"Notes" "Age" "Age Code" "Month Reported" "Month Reported Code" "VAERS ID"

"VAERS ID Code" Adverse Event Description Adverse Events After Prior

Vaccinations Medications At Time Of Vaccination History/Allergies
"18-29 years" "18-29" "Jan., 2021" "2021/01" "936805-1"
"936805-1" "Patient received the vaccine on 12/22/20 without complication.
It was reported today that the patient was found unresponsive and subsequently
expired at home on 1/11/21." "No prior vaccinations for this event." "See
Continuation Field" "Septal defect (heart), chronic sinusitis,Ceftriaxone"
"18-29 years" "18-29" "Jan., 2021" "2021/01" "943397-1"
"943397-1" "On day due for 2nd dose, Patient was found unresponsive at work
in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated
for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and
epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was
shocked multiple times." "No prior vaccinations for this event." "None"
"None,Ceclor, Penicillin, Sulfa"
"30-39 years" "30-39" "Jan., 2021" "2021/01" "921667-1"
"921667-1" "LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead
received a call indicating that a staff member deceased somewhere between 1/3/2021
and 1/4/2021. Cause of death is unknown, and an autopsy is being performed."
"No prior vaccinations for this event." "No other medications for this
event." ","
"30-39 years" "30-39" "Jan., 2021" "2021/01" "939050-1"
"939050-1" "Patient vaccinated on 12/28. Approximately one day later,
develops cough and on azithromycin x 1 week. On 1/3, patient develops left-sided
weakness and aphasia. Taken to the hospital, tested COVID+, required intubation --
acute hypoxic respiratory failure secondary to COVID - on H&P. Patient died on
1/4/21 at 7:20am." "No prior vaccinations for this event." "Unknown"
"Morbid obesity and hypothyroidism,Unknown"
"40-49 years" "40-49" "Jan., 2021" "2021/01" "933578-1"
"933578-1" "Pronounced dead 1/9/2021 at 12:42. Received first dose of
vaccine 1/8/2021" "No prior vaccinations for this event." "metform, atorvastin"
"Hx smoking,NKA"
"40-49 years" "40-49" "Jan., 2021" "2021/01" "937527-1"
"937527-1" "unsure if related to vaccine, but was notified by her next of
kin that she died on 1/4/2021. No reports of side effects or hospitalization were
reported to the facility prior to the notification of death." "No prior
vaccinations for this event." "unknown" "unknown,unknown"
"40-49 years" "40-49" "Jan., 2021" "2021/01" "939270-1"
"939270-1" "Sudden cardiac death" "No prior vaccinations for this event."
"No other medications for this event." ","
"50-59 years" "50-59" "Jan., 2021" "2021/01" "918518-1"
"918518-1" "syncopal episode - arrested - CPR - death" "No prior
vaccinations for this event." "To be determined" "To be determined,To be
determined"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "920815-1"
"920815-1" "Found deceased in her home, unknown cause, 6 days after
vaccine." "No prior vaccinations for this event." "unknown" "Per employee
health records HTN, DM, Breast CA 2016 with radiation, obesity, gastric sleeve 10
years ago, arthritis, plantar fasciitis, ankle tendonitis, DeQuarvains, carpal
tunnel, anxiety,Lisinpril, Codeine, Latex , environmental (hay fever)"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "921768-1"
"921768-1" "Vaccine received at about 0900 on 01/04/2021 at her place of
work, Medical Center, where she was employed as a housekeeper. About one hour after
receiving the vaccine she experienced a hot flash, nausea, and feeling like she was
going to pass out after she had bent down. Later at about 1500 hours she appeared
tired and lethargic, then a short time later, at about 1600 hours, upon arrival to
a friends home she complained of feeling hot and having difficulty breathing. She
then collapsed, then when medics arrived, she was still breathing slowly then went
into cardiac arrest and was unable to be revived." "No prior vaccinations for
this event." "No other medications for this event." ",None Known"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "928933-1"
"928933-1" "Patient had been diagnosed with COVID-19 on Dec. 11th, 2020.
Symptoms were thought to have started on 12/5/2020. Received Moderna vaccine on
12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful" "No
prior vaccinations for this event." "No other medications for this event." ","
"50-59 years" "50-59" "Jan., 2021" "2021/01" "930910-1"
"930910-1" "Patient received COVID vaccination around 12:15pm. Patient was
monitored for the appropriate amount of time by nursing staff. Patient passed away
at 2:15pm." "No prior vaccinations for this event." "Patient was refusing to take
all medications for over a year" "Hemiplegia and hemiparesis following cerebral
infarction affecting right dominant side, major depressive disorder, aphasia
following cerebral infarction, muscle weakness, dysphagia, hypothyrodism, type 2
diabetes, hyperlipidemia, hypomagnesemia, hypokalemia, hypertension, gastro
esophageal reflux disease, gastritis, constipation,Metformin, morphine, statins,
latex"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "933739-1"
"933739-1" ""Staff member checked on her at 3am and patient stated that she
felt like she couldn't breathe. 911 was called and taken to the hospital. While
in the ambulance, patient coded. Patient was given CPR and ""brought back"". Once
at the hospital, patient was placed on a ventilator and efforts were made to
contact the guardian for end of life decisions. Two EEGs were given to determine
that patient had no brain activity. Guardian, made the decision to end all life
saving measures. Patient was taken off the ventilator on 1/9/2021 and passed away
at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient
had a mucus plug that she couldn't clear."" "No prior vaccinations for this
event." "Aspirin, Diazepam, Doxepin HCL, Duloxetine, Juven POW, Lamotri
Levothyroxin, Loratadine, Melatonin, Mucus Relief, Olanzapine, Prazosin HCL,
Pregabalin," "Major depression, borderline personality disorder, Cerebral
Palsy, History of dissected left carotid artery,Penicillin"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "934968-1"
"934968-1" "he passed away; not responsive; mind just seemed like it was
racing; body was hyper dried; Restless; not feeling well; ate a bit but not much;
kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous
report from a contactable consumer (brother of the patient). A 54-year-old male
patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified
route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose
for COVID-19 immunization. Medical history included diabetes and high blood
pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken
for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril
(MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient
experienced not feeling well, ate a bit but not much, kind of pale, vomiting,
trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless
on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive
and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The
clinical course was reported as follows: The patient received the vaccine on
04Jan2021, after which he started not feeling well. He went right home and went to
bed. He woke up and ate a bit but not much and then was kind of pale. The patient
then started to vomit, which continued throughout the night. He was having trouble
in breathing. Emergency services were called, and they took his vitals and said
that everything was okay, but he was very agitated; reported as not like this prior
to the vaccine. The patient was taken to urgent care where they gave him an
unspecified steroid shot and unspecified medication for vomiting. The patient was
told he was probably having a reaction to the vaccine, but he was just dried up.
The patient continued to vomit throughout the day and then he was very agitated
again and would fall asleep for may be 15-20 minutes. When the patient woke up, he
was very restless (reported as: his body was just amped up and could not calm
down). The patient calmed down just a little bit in the evening. When the patient
was awoken at 6:00 AM in the morning, he was still agitated. The patient stated
that he couldn't breathe, and his mind was racing. The patient's other brother went
to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM.
It was reported that none of the symptoms occurred until the patient received the
vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned.
The clinical outcome of all of the events was unknown; not responsive was not
recovered, the patient died on 06Jan2021. The cause of death was unknown (reported
as: not known by reporter). An autopsy was not performed. The batch/lot number for
the vaccine, BNT162B2, was not provided and has been requested during follow up.;
Reported Cause(s) of Death: not responsive and he passed away" "No prior
vaccinations for this event." "; ; ;" "Medical History/Concurrent Conditions:
Blood pressure high; Diabetes,"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "935511-1"
"935511-1" "Patient received the 1st dose of Moderna and was found deceased
in her home the next day." "No prior vaccinations for this event." "unknown"
"history of vaginal adenocarcinoma- removed with surgery in 2019,latex (skin
reaction)"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "938118-1"
"938118-1" "on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage,
stroke, aneurysm" "No prior vaccinations for this event." "multivitamin;
vitamin D" "no significant past medical history,latex"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "941811-1"
"941811-1" "Resident began having fever on 1/11/21 @0600. VS= T-102 B/P-
100/57 P- 112 RR- 24 O2 Sat 92% on RA. MD called. Rapid COVID Test was negative.
CBC,CMP, U/A were ordered as well as CXR. Resident's condition declined. At 3:00pm
resident started having respiratory distress and hypoxia O2 Sat 89%. Supplemental
O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered. Condition worsened.
Resident sent to nearest ER for evaluation. Later in the evening the staff AT
Medical Center called to inform staff that resident had expired @ 2230 as a result
of Respiratory Failure and Sepsis." "No prior vaccinations for this event."
"Haldol 2mg TWICE DAILY, DEPAKENE 750MG THREE TIMES" "HUNTINGTON'S CHOREA,
HTN, HLP, HYPOTHYROID, DEPRESSION, CONSTIPATION, AND DYSPHAGIA,NKDA & NO FOOD
ALLERGIES"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "942106-1"
"942106-1" "54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve
Stenosis, and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS,
the patient called because he was having constant, diffuse abdominal pain x 1 day
that radiated to his chest. On scene, the patient had a witnessed arrest with EMS
starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated
shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the
prior day." "No prior vaccinations for this event." "No other medications for
this event." ","
"50-59 years" "50-59" "Jan., 2021" "2021/01" "944595-1"
"944595-1" "Cardiac arrest within 1 hour Patient had the second vaccine
approximately 2 pm on Tuesday Jan 12th He works at the extended care community
and was in good health that morning with no complaints. He waited 10-15
minutes at the vaccine admin site and then told them he felt fine and was
ready to get back to work. He then was found unresponsive at 3 pm within an hour
of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field
then 30 minutes at ER was able to put him on life support yet deemed Brain dead
1-14-21 and pronounced dead an hour or so later" "No prior vaccinations for
this event." "losartan, spironolactone, carvedilol" "Cardiomyopathy,nkda"
"50-59 years" "50-59" "Jan., 2021" "2021/01" "946293-1"
"946293-1" "51 year old M with h/o O2 dependent COPD, Severe pulmonary
fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported
to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he
decompensated further, and after discussing with family and palliative care, He was
changed to comfort care. He expired on 1/12/2021@2325 at medical center." "No
prior vaccinations for this event." "Alvesco inh, Mepron susp, Coreg, Zetia,
Tricor, Umeclidinum, Cellcept, Zyprexa, Prilosec, paxil, Miralax, prednisone,
trazodone, xopenex inh" "COPD,Severe pulmonary fibrosis,HTN,GERD,none"
"60-64 years" "60-64" "Dec., 2020" "2020/12" "914805-1"
"914805-1" "RESIDENT CODED AND EXPIRED" "No prior vaccinations for this
event." "Asa-81mg, Lisinopril 10mg daily, ferrous sulfate-325, MVI with min,
zyprexia-20mg, Flomax-0.4, famotidine-20mg, vit C, carbamazepine-250mg bid,
Depakote-750mg bid, metformin-1000 bid, sertraline-100 bid, albuterol,buspar-10mg
TID, Fibercon-" "dysphagia, violent behaviors, depressive disorder,
schizophrenia, aspiration, gerd, hyperlipidemia, dipolar, rectal bleeding, HTN,NKA"
"60-64 years" "60-64" "Dec., 2020" "2020/12" "914917-1"
"914917-1" "Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine
EUA" "No prior vaccinations for this event." "Atenolol, Chlorthalidone,
Tamsulosin" "hypertension,None"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "918065-1"
"918065-1" "1/1/2020: Residents was found unresponsive. Pronounced deceased
at 6:02pm" "No prior vaccinations for this event." "- Invega Trenza 546mg
Q3months - Lithium 300mg BID - Oxybutynin 5mg QID - lipitor 20mg QHS - cogentin
2mg BID - Norvasc 5mg QD - Dyazide Capsule 37.5-25 MG (Triamterene-HCTZ) QD"
"- SCHIZOPHRENIA, UNSPECIFIED - ANEMIA, UNSPECIFIED - OVERWEIGHT -
OVERACTIVE BLADDER - ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY
WITHOUT ANGINA PECTORIS - HYPOTHYROIDISM DUE TO MEDICAMENTS AND OTHER EXOGENOUS
SUBSTANCES - NICOTINE DEPENDENCE, UNSPECIFIED, UNCOMPLICATED - CHRONIC VIRAL
HEPATITIS C - UNSPECIFIED AGE-RELATED CATARACT - ESSENTIAL (PRIMARY) HYPERTENSION
- CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED - UNSPECIFIED CONVULSIONS -
INHALANT ABUSE, UNCOMPLICATED - OTHER SEIZURES,- Clozaril - Tegretol"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "923993-1"
"923993-1" "Patient was vaccinated Dec 30, 2020. Prime dose of Moderna
vaccine. Observed for full 15 minutes post-injection. No complaints when asked
during observation. Released. Subsequently, vaccine clinic staff learned from the
patient's supervisor that on Jan 4, 2021 that the patient had expired on Jan 2,
2021. By report from the supervisor, the patient was found dead at his home. The
patient's primary care provider was unaware of his death when contacted by this
reporter today (Jan 6, 2021). Electronic Medical Record without any information
since the vaccination." "No prior vaccinations for this event." "Unknown"
"History of stage II (T3N0) appendiceal carcinoma - s/p resection Dec 2014.
CAD s/p stenting Diabetes Mellitus Hyperlipidemia Hypertension Glaucoma,Hay fever"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "924464-1"
"924464-1" "coughing up blood, significant hemoptysis -- > cardiac arrest.
started day after vaccine but likely related to ongoing progression of lung cancer"
"No prior vaccinations for this event." "No other medications for this
event." "COPD, lung cancer,"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "930154-1"
"930154-1" "Notified today that he passed away. No other details known at
this time." "No prior vaccinations for this event." "unknown" "unknown,Sulfa"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "932898-1"
"932898-1" "The patient had an apparent cardiac arrest on 12/23/20 and was
admitted to the ICU. He was taken off of life support on 12/30/20. He had known
cardiac disease." "No prior vaccinations for this event." "Amlodipine,
Atorvastatin, Xarelto, Aspirin (These were medications listed with our office in
2019. Unknown if this patient was still taking at time of vaccination)." "High
blood pressure. Congenital unicuspid aortic valve s/p aortic valve replacement 2001
& 2011. Pacemaker placement 2011. Melanoma,None known."
"60-64 years" "60-64" "Jan., 2021" "2021/01" "933090-1"
"933090-1" "Patient died, I have a copy of his vaccination card""No prior
vaccinations for this event." "Unknown" "Unknown,Unknown"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "935815-1"
"935815-1" "Difficulty breathing, death." "No prior vaccinations for
this event." "No other medications for this event." ","
"60-64 years" "60-64" "Jan., 2021" "2021/01" "937569-1"
"937569-1" "patient reported expired 1/7/2021" "No prior vaccinations for
this event." "unknown" "unknown,unknown"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "941743-1"
"941743-1" "This person was found to be deceased on routine rounds during
the night, 3am. No symptoms of reaction noted post vaccine. No injection site
reaction. No reports of any allergic reaction." "No prior vaccinations for this
event." "Amitiza, Anastrozole, Calcium Carbonate, Levemir, Novolog, Docusate,
Fiber Lax, Fluvoxamine Maleate, Gavilax, Glucerna, Ketoconazole, levetiracetam,
loratadine, Selenium sulfide lotion, vimpat, vitamin D3, Prolia AS needed
medications: fle" "Benign polycythemia, Type II DM, Anxiety, Epilepsy, Blepharitis
(bilateral), cataract (not specified), Allergic rhinitis, constipation, scoliosis,
osteoporosis, dyspahgia, urinary incontinence, Dermatitis, breast cancer (right
breast lumpectomy), history of respiratory infection, DNR AND MOLST were in place
at time of death,No known drug or food allergies"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "942085-1"
"942085-1" "No adverse effects from vaccination seen on 1/2/21. On 1/6/21
resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen
4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over
3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02
70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was
notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA
noted, reported all over pain. At 0850 when they attempted to reposition the
resident, she was not responsive. Licensed nurse assessed her and no heartbeat
heard or pulse found." "No prior vaccinations for this event." "Ativen, Butrans
Patch, Tylenol, Potassium Citrate-Citric Acid" "see #11.,Amoxicillin, Clavulanic
Acid, Codeine, Morphine, Pencillin"
"60-64 years" "60-64" "Jan., 2021" "2021/01" "944439-1"
"944439-1" "Resident expired on 1/2/21." "No prior vaccinations for this
event." "Keppra, Levothyroxine, Miralax, Olanzapine, Trazadone, Risperidone,
and Lorazepam" "Stage 4 kidney function,N/A"
"65+ years" "65+" "Dec., 2020" "2020/12" "909095-1" "909095-1" "on
12/24/2020 the resident was sleepy and stayed in bed most of the shift. He stated
he was doing okay but requested pain medication for his legs at 250PM. At 255AM on
12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
foam coming from mouth and unresponsive. He was not breathing and with no pulse"
"No prior vaccinations for this event." "Tamsulosin 0.4mg, Lactobacillus
tablet, Nephro-vite tablet 0.8mg, Allopurinol 100mg, ferrous gluconate 324mg,
melatonin 6mg, lisinopril 2.5mg, colace 100mg, metamucil powder, aspirin 81mg,
amidoarone 200mg, hydrooxyzine 25mg, cholestyramine" "Refused dialysis frequently
resulting in episodes of hypokalemia and hospitalization, resident dependent on
supplemental oxygen. The resident refused to go to dialysis on 12/23/2020 and said
he was feeling fine.,alprazolam, Lorazepam"
"65+ years" "65+" "Dec., 2020" "2020/12" "910363-1" "910363-1"
"Patient had mild hypotension, decreased oral intake, somnolence starting 3
days after vaccination and death 5 days after administration. He did have advanced
dementia and was hospice eligible based on history of aspiration pneumonia." "No
prior vaccinations for this event." "risperidone daily doxazosin" "history of
aspiration pneumonia BPH,none"
"65+ years" "65+" "Dec., 2020" "2020/12" "913143-1" "913143-1"
"Vaccine administered with no immediate adverse reaction at 11:29am. Vaccine
screening questions were completed and resident was not feeling sick and
temperature was 98F. At approximately 1:30pm the resident passed away." "No
prior vaccinations for this event." "Gabapentin 100mg, Memantine 10mg" "dementia,
aphasia, type 2 DM, iron deficiency, asthenia, osteoporosis, polyneuropathy,
anxiety, MDD,codeine, phenobarbital, penicillin"
"65+ years" "65+" "Dec., 2020" "2020/12" "913733-1" "913733-1" "My
grandmother died a few hours after receiving the moderna covid vaccine booster 1.
