Reporting and

Investigation tools for AEFI

Adama
Nov, 12 2021
 Outline

• AEFI reporting system

• AEFI reporting tools
 AEFI Reporting system

What to report?

When to report?

Who should report?

To whom to report?

How to report?
 What, and When to report

What to report
• Serious AEFI
• AEFI as a result of potential immunization errors
• Clusters
• AEFI causing parental or community concern resulting in the family
notifying the case back to the healthcare system
• Those that are unexpected, and
• Those that are known but occur with unexpected frequency
 What, and When to report

What to report for COVID-19 vaccine

• Because this is a new vaccine, it is essential to notify any safety
concern
• Report all AEFIs that are brought to your notice.
– Include all available information as accurately as possible
– Report all non-serious AEFI
– There is no need to confirm the AEFIs
 What, and When to report

When to report
• As soon as possible
• In case of serious AEFI,
– Inform your supervisor and/or AEFI focal person or EFDA immediately
and
– Complete and submit the reporting form within 24 hours
 Where to report
 Currently EFDA uses both the centralized and decentralized
approach of AEFI information collection.
Centralized
 HCPs EFDA /NPVC/
Decentralized
 HCPs RPVC
 HCPs Branch EFDA office/PV focal person/
 HCPs RHB
 HCPs Woreda EPI focal person
 Who should report

 All health care professionals are responsible for reporting AEFIs

 Physicians
 Nurse
 Pharmacy professionals
 Public health professionals
 Laboratory professionals
 Others
 How to report

AEFI reporting tools

 Paper based tools

 Web Based (E-Reporting) System

 Mobile Apps and others

 AEFI reporting tools cont.

1. Paper based tools

Standard AEFI reporting Form (yellow)

 Line listing form

Standard AEFI reporting Form (yellow)
 Line listing form
• AEFI linelist.xlsx
 AEFI reporting tools cont.

2. E-Reporting System
– Online reporting
• www.fmhaca.gov.et
• https://med-safety.redant.cloud/login

– Mobile based application system

 Online reporting www.fmhaca.gov.et

14
 E-Reporting System cont.

 Online reporting
• https://med-safety.redant.cloud/login

• Create an account

• Choose organization (EFDA)

• Personal details

• Create user
 3. Mobile based application system

Mobile application based system

– Using a mobile application (Med safety)

– Can be downloaded from Google play store for Android

phones or APP store for IOS users
– Creating an account through an email address

– Enter through the “new report” button and enter the required
data in the reporting page
16
Mob. App Instructions on how to use

17
 4. Telephone and Email Address

 Toll free number 8482

 Mail: pharmacovigilance@efda.gov.et

 Scan copy of the filled reporting form

Thank you
 Autopsy
Date of Date of
Age (date of Birth or Vaccine/s Manufacture Vaccine Batch Diluent Batch Adverse Place of Date of Date of *Serious Resone for Conuctd in Reported Reporter Reporter Investigation Date Reported
Dose Vaccination Notificaton(DON outcome
age at on set) Brand Nam No No Event Vaccination onset Reporting (DOR) (y/N) Serious Case Death by Location 1 Location 2 Planned (y/N) at National Level
(DOV) )
(y/N)
AEFI Reporting ID Patient Location Patient Location Pregnant Lactatng
Source S.No Patient Name /identifier Number (Village /Town (District) sex (m/F) (y/N) (Y/N)

*A serious adverse event or reaction is any untoward medical occurrence that at any dose:
1. Results in death 5. is
life-
3. Results in threate
persistent or ning
significant
disability/incapacit
y

2.Requires inpatient 4. Congenital

hospitalization or prolongation abnormality (birth
of existing hospitalization defect)
የመደኃኒት አለርጂ መታወቂያ ካርድ
ከጀርባ