Case Data Entry

Case ID: AEFI ID:

CASE INVESTIGATION FORM

Field marked * are mandatory fields.
* Please fill 'all' mandatory fields, In mandatory text fields where information is not available, please consult your DIO/MO or enter 'Information Not Available'.

Page 1

Section A - Basic details

State

District

Subdistrict

Health facility

Block/Ward:

Block Ward

Village/Urban Area

Village Urban Area

Block

Ward

Urban Area

Village

Patient's name *

Sex*

Date of Birth *

(If exact DOB is not available please consult Dio/Mo for approximate DOB)

Age (in years)

Age (in months)

Age (in days)

Mother's name*

Spouse/Father/Guardian’s name *

Complete address of the case with landmarks (street name, house number, village, block, tehsil, pin no., telephone no.)

Address *

Phone

Date of vaccination *

Time of vaccination *

Address of session site *

Date first notified to government health system
( Note : Information in above two fields are taken from CRF and are not editable. For any changes required in these fields, please request state level user.)

Name of vaccines received (write vaccine & diluent details in seperate rows)*	Dose no. (zero/ first / second/ etc. as applicable)*	Name of Manufacturer / Brand Name**	Batch/Lot No.*	Expiry date Month Year		Mfg date	Date of opening of vial	Time of opening vaccine vial / vaccine reconstitution	No. of OTHER beneficiaries who received vaccine from the SAME vial in this session

Any other vaccine:

Page 2

Date of first symptom *

Time of first symptom ( hh:mm ) *

Date of key symptom

Time of key symptom

Hospitalization *

If Hospitalized, outcome

Date of hospitalization

Time of hospitalization ( hh:mm )

Name and Address of Hospital: (if hospitalized)

Hospital Reg. No. (OPD/Admission/Bed Head Ticket)

Describe AEFI (sequence of events, signs and symptoms after vaccination)

Current status (encircle) *

If died, date of death

Time of death

Place of Death

Post mortem done?

If Yes, then write date post mortem done

If not done, but planned, write date planned

Section B - Relevant patient information prior to immunization

Criteria & Finding

Provide details here if “yes” marked to any question

Any past history of similar reaction event (without vaccination)? *

Any adverse event after previous vaccination(s) *

Any history of allergies for drugs, vaccine, food or other products? *

Any concomitant medication at the time of vaccination, if any (If yes, name the drug, indication, doses, treatment dates/duration)? *

Any pre-existing illness / comorbidity / congenital disorder?*

Any pre-existing acute illness 30 days prior to vaccination? *

Any history of hospitalization 30 days prior to vaccination (mention reason)?*

Family history of any disease (relevant to AEFI) or allergy *

Any antenatal / postnatal complications

If yes please specify

If patient is an adult women

Currently pregnant? *

Weeks

Currently breastfeeding? *

If patient is an infant, birth details

Any birth complication(specify)

1

Birth weight: *

2

Duration of pregnancy *

3

Place of birth *

4

Delivery procedure *

Section C - Details of first examination** of reported AEFI case

Source of information ( ✔ all that apply): *

Examination by the investigator Medical case records AEFI Verbal autopsy form AEFI Case Reporting Form Interview with patient / caregiver Telephonic enquiry with patient / caregiver Interview with treating physician Other

If from verbal autopsy, please mention relationship with the deceased

In case of sudden unexplained death, please also fill SUD verbal autopsy form as per the guidelines

Name of the person who first examined/treated the patient

Name of other persons from whom care was sought

Other sources who provided information (specify)

Signs and symptoms (in chronological order from the time of vaccination)

Page 3

**Instructions - Attach copies of ALL available documents (including case sheets, discharge summary, case notes, lab and autopsy reports) and then complete additional information NOT AVAILABLE in existing documents, i.e
• If patient has taken medical care - attach copies of all available documents (including cases sheet, discharge summary, laboratory reports and post mortem reports, if available) and write only information unavailable in the attached documents below

• If patient has not taken medical care - obtain histroy, examine the patient and write down your findings below (add additional sheets as required)

Name of person filling up clinical details given below

Designation

Date

Time

Consciousness

Alert Drowsy Unconscious Other

Vitals

Pulse

Temperature

Respiratory rate

BP Systolic Value

BP Diastolic Value

Weight(in kg)

