FDA Received
05-Nov-2009

Case # 7167641

Case Type NON-EXPEDITED

Health Professional N

Preferred Term MUSCULOSKELETAL PAIN CHEST PAIN

Product YAZ

Duration

Manufacturer BAYER

7167642 Date FDA Received
05-Nov-2009

Case # 7167642

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935737NA

Age

Sex Female

Country USA

Preferred Term WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 455 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7167645 Date FDA Received
05-Nov-2009 Case # 7167645 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935772NA Role Route S ORAL Dosage Text Duration 2 YEAR Age Sex Female Country USA

Preferred Term ABDOMINAL PAIN LOWER MENSTRUAL DISORDER

Product YAZ

Manufacturer BAYER

7167646 Date FDA Received
05-Nov-2009

Case # 7167646

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935600NA

Age 25 YR

Sex Female

Country USA

Preferred Term ACNE MENORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7167654 Date FDA Received
05-Nov-2009

Case # 7167654

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935513NA

Age 19 YR

Sex Female

Country USA

Preferred Term HEADACHE ASTHENIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7167656 Date FDA Received
05-Nov-2009

Case # 7167656

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936802NA

Age

Sex Female

Country USA

Preferred Term RENAL DISORDER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 456 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7167657 Date FDA Received
05-Nov-2009 Case # 7167657 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937657NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Duration 3 MTH Age Sex Female Country USA

Preferred Term VULVOVAGINAL MYCOTIC INFECTION ABDOMINAL DISTENSION ABDOMINAL PAIN UPPER ALOPECIA BACK PAIN BREAST TENDERNESS CHEST PAIN FATIGUE INCREASED APPETITE MIGRAINE NAUSEA VOMITING

Product YAZ

Manufacturer BAYER

7168010 Date FDA Received
05-Nov-2009

Case # 7168010

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # BRBAYER-200923495LA Dosage Text

Age

Sex

Country BRA

< 1 DAY Male

Preferred Term PLATELET COUNT DECREASED PURPURA

Product YAZ

Role Route S TRANSPLACENTAL

Duration

Manufacturer BAYER

7174715 Date FDA Received
05-Nov-2009 Preferred Term

Case # 7174715

Case Type DIRECT Product YAZ

Health Professional N

Outcomes

Manufacturer Control #

Age 31 YR

Sex Unknown

Country USA

Role Route S

Dosage Text 1 TABLET 1X DAILY

Duration

Manufacturer

NO THERAPEUTIC RESPONSE AMENORRHOEA VULVOVAGINAL MYCOTIC INFECTION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 457 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7168724 Date FDA Received
06-Nov-2009 Case # 7168724 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE Manufacturer Control # DEBAYER-200937425GPV Dosage Text Age 23 YR Sex Female Country LTU

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S ORAL

Duration

Manufacturer BAYER

7168740 Date FDA Received
06-Nov-2009

Case # 7168740

Outcomes OT

Manufacturer Control # USBAYER-200937593NA Dosage Text Total daily dose: 1 DF

Age 17 YR

Sex Female

Country USA

Preferred Term RENAL FAILURE

Product YAZ YASMIN

Role Route S S Health Professional Y ORAL ORAL

Duration

Manufacturer BAYER BAYER

7168744 Date FDA Received
06-Nov-2009

Case # 7168744

Case Type NON-EXPEDITED

Outcomes HO

Manufacturer Control # USBAYER-200937706NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200937930NA Dosage Text

Age 46 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7168745 Date FDA Received
06-Nov-2009

Case # 7168745

Outcomes HO

Age

Sex Female

Country USA

Preferred Term GALLBLADDER DISORDER

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7168750 Date FDA Received
06-Nov-2009

Case # 7168750

Manufacturer Control # USBAYER-200937717NA Dosage Text

Age

Sex Female

Country USA

Preferred Term TUBERCULIN TEST POSITIVE

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 458 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7168801 Date FDA Received
06-Nov-2009 Case # 7168801 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935384NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200935906NA Role Route S Health Professional N INTRAUTERINE Dosage Text CONTINUOUS Manufacturer Control # USBAYER-200935909NA Role Route S Health Professional N Product YAZ ORAL Manufacturer Control # Age 21 YR Dosage Text 1 PILL DAILY PO Duration Sex Female Dosage Text Age 19 YR Sex Female Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7168808 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7168808 Date FDA Received
06-Nov-2009

Preferred Term BLOOD CHOLESTEROL INCREASED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7168810 Date FDA Received
06-Nov-2009

Case # 7168810

Outcomes

Preferred Term ACNE

Product YAZ Case # 7175509 Case Type DIRECT

Duration

Manufacturer BAYER Country USA

7175509 Date FDA Received
06-Nov-2009 Preferred Term HOT FLUSH DYSMENORRHOEA ERUCTATION

Outcomes LT,OT,RI Role Route S ORAL

Manufacturer BAYER

GALLBLADDER DISORDER LIVER INJURY NAUSEA POLYMENORRHOEA RETCHING

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 459 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144809 Date FDA Received
09-Nov-2009 Case # 7144809 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200932894NA Role Route S ORAL Dosage Text Total daily dose: 1 DF Age 18 YR Sex Female Country USA

Preferred Term ACNE METRORRHAGIA

Product YAZ

Duration 1 YEAR

Manufacturer BAYER

7168726 Date FDA Received
09-Nov-2009

Case # 7168726

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200937392NA Dosage Text

Age 25 YR

Sex Female

Country USA

Preferred Term VENOUS THROMBOSIS Embolism arterial

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7168729 Date FDA Received
09-Nov-2009

Case # 7168729

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200937378NA Dosage Text

Age 25 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7168735 Date FDA Received
09-Nov-2009

Case # 7168735

Outcomes HO

Manufacturer Control # USBAYER-200937385NA Dosage Text Total daily dose: 1 DF Manufacturer Control # ESBAYER-200937840GPV Dosage Text

Age 18 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7168746 Date FDA Received
09-Nov-2009

Case # 7168746

Outcomes OT

Age 29 YR

Sex Female

Country ESP

Preferred Term HYPERTENSIVE CRISIS VISION BLURRED

Product YAZ

Role Route S

Duration 3 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 460 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7170483 Date FDA Received
09-Nov-2009 Case # 7170483 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935753NA Role Route S ORAL Dosage Text Age 28 YR Sex Female Country USA

Preferred Term ABNORMAL SENSATION IN EYE WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7170489 Date FDA Received
09-Nov-2009

Case # 7170489

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935918NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ Case # 7170490 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7170490 Date FDA Received
09-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200935920NA

Age

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN LOWER

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7170498 Date FDA Received
09-Nov-2009

Case # 7170498

Manufacturer Control # USBAYER-200935927NA

Age 23 YR

Sex Female

Country USA

Preferred Term RASH DERMATITIS ALLERGIC RASH ERYTHEMATOUS RASH PAPULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 461 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7170503 Date FDA Received
09-Nov-2009 Case # 7170503 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935921NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200935988NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7170515 Date FDA Received
09-Nov-2009

Case # 7170515

Outcomes

Preferred Term FATIGUE VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

7170522 Date FDA Received
09-Nov-2009

Case # 7170522

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200935992NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7170533 Date FDA Received
09-Nov-2009

Case # 7170533

Outcomes

Manufacturer Control # USBAYER-200935986NA

Age 25 YR

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7170539 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7170539 Date FDA Received
09-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200936049NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ

Role Route S

Dosage Text ON YAZ FOR YEARS (NOS)

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 462 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7170542 Date FDA Received
09-Nov-2009 Case # 7170542 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936113NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200936095NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200936052NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200936060NA Role Route S S Dosage Text TOOK PRIOR TO BIRTH OF CHILD (NOS) Age 39 YR Sex Female Dosage Text Duration Dosage Text Duration 1 YEAR Age Sex Female Age Sex Female Dosage Text Age 21 YR Sex Female Country USA

Preferred Term URINARY TRACT INFECTION

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7170555 Date FDA Received
09-Nov-2009

Case # 7170555

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7170577 Date FDA Received
09-Nov-2009

Case # 7170577

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7170581 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7170581 Date FDA Received
09-Nov-2009

Preferred Term HEADACHE IRRITABILITY ACNE SEBORRHOEA

Product YASMIN YAZ

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 463 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7170597 Date FDA Received
09-Nov-2009 Case # 7170597 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936236NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200936197NA Role Route S INTRAUTERINE Dosage Text Age 30 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7170602 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7170602 Date FDA Received
09-Nov-2009

Outcomes

Preferred Term MENSTRUATION DELAYED ABDOMINAL PAIN

Product YAZ

Duration

Manufacturer BAYER

7175745 Date FDA Received
09-Nov-2009 Preferred Term HYPERTENSION CHEST PAIN DIZZINESS NAUSEA RESTLESSNESS VOMITING

Case # 7175745

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text ONCE A DAY PO

Duration

Manufacturer

7175759 Date FDA Received
09-Nov-2009 Preferred Term

Case # 7175759

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 44 YR

Sex Female

Country USA

Dosage Text 1 DAILY

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 464 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177246 Date FDA Received
09-Nov-2009 Preferred Term PULMONARY EMBOLISM PLEURAL EFFUSION PLEURISY Case # 7177246 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,OT Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer BAYER

7136955 Date FDA Received
10-Nov-2009

Case # 7136955

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200933729NA

Age 24 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE BREAST TENDERNESS VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration 2 YEAR

Manufacturer BAYER

7139453 Date FDA Received
10-Nov-2009

Case # 7139453

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200934076NA

Age 27 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF Manufacturer Control #

Duration

Manufacturer BAYER

7177213 Date FDA Received
10-Nov-2009 Preferred Term

Case # 7177213

Case Type DIRECT

Outcomes HO Role Route S

Age 19 YR

Sex Female

Country USA

Dosage Text AS PRESCRIBED DAILY, APPROXIMATELY 4 YEARS

Duration

Manufacturer BAYER

CEREBRAL ARTERY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 465 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177215 Date FDA Received
10-Nov-2009 Preferred Term CRYING ANXIETY HEADACHE PANIC ATTACK Case # 7177215 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text NORMAL DOSE DAILY PO Manufacturer Control # Age 28 YR Duration Sex Female Country USA

Manufacturer

7177228 Date FDA Received
10-Nov-2009 Preferred Term CONFUSIONAL STATE

Case # 7177228

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO,DS,OT Role Route S ORAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text 1 SID PO

Duration

Manufacturer

GALLBLADDER NON-FUNCTIONING LETHARGY

7177236 Date FDA Received
10-Nov-2009 Preferred Term WEIGHT INCREASED

Case # 7177236

Case Type DIRECT Product YAZ

Health Professional N

Outcomes RI Role Route S

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

BLOOD PRESSURE INCREASED GALLBLADDER OPERATION MALAISE

7177276 Date FDA Received
10-Nov-2009 Preferred Term HYPOAESTHESIA GAIT DISTURBANCE MIGRAINE

Case # 7177276

Case Type DIRECT Product YAZ

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text 1 DAILY

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 466 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177313 Date FDA Received
10-Nov-2009 Preferred Term GALLBLADDER DISORDER Case # 7177313 Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ SYNTHROID DAILY MULTIVITAMIN ADVIL Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes HO,LT,RI Role Route S C C C Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200934066NA Dosage Text Age 24 YR Sex Female Country USA Dosage Text Manufacturer Control # Age 28 YR Duration Sex Female Country USA Dosage Text Manufacturer Control # Age 29 YR Duration Sex Female Country USA

Manufacturer

7177334 Date FDA Received
10-Nov-2009 Preferred Term

Case # 7177334

Manufacturer BAYER

DEEP VEIN THROMBOSIS

7133664 Date FDA Received
11-Nov-2009

Case # 7133664

Case Type EXPEDITED (15-DAY)

Preferred Term SUPRAVENTRICULAR TACHYCARDIA

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration 2 YEAR

Manufacturer BAYER Sex Female Country USA

7173551 Date FDA Received
11-Nov-2009

Case # 7173551

Outcomes HO,OT

Manufacturer Control # USBAYER-200938262NA Dosage Text Total daily dose: 1 DF

Age

Preferred Term PULMONARY EMBOLISM RENAL DISORDER

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 467 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7173556 Date FDA Received
11-Nov-2009 Case # 7173556 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE Manufacturer Control # USBAYER-200938684NA Dosage Text Age 18 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ ANTIHISTAMINES

Role Route S C Outcomes HO,LT Role Route S Health Professional N ORAL ORAL

Duration

Manufacturer BAYER

7178730 Date FDA Received
11-Nov-2009 Preferred Term

Case # 7178730

Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ

Health Professional N

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO Manufacturer Control #

Duration

Manufacturer BAYER

PULMONARY EMBOLISM

7178842 Date FDA Received
11-Nov-2009 Preferred Term

Case # 7178842

Outcomes HO,DS,LT,OT,RI Role Route S ORAL

Age 45 YR

Sex Female

Country USA

Dosage Text 1 PILL PER DAY PO

Duration

Manufacturer BAYER

CEREBROVASCULAR ACCIDENT PARALYSIS PRODUCT QUALITY ISSUE THROMBOSIS

7171686 Date FDA Received
12-Nov-2009

Case # 7171686

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200937913NA Dosage Text

Age

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 468 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7174440 Date FDA Received
12-Nov-2009 Case # 7174440 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # CABAYER-200938116NA Dosage Text Age 34 YR Sex Female Country CAN

Preferred Term HYPOAESTHESIA HEADACHE METRORRHAGIA MUSCLE SPASMS VISUAL IMPAIRMENT

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7174521 Date FDA Received
12-Nov-2009

Case # 7174521

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936257NA

Age 20 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7174539 Date FDA Received
12-Nov-2009

Case # 7174539

Manufacturer Control # USBAYER-200936279NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7174544 Date FDA Received
12-Nov-2009

Case # 7174544

Outcomes

Manufacturer Control # USBAYER-200936238NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 469 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7174554 Date FDA Received
12-Nov-2009 Case # 7174554 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936415NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200936422NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VOMITING