While I don?t expect that the events are related, the treating hospital did not
acknowledge this and I wanted to be sure a report was made." "No prior
vaccinations for this event." "No other medications for this event." ","
 "65+ years" "65+" "Dec., 2020" "2020/12" "913881-1" "913881-1" "the
patient died; This is a spontaneous report from a contactable consumer through a
Pfizer employee. A 98-99 years old patient of an unspecified gender received
bnt162b2 (COMIRNATY), via an unspecified route of administration possibly on
27Dec2020 at single dose for covid-19 immunization. The patient's medical history
and concomitant medications were not reported. The patient died on 29Dec2020. Event
details: The Pfizer employee was informed, by a member of the Covid vaccine team at
the ministry of health, that an elderly person 98-99 years old, who used to stay in
an elderly home, who also had other serious diseases and received the vaccine
possibly on 27Dec2020, had died this morning (29Dec2020). As it was mentioned to
the Pfizer employee, they were 'sure' that the cause of death did not related to
the vaccine. It was not reported if an autopsy was performed. Information on the
lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of
death" "No prior vaccinations for this event." "No other medications for
this event." ","
"65+ years" "65+" "Dec., 2020" "2020/12" "914604-1" "914604-1"
"Spouse awoke 12/20 and found spouse dead. Client was not transferred to
hospital." "No prior vaccinations for this event." "No other medications for
this event." ","
"65+ years" "65+" "Dec., 2020" "2020/12" "914621-1" "914621-1"
"Resident in our long term care facility who received first dose of Moderna
COVID-19 Vaccine on 12/22/2020, only documented side effect was mild fatigue after
receiving. She passed away on 12/27/2020 of natural causes per report. Has
previously been in & out of hospice care, resided in nursing home for 9+ years,
elderly with dementia. Due to proximity of vaccination we felt we should report the
death, even though it is not believed to be related." "No prior vaccinations for
this event." "No other medications for this event." "Resident in long term
care facility for 9+ years Coronary Artery Disease Dementia Hypothyroidism
Hypertension,"
"65+ years" "65+" "Dec., 2020" "2020/12" "914690-1" "914690-1"
"Within 24 hours of receiving the vaccine, fever and respiratory distress,
and anxiety developed requiring oxygen, morphine and ativan. My Mom passed away on
the evening of 12/26/2020." "No prior vaccinations for this event." "Contact
facility for medical records. We think levothyroxine daily and ativan prn."
"COPD,none known"
"65+ years" "65+" "Dec., 2020" "2020/12" "914895-1" "914895-1"
"Injection given on 12/28/20 - no adverse events and no issues yesterday;
Death today, 12/30/20, approx.. 2am today (unknown if related - Administrator
marked as natural causes)" "No prior vaccinations for this event." "Senna Plus,
Loperamide, Ondansetron, Acetaminophen, Mucus & Chest Relief cough syrup,
Oystershell Calcium Plus D, Vitamin D3, Escitalopram, Bupropion,
Hydrocodone/Acetaminophen, Bisacodyl Suppositories" "Alzheimer's Disease,
Encephalopathy, Hypertension,No known drug allergies"
"65+ years" "65+" "Dec., 2020" "2020/12" "914961-1" "914961-1" "pt
passed away with an hour to hour and 1/2 of receiving vaccine. per nursing home
staff they did not expect pt to make it many more days. pt was unresponsive in
room when shot was given. per nursing home staff pt was 14 + days post covid"
"No prior vaccinations for this event." "No other medications for this
event." ",none listed"
"65+ years" "65+" "Dec., 2020" "2020/12" "914994-1" "914994-1" "pt
was a nursing home pt. pt received first dose of covid vaccine. pt was monitored
for 15 minutes after getting shot. staff reported that pt was 15 days post covid.
Pt passed away with in 90 minutes of getting vaccine" "No prior vaccinations for
this event." "not known" ","
"65+ years" "65+" "Dec., 2020" "2020/12" "915562-1" "915562-1" "pt
received vaccine at covid clinic on 12/30 at approximately 3:30, pt vomited 4
minutes after receiving shot--dark brown vomit, staff reported pt had vomited night
before. Per staff report pt became short of breath between 6 and 7 pm that night.
Pt had DNR on file. pt passed away at approximately 10pm. Staff reported pt was
14 + days post covid" "No prior vaccinations for this event." "No other
medications for this event." ",none listed"
"65+ years" "65+" "Dec., 2020" "2020/12" "915682-1" "915682-1"
"Resident received vaccine per pharmacy at the facility at 5 pm.
Approximately 6:45 resident found unresponsive and EMS contacted. Upon EMS arrival
at facility, resident went into cardiac arrest, code initiated by EMS and
transported to hospital. Resident expired at hospital at approximately 8 pm"
"No prior vaccinations for this event." "No other medications for this
event." "Respiratory Disease, Essential Hypertension, Coronary Artery Disease,
History of positive COVID 11/17/20,No Known allergies"
"65+ years" "65+" "Dec., 2020" "2020/12" "915880-1" "915880-1"
"Patient died within 12 hours of receiving the vaccine." "No prior
vaccinations for this event." "Refused anything PO for about one week prior to
death." ",No known allergies."
"65+ years" "65+" "Dec., 2020" "2020/12" "915920-1" "915920-1"
"Resident received vaccine in am and expired that afternoon." "Tetanus
toxoid" "ASA 81, Vitamin D, Vitamin B12, Atorvastatin, Omeprazole, Tylenol,
Donepezil, Amlodipine, Coreg, Remeron" "Vitamin deficiency, hyperlipidemia,
hypertension, anemia, dementia, chronic kidney disease III, osteoporosis, history
of breast cancer/MI/pulmonary embolism, depression.,Tetanus toxoid"
"65+ years" "65+" "Dec., 2020" "2020/12" "922977-1" "922977-1"
"Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100
mg daily" "No prior vaccinations for this event." "No other medications for
this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "917117-1" "917117-1" "After
vaccination, patient tested positive for COVID-19. Patient was very ill and had
numerous chronic health issues prior to vaccination. Facility had a number of
patients who had already tested positive for COVID-19. Vaccination continued in an
effort to prevent this patient from contracting the virus or to mitigate his risk.
This was unsuccessful and patient died." "No prior vaccinations for this event."
"Quietapine, Mertazipine, Hydrocodone, Fentanyl" "Yes,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "917790-1" "917790-1" "At
the time of vaccination, there was an outbreak of residents who had already tested
positive for COVID 19 at the nursing home where patient was a resident. About a
week later, patient tested positive for COVID 19. She had a number of chronic,
underlying health conditions. The vaccine did not have enough time to prevent
COVID 19. There is no evidence that the vaccination caused patient's death. It
simply didn't have time to save her life." "No prior vaccinations for this
event." "Torsemide, Trazadone, Amitizide, Morphine Sulfate, Fentanyl,
Carbidoba-Levodopa, Prednisone, Potassium Chloride, Escalitapram, Incruse Ellipta,
Mirtazipane, Clonazepam, Levothyroxine" "Thyroid disease, chronic elderly
conditions.,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "917793-1" "917793-1" "Prior
to the administration of the COVID 19 vaccine, the nursing home had an outbreak of
COVID-19. Patient was vaccinated and about a week later she tested positive for
COVID-19. She had underlying thyroid and diabetes disease. She died as a result
of COVID-19 and her underlying health conditions and not as a result of the
vaccine." "No prior vaccinations for this event." "Metoprolol-Tartrate,
Latanoprost, Glipizide, Pravastatin, Metformin, Benaprezil, Potassium-Chloride,
Levothyroxine" "Diabetes, Thyroid Disease,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "918388-1" "918388-1"
"Resident found unresponsive without pulse, respirations at 04:30 CPR
performed, expired at 04:52 by Rescue" "No prior vaccinations for this event."
"Albuteral Sulfate Amlodipine Carvedilol Ipratropium Levetiracetam Olanzapine
Sodium Chloride Symbicort Valproic Acid" "As noted above,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "918418-1" "918418-1"
"Resident became SOB, congested and hypoxic requiring oxygen, respiratory
treatments and suctioning. Stabilized after treatment and for the next 72 hours
with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and
respirations. Resident was a DNR on Hospice." "No prior vaccinations for this
event." "Mucomyst ASA Benadryl Periactin Colace Ferrous Sulfate Folic Acid
Gabapentin Sennosides Albuterol Ipratropium Melatonin MVI Oxycodone Polyethylene
Glycol Seroquel Rosuvastatin Valproic Acid Venlafaxine Vitamin C" "As noted
above,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "918487-1" "918487-1" "Two
days post vaccine patient went into cardiac arrest and passed away." "No prior
vaccinations for this event." "Loratadine, Plavix, flomax, Lisinopril,
atrovastatin, amlodipine, Pentoxifylline, ASA, Donepezil, trazodone, Metoprolol
tartrate." "HTN, PVD, Dementia,Beta Adrenergic Blockers"
"65+ years" "65+" "Jan., 2021" "2021/01" "919108-1" "919108-1"
"Fever, Malaise" "No prior vaccinations for this event." "No other
medications for this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "919537-1" "919537-1"
"Resident exhibited no adverse events during 30 minute monitoring following
vaccine administration. Resident found without pulse at 1900." "No prior
vaccinations for this event." "Robitussin Cough+Chest Cong DM Liquid 5-100 MG/5ML
(Dextromethorphan-guaiFENesin) Tylenol Extra Strength Tablet (Acetaminophen)
amLODIPine Besylate Tablet 5 MG Morphine Solu Tab 2.5MG Capsaicin Cream 0.025 %
Leflunomide Tablet 10 MG Levothy" "ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART
FAILURE RHEUMATOID ARTHRITIS, UNSPECIFIED ANEMIA, UNSPECIFIED HYPOTHYROIDISM,
UNSPECIFIED CACHEXIA ESSENTIAL (PRIMARY) HYPERTENSION DEMENTIA IN OTHER DISEASES
CLASSIFIED ELSEWHERE WITHOUT BEHAVIORAL DISTURBANCE AGE-RELATED PHYSICAL DEBILITY
OTHER CHRONIC PAIN DILATED CARDIOMYOPATHY ERYTHEMATOUS CONDITION, UNSPECIFIED
UNSPECIFIED OSTEOARTHRITIS, UNSPECIFIED SITE PRIMARY GENERALIZED (OSTEO)ARTHRITIS
OTHER SPONDYLOSIS WITH RADICULOPATHY, LUMBAR REGION HYPERKALEMIA OTHER
INTERVERTEBRAL DISC DEGENERATION, LUMBAR REGION AGE-RELATED OSTEOPOROSIS WITHOUT
CURRENT PATHOLOGICAL FRACTURE CERVICALGIA OTHER BIOMECHANICAL LESIONS OF LUMBAR
REGION ��� BILATERAL PRIMARY OSTEOARTHRITIS OF KNEE LOCALIZED EDEMA HYPO-OSMOLALITY
AND HYPONATREMIA OTHER SPECIFIED DISORDERS OF BONE DENSITY AND STRUCTURE,
UNSPECIFIED SITE HISTORY OF FALLING WEAKNESS,Celebrex and Tramadol"
"65+ years" "65+" "Jan., 2021" "2021/01" "920326-1" "920326-1"
"Redness and warmth with edema to right side of neck and under chin.
Resident was on Hospice services and expired on 1.1.21" "No prior vaccinations
for this event." "Cetirizine, Lactaid" "G30.1 Alzheimer's disease with late
onset (Primary) M19.90 Unspecified osteoarthritis, unspecified site J44.9 Chronic
obstructive pulmonary disease, unspecified I95.1 Orthostatic hypotension J45.909
Unspecified asthma, uncomplicated R13.12 Dysphagia, oropharyngeal phase M15.0
Primary generalized (osteo)arthritis M85.80 Other specified disorders of bone
density and structure, unspecified site Note: Osteopenia J30.9 Allergic rhinitis,
unspecified F41.1 Generalized anxiety disorder M24.511 Contracture, right
shoulder M24.512 Contracture, left shoulder M24.521 Contracture, right elbow
R29.3 Abnormal posture M17.4 Other bilateral secondary osteoarthritis of knee
M25.561 Pain in right knee R26.89 Other abnormalities of gait and mobility Z74.1
Need for assistance with personal care Z91.81 History of falling M62.81 Muscle
weakness (generalized) R29.6 Repeated falls R27.8 Other lack of coordination
R63.3 Feeding difficulties E73.8 Other lactose intolerance R53.1 Weakness I95.89
Other hypotension,Lactose"
"65+ years" "65+" "Jan., 2021" "2021/01" "920368-1" "920368-1"
"12/30/2020 07:02 AM Resident noted to have some redness in face and
respiration were fast. Resident vital signs were abnormal except blood pressure.
Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored
at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable
in bed. Notified triage of change in condition also made triage aware of resident
receiving Covid vaccination yesterday morning. Resident appetite and fluid
consumption has been poor for few days. 12/30/2020 07:32 AM Received order from
agency to administer Acetaminophen 650mg suppos rectally due to resident not
wanting to swallow anything including fluids, medications and food. This writer
administered medication as NP ordered. Will monitor for effectiveness and adverse
effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab,
obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of
resident having temperature and vital signs excluding b/p that was abnormal. Family
was thankful for call and inierated to nurse that family does not want resident
sent to hospital. Did educate family on benefits of Hospice services, but family
persistant on continued daily care provided by nursing staff. Requests visits if
decline continues. Family assured if resident continues to decline, facility will
accomandate resident family to be able to be at bedside when time comes to do so.
NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for
Hospice services and not have resident provided with IVF or IV Antibiotics" "No
prior vaccinations for this event." "Acetaminophen, Atenolol, Colace, Lisinopril,
Mirtazapine, Omeprazole, Simvastatin, Vitamin D3" "U07.1 2019-nCoV acute
respiratory disease (Primary) F03.90 Unspecified dementia without behavioral
disturbance E78.5 Hyperlipidemia, unspecified K21.9 Gastro-esophageal reflux
disease without esophagitis I10 Essential (primary) hypertension Z74.09 Other
reduced mobility M62.81 Muscle weakness (generalized) R13.12 Dysphagia,
oropharyngeal phase R26.81 Unsteadiness on feet R27.8 Other lack of coordination
R41.841 Cognitive communication deficit R54 Age-related physical debility D53.9
Nutritional anemia, unspecified R29.6 Repeated falls M13.80 Other specified
arthritis, unspecified site M25.512 Pain in left shoulder M19.012 Primary
osteoarthritis, left shoulder K59.09 Other constipation R26.89 Other
abnormalities of gait and mobility R63.8 Other symptoms and signs concerning food
and fluid intake M85.89 Other specified disorders of bone density and structure,
multiple sites Note: Osteopenia M24.512 Contracture, left shoulder J43.9
Emphysema, unspecified,quinine sulfate"
"65+ years" "65+" "Jan., 2021" "2021/01" "920545-1" "920545-1" ""The
resident received is vaccine around 11:00 am and tolerated it without any
difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22
pm when he stated he was too tired and could not do anymore. The therapist took him
back to his room at that time and he got into bed himself but stated his legs felt
heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to
the bathroom. She stated that when he went to get back into the bed it was
""abnormal"" how he was getting into it so she assisted him. At that time he quit
breathing and she called a RN into the room immediately. He was found without a
pulse, respirations, or blood pressure at 1:54 pm. He was a DNR."" "No prior
vaccinations for this event." "Ferrex 150 mg, Folic Acid 1 mg, Furosemide 20 mg,
Isosorbide Mononoitrate ER 30 mg, Lactulose 15 mL, Omeprazole 40 mg, Potassium
Chloride ER 20 MEQ, Metoprolol 12.5 mg, PreserVision AREDS 2 one capsule,
Ranolazine ER 1,000 mg, and Sucralf" "ACUTE POSTHEMORRHAGIC ANEMIA,
ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH OTHER FORMS OF ANGINA
PECTORIS, CARDIAC MURMUR, UNSPECIFIED, CHRONIC KIDNEY DISEASE, STAGE 2, CHRONIC
OBSTRUCTIVE PULMONARY DISEASE, EMPHYSEMA, ESSENTIAL (PRIMARY) HYPERTENSION,
FRACTURE OF NASAL BONES, INITIAL ENCOUNTER FOR CLOSED FRACTURE, HYPOXEMIA,
PAROXYSMAL ATRIAL FIBRILLATION, PRESENCE OF CARDIAC PACEMAKER, THROMBOCYTOPENIA,
UNSPECIFIED CIRRHOSIS OF LIVER, and UNSPECIFIED DIASTOLIC (CONGESTIVE) HEART
FAILURE.,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "920832-1" "920832-1"
"Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID
test result came back positive 1/2/2021 Deceased 1/4/2021" "No prior vaccinations
for this event." "No other medications for this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "920891-1" "920891-1"
""deceased on 31Dec2020 with no previous side effect; This is a spontaneous
report from a contactable physician via ""Pfizer"". An 87-year-old female patient
received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot
Number: ""not known because vaccination team vaccinated at care home""), via an
unspecified route of administration on 29Dec2020 at a single dose for COVID-19
immunization. The patient's medical history included upper respiratory tract
infection, changing patient weakness; both from an unknown date and unknown if
ongoing. Concomitant medications were not reported. The patient experienced:
deceased on 31Dec2020 with no previous side effect; which resulted in death on
31Dec2020. The clinical course was reported as follows: the patient received the
first dose of the PFIZER-BIONTECH COVID-19 MRNA VACCINE on 29Dec2020; and the
patient was deceased on 31Dec2020 with no previous side effect. The patient
received the vaccination with a negative COVID-test on 25Dec2020; ""in case of
upper respiratory tract infection and changing patient weakness"". The physician
reported that ""after good breakfast at 09:13 found without vital signs during
routine control."" The clinical outcome of the event was fatal. The patient died on
31Dec2020 due to unknown cause of death. It was unknown if an autopsy was
performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA
VACCINE, were not provided and will be requested during follow up.; Sender's
Comments: The limited information available does not allow a meaningful assessment
by the company. The advance old patient had upper respiratory tract infection,
changing patient weakness; further information such as complete medical history,
concomitant treatments, particularly death cause and autopsy results are needed for
fully medical assessment. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate.; Reported Cause(s) of Death: deceased on
31Dec2020 with no previous side effect"" "No prior vaccinations for this event."
