Guidelines for investigation of AEFI Cases for JE Vaccination with

live attenuated SA14-14-2 JE Vaccine

What is AEFI?

AEFI is Adverse Event Following Immunization.

AEFI is any medical incident that takes place within a defined period
after an immunization. Such events cause concern, but may or may not
be caused by immunization and should be investigated.

General comments on the safety of the Live attenuated SA14-14-

2 JE Vaccine:

The SA14-14-2 JE vaccine has been demonstrated to be a safe and

effective vaccine in use in 4 Asian countries. Over 200 million children
have been vaccinated in China with this vaccine since 1988. The vaccine
has also been used in South Korea, Nepal and India.

In 2006 more than 9 million children have been vaccinated with SA14-
14-2 JE vaccine in 11 districts in India. To ensure the safety of the
vaccine in India, an independent committee was set up by the Ministry of
Health and Family Welfare to review State Investigation reports and to
investigate the AEFI with live attenuated SA14-14-2 JE vaccine in high
risk districts covering 4 States in the country.

The committee reported that in all serious events reported after

vaccination 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.

The Committee emphasized the importance of case investigation in the

hospitals when patients present and pointed out several gaps in the AEFI
investigation(s) carried out in the Medical Colleges and other hospitals in
the State.

Minor side effects commonly observed with vaccines have been also
reported following vaccination with the SA14-14-2 JE vaccine are:

Mild fever
Rash
Tenderness at injection site
Irritability
Protocol for investigation of all cases of Adverse Events
Following Immunization with Live attenuated SA14-14-2 JE
Vaccine:

Following vaccination campaigns it is important to undertake a detailed

investigation of all cases as per the National guidelines for AEFI. All cases
should be investigated and documented to establish the cause of
sickness and death in these children especially taking appropriate
clinical specimens (including CSF in all neurological events). Case
investigations should compliment clinical care.

District AEFI Committee:

An AEFI Committee under the chairmanship of the Chief Medical officer

of Health will be set up at the district prior to the campaigns. Other
members of the committee will comprise of the following:

Pediatrician/Physician
District Laboratory Representative. (a Pathologist or a Microbiologist or
any Senior Laboratory staff / Medical Officer trained in clinical pathology)
District Malaria Officer
District Immunization Officer
Anesthetist
Civil Surgeon / Residential Medical Officer

Roles and responsibilities of the District AEFI Committee:

Before the campaigns, the Committee will ensure and review

preparedness of the Medical College, District Hospital and other possible
sites of AEFI case referral
The Committee will hold one orientation meeting of all Medical officers
from PHCs, district hospital and Medical College.
The Committee will identify one nodal person for AEFI investigation and
reporting in each of these institutions. Following should preferably be
identified as the nodal person:

PHC: Medical officer

District Hospital: Pediatrician
Medical College: Pediatrician
Each and every case reported as a serious AEFI (hospitalized cases
and/or deaths) will be investigated at the earliest (within 24 hours) by at
least one member of the AEFI committee. This investigation will include a
visit to the facility where the case is admitted or the community if the
child has died before hospitalization. The committee member will also
ensure that each case has been diagnosed provisionally pending final
diagnosis.
Detail protocol as prescribed in the Operational Guidelines Japanese
Encephalitis Vaccination in India: as issued by the Immunization Division,
Department of family Welfare, Ministry of Health and Family Welfare,
Government of India should be followed in investigation of the AEFI cases
The committee will also identify and prepare a local laboratory (e.g.:
District Laboratory) for preliminary testing (cytology, grams stain and
biochemistry) of CSF samples. The committee will also define the
process of transfer of specimens to NIV, Pune for further testing of CSF)

Forms to be filled up in AEFI:

FIR:

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

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

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.

Illustration of investigation of a case of AEFI admitted in a

hospital:

This process runs parallel to the clinical management of the case.

FIR filled up.

Complete FIR immediately faxed or sent by messenger to the District
Immunization Officer and the Immunization Division , MoHFW,
Government of India ( Fax Number: 23062728).All complete FIRs must
reach the Immunization Division, MoHFW, Government of India within 48
hours of the first investigation of the case.
CSF sample collected if the patient has neurological symptoms.
CSF sample sent to the District in cold chain. (Note 1: CSF sample
collection is essential to determine the etiology of the encephalitis
particularly in a child vaccinated recently with JE vaccine. Every attempt
should be made to collect CSF. In the rare event of not being able to
collect CSF specimens, serum samples should be collected. Note 2:
Adequate amount of CSF should be collected for laboratory testing and
validation)
PIR filled up within 2-4 days of investigation of the child. The PIR should
also be filled up at the earliest opportunity.
Complete PIR immediately faxed or sent by messenger to the District
Immunization Officer and the Immunization Division , MoHFW,
Government of India ( Fax Number: 23062728).All complete FIRs must
reach the Immunization Division, MoHFW, Government of India within 7
days of the first investigation of the case.
DIR filled up by the District immunization officer or Medical officer of the
Hospital within 1-3 months of initial investigation of the case.