Product YAZ Case # 7174556 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7174556 Date FDA Received
12-Nov-2009

Outcomes

Preferred Term METRORRHAGIA MENSTRUATION DELAYED

Product YAZ

Manufacturer BAYER

7179018 Date FDA Received
12-Nov-2009 Preferred Term ANXIETY ANGER

Case # 7179018

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control #

Age 38 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer BAYER

CEREBROVASCULAR ACCIDENT HEADACHE HEART RATE INCREASED HYPERTENSION PARANOIA

7179053 Date FDA Received
12-Nov-2009 Preferred Term

Case # 7179053

Case Type DIRECT Product YAZ YASMIN

Health Professional Y

Outcomes HO,OT Role Route S S ORAL ORAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY ORAL 1 TABLET DAILY ORAL

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT UNEVALUABLE EVENT

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 470 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7179230 Date FDA Received
12-Nov-2009 Preferred Term VISION BLURRED Case # 7179230 Case Type DIRECT Product YAZ Case # 7179718 Case Type DIRECT Product YAZ Health Professional Y Health Professional N Outcomes OT Role Route S ORAL Dosage Text 1 PILL DAILY PO Manufacturer Control # Age 45 YR Dosage Text ONE TAB.,24 LIGHT PINK. 4 DAILY P.O. CONSECUTIVE DAY OF MENSTRUAL Duration Sex Female Manufacturer Control # Age 38 YR Duration Sex Female Country USA

Manufacturer BAYER Country USA

7179718 Date FDA Received
12-Nov-2009 Preferred Term MENORRHAGIA

Outcomes HO,DS,LT,RI Role Route S ORAL

Manufacturer

ASTHENIA BENIGN VASCULAR NEOPLASM BREAST SWELLING DEPRESSION DYSPNOEA ERYTHEMA FEELING ABNORMAL FOOD ALLERGY JOINT SWELLING MALAISE MUSCLE TIGHTNESS OEDEMA PERIPHERAL SWELLING FACE VENA CAVA THROMBOSIS

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 471 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144560 Date FDA Received
13-Nov-2009 Case # 7144560 Case Type NON-EXPEDITED Health Professional N Outcomes HO Manufacturer Control # USBAYER-200934616NA Dosage Text Age 24 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ OMEPRAZOLE ZOLOFT COUMADIN

Role Route S C C C Health Professional Y Outcomes OT ORAL ORAL

Duration

Manufacturer BAYER

7151069 Date FDA Received
13-Nov-2009

Case # 7151069

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200935948NA Dosage Text

Age

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration

Manufacturer BAYER

7176288 Date FDA Received
13-Nov-2009

Case # 7176288

Manufacturer Control # USBAYER-200936481NA

Age 27 YR

Sex Female

Country USA

Preferred Term TOOTH INFECTION

Product YAZ Case # 7176300 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7176300 Date FDA Received
13-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200936435NA

Age

Sex Female

Country USA

Preferred Term MIGRAINE

Product YAZ

Role Route S

Dosage Text

Duration 2 WEEK

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 472 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7176310 Date FDA Received
13-Nov-2009 Case # 7176310 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936473NA Role Route S Dosage Text Age 19 YR Sex Female Country USA

Preferred Term ABDOMINAL PAIN VAGINAL HAEMORRHAGE

Product YAZ

Duration

Manufacturer BAYER

7176318 Date FDA Received
13-Nov-2009

Case # 7176318

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936563NA

Age 52 YR

Sex Female

Country USA

Preferred Term HYPERCALCAEMIA

Product YAZ Case # 7176325 Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7176325 Date FDA Received
13-Nov-2009

Outcomes OT

Manufacturer Control # USBAYER-200938176NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT HEMIPLEGIA WALKING AID USER

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7176332 Date FDA Received
13-Nov-2009

Case # 7176332

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200938591NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ YASMIN DROSPIRENONE

Role Route S S S ORAL ORAL ORAL

Duration

Manufacturer BAYER BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 473 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7176334 Date FDA Received
13-Nov-2009 Case # 7176334 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200936565NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200932514NA Role Route S C ORAL Dosage Text Total daily dose: 1 DF Age 22 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term HYPERCALCAEMIA

Product YAZ Case # 7142008 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7142008 Date FDA Received
16-Nov-2009

Outcomes

Preferred Term HEADACHE VOMITING ABDOMINAL PAIN LOWER AMENORRHOEA DIZZINESS IRRITABILITY

Product YAZ VALIUM

Duration

Manufacturer BAYER

7177882 Date FDA Received
16-Nov-2009

Case # 7177882

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936545NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7177883 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7177883 Date FDA Received
16-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200936534NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 474 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177890 Date FDA Received
16-Nov-2009 Case # 7177890 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936549NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200936585NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200936642NA Role Route S Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Unknown Country USA

Preferred Term INJURY

Product YAZ Case # 7177893 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7177893 Date FDA Received
16-Nov-2009

Preferred Term AMENORRHOEA

Product YAZ Case # 7177913 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7177913 Date FDA Received
16-Nov-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE MENSTRUATION DELAYED

Product YAZ

Manufacturer BAYER

7177918 Date FDA Received
16-Nov-2009

Case # 7177918

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936644NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7177922 Date FDA Received
16-Nov-2009

Case # 7177922

Outcomes

Manufacturer Control # USBAYER-200936645NA

Age

Sex Female

Country USA

Preferred Term DIZZINESS ABDOMINAL PAIN UPPER VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 475 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177927 Date FDA Received
16-Nov-2009 Case # 7177927 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936646NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200936913NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200936918NA Role Route S S INTRAUTERINE Dosage Text CONTINUOUS 1 YEAR Duration Dosage Text Age 46 YR Sex Female Dosage Text Age 20 YR Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7177944 Date FDA Received
16-Nov-2009

Case # 7177944

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7177968 Case Type NON-EXPEDITED

Duration 1.5 YEAR Age Sex

Manufacturer BAYER Country USA

7177968 Date FDA Received
16-Nov-2009

Female

Preferred Term MIGRAINE HEADACHE ALCOHOL INTOLERANCE NAUSEA

Product MIRENA YAZ

Manufacturer BAYER BAYER

7177971 Date FDA Received
16-Nov-2009

Case # 7177971

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936947NA

Age

Sex Female

Country USA

Preferred Term HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text Total daily dose: 1 DF

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 476 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7178739 Date FDA Received
17-Nov-2009 Case # 7178739 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936591NA Role Route S S ORAL Dosage Text Age 18 YR Sex Female Country USA

Preferred Term DIZZINESS VISION BLURRED CONTRAST MEDIA REACTION FEELING ABNORMAL

Product YAZ MAGNEVIST

Duration

Manufacturer BAYER BAYER

7178742 Date FDA Received
17-Nov-2009

Case # 7178742

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936911NA

Age 25 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7180938 Case Type DIRECT Product YAZ Health Professional N

Role Route S Outcomes OT Role Route S

Dosage Text

Duration

Manufacturer BAYER

7180938 Date FDA Received
17-Nov-2009 Preferred Term

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

DEEP VEIN THROMBOSIS PREGNANCY

7182835 Date FDA Received
17-Nov-2009 Preferred Term

Case # 7182835

Case Type DIRECT Product YAZ

Health Professional Y

Outcomes HO,LT,OT,RI Role Route S ORAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM COR PULMONALE FACTOR V DEFICIENCY PLEURISY

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 477 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7183386 Date FDA Received
17-Nov-2009 Preferred Term PULMONARY EMBOLISM Case # 7183386 Case Type DIRECT Product YAZ Case Type EXPEDITED (15-DAY) Product CLARAVIS YAZ CLARAVIS Case # 7183984 Case Type DIRECT Product YAZ Health Professional Health Professional N Health Professional N Outcomes HO,LT Role Route S Outcomes DE,OT Role Route S S C Outcomes LT Role Route S Dosage Text 1 EVERY DAY Manufacturer Control # Age 25 YR Duration Sex Female BARR Country USA ORAL Dosage Text DAILY Manufacturer Control # US-TEVA-214970USA Dosage Text Duration Manufacturer Control # Age 38 YR Duration 4 YEAR Age Sex Female Country USA Sex Female Country USA

Manufacturer

7180332 Date FDA Received
18-Nov-2009 Preferred Term COMPLETED SUICIDE SUICIDAL IDEATION DEPRESSION

Case # 7180332

Manufacturer BARR

7183984 Date FDA Received
18-Nov-2009 Preferred Term HEADACHE PAIN

Manufacturer

7183987 Date FDA Received
18-Nov-2009 Preferred Term

Case # 7183987

Case Type DIRECT Product YAZ Case Type NON-EXPEDITED

Health Professional N

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text DAILY ORAL Manufacturer Control # USBAYER-200936746NA

Duration

Manufacturer BAYER

VENOUS THROMBOSIS LIMB

7181157 Date FDA Received
19-Nov-2009

Case # 7181157

Health Professional N

Outcomes

Age 42 YR

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ TOPICAL ANTI FUNGAL SYNTHROID ALLERGY MEDICINE

Role Route S C C C ORAL

Dosage Text

Duration 1 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 478 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7181158 Date FDA Received
19-Nov-2009 Case # 7181158 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936795NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term WEIGHT INCREASED BREAST ENLARGEMENT

Product YAZ

Manufacturer BAYER

7181159 Date FDA Received
19-Nov-2009

Case # 7181159

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936791NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration 1 MTH

Manufacturer BAYER Sex Female Country USA

7181160 Date FDA Received
19-Nov-2009

Case # 7181160

Outcomes

Manufacturer Control # USBAYER-200936749NA

Age

Preferred Term VOMITING NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text As used: I DF

Duration

Manufacturer BAYER

7181169 Date FDA Received
19-Nov-2009

Case # 7181169

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936951NA

Age 26 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED ABDOMINAL DISTENSION BREAST PAIN

Product YAZ

Role Route S ORAL

Dosage Text

Duration 5 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 479 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7181170 Date FDA Received
19-Nov-2009 Case # 7181170 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937199NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term DRUG DOSE OMISSION VOMITING

Product YAZ

Manufacturer BAYER

7181171 Date FDA Received
19-Nov-2009

Case # 7181171

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936973NA

Age 17 YR

Sex Female

Country USA

Preferred Term WEIGHT INCREASED AMENORRHOEA ANXIETY HEAT EXHAUSTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7181189 Date FDA Received
19-Nov-2009

Case # 7181189

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937209NA

Age 23 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7181191 Date FDA Received
19-Nov-2009

Case # 7181191

Outcomes

Manufacturer Control # USBAYER-200937166NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 480 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7181192 Date FDA Received
19-Nov-2009 Case # 7181192 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200936970NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ANGER DEPRESSION

Product YAZ

Manufacturer BAYER

7180004 Date FDA Received
20-Nov-2009

Case # 7180004

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200938735NA Dosage Text

Age 44 YR

Sex Female

Country USA

Preferred Term GALLBLADDER DISORDER PULMONARY EMBOLISM

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7182568 Date FDA Received
20-Nov-2009

Case # 7182568

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937080NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA DRUG DOSE OMISSION MENOMETRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7182573 Date FDA Received
20-Nov-2009

Case # 7182573

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937175NA

Age 27 YR

Sex Female

Country USA

Preferred Term MOOD ALTERED DIARRHOEA

Product YAZ ZOLOFT

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 481 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7182576 Date FDA Received
20-Nov-2009 Case # 7182576 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937168NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ABDOMINAL PAIN ANXIETY

Product YAZ

Manufacturer BAYER

7182577 Date FDA Received
20-Nov-2009

Case # 7182577

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937178NA

Age 43 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7182597 Date FDA Received
20-Nov-2009

Case # 7182597

Outcomes

Manufacturer Control # USBAYER-200937231NA

Age

Sex Female

Country USA

Preferred Term ADVERSE DRUG REACTION MENSTRUATION DELAYED WEIGHT INCREASED

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7186259 Date FDA Received
20-Nov-2009 Preferred Term METRORRHAGIA

Case # 7186259

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,LT Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text ONE A DAY PO

Duration

Manufacturer BAYER

ABDOMINAL PAIN UPPER BACK PAIN CHOLELITHIASIS INFECTION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 482 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7187246 Date FDA Received
20-Nov-2009 Preferred Term FEELING ABNORMAL ACNE ALOPECIA AMNESIA ANXIETY CHEST PAIN CONFUSIONAL STATE CRYING DEPRESSION DISTURBANCE IN ATTENTION EYE PAIN FACIAL PAIN HEADACHE HYPOAESTHESIA INSOMNIA LOSS OF LIBIDO MUSCULOSKELETAL CHEST PAIN OROPHARYNGEAL PAIN PANIC ATTACK Case # 7187246 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S Dosage Text 1 A DAY ABOUT 6 MONTHS Duration Manufacturer Control # Age Sex Female Country USA

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 483 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7053480 Date FDA Received
23-Nov-2009 Case # 7053480 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200918924NA Role Route S ORAL Dosage Text Age 43 YR Sex Female Country USA

Preferred Term GASTROINTESTINAL DISORDER BACK PAIN DIARRHOEA EPIGASTRIC DISCOMFORT FATIGUE FEELING ABNORMAL NAUSEA

Product YAZ

Duration

Manufacturer BAYER

7083125 Date FDA Received
23-Nov-2009

Case # 7083125

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200921690NA

Age 20 YR

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7098231 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7098231 Date FDA Received
23-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200924260NA

Age 25 YR

Sex Female

Country USA

Preferred Term ABDOMINAL PAIN LOWER METRORRHAGIA NAUSEA NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 484 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7182869 Date FDA Received
23-Nov-2009 Case # 7182869 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200939047NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PULMONARY EMBOLISM GALLBLADDER DISORDER

Product YASMIN YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S S Outcomes