"No other medications for this event." "Medical History/Concurrent
Conditions: Upper respiratory tract infection; Weakness,"
"65+ years" "65+" "Jan., 2021" "2021/01" "921175-1" "921175-1"
"Resident received Covid Vaccine, noted after 30 mins with labored breathing
BP 161/77, HR 116, R 38, T 101.4," "No prior vaccinations for this event." "No
other medications for this event." "CHF, COPD, DM, heart failure, anemia, sleep
apnea,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "921481-1" "921481-1"
"Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic
and sluggish and developed a rash on forearms. He was a Hospice recipient and
doctor and Hospice ordered no treatment, just to continue to monitor. When no
improvement of codition reported, doctor and Hospice ordered comfort meds
(Morphine, Ativan, Levsin). Resident expired on 1/4/2021" "No prior vaccinations
for this event." "Vitamin D3 5000 units qd Furosemide 20mg qd Olanzapine 2.5mg
bid" "Dementia PVD,No known allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "921547-1" "921547-1" "DEATH
ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20" "No prior vaccinations for
this event." "Acetaminophen Tablet 325 MG Give 2 tablet by mouth every 6 hours
as needed for Pain. elevated Temp. Phone Active 05/08/2020 05/08/2020 AmLODIPine
Besylate Tablet 10 MG Give 1 tablet by mouth one time a day related to ESSENTIAL
(PRIMARY) HYP" "UNCONTROLLED DIABETES MELLITUS ON INSULIN,NKDA"
"65+ years" "65+" "Jan., 2021" "2021/01" "921572-1" "921572-1"
"Resident had body aches, a low O2 sat and had chills starting on 12/30/20.
He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a
diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat
dropped again. He later went unresponsive and passed away.""No prior vaccinations
for this event." "Fluticasone, Lasix, Omeprazole, Sucarafate, Ropinrole HCl"
"Chronic Kidney Disease, Atherosclerotic Heart Disease,Lisinopril, Losartan"
"65+ years" "65+" "Jan., 2021" "2021/01" "921880-1" "921880-1" "The
resident was found deceased a little less than 12 hours following COVID
vaccination, and he had had some changes over the last 2 days. He was 96 and had
been on hospice care for a little while. Noone noticed any side effects from
vaccine after it was given" "No prior vaccinations for this event." "Olanzapine,
polyethylene glycol, ativan, morphine, senna" "alzheimers disease, ataxia, HTN,
Kidney malignancy history, Prostate cancer history, GERD, sleep apnea, history
falls,oxycodone"
"65+ years" "65+" "Jan., 2021" "2021/01" "924126-1" "924126-1"
 "resident expired 1/1/2021" "No prior vaccinations for this event."
"Singulair, lopressor, pepcid, omeprazole, lasix, albuterol, azelastine eye
gtts, calcium, eliquis, prozac, terazosin, magnesium oxide, potassium" "CHF, Heart
Failure, hypertension, Atrial-fibrillation, Crohns disease.,Asa, Cardizem, delsyn,
doxycycline, levaquin, motrin, prevacid, vicodin"
"65+ years" "65+" "Jan., 2021" "2021/01" "924186-1" "924186-1"
"Resident expired 1/3/21" "No prior vaccinations for this event."
"aldactone, lasix, aspirin, tylenol, potassium, spiriva" "alzheimers
dementia, COPD , DM- type 2,Codeine, Penicillin, Sulfa"
"65+ years" "65+" "Jan., 2021" "2021/01" "924456-1" "924456-1"
"Patient did not display any obvious signs or symptoms; the vaccination was
administered at approximately 10:00 AM and the patient continued throughout her day
without any complaints or signs of adverse reaction. Patient was helped to bed by
the nursing assistant estimated at around 9:00 PM. The facility received
notification from the lab around 11:00 PM that the patient's COVID-19 specimen
collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to
the room to check on the resident and prepare her to move to a COVID-19 care area
the patient was found unresponsive, no movement, no chest rises, noted
regurgitated small amount of food to mouth left side, lying on left side. Pupils
non reactive." "No prior vaccinations for this event." "Lexapro, famotidine,
Namenda, Seroquel, simvastatin, Trazodone; Tamsulosin; Docusate sodium;
Polyethylene glycol; Celebrex; Acetaminophen" "Hyperlipidemia; Alzheimer's
disease; Atherosclerotic heart disease of native coronary artery w/o angina
pectoris; Osteoarthritis; Major depressive disorder, single episode, unspecified;
unspecified severe protein-calorie malnutrition,No known allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "924664-1" "924664-1" "At
approximately, 1855, I was alerted by caregiver, resident was not responding. Per
caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth
open, observed gurgling noises and tongue hanging out of mouth. This primary
caregiver observed resident at baseline and ambulating after dinner at
approximately, 1800 less than an hour prior to incident. This PCG called 911 for
EMS and gave report of incident. Resident was taken to Medical Center Emergency
Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT
scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN,
resident was still unresponsive and was admitted to Medical Center for observation
and comfort measures. This primary caregiver reported to RN, resident recently
received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received
a call from Castle RN at 0700, resident expired at 0615." "No prior vaccinations
for this event." "Metoprolol succ ER 50mg 1 tab PO daily Omeprazole DR 20mg 1 cap
PO daily Amlodipine besylate 5mg 1 tab PO daily Aspirin 81mg 1 tab PO daily
Carbamazepine ER 100mg 1 tab PO TID Docusate 100mg 1 cap PO daily Multivitamin 1
tab PO daily Olmesa" "history of stroke, hyperlipidemia, dementia, GERD, and
macular degeneration,Hydrochlorothiazide"
"65+ years" "65+" "Jan., 2021" "2021/01" "925154-1" "925154-1"
"Deceased" "No prior vaccinations for this event." "Avorstatin Aspirin
Oxycodone" "COPD,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "925264-1" "925264-1" "PT
was found deceased in his home on 1/5/2021" "No prior vaccinations for this
event." "Norco 5/325 1 tablet every 6 hours as needed. Warfarin 4mg , 2 tablets
orally Monday and Friday Torsemide 100mg, 1/2 tablet orally once a day Sabcubitril-
Valsartan 24/26mg 1/4 tablet orally twice a day Gabapentin 300mg, tablet once daily
Ca" "CHF HTN DM 2 CKD Obesity DDD,NKDA"
"65+ years" "65+" "Jan., 2021" "2021/01" "925556-1" "925556-1"
"Expired 1/05/2021" "No prior vaccinations for this event." "No other
medications for this event." "CAD, CKD, DM type 2, CHF, Hx TIA, Atrial
fibrillation,"
"65+ years" "65+" "Jan., 2021" "2021/01" "926269-1" "926269-1" ""Pt
last seen at 1200 by nurse for ID band check. No visible signs of distress noted.
Pt states ""I just want to be left alone"". 1230 nurse was called to pt room. Pt
was noted unresponsive, no pulse and respiration noted. CPR started immediately, at
1239 first shock given. 1245 EMT took over, at 1319 EMT called time of death""
"No prior vaccinations for this event." "Acetaminophen Tablet 325 MG,
Enulose Solution 10 GM/15ML (Lactulose Encephalopathy), HYDROcodone-Acetaminophen
Tablet 5-325 MG, Milk of Magnesia Suspension 400 MG/5ML (Magnesium Hydroxide,
Potassium Chloride ER Tablet Extended Release 20 ME" "Abdominal aortic aneurysm
CHRONIC OBSTRUCTIVE PULMONARY DISEASE tobacco abuse, EtOH abuse Ambulatory
dysfunction, debility, high risk for falls, deconditioning, ambulatory
dysfunction/debility/deconditioning/high fall risk/generalized weakness MAJOR
DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED PERSONAL HISTORY OF MALARIA,No Known
Allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "926462-1" "926462-1"
"Patient developed hypoxia on 1/4/2021 and did not respond to maximal
treatment and passed way on 1/5/2021" "No prior vaccinations for this event."
"Lorazepam, pantoprazole, miralax, senna plus, carbodopa-levodopa,
metoprolol, mirtazipine, quetiapine" "Advanced dementia, Parkinson's'
disease ,chronic kidney disease, sciatica, hyperlipidemia,no known food or
medication allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "926568-1" "926568-1"
"patient declined 12/30/2020 and was transferred to hospital where he did not
respond to treatment and passed away 1/4/2020" "No prior vaccinations for this
event." "alprazolam, amlodipine, ASA, cilostazol, advair, lamotrigine,
,losartan, metoprolol,omprazole,simvastatin" "dementia, peripheral vascular
disease, COPD, hypertension, GERD, S/P CVA with stent of left carotid ,right common
iliac and right external iliac arteries, CDK,diabetes,clopidigrel, sulfa, vicodin"
"65+ years" "65+" "Jan., 2021" "2021/01" "926600-1" "926600-1"
"Patient did not report any signs or symptoms of adverse reaction to vaccine.
Patient suffered from several comorbidities (diabetes and renal insufficiency).
Patient reported not feeling well 01/06/2021 and passed away that day." "No
prior vaccinations for this event." "Unknown" "Diabetes, renal
insufficiency,Penicillin, ibuprofen"
"65+ years" "65+" "Jan., 2021" "2021/01" "926797-1" "926797-1" "had a
vaccination on 12/31/2020 late morning passed away early morning 01/01/2020. This
is a 93 year old with significant heart issues. EF of 20% among other
comorbidities. He died suddenly approximately 0430, it is unlikely it was related
to receiving the vaccine." "No prior vaccinations for this event." "No other
medications for this event." "Heart disease,"
"65+ years" "65+" "Jan., 2021" "2021/01" "927189-1" "927189-1"
"Patient was vaccinated at 11am and was found at the facility in his room
deceased at approximately 3:00pm. Nurse did not have cause of death" "No prior
vaccinations for this event." "unknown" "hypertension, atrial fibrillation,
atherosclerosis,,none"
"65+ years" "65+" "Jan., 2021" "2021/01" "927260-1" "927260-1" "No
adverse effects noted after vaccination. Patient with cardiac history was found
unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed
SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
was regained and patient was breathing. Patient sent to Hospital ER were she
remained in an unstable condition had multiple cardiac arrest and severe
bradycardia and in the end the hospital was unable to bring her back." "No prior
vaccinations for this event." "Vit D3, Miralax, Spironolactone, Tramadol,
Metoprolol Succinate, MOM, Ferrous Gluconate, Ondansetron, Nitroglycerin
Sublingual PRN, PreserVision AREDS, Fluticasone Propionate Suspension, Lisinopril,
Clopidogrel Bisulfate, Campor-Methol-Met" "HTN, AAA, Chronic Diastolic Heart
Failure, Diabetes Type 2, Paroxysmal atrial fibrillation, bradycardia, Hx of
STEMI, Hx of CVA, HX of uterine cancer,,Codeine, Meperidine, Morphine, Estrogens,
Penicillins, Tetanus Toxoids"
"65+ years" "65+" "Jan., 2021" "2021/01" "928062-1" "928062-1"
"vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21.
Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died
01/07/21." "No prior vaccinations for this event." "ACETAMINOPHEN CARBIDOPA-
LEVODOPA CARBIDOPA-LEVODOPA ER CITALOPRAM HBR DONEPEZIL HCL EUCERIN FINASTERIDE
FLOMAX LATANOPROST OMEPRAZOLE QUETIAPINE FUMARATE QUETIAPINE FUMARATE SENNA LAX"
"Parkinson's Disease with advanced dementia, dysphagia. Alcoholism in
remission. HTN. BPH. GERD,angioedema due to ACE and ARB meds"
"65+ years" "65+" "Jan., 2021" "2021/01" "928513-1" "928513-1"
"Resident passed away in her sleep" "No prior vaccinations for this event."
"Amiodarone Hcl, Carvedilol, Ferrous sulfate, Eliquis (cont)" "CDK stage
4, Atrial fibrillation, 1st degree AV block, Patient was under hospice
care,Aldactone, contrast dye"
"65+ years" "65+" "Jan., 2021" "2021/01" "929023-1" "929023-1"
"possible myocardial infarction; Dyspnoea; unwell; Cough; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Agency. Regulatory authority GB-MHRA-WEBCOVID-20210105105739, other manufacturer
number is GB-MHRA-ADR 24556743. A 76-year-old male patient received BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ0553-v0003), via unspecified route
of administration on 19Dec2020 at single dose for COVID-19 vaccination. Medical
history included diabetes mellitus, angiocardiogram, cardiac failure, hypertension,
all from unspecified date and unknown if ongoing and cerebrovascular accident from
2001 and unknown if ongoing. Patient has not had symptoms associated with COVID-19
Patient has not been tested/or has had an inconclusive test for COVID-19. Unsure if
patient is enrolled in clinical trial. Concomitant medication included amlodipine,
acetylsalicylic acid (ASPIRIN (E.C.)), atorvastatin, bisoprolol, fluticasone
propionate (FLIXONASE), folic acid, colecalciferol (FULTIUM-D3), furosemide,
latanoprost, levothyroxine, insulin aspart (NOVORAPID), ramipril and insulin
detemir (LEVEMIR). On 24Dec2020, the patient experienced a cough. It was noted that
the patient's son and wife had already been coughing but no coronavirus tests had
been done at the time of this event. On an unknown date, the patient experienced
dyspnoea. It was noted that the he had become increasingly short of breath and
unwell. On 28Dec2020, the patient died. It was noted to be a possible myocardial
infarction. The patients COVID test score was unknown. The autopsy was awaited at
the time of this report. The outcome of the event possible myocardial infarction
was fatal, while other events were unknown. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: possible myocardial
infarction" "No prior vaccinations for this event." "; ASPIRIN (E.C.); ; ;
FLIXONASE; ; FULTIUM D3; ; ; ; NOVORAPID; ; LEVEMIR" "Medical
History/Concurrent Conditions: Cerebrovascular accident; Coronary angiogram (nov);
Diabetes; Heart failure; Hypertension,"
"65+ years" "65+" "Jan., 2021" "2021/01" "929359-1" "929359-1" "3:07
pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low
for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21" "No prior
vaccinations for this event." "none" "Cerebral Atherosclerosis, malnutrition,
thrombocytopenia, cva, hypothyroidism,none"
"65+ years" "65+" "Jan., 2021" "2021/01" "929997-1" "929997-1"
"Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal
failure, but was able to get up in his wheelchair and eat and take medications and
talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble,
could not swallow. No localizing neurologic findings. He was too lethargic to get
up in chair." "No prior vaccinations for this event." "Amlodipine 5 mg daily,
Dexamethasone 4 mg daily (for itching related to renal failure), Isosorbide
dinitrate 30 mg daily, Levothyroxine 0.075 mg daily, Bisoprolol 5 mg BID,
Furosemide 80 mg BID, saline nasal spray, Tylenol 1000 mg PO TID" "He was on
hospice for about the last 1 month for CHF (EF 20-25%) and renal failure (creat 3-
4). He was on hospice but was up and around and able to eat and take pills. The
day after he had his injection, he was very lethargic and only mumbled. Was not
able to take meds or eat. He was on hospice, so did not want work-up or treatment.
He passed away on 1/7 am. We don't know if it was a coincidence that he died or
if the vaccine caused him to deteriorate more quickly.,Losartan, lisinopril,
metoprolol"
 "65+ years" "65+" "Jan., 2021" "2021/01" "930386-1" "930386-1"
"Patient received first dose of vaccine on 12/28, developed COVID-19
infection shortly thereafter and expired on 1/6/2021." "No prior vaccinations
for this event." "No other medications for this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "930418-1" "930418-1"
"Patient received first dose of vaccine on 12/28, developed COVID-19
infection shortly thereafter and expired on 1/4/2021" "No prior vaccinations for
this event." "No other medications for this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "930466-1" "930466-1"
"Fever, shortness of breath and chest pain that resulted in a heart attack a
few hours after vaccination" "No prior vaccinations for this event." "No other
medications for this event." ",None"
"65+ years" "65+" "Jan., 2021" "2021/01" "930487-1" "930487-1"
"Medical docter state patient has a acute cardiac attack" "No prior
vaccinations for this event." "calcium-D tablet, cholecalciferol, fish oil,
melatonin, tylenol," "bph, apraxia, , dysphagia, muscle weakness, alzheimers
disease,cephalexin"
"65+ years" "65+" "Jan., 2021" "2021/01" "930876-1" "930876-1"
"Death" "No prior vaccinations for this event." "No other medications
for this event." "Prostate Cancer,"
"65+ years" "65+" "Jan., 2021" "2021/01" "930912-1" "930912-1"
"Diarrhea followed by death 24 hrs after vaccination""No prior vaccinations
for this event." "None" "None,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "932346-1" "932346-1" "1/7-
21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness,
headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient
deceased" "No prior vaccinations for this event." "Unknown" "hypertension,
hyperlipidemia.,Statin - muscle aches"
"65+ years" "65+" "Jan., 2021" "2021/01" "932787-1" "932787-1"
"RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS
NOTED" "No prior vaccinations for this event." "CRANBERRY, PROZAC, NEUROTIN
PERCOCET, IMMODIUM, SYNTHROID, LINZESS, LIPITOR, MELATONIN METFORMIN, PROTONIX
PLAVIX, PROAIR, ropinirole, PROAIR SYMBICORT, THIAMINE TYLENOL VIT C VOLTAREN.
ZANAX, ZOFRAN" "DEPRESSION CHRONIC LUNG ANEMIA,TRAMADOL, methocarbamol"
"65+ years" "65+" "Jan., 2021" "2021/01" "933846-1" "933846-1" ""1-2-
2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained
Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her
deceased at 3:30 pm. Dr. at hospital said it was ""cardiac
event"" according to death certificate."" "No prior vaccinations for this event."