Weight(in gm)

Skin

NAD Rash Cyanosis Petechiae Pallor Jaundice Others

Eyes

Vision:
Normal Impaired

Pupil
Normal Constricted Dilated Reacting to light

Hearing

Normal Impaired

Speech

Normal Abnormal

Neck

Neck stiffness
Present Absent

Chest

Auscultation:
Normal Crepts Rhonchi

Heart sounds
Normal Murmur

Respiration

Normal Cough Shortness Of Breath Others

GI

NAD Pain abdomen Vomiting Diarrhoea Dysentery Others

Abdomen

Normal Distended Tender

Liver
Not palpable Palpable

Spleen
Not palpable Palpable

Limbs

Tone

Upper Limbs
Normal Increased Decreased

Lower Limbs
Normal Increased Decreased

Page 4

Reflexes

Biceps
Normal Increased Decreased Absent

Triceps
Normal Increased Decreased Absent

Supinator
Normal Increased Decreased Absent

Plantar
Extensor Flexor

Systemic examination findings (mention the important positive and negative findings)

Treatment provided

Provisional / Final diagnosis (as per the treating doctor and/or the Investigation team [encircle one] , if no medical care received) *

(Please consult DIO for this information if not available in this form)

Section D - Details of vaccines provided on VACCINATION DAY at the site linked to AEFI

Number immunized for EACH VACCINE AT SESSION SITE. Attach record if available. Vaccine name

No of doses administered

Number of vaccine vials used

Vaccine name

No of doses administered

Vaccine name

No of doses administered

1

Sequence of patient

A

At session site on day of vaccination

Within the first half beneficiaries at the session site Within the last half beneficiaries the session site Unknown

B

For a multi dose vaccine vial (since the vial has been opened)

Within the first half beneficiaries of the vaccine vial Within the last half beneficiaries of the vaccine vial Unknown

2

Based on the investigation, answer the following: (Please provide explanation in the remark column for any ‘yes’)

A

Could the vaccine given to this patient have quality defect or is substandard or falsified?

Yes No Unable to assess

B

In this case, was there an error in prescribing or non-adherence to recommendations for use of this vaccine? (e.g. use beyond the expiry date, wrong recipient etc.) *

Yes No Unable to assess

C

In this case, was the vaccine (ingredients) or diluent administered in an unsterile manner? *

Yes No Unable to assess

D

In this case, was the vaccine's physical condition (e.g. colour, turbidity, presence of foreign substances etc.) abnormal when administered? *

Yes No Unable to assess

E

When this case was vaccinated, was there an error in vaccine reconstitution / preparation by the vaccinator (e.g., wrong product, wrong diluent, improper mixing, improper syringe filling etc.? *

Yes No Unable to assess

F

In this case, was there an error in vaccine handling? (e.g. Break in cold chain during transport, storage and/or immunization session etc.)? *

Yes No Unable to assess

G

In this case, was the vaccine was administered incorrectly (e.g. wrong dose, site or route of administration, wrong needle size, not following good injection practice etc.)? *

Yes No Unable to assess

H

In this case, could this event be a stress response triggered by immunization (e.g. acute stress response, vasovagal reaction, hyperventilation or anxiety etc.)?*

Yes No Unable to assess

Page 5

3

Multidose vials administered to the case No. of beneficiaries vaccinated from each vial on session day No. of beneficiaries vaccinated from same vial since opening or reconstitution No. of times each vial was issued to sessions before being issued to this session

A

B

C

D

E

4

Number immunized from the CONCERNED VACCINE vial/ampoule in this session

5

Number immunized from the CONCERNED VACCINE vial/ampoule since vial was opened (in case of open vial policy)

6

Number immunized with the CONCERNED VACCINE having the same batch number in other locations:

Specify locations

4

Is this case a part of a cluster ?*

Yes No Unknown

A

If yes, how many other cases have been detected in the cluster ?

B

Did all the cases in the cluster receive vaccine from the same vial ?