Manufacturer BAYER BAYER

7184317 Date FDA Received
23-Nov-2009

Case # 7184317

Manufacturer Control # USBAYER-200937277NA

Age 17 YR

Sex Female

Country USA

Preferred Term VOMITING NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7184334 Date FDA Received
23-Nov-2009

Case # 7184334

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937293NA

Age 45 YR

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7184338 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7184338 Date FDA Received
23-Nov-2009

Manufacturer Control # USBAYER-200937305NA

Age

Sex Female

Country USA

Preferred Term PRURITUS GENERALISED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration 2 DAY

Manufacturer BAYER Sex Female Country USA

7184342 Date FDA Received
23-Nov-2009

Case # 7184342

Outcomes

Manufacturer Control # USBAYER-200937308NA

Age

Preferred Term NAUSEA APPETITE DISORDER

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 485 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7184349 Date FDA Received
23-Nov-2009 Case # 7184349 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937358NA Role Route S Health Professional N INTRAUTERINE Manufacturer Control # USBAYER-200937355NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200937352NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200937351NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 20 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Age 23 YR Sex Female Country USA

Preferred Term SINUSITIS

Product YAZ Case # 7184355 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7184355 Date FDA Received
23-Nov-2009

Outcomes

Preferred Term SINUSITIS

Product YAZ Case # 7184367 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7184367 Date FDA Received
23-Nov-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7184368 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7184368 Date FDA Received
23-Nov-2009

Outcomes

Preferred Term SINUSITIS INFLUENZA

Product YAZ

Manufacturer BAYER

7184372 Date FDA Received
23-Nov-2009

Case # 7184372

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937346NA

Age

Sex Female

Country USA

Preferred Term WISDOM TEETH REMOVAL

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 486 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7184384 Date FDA Received
23-Nov-2009 Case # 7184384 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937471NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200937566NA Role Route S Health Professional N Product YAZ Outcomes LT Role Route S Dosage Text ONE/DAY APRIL - MAY Manufacturer Control # Age 40 YR Duration Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7184399 Date FDA Received
23-Nov-2009

Case # 7184399

Outcomes

Preferred Term BREAST ENLARGEMENT

Product YAZ Case Type DIRECT

Manufacturer BAYER Country USA

7192065 Date FDA Received
23-Nov-2009 Preferred Term HALLUCINATION AGGRESSION DEPRESSED MOOD HEADACHE

Case # 7192065

Manufacturer BAYER

HEART RATE INCREASED LOSS OF LIBIDO MYOCARDIAL INFARCTION

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 487 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7107189 Date FDA Received
24-Nov-2009 Case # 7107189 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200931266NA Dosage Text Age 28 YR Sex Female Country USA

Preferred Term SYNCOPE ANXIETY ASTHENIA CHEST PAIN DIZZINESS FATIGUE PANIC ATTACK WITHDRAWAL BLEED

Product YAZ

Role Route S

Duration 1 MTH

Manufacturer BAYER

7165339 Date FDA Received
24-Nov-2009

Case # 7165339

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # CABAYER-200937286NA Dosage Text

Age

Sex Female

Country CAN

Preferred Term DYSPNOEA ABDOMINAL DISTENSION ABDOMINAL PAIN LOWER ANXIETY BACK PAIN CHEST PAIN DIZZINESS HEADACHE INJURY MOOD SWINGS NAUSEA PAIN PAIN IN EXTREMITY VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Duration 2 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 488 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7182852 Date FDA Received
24-Nov-2009 Case # 7182852 Case Type NON-EXPEDITED Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200939027NA Dosage Text Duration Age Sex Female Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S Outcomes OT

Manufacturer BAYER

7186431 Date FDA Received
24-Nov-2009

Case # 7186431

Manufacturer Control # US-PFIZER INC-2009298590 Dosage Text 10 mg, 6 doses/day UNK Manufacturer Control # USBAYER-200937819NA

Age 18 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product PROVERA YAZ

Role Route S S Health Professional N Outcomes

Duration

Manufacturer PFIZER

7186771 Date FDA Received
24-Nov-2009

Case # 7186771

Case Type NON-EXPEDITED

Age 23 YR

Sex Female

Country USA

Preferred Term CHEST PAIN

Product YAZ Case # 7187355 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes HO

Dosage Text

Duration

Manufacturer BAYER

7187355 Date FDA Received
24-Nov-2009

Manufacturer Control # USBAYER-200940742NA Dosage Text

Age 15 YR

Sex Female

Country USA

Preferred Term IMPAIRED GASTRIC EMPTYING

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7187357 Date FDA Received
24-Nov-2009

Case # 7187357

Outcomes OT

Manufacturer Control # USBAYER-200940344NA Dosage Text

Age

Sex Female

Country USA

Preferred Term ALOPECIA MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 489 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7195019 Date FDA Received
24-Nov-2009 Preferred Term VENTRICULAR EXTRASYSTOLES CARDIAC MURMUR PANIC ATTACK Case # 7195019 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,OT Role Route S ORAL Dosage Text ONCE A DAY DAILY PO Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer BAYER

7152173 Date FDA Received
25-Nov-2009

Case # 7152173

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200935958NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PREGNANCY ABORTION SPONTANEOUS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7184575 Date FDA Received
25-Nov-2009

Case # 7184575

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200939251NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS CONVULSION HEAD INJURY HYPERTENSION STATUS EPILEPTICUS SYNCOPE

Product YAZ

Role Route S ORAL

Duration 1.08 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 490 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7196939 Date FDA Received
25-Nov-2009 Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS Case # 7196939 Case Type DIRECT Product YAZ BUPROPION HYDROCHLORIDE EFFEXOR XR LORTAB MOTRIN LEVOTHYROXINE SODIUM PRAVASTATIN FISH OIL RANITIDINE Health Professional Y Outcomes HO Role Route S C C C C C C C C Health Professional N Product YAZ Outcomes RI Role Route S ORAL Dosage Text 1 PACK OF BIRTH CONTROL ONCE A DAY PO Manufacturer Control # Age 18 YR Duration 1 WEEK Sex Female Country USA ORAL Dosage Text 1 TABLET DAILY PO Manufacturer Control # Age 35 YR Duration 6 MTH Sex Female Country USA

Manufacturer

7197666 Date FDA Received
25-Nov-2009 Preferred Term PALPITATIONS

Case # 7197666

Case Type DIRECT

Manufacturer

CARDIAC DISORDER CHEST PAIN SLEEP DISORDER

6896644 Date FDA Received
27-Nov-2009

Case # 6896644

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200911300NA Dosage Text

Age 35 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE DIABETES COMPLICATING PREGNANCY

Product YAZ ZOLOFT

Role Route S C ORAL ORAL

Duration 168 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 491 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6945386 Date FDA Received
27-Nov-2009 Case # 6945386 Case Type NON-EXPEDITED Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200915294NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product YAZ

Role Route S ORAL

Manufacturer BAYER

7062392 Date FDA Received
27-Nov-2009

Case # 7062392

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200927232NA Dosage Text

Age 19 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration 1.1 YEAR

Manufacturer BAYER Country USA

7062447 Date FDA Received
27-Nov-2009

Case # 7062447

Outcomes

Manufacturer Control # USBAYER-200924757NA

Age 36 YR

Sex Female

Preferred Term FATIGUE ASTHENIA CHILLS DYSGEUSIA EYE PAIN FEELING ABNORMAL HEADACHE HYPERHIDROSIS MYALGIA VISION BLURRED

Product YAZ

Role Route S ORAL

Dosage Text

Duration 116 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 492 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7111119 Date FDA Received
27-Nov-2009 Case # 7111119 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200932288NA Dosage Text Age 43 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM CHEST PAIN BACK PAIN DYSPNOEA PREGNANCY ON ORAL CONTRACEPTIVE MUSCLE SPASMS CONVULSION Haemorrhage in pregnancy URINARY TRACT INFECTION

Product YAZ FLEXERIL REBIF REBIF FISH OIL NORCO

Role Route S C C C C C ORAL ORAL SUBCUTANEOUS SUBCUTANEOUS

Duration

Manufacturer BAYER

1 TO 2 EVERY 4 HOURS

7111129 Date FDA Received
27-Nov-2009

Case # 7111129

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes DE,CA

Manufacturer Control # USBAYER-200932318NA Dosage Text MOTHER RECEIVED 44 MCG SQ INJECTION 3 TIMES/WEEK 20 MG ONCE DAILY TO MOTHER 1 TO 2 EVERY 4 HOURS AS REQUIRED FOR PAIN

Age 43 YR

Sex Unknown

Country USA

Preferred Term SPINA BIFIDA MENINGOMYELOCELE

Product YAZ REBIF

Role Route S S TRANSPLACENTAL TRANSPLACENTAL

Duration 6 MTH

Manufacturer BAYER

TALIPES HYDROCEPHALUS

FLEXERIL LOVENOX NORCO

S S C

TRANSPLACENTAL

CYMBALTA NAPROSYN FISH OIL SULFAMETHOXAZOLE AND TRIMETHOPRIM

C C C C

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 493 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7136069 Date FDA Received
27-Nov-2009 Case # 7136069 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200934298NA Dosage Text Age 23 YR Sex Female Country USA

Preferred Term THROMBOPHLEBITIS SUPERFICIAL

Product YAZ ZYRTEC SINGULAIR PROVENTIL PRENATABS FA

Role Route S C C C C ORAL ORAL INHALATION ORAL

Duration

Manufacturer BAYER

7136882 Date FDA Received
27-Nov-2009

Case # 7136882

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200934671NA Dosage Text

Age 29 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ LEVLEN OVCON 35

Role Route S C C Health Professional N Outcomes OT ORAL

Duration

Manufacturer BAYER

7154181 Date FDA Received
27-Nov-2009

Case # 7154181

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200936633NA Dosage Text

Age 49 YR

Sex Female

Country USA

Preferred Term CEREBRAL ARTERY THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Duration

Manufacturer BAYER

7156339 Date FDA Received
27-Nov-2009

Case # 7156339

Manufacturer Control # USBAYER-200936213NA

Age 30 YR

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Role Route S

Dosage Text STANDARD DOSE

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 494 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7168732 Date FDA Received
27-Nov-2009 Case # 7168732 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes Manufacturer Control # CABAYER-200936980NA Role Route S Health Professional Y ORAL Manufacturer Control # DEBAYER-200937865GPV Dosage Text Age 17 YR Sex Female Dosage Text Age 42 YR Sex Female Country CAN

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Duration

Manufacturer BAYER Country DEU

7170400 Date FDA Received
27-Nov-2009

Case # 7170400

Case Type EXPEDITED (15-DAY)

Outcomes HO

Preferred Term PANCREATITIS ACUTE VIRAL INFECTION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7177661 Date FDA Received
27-Nov-2009

Case # 7177661

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200938508NA Dosage Text 10MG FOR 6 DOSES/ DAYS Manufacturer Control # USBAYER-200939555NA Dosage Text

Age 18 YR

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ PROVERA

Role Route S S Health Professional N Outcomes DE

Duration

Manufacturer BAYER

7180012 Date FDA Received
27-Nov-2009

Case # 7180012

Case Type EXPEDITED (15-DAY)

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 495 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7180021 Date FDA Received
27-Nov-2009 Case # 7180021 Case Type NON-EXPEDITED Health Professional Y Outcomes HO Manufacturer Control # USBAYER-200938803NA Dosage Text Total daily dose: 1 DF Age 18 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM COAGULOPATHY

Product YAZ

Role Route S ORAL

Duration 6 MTH

Manufacturer BAYER

7184576 Date FDA Received
27-Nov-2009

Case # 7184576

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200939114NA Dosage Text

Age

Sex Female

Country USA

Preferred Term EMBOLISM VENOUS

Product YAZ Case # 7184579 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7184579 Date FDA Received
27-Nov-2009

Outcomes OT

Manufacturer Control # USBAYER-200939112NA Dosage Text

Age

Sex Female

Country USA

Preferred Term EMBOLISM VENOUS

Product YAZ Case # 7184581 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7184581 Date FDA Received
27-Nov-2009

Manufacturer Control # USBAYER-200939227NA Dosage Text

Age

Sex Female

Country USA

Preferred Term SEPSIS ABDOMINAL DISTENSION ABDOMINAL PAIN HEADACHE HYPOAESTHESIA WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Duration 2.5 YEAR

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 496 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7184583 Date FDA Received
27-Nov-2009 Case # 7184583 Case Type NON-EXPEDITED Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200939262NA Dosage Text Duration Age Sex Female Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER

7184587 Date FDA Received
27-Nov-2009

Case # 7184587

Outcomes OT

Manufacturer Control # USBAYER-200939116NA Dosage Text

Age

Sex Female

Country USA

Preferred Term EMBOLISM VENOUS

Product YAZ Case # 7186972 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7186972 Date FDA Received
27-Nov-2009

Outcomes OT

Manufacturer Control # USBAYER-200939331NA Dosage Text

Age 19 YR

Sex Female

Country USA

Preferred Term THYROID MASS THYROID FUNCTION TEST ABNORMAL

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7189093 Date FDA Received
27-Nov-2009

Case # 7189093

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200939583NA Dosage Text

Age 22 YR

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ YASMIN

Role Route S S Health Professional N Outcomes OT

Duration 4 YEAR

Manufacturer BAYER BAYER Sex Female Country USA

7190891 Date FDA Received
27-Nov-2009

Case # 7190891

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200939640NA Dosage Text

Age 17 YR

Preferred Term PAIN IN EXTREMITY CHEST PAIN

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 497 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7190892 Date FDA Received
27-Nov-2009 Case # 7190892 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200939712NA Dosage Text Age 34 YR Sex Female Country USA

Preferred Term CHOLECYSTECTOMY HOT FLUSH

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7190912 Date FDA Received
27-Nov-2009

Case # 7190912

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200940131NA Dosage Text

Age

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7190917 Date FDA Received
27-Nov-2009