"NONE" "NONE,NKDA"
"65+ years" "65+" "Jan., 2021" "2021/01" "934050-1" "934050-1" "Staff
reported that patient was found Friday morning (Jan 8) sitting at a table with his
head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered
patient to floor and started CPR. EMS was called and continued CPR at scene,
however they were not able to revive patient. Patient was pronounced dead at the
scene. Staff written statements following the death of patient show that he had a
fall about 1 hr. prior. It is unknown if this fall contributed to patient's death.
An autopsy has been requested." "No prior vaccinations for this event."
"Patient was a resident in Group Home Current Medications Treatments/PRN
Medications: Start Date: 04/02/14: Benztropine 2mg tab BID (8-8) 02/27/15:
Midodrine (Proamatine) 5mg tab TID (8-12-8) 12/30/15: Cetirizine 10mg tab daily
@8am 1" "Diagnosis: - Impulse Control Disorder - Epilepsy - Tardive
Dyskinesia - Ulcerative Proctitis and Colitis - Mental Retardation (mod) -
Hammer toes (bilat.) - Dermatitis (scalp/torso) - Seborrheic keratosis of left
armpit - Major Depression - Infantile Meningitis - History of Squamous Cell
Carcinoma (L arm),Allergies: NKDA"
"65+ years" "65+" "Jan., 2021" "2021/01" "934059-1" "934059-1" "Acute
anterior MI with death" "No prior vaccinations for this event." "tramadol,
calcium, Tylenol, lisinopril, Mucinex, MVI, namenda" ",anastrozole"
 "65+ years" "65+" "Jan., 2021" "2021/01" "934263-1" "934263-1" "The
resident resides in an independent living facility/apartment. The reporter at the
center was informed by his daughter he was not feeling well on 1/1/2021 (specific
symptoms could not be ascertained). He reportedly went to be COVID tested on
1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have
confirmation of his COVID results, although the reporter indicates his daughter
reports his test was positive." "No prior vaccinations for this event." "No
other medications for this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "934373-1" "934373-1"
"Patient went to bed around 11pm on Saturday PM and sometime between then and
1:30am on Sunday morning got up and went into the living room without waking up her
husband (which is normal). At 1:30am, the husband got up to use the restroom and
she was out of bed then, but the husband did not know if she was having any
problems at this time. When he got up at 7:45am, she was in the recliner and did
not move or anything, which is normal for her. At 8:45am, the husband went back
into the living room and tried to wake his wife and that is when he noticed there
was no pulse and he called 9-1-1 at this time. EMS got on scene and did CPR for 30
mins and she was pronounced dead at 9:21am." "No prior vaccinations for this
event." "Husband only knew that she took several medications." "She did
have open heart surgery in 2013. She last saw her cardiologist 4 months ago, and
she did a phone consult with him a week or so ago.,PCN & Sulfa drugs"
"65+ years" "65+" "Jan., 2021" "2021/01" "934507-1" "934507-1"
"Resident died suddenly and expectantly on 01/05/2021" "No prior
vaccinations for this event." "Coumadin 2mg po Sat-Mon-Tues-Thurs Coumadin 1mg po
Fri Sun APAP 650 mg po PRN pain or temp above 101 Amiodarone 200mg po daily Ativan
0.5mg po PRN anxiety Claritin 10mg po daily Gabapentin 100mg po BID PRN phantom
pain Miralax 17Gm po with" "Covid 19 Recovered spring 2020 Chronic stage 5
kidney disease with dialysis 3 times weekly Chronic diastolic congestive heart
failure Chronic A-fib Diabetes Mellitus with other circulatory complications
Hypertension Right and Left Below the knee amputations,KNDA KNFA"
"65+ years" "65+" "Jan., 2021" "2021/01" "934539-1" "934539-1"
"Patient received COVID-19 (Moderna) vaccine from the Health Department on
afternoon of January 8, 2021 and went to sleep approximately 2300 that night. Was
found unresponsive in bed the following morning and pronounced dead at 1336 on
January 9, 2021" "No prior vaccinations for this event." "Singulair, Oxybutynin,
Fosamax, Prednisone, Meloxicam, Eliquis, Bumetanide, Triamcinolone cream, Klor-
Con, Lisinopril, Promethazine," "Hypertension,No known allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "935222-1" "935222-1"
"Patient was reported to be deceased at home by law enforcement on 1/7/21"
"No prior vaccinations for this event." "Oxybutynin Chloride, Lasix 80mg,
hydyralazine 50mg, amlodipine 10mg, amitriptyline 10mg, ASA, Klor-Con 20meq,
Tylenol, allopurinol 100mg, Vit D3, turmeric 400mg, Lipitor 80mg, gabapentin 100mg,
baclofen 5mg, candesartan 32mg, insulin lispro" "Diabetes, CKD, CHF, HTN,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "935343-1" "935343-1" "There
were no adverse reactions. Resident Died, she had a history of issues with her
health prior to the vaccine." "No prior vaccinations for this event." "No other
medications for this event." "This resident had covid a couple months ago. she had
a bad heart and also dementia. I do not believe it was the vaccine that killed her.
I was instructed by EMS to report because the date of vaccination was three days
ago.,"
"65+ years" "65+" "Jan., 2021" "2021/01" "935350-1" "935350-1"
"Patient was found unresponsive at home with SpO2 20% 1/2/2021" "No prior
vaccinations for this event." "Symbicort 160/4.5 mcg/act inhaler Dilitiazem ER
360mg PO daily Eliquis 5mg PO twice a day Furosemide 20mg PO daily Losartan 100mg
PO daily KCL 10mEq ER PO daily Ranitidine 150mg PO Ventolin HFA 0.09mg/1ACT 2 puffs
every 4 hours as needed Me" "Paroxysmal atrial fibrillation Hypertension Chronic
iron deficiency anemia Congestive heart failure with chronic diastolic,No known
allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "935767-1" "935767-1" "My
mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on
Sunday!!!" "No prior vaccinations for this event." "IDK" "Dementia,IDK"
"65+ years" "65+" "Jan., 2021" "2021/01" "936043-1" "936043-1"
"RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM,
RESIDENT FOUND UNRESPONSIVE ON 01/05/2021." "No prior vaccinations for this
event." "atorvastatin,senna,MultiVitamin,Metamucil,metformin,Levothyroxine"
"S82.001D Unspecified fracture of right patella, subsequent encounter for closed
fracture with routine healing(Primary, Admission), M62.81 Muscle weakness
(generalized), R29.3 Abnormal posture, M19.90 Unspecified osteoarthritis,
unspecified site, E11.9 Type 2 diabetes mellitus without complications, Z86.73
Personal history of transient ischemic attack (TIA), and cerebral infarction
without residual deficits, E03.9 Hypothyroidism, unspecified, E78.5 Hyperlipidemia,
unspecified, F03.90 Unspecified dementia,PENICILLINS"
"65+ years" "65+" "Jan., 2021" "2021/01" "936738-1" "936738-1" "loss
of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21
w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any
injection site reactions, denied pain or tenderness at injection site, no
dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely
nonresponsive after being helped to the edge of bed. Per nurses, he was previously
awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid
response emergency team called d/t patient's sudden change of condition. Emergency
team helped patient into lying position. Per 1/9/21 ICU emergency team note,
patient appeared comfortable w/ no palpable radial pulse and had minimal shallow
agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP
cuffx3. Resident passed at 18:20 pm." "No prior vaccinations for this event."
"No other medications for this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "937127-1" "937127-1" "The
facility had positive cases of COVID when we were able to begin vaccinating
residents. Within about a week of vaccination, patient was tested positive for
COVID. He was 91 years old and his immune system did not have the time to allow
the vaccine to begin working before exposure. His age was a major contributing
factor to his death." "No prior vaccinations for this event." "Mirtazapine,
Fentanyl Patch," "Pain,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "937152-1" "937152-1" "The
facility had positive cases for COVID 19 when the vaccine was received and
administered to patient. With her advanced age and chronic conditions, she did not
have time to build immunity between the time of vaccination and her testing
positive." "No prior vaccinations for this event." "Metoprolol, Cephalexin,
Brimonidine, Donepezil, Losartan, Latanoprost, Timolol" "Blood pressure,
pain,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "937186-1" "937186-1" "The
facility had a number of positive COVID 19 cases prior to patients vaccination.
Due to her advanced age, chronic condition, and exposure, patient did not have the
time to build immunity after exposure before becoming positive." "No prior
vaccinations for this event." "Hydrocodone-Acetamenaphin, Lidocaine, Cefritriaxone,
Citalopram" "Pain,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "937434-1" "937434-1" "Pt
expired due to possible cardiac arrest. Unsure if this was vaccine related."
"No prior vaccinations for this event." "No other medications for this
event." "only had 1 lung,"
"65+ years" "65+" "Jan., 2021" "2021/01" "937444-1" "937444-1"
"Resident was found deceased at approximately 6pm in her apartment" "No
prior vaccinations for this event." "No other medications for this event." "Brain
bleed, sleep apnea, htn,"
"65+ years" "65+" "Jan., 2021" "2021/01" "938974-1" "938974-1"
"Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21
resident had decreased appetite noted in am but ate 100% of meal at dinner. 1/9/21
resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to
hospice. 1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake.
No emesis or loose stool noted. 12PM nurse noted resident not eating meals but
ingesting milkshake and medications without any problems. Hospice contacted for
change in condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs
to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident had blood in
stool. Resident denies any pain, on 2L of O2 for comfort." "No prior vaccinations
for this event." "No other medications for this event." ",NKDA"
"65+ years" "65+" "Jan., 2021" "2021/01" "939845-1" "939845-1" "Three
hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a
critical level and went into cardiac arrest. Staff performed full code but was
unable to bring back patient from cardiac arrest." "No prior vaccinations for
this event." "No other medications for this event." "CHF,"
"65+ years" "65+" "Jan., 2021" "2021/01" "940602-1" "940602-1"
""Patient received vaccine on 1/8/2021. On 1/9/2021 I checked on patient via
phone for symptoms or problems and he reported none but mild soreness at injection
site. On 1/10/2021 family friend called me to tell me that patient had expired at
about 8:00 pm. Patient reportedly complained of ""pain"" unspecific and collapsed
at home. Hospital reportedly told family that it appeared to be a ""heart
attack""."" "No prior vaccinations for this event." "see attached" "HTN, Type
II DM, High cholesterol,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "940822-1" "940822-1"
"patient passed away after receiving the Covid vaccine; This is a spontaneous
report from a contactable nurse. An 81-year-old male patient received BNT162B2
(PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on
07Jan2021 at 0.3 mL, single for covid-19 immunization. There was no medical
history and no concomitant medications. On 08Jan2021, the patient passed away
after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was
not performed. Investigations indicate that unspecified labs were done, but nothing
two weeks prior; no further details were provided. The patient received the first
dose the day prior. The reporting nurse discussed it with the medical director, and
he thought that he potentially passed away from the COVID vaccine. The relatedness
of the event to the suspect vaccine was reported as related by the reporting nurse
per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided
and will be requested during follow-up .; Sender's Comments: Based on the limited
information available, it is medically not possible to make meaningful causality
assessment, it is unlikely the vaccine could have contributed to the death of the
patient based on the known safety profile. However case will be reevaluated when
additional information is received during the follow-up The impact of this report
on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.; Reported
Cause(s) of Death: Stated that the patient passed away after receiving the Covid
vaccine" "No prior vaccinations for this event." "No other medications for
this event." "Comments: List of non-encoded Patient Relevant History: Patient
Other Relevant History 1: None,"
"65+ years" "65+" "Jan., 2021" "2021/01" "940855-1" "940855-1"
"Patient received her vaccination on 1/12/21 administered by pharmacy*+. She
expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse
reactions and was a hospice patient." "No prior vaccinations for this event."
"LORazepam Solution 2 MG/ML" "Resident on hospice care due to end of
life.,None"
"65+ years" "65+" "Jan., 2021" "2021/01" "940866-1" "940866-1"
""Patient was found ""acting abnormal"" on 1/9/2021 at 1215. VS HR 20-30's.
EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole, CPR
and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and
expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest."" "No
prior vaccinations for this event." "Amlodipine, ASA, Atorvastatin, Baclofen,
Risperidone, Levothyr" "Hypothyroidism, Bipolar, Profound ID, HTN, Osteopenia,
dysphagia, aphasia, TBI as a young adult,Muscle spasm, Hernia,Loxapine,
Thioridazine"
"65+ years" "65+" "Jan., 2021" "2021/01" "940954-1" "940954-1"
""Heart attack; This is a spontaneous report from a contactable consumer. An
82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH
COVID-19 MRNA VACCINE; Lot Number: and Expiration Date: Unknown), via an
unspecified route of administration in the left arm on 05Jan2021 at 13:00 at a
single dose for COVID-19 immunization; administered in doctor's office/urgent care.
The patient's medical history and concomitant medications were not reported. It was
unknown if the patient received any other vaccines within four weeks prior to the
COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-
19. Since the vaccination, the patient had not been tested for COVID-19. On
05Jan2021, the patient experienced heart attack; which resulted in death and was
assessed as medically significant. The patient also experienced the associated
symptoms of cold sweats, chest pain, shortness of breath. Therapeutic measures were
taken as a result of heart attack, which included ""life saving measures"" by the
paramedics performed upon arrival with no success. The clinical outcome of the
event, heart attack, was fatal. The patient died on 05Jan2021 due to heart attack;
as ruled by the paramedics. It was unknown if an autopsy was performed. The
batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not
provided and will be requested during follow up.; Reported Cause(s) of Death: Heart
attack"" "No prior vaccinations for this event." "No other medications for
this event." ","
"65+ years" "65+" "Jan., 2021" "2021/01" "940955-1" "940955-1"
""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes
following the vaccine administration.; Patient was found pulseless and breathless
20 minutes following the vaccine administration.; This is a spontaneous report from
a contactable other healthcare professional (HCP). A 66-year-old female patient
(pregnant at the time of vaccination: no) received the second dose of BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left
arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history
included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary
hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with
COVID-19). The patient received medication within 2 weeks of vaccination included
amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole
(ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL),
famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol
sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA
ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not
receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used
took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to
them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via
intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19
immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-
cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was
found pulseless and breathless 20 minutes following the vaccine administration
(11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021
12:30 AM because of cardiac arrest. No treatment received for the events. Outcome
of pulseless and breathless was unknown. the autopsy was performed, and autopsy
remarks was unknown. Autopsy-determined cause of death was unknown. It was
reported as non-serious, not results in death, Life threatening, caused/prolonged
hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.;
Sender's Comments: Based on the available information this patient had multiple
underlying medical conditions including morbid obesity, diastolic CHF, epilepsy,
pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these
conditions more likely contributed to patients cardiac arrest resulting in death.
However, based on a close temporal association (""Patient was found pulseless and
breathless 20 minutes following the second dose of BNT162B2 vaccine administration,
contributory role of BNT162B2 vaccine to the onset of reported events cannot be
completely excluded. The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to Regulatory Authorities, Ethics Committees
and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest;
Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-
determined cause of death was unknown"" "No prior vaccinations for this event."
"; ; EFFEXOR; ; ABILIFY; ; CRANBERRY; ; TYLENOL; ; LASIX [FUROSEMIDE];
IPRATROPIUM/ALBUTEROL; ; SENNA [SENNA ALEXANDRINA LEAF]; POLYETHYLENE GLYCOL
3350;" "Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination,
the patient was diagnosed with COVID-19); Diastolic heart failure; Epilepsy; Morbid
obesity; Pulmonary hypertension; Spinal stenosis,"
"65+ years" "65+" "Jan., 2021" "2021/01" "941215-1" "941215-1"
"Actual event and cause of death were unknown; This is a spontaneous report
from a non-contactable consumer. A 90-year-old female patient received first dose
of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 06Jan2021 at single dose for COVID Prevention. The relevant
medical history included aortic valve replacement from Nov2019. Concomitant
medications were not reported. The consumer stated that she was taking the
reporting responsibilities to report that a friend of hers, informed that the
patient passed away on Friday, and had received the COVID vaccine on Wednesday. The
consumer stated that it was unknown to her at this time, if the friend had called
to complete a report herself, regarding the incident. Their conversation was very
brief. The patient was 90 years old, and it was her friend's mother that was the
patient. Actual event and cause of death were unknown. The patient had her vaccine
on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at
Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown.
The outcome of the event was fatal. No follow-up attempts are possible;
information about lot/batch number cannot be obtained.; Reported Cause(s) of Death:
Actual event and cause of death were unknown" "No prior vaccinations for this
event." "No other medications for this event." "Medical History/Concurrent
Conditions: Aortic valve replacement (Verbatim: Aortic valve replacement),"
"65+ years" "65+" "Jan., 2021" "2021/01" "941561-1" "941561-1" "Staff
walked into resident's room around 10:00am and noted resident's left side of his
face was flaccid. Nurse was called and upon assessment resident noted to have an
unequal hand grasp with left worse. He was able to talk but was mumbled and hard to
understand. Physician, hospice, and family were notified. Resident had a stroke at
10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed
away on 1/11/2020." "No prior vaccinations for this event." "Escitalopram
Oxalate, Metformin ER, Systane balance, Colace, Refresh tears, Milk of Magnesia,
Diltiazem" "Alzheimer's Disease, Type II diabetes, Major depression disorder,
Elevated B/P readings with Hypertension, history of stroke (7/22/2019 - Acute
Lacunar Stroke),No known Allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "941607-1" "941607-1" "The
patient passed away today, 1/13/2021. She was a hospice patient. She showed no
adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up
as normal and during her morning shower she had a bowel movement, went limp and was
non-responsive. The patient passed away at 7:45 am." "No prior vaccinations for
this event." "Tylenol 325mg, Lasix 20mg, Senna 8.6mg, Aspirin 81mg,
Levothyroxine 75mcg" "End stage dementia, cerebro vascular disease, Hx left
vertebral artery aneurysm,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "942040-1" "942040-1"
"little bit of a reaction light headed after 5 minutes. vitals were low, so
observed for 30 minutes after being light headed. Patient was found unresponsive
and pronounced dead later that day." "No prior vaccinations for this event."
