AEFI INVESTIGATION FORM

(Only for Serious Adverse Events Following Immunization - Death / Disability / Hospitalization / Cluster)

*Please input the case ID in the box below if you are a "VAEIMS-Harmonia" user or if your country has bridged its database to this module

Case ID:
Please enter valid case id
Section A - Basic details
Province/State:
District:
Case ID:
Name of Reporting Officer:
Designation / Position:
Telephone # landline (with code):
Mobile:
Date of investigation:
Date of filling this form:
e-mail:
This report is :
Patient Name:
Sex:
Date of birth:
OR Age at onset
years months days
OR Age group
Patient’s full address with landmarks (Street name, house number, locality, phone number etc.):
Brand name of vaccines (including manufacturer)/diluent received by patient Date of vaccination Time of vaccination Dose (e.g. 1st, 2nd, etc.) Batch/Lot number Expiry date
Date of first/key symptom:
Time of first symptom:
Date of hospitalization:
Date first reported to the health authority :
If died, date and time of death
Autopsy done? :
Attach report (if available)
Section B - Relevant patient information prior to immunization
Criteria Finding Remarks (If yes provide details)
Past history of similar event
Please explain
Adverse event after previous vaccination(s)
Please explain
History of allergy to vaccine, drug or food
Please explain
Pre-existing comorbidity/ congenital disorder?
Please explain
Pre-existing acute illness (30 days) prior to vaccination?
Please explain
Has the patient tested Covid19 positive prior to vaccination?
Please explain
Pre-existing illness (30 days) / congenital disorder
Please explain
History of hospitalization in last 30 days, with cause
Please explain
Was the patient receiving any concomitant medication? (If yes, name the drug, indication, doses & treatment dates)
Please explain
Patient currently on concomitant medication?
(If yes, name the drug, indication, doses & treatment dates)
Please explain
Family history of any disease (relevant to AEFI) or allergy
Please explain
For Adult women
Currently pregnant?
Currently breastfeeding?
For infants
The birth was
Birth weight:
Delivery procedure was
Section C - Details of first examination** of serious AEFI case
Source of information ( all that apply):
If from verbal autopsy, please mention source:
Name of the person who first examined/treated the patient:
Name of other persons treating the patient:
Other sources who provided information (specify):
Signs and symptoms in chronological order from the time of vaccination:
Name and contact information of person completing these clinical details Designation Date/time
**Instructions – Attach copies of ALL available documents (including case sheet, discharge summary, case notes, laboratory reports and autopsy reports) and then complete additional information NOT AVAILABLE in existing documents, i.e.
  • If patient has received medical care -
    Attach copies of all available documents (including case sheet, discharge summary, laboratory reports and autopsy reports,prescriptions for concomitant medication, if available) and write only the information that is not available in the attached documents below
  • If patient has not received medical care –
    Obtain history, examine the patient and write down your findings below (add additional sheets if necessary)
Provisional / Final diagnosis:
Section D - Details of vaccines provided at the site linked to AEFI on the corresponding day
Number immunized for each antigen at session site. Attach record if available. Vaccine name
Number of doses
a) When was the patient immunized? ( below respond to ALL questions)
In case of multidose vials, was the vaccine given
b) Was there an error in prescribing or non-adherence to recommendations for use of this vaccine?
Please explain
c) Based on your investigation, do you feel that the vaccine (ingredients) administered could have been unsterile?
Please explain
d) Based on your investigation, do you feel that the vaccine's physical condition (e.g. colour, turbidity, foreign substances etc.) was abnormal at the time of administration?
Please explain
e) Based on your investigation, do you feel that there was an error in vaccine reconstitution/preparation by the vaccinator (e.g. wrong product, wrong diluent, improper mixing, improper syringe filling etc.)?
Please explain
f) Based on your investigation, do you feel that there was an error in vaccine handling (e.g. break in cold chain during transport, storage and/or immunization session etc.)?
Please explain
g) Based on your investigation, do you feel that the vaccine was administered incorrectly (e.g. wrong dose, site or route of administration, wrong needle size, not following good injection practice etc.)?
Please explain
h) Number immunized from the concerned vaccine vial/ampoule
i) Number immunized with the concerned vaccine in the same session
j)Number immunized with the concerned vaccine having the same batch number in other locations. Specify locations:
k) Could the vaccine given to this patient have a quality defect or is substandard or falsified?
Please explain
l) Could this event be a stress response related to immunization (e.g. acute stress response, vasovagal reaction, hyperventilation, dissociative neurological symptom reaction etc)?
Please explain
m) Is this case a part of a cluster?
i. If yes, how many other cases have been detected in the cluster?
a.Did all the cases in the cluster receive vaccine from the same vial?
b.If no, number of vials used in the cluster (enter details separately)
To assist AEFI causality assessment, please respond to the following questions
a) In this patient, does the medical history, clinical examination and/ or investigations, suggest another cause for the event?
Please explain
b) In this patient, were lab tests conducted? If, “Yes”, mention the lab tests done (and lab results if possible).
Please explain
Section E - Immunization practices at the place(s) where concerned vaccine was used
(Complete this section by asking and/or observing practice)
Are AD syringes used for immunization?
If no, specify the type of syringes used:
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?
Same reconstitution syringe used for reconstituting different vaccines?
Separate reconstitution syringe for each vaccine vial?
Separate reconstitution syringe for each vaccination?
Are the vaccines and diluents used the same as those recommended by the manufacturer?
Specific key findings/additional observations and comments:
Injection technique in vaccinator(s): (Observe another session in the same locality – same or different place Status Remarks
Correct dose and route?
Please explain
Non-touch technique followed?
Please explain
Contraindications screened prior to vaccination?
Please explain
How many AEFI were reported from the centre that distributed the vaccine in the last 30 days?
Training received by the vaccinator: (if Yes, specify the date of last training )?
Please explain
Specific key findings/additional observations and comments:
Section F - Cold chain and transport
(Complete this section by asking and/or observing practice)
Last vaccine storage point Status
Is the temperature of the vaccine storage refrigerator monitored?
If “yes”, was there any deviation outside of 2-8° C after the vaccine was placed inside?
If “yes”, provide details of monitoring separately
Was the correct procedure for storing vaccines, diluents and syringes followed?
Was any other item (other than EPI vaccines and diluents) in the refrigerator or freezer?
Were any partially used reconstituted vaccines in the refrigerator?
Were any unusable vaccines (expired, no label, VVM at stages 3 or 4, frozen) in the refrigerator?
Were any unusable diluents (expired, manufacturer not matched, cracked, dirty ampoule) in the store?
Specific key findings/additional observations and comments:
Vaccine transportation Status
Type of vaccine carrier used
Was the vaccine carrier sent to the site on the same day as vaccination?
Was the vaccine carrier returned from the site on the same day as vaccination?
Was a conditioned ice-pack used?
Specific key findings/additional observations and comments:
Section G - Community investigation (Please visit locality and interview parents/others)
Were any similar events reported within a time period similar to when the adverse event occurred and in the same locality?
If yes, describe:
If yes, how many events/episodes?
Of those effected, how many are
  • Vaccinated
  • Not Vaccinated
  • Unknown
Other comments:
Section H - Other findings/observations/comments