Case # 7190917

Manufacturer Control # USBAYER-200939915NA Dosage Text

Age 27 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration 3 YEAR

Manufacturer BAYER Sex Female Country USA

7190918 Date FDA Received
27-Nov-2009

Case # 7190918

Manufacturer Control # USBAYER-200940137NA Dosage Text

Age

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7190947 Date FDA Received
27-Nov-2009

Case # 7190947

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937533NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 498 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7190957 Date FDA Received
27-Nov-2009 Case # 7190957 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937652NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term WEIGHT INCREASED HEADACHE

Product YAZ

Manufacturer BAYER

7190958 Date FDA Received
27-Nov-2009

Case # 7190958

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937400NA

Age

Sex Female

Country USA

Preferred Term VISION BLURRED METAMORPHOPSIA SENSATION OF HEAVINESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7190959 Date FDA Received
27-Nov-2009

Case # 7190959

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937653NA

Age

Sex Female

Country USA

Preferred Term MALAISE

Product YAZ Case # 7190974 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7190974 Date FDA Received
27-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200937556NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text

Duration 2 DAY

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 499 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7190976 Date FDA Received
27-Nov-2009 Case # 7190976 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937587NA Role Route S C INTRAUTERINE Manufacturer Control # USBAYER-200937613NA Role Route S Health Professional N ORAL Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200937703NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200937689NA Role Route S C C ORAL Dosage Text Age 18 YR Sex Female Dosage Text Duration 3 MTH Age 39 YR Sex Female Age Sex Female Country USA Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE FEELING ABNORMAL

Product YAZ PARAGARD T380A Case # 7190982 Case Type NON-EXPEDITED Health Professional Y

Manufacturer BAYER

7190982 Date FDA Received
27-Nov-2009

Outcomes

Preferred Term MIGRAINE WITH AURA

Product YAZ Case # 7190990 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7190990 Date FDA Received
27-Nov-2009

Outcomes

Preferred Term ALOPECIA

Product YAZ Case # 7190992 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7190992 Date FDA Received
27-Nov-2009

Outcomes

Preferred Term VAGINAL HAEMORRHAGE MENSTRUAL DISORDER CRYING ABDOMINAL DISTENSION IRRITABILITY WEIGHT INCREASED

Product YAZ LEVONORGESTREL LEVONORGESTREL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 500 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7190996 Date FDA Received
27-Nov-2009 Case # 7190996 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937654NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term PHARYNGITIS AMENORRHOEA

Product YAZ

Manufacturer BAYER

7191000 Date FDA Received
27-Nov-2009

Case # 7191000

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937720NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7191005 Date FDA Received
27-Nov-2009

Case # 7191005

Outcomes

Manufacturer Control # USBAYER-200937828NA

Age

Sex Female

Country USA

Preferred Term BRONCHITIS VAGINAL HAEMORRHAGE

Product YAZ ANTIBIOTICS Case Type NON-EXPEDITED Health Professional N

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7191006 Date FDA Received
27-Nov-2009

Case # 7191006

Manufacturer Control # USBAYER-200937999NA

Age

Sex Female

Country USA

Preferred Term MOOD SWINGS

Product YAZ Case # 7191010 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7191010 Date FDA Received
27-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200937718NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 501 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7191017 Date FDA Received
27-Nov-2009 Case # 7191017 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200938001NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term MOOD SWINGS EMOTIONAL DISORDER

Product YAZ

Manufacturer BAYER

7191020 Date FDA Received
27-Nov-2009

Case # 7191020

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200938000NA

Age

Sex Female

Country USA

Preferred Term HYPERSENSITIVITY RASH PAPULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7170384 Date FDA Received
30-Nov-2009

Case # 7170384

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USBAYER-200937926NA Dosage Text

Age 39 YR

Sex Female

Country USA

Preferred Term PAIN IN EXTREMITY ABASIA MUSCLE SPASMS MUSCULAR WEAKNESS

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7177664 Date FDA Received
30-Nov-2009

Case # 7177664

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200938510NA Dosage Text

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 502 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7182868 Date FDA Received
30-Nov-2009 Case # 7182868 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200939028NA Dosage Text Duration Age Sex Female Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Manufacturer BAYER

7189104 Date FDA Received
30-Nov-2009

Case # 7189104

Outcomes HO

Manufacturer Control # CHBAYER-200935356GPV Dosage Text Total daily dose: 1 DF

Age 24 YR

Sex Female

Country CHE

Preferred Term PSYCHOMOTOR HYPERACTIVITY ASTHENIA CHILLS CRYING DECREASED APPETITE DEPERSONALISATION DYSPHAGIA DYSPNOEA DYSURIA FEELING ABNORMAL HYPERHIDROSIS NERVOUSNESS PALPITATIONS SLEEP DISORDER TACHYCARDIA TREMOR VERTIGO

Product YAZ

Role Route S ORAL

Duration 19 DAY

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 503 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7193806 Date FDA Received
30-Nov-2009 Case # 7193806 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200937987NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ALOPECIA METRORRHAGIA

Product YAZ

Manufacturer BAYER

7193809 Date FDA Received
30-Nov-2009

Case # 7193809

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200937993NA

Age 23 YR

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA

Product YAZ Case # 7193821 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7193821 Date FDA Received
30-Nov-2009

Outcomes

Manufacturer Control # USBAYER-200938020NA

Age 21 YR

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ Case # 7193844 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration 1 YEAR

Manufacturer BAYER Sex Female Country USA

7193844 Date FDA Received
30-Nov-2009

Manufacturer Control # USBAYER-200938046NA

Age

Preferred Term HYPOMENORRHOEA

Product YAZ Case # 7193916 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7193916 Date FDA Received
30-Nov-2009

Outcomes HO

Manufacturer Control # USBAYER-200940868NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 504 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7193940 Date FDA Received
30-Nov-2009 Case # 7193940 Case Type NON-EXPEDITED Health Professional Y Outcomes HO Manufacturer Control # USBAYER-200940403NA Dosage Text Duration Age Sex Female Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 7193942 Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes HO

Manufacturer BAYER

7193942 Date FDA Received
30-Nov-2009

Manufacturer Control # USBAYER-200940825NA Dosage Text

Age 40 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type EXPEDITED (15-DAY) Product REBIF Health Professional Y

Role Route S ORAL

Duration 1 YEAR

Manufacturer BAYER Sex Female Country USA

7083995 Date FDA Received
01-Dec-2009 Preferred Term

Case # 7083995

Outcomes HO Role Route S SUBCUTANEOUS

Manufacturer Control # 232478K08USA Dosage Text 44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS : 22 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS ORAL 10 MG, AS REQUIRED, ORAL

Age 42 YR Duration

Manufacturer

RETAINED PLACENTA OR MEMBRANES

HAEMORRHAGE IN PREGNANCY CONVULSION MUSCLE SPASMS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY CHEST PAIN BACK PAIN DYSPNOEA INDUCED LABOUR PULMONARY EMBOLISM

YAZ FLEXERIL FISH OIL NORCO CYMBALTA NAPROSYN BACTRIM LOVENOX

S S C C C C C C

ORAL ORAL

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 505 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7085463 Date FDA Received
01-Dec-2009 Preferred Term NEURAL TUBE DEFECT Case # 7085463 Case Type EXPEDITED (15-DAY) Product REBIF Health Professional Y Outcomes CA Role Route S TRANSPLACENTAL Manufacturer Control # 238358K09USA Dosage Text 44 MCG, 3 IN 1 WEEKS, TRANSPLACENTAL TRANSPLACENTAL 10 MG, TRANSPLACENTAL Age Sex Country USA 140 DAY Unknown Duration

Manufacturer

MENINGOMYELOCELE CONGENITAL HYDROCEPHALUS TALIPES ABORTION INDUCED MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY ON ORAL CONTRACEPTIVE SPINA BIFIDA

YAZ FLEXERIL NORCO

S S S

TRANSPLACENTAL TRANSPLACENTAL

7180005 Date FDA Received
01-Dec-2009

Case # 7180005

Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO,OT

Manufacturer Control # USBAYER-200938801NA Dosage Text

Age 32 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7194985 Date FDA Received
01-Dec-2009

Case # 7194985

Outcomes HO

Manufacturer Control # USBAYER-200941289NA Dosage Text

Age 27 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 506 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7199091 Date FDA Received
01-Dec-2009 Preferred Term CARDIAC DISORDER HEART RATE INCREASED CHOLECYSTECTOMY CHOLELITHIASIS DEHYDRATION DIARRHOEA DYSPNOEA GASTRIC DISORDER HYPOAESTHESIA MIGRAINE NERVOUS SYSTEM DISORDER PERIPHERAL COLDNESS PRESYNCOPE SKIN DISCOLOURATION Case # 7199091 Case Type DIRECT Product YASMIN YAZ Health Professional N Outcomes OT Role Route S S ORAL ORAL Dosage Text ONE PILL DAILY PO ONE PILL DAILY PO Manufacturer Control # Age 23 YR Duration Sex Female Country USA

Manufacturer BAYER BAYER

7199446 Date FDA Received
01-Dec-2009 Preferred Term CHOLECYSTECTOMY

Case # 7199446

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text 1 PILL ONCE DAILY PO Manufacturer Control #

Duration 1 YEAR Age 29 YR Sex

Manufacturer

7199592 Date FDA Received
01-Dec-2009 Preferred Term

Case # 7199592

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO Role Route S ORAL

Country USA

Female

Dosage Text 1 PILL DAILY PO

Duration

Manufacturer BAYER

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 507 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7199729 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7199729 Case Type DIRECT Product YAZ Case Type DIRECT Product YAZ Case # 7103124 Case Type NON-EXPEDITED Health Professional Y Health Professional N Health Professional N Outcomes HO,LT,RI Role Route S ORAL Dosage Text 1 TABLET DAILY ORAL Manufacturer Control # Age 23 YR Dosage Text 1 PILL DAILY PO Manufacturer Control # USBAYER-200930905NA Role Route S S S C ORAL INTRAUTERINE Dosage Text CONTINUOUS Age 22 YR Sex Female Country USA Duration Sex Female Country USA Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer

7199753 Date FDA Received
01-Dec-2009 Preferred Term CHOLELITHIASIS

Case # 7199753

Outcomes OT Role Route S ORAL

Manufacturer

7103124 Date FDA Received
02-Dec-2009

Outcomes

Preferred Term Medical device complication PELVIC PAIN PAIN IN EXTREMITY ANXIETY ABDOMINAL PAIN AMENORRHOEA DEPRESSION MOOD SWINGS NAUSEA OVARIAN CYST PROCEDURAL PAIN VAGINAL HAEMORRHAGE

Product MIRENA YAZ YASMIN LOESTRIN 1.5/30 21 DAY

Duration

Manufacturer BAYER BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 508 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7136881 Date FDA Received
02-Dec-2009 Case # 7136881 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200934300NA Dosage Text Age 19 YR Sex Female Country USA

Preferred Term THROMBOPHLEBITIS SUPERFICIAL

Product YAZ M.V.I. ADULT LOVAZA

Role Route S C C Health Professional N Outcomes OT

Duration

Manufacturer BAYER

7195354 Date FDA Received
02-Dec-2009

Case # 7195354

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200941194NA Dosage Text

Age 30 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7196740 Date FDA Received
02-Dec-2009

Case # 7196740

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200941148NA Dosage Text

Age

Sex Female

Country USA

Preferred Term GALLBLADDER INJURY

Product YASMIN YAZ

Role Route S S Health Professional N Outcomes

Duration

Manufacturer BAYER BAYER

7176304 Date FDA Received
03-Dec-2009

Case # 7176304

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200936437NA

Age 28 YR

Sex Female

Country USA

Preferred Term PAIN IN EXTREMITY

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 509 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177653 Date FDA Received
03-Dec-2009 Case # 7177653 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DS Manufacturer Control # ZABAYER-200938553GPV Dosage Text Age 40 YR Sex Female Country ZAF

Preferred Term VISION BLURRED HEADACHE ACNE INSOMNIA

Product YAZ YAZ

Role Route S S ORAL ORAL

Duration 19 DAY

Manufacturer BAYER BAYER

7177667 Date FDA Received
03-Dec-2009

Case # 7177667

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # ZABAYER-200938634GPV Dosage Text

Age 29 YR

Sex Female

Country ZAF

Preferred Term HEADACHE ABDOMINAL DISTENSION EYE IRRITATION INSOMNIA VISION BLURRED

Product YAZ YAZ

Role Route S S ORAL ORAL

Duration 29 DAY

Manufacturer BAYER BAYER

7197999 Date FDA Received
03-Dec-2009

Case # 7197999

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200941463NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY PAIN

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7198008 Date FDA Received
03-Dec-2009

Case # 7198008

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # USBAYER-200941413NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY LIVER DISORDER

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 510 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7198009 Date FDA Received
03-Dec-2009 Case # 7198009 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200941428NA Dosage Text Duration Age Sex Female Country USA

Preferred Term ALOPECIA

Product YAZ Case # 7198047 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER

7198047 Date FDA Received
03-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200938196NA

Age

Sex Female

Country USA

Preferred Term ADVERSE EVENT

Product YAZ Case # 7198050 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7198050 Date FDA Received
03-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200938179NA

Age 19 YR

Sex Female

Country USA

Preferred Term METRORRHAGIA ADVERSE EVENT AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7198051 Date FDA Received
03-Dec-2009

Case # 7198051

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200938216NA

Age 23 YR

Sex Female

Country USA

Preferred Term THYROID FUNCTION TEST ABNORMAL BLOOD TESTOSTERONE INCREASED ALOPECIA MIGRAINE WEIGHT DECREASED

Product YAZ YAZ

Role Route S S ORAL ORAL

Dosage Text Total daily dose: 1 DF Total daily dose: 1 DF

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 511 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7198059 Date FDA Received
03-Dec-2009 Case # 7198059 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200938221NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200938193NA Role Route S Health Professional N ORAL Manufacturer Control # PRBAYER-200938231NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Age 21 YR Sex Female Dosage Text Age 14 YR Sex Female Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7198062 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country USA

