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Case Reporting Form (CRF) For Adverse Events Following Immunisation (Aefi)

This document is a case reporting form for adverse events following immunisation (AEFI). It collects identifying information about the patient and reporter, details of the vaccine(s) administered, descriptions of the adverse event(s) including date of onset and symptoms, any similar previous or current cases, medical history, and an initial assessment of the event. The form has sections for vaccine details, trigger events, previous history, and preliminary actions/assessment. It requires collection of key details like patient name, date of birth, vaccines given, date and time of AEFI onset, adverse events, and determination of whether the event is considered serious.

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hetal babubhai
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0% found this document useful (0 votes)
657 views3 pages

Case Reporting Form (CRF) For Adverse Events Following Immunisation (Aefi)

This document is a case reporting form for adverse events following immunisation (AEFI). It collects identifying information about the patient and reporter, details of the vaccine(s) administered, descriptions of the adverse event(s) including date of onset and symptoms, any similar previous or current cases, medical history, and an initial assessment of the event. The form has sections for vaccine details, trigger events, previous history, and preliminary actions/assessment. It requires collection of key details like patient name, date of birth, vaccines given, date and time of AEFI onset, adverse events, and determination of whether the event is considered serious.

Uploaded by

hetal babubhai
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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CASE REPORTING FORM (CRF) FOR ADVERSE EVENTS FOLLOWING IMMUNISATION (AEFI)

EPID Number: S O A - - - - Received on


Level Signature
Country - Province - District - Year - Case no (date)
District
Province
All fields in this form are mandatory
National EPI
National SAHPRA
*Compulsory field
(For Office use only)

SECTION A: IDENTIFYING INFORMATION


*Patient name and surname: *Reporter’s name and surname:
____________________________________________________ _________________________________________________

*Patient’s residential address: ___________________________ Designation/Position: _______________________________

____________________________________________________ Institution: ________________________________________

____________________________________________________ Telephone: ________________________________________

Caregiver’s name and surname: __________________________ *Mobile no: _______________________________________

Telephone: __________________________________________ *E-mail: __________________________________________

Please tick ( ) the appropriate box Date patient notified event to health system (DD/MM/YYYY):

Gender: M F Term: Full term Premature __ __/__ __/__ __ __ __

*Date of birth (DD/MM/YYYY): __ __/__ __/__ __ __ __ Today’s date (DD/MM/YYYY): __ __/__ __/__ __ __ __

Age at onset: Years Months Days

SECTION B: VACCINE INFORMATION (Please attach a copy of the Road to Heath Booklet (RTHB))

Health facility (or vaccination center) name: _____________________________________________________________


Vaccine/s administered Diluent
(Complete this section only for alleged vaccines /vaccines that were administered before the event) (Where applicable)
Dose *VVM
*Batch/ *Batch/
*Vaccines given *Date of *Time of number Stage Expiry Date and time of
Lot Expiry date *Manufacturer Lot
(Use trade names) vaccination vaccination (e.g. 1st, (If date reconstitution
number number
2nd, 3rd) applies)

AEFI CRF Page 1/3 ZA_AEFI_CRF_NISEC_Oct_2018_final


Patient name & surname: ________________________________ EPID Number: _____________________________

SECTION C: TRIGGER EVENTS


Date & time AEFI started: (DD/MM/YYYY) __ __/__ __/__ __ __ __ Hr Min
*Adverse event (s): (Tick () all boxes that apply)
Minor reactions Severe local reactions Systemic reactions
Swelling <5cm Pain, redness and/or swelling of Hospitalization
Redness more than 3 days duration Death
Rash Swelling >5cm Anaphylaxis
Excessive crying Swelling beyond nearest joint Fever ≥38°C
Fever <38°C Lymphadenitis Encephalopathy
Other (specify): Abscess Collapse / shock-like state
___________________________________ Other (specify): Seizures Febrile Afebrile
___________________________________ ___________________________________ Intussusception
___________________________________ ___________________________________ Diarrhoea
___________________________________ Vomiting
Toxic shock syndrome
Thrombocytopenia
Sepsis
Other (specify): __________________

_______________________________

Severe or Serious Adverse Event: Immediately Notify District Office for Case Investigation

Brief narrative of caregiver/client complaint (Use additional sheet if needed):


____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________

Were there any other similar AEFIs reported in the facility in the past 30 days? Yes No (If yes, specify)
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________

AEFI CRF Page 2/3 ZA_AEFI_CRF_NISEC_Oct_2018_final


Patient name & surname: ________________________________ EPID Number: _____________________________

SECTION D: PREVIOUS HISTORY


*History of previous reactions to immunisation/treatment:
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________

SECTION E: PRELIMINARY ASSESSMENT AND ACTIONS AT THE TIME OF REPORT


(Tick () boxes that apply)

*Is this event a serious AEFI? Yes No

If Yes, tick ( ) in the appropriate box below

Death  Date of death (DD/MM/YYYY): __ __ / __ __ / __ __ __ __  Autopsy: Yes No Unknown

Hospitalisation  Date of admission (DD/MM/YYYY): __ __ / __ __ / __ __ __ __

 Name of hospital: __________________________ Hospital number: ______________________

Disability

Life threatening

Congenital anomaly

SECTION F (If applicable): WHAT WAS THE OUTCOME OF THE CASE FOLLOWING THE SUSPECTED AEFI?
(Tick () boxes that apply)

Recovering

Recovered fully (no complications)

Recovered with sequelae Specify: _________________________________________________________________

Not Recovered

Died

Unknown

SECTION G: FIRST DECISION MAKING LEVEL TO COMPLETE


Case investigation needed: Yes No If yes, date notified (DD/MM/YYYY):
__ __ / __ __ / __ __ __ __
District Office notified: Yes No
Date investigation planned (DD/MM/YYYY):
__ __ / __ __ / __ __ __ __

AEFI CRF Page 3/3 ZA_AEFI_CRF_NISEC_Oct_2018_final

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