AEFI guidelines

1. Adverse Events Following
Immunization
Current Status & National Guidelines
State EPI Officers Meeting
8 July 2005

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RAJASTHAN
ORISSA
GUJARAT
MAHARASHTRA
MADHYA PRADESH
BIHAR
KARNATAKA
UTTAR PRADESH
ANDHRA PRADESH
JAMMU & KASHMIR
ASSAM
TAMIL NADU
CHHATTISGARH
PUNJAB
JHARKHAND
WEST BENGAL
ARUNACHAL PR.
HARYANA
KERALA
UTTARANCHAL
HIMACHAL PRADESH
MANIPUR
MIZORAM
MEGHALAYA
NAGALAND
TRIPURA
SIKKIM
GOA
A&N ISLANDS
DELHI
D&N HAVELI
DAMAN & DIU
PONDICHERRY
LAKSHADWEEP
72 Cases
1 Dot= 1 Case

3. RAJASTHAN
ORISSA
GUJARAT
MAHARASHTRA
MADHYA PRADESH
BIHAR
KARNATAKA
UTTAR PRADESH
ANDHRA PRADESH
JAMMU & KASHMIR
ASSAM
TAMIL NADU
CHHATTISGARH
PUNJAB
JHARKHAND
WEST BENGAL
ARUNACHAL PR.
HARYANA
KERALA
UTTARANCHAL
HIMACHAL PRADESH
MANIPUR
MIZORAM
MEGHALAYA
NAGALAND
TRIPURA
SIKKIM
GOA
A&N ISLANDS
D&N HAVELI
DAMAN & DIU
PONDICHERRY
LAKSHADWEEP
Not Reporting (16)
Zero Reporting (10)
Reporting (9)

4. Why monitor AEFI?
No vaccines are 100% safe and without
any risks
It is important to know the risks and how to
handle such an event when it occurs
Informing people correctly on AEFI helps
keep public’s confidence in the
immunization programmes
Monitoring AEFI also helps improve the
quality of service

5. Steps in AEFI surveillance
Detection and reporting
Investigation
Data analysis
Corrective and other actions
Evaluation

6. AEFI
Detection and reporting
Every individual that administers an
immunization injection should know about AEFI
The following are events need to be reported and
investigated immediately (Serious Events)
All deaths suspected to be related to
immunization
All hospitalisation suspected to be related to
immunization
Any other event in which vaccine quality is
suspected

7. AEFI
Detection and reporting
The above basic categories act as “trigger”
mechanisms for further course of action
Minor events
 Sudden, unexplained deaths or large scale
hospitalisation or a cluster of events reported
following immunisation warrants immediate
investigation

8. HOW , WHOM & WHEN TO
REPORT
PHC level
Minor Events
By ANM to MO PHC In Monthly Report
By MO PHC to DIO in Monthly Report
District Level
By DIO to SEPIO in Monthly Report
State level
By SEPIO to GoI in Monthly Report

9. HOW , WHOM & WHEN TO
REPORT
Serious events
PHC level
ANM to the MO (PHC) immediately by
telephone.
The MO (PHC)
First Information Report (FIR): to DIO in
24 hrs

10. HOW , WHOM & WHEN TO
REPORT
Serious events
District Level
DIO informs AC (UIP), GoI & SEPIO within
next 24 hrs.
Preliminary Investigation (PIR)
PIR to AC (UIP) & SEPIO within 7 days of
the AE.
This report will include the probable
cause of death and also mention the
further investigation planned for the case

11. HOW , WHOM & WHEN TO
REPORT
Detailed Investigation (DIR)
The DIO with team/ Regional investigation
team/ State investigation team
Prepare & Forward DIR, Post mortem report,
vaccine test report, medical documents etc
of the case to the AC (UIP) within 90 days
Field workers are encouraged to report
AEFIs

12. Sub Center /
Outreach
Patient &
Community
Vaccine
Manufacturer
DCG(I)
MoHFWState FDA
Private
Practitioner
District
FDA
District Hospital/
UHC/ Other
Institutions
State
District
PHC/ CHC
NCL
Immediateby fastest
means
FIR within24 hours
Immediately
Immediately
In consultation with
State
Immediately Informs
about deaths
FIR within 24 hrs
FIR within 24 hrs/ PIR in 7 days/
DIR in 90 days
FIR within24 hrs/ PIRin 7 days/DIR in 90days
VaccineSample Shares
Information
CHANNELS AND TIMELINE FOR
REPORTING SERIOUS AEFI CASES

13. AEFI
Investigation
AEFI investigation will attempt to
confirm or propose alternative diagnosis of the
reported event
identify the specifications of the vaccine incriminated
examine the operational aspects of the programme
identify whether it was an isolated event or a cluster
of events and, if a cluster, where the immunization
was given and what vaccines were used
Preliminary investigation may be carried out by the
local health worker, but serious AEFIs or clusters of
AEFIs should be investigated from district or
state/central level

14. AEFI
Investigation
Data on the patient(s)
Vaccine (lot number, expiry, manufacturer, lab
results if any), storage, reconstitution practice,
diluent used,
General disease information
Similar disease episodes
Collect samples of vaccines and diluents used
(make sure vaccine sample collected are kept in
the cold chain)

15. FORMS USED FOR
INVESTIGATION
The reporting of the minor events is done on
monthly basis in the form 6-9 of RCH
The reporting for severe cases is done using
First Information report (FIR) in 48 hrs
Followed by Preliminary investigation report
(PIR) within 7 days
And a Final report in form of Detailed
investigation report (DIR) within 90 days

16. AEFI
Data analysis
Quickly to determine whether the AEFI is
Programme related (incorrect dose of
vaccine, wrong site, wrong diluent,
improper storage & handling, use of other
medicines as diluent, etc.)
Vaccine induced AEFI
Coincidental AEFIs (caused by something
other than vaccine or programme errors)
Unknown

17. Laboratory support
If patient hospitalised, tests may
confirm diagnosis
Testing vaccines
Send Vaccine & Diluents in reverse
cold chain to CRI Kasauli
Send case investigation report with
vaccine for test

18. AEFI
Corrective and other actions
Action must not wait for investigation to be
completed
Treat
Communicate
Publicise the results
Take corrective actions, where necessary
Training of health workers & supervision to
prevent avoidable AEFIs in future

19. AEFI
Avoiding Programme Errors
Use sterile needle & syringe for every injection
Reconstitute only with specific diluent
Discard reconstituted vaccines after Four hours
Do not store drugs & other medicines in the
same fridge as the vaccines and diluents
Train & supervise health workers to ensure safe
injection practices
Monitor, Investigate and Act when AEFIs occur

20. AEFI
Evaluation
Periodically to examine its usefulness and to modify it
if necessary
Issues to consider when evaluating a surveillance
system are
timeliness, completeness, accuracy of the
system
swiftness with which response was effected
when a trigger event was reported
appropriateness of actions taken
potential for strengthening of immunization
system