7198062 Date FDA Received
03-Dec-2009

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED

Duration

Manufacturer BAYER Country PRI

7198063 Date FDA Received
03-Dec-2009

Case # 7198063

Outcomes

Preferred Term ABDOMINAL PAIN UPPER DYSPEPSIA PREMENSTRUAL SYNDROME

Product YAZ

Manufacturer BAYER

7198075 Date FDA Received
03-Dec-2009

Case # 7198075

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200938272NA

Age

Sex Female

Country USA

Preferred Term VOMITING ADVERSE EVENT MIGRAINE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 512 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7198082 Date FDA Received
03-Dec-2009 Case # 7198082 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200938224NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200938326NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941591NA Dosage Text Age 44 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7198084 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7198084 Date FDA Received
03-Dec-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7200038 Case Type EXPEDITED (15-DAY)

Manufacturer BAYER Country USA

7200038 Date FDA Received
04-Dec-2009

Outcomes HO,OT

Preferred Term OVARIAN CYSTECTOMY THROMBOSIS

Product YAZ METROGEL ORENCIA CALCIUM ADVIL

Role Route S C C C C Health Professional N Outcomes

Duration

Manufacturer BAYER

7200136 Date FDA Received
04-Dec-2009

Case # 7200136

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200938445NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 513 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7200143 Date FDA Received
04-Dec-2009 Case # 7200143 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200938334NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term VAGINAL HAEMORRHAGE ABDOMINAL PAIN ADVERSE EVENT

Product YAZ

Manufacturer BAYER

6671999 Date FDA Received
07-Dec-2009

Case # 6671999

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200822552NA

Age 50 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE NO ADVERSE EVENT

Product YAZ YAZ Case # 7159048 Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL ORAL

Dosage Text ONE TABLET PER DAY

Duration

Manufacturer BAYER BAYER

7159048 Date FDA Received
07-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200933060NA

Age

Sex Female

Country USA

Preferred Term MALAISE ACNE PREMENSTRUAL SYNDROME WEIGHT FLUCTUATION

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7201981 Date FDA Received
07-Dec-2009

Case # 7201981

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200941588NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ YASMIN

Role Route S S

Duration

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 514 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7202146 Date FDA Received
07-Dec-2009 Case # 7202146 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200938569NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term AMENORRHOEA ABDOMINAL PAIN

Product YAZ

Manufacturer BAYER

7202158 Date FDA Received
07-Dec-2009

Case # 7202158

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200938641NA

Age 34 YR

Sex Female

Country USA

Preferred Term ADVERSE EVENT VAGINAL HAEMORRHAGE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7202175 Date FDA Received
07-Dec-2009

Case # 7202175

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200938562NA

Age

Sex Female

Country USA

Preferred Term ADVERSE EVENT AMENORRHOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7202207 Date FDA Received
07-Dec-2009

Case # 7202207

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939054NA

Age

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ Case # 7202253 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7202253 Date FDA Received
07-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200939286NA

Age 43 YR

Sex Female

Country USA

Preferred Term NAUSEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 515 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114878 Date FDA Received
08-Dec-2009 Case # 7114878 Case Type NON-EXPEDITED Health Professional Y Outcomes HO,OT Manufacturer Control # USBAYER-200932601NA Dosage Text Age 32 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PAIN IN EXTREMITY

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7114880 Date FDA Received
08-Dec-2009

Case # 7114880

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200932598NA Dosage Text

Age 16 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7114883 Date FDA Received
08-Dec-2009

Case # 7114883

Outcomes OT

Manufacturer Control # USBAYER-200932600NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional Y

Role Route S ORAL

Duration

Manufacturer BAYER

7144544 Date FDA Received
08-Dec-2009

Case # 7144544

Outcomes HO

Manufacturer Control # USBAYER-200934745NA Dosage Text

Age 24 YR

Sex Female

Country USA

Preferred Term PULMONARY THROMBOSIS BACK PAIN CHEST PAIN

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 516 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144558 Date FDA Received
08-Dec-2009 Case # 7144558 Case Type NON-EXPEDITED Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200934748NA Dosage Text Duration Age Sex Female Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Manufacturer BAYER

7146633 Date FDA Received
08-Dec-2009

Case # 7146633

Manufacturer Control # USBAYER-200935176NA Dosage Text

Age 30 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DYSPNOEA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7194986 Date FDA Received
08-Dec-2009

Case # 7194986

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200940391NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7203888 Date FDA Received
08-Dec-2009

Case # 7203888

Outcomes

Manufacturer Control # USBAYER-200939092NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7204360 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Dosage Text

Duration

Manufacturer BAYER

7204360 Date FDA Received
08-Dec-2009

Manufacturer Control # ATBAYER-200936747GPV Dosage Text

Age 39 YR

Sex Female

Country AUT

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE ABORTION MISSED

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 517 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7212918 Date FDA Received
08-Dec-2009 Preferred Term MOOD SWINGS AFFECT LABILITY CRYING Case # 7212918 Case Type DIRECT Product YAZ Health Professional N Outcomes OT Role Route S ORAL Dosage Text 1 PILL DAILY PO 3-4 MONTHS Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer BAYER

7206374 Date FDA Received
09-Dec-2009

Case # 7206374

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200941782NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLELITHIASIS

Product YAZ Case # 7206377 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7206377 Date FDA Received
09-Dec-2009

Outcomes OT

Manufacturer Control # USBAYER-200941775NA Dosage Text

Age

Sex Female

Country USA

Preferred Term SYNCOPE ARRHYTHMIA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7206382 Date FDA Received
09-Dec-2009

Case # 7206382

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200942049NA Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Total daily dose: 1 DF Unit dose: 1 DF

Age 26 YR

Sex Female

Country USA

Preferred Term SUICIDAL IDEATION NERVOUSNESS MENSTRUATION IRREGULAR TENSION

Product YAZ YAZ

Role Route S S

Duration 1 MTH 1 MTH

Manufacturer BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 518 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7206383 Date FDA Received
09-Dec-2009 Case # 7206383 Case Type NON-EXPEDITED Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200942051NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PANCREATITIS

Product YAZ Case # 7206385 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Manufacturer BAYER

7206385 Date FDA Received
09-Dec-2009

Outcomes DE

Manufacturer Control # USBAYER-200941874NA Dosage Text

Age

Sex Female

Country USA

Preferred Term COMPLETED SUICIDE DEPRESSION SUICIDAL

Product YAZ CLARAVIS Case Type NON-EXPEDITED Health Professional N

Role Route S S ORAL ORAL

Duration

Manufacturer BAYER

7206396 Date FDA Received
09-Dec-2009

Case # 7206396

Outcomes

Manufacturer Control # USBAYER-200941434NA

Age 30 YR

Sex Female

Country USA

Preferred Term ALOPECIA

Product YAZ MIRENA

Role Route S S Health Professional N ORAL INTRAUTERINE

Dosage Text CO NTINUOUS Manufacturer Control # USBAYER-200941814NA

Duration

Manufacturer BAYER BAYER

7206397 Date FDA Received
09-Dec-2009

Case # 7206397

Case Type NON-EXPEDITED

Outcomes

Age

Sex Female

Country USA

Preferred Term UNEVALUABLE EVENT

Product YAZ Case # 7211989 Case Type DIRECT Product YAZ Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7211989 Date FDA Received
09-Dec-2009 Preferred Term CHOLECYSTECTOMY

Outcomes HO,OT Role Route S ORAL

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Dosage Text 1 TAB EVERY DAY PO

Duration

Manufacturer BAYER

GALLBLADDER DISORDER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 519 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7213672 Date FDA Received
09-Dec-2009 Preferred Term COMPLEX PARTIAL SEIZURES Case # 7213672 Case Type DIRECT Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N Health Professional N Outcomes LT,OT Role Route S Outcomes OT Manufacturer Control # TRBAYER-200938132GPV Dosage Text Age 34 YR Sex Female Dosage Text Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer BAYER Country TUR

7603032 Date FDA Received
09-Dec-2009

Case # 7603032

Preferred Term BREAST PAIN ABDOMINAL DISTENSION ABDOMINAL PAIN BREAST SWELLING HORMONE LEVEL ABNORMAL

Product YAZ

Role Route S ORAL

Duration 4 MTH

Manufacturer BAYER

7209856 Date FDA Received
10-Dec-2009

Case # 7209856

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200941601NA Dosage Text

Age 28 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration

Manufacturer BAYER

7209927 Date FDA Received
10-Dec-2009

Case # 7209927

Manufacturer Control # USBAYER-200939388NA

Age 20 YR

Sex Female

Country USA

Preferred Term COITAL BLEEDING

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 520 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7209928 Date FDA Received
10-Dec-2009 Case # 7209928 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200939391NA Role Route S Dosage Text Age 26 YR Sex Female Country USA

Preferred Term MOOD SWINGS MENSTRUATION DELAYED MIGRAINE

Product YAZ

Duration

Manufacturer BAYER

7209934 Date FDA Received
10-Dec-2009

Case # 7209934

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939287NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7209936 Date FDA Received
10-Dec-2009

Case # 7209936

Outcomes

Manufacturer Control # USBAYER-200939301NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7209941 Date FDA Received
10-Dec-2009

Case # 7209941

Manufacturer Control # USBAYER-200939312NA

Age

Sex Female

Country USA

Preferred Term POLYMENORRHOEA

Product YAZ Case # 7209944 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7209944 Date FDA Received
10-Dec-2009

Manufacturer Control # USBAYER-200939304NA

Age

Sex Female

Country USA

Preferred Term MALAISE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 521 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7213853 Date FDA Received
10-Dec-2009 Preferred Term THROMBOSIS PULMONARY THROMBOSIS Case # 7213853 Case Type DIRECT Product YAZ Health Professional N Outcomes HO,LT Role Route S Dosage Text Manufacturer Control # Age 28 YR Duration Sex Female Country USA

Manufacturer

7082964 Date FDA Received
11-Dec-2009

Case # 7082964

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USJNJFOC-20090804099 Dosage Text 10 mg 3-4 times/daily

Age 41 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM RETAINED PLACENTA OR MEMBRANES Haemorrhage in pregnancy Maternal exposure during pregnancy CONVULSION

Product FLEXERIL FLEXERIL REBIF YAZ UNSPECIFIED INGREDIENT NAPROSYN CYMBALTA FISH OIL NORCO

Role Route S S S S S C C C C SUBCUTANEOUS ORAL

Duration

Manufacturer

10/325 1-2 every 4 hours as needed

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 522 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7082965 Date FDA Received
11-Dec-2009 Case # 7082965 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes CA Manufacturer Control # USJNJFOC-20090804106 Dosage Text 10 mg 3-4 times/day Duration Age Sex Unknown Country USA

Preferred Term Maternal exposure during pregnancy SPINA BIFIDA

Product FLEXERIL FLEXERIL REBIF YAZ ENOXAPARIN SODIUM UNSPECIFIED INGREDIENT NORCO CYMBALTA NAPROSYN FISH OIL

Role Route S S S S S S S S S C Health Professional N Outcomes INTRAUTERINE INTRAUTERINE

Manufacturer

7132572 Date FDA Received
11-Dec-2009

Case # 7132572

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200928787NA

Age 22 YR

Sex Female

Country USA

Preferred Term VULVOVAGINAL MYCOTIC INFECTION

Product YAZ

Role Route S

Dosage Text

Duration 2 MTH

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 523 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177654 Date FDA Received
11-Dec-2009 Case # 7177654 Case Type NON-EXPEDITED Health Professional N Outcomes HO,LT,OT Manufacturer Control # USBAYER-200938302NA Dosage Text Total daily dose: 1 DF 33 ML PER WEEK SUBCUTANEOUS INJECTION Age 21 YR Sex Female Country USA

Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS HEADACHE

Product YAZ VIVAGLOBIN

Role Route S S ORAL SUBCUTANEOUS

Duration

Manufacturer BAYER

ASTHENIA CEREBROVASCULAR ACCIDENT URTICARIA

ALEVE IMITREX ALBUTEROL

C C C LAST USES TWO MONTHS PRIOR TO EVENT

IBUPROFEN AUGMENTIN TOPAMAX SINGULAIR VITAMIN B12 ZYRTEC

C C C C C C

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 524 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7187723 Date FDA Received
11-Dec-2009 Case # 7187723 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes CA Manufacturer Control # USWATSON-2009-09800 Dosage Text "one to two every four hours as required" "one to two every four hours prn" "one to two every four hours as required for pain" 44 mcg, 3 in 1 week UNK 20 mg, daily 10 mg, 3-4 times daily UNK UNK 800 mg, daily 6- 100 mg tabs prn UNK 110 DAY Age Sex Country USA 140 DAY Unknown

Preferred Term MENINGOMYELOCELE NEURAL TUBE DEFECT CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY CONGENITAL HYDROCEPHALUS TALIPES MATERNAL DRUGS AFFECTING FOETUS SPINA BIFIDA ABORTION INDUCED

Product ACETAMINOPHEN \HYDROCODONE BITARTRATE NORCO ACETAMINOPHEN \HYDROCODONE BITARTRATE REBIF YAZ FLEXERIL FLEXERIL ENOXAPARIN SODIUM ENOXAPARIN SODIUM CYMBALTA NAPROSYN FISH OIL BACTRIM

Role Route S S S TRANSPLACENTAL TRANSPLACENTAL TRANSPLACENTAL

Duration

Manufacturer WATSON WATSON WATSON

S S S S S S C C C C

TRANSPLACENTAL TRANSPLACENTAL TRANSPLACENTAL TRANSPLACENTAL TRANSPLACENTAL UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 525 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7187739 Date FDA Received
11-Dec-2009 Case # 7187739 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # USWATSON-2009-09804 Dosage Text "one to two every four hour as required for pain" "one to two q 4 hours prn pain "one to two every four hours as required for pain" 44 mcg, 3/week UNK 20 mg, daily 10 mg, 3-4 times per day UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNK 6-100 mg tabs prn UNK 800 mg, daily UNK Manufacturer Control # USBAYER-200942232NA Dosage Text Duration Age Sex Female Country USA 110 DAY Age 41 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product ACETAMINOPHEN \HYDROCODONE BITARTRATE NORCO ACETAMINOPHEN \HYDROCODONE BITARTRATE REBIF YAZ FLEXERIL FLEXERIL ENOXAPARIN SODIUM ENOXAPARIN SODIUM FISH OIL CYMBALTA NAPROSYN BACTRIM