"unknown" "yes,unknown"
"65+ years" "65+" "Jan., 2021" "2021/01" "942072-1" "942072-1" "Death
occurred 3 days after vaccine receipt; attributed to complications of her chronic
advanced dementia with aspiration at age 87. No evidence of acute vaccine
reaction." "No prior vaccinations for this event." "Tramadol, risperidone,
fluoxetine, cyanocobalamin, colchicine, torsemide, levothyroxine" "Advanced
dementia with severe violent behavioral symptoms. Progressive decline and frailty
due to late stage dementia with likely terminal aspiration after completion of
treatment for previous aspiration pneumonia. Death attributed to complications of
her advanced dementia. No evidence of acute reaction to vaccine (rash, dyspnea,
swelling, redness). Chronic kidney disease, hypothyroidism, type 2 diabetes, gout,
B12 deficiency,No known allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "942290-1" "942290-1"
"Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB,
increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2
sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results.
Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident
transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021
with new diagnosis of Leukemia and orders for hospice. Continued with fever,
crackles and N/V and loss of appetite from the 9th and 10th of January. Resident
expired at 820am on 1/11/2021." "Influenza Virus Vaccines - Unknown date/type
or brand" "Tylenol, tylenol with codeine, Artificial Tears, ASA, Cal-Mag-Zinc,
Claritin, Sertraline, Melatonin, MOM, Latuda, Estradiol, Gabapentin, Alendronate,
Atorvastatin, Multi-Vit" "Glaucoma, Low back pain, restless leg syndrome,
Osteoporosis, Compression Fx-Lumbar,Dilaudid; Morphine Sulfate; Sulfonamides;
Influenza Virus Vaccines"
"65+ years" "65+" "Jan., 2021" "2021/01" "943266-1" "943266-1"
"Initial pain in back of head and extreme headache. Some vomiting. At
emergency, went into coma and was intubated. Hole drilled in skull to relieve
pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death
approximately 14 hours after initial symptoms." "No prior vaccinations for this
event." "Losartan, Levothyroxine, Carvedilol" "Arthritis, high blood
pressure,Penicillin, Sulfa, Gluten"
"65+ years" "65+" "Jan., 2021" "2021/01" "943362-1" "943362-1" "Pt
collapsed at home approx 5:30 pm and died" "No prior vaccinations for this
event." "unknown none reported" "none,none reported"
"65+ years" "65+" "Jan., 2021" "2021/01" "943442-1" "943442-1"
"Systemic: reported by staff patient expired under suspicious circumstnces
after receiving vaccine. Patient was on hospice, reported not expected to pass this
soon; symptoms lasted 0 days" "No prior vaccinations for this event." "No other
medications for this event." ",nka"
"65+ years" "65+" "Jan., 2021" "2021/01" "943889-1" "943889-1" "No
adverse reactions observed after administration of medication. Patient starting
complaining of shortness of breath around 0500 the following morning. SP02 checked
in the 80s. Patient expired 01/09/2021;" "No prior vaccinations for this event."
"Alvesco, Amiodarone, Lipitor, Atrovent, Coreg, Cymbalta, Guaifenesin,
Keppra, Levothroid, Megace, Protonix, Potassium, Prednisone, Rifampin, Carafate,
Bactrim, Flomax" "Hypertension, seizure, hypothyroidism, CHF,No known allergies"
"65+ years" "65+" "Jan., 2021" "2021/01" "944273-1" "944273-1" "death
2 days after vaccine; 101 fever on day of booster shot; This is a spontaneous
report from a contactable consumer. A 65-year-old male patient received BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on
09Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization.
Medical history included high blood pressure, high cholesterol, enlarged prostate,
and lifelong digestive issues/irritable bowel syndrome (IBS). Prior to the
vaccination, the patient was not diagnosed with COVID-19. The patient had no
allergies to medications, food, or other products. The patient's concomitant
medications were not reported. The patient did not receive any other vaccines
within four weeks prior to the vaccination. The patient experienced 101 fever on
day of booster shot on 09Jan2021 and death 2 days after vaccine on 10Jan2021. The
event, death 2 days after vaccine, was reported as fatal. The patient underwent lab
tests and procedures, which included body temperature: 101 on 09Jan2021. The
patient did not receive treatment for the events. The clinical outcome of 101 fever
on day of booster shot was unknown and of death 2 days after vaccine was fatal. The
patient died on 10Jan2021. The cause of death was unknown. It was unknown if an
autopsy was done. It was also reported that since the vaccination, the patient had
not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was
not provided and has been requested during follow up.; Reported Cause(s) of Death:
death 2 days after vaccine" "No prior vaccinations for this event." "No other
medications for this event." "Medical History/Concurrent Conditions: Blood
pressure high; Enlarged prostate; Gastrointestinal disorder; High cholesterol;
Irritable bowel syndrome,"
"65+ years" "65+" "Jan., 2021" "2021/01" "944282-1" "944282-1"
"resident coded on 09Jan at 8am and expired; This is a spontaneous report
from a contactable Other Health Professional. A 70-year-old male patient received
first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number:
EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19
immunization. Medical history included DM2(Type two diabetes mellitus),
CHF(congestive heart failure), open wound, wound infection, heart failure.
Allergies to medications, food, or other products: none. Concomitant medications
included unspecified products (List of any other medications the patient received
within 2 weeks of vaccination: yes). If the patient received any other vaccines
within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent
COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The
resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An
autopsy was not performed. AE resulted in: patient died. Death cause: unknown at
this time. Was treatment received for the adverse event: Unknown. Prior to
vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination,
has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-
Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness
criteria-Caused/prolonged hospitalization: No. Seriousness criteria-
Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect:
No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart
failure, open wound complicated by infection, all these pre-existing medical
conditions contribute to the patient death. More information including complete
medical history, concomitant medications and event term details especially death
cause and autopsy results are needed for a full assessment of the case. The impact
of this report on the benefit/risk profile of the Pfizer product is evaluated as
part of Pfizer procedures for safety evaluation, including the review and analysis
of aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate;
Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired" "No
prior vaccinations for this event." "No other medications for this event."
"Medical History/Concurrent Conditions: Congestive heart failure; Heart
failure; Open wound; Type 2 diabetes mellitus; Wound infection,"
"65+ years" "65+" "Jan., 2021" "2021/01" "944365-1" "944365-1"
"Resident expired on 12/30/20, dx cardiac arrest." "No prior vaccinations
for this event." "Diazepam, Levothyroxine, Magnesium Oxide, Olanzapine,
Omeprazole, Sertraline, and Vitamin D3" "Schziophrenia,N/A"
"65+ years" "65+" "Jan., 2021" "2021/01" "944641-1" "944641-1"
"Patient died on 1/21-2021" "No prior vaccinations for this event."
"Atorvastatin 80mg daily, biotin 2500mg daily, Calcium-Mag-Zinc tab daily,
Restasis eye drop q12hr, ezetimibe 10mg qhs, gabapentin 100mg bid, lysine 1000mg
daily, metoprolol tart 50mg bid, fish oil 1000mg daily, prilosec 20mg daily,
ranola" "CAD,Sulfa"
"65+ years" "65+" "Jan., 2021" "2021/01" "944659-1" "944659-1"
"Patient died. A friend called to let us know." "No prior vaccinations
for this event." "Atorvastatin 80mg daily, biotin 2500mg daily, Calcium-Mag-Zinc
tab daily, Restasis eye drop q12hr, ezetimibe 10mg qhs, gabapentin 100mg bid,
lysine 1000mg daily, metoprolol tart 50mg bid, fish oil 1000mg daily, prilosec
20mg daily, ranola" "CAD,Sulfa"
"65+ years" "65+" "Jan., 2021" "2021/01" "944732-1" "944732-1"
"Resident found unresponsive and without pulse at 05:45am.""No prior
vaccinations for this event." "Cholecalciferol, furosemide, metoprolol tartrate,
tamsulosin, amlodipine, finasteride" "CHF, atrial fibrilation, Dysphagia,
macular degeneration, Vitamin D deficiency, impaired fasting glucose, benign
prostatic hyperplasia, osteoporosis, retention of urine, anemia,hydrocodone"
"65+ years" "65+" "Jan., 2021" "2021/01" "944998-1" "944998-1" "On
1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident
expired." "No prior vaccinations for this event." "Resident in skilled nursing
facility. Please contact facility if needing all medications." "Asthma,
hypothyroidism, essential hypertension, atherosclerotic heart disease of native
coronary artery, spinal stenosis, fibromyalgia, dementia. Please contact nursing
facility for further needed information.,Phenazopyridine, Demerol, Pyridium,
Penicillins"
"65+ years" "65+" "Jan., 2021" "2021/01" "945241-1" "945241-1" "71yo
female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS
taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At 11:30am, Patient showed no
s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test and
assessment (the facility is experiencing an outbreak), and found the patient
unresponsive on the bathroom floor. CPR was immediately started; no shock advised
per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death."
"No prior vaccinations for this event." "UNK" "UNK,UNK"
"65+ years" "65+" "Jan., 2021" "2021/01" "945247-1" "945247-1" "Has
underlying dementia and often with difficulty eating. 1 week after immunization
she developed a stroke with left sided weakness and difficulty swallowing. Comfort
measures instituted. Not sure if this is related to the vaccine, but thought I
should report" "No prior vaccinations for this event." "depakote, lexapro,
lisinopril, multiple vitamin, senna, seroquel, tylenol" "dementia, hypertension,
depression, delusions, anxiety,aricept, namenda, penicillin, actonel, erythromycin,
niacin"
"65+ years" "65+" "Jan., 2021" "2021/01" "945253-1" "945253-1" ""83yo
female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021,
the patient reportedly got up in the middle of the night with c/o feeling ""blah"",
restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was
asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do
morning VS and found the patient unresponsive, no pulse, no respirations. GNA
notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived
and took over. At or around 6:30am, EMT called time of death"" "No prior
vaccinations for this event." "UNK" "UNK,UNK"
"65+ years" "65+" "Jan., 2021" "2021/01" "945578-1" "945578-1" "No
reactions immediately after vaccine was given. Resident has dementia, has had
multiple hospitalizations related to a renal stone recently. Had a tooth that was
bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they
noted feet and ankles are dark purple with white splotches appears to be mottling.
Minimally responsive to voice and touch. Not eating. Compassionate visit with
family. Family did not want hospice, did not feel it was needed, said, what more
could they do for her than you're already doing? On 1/11 at 1950 was determined to
be deceased." "No prior vaccinations for this event." "Aspirin 81 mg,
metformin, namenda, effexor XR, donepezil, potassium chloride, Vitamin B12,
Brillinta, clonzepam, flomax, ultram, oxybutynin chloride, sucralfate, ferrous
sulfate, protonix, percocent, metoprolol succinate ER, senna Colace, n"
"Dementia, COPD, Type 2 DM, Atherosclerotic Heart Disease, Depression,
Hypertensive Heart disease without heart failure GI hemorrhage, calculus of ureter,
systolic CHF, Peripheral vascular disease, GERD, anxiety.,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "945603-1" "945603-1" "Had
no immediate issues with the vaccine. He had returned from the hospital on 12/21
and had some concerns about his weight which were shared with his physician on
1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On
1/8/21 staff were called to his room, he was on the floor, bluish skin color. No
vital signs found, no heart rhythm heard at 2200." "No prior vaccinations for
this event." "Verapamil ER, Pepcid, Norco, Vit D3, synthroid, flecainide Ace
acetate, mucinex, lisinpril, amitriptyline, eliquis, atorvastatin, furosemide,
acetaminophen, Coenzyme Q-10, metoprolol succinate ER" "anemia, hypothyroidism,
BPH, paroxysmal atrial fib, HTN, atherosclerotic heart disease, Chronic Kidney dz
stage 3, CHF,NKA"
"65+ years" "65+" "Jan., 2021" "2021/01" "946097-1" "946097-1" "died
3 days after receiving the vaccine/Death cause: Pneumonia per doctor; This is a
spontaneous report from a contactable consumer. An 85-year-old non-pregnant female
patient (reporter's mother) received the first dose bnt162b2 (PFIZER-BIONTECH
COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at
single dose for covid-19 immunization. Medical history included dementia from an
unknown date. The patient's concomitant medications were not reported. The patient
died 3 days after receiving the vaccine on 10Jan2021 11:00, death cause was
pneumonia per doctor. The event was reported as serious as resulted in death. It
was unknown if the patient received treatment for the event. The patient did not
receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient
was not diagnosed with COVID-19 prior to vaccination, and it was unknow if the
patient has been tested for COVID-19 since the vaccination. The patient died on
10Jan2021. It was not reported if an autopsy was performed. Information about
lot/batch number has been requested.; Reported Cause(s) of Death: Pneumonia" "No
prior vaccinations for this event." "No other medications for this event."
"Medical History/Concurrent Conditions: Dementia (other medical history:
Dementia),"
"65+ years" "65+" "Jan., 2021" "2021/01" "946225-1" "946225-1" "At
approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face,
hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal
cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second
set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift
advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP
151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At
approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began
to worsen with breathing tx. This LPN updated at 0248 doctor on resident's
condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er
called to say resident passed away." "No prior vaccinations for this event."
"CloZAPine 550 mg QD, Clozaril 150 mg QD, Ergocalciferol Capsule 1.25 MG
(50000 UT) QD, MiraLax Powder 17 gram QD, Multivitamin QD, Remeron 45 MG QD,
Sertraline HCl 200 mg QD, Simvastatin 20 MG QD, Synthroid Tablet 75 MCG QD,
Tricor 14" "Dx with Covid-19 on 12/11/2020, PERIPHERAL VASCULAR DISEASES,
SCHIZOAFFECTIVE DISORDER, BIPOLAR DISORDER, EPILEPSY, HYPERLIPIDEMIA, SECONDARY
PARKINSONISM, MAJOR DEPRESSIVE DISORDER, ANXIETY DISORDER, HYPOTHYROIDISM,
HYPERTENSION, OBESITY, and UNSPECIFIED CHRONIC BRONCHITIS,,Lithium"
"Unknown" "U" "Dec., 2020" "2020/12" "907575-1" "907575-1"
"Diarrhoea; This is a spontaneous report from a contactable other healthcare
professional via Agency and downloaded from the Regulatory Authority GB-MHRA-
WEBCOVID-20201212222117, Safety Report Unique Identifier GB-MHRA-ADR 24542707 and
EU-EC-10007191252. An elderly patient of an unspecified gender received bnt162b2
(batch/lot number not provided), via an unspecified route of administration in 2020
at single dose for COVID-19 immunisation. The patient's medical history and
concomitant medications were not reported. The patient experienced diarrhoea in
2020. The patient died due to diarrhoea on 10Dec2020. It was not reported if an
autopsy was performed. No follow-up attempts are possible. Information on the
lot/batch number not obtainable. No further information is expected.; Reported
Cause(s) of Death: diarrhoea" "No prior vaccinations for this event." "No other
medications for this event." ","
"Unknown" "U" "Dec., 2020" "2020/12" "908245-1" "908245-1"
"Asystole; Circulatory collapse; This is a spontaneous report from a
contactable pharmacist received from Agency and downloaded from the Regulatory
Authority-WEB GB-MHRA-WEBCOVID-20201214111558, Safety Report Unique Identifier GB-
MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority. An
adult female patient received bnt162b2 (batch/lot number not provided), via an
unspecified route of administration on 13Dec2020 at single dose for COVID-19
vaccination. The patient's medical history was not reported. Concomitant medication
included sildenafil, acetylsalicylic acid, allopurinol, levothyroxine,
spironolactone, amiloride hydrochloride, furosemide and desogestrel. The patient
experienced asystole on 13Dec2020, circulatory collapse on 13Dec2020. The patient
died due to asystole and circulatory collapse on 13Dec2020. It was not reported if
an autopsy was performed. No follow-up attempts are possible. Information about
batch number is not obtainable. No further information is expected.; Reported
Cause(s) of Death: circulatory collapse; Asystole" "No prior vaccinations for
this event." "; ; ; ; ; ; ;" ","
"Unknown" "U" "Dec., 2020" "2020/12" "918721-1" "918721-1"
"cardiac arrest; heart failure; did not feel well, lost consciousness and
died; did not feel well, lost consciousness and died; This is a spontaneous report
from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020
08:30 at single dose for covid-19 immunisation. Medical history included suffered
from the past from heart attacks, active heart disease, malignant disease. The
patient's concomitant medications were not reported. A man of 75 years old, who
suffers from many different background diseases, died (this morning 28Dec2020) from
cardiac arrest, two hours after he received the injection. The man received the
injection at 8.30am, and after he was feeling okay he was released to go home.