Yes No Unknown

C

If no, number of vials used in the cluster

5

If similar events have been reported from other session sites, comments

Section E Immunization practices at the place (s) where concerned vaccine was used
(based on observations and assessment)

Syriges and needles used:

•

Are AD syringes used for immunization ?*

Yes No Unknown

If "No", specify the type of syringes used

Glass Disposable Recycled disposable Other

Specific key findings/additional observations and comments:

Reconstitution:(complete only if applicable, ✔ NA if not applicable)

•

Reconstitution procedure (✔)

Status

Same reconstitution syringe used for multiple vials of same vaccine ?*

Yes No NA

Same reconstitution syringe used for reconstituting different vaccines ?*

Yes No NA

Seperate reconstitution syringe used for each vaccine vial ?*

Yes No NA

•

Were/Are the diluents used same as recommended by the manufacturer?*

Yes No NA

Specific key findings/additional observations and comments:

6

Vaccine handling and vaccination (examine the available used vaccine vials and observe an immunization session, if needed)

•

Noncompliance to recommendations for use of this vaccine (e.g. any contraindication ignored?)

Yes No Unknown

•

Wrong selection of the beneficiary(ies) (e.g. NOT age appropriate for the vaccine)

Yes No Unknown

•

Unsterile condition of the vaccine (ingredients) or diluent administered (sterile/unsterile)

Yes No Unknown

•

Abnormal vaccine's physical condition (e.g. colour, turbidity, presence of foreign substances, etc.)

Yes No Unknown

•

Error in vaccine reconstitution/preparation by the vaccinator (e.g., wrong product, wrong diluent, improper mixing, improper syringe filling etc.)

Yes No Unknown

•

Date and time of opening the vial clearly NOT mentioned on the vials being used in the session under observation

Yes No Unknown

•

Error in vaccine handling (break in cold chain during transport, storage and/or immunization session etc.)

Yes No Unknown

•

Error in vaccine administration (e.g. wrong dose, site or route of administration, wrong needle size, not following good injection practice etc.)?

Yes No Unknown

Specific key findings/additional observations and comments:

Section F Cold Chain and Transport
(Answer the following based on observations and assessment)

Last vaccine storage point:

•

The temperature of the ILR/vaccine storage refrigerator monitored (thermometer and documentation) *

Yes No

⚬

If, ‘yes’, any deviation outside of 2- 8 ℃ after the concerned vaccine vial was received at cold chain point

Yes No

⚬

If, ‘yes’ attach relevant monitoring documents separately

•

Correct procedure of storing vaccines, diluents and syringes followed*

Yes No Unknown

•

Any other item (other than vaccines and diluents) available in the refrigerator or freezer*

Yes No Unknown

•

Partially used reconstituted vaccines available in the refrigerator*

Yes No Unknown

•

Unusable vaccines (expired, no label, VVM stage 3 & 4, frozen) available in the refrigerator*

Yes No Unknown

•

Unusable diluents (expired, manufacturer not matched, cracked, dirty ampoule) available in the store/refrigerator*

Yes No Unknown

Specific key findings/additional observations and comments:

Page 6

Vaccine transportation:

•

Type of vaccine carrier used ?*

•

Vaccine carrier sent to the site on the same day of vaccination ?*

Yes No Unknown

•

Vaccine carrier returned from the site on the same day of vaccination ?*

Yes No Unknown

•

Conditioned ice-pack used in the vaccine carrier *

Yes No Unknown

•

All empty/partially used/unused vaccine vials (and diluents) return to cold chain point on the same day of vaccination

Yes No Unknown

Comment on vaccine handling (any error, e.g. Break in cold chain during transport, storage and/or immunization session etc.)?

Specific key findings/additional observations and comments:

Section G - Community investigation (please visit locality and interview parents/others)

Any similar events reported recently in the locality ?

Yes No Unknown

If "Yes", describe:

If Yes, How many events / episodes and the category of people affected (children, adults, any specific locality/area)?

Of those effected, how many are :

Vaccinated

Not vaccinated

Unknown

Other findings beyond vaccine or vaccination:

Section H - Other findings/observations/comments

Section H District AEFI Committee Review

A

Was the case discussed by the district AEFI committee ? If "Yes", then date case discussed by district AEFI committee*

Yes No

B

What was the provisional diagnosis of the case concluded by the district AEFI committee ?*

C

Did the district AEFI committee recommend that samples be sent for testing ?*

Yes No

D

Please describe the events, clinical and epidemiological findings in support of provisional diagnosis.