All records related to the AEFI case must be retained for at least 12
months following the investigation of the case.

Illustration of investigation of an AEFI case who died before

investigation:

FIR filled up.

Complete FIR immediately faxed or sent by messenger to the District
Immunization Officer and the Immunization Division , MoHFW,
Government of India ( Fax Number: 23062728). All complete FIRs must
reach the Immunization Division, MoHFW, Government of India within 48
hours of the first investigation of the case.
Autopsy must be carried out in all deaths which have occurred before
investigation. (In case of deaths following investigation and admitted in a
hospital , autopsy must also be carried out for further clues to the
etiology)
Brain tissue should be collected and transported in cold chain to District
Immunization officer for further histo-pathological investigation.
PIR filled up within 2-4 days of investigation of the death.
Complete PIR immediately faxed or sent by messenger to the District
Immunization Officer and the Immunization Division , MoHFW,
Government of India ( Fax Number: 23062728).All complete FIRs must
reach the Immunization Division, MoHFW, Government of India within 7
days of the first investigation of the case.
DIR filled up by the District immunization officer or Medical officer of the
Hospital within 1-3 months of initial investigation of the case.

All records related to the AEFI case must be retained for at least 12
months following the investigation of the case.

Guidelines for collection and shipment of samples for Laboratory

investigation in a major AEFI case following vaccination with live
attenuated SA14-14-2 JE vaccine:

Collection of laboratory specimens in all children who are admitted in a

hospital with any illness within 28 days of vaccination with live
attenuated SA14-14-2 vaccine is a critical criterion for determining the
cause and any association of the illness with the vaccine.

Following samples need to be collected in all children who are admitted

in a hospital with any illness within 28 days of vaccination with live
attenuated SA14-14-2 vaccine:

Cerebrospinal Fluid (CSF) ( Only in children presenting with any

neurological signs and symptoms)
Serum
Stool ( if the child presents with Acute Flaccid Paralysis-AFP)

Cerebrospinal Fluid Collection:

CSF is the sample of choice in all children who are admitted to a hospital
with any neurological illness and have been vaccinated with live
attenuated SA14-14-2 JE vaccine within the past 28 days.
Every attempt should be made to collect sample immediately following
admission of the child
In case necessary equipment and expertise is unavailable at the
hospital, please inform the District Immunization Officer.
The DIO will arrange to collect the CSF sample immediately by sending
an expert with necessary arrangements from the District.
At least 5 ml of the CSF must be collected.
Following collection of the CSF in a sterile tube if possible collect an
extra 5ml of the CSF in a separate tube for possible holding in the
laboratory for further testing.
Before the process of collection of the samples please paste a label on
the outer wall of the sterile tube. The label should have the name, age of
the patient and the date of specimen collection.
Transfer the sterile tube(s) with the specimen in a specimen carrier
(vaccine carrier earmarked for sample sending) with four frozen
icepacks.
Fill up the Laboratory Requisition Form (LRF)
Send the Specimen carrier containing the specimens and four frozen ice
packs along with the Laboratory Request Form (as in the Operational
Guideline Hand Book) immediately to the DIO by a special messenger.
Please intimate the District Immunization officer over phone that the
samples have been dispatched to him.
The District Immunization officer will receive the samples. He will match
the record on the laboratory request Form with the information on the
FIR of the concerned patient. DIO will also check the same for the label
on the test tubes containing the specimens.
The DIO will check the condition of the ice packs in the specimen carrier.
If required DIO will replace four fresh frozen ice packs in the specimen
carrier.
Immediately following check of records on the FIR, LRF and the labels on
the specimen tubes, DIO will dispatch the specimens to National institute
of Virology, Pune.
The specimen will be accompanied by two copies of the LRF. One copy
will be retained at the laboratory and the second copy will be used as
receipt and returned to the DIO.
DIO will intimate Assistant Commissioner (EPI) immediately following
dispatch of the samples to the laboratory. A copy of the LRF will be faxed
to the office of the Assistant Commissioner(EPI) in Delhi ( FAX N. : 011- )
DIO will also follow up with the designated person in NIV Pune (name to
be intimated later by AC(EPI) after 48 hours of dispatch of the sample.
The laboratory will receive the sample and comment on condition of the
sample and cold chain on receipt on the duplicate LRF.
The CSF may be tested for Chemistry; Microbiology and antibody testing
(in particular JE IgM) in the laboratory.