After a while when he was home he did not feel well, lost consciousness and died,
and he was pronounced dead from heart failure. The patient died on 28Dec2020. It
was not reported if an autopsy was performed. The outcome of the event cardiac
arrest and heart failure was fatal while the outcome of the other events was
unknown. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Sender's Comments: Linked Report(s) : IL-PFIZER INC-2020517177
same reporter, same vaccine, reporting similar events in different patients.;
Reported Cause(s) of Death: heart failure; cardiac arrest" "No prior vaccinations
for this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Cancer (NOS); Heart disease, unspecified; Heart
failure, unspecified,"
"Unknown" "U" "Dec., 2020" "2020/12" "918722-1" "918722-1" "found
dead in his bed; This is a spontaneous report from a contactable healthcare
professional received via the Ministry of Health department of epidemiology. The
department of epidemiology reported similar events for two patients. This is the
second of two reports. A 61-year-old male patient received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4175), via an
unspecified route of administration on 24Dec2020 as a single dose for COVID-19
immunization. Medical history included schizophrenia, very heavy smoker for almost
50 years, emphysema, and tumor resection in the bladder. The patient's concomitant
medications were not reported. On 28Dec2020, the patient was found dead in his
bed. It was reported that the patient did not have any complaints in the days
following the vaccination. Then, on 28Dec2020, the patient was found dead. The
cause of death was unknown. It was not reported if an autopsy was performed.;
Sender's Comments: A reasonable possibility that the event unknown cause of death
is related to vaccination with BNT162B2 cannot be completely excluded until further
information regarding clinical course and death cause is provided. Of note, the
patient did not have any complaints in the days following the vaccination. The case
was confounded by the patient's underlying conditions. The impact of this report on
the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.,Linked
Report(s) : IL-PFIZER INC-2020517122 same reporter, same vaccine, reporting similar
events in different patients.; Reported Cause(s) of Death: found dead in his bed"
"No prior vaccinations for this event." "No other medications for this
event." "Medical History/Concurrent Conditions: Bladder tumor resection;
Emphysema; Heavy smoker (for almost 50 years); Schizophrenia,"
"Unknown" "U" "Jan., 2021" "2021/01" "918727-1" "918727-1" "died
the day after receiving the first injection of vaccine against Covid-19 in
suspected cardiac arrest; This is a spontaneous report from a web page with a
contactable physician as publisher. A multi-sick, elderly patient of an unspecified
gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via
an unspecified route of administration on an unspecified date at single dose for
covid vaccination. The patient medical history was not reported. The patient's
concomitant medications were not reported. The patient died the day after
vaccination of a suspected heart stop. The patient died the day after receiving the
first injection of vaccine against covid-19. The patient died on an unspecified
date. It was not reported if an autopsy was performed. No follow-up attempts are
possible; information about LOT/batch number cannot be obtained.; Sender's
Comments: The information available in this report is limited and does not allow a
medically meaningful assessment of the case. In particular the following relevant
information is not available: complete medical history and complete demographics,
treatment dates and dose, concomitant medications (if any), event descriptors,
autopsy report. The impact of this report on the benefit/risk profile of the Pfizer
product is evaluated as part of Pfizer procedures for safety evaluation, including
the review and analysis of aggregate data for adverse events. Any safety concern
identified as part of this review, as well as any appropriate action in response,
will be promptly notified to regulatory authorities, Ethics Committees, and
Investigators, as appropriate.; Reported Cause(s) of Death: suspected heart stop"
"No prior vaccinations for this event." "No other medications for this
event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "923149-1" "923149-1" "first
death case due to Covid-19 vaccination in country; deterioration in the general
condition; stomach was hard and caused pain under pressure; Urethral and abdominal
pain; Urethral and abdominal pain; restless; his blood pressure dropped; pulse
increased; This is a spontaneous report from five contactable consumers and a
contactable other health professional via Pfizer Employee received form Internet
source. A 91-year-old female patient receive BNT162B2 (COMIRNATY), via an
unspecified route of administration on 24Dec2020 at single dose for covid-19
vaccination. Medical history included dementia from an unknown date and unknown if
ongoing. The patient's concomitant medications were not reported. The resident had
previously reacted negatively to a flu vaccine and therefore no further
vaccinations were recommended. The patient experienced urethral and abdominal pain,
urethral and abdominal pain, restless, his blood pressure dropped, pulse increased
all on 26Dec2020, deterioration in the general condition and death on 29Dec2020.
On Christmas Eve, the residents of a nursing home for dementia in the Lucerne were
vaccinated with the Pfizer/Biontech vaccine. The affected, otherwise healthy
resident, suffered from pain in the urethra and abdomen two days later. The
examination by the home doctor revealed a decrease in blood pressure and an
increase in the pulse. At the last consultation on Sunday evening, 27 December, the
patient was stable with persistent sensitivity to pressure of the abdomen. The
following day, the management of the institution did not report back to the home
doctor. On the morning of December 29, the nursing home informed the doctor about a
deterioration of the general condition. By the time the doctor was called back the
same morning, the patient had already died, vaccinated on Christmas Eve and dead
five days later. The patient underwent lab tests and procedures which included
blood pressure measurement: decreased on 26Dec2020, heart rate: increased on
26Dec2020, home doctor examination: decrease in blood pressure and an increase in
the pulse on 26Dec2020, home doctor examination: condition was stable with
persistent sensitivity to pressure of the abdomen on 27Dec2020. The patient died on
29Dec2020. It was not reported if an autopsy was performed. The news of the death
of a 91-year-old person after she was vaccinated against Covid-19 is circulating on
social media channels and information platforms. Investigations by the health
authorities and have shown that due to the medical history and the course of the
disease, a connection between death and the Covid-19 vaccination is unlikely.
Neither the medical history nor the acute course of the disease suggest a direct
causal connection between the Covid-19 vaccination and death. The comprehensive
information available indicates the pre-existing diseases as a natural cause of
death. This was also noted on the death certificate. Event occurred in a country
different from that of the reporter. This may be a duplicate report if another
reporter from the country where the event occurred has submitted the same
information to his/her local agency. Information on the Lot/Batch number has been
requested.; Sender's Comments: The reported information is limited and does not
allow a meaningful assessment of the case. It will be reassessed upon receipt of
follow up information. The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of
death" "No prior vaccinations for this event." "No other medications for
this event." "Medical History/Concurrent Conditions: Dementia,"
"Unknown" "U" "Jan., 2021" "2021/01" "923219-1" "923219-1"
"Sudden death; This is a spontaneous report from a contactable physician and
consumer. A 41-year-old female patient received the first dose of BNT162B2
(COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on
30Dec2020 at 0.3 mL single dose for COVID-19 immunisation. Medical history
included hypertension. The patient's concomitant medications were not reported.
On 01Jan2021, the patient experienced sudden death. The clinical course was as
follows: The patient didn't experience any adverse event at the moment of
inoculation with COVID-19 vaccine or the following days. On 01Jan2021, at lunch
time, two days after receiving the vaccine, the patient was found unresponsive in
her bed by her partner. The cause of death was unknown. It was reported that an
autopsy would be performed in the next days; the results were not yet available.
The lot number for the vaccine, BNT162B2, was not provided and will be requested
during follow up.; Sender's Comments: The reported information is limited and does
not allow a meaningful assessment of the case. It will be reassessed upon receipt
of follow up information. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death"
"No prior vaccinations for this event." "No other medications for this
event." "Medical History/Concurrent Conditions: Hypertension,"
"Unknown" "U" "Jan., 2021" "2021/01" "925616-1" "925616-1"
"cardiac arrest; This is a spontaneous report from a contactable physician.
A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA
VACCINE), via an unspecified route of administration on 30Dec2020 as single dose
for covid-19 immunization. Medical history included asthma and a little overweight
from an unknown date. The patient's concomitant medications were not reported.
The patient experienced cardiac arrest on an unspecified date, which was serious as
it lead to death. The patient died on an unspecified date. It was not reported if
an autopsy was performed. This batch/lot number is not available despite the
follow-up attempts made. No further information is expected.; Sender's Comments:
The reported information is limited and does not allow a meaningful assessment of
the case. It will be reassessed upon receipt of follow up information. The impact
of this report on the benefit/risk profile of the Pfizer product is evaluated as
part of Pfizer procedures for safety evaluation, including the review and analysis
of aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
regulatory authorities, Ethics Committees, and Investigators, as appropriate.;
Reported Cause(s) of Death: cardiac arrest" "No prior vaccinations for this
event." "No other medications for this event." "Medical History/Concurrent
Conditions: Asthma; Overweight,"
"Unknown" "U" "Jan., 2021" "2021/01" "928992-1" "928992-1"
"Atrial fibrillation; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Authority. The regulatory authority report
number is GB-MHRA-EYC 00236011. An 87-year-old female patient received BNT162B2
(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553), intramuscular on
18Dec2020 at 0.3 mL, single for covid-19 immunization. Medical history included
ongoing hypothyroidism, ongoing diabetes, ongoing atrial fibrillation, ongoing
frailty and, ongoing osteoporosis, all from unknown dates. Concomitant medication
included prednisolone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN),
salbutamol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), doxycycline
(MANUFACTURER UNKNOWN). The patient experienced atrial fibrillation on an
unspecified date, which was serious as it was medically significant, involved
hospitalization and lead to death. Clinical course was as follows: the patient was
vaccinated. Consent was obtained and a pre immunization checklist was completed.
She was observed following the administration of the vaccine, and no adverse
effects were noted. She returned home. She became unwell and was admitted to
hospital approximately 24 hours later. The patient was admitted to the hospital 24
hours following the vaccination, and subsequently died later, while in the
hospital. The full clinical details were unknown, but the diagnosis from Accident
& Emergency was atrial fibrillation. It is not clear if this had any relation to
the vaccine that was administered, but could not be excluded, per the reporter. The
patient died on 20Dec2020. It was not reported if an autopsy was performed. No
follow-up activities are possible. No further information is expected.; Reported
Cause(s) of Death: Atrial fibrillation" "No prior vaccinations for this event."
"; ; ; ;" ","
"Unknown" "U" "Jan., 2021" "2021/01" "929016-1" "929016-1"
"Death; Loose stools; Vomited; This is a spontaneous report from a
contactable other healthcare professional by Pfizer from the Regulatory Agency (UK-
MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20201230164020.
An elderly female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Batch:
EJ1677, Expiration date: Feb2021) via an unspecified route on 29Dec2020 at single
dose for Covid-19 vaccination. Medical history included dementia and a history of
urinary tract infection and delirium, all from an unknown date and unknown of
ongoing. Concomitant medication included influenza vaccine (INFLUENZA VIRUS, Batch:
4924B1A) for influenza immunization. Patient has not had symptoms associated with
COVID-19. Patient is not enrolled in clinical trial. No known allergies. The
patient had not tested positive for COVID-19 since having the vaccine. On the
29Dec2020 the patient experienced loose stools and vomited. The patient underwent
lab tests and procedures which included COVID-19 virus test: no -negative on
08Dec2020. The patient died on the 30Dec2020 at 11:25 am in the morning. It was
unknown if a postmortem was going to be carried out, after talking to the general
practice surgery they advised that the general practitioner was only passed
notification of the patient's death that afternoon (04Jan2021). It was advised that
they may go to the coroner but couldn't give a definitive answer until the general
practitioner had looked at the notification. It was not reported if an autopsy was
performed. No follow up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: Death" "No prior vaccinations for this
event." "INFLUENZA VIRUS" "Medical History/Concurrent Conditions: Delirium
(History of); Dementia; Urinary tract infection (History of),"
"Unknown" "U" "Jan., 2021" "2021/01" "929027-1" "929027-1" "At
night they found him lifeless. Probably following acute MI; pain in the arm and
swelling in the arm of vaccination; pain in the arm and swelling in the arm of
vaccination; This is a spontaneous report from a contactable other healthcare
professional via Division of Health. The other healthcare professional reported
similar events for three patients. This is the second of three reports. A male
patient of an unspecified age received BNT162B2 (lot# EK4175), via an unspecified
route of administration on 25Dec2020 at single dose for Covid-19 immunisation.
Medical history included chronic obstructive pulmonary disease (COPD) with smoking
background, atrial fibrillation, aortic stenosis, diabetes with damage to all
target organs (nephropathy, retinopathy, neuropathy), carotid stenosis, deep vein
thrombosis (DVT) history, history of alcohol use with hepatitis, history of
Hodgkin's lymphoma after successful chemotherapy treatment, got around on a
scooter. The patient's concomitant medications were not reported. The patient was
vaccinated on 25Dec2020 and passed away at home on 28Dec2020. Before his death,
according to his daughter, he complained about pain in the arm and swelling in the
arm of vaccination on an unspecified date of Dec2020. At night they found him
lifeless. Probably following acute myocardial infarction (MI). The outcome of pain
in the arm and swelling in the arm of vaccination was unknown, acute MI was fatal.
It was not reported if an autopsy was performed. Follow-up attempts are completed.
No further information is expected.; Sender's Comments: Fatal acute myocardial
infarction is more likely attributed to the patient underlying medical conditions
including vascular stenosis and diabetes with complications. The impact of this
report on the benefit/risk profile of the Pfizer product is evaluated as part of
Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked
Report(s) : IL-PFIZER INC-2020519349 same reporter/product, similar event,
different patient;IL-PFIZER INC-2021009752 same reporter/product, similar event,
different patient; Reported Cause(s) of Death: acute MI" "No prior vaccinations
for this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Alcohol use; Aortic stenosis; Atrial fibrillation;
Carotid artery stenosis; Chemotherapy; COPD; Diabetes; Diabetic nephropathy;
Diabetic neuropathy; Diabetic retinopathy; DVT; Hepatitis; Hodgkin's lymphoma;
Mobility decreased; Smoker,"
"Unknown" "U" "Jan., 2021" "2021/01" "929028-1" "929028-1"
"SEPSIS; respiratory distress; PLEURAL EFFUSION; This is a spontaneous report
received from other healthcare professional via the Division of epidemiology of the
Ministry of Health. The other healthcare professional reported similar events for
three patients. This is the third of three reports. A 91-year-old male patient
received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 30Dec2020 at single dose for covid-19 immunisation. Medical
history included known background of blood pressure disease, diabetes, malignant
bladder from an unknown date and unknown if ongoing. The patient's concomitant
medications were not reported. Patient was received at the emergency room 3 days
after receiving the corona vaccine in Jan2021, with fever, vomiting more than 40
times, in respiratory distress, was hospitalized in internal medicine department
with sepsis diagnosis due to respiratory distress and pleural effusion, intubated,
his condition was serious, patient passed away on 04Jan2021. Cause of death was
reported as sepsis, respiratory distress and pleural effusion. It was not reported
if an autopsy was performed. Follow-up attempts are completed. No further
information is expected. Information about batch/lot number cannot be obtained.;
Sender's Comments: Based on the information currently provided, the fatal events
sepsis, respiratory distress and pleural effusion are more likely attributed to
intercurrent infectious conditions associated with the advanced old patient
underlying diseases . The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to Regulatory Authorities, Ethics Committees
and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020519349 same
reporter, product, similar event, different patient;IL-PFIZER INC-2021009751 same
reporter, product, similar event, different patient; Reported Cause(s) of Death:
SEPSIS; respiratory distress; PLEURAL EFFUSION" "No prior vaccinations for this
event." "No other medications for this event." "Medical History/Concurrent
Conditions: Bladder cancer; Blood pressure abnormal; Diabetes,"
"Unknown" "U" "Jan., 2021" "2021/01" "930431-1" "930431-1"
"Cardiac event, 2 days after vaccination, patient expired.""No prior
vaccinations for this event." "Enteric Coded Aspirin, Atenolol, Centrum Silver,
Citrical, Levothyroxin, Lisinipril, Phillips Colon Health Caps, Vitamin D"
"Aortic Stenosis, Status post Tavr procedure, Hypothyroidism, Hypertension,
Thoracogenic Scoliosis, Polymyalgia Rheumatica, Heart Valve Replacement,
Hyperparathyroidism,None"
"Unknown" "U" "Jan., 2021" "2021/01" "933230-1" "933230-1" "Death
within 24 hours after dose; This is a spontaneous report from a contactable
consumer downloaded from the regulatory authority (GB-MHRA-EYC 00236003 and GB-
MHRA-ADR 24545815). A 78-year-old male patient received BNT162B2 (COMIRNATY), via
an unspecified route of administration, on 20Dec2020 at 16:00 as a single dose for
COVID-19 immunization. Medical history included cardiac disease and lung disease.
The patient had no known allergies. Concomitant medications included an unspecified
hypertensive taken for hypertension, an unspecified drug for ischaemic heart
disease, and an unspecified drug for chronic obstructive pulmonary disease (COPD).
The patient experienced death within 24 hours after dose on 21Dec2020. The event
was reported as fatal. The clinical course was reported as follows: The patient was
observed for 15 minutes after the dose was given and had no side effects. In the
evening, the patient felt well. The patient received the vaccination as he was a
high risk patient, elderly, and with a background of cardiac and lung disease. The
clinical outcome of death within 24 hours after dose was fatal. The patient died on
21Dec2020. The cause of death was unexplained. It was unknown if an autopsy was
performed. The reporter assessed the causality between the vaccination and death as
unlikely. No follow-up attempts possible; information on lot and batch numbers
cannot be obtained.; Reported Cause(s) of Death: Death unexplained" "No prior
vaccinations for this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Cardiac disorder; Lung disease,"
"Unknown" "U" "Jan., 2021" "2021/01" "933232-1" "933232-1"
"Death; Head ache and dizziness; Head ache and dizziness; Spitting blood;
Vomiting blood; Nose bleed; This is a spontaneous report a contactable consumer
downloaded from the Regulatory Authority(GB-MHRA-WEBCOVID-20201220100831 and GB-
MHRA-ADR 24545199). A male patient of an unspecified age received BNT162B2
(COMIRNATY), via an unspecified route of administration, on 17Dec2020 as a single
dose for COVID-19 immunisation. Medical history included vitamin D3 deficiency and
asthma. Concomitant medications included colecalciferol (MANUFACTURER UNKNOWN) for
vitamin deficiency and salbutamol sulfate (VENTOLINE) for asthma. The patient
experienced nose bleed on 17Dec2020, head ache and dizziness, spitting blood, and
vomiting blood on 18Dec2020, and death on 20Dec2020. All of the events were
reported as fatal. It was reported that a healthcare professional advised the
patient to take unspecified pain medication after explaining mild and strong side
effects to help with pain. The patient underwent lab tests and procedures which
included COVID-19 virus test: No - negative COVID-19 test on an unspecified date.