Details of vaccine/diluent samples sent to CDL Kasauli

Vaccine/diluent name Site of collection Used vial/amp quantity Batch no, Lot no,date of expiry Date sent Unused vial/amp quantity Batch no, Lot no,date of expiry Date sent

Page 7

Details of syringe/needle samples sent to CDL Kolkata

Type of syringes Quantity Site of collection Batch no, Lot no,date of expiry Date sent Type of needles Quantity Batch no, lot no,date of expiry Date sent

A

Any biological product (CSF, blood, urine) sent for testing ?
If "Yes", specify details of the lab; attach copy of report if available
Note: for AEFI resulting within 28 days following JE vaccine, send sample of CSF, serum to nearest NIV lab in Pune or Gorakhpur

Yes No

Specify details of the lab.

B

Was the local drug inspector involved in collecting additional samples ?*

Yes No

C

Specify any other relevant investigation done and attach reports.

Attached copies of reports/documents with this case investigation report

** These options will be automatically populated as you upload the documents in Other supporting document section

Ser No. List of document copies received Available and submitted with CIF Not submitted if not submitted,select the reason

1. Case reporting form (CRF) Yes No

2. Post mortem report

2A. Post mortem report preliminary Yes No

2B. Post mortem report Final Yes No

3. Verbal autopsy form (in case of sudden unexplained death) Yes No

4 Any clinical laboratory test report (Pathology / Microbiology / Hematology / Blood / CSF / Urine / AFP / any radiology imaging report / EEG report, etc.) Yes No

5. Doctor's prescription/treatment record for AEFI Yes No

6. Doctor's prescription/treatment record for other illness Yes No

7. Laboratory result of vaccine (if sent for testing) Yes No

8. Laboratory result of syringes/other drugs (if sent for testing) Yes No

9. Any other document relevant to the case :1 Yes No

10. Any other document relevant to the case :2 Yes No

11. Any other document relevant to the case :3 Yes No

12. Any other document relevant to the case :4 Yes No

13. Any other document relevant to the case :5 Yes No

District AEFI committee that conducted the investigation

Sr No. Name Designation Phone# Signature

1

2

3

4

5

6

7

8

9

10

Page 8

Section I DIO/district nodal person (officer forwarding this report)

Name

Designation

Date of submission to state/national level

Mobile No

Landline(with STD code)

Fax No

E-Mail Id

Complete office address(with Pin code)

Signature and seal

Date

Please ensure that this preliminary investigation form reaches within 10 days of notification to:
1. State Immunization Officer
2. Deputy commissioner, Immunization Division of Govt. of India, MoHFW, Nirman Bhawan, New Delhi-110108.
(Fax: 011 23062728. email: aefiindia@gmail.com)

Ser No.	List of document copies received	Available and submitted with CIF	Not submitted
1.	Case reporting form (CRF)	Yes	No
2.	Post mortem report
2A.	Post mortem report preliminary	Yes	No
2B.	Post mortem report Final	Yes	No
3.	Verbal autopsy form (in case of sudden unexplained death)	Yes	No
4	Any clinical laboratory test report (Pathology / Microbiology / Hematology / Blood / CSF / Urine / AFP / any radiology imaging report / EEG report, etc.)	Yes	No
5.	Doctor's prescription/treatment record for AEFI	Yes	No
6.	Doctor's prescription/treatment record for other illness	Yes	No
7.	Laboratory result of vaccine (if sent for testing)	Yes	No
8.	Laboratory result of syringes/other drugs (if sent for testing)	Yes	No
9.	Any other document relevant to the case :1	Yes	No
10.	Any other document relevant to the case :2	Yes	No
11.	Any other document relevant to the case :3	Yes	No
12.	Any other document relevant to the case :4	Yes	No
13.	Any other document relevant to the case :5	Yes	No

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Number immunized for EACH VACCINE AT SESSION SITE. Attach record if available.	Vaccine name
	No of doses administered
	Number of vaccine vials used
	Vaccine name
	No of doses administered
	Vaccine name
No of doses administered

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