Blood Collection:

Blood/Serum is not the sample of choice in a sick child vaccinated with

live attenuated SA14-14-2 JE vaccine
However blood samples may be collected for routine, biochemical and
specific tests ( e.g. tests for malaria parasite) to determine the cause
and progress of illness in the child
In the rare event where CSF samples can not be collected, paired blood
samples must be collected. Blood samples will be collected on the day of
admission and on the 10th. Day or at discharge or death which ever is
earlier.
5 ml of blood should be collected in a tube that does not contain any
anticoagulants.
Before the process of collection of the samples please paste a label on
the outer wall of the sterile tube. The label should have the name, age of
the patient and the date of specimen collection.
Transfer the sterile tube(s) with the specimen in a specimen carrier
(vaccine carrier earmarked for sample sending) with four frozen
icepacks.
Fill up the Laboratory Requisition Form (LRF)
Send the Specimen carrier containing the specimens and four frozen ice
packs along with the Laboratory Request Form (as in the Operational
Guideline Hand Book) immediately to the DIO by a special messenger.
Please intimate the District Immunization officer over phone that the
samples have been dispatched to him.
The District Immunization officer will receive the samples. He will match
the record on the laboratory request Form with the information on the
FIR of the concerned patient. DIO will also check the same for the label
on the test tubes containing the specimens.
The DIO will check the condition of the ice packs in the specimen carrier.
If required DIO will replace four fresh frozen ice packs in the specimen
carrier.
Immediately following check of records on the FIR, LRF and the labels on
the specimen tubes, DIO will dispatch the specimens to National institute
of Virology, Pune.
The specimen will be accompanied by two copies of the LRF. One copy
will be retained at the laboratory and the second copy will be used as
receipt and returned to the DIO.
DIO will intimate Assistant Commissioner (EPI) immediately following
dispatch of the samples to the laboratory. A copy of the LRF will be faxed
to the office of the Assistant Commissioner(EPI) in Delhi ( FAX N. : 011- )
DIO will also follow up with the designated person in NIV Pune (name to
be intimated later by AC(EPI) after 48 hours of dispatch of the sample.
The laboratory will receive the sample and comment on condition of the
sample and cold chain on receipt on the duplicate LRF.
If CSF samples have been collected it is not necessary to send the serum
samples to NIV, Pune for further testing. The serum samples in that case
can be tested at the district laboratory for biochemical, routine and
specific test like presence of malarial parasite.
Stool samples:

Please inform the Surveillance Medical officer (SMO)/ District

Immunization Officer if the child presents with AFP.
Stool samples will be collected and sent to the designated laboratory as
per NPSP guidelines.
Samples from the DIO Office will be sent to:

Dr. Milind Gore, Deputy Director

National Institute of Virology,

Sus Road Campus, Pashan,

Pune 411021, India

Tel: 91-20-25880982,

Fax: 91-20-25883595

MINUTES OF EXPERT AEFI COMMITTEE MEETING

Constitution of Expert Committee of AMCH, Dibrugarh for Management

of AEFI in Upper Assam for ensuing JE Vaccination.

1. Team Leader: Dr D Hazarika, Principal, Assam Medical

College, Dibrugarh. In the event of his absence in the

headquarter the Team Leader will delegate a competent person

to tackle the problem.

2. Technical Expert: a.) Paediatric Medicine

b.) General Medicine

c.) Pathologist

d.) Biochemist

e.) Microbiology

f.) Anaesthetist
g.) Forensic Medicine

h.) Community Medicine

Committee constitutes:

Principal Dr D Hazarika, AMC, Dibrugarh

Paediatrics - Associate Prof. (Dr) P Vishwanath, AMC, Dibrugarh
General Medicine - Associate Prof. (Dr) Anup Das, AMC, Dibrugarh
Neurologist Prof. & HOD (Dr) Narayan Upadhyay, AMC, Dibrugarh
Pathologist Asst. Prof. (Dr) Ram Hazarika, AMC, Dibrugarh
Biochemistry Dr (Mrs) Rita Changakakoti, AMC, Dibrugarh
Community Medicine Asst. Prof. Dr (Mrs) Tulika Goswami Mahanta,
AMC, Dibrugarh
Microbiology Prof. & HOD (Dr) A Borothakur, AMC, Dibrugarh
Anaesthesiologist Asst. Prof. (Dr) R Bhattacharjee, AMC, Dibrugarh

10.) Forensic Medicine Asst. Prof. (Dr) R Gogoi, AMC, Dibrugarh

The chairman Dr Narayan Upadhyay stated in the meeting to all the

members that whenever a case is referred it will be referred to the
expert committee immediately for necessary treatment. Details of
management procedure and referral form should accompany the patient.

