AEFI

Reporting, Investigation
& Management
 AEFI

• AEFI is Adverse Event Following

Immunization.

• AEFI is a medical incident that takes

place within a defined period after an
immunization, causes concern, but
may or may not be caused by
immunization
 Frequency of AEFI

Vaccine Estimated rate* BCG1 1 in 1000 to1 In

50,000
doses
OPV 1 in 3 million doses
for the first dose of
OPV
Measles 1 in one million doses
DTP1 in 750,000
*Only the rate for severe
 Probable Causes

• Vaccine reaction - caused by vaccines inherent

properties
• Programme error - caused by error in vaccine
preparation, handling, or administration
• Coincidental - happens after immunization but not
caused by it (a chance association)
• Injection reaction - anxiety or pain of injection not
vaccine
• Unknown - cause cannot be determined
 COMPONENTS OF THE
VACCINE FORMULATION

• Suspending agents e.g. water, saline

• Preservatives e.g. thiomerosal
• Stabilisers e.g. sorbitol and hydrolyzed gelatin - MMR
• Adjuvants e.g. aluminium Salts

Other substances which may be present

• Residuals in the growth medium
• Antibiotics, e.g. neomycin, streptomycin - IPV, varicella
vaccine
• consider these components as well
when assessing causality!
 INVESTIGATING ADVERSE events
following IMMUNIZATION

Detect Report

Respond Investigate
Live Attenuated SA14-14-2 JE
Vaccine
• Used since 1988: China
• Also used in Nepal; S.Korea and India
• Over 210 Million children vaccinated
• WHO Position paper and GACVS report on
safety and efficacy
• Independent commission report on AEFI of
2006 campaign
 “no direct causality has been established between the
reported illnesses and the live attenuated SA14-14-2 JE
vaccine. No stricture on the further use of the vaccine
is warranted.”
 National Level Committee of
Experts
• NO PRIMA FACIE EVIDENCE THAT AEFI
HAS CONTRIBUTED EXCESS
MORTALITY
o No Systemic adverse events were seen

o No consistency in cause of death were noted

o Even statistically there were no anomalies detected

o Strengthening of documentation – Hospital Case

records
 Major & Minor AEFI

• Minor AEFI: Any vaccinated child presenting with

any symptom of illness that is resolved in a short
time following preliminary care and medication.
Hospitalization is not required and the child is
completely recovered without any sequelae
• Mild Fever
• Rash
• Tenderness at Injection site
• Irritability
• Abdominal discomfort
• Major AEFI: Any vaccinated child presenting with
any symptom of illness that requires
hospitalization and/or the child dies from the
illness
 Investigation of Major AEFI

• District AEFI Committee

• Reporting major AEFIs

• Laboratory Investigation

• Management
 District AEFI Committee

• A district AEFI Committee has been

formed under the chairmanship of the
DHO/CS/DIO
• The Committee
o A pediatrician/physician
o A pathologist/microbiologist/MO trained in
pathology
o Anesthesiologist
o District Immunization officer
o District Malaria Officer
 Roles and Responsibilities

• Review preparedness of the District hospital and

other possible referral centers for management of
AEFI
• Hold one orientation meeting for all PHC MOs in
management and reporting of AEFI
• All major AEFI cases will be investigated physically
by at least one member of the committee
immediately following report ( w/in 24 hours)
• Ensure that the investigation is carried out as per
National Guidelines
• Brief the official spokesperson of the District for
media update and response
 Forms to be filled up

• FIR
o To be filled up for all cases by the investigator immediately
following investigation of the case. This form may be filled up
by the Health worker at the vaccination site, the Medical officer
at the PHC, District Hospital and the Medical College
immediately following their investigation of the case.
• PIR
o To be filled up for all cases by the investigator within 2- 4 days
of investigation of the case. This form may be filled up by the
Medical officer at the PHC, District Hospital and the Medical
College immediately following their investigation of the case.
• DIR
o To be filled up for all cases by the investigator within 1 to 3
months following investigation of the case. This form may be
filled up by the District Immunization officer, Medical officer at
the PHC, District Hospital and the Medical College immediately
following their investigation of the case.
 What to collect following a
major AEFI
• Vaccine vials: collect the actual
opened vial of vaccine and diluent
used to vaccinate the child
( wherever possible); collect
unopened vials

• Collect syringes and needles

• Ensure needles are capped

 Specimens...1

• It is mandatory to collect CSF Specimens from all

major AEFI cases with neurological symptoms

• In case CSF collection is not possible at PHC level,

the DIO should ensure that that the CSF is collected
by specialist from the district hospital or elsewhere

• If CSF is not collected then paired blood samples

o Ist. on the day of the admission

o IInd. on 10th. day or the day of discharge in case of death

immediately after death-which ever is earlier
 Specimens...2

• Routine: urine, serum

• If the child dies-Autopsy and brain specimens collection

• All specimens should be collected and transported in

reverse cold chain to the designated laboratory
(NIV,PUNE) under the supervision of the DIO

Dr Milind Gore, Director I/C

National Institute of Virology,
Sus Road Campus, Pashan,
Pune 411021, India
Tel: 91-20-25880982,
Fax: 91-20-25883595
 Vaccine vials

• Collect the actual opened vial of vaccine

and diluents used to vaccinate the child
( wherever possible);
• Collect unopened vials :
o 2 from central store
o Five from ILR of implementing unit (PHC)
• These vials will be sent to the laboratory for
testing of any adventitious tissue , adjuvant
or sterility
 Expectations from AEFI
Committee
• Identification of members
• Communication to the district of all
AEFI cases
• Specimens: Routine CSF; blood
and slide for MP; autopsy ( in death)
• CSF and Serum for apex laboratory
• One official spokesperson from the Dist.
• Completed investigations forms:
 Form 8 - FIR
 Form 9 - PIR
Collection, Storage & Shipment

• Samples
 CSF - 2-5 ml
 Blood - 5 ml (Centrifuge and segregate
Serum and Cells)

• Reverse Cold Chain:

 Vaccine Carrier/ILR/Cold Box

• Within 72 Hrs. of collection

 Communicate

• District Health Officer/Civil Surgeon

• ACMO

• DIO

• DMO
 Useful Instruction

• Do not vaccinate a child if the child /parents

complain of any sickness in the child including
mild fever

• Not the name and full address of the child

• Vaccinate the child once he recovers

• In case of doubt, the health worker should consult

the Medical Officer of the PHC
Your support in AEFI investigation and
coordination at all level is crucial
Muito Obrigado!
Thank You
Dr Dhananjay Singh
Consultant
Kala-azar Project
John Snow Inc.
Cell:94311 05617