Role Route S UNKNOWN

Duration

Manufacturer WATSON

DYSPNOEA CHEST PAIN

S S

UNKNOWN UNKNOWN

WATSON WATSON

BACK PAIN ABORTION INDUCED Maternal exposure during pregnancy

S S S S S S C C C C Health Professional N

SUBCUTANEOUS UNKNOWN ORAL

7212567 Date FDA Received
11-Dec-2009

Case # 7212567

Case Type NON-EXPEDITED

Outcomes OT

Preferred Term PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 526 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7212574 Date FDA Received
11-Dec-2009 Case # 7212574 Case Type NON-EXPEDITED Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200942292NA Dosage Text Duration Age Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Manufacturer BAYER

7212591 Date FDA Received
11-Dec-2009

Case # 7212591

Manufacturer Control # USBAYER-200939265NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7212602 Date FDA Received
11-Dec-2009

Case # 7212602

Manufacturer Control # USBAYER-200939218NA

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA

Product YAZ Case # 7212605 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7212605 Date FDA Received
11-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200939261NA

Age

Sex Female

Country USA

Preferred Term NAUSEA DIZZINESS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7212615 Date FDA Received
11-Dec-2009

Case # 7212615

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939264NA

Age

Sex Female

Country USA

Preferred Term MALAISE

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 527 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7219145 Date FDA Received
11-Dec-2009 Preferred Term GALLBLADDER NON-FUNCTIONING CHOLECYSTECTOMY Case # 7219145 Case Type DIRECT Product YAZ Health Professional N Role Route S ORAL Dosage Text 1 TABLET 1X DAILY ORAL Outcomes Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer

7213896 Date FDA Received
14-Dec-2009 Preferred Term COMPLETED SUICIDE

Case # 7213896

Case Type NON-EXPEDITED Product CLARAVIS YAZ Case Type NON-EXPEDITED

Health Professional N

Outcomes DE,OT Role Route S S ORAL ORAL

Manufacturer Control # US-TEVA-217534USA Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer BARR

DEPRESSION SUICIDAL

7214189 Date FDA Received
14-Dec-2009

Case # 7214189

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939406NA

Age 39 YR

Sex Female

Country USA

Preferred Term MUSCLE SPASMS ABDOMINAL PAIN UPPER BREAST PAIN RASH

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7214190 Date FDA Received
14-Dec-2009

Case # 7214190

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939403NA

Age 41 YR

Sex Female

Country USA

Preferred Term ABNORMAL WITHDRAWAL BLEEDING

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 528 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7214193 Date FDA Received
14-Dec-2009 Case # 7214193 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200939400NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200939495NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200939529NA Role Route S Health Professional N Outcomes Manufacturer Control # USBAYER-200939549NA Role Route S C Health Professional N ORAL ORAL Manufacturer Control # USBAYER-200939538NA Role Route S Dosage Text Age 16 YR Sex Female Country USA Dosage Text Age 31 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Dosage Text Duration 6 MTH Age Sex Female Age Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7214207 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7214207 Date FDA Received
14-Dec-2009

Preferred Term PARANASAL CYST

Product YAZ Case # 7214214 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7214214 Date FDA Received
14-Dec-2009

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7214216 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7214216 Date FDA Received
14-Dec-2009

Preferred Term ALOPECIA NERVOUSNESS

Product YAZ PROZAC Case # 7214220 Case Type NON-EXPEDITED

Duration

Manufacturer BAYER

7214220 Date FDA Received
14-Dec-2009

Outcomes

Preferred Term ABDOMINAL PAIN UPPER NAUSEA VOMITING

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 529 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7214224 Date FDA Received
14-Dec-2009 Case # 7214224 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200939558NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200939612NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200939608NA Role Route S ORAL Dosage Text Duration 2 MTH Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term VOMITING

Product YAZ Case # 7214229 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7214229 Date FDA Received
14-Dec-2009

Outcomes

Preferred Term VOMITING

Product YAZ Case # 7214231 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7214231 Date FDA Received
14-Dec-2009

Outcomes

Preferred Term BREAST PAIN BLOOD PRESSURE INCREASED WEIGHT FLUCTUATION

Product YAZ

Manufacturer BAYER

7214234 Date FDA Received
14-Dec-2009

Case # 7214234

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939553NA

Age 30 YR

Sex Female

Country USA

Preferred Term FEELING HOT SEBORRHOEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7214243 Date FDA Received
14-Dec-2009

Case # 7214243

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939606NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 530 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7222654 Date FDA Received
15-Dec-2009 Preferred Term GALLBLADDER OPERATION Case # 7222654 Case Type DIRECT Product YASMIN YAZ Health Professional N Outcomes HO Role Route S S Health Professional N Outcomes OT Manufacturer Control # USBAYER-200941813NA Dosage Text Duration Age Sex Female Country USA Dosage Text Manufacturer Control # Age 27 YR Duration Sex Female Country USA

Manufacturer

7218241 Date FDA Received
16-Dec-2009

Case # 7218241

Case Type NON-EXPEDITED

Preferred Term TRANSIENT ISCHAEMIC ATTACK

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Manufacturer BAYER

7220341 Date FDA Received
16-Dec-2009

Case # 7220341

Outcomes HO,DS

Manufacturer Control # BSBAYER-200924614LA Dosage Text

Age 43 YR

Sex Female

Country BHS

Preferred Term CEREBROVASCULAR ACCIDENT HEMIPLEGIA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7221369 Date FDA Received
17-Dec-2009

Case # 7221369

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939683NA

Age

Sex Female

Country USA

Preferred Term HEADACHE NAUSEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 531 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7221371 Date FDA Received
17-Dec-2009 Case # 7221371 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200939686NA Role Route S Dosage Text Age 40 YR Sex Female Country USA

Preferred Term NAUSEA ACNE

Product YAZ

Duration

Manufacturer BAYER

7221377 Date FDA Received
17-Dec-2009

Case # 7221377

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939693NA

Age

Sex Female

Country USA

Preferred Term BREAST DISCOMFORT

Product YAZ Case # 7221379 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7221379 Date FDA Received
17-Dec-2009

Manufacturer Control # USBAYER-200939697NA

Age 20 YR

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE DYSMENORRHOEA

Product YAZ

Role Route S

Dosage Text Total daily dose: 1 DF Unit dose: 1 DF

Duration

Manufacturer BAYER

7221380 Date FDA Received
17-Dec-2009

Case # 7221380

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939703NA

Age

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT

Product YAZ Case # 7221397 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7221397 Date FDA Received
17-Dec-2009

Manufacturer Control # USBAYER-200939752NA

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 532 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7221398 Date FDA Received
17-Dec-2009 Case # 7221398 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200939908NA Role Route S S C Health Professional N Outcomes Manufacturer Control # USBAYER-200939909NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA ORAL ORAL Dosage Text Age 19 YR Sex Female Country USA

Preferred Term PAIN IN EXTREMITY MUSCULOSKELETAL STIFFNESS

Product YAZ YAZ DENIE

Duration 1 YEAR

Manufacturer BAYER BAYER

7221400 Date FDA Received
17-Dec-2009

Case # 7221400

Case Type NON-EXPEDITED

Preferred Term VAGINAL DISCHARGE MENORRHAGIA

Product YAZ

Manufacturer BAYER

7221434 Date FDA Received
17-Dec-2009

Case # 7221434

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes DE

Manufacturer Control # USBAYER-200942635NA Dosage Text

Age 34 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type DIRECT Product YAZ Health Professional N

Role Route S Outcomes OT Role Route S ORAL

Duration

Manufacturer BAYER

7225667 Date FDA Received
17-Dec-2009 Preferred Term NEPHROLITHIASIS

Case # 7225667

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text 1 TABLET DAILY PO

Duration 5 MTH

Manufacturer

ABDOMINAL DISTENSION BLOOD POTASSIUM INCREASED FLANK PAIN WEIGHT INCREASED

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 533 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7173382 Date FDA Received
18-Dec-2009 Case # 7173382 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200935407NA Role Route S ORAL Dosage Text Age 29 YR Sex Female Country USA

Preferred Term ACNE MENSTRUATION DELAYED MENSTRUATION IRREGULAR

Product YAZ

Duration 2 MTH

Manufacturer BAYER

7222938 Date FDA Received
18-Dec-2009

Case # 7222938

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # CABAYER-200942308NA Dosage Text

Age 28 YR

Sex Female

Country CAN

Preferred Term CHEST PAIN CARDIAC DISORDER DYSPNOEA FATIGUE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7223003 Date FDA Received
18-Dec-2009

Case # 7223003

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939867NA

Age

Sex Female

Country USA

Preferred Term VOMITING HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7223010 Date FDA Received
18-Dec-2009

Case # 7223010

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200939969NA

Age 26 YR

Sex Female

Country USA

Preferred Term HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 534 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7223022 Date FDA Received
18-Dec-2009 Case # 7223022 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200939992NA Role Route S Health Professional Y Product YAZ ORAL Manufacturer Control # Age 29 YR Dosage Text 0.02MG 1X DAY MOUTH Duration Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ Case Type DIRECT

Manufacturer BAYER Country USA

7228517 Date FDA Received
18-Dec-2009 Preferred Term

Case # 7228517

Outcomes HO,LT,RI Role Route S ORAL

Manufacturer BAYER

DEEP VEIN THROMBOSIS MITRAL VALVE INCOMPETENCE PULMONARY EMBOLISM PULMONARY VALVE INCOMPETENCE

7228655 Date FDA Received
18-Dec-2009 Preferred Term POLYMYOSITIS

Case # 7228655

Case Type DIRECT Product YAZ

Health Professional N

Outcomes RI Role Route S ORAL

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text DAILY PO Manufacturer Control # USBAYER-200915724NA

Duration 1.83 YEAR Age Sex

Manufacturer BAYER Country USA

6986623 Date FDA Received
21-Dec-2009

Case # 6986623

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Female

Preferred Term NO ADVERSE EVENT ABNORMAL WITHDRAWAL BLEEDING ADVERSE EVENT METRORRHAGIA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 535 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7101347 Date FDA Received
21-Dec-2009 Case # 7101347 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200930708NA Dosage Text Age 35 YR Sex Female Country USA

Preferred Term RASH GENERALISED MAJOR DEPRESSION TACHYPHRENIA DECREASED APPETITE EMOTIONAL DISORDER CRYING DYSMENORRHOEA MOOD SWINGS SUICIDAL IDEATION VAGINAL HAEMORRHAGE

Product YAZ YAZ EFFEXOR XR SYNTHROID LAMICTAL ENSURE

Role Route S S C C C C ORAL ORAL ORAL

Duration 5 MTH

Manufacturer BAYER BAYER

Unit dose: 25 MG

7202173 Date FDA Received
21-Dec-2009

Case # 7202173

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200938532NA

Age 39 YR

Sex Female

Country USA

Preferred Term DRUG HYPERSENSITIVITY MIGRAINE AMENORRHOEA FATIGUE HEADACHE MALAISE MENSTRUATION IRREGULAR WEIGHT INCREASED

Product YAZ YASMIN DROSPIRENONE

Role Route S S S ORAL ORAL ORAL

Dosage Text

Duration 7 MTH

Manufacturer BAYER BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 536 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7223969 Date FDA Received
21-Dec-2009 Case # 7223969 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # USBAYER-200942582NA Dosage Text Age 24 YR Sex Female Country USA

Preferred Term GALLBLADDER INJURY CHOLELITHIASIS

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7224223 Date FDA Received
21-Dec-2009

Case # 7224223

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940177NA

Age

Sex Female

Country USA

Preferred Term ACNE

Product YAZ Case # 7224227 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7224227 Date FDA Received
21-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200940186NA

Age 21 YR

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ YAZ

Role Route S S Health Professional N ORAL ORAL

Dosage Text

Duration

Manufacturer BAYER BAYER

7224256 Date FDA Received
21-Dec-2009

Case # 7224256

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # USBAYER-200940759NA

Age

Sex Female

Country USA

Preferred Term DEPRESSION ACNE

Product YAZ

Role Route S ORAL

Dosage Text

Duration 12 DAY

Manufacturer BAYER

7224257 Date FDA Received
21-Dec-2009

Case # 7224257

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940779NA

Age

Sex Female

Country USA

Preferred Term CYST

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 537 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7224261 Date FDA Received
21-Dec-2009 Case # 7224261 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200940798NA Role Route S ORAL Dosage Text Age 18 YR Sex Female Country USA

Preferred Term PAIN IN EXTREMITY BREAST PAIN MALAISE WITHDRAWAL BLEED

Product YAZ

Duration 2 WEEK

Manufacturer BAYER

7224272 Date FDA Received
21-Dec-2009

Case # 7224272

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940784NA

Age

Sex Female

Country USA

Preferred Term ALOPECIA WEIGHT INCREASED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7224273 Date FDA Received
21-Dec-2009

Case # 7224273

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940424NA

Age

Sex Female

Country USA

Preferred Term VOMITING FAECAL INCONTINENCE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7224274 Date FDA Received
21-Dec-2009

Case # 7224274

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940453NA

Age

Sex Female

Country USA

Preferred Term VOMITING NO ADVERSE EVENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 538 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7224287 Date FDA Received
21-Dec-2009 Case # 7224287 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200941116NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941097NA Role Route S ORAL Dosage Text Duration 2 MTH Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term DRUG SCREEN POSITIVE

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7224292 Date FDA Received
21-Dec-2009