Discussion about AEFI medicine and kit by Dr Narayan Upadhyay and the
list was finalized as suggested by Dr Anup Das.

For critical care at the AMCH and at Dist. Hospital, Sibsagar, Govt. is
requested to provide two ventilators at Assam Medical College Hospital
and one at Sibsagar district hospital.

The ICMR will be requested by the Jt. Director of Health and FW,
Dibrugarh and Sibsagar district to do ELISA TEST for the confirmation of
JE Antibody whenever necessary.

Meeting was conducted under the chairmanship of Prof. & HOD of

Neurology, Dr Narayan Upadhyay, AMCH, Dibrugarh.

Date: June 27, 2006 Dr Narayan Upadhyay

Chairman, Prof. & HOD of Neurology

MINUTES OF AEFI MEETING

 Date: 13th March, 2007; Venue: Conference Room, AMC, Dibrugarh

2nd meeting of Expert AEFI Committee was held on 13 March, 07 at Conference Room of AMC
under the chairmanship of Dr. N. Upadhyayay (Prof. & HOD, Neurology, AMC) and the
following doctors attended it.

Dr. D. K. Patgiri, Vice-Principal cum HOD, Paediatrics

Dr. N. Upadhyayay, Prof. & HOD, Neurology
Dr. AK Borthakur, HOD, Microbiology
Dr. M.K. Goswami, Asstt. Prof., Medicine
Dr. T. Goswami Mahanta, Asstt. Prof. Community Medicine

District AEFI Group of Jorhat Dist:

Dr. Durlav Baruah, DIO

Dr. DN Phukan, Paeditrician
Dr. K Rajkumar, Anaesthetist

District AEFI Group of Golaghat Dist:

Dr. Dhairya Bharaly, Addl. C.M. & H.O., Golaghat

Dr. Rajiv Phukan, Paediatrician
Dr. Mukul Sharma
Dr. Rupak Bora
Dr. ST Hussain

Representative from PATH:

Dr. Dhananjay Singh

Representative from WHO-NPSP:

Dr. Bhabajyoti Bora

The committee unanimously adopted the following resolutions:

Expert AEFI Committee will be investigating all cases of AEFI coming to AMCH as done earlier.
Detailed discussion on anaphylactic shock and its management by use of adrenaline inj. at session site
whenever necessary and the committee adopted the resolution that inj. adrenaline should be available at
all the session site and all vaccinators should be trained to administer adrenaline.
Dr. Patgiri agreed to engage two P.G. students of Paed.( Dr. Anup Thakur and another junior P.G.
student) to investigate all AEFI cases admitted in AMCH and collect necessary sample for
investigations.
Dr. A. Borthakur said that as now Deptt. Microbiology can perform the Elisa Test and the test can be
done in his department. But only limited test could be performed with existing 10 kits available in his
department.
Form 8 & 9 (FIR & PIR) will be filled at AMCH for cases coming directly to medical college.
DIOs of respective districts will make arrangements shipment of samples to NIV, Pune.
AMCH will communicate to concerned district about the AEFI cases admitted directly.
Referred cases from district must accompany with Form-8 i.e. FIR and reports on any investigation
done.
The committee also resolved that Dr. N. Upadhyaya, Prof. & HOD, Neurology will act as a spokesman
to the media whenever necessary.
Routine Investigations should be done at the district level, if time permits before referral.
Parachek, IMF, PBS and Optimal0 test for malaria, Routine Blood and CSF

hould be done at PHC/Dist. level for confirmation of diagnosis and

management if facilities are available.

Dr. N. Upadhyayay, Prof. & HOD, Neurology

Chairman,

Expert AEFI Committee, AMCH, Dibrugarh

Date: March 13, 2007

Guidelines for investigation of a case of Adverse Event Following Immunization with the Live
attenuated SA14-14-2 JE vaccine

Immunization Division, Ministry of Health and Family Welfare, Government of india