Therapeutic measures were taken as a result of nose bleed, head ache and dizziness,
spitting blood, and vomiting blood as aforementioned. The clinical outcome of nose
bleed, head ache and dizziness, spitting blood, vomiting blood, and death was
fatal. The patient died on 20Dec2020. The cause of death was unexplained. It was
not reported if an autopsy was performed. It was also reported that since the
vaccination, the patient had not been tested positive for COVID-19. No follow-up
attempts are possible; information about lot/batch number cannot be obtained.;
Reported Cause(s) of Death: Death unexplained" "No prior vaccinations for this
event." "; VENTOLINE [SALBUTAMOL SULFATE]" "Medical History/Concurrent
Conditions: Asthma; Vitamin D3 deficiency,"
"Unknown" "U" "Jan., 2021" "2021/01" "934465-1" "934465-1"
"patient died after collapsing in his home several hours after he received
the vaccine; patient died after collapsing in his home several hours after he
received the vaccine; The initial case was missing the following minimum criteria:
the reporter does not have first-hand knowledge of the reported events and was not
identifiable. Upon receipt of follow-up information on 06Jan2021, this case now
contains all required information to be considered valid. This is a spontaneous
report from a contactable healthcare professional via regulatory Authority. The
regulatory authority reported similar events for three patients. This is the first
of three reports. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 mRNA VACCINE; Lot Number: EK4237), via an unspecified route of
administration on 28Dec2020 as a single dose for COVID-19 immunization. Medical
history included dementia, cardiac background with pacemaker, atrial fibrillation,
heart failure, and penicillin allergy. The patient was not allergic to polyethylene
glycol. The patient's concomitant medications were not reported. On 29Dec2020,
the patient died after collapsing in his home several hours after he received the
vaccine. Outcome of collapsing was not recovered. The patient had no pulse when
he arrived at the hospital. It was not reported if an autopsy was performed. The
cause of death was unknown. Follow-up attempts are completed. No further
information is expected.; Sender's Comments: The advance old patient had underlying
cardiac background with pacemaker, atrial fibrillation and heart failure, therefore
the pre-existing cardiovascular medical conditions more likely provide explanations
for collapsing lead to the patient death. More information especially death cause
and autopsy results are needed for further meaningful assessment. The impact of
this report on the benefit/risk profile of the Pfizer product is evaluated as part
of Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked
Report(s) : IL-PFIZER INC-2021009752 same reporter, product, similar event,
different patient;IL-PFIZER INC-2021009751 same reporter, product, similar event,
different patient; Reported Cause(s) of Death: Unknown cause of death" "No prior
vaccinations for this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Atrial fibrillation; Cardiac disorder; Cardiac
pacemaker insertion; Dementia; Heart failure; Penicillin allergy,"
"Unknown" "U" "Jan., 2021" "2021/01" "934760-1" "934760-1" "Death
in connection with the vaccination and/or Covid19 disease / positivity; Death in
connection with the vaccination and/or Covid19 disease / positivity; This is a
spontaneous report from a contactable physician. This physician reported similar
events for two patients. This is the second of two reports. A patient of
unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),
via an unspecified route of administration on an unspecified date at single dose
for COVID-19 immunization. The patient's medical history and concomitant
medications were not reported. It was reported 2 deceased were autopsied, death in
connection with the vaccination or Covid19 disease / positivity.; Sender's
Comments: The information currently provided is too limited to make a meaningful
medical assessment hence, the events are conservatively assessed as related to the
suspect drug BNT162B2 until further information becomes available. The impact of
this report on the benefit/risk profile of the Pfizer product is evaluated as part
of Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-
PFIZER INC-2021006738 same reporter, same product, same event, different patient;
Reported Cause(s) of Death: Death in connection with the vaccination and/or Covid19
disease / positivity; Death in connection with the vaccination and/or Covid19
disease / positivity" "No prior vaccinations for this event." "No other
medications for this event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "934763-1" "934763-1"
""Sudden death; This is a spontaneous report downloaded from the regulatory
authority DK-DKMA-WBS-0028211. Report was received from a contactable nurse via
regulatory authority. A 94-years-old female patient received BNT162B2 (COMIRNATY)
(Lot # EJ6797, exp date 30Apr2021), via intramuscular on 30Dec2020 at first single
dose for covid-19 immunization. Medical history included ongoing periodic
obstipation (periodic treated), ongoing dementia, ongoing atrial fibrillation,
ongoing depression, tibia fracture from 01Nov2020 (treated conservatively).
Concomitant medication included apixaban (ELIQUIS) from 09Apr2018 to unknown date
for atrial fibrillation, sertraline from 20Jun2018 to unknown date for depression.
The patient had not received BNT162B2 before. The patient experienced sudden death
on 01Jan2021. There was no immediate illness until the time of vaccination and the
nurse described that she ""seemed like herself and fresh"". The ADRs were by the
reporter reported as fatal. Reported cause of death: Unknown caused of death,
sudden death. No treatment due to the death was described. There is no information
regarding test results. An autopsy was not performed. Causality: The doctor who
issued the death certificate does not suspect that it is the COVID-19 vaccine that
is the cause of her death. She slept quietly in, and was old. Due to reporting
obligation this case is reported. If the regulatory authority receives
supplemental significant information regarding this case the case will be re-
submitted.; Reported Cause(s) of Death: Sudden death; Unknown cause of death""
"No prior vaccinations for this event." "ELIQUIS;" "Medical
History/Concurrent Conditions: Tibia fracture (conservative treatment),"
"Unknown" "U" "Jan., 2021" "2021/01" "934764-1" "934764-1"
"Hypoxic respiratory failure; Dyspnea exacerbated; This is a spontaneous
report downloaded from the Medicines Agency (MA) WEB DK-DKMA-WBS-0028232. The
report was received from a contactable physician via The Medicines Agency (MA). A
45-year-old male patient received BNT162B2 (COMIRNATY) (Lot #: EJ6797, Expiration
Date: 30Apr2021), via intramuscular on 30Dec2020 at single dose for Covid-19
vaccination. Medical history included ongoing treatment noncompliance, ongoing
alcohol abuse chronic, ongoing psychosis, dyspnoea from 20Dec2020 and ongoing,
ongoing hallucination, ongoing tobacco abuse, ongoing paranoid schizophrenia,
chronic obstructive airways disease exacerbated from Aug2020 and ongoing, chronic
obstructive airways disease exacerbated from Nov2020 to an unknown date (not
ongoing), hypoxic down to 60 % from 20Dec2020 and ongoing, Amphetamine abuse (not
ongoing), ongoing pain, ongoing opioid abuse, ongoing anxiety, and ongoing
insomnia. There is no information regarding past medication. Concomitant medication
included prednisolone (PREDNISOLON ACTAVIS) from 20Nov2020 for Chronic obstructive
airways disease, ipratropium bromide, salbutamol sulfate (IPRAMOL) from 20Nov2020
for Chronic obstructive airways disease exacerbated, orphenadrine hydrochloride
(LYSANTIN) from 02Dec2019 to 03Jan2021 for Anxiety aggravated, quetiapine fumarate
(QUETIAPIN ACCORD) from 16Dec2020 to 03Jan2021 for Psychiatric symptom, salbutamol
sulfate (VENTOLINE) from 03Nov2018 for Chronic obstruct airways disease,
paracetamol (PARACETAMOL ORIFARM) from 30Nov2020 to 03Jan2021 for Pain, quetiapine
fumarate (QUETIAPIN ARROW) from 15Aug2020 to 03Jan2021 for Psychiatric symptom,
buprenorphine hydrochloride, naloxone hydrochloride (BUPRENORPHINE/NALOXONE MYLAN)
from 29Jun2020 to 03Jan2021 for Opioid abuse, paliperidone palmitate (XEPLION) from
19Dec2019 to 03Jan2021 for Psychiatric disorder prophylaxis, fluticasone furoate,
umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) from 04Jul2019 to
Jul2019 for Chronic obstruct airways disease, promethazine hydrochloride
(PHENERGAN) from 24Sep2020 to 03Jan2021 for Insomnia. The patient experienced
hypoxic respiratory failure on 31Dec2020, dyspnea exacerbated on 31Dec2020. Patient
treatment: On the 31Dec2020 it is recorded that the patient did not want
resuscitation in the event of cardiac arrest or respiratory treatment in the event
of respiratory failure. Initially the patient did not want to transfer to somatic
treatment. But because of anxiety after dyspnoea the patient got treatment with
oxygen. On 01Jan2021 the patient denied again treatment despite clear indication
for oxygen therapy and COPD exacerbations treatment with ipratropium bromide and
salbutamol sulfate (IPRAMOL) and inhalations. On 02Jan2021 the patient received
oxygen-treatment, but the patient did not want further somatic treatment. It was
stated in the patient journal that the patient did not want treatment and that in
the given situation there was nothing more to do. Therefore the patient was
returned to department with palliative treatment in the form of oxygen, midazolam
subcutaneous (S.C.) and morphine S.C. On the 03Jan2021 the patient's respiration
was calm. The patient was unreachable. At 14:00 he was restless and got palliative
treatment with midazolam and morphine. The patient underwent lab tests and
procedures which included c-reactive protein: normal on an unspecified date, 16 on
27Dec2020, fibrin D dimer: normal on 31Dec2020, fluid balance assessment: normal on
27Dec2020, forced expiratory volume (FEV 1): 37 % on 2018, hepatic enzyme: normal
on 27Dec2020, oxygen saturation: 64 % on an unspecified date, 60 % on 20Dec2020, 58
% on 27Dec2020, 62 % on 31Dec2020, 35 % (in the ambulance) on 31Dec2020, 100 % (on
oxygen-treatment) on 31Dec2020, 40-60% on 02Jan2021 12:47 pm, 58 % (in the
ambulance) on 02Jan2021 09:00 am, 30 % on 02Jan2021 04:24 am, 99 % (on oxygen-
treatment) on 02Jan2021, PCO2 up to 12.8 (Unit not specified) on an unspecified
date, PO2 Down to 4.8 (Unit not specified) on an unspecified date. The patient died
on 03Jan2021. An autopsy was not performed. The outcome of the events was fatal.
Causality: The reporter assessed that even though the patient's symptoms have
occurred long before the vaccination, it can not be ruled out that the patient's
dyspnoea and hypoxia due to COPD have been aggravated by the vaccine. If the
Medicines Agency receives supplemental significant information regarding this case
the case will be re-submitted.; Reported Cause(s) of Death: Dyspnea exacerbated;
Hypoxic respiratory failure" "No prior vaccinations for this event." "PREDNISOLON
ACTAVIS; IPRAMOL; LYSANTIN; QUETIAPIN ACCORD; VENTOLINE [SALBUTAMOL SULFATE];
PARACETAMOL ORIFARM; QUETIAPIN ARROW; BUPRENORPHINE/NALOXONE MYLAN; XEPLION;
TRELEGY ELLIPTA; PHENERGAN [PROMETHAZINE HYDROCHLORIDE]" "Medical
History/Concurrent Conditions: Amphetamine abuse; Chronic obstructive airways
disease exacerbated,"
"Unknown" "U" "Jan., 2021" "2021/01" "934765-1" "934765-1"
"Dyspnoea; suspected pulmonary edema; This is a spontaneous report downloaded
from the regulatory authority DK-DKMA-WBS-0028304. Report was received from a
contactable physician via from the regulatory authority. An 80-year-old female
patient received bnt162b2 (COMIRNATY, lot EJ6797, expiration date 30Apr2021),
intramuscularly on 03Jan2021 at single dose for covid-19 immunisation. Medical
history included dementia with lewy bodies from an unknown date and unknown if
ongoing, osteoporosis from an unknown date and unknown if ongoing, hypertension
from an unknown date and unknown if ongoing. No previous drug was given. The
patient's concomitant medications were not reported. On 04Jan2021 around 12,
approximately 25 hours after the vaccination the patient developed dyspnoea and
pulmonary edema. 4 hours later she died. The patient did not experience any
allergic symptoms. Events reported as dyspnoea and suspected pulmonary edema. The
ADRs were by the reporter reported as fatal. No treatment due to the ADRs was
reported. Reported cause of death was pulmonary edema. Outcome of event dyspnoea
also reported as not recovered. There was no information regarding test results. It
was not reported if an autopsy was performed.; Reported Cause(s) of Death:
Pulmonary edema; Dyspnoea" "No prior vaccinations for this event." "No other
medications for this event." "Medical History/Concurrent Conditions: Dementia with
Lewy bodies; Hypertension; Osteoporosis,"
"Unknown" "U" "Jan., 2021" "2021/01" "934781-1" "934781-1"
"Sepsis; Acute bronchopneumonia; This is a spontaneous report received from a
contactable physician downloaded from the Regulatory Authority (GB-MHRA-EYC
00236063 and GB-MHRA-ADR 24546059). An 85-year-old female patient received the
first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on
15Dec2020 as a single dose for COVID-19 vaccination. The patient's medical history
was not reported. Concomitant medications included pregabalin (MANUFACTURER
UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN),
candesartan (MANUFACTURER UNKNOWN), and levothyroxine (MANUFACTURER UNKNOWN). The
patient experienced acute bronchopneumonia on 18Dec2020 and sepsis on an
unspecified date. The events caused hospitalization and were reported as fatal. The
clinical course was reported as follows: The patient was brought to the hospital by
ambulance with severe sepsis and bronchopneumonia. She was resuscitated but
unfortunately died shortly after arriving. The family reported that the patient
received the coronavirus vaccine on 15Dec2020. It was reported that it is unclear
from the family history whether she was unwell before she received the vaccine. The
clinical outcome of acute bronchopneumonia and sepsis was fatal. The patient died
on 19Dec2020. The cause of death was reported as acute bronchopneumonia and sepsis.
It was not reported if an autopsy was performed. No follow-up attempts are
possible; information on batch number cannot be obtained.; Sender's Comments: The
information available in this report is limited and does not allow a medically
meaningful assessment of the case. In particular the following relevant information
is not available: medical history, autopsy report.; Reported Cause(s) of Death:
Sepsis; Acute bronchopneumonia" "No prior vaccinations for this event." "; ;
; ;" ","
"Unknown" "U" "Jan., 2021" "2021/01" "934782-1" "934782-1" "Lower
respiratory tract infection; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Authority GB-MHRA-EYC 00236087, Safety
Report Unique Identifier: GB-MHRA-ADR 24546153 . A 83-year-old female patient
received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 18Dec2020
at single dose for covid-19 immunization. Medical history included vascular
dementia from an unknown date and unknown if ongoing, severely frail from an
unknown date and unknown if ongoing. This patient was severely frail as a result of
vascular dementia and was a permanent nursing home resident. Concomitant medication
included amoxicillin, doxycycline, sodium valproate, quetiapine, omeprazole,
paracetamol. The patient experienced lower respiratory tract infection (LRTI) on an
unspecified date. Patient died on 22Dec2020 within 5 days of receiving Covid
vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be
improving, temperature was settled before vaccine was administered. She had a
negative Covid swab at the onset of her symptoms. It would seem more likely that
this patient died as a result of an evolving LRTI than as a result of receiving
Covid vaccination. She was changed to amoxicillin 2 days before she died. The other
outcome for Death was: Died 22Dec2020 but cause of death felt to be due to LRTI not
vaccine. It was not reported if an autopsy was performed. No follow-up attempts
are possible, information on batch number cannot be obtained.; Sender's Comments:
The underlying predisposing condition (severely frail, lower respiratory tract
infection) have been assessed to have played a major role toward the event.;
Reported Cause(s) of Death: Lower respiratory tract infection" "No prior
vaccinations for this event." "; ; SODIUM VALPROATE; ; ;" "Medical
History/Concurrent Conditions: Frailty (severely); Vascular dementia,"
"Unknown" "U" "Jan., 2021" "2021/01" "934826-1" "934826-1"
"Death; This is a spontaneous report from a contactable consumer and a
physician downloaded from the Regulatory Authority number GB-MHRA-WEBCOVID-
20201222043330 and Safety Report Unique Identifier GB-MHRA-ADR 24545938. A 78-
year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE, Solution for injection, LOT: EJ0553) via an unspecified route of
administration on 20Dec2020 around 15:45 at single dose in left upper arm for
COVID-19 vaccination. The patient ongoing medical history included Depression,
Hypertension, chronic obstructive pulmonary disease and ischaemic heart disease.
Patient is not enrolled in clinical trial. Patient has not been tested/or has had
an inconclusive test for COVID-19. Patient has not had symptoms associated with
COVID-19. Concomitant medication included citalopram taken for Depression. The
patient was taking unspecified concomitant medications for hypertension, chronic
obstructive pulmonary disease (COPD) and ischaemic heart disease. The patient
experienced death in Dec2020 (reported as in the evening of the 20Dec2020 or
morning of 21Dec2020). Specifically, it was reported that the patient had the first
dose of the vaccine at around 15:45 on 20Dec2020 and was observed for 15 minutes
after with no side effects, the patient then left the site with family member. He
was well that evening, he lived alone but spoke on the phone in the evening and
felt well. On the 21Dec2020, after went to check on him and he was found in his bed
passed away. When seeing the body, it was assumed that he had passed away in the
evening of the 20Dec2020 or morning of 21Dec2020. Although unlikely, it was less
than 24 hours after taking the vaccine. Patient has not tested positive for COVID-
19 since having the vaccine. The patient was found dead in his flat the next day on
21Dec2020 by next of kin. He was dropped of home by family after the vaccination,
he spoke to his family on the night after having the vaccination and told them he
was feeling fine and was going to bed. He did not respond to telephone calls the
next day (on Monday 21Dec2020) so the family went over to his flat and found he had
passed away. The patient was registered at another surgery. Screening questions
were asked, no contra indication found. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: death" "No prior vaccinations for this
event." "No other medications for this event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "934881-1" "934881-1"
"Fever; This is a spontaneous report from a newsletter, from a contactable
consumer (profession unspecified). Regulatory authority report number was not
provided. An elderly female patient received bnt162b2 (COMIRNATY, Solution for
injection, lot number and expiration date not provided), via an unspecified route
of administration on an unspecified date at single dose for COVID-19 immunization.
Medical history included ongoing dementia in a palliative state. The patient's
concomitant medications were not reported. The verbatim narrative was reported as
follows: 'Status report on suspected side effects from vaccination against covid-
19. The report on the second death was received on 05Jan2020. It concerns an
elderly female with dementia in a palliative state. The female was vaccinated with
Comirnaty, had fever on an unspecified date and passed away three days later. The
information in the report is very brief and will seek additional information from
the reporter. Currently, has no information on the female's confirmed cause of
death and there is no established causality with the vaccine.' The patient died on
an unspecified date. It was not reported if an autopsy was performed. The outcome
of the event was fatal. No follow-up attempts are possible; information about
LOT/batch number cannot be obtained.; Reported Cause(s) of Death: had fever and
passed away three days later" "No prior vaccinations for this event." "No other
medications for this event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "934882-1" "934882-1" "heart
attack; This is a spontaneous report from a non-contactable consumer (discovered on
news page and heard in news). An elderly female patient (elderly than 90-year old
from home for elderly) received bnt162b2 (COMIRNATY) via unspecified route of
administration on unspecified date at single dose for COVID-19 immunization (other
details not reported). Medical history included heart attack. Concomitant
medications were not reported. patient experienced heart attack six hours after
vaccination that obviously occurred after repeated heart attack. It was stated that
heart attack was not connected to the vaccination. There was no acute allergic
reaction. Case was further investigated (independent committee) and confirmed the
vaccination was not reason of death. Patient died from heart attack, it was unknown
if autopsy was done. Information on batch number has been request.; Sender's
Comments: Fatal heart attack is not related to bnt162b2 use; the advanced old
patient had pre-existing medical condition including previous episode of heart
attack thus the underlying cardiovascular provided an explanation for the event
onset.; Reported Cause(s) of Death: heart attack" "No prior vaccinations for
this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Heart attack,"
"Unknown" "U" "Jan., 2021" "2021/01" "934963-1" "934963-1"
"Death; This is a spontaneous report from a contactable Physician. An elderly
male patient received BNT162B2 (COVID vaccine), via an unspecified route of
administration on an unspecified date in Dec2020 at single dose for COVID-19
immunisation. The patient's medical history and concomitant medications were not
reported. The patient experienced death in Jan2021. It was unknown if an autopsy
was performed. It was unknown if any treatment was received for the event. It was
unknown if the patient was diagnosed with COVID prior vaccination or if the patient
had been tested for COVID post vaccination. Seriousness criteria for the event was
reported as death and hospitalization. Pfizer is a marketing authorization holder
of [COVID vaccine] in the country of incidence or the country where the product was
purchased (if different). This may be a duplicate report if another marketing
authorization holder of [COVID vaccine] has submitted the same report to the
regulatory authorities. Information about lot/batch number has been requested.;
Sender's Comments: Current information is very limited for full assessment.