Case # 7224292

Outcomes

Preferred Term HEADACHE Eye complication associated with device NAUSEA

Product YAZ

Manufacturer BAYER

7224298 Date FDA Received
21-Dec-2009

Case # 7224298

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940877NA

Age

Sex Female

Country USA

Preferred Term HEADACHE ABDOMINAL PAIN UPPER VOMITING

Product YAZ YAZ

Role Route S S

Dosage Text

Duration 2 MTH 1 MTH

Manufacturer BAYER BAYER

7229147 Date FDA Received
21-Dec-2009 Preferred Term SUDDEN DEATH ABDOMINAL PAIN ACNE ADRENAL DISORDER ALOPECIA ASTHENIA BACK PAIN

Case # 7229147

Case Type DIRECT Product YAZ

Health Professional N

Outcomes DE Role Route S ORAL

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text ONCE DAILY PO

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 539 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7229147
Preferred Term BLOOD POTASSIUM INCREASED CONTRAINDICATION TO MEDICAL TREATMENT COUGH CYSTITIS DEPRESSION DIARRHOEA DYSMENORRHOEA FATIGUE GLUCOSE TOLERANCE DECREASED HEADACHE HYPOAESTHESIA INFECTION INFLUENZA INSOMNIA MENSTRUAL DISORDER METRORRHAGIA MIGRAINE MUSCULOSKELETAL PAIN NAUSEA NECK PAIN NERVOUSNESS OROPHARYNGEAL PAIN PAIN IN EXTREMITY PAIN IN JAW PARAESTHESIA RENAL DISORDER SINUSITIS UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION VOMITING VULVOVAGINAL CANDIDIASIS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 540 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7229147
Preferred Term WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

7102095 Date FDA Received
22-Dec-2009

Case # 7102095

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200930709NA Dosage Text

Age

Sex Female

Country USA

Preferred Term SUICIDAL IDEATION AFFECT LABILITY DYSMENORRHOEA MAJOR DEPRESSION RASH GENERALISED VAGINAL HAEMORRHAGE

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7225761 Date FDA Received
22-Dec-2009

Case # 7225761

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200940793NA

Age 28 YR

Sex Female

Country USA

Preferred Term CHEST PAIN DYSPNOEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7225894 Date FDA Received
22-Dec-2009

Case # 7225894

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO

Manufacturer Control # USBAYER-200942856NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ Case # 7225898 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7225898 Date FDA Received
22-Dec-2009

Outcomes HO,OT

Manufacturer Control # USBAYER-200942855NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 541 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7225903 Date FDA Received
22-Dec-2009 Case # 7225903 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200942814NA Dosage Text Age 19 YR Sex Female Country USA

Preferred Term EPILEPSY GRAND MAL CONVULSION SOMNOLENCE VITAMIN B12 DECREASED

Product YAZ

Role Route S

Duration 3 WEEK

Manufacturer BAYER

7225910 Date FDA Received
22-Dec-2009

Case # 7225910

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200942891NA Dosage Text

Age 27 YR

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ YASMIN DROSPIRENONE

Role Route S S S Outcomes OT

Duration

Manufacturer BAYER BAYER BAYER

7225911 Date FDA Received
22-Dec-2009

Case # 7225911

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200943148NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ YASMIN DROSPIRENONE

Role Route S S S Outcomes OT

Duration

Manufacturer BAYER BAYER BAYER

7225917 Date FDA Received
22-Dec-2009

Case # 7225917

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200943156NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ YASMIN DROSPIRENONE

Role Route S S S

Duration 3 MTH 3 MTH 3 MTH

Manufacturer BAYER BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 542 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7229918 Date FDA Received
22-Dec-2009 Preferred Term EMBOLIC STROKE ISCHAEMIC STROKE Case # 7229918 Case Type DIRECT Product YAZ ADVIL TYLENOL Health Professional N Outcomes HO Role Route S C C Health Professional Y Product YAZ Outcomes HO,DS,LT Role Route S ORAL Dosage Text 20MCG DAILY PO Manufacturer Control # Age 26 YR Duration Sex Female Country USA ORAL Dosage Text 1 TAB DAILY PO Manufacturer Control # Age 46 YR Duration 2.25 YEAR Sex Female Country USA

Manufacturer BAYER

7229952 Date FDA Received
22-Dec-2009 Preferred Term THROMBOSIS

Case # 7229952

Case Type DIRECT

Manufacturer BAYER

INTRACARDIAC THROMBUS PULMONARY THROMBOSIS

7230038 Date FDA Received
22-Dec-2009 Preferred Term

Case # 7230038

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,DS,LT,OT Role Route S ORAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 1/DAY PO

Duration 315 DAY

Manufacturer BAYER

PULMONARY EMBOLISM CARDIAC DISORDER

7228741 Date FDA Received
23-Dec-2009

Case # 7228741

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200943135NA Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM GALLBLADDER DISORDER

Product YAZ YASMIN DROSPIRENONE

Role Route S S S

Duration

Manufacturer BAYER BAYER BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 543 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7228742 Date FDA Received
23-Dec-2009 Case # 7228742 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200943223NA Dosage Text Age 18 YR Sex Female Country USA

Preferred Term GALLBLADDER DISORDER

Product YAZ YASMIN DROSPIRENONE

Role Route S S S Outcomes OT

Duration 3.17 YEAR 3.17 YEAR

Manufacturer BAYER BAYER BAYER Country USA

7228748 Date FDA Received
23-Dec-2009

Case # 7228748

Case Type EXPEDITED (15-DAY)

Health Professional N

Manufacturer Control # USBAYER-200942816NA Dosage Text

Age

Sex Female

Preferred Term CONVULSION

Product YAZ Case # 7228755 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7228755 Date FDA Received
23-Dec-2009

Manufacturer Control # USBAYER-200942820NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CONVULSION

Product YAZ Case # 7228801 Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration

Manufacturer BAYER

7228801 Date FDA Received
23-Dec-2009

Outcomes

Manufacturer Control # USBAYER-200941965NA

Age

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED

Product YAZ Case # 7232068 Case Type DIRECT Product YAZ Health Professional

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7232068 Date FDA Received
23-Dec-2009 Preferred Term

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text ONE PILL DAILY PO

Duration

Manufacturer

HAIR TEXTURE ABNORMAL

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 544 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7105329 Date FDA Received
24-Dec-2009 Case # 7105329 Case Type NON-EXPEDITED Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200931263NA Dosage Text Total daily dose: 1 DF Manufacturer Control # USBAYER-200941118NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941121NA Role Route S ORAL Dosage Text Age 30 YR Sex Female Dosage Text Duration Age 38 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Duration 350 DAY Age Sex

Manufacturer BAYER Country USA

7230532 Date FDA Received
24-Dec-2009

Case # 7230532

Outcomes

Female

Preferred Term METRORRHAGIA

Product YAZ Case # 7230539 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7230539 Date FDA Received
24-Dec-2009

Outcomes

Preferred Term PALPITATIONS ANXIETY DIZZINESS MOOD SWINGS WEIGHT INCREASED

Product YAZ

Duration

Manufacturer BAYER

7230599 Date FDA Received
25-Dec-2009

Case # 7230599

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200941366NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ ZOLOFT

Role Route S C ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 545 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7230608 Date FDA Received
25-Dec-2009 Case # 7230608 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200941398NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term INFLAMMATORY BOWEL DISEASE CONSTIPATION MUCOUS STOOLS

Product YAZ

Manufacturer BAYER

7177936 Date FDA Received
28-Dec-2009

Case # 7177936

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200936854NA

Age

Sex Female

Country USA

Preferred Term PREMENSTRUAL SYNDROME

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration 5 MTH

Manufacturer BAYER Sex Female Country USA

7231176 Date FDA Received
28-Dec-2009

Case # 7231176

Manufacturer Control # USBAYER-200941710NA

Age 22 YR

Preferred Term VAGINAL HAEMORRHAGE AMENORRHOEA NO ADVERSE EVENT

Product YAZ

Role Route S

Dosage Text

Duration 4 MTH

Manufacturer BAYER

7231178 Date FDA Received
28-Dec-2009

Case # 7231178

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200941712NA

Age 39 YR

Sex Female

Country USA

Preferred Term MUSCLE SPASMS

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 546 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7231190 Date FDA Received
28-Dec-2009 Case # 7231190 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200941708NA Role Route S INTRAUTERINE Dosage Text Duration Age Sex Female Country USA

Preferred Term BACK PAIN AMENORRHOEA

Product YAZ

Manufacturer BAYER

7231191 Date FDA Received
28-Dec-2009

Case # 7231191

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200941730NA

Age

Sex Female

Country USA

Preferred Term VOMITING

Product YAZ Case # 7232856 Case Type DIRECT Product YAZ Health Professional

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7232856 Date FDA Received
28-Dec-2009 Preferred Term

Outcomes RI Role Route S ORAL

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text 1 DAILY PO

Duration 4 YEAR

Manufacturer BAYER

GALLBLADDER DISORDER CHOLECYSTECTOMY

7233427 Date FDA Received
28-Dec-2009 Preferred Term CHOLECYSTECTOMY

Case # 7233427

Case Type DIRECT Product YAZ

Health Professional N

Outcomes HO,RI Role Route S ORAL

Manufacturer Control #

Age 15 YR

Sex Female

Country USA

Dosage Text 1 PILL ONCE PER DAY PO, APPROXIMATELY 4 YEARS

Duration

Manufacturer BAYER

GALLBLADDER DISORDER GALLBLADDER PAIN GASTROINTESTINAL DISORDER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 547 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7232402 Date FDA Received
29-Dec-2009 Case # 7232402 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-200943515NA Dosage Text Duration Age Sex Female Country USA

Preferred Term CEREBROVASCULAR ACCIDENT

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Manufacturer BAYER

7232412 Date FDA Received
29-Dec-2009

Case # 7232412

Outcomes LT,OT

Manufacturer Control # USBAYER-200943693NA Dosage Text

Age

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS LUNG DISORDER PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7233908 Date FDA Received
30-Dec-2009

Case # 7233908

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200943593NA Dosage Text

Age

Sex Female

Country USA

Preferred Term GALLBLADDER DISORDER DRY EYE

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7233913 Date FDA Received
30-Dec-2009

Case # 7233913

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes LT,OT

Manufacturer Control # USBAYER-200943665NA Dosage Text

Age

Sex Female

Country USA

Preferred Term ORGAN FAILURE GALLBLADDER DISORDER

Product YAZ

Role Route S

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 548 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7233914 Date FDA Received
30-Dec-2009 Case # 7233914 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # USBAYER-200943592NA Dosage Text Total daily dose: 1 DF Unit dose: 1 DF Age 47 YR Sex Female Country USA

Preferred Term VENTRICULAR ARRHYTHMIA ARRHYTHMIA CHEST DISCOMFORT DIZZINESS DYSPNOEA HYPOAESTHESIA MUSCULOSKELETAL PAIN PAIN IN JAW PALPITATIONS VISION BLURRED

Product YAZ LOPRESSOR

Role Route S C ORAL

Duration

Manufacturer BAYER

7235138 Date FDA Received
31-Dec-2009

Case # 7235138

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200941752NA

Age 40 YR

Sex Female

Country USA

Preferred Term NO ADVERSE EVENT NAUSEA

Product YAZ NEXIUM Case # 7235146 Case Type NON-EXPEDITED Health Professional N

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7235146 Date FDA Received
31-Dec-2009

Manufacturer Control # USBAYER-200941822NA

Age

Sex Female

Country USA

Preferred Term DIZZINESS NAUSEA

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 549 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7235151 Date FDA Received
31-Dec-2009 Case # 7235151 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200941821NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term ALOPECIA AMENORRHOEA

Product YAZ

Manufacturer BAYER

7235153 Date FDA Received
31-Dec-2009

Case # 7235153

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200941491NA

Age

Sex Female

Country USA

Preferred Term AFFECT LABILITY RASH

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7235155 Date FDA Received
31-Dec-2009

Case # 7235155

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200941347NA

Age 18 YR

Sex Female

Country USA

Preferred Term MIGRAINE WITH AURA

Product YAZ AMNESTEEM

Role Route S C Outcomes ORAL

Dosage Text

Duration

Manufacturer BAYER

7235159 Date FDA Received
31-Dec-2009

Case # 7235159

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200941811NA

Age

Sex Female

Country USA

Preferred Term EAR INFECTION

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 550 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7237812 Date FDA Received
31-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7237812 Case Type DIRECT Product YAZ EFFEXOR WELLBUTRIN LEVOTHYROXINE SODIUM Health Professional Y Outcomes HO,LT Role Route S C C C Outcomes Manufacturer Control # USBAYER-200934082NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200934081NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200938609NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200937126NA Role Route S Dosage Text Age 16 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA Dosage Text 3MG/0.02MG 28 TABLETS 1 DAILY 047 Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer BAYER

7156298 Date FDA Received
04-Jan-2010

Case # 7156298

Case Type NON-EXPEDITED

Health Professional N

Preferred Term BLOOD CHOLESTEROL INCREASED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7156317 Date FDA Received
04-Jan-2010

Case # 7156317

Outcomes

Preferred Term BLOOD CHOLESTEROL INCREASED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7178741 Date FDA Received
04-Jan-2010

Case # 7178741

Outcomes

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ

Manufacturer BAYER Country USA

7190949 Date FDA Received
04-Jan-2010

Case # 7190949

Case Type NON-EXPEDITED

Outcomes

Preferred Term ALOPECIA

Product YAZ

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 551 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7206376 Date FDA Received
04-Jan-2010 Case # 7206376 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USBAYER-200941703NA Dosage Text Age 36 YR Sex Female Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ XANAX CELEXA DIFLUCAN BUSPIRONE HYDROCHLORIDE AMBIEN MACROBID FIORICET SYNTHROID

Role Route S C C C C C C C C Health Professional N Outcomes ORAL

Duration

Manufacturer BAYER

7236049 Date FDA Received
04-Jan-2010

Case # 7236049

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200941517NA

Age

Sex Female

Country USA

Preferred Term PREGNANCY ON ORAL CONTRACEPTIVE

Product YAZ Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7236061 Date FDA Received
04-Jan-2010

Case # 7236061

Case Type NON-EXPEDITED

Manufacturer Control # USBAYER-200941835NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7236064 Date FDA Received
04-Jan-2010

Case # 7236064

Outcomes

Manufacturer Control # USBAYER-200941834NA

Age

Sex Female

Country USA

Preferred Term WITHDRAWAL BLEED HEADACHE

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 552 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7236074 Date FDA Received
04-Jan-2010 Case # 7236074 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200941836NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941831NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941842NA Role Route S C C ORAL ORAL Dosage Text Age 25 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7236075 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7236075 Date FDA Received
04-Jan-2010

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7236076 Date FDA Received
04-Jan-2010

Case # 7236076

Outcomes

Preferred Term NAUSEA

Product YAZ ANTACIDS NOS DEXTROMETHORPHAN HYDROBROMIDE \PSEUDOEPHEDRINE HYDROCHLORIDE

Duration

Manufacturer BAYER

7236085 Date FDA Received
04-Jan-2010

Case # 7236085

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # USBAYER-200941981NA

Age

Sex Female

Country USA

Preferred Term PARAESTHESIA

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 553 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7236086 Date FDA Received
04-Jan-2010 Case # 7236086 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200941824NA Role Route S C Outcomes Manufacturer Control # USBAYER-200941825NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941982NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200941839NA Role Route S Health Professional N ORAL Manufacturer Control # USBAYER-200942058NA Role Route S ORAL Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA ORAL Dosage Text Age 25 YR Sex Female Country USA

Preferred Term NAUSEA

Product YAZ MEDICATION NOS

Duration

Manufacturer BAYER

7236089 Date FDA Received
04-Jan-2010

Case # 7236089

Case Type NON-EXPEDITED

Health Professional N

Preferred Term HYPOMENORRHOEA

Product YAZ Case # 7236107 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7236107 Date FDA Received
04-Jan-2010

Outcomes

Preferred Term PARAESTHESIA

Product YAZ Case # 7236120 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7236120 Date FDA Received
04-Jan-2010

Outcomes

Preferred Term METRORRHAGIA

Product YAZ Case # 7236130 Case Type NON-EXPEDITED

Manufacturer BAYER Country USA

7236130 Date FDA Received
04-Jan-2010

Outcomes

Preferred Term MENSTRUATION DELAYED

Product YAZ

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 554 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7236134 Date FDA Received
04-Jan-2010 Case # 7236134 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200942091NA Role Route S ORAL Dosage Text Duration 1 YEAR Age Sex Female Country USA

Preferred Term MENSTRUATION DELAYED VAGINAL HAEMORRHAGE

Product YAZ

Manufacturer BAYER

7236139 Date FDA Received
04-Jan-2010

Case # 7236139

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200942033NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION DELAYED

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7236151 Date FDA Received
04-Jan-2010

Case # 7236151

Outcomes

Manufacturer Control # USBAYER-200943882NA

Age

Sex Female

Country USA

Preferred Term MIGRAINE VISUAL IMPAIRMENT

Product YAZ

Role Route S

Dosage Text

Duration

Manufacturer BAYER

7236219 Date FDA Received
04-Jan-2010

Case # 7236219

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200943904NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY PAIN

Product YAZ

Role Route S

Duration

Manufacturer BAYER

7238089 Date FDA Received
04-Jan-2010 Preferred Term

Case # 7238089

Case Type DIRECT Product YAZ

Health Professional N

Outcomes RI Role Route S

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text 1 PER DAY

Duration

Manufacturer

EMOTIONAL DISORDER LIBIDO DECREASED

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 555 of 7,840

7238794 Date FDA Received
04-Jan-2010 Preferred Term

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report
Case # 7238794 Case Type DIRECT Product YAZ Health Professional Y Outcomes LT,OT Role Route S Dosage Text Manufacturer Control # Age 18 YR Duration Sex Female Country USA

Manufacturer BAYER

EMOTIONAL DISORDER ABDOMINAL DISTENSION ANGER ANXIETY BACK PAIN BREAST SWELLING CONSTIPATION CRYING DEPRESSION DIARRHOEA DYSPNOEA FATIGUE FLATULENCE GASTRIC DISORDER HEADACHE HOT FLUSH IRRITABILITY MOOD SWINGS MUSCLE SPASMS NECK PAIN NIGHTMARE PALPITATIONS PARAESTHESIA PSYCHOMOTOR HYPERACTIVITY RESTLESSNESS SUICIDAL IDEATION URINARY TRACT INFECTION VERTIGO VISUAL IMPAIRMENT

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 556 of 7,840

7238794
Preferred Term VOMITING WEIGHT DECREASED WEIGHT INCREASED Product

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report
Role Route Dosage Text Duration Manufacturer

7236990 Date FDA Received
05-Jan-2010

Case # 7236990

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200942067NA

Age

Sex Female

Country USA

Preferred Term VAGINAL HAEMORRHAGE

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7236993 Date FDA Received
05-Jan-2010

Case # 7236993

Manufacturer Control # USBAYER-200942110NA

Age

Sex Female

Country USA

Preferred Term RASH

Product YAZ Case # 7237135 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Dosage Text

Duration

Manufacturer BAYER

7237135 Date FDA Received
05-Jan-2010

Manufacturer Control # USBAYER-201010017NA Dosage Text

Age

Sex Female

Country USA

Preferred Term CHOLECYSTECTOMY

Product YAZ YASMIN

Role Route S S Health Professional N ORAL ORAL

Duration

Manufacturer BAYER BAYER

7238764 Date FDA Received
05-Jan-2010 Preferred Term RASH ABDOMINAL PAIN

Case # 7238764

Case Type DIRECT Product YAZ

Outcomes OT Role Route S ORAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text TAKE ONE TABLET DAILY EVERYDAY PO

Duration

Manufacturer

GALLBLADDER NON-FUNCTIONING

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 557 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7239258 Date FDA Received
05-Jan-2010 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ATELECTASIS PULMONARY THROMBOSIS Case # 7239258 Case Type DIRECT Product YASMIN YAZ Health Professional Outcomes HO,LT Role Route S S Dosage Text 6 Manufacturer Control # Age 29 YR Duration 6 3 Sex Female Country USA

Manufacturer

7239653 Date FDA Received
05-Jan-2010 Preferred Term MOOD SWINGS DEPRESSION DYSMENORRHOEA HEADACHE

Case # 7239653

Case Type DIRECT Product YAZ

Health Professional

Outcomes LT,OT,RI Role Route S ORAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 PILL EVERY DAY PO

Duration

Manufacturer BAYER

HEART RATE IRREGULAR HYPERTENSION MENORRHAGIA SUICIDAL IDEATION

7148436 Date FDA Received
06-Jan-2010

Case # 7148436

Case Type NON-EXPEDITED

Health Professional N

Outcomes OT

Manufacturer Control # USBAYER-200932201NA Dosage Text

Age 43 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS DYSPNOEA PAIN IN EXTREMITY PULMONARY EMBOLISM

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 558 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7238201 Date FDA Received
06-Jan-2010 Case # 7238201 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-201010175NA Dosage Text Age 30 YR Sex Female Country USA

Preferred Term GALLBLADDER DISORDER

Product YAZ YAZ YASMIN YASMIN DROSPIRENONE\ETHINYL ESTRADIOL DROSPIRENONE\ETHINYL ESTRADIOL

Role Route S S S S S S Outcomes

Duration

Manufacturer BAYER BAYER BAYER BAYER BAYER BAYER

7238238 Date FDA Received
06-Jan-2010

Case # 7238238

Case Type NON-EXPEDITED

Health Professional N

Manufacturer Control # USBAYER-200942068NA

Age

Sex Female

Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7238239 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7238239 Date FDA Received
06-Jan-2010

Manufacturer Control # USBAYER-200942104NA

Age

Sex Female

Country USA

Preferred Term URINARY TRACT INFECTION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text

Duration

Manufacturer BAYER

7238240 Date FDA Received
06-Jan-2010

Case # 7238240

Manufacturer Control # USBAYER-200942182NA

Age

Sex Female

Country USA

Preferred Term BREAST ENLARGEMENT

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 559 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7238246 Date FDA Received
06-Jan-2010 Case # 7238246 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200942238NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA DIZZINESS

Product YAZ

Manufacturer BAYER

7238247 Date FDA Received
06-Jan-2010

Case # 7238247

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200942153NA

Age

Sex Female

Country USA

Preferred Term HYPOMENORRHOEA MENSTRUATION DELAYED

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7238248 Date FDA Received
06-Jan-2010

Case # 7238248

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200942234NA

Age

Sex Female

Country USA

Preferred Term METRORRHAGIA

Product YAZ Case # 7220351 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7220351 Date FDA Received
07-Jan-2010

Outcomes HO,OT

Manufacturer Control # USBAYER-200942356NA Dosage Text

Age 18 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM FLANK PAIN LOBAR PNEUMONIA PAIN PULMONARY INFARCTION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 560 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7239019 Date FDA Received
07-Jan-2010 Case # 7239019 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200942243NA Role Route S ORAL Dosage Text Duration Age Sex Female Country USA

Preferred Term NAUSEA VOMITING

Product YAZ

Manufacturer BAYER

7239022 Date FDA Received
07-Jan-2010

Case # 7239022

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200942279NA

Age

Sex Female

Country USA

Preferred Term ADVERSE DRUG REACTION

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7239027 Date FDA Received
07-Jan-2010

Case # 7239027

Outcomes

Manufacturer Control # USBAYER-200941746NA

Age

Sex Female

Country USA

Preferred Term MENORRHAGIA

Product YAZ Case # 7244076 Case Type DIRECT Product YAZ DROSPIRENONE\ETHINYL ESTRADIOL Health Professional Y

Role Route S ORAL

Dosage Text

Duration 3 YEAR

Manufacturer BAYER Sex Female Country USA

7244076 Date FDA Received
07-Jan-2010 Preferred Term MENINGIOMA

Outcomes OT Role Route S S ORAL ORAL

Manufacturer Control #

Age 37 YR

Dosage Text ONCE DAILY PO, 3-4 YEARS ONCE DAILY PO, 1-2 YEARS

Duration

Manufacturer

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 561 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7240344 Date FDA Received
08-Jan-2010 Case # 7240344 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # CLBAYER-200925486LA Dosage Text Age 26 YR Sex Female Country CHL

Preferred Term FATIGUE HYPERKALAEMIA

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7240382 Date FDA Received
08-Jan-2010

Case # 7240382

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200941098NA

Age

Sex Female

Country USA

Preferred Term PHARYNGITIS STREPTOCOCCAL

Product YAZ Case Type DIRECT Product YAZ Health Professional Y

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7244486 Date FDA Received
08-Jan-2010 Preferred Term

Case # 7244486

Outcomes LT Role Route S ORAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text 1 TABLET EVERY DAY PO Manufacturer Control # USBAYER-200938685NA Dosage Text

Duration

Manufacturer BAYER

THROMBOPHLEBITIS SUPERFICIAL

7180008 Date FDA Received
11-Jan-2010

Case # 7180008

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Age 30 YR

Sex Female

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer BAYER

7241619 Date FDA Received
11-Jan-2010

Case # 7241619

Manufacturer Control # USBAYER-201010271NA Dosage Text

Age

Sex Female

Country USA

Preferred Term THROMBOSIS DEPRESSION

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 562 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7241637 Date FDA Received
11-Jan-2010 Case # 7241637 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # USBAYER-201010523NA Dosage Text Duration Age Sex Female Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product YAZ Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S ORAL

Manufacturer BAYER

7242992 Date FDA Received
12-Jan-2010

Case # 7242992

Outcomes HO,LT

Manufacturer Control # DEBAYER-200938011GPV Dosage Text

Age 17 YR

Sex Female

Country DEU

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS HYPERTHERMIA LOCAL SWELLING OEDEMA PERIPHERAL PNEUMONIA RENAL VEIN THROMBOSIS VENA CAVA THROMBOSIS

Product YAZ

Role Route S ORAL

Duration

Manufacturer BAYER

7243146 Date FDA Received
12-Jan-2010

Case # 7243146

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-201010350NA

Age 17 YR

Sex Female

Country USA

Preferred Term CHOLELITHIASIS ABDOMINAL PAIN UPPER

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

7243150 Date FDA Received
12-Jan-2010

Case # 7243150

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200942531NA

Age

Sex Female

Country USA

Preferred Term MENSTRUATION IRREGULAR

Product YAZ

Role Route S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 563 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7243153 Date FDA Received
12-Jan-2010 Case # 7243153 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USBAYER-200942530NA Role Route S Health Professional N Product YAZ ORAL Manufacturer Control # Age 35 YR Dosage Text 1 PILL DAILY PO Duration Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term AMENORRHOEA

Product YAZ Case # 7246948 Case Type DIRECT

Manufacturer BAYER Country USA

7246948 Date FDA Received
12-Jan-2010 Preferred Term SUDDEN DEATH ABDOMINAL PAIN ACNE ALOPECIA ASTHENIA BACK PAIN

Outcomes DE Role Route S ORAL

Manufacturer

BLOOD POTASSIUM INCREASED COUGH CYSTITIS DEPRESSION DIARRHOEA DYSMENORRHOEA FATIGUE GLUCOSE TOLERANCE DECREASED HEADACHE HYPOAESTHESIA INFLUENZA LIKE ILLNESS INSOMNIA MENSTRUAL DISORDER METRORRHAGIA MIGRAINE MUSCULOSKELETAL PAIN NAUSEA

Date - Time: 02-04-2013 9:57:10 AM EST

Note: If the field is blank, there is no data

Page: 564 of 7,840

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7246948
Preferred Term NECK PAIN NERVOUSNESS OROPHARYNGEAL PAIN PAIN IN EXTREMITY PA