Further information such medical history, concomitant medications, concurrent
illness and event term details especially death cause and autopsy results are
needed for meaningful evaluation. The impact of this report on the benefit/risk
profile of the Pfizer product is evaluated as part of Pfizer procedures for safety
evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate
action in response, will be promptly notified to Regulatory Authorities, Ethics
Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death"
"No prior vaccinations for this event." "No other medications for this
event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "934966-1" "934966-1"
"COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous
report from a contactable consumer. An 80-year-old female patient received first
dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of
administration on 02Jan2021 for COVID-19 immunization. Medical history included
Alzheimer's and others. No known allergies. Concomitant medications included
unspecified medications. The reporter's mother in law was tested for COVID-19 at a
nursing facility on 25Dec2020 and she was negative. On 02Jan2021, she received the
first dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed
oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her
death was listed as pneumonia, respiratory failure and COVID-19. No autopsy
performed. No treatment received. No one knew if the vaccination contributed to her
death. It was hard to know if her death was due to the administration of the
vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this
was unknown, it could have been a possibility. The reporter wanted to give us this
information because we might want to consider having high risk population, patients
with underlying conditions, older population tested for COVID-19 prior to the
vaccination, as this is not currently a recommendation or a requirement. All is
very new and they are all learning so the reporter wanted to share this information
with us. The patient did not receive any other vaccines within 4 weeks prior to the
COVID vaccine. There are medications the patient received within 2 weeks of
vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.
Since the vaccination, the patient has been tested for COVID-19. The outcome of the
events was fatal. Information about Lot/Batch has been requested.; Sender's
Comments: The association between the fatal event lack of effect (pneumonia,
respiratory failure and COVID-19) with BNT162b2 can not be fully excluded. The
impact of this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including the review
and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be
promptly notified to regulatory authorities, Ethics Committees, and Investigators,
as appropriate.; Reported Cause(s) of Death: Pneumonia, respiratory failure and
COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory
failure and COVID-19; Pneumonia, respiratory failure and COVID-19" "No prior
vaccinations for this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Alzheimer's disease,"
"Unknown" "U" "Jan., 2021" "2021/01" "936170-1" "936170-1"
"Myocardial infarct; Circulatory collapse; This is a spontaneous report from
a contactable physician from the regulatory authroity. The regulatory authority
report number is GB-MHRA-ADR 24553112 and GB-MHRA-WEBCOVID-20210104143047. An 82-
year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot
number: EJ1688), via an unspecified route of administration, on 31Dec2020 at a
single dose for COVID-19 vaccination. Medical history included mitral valve
incompetence from 08May2020, myocardial ischaemia from 07May2020, acute myocardial
infarction from 07May2020, cataract from 29Nov2019, chronic kidney disease from
03Oct2013, colitis ischaemic from 23May2013, basal cell carcinoma from 20Apr2012,
transurethral bladder resection on 06Sep2005, neoplasm malignant (other/unspecified
site) from 16Aug2005, debridement (arthroscopic debridement of patella) on
12Jan2005, and essential hypertension from 2005. The patient had not had symptoms
associated with COVID-19. The patient was not been tested/or had an inconclusive
test for COVID-19. The patient was not enrolled in clinical trial. Concomitant
medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER
UNKNOWN), betamethasone valerate (BETNOVATE), bisoprolol (MANUFACTURER UNKNOWN),
furosemide (MANUFACTURER UNKNOWN), glyceryl trinitrate (MANUFACTURER UNKNOWN),
loperamide (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN),
phenoxymethylpenicillin (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER
UNKNOWN). The patient experienced myocardial infarct and circulatory collapse on
31Dec2020. The event, myocardial infarct, was reported as fatal. It was reported
that the patient collapsed at home the evening after vaccination. The clinical
outcome of myocardial infarct was fatal and of circulatory collapse was not
recovered. The patient died on 31Dec2020. The cause of death was reported as
myocardial infarct. It was unknown if an autopsy was performed. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of
Death: Myocardial infarct" "No prior vaccinations for this event." "; ;
BETNOVATE; ; ; ; ; ; ;" "Medical History/Concurrent Conditions: Acute
myocardial infarction; Basal cell carcinoma; Cataract; Chronic kidney disease;
Colitis ischaemic; Debridement (Arthroscopic debridement of patella); Essential
hypertension; Mitral valve incompetence; Myocardial ischaemia; Neoplasm malignant
(other/unspecified site); Transurethral bladder resection; Comments: Patient has
not had symptoms associated with COVID-19. Patient has not been tested/or has had
an inconclusive test for COVID-19. Patient is not enrolled in clinical trial.,"
"Unknown" "U" "Jan., 2021" "2021/01" "937724-1" "937724-1" "Death
in connection with the vaccination and/or COVID-19 disease/positivity; Death in
connection with the vaccination and/or COVID-19 disease/positivity; This is a
spontaneous report from a contactable physician. This physician reported similar
events for two patients. This is the first of two reports. A patient of unspecified
age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration, on an unspecified date at single dose for
COVID-19 immunization. The patient's medical history and concomitant medications
were not reported. On an unspecified date, there was death in connection with the
vaccination and/or COVID-19 disease/positivity. It was reported that: two deceased
were autopsied, whose death was in connection with the vaccination or COVID-19
disease/positivity. The clinical outcome of death in connection with the
vaccination and/or COVID-19 disease/positivity was fatal. The patient died on an
unspecified date. The cause of death was reported as: death in connection with the
vaccination and/or COVID-19 disease/positivity. An autopsy was performed, and the
results were not reported.; Sender's Comments: The association between the event
lack of effect (death was in connection with the vaccination or COVID-19 disease
positivity) with BNT162b2 can not be fully excluded given the limited information.
The impact of this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including the review
and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be
promptly notified to regulatory authorities, Ethics Committees, and Investigators,
as appropriate.,Linked Report(s) : DE-PFIZER INC-2021006905 same reporter, same
product, same event, different patient; Reported Cause(s) of Death: Death in
connection with the vaccination and/or COVID-19 disease/positivity; Death in
connection with the vaccination and/or COVID-19 disease/positivity" "No prior
vaccinations for this event." "No other medications for this event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "937985-1" "937985-1" "death
following BNT 162b2 vaccination; This is a spontaneous report from a contactable
consumer. A patient of unspecified age and gender received BNT162B2 (COMIRNATY;
PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration
on an unspecified date as the first single dose for COVID-19 immunization. The
patient's medical history and concomitant medications were not reported. Death
following BNT162B2 vaccination was noted on an unspecified date. The patient died
on an unspecified date. It was not reported if an autopsy was performed.; Reported
Cause(s) of Death: death" "No prior vaccinations for this event." "No other
medications for this event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "938038-1" "938038-1" "Acute
cardio-respiratory event and died a few hours later; This is a spontaneous report
received from a contactable physician by Pfizer from the Regulatory Agency. The
regulatory authority report number is GB-MHRA-WEBCOVID-20210107093111. Safety
Report Unique Identifier GB-MHRA-ADR 24565959. An 84-years-old female patient
received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, on 04Jan2021,
for COVID-19 immunisation. Patient was elderly and frail and gradually declining in
mobility, communication and memory over the last 12 months. Relevant medical
history also included vascular dementia form an unspecified date and unknown if
ongoing. Concomitant medications were unknown. Patient was not enrolled in clinical
trial. COVID-19 virus test was performed twice on an unspecified date, in Dec2020
and on 18Dec2020 and the results were negative. On 04Jan2021, at 06:00 PM, the
patient experienced acute cardio-respiratory event and died a few hours later. It
was unknown if autopsy was done. Since the vaccination, the patient has not been
tested for COVID-19. Patient did not have symptoms associated with COVID-19. The
patient was kept comfortable in the nursing home in these last few hours. There was
no way to know whether the vaccine was to blame at all, it was unlikely. No
follow-up attempts are possible, information about lot number cannot be obtained.;
Reported Cause(s) of Death: Cardio-respiratory failure" "No prior vaccinations
for this event." "No other medications for this event." "Medical
History/Concurrent Conditions: Vascular dementia,"
"Unknown" "U" "Jan., 2021" "2021/01" "938097-1" "938097-1" "died;
This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored
program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH
COVID-19 VACCINE, via an unspecified route of administration on an unspecified date
at single dose for covid-19 immunisation. The patient medical history and
concomitant medications were not reported. It was reported the patient was a
doctor, died after the vaccine with no apparent disease. It was not reported if an
autopsy was performed. No follow-up attempts are possible. Information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of
death" "No prior vaccinations for this event." "No other medications for
this event." ","
"Unknown" "U" "Jan., 2021" "2021/01" "939332-1" "939332-1"
"Death; Malaise; Vomiting; This is a spontaneous report received from a
contactable physician from the Regulatory Agency (RA). The Regulatory Authority
report number is GB-MHRA-WEBCOVID-20210105172532, Safety Report Unique Identifier
GB-MHRA-ADR 24558660. An 81-year-old female patient received bnt162b2 (BNT162B2)
(lot# EJ1688), via an unspecified route of administration, on 30Dec2020, at single
dose, for COVID-19 immunisation. Medical history included vascular dementia
(advanced dementia), dementia Alzheimer's type (vascular and Alzheimer's mixed
dementia), oral intake reduced (patient known to not be eating or drinking), fluid
intake reduced, (patient known to not be eating or drinking), general physical
health deterioration (patient known to be declining); all from an unknown date and
unknown if ongoing. Concomitant medications were not reported. The patient
experienced death on 03Jan2021, malaise on 01Jan2021 with fatal outcome, vomiting
on 01Jan2021 with fatal outcome. It was reported that 48 hours after vaccination
the patient became unwell, vomited and then died on 03Jan2021. The patient
underwent lab tests and procedures which included COVID-19 virus test: negative on
27Dec2020. Patient has been not tested positive for COVID-19 since having the
vaccine. It was not reported if an autopsy was performed. It was not known whether
vaccine caused reaction. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Malaise; Vomiting; Death"
"No prior vaccinations for this event." "No other medications for this
event." "Medical History/Concurrent Conditions: Dementia Alzheimer's type
(Vascular and Alzheimer's mixed dementia); Fluid intake reduced (patient known to
not be eating or drinking); General physical health deterioration (Patient known to
be declining); Oral intake reduced (patient known to not be eating or drinking);
Vascular dementia (advanced dementia),"
"Unknown" "U" "Jan., 2021" "2021/01" "939334-1" "939334-1"
"breathless on exertion; This is a spontaneous report received from a
contactable other health professional received from the United Kingdom's Medicines
and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority
report number is GB-MHRA-ADR 24561910, other case identifier number: GB-MHRA-
WEBCOVID-20210106094618. An 80-years-old male patient received bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE, Batch/lot no: EJ1688), via an unspecified route of
administration on 30Dec2020 single dose for covid-19 immunisation. Medical history
included Bowen's disease, basal cell carcinoma, chronic kidney disease and
essential hypertension, all unknown if ongoing. Concomitant medication included
alfacalcidol (unknown manufacturer), amlodipine (unknown manufacturer),
atorvastatin (unknown manufacturer), clopidogrel (unknown manufacturer), prazosin
(unknown manufacturer), sodium bicarbonate (unknown manufacturer), folic acid
(unknown manufacturer), furosemide (unknown manufacturer). The patient experienced
breathless on exertion on 02Jan2021. The patient died on 02Jan2021 due to the
event. The patient underwent lab tests and procedures which included sars-cov-2
test: no - negative covid-19 test on unknown date. It was not reported if an
autopsy was performed. No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: Dyspnoea exertional""No prior vaccinations
for this event." "; ; ; ; ; ; ;" "Medical History/Concurrent Conditions:
Basal cell carcinoma; Bowen's disease; Chronic kidney disease; Essential
hypertension,"
"Unknown" "U" "Jan., 2021" "2021/01" "940950-1" "940950-1"
"thrombopenia; pulmonary embolism; neutropenia fever; This is a spontaneous
report from a Pfizer-sponsored program . A contactable consumer reported for a
patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an
unspecified route of administration on an unspecified date at a single dose for
COVID-19 immunization. The patient's medical history and concomitant medications
were not reported. The patient experienced thrombopenia, pulmonary embolism and
neutropenia fever on an unspecified date. The clinical outcome of thrombopenia,
pulmonary embolism and neutropenia fever was fatal. The patient died on an
unspecified date. It was unknown if an autopsy was performed. The batch/lot
number for the vaccine, BNT162B2, was not provided and will be requested during
follow-up.; Reported Cause(s) of Death: thrombopenia; pulmonary embolism;
neutropenia fever" "No prior vaccinations for this event." "No other
medications for this event." ","
"---"
"Dataset: The Vaccine Adverse Event Reporting System (VAERS)"
"Query Parameters:"
"Date Report Completed: Dec., 2020 to Jan., 2021"
"Date Report Received: Dec., 2020 to Jan., 2021"
"Event Category: Death"
"Vaccine Products: COVID19 VACCINE (COVID19)"
"VAERS ID: All"
"Group By: Age; Month Reported; VAERS ID"
"Show Totals: False"
"Show Zero Values: False"
"---"
"Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information."
"---"
"Query Date: Jan 28, 2021 12:58:32 AM"
"---"
"Suggested Citation: United States Department of Health and Human Services (DHHS),
Public Health Service (PHS), Centers for"
"Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event
Reporting System (VAERS) 1990 - Previous"
"Friday, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html
on Jan 28, 2021 12:58:32 AM"
"---"
Messages:
"1. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same
query can change from week to week."
"2. These results are for 179 total events."
"3. When grouped by VAERS ID, results initially don't show Events Reported,
Percent, or totals. Use Quick or More Options to"
"restore them, if you wish."
"4. Click on a VAERS ID to see a report containing detailed information for the
event."
"5. Rows with zero Events Reported are hidden. Use Quick Options above to show zero
rows."
"---"
Footnotes:
"1. Submitting a report to VAERS does not mean that healthcare personnel or the
vaccine caused or contributed to the adverse"
"event (possible side effect)."
"---"
Caveats:
"1. <p> VAERS accepts reports of adverse events and reactions that occur following
vaccination. Healthcare providers, vaccine"
"manufacturers, and the public can submit reports to VAERS. While very important in
monitoring vaccine safety, VAERS reports"
"alone cannot be used to determine if a vaccine caused or contributed to an adverse
event or illness. The reports may contain"
"information that is incomplete, inaccurate, coincidental, or unverifiable. Most
reports to VAERS are voluntary, which means they"
"are subject to biases. This creates specific limitations on how the data can be
used scientifically. Data from VAERS reports"
"should always be interpreted with these limitations in mind. </p> <p> The
strengths of VAERS are that it is national in scope"
"and can quickly provide an early warning of a safety problem with a vaccine. As
part of CDC and FDA's multi-system approach to"
"post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect
unusual or unexpected patterns of adverse events,"
"also known as ""safety signals."" If a safety signal is found in VAERS, further
studies can be done in safety systems such as"
"the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety
Assessment (CISA) project. These systems do not have"
"the same limitations as VAERS, and can better assess health risks and possible
connections between adverse events and a vaccine."
"</p> <p> Key considerations and limitations of VAERS data: <ul><li> Vaccine
providers are encouraged to report any clinically"
"significant health problem following vaccination to VAERS, whether or not they
believe the vaccine was the cause. </li><li>"
"Reports may include incomplete, inaccurate, coincidental and unverified
information. </li><li> The number of reports alone"
"cannot be interpreted or used to reach conclusions about the existence, severity,
frequency, or rates of problems associated"
"with vaccines. </li><li> VAERS data are limited to vaccine adverse event reports
received between 1990 and the most recent date"
"for which data are available. </li><li> VAERS data do not represent all known
safety information for a vaccine and should be"
"interpreted in the context of other scientific information. </li></ul> </p>"
"2."
"3. Some items may have more than 1 occurrence in any single event report, such as
Symptoms, Vaccine Products, Manufacturers, and"
"Event Categories. If data are grouped by any of these items, then the number in
the Events Reported column may exceed the total"
"number of unique events. If percentages are shown, then the associated percentage
of total unique event reports will exceed 100%"
"in such cases. For example, the number of Symptoms mentioned is likely to exceed
the number of events reported, because many"
"reports include more than 1 Symptom. When more then 1 Symptom occurs in a single
report, then the percentage of Symptoms to"
"unique events is more than 100%. More information:
http://wonder.cdc.gov/wonder/help/vaers.html#Suppress."
"4. Data contains VAERS reports processed as of the previous Friday. The VAERS data
in WONDER are updated weekly, yet the VAERS"
"system receives continuous updates including revisions and new reports for
preceding time periods. More information:"
"http://wonder.cdc.gov/wonder/help/vaers.html#Reporting."
"5. Values of Event Category field vary in their availability over time due to
changes in the reporting form. The ""Emergency"
"Room/Office Visit"" value was avaliable only for events reported using the VAERS-1
form, active 07/01/1990 to 06/29/2017. The"
"""Congenital Anomaly/Birth Defect"", ""Emergency Room"", and ""Office Visit""
values are available only for events reported"
"using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be
considered when evaluating count of events for"
"these categories."