Manitoba Reporting Form on Causality Assessment
of Adverse Event Following Immunization (WHO)
Assessment date:
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Elevate to full provincial AEFI causality assessment team?
Name of client:
Vaccine/s administered:
Adverse event/s:
Assessor/s:
Assessment Conclusion
Conclusion Reset
Vaccine product-related reaction (as per published literature)
Vaccine quality defect-related reaction
Immunization error-related reaction
Immunization anxiety-related reaction
Insufficient definitive evidence
Conflicting trends of consistency/inconsistency
Coincidental
Specify additional information
For details on the process of arriving at the above conclusion, see Assessment Checklist.
MB AEFI Causality Assessment Form (WHO – June 2016)
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Assessment Checklist
Steps
I
Is there strong evidence for other causes?
Checklist Reset
Responses/Directions
If yes, conclude as “Inconsistent causal association.”
Otherwise, proceed to Step II.
Does a clinical examination, or laboratory tests on the patient,
confirm another cause?
REMARKS:
II
Is there a known causal association with the vaccine
or vaccination?
If yes to any question in Step II, proceed to Step II (Time).
Otherwise, proceed to Step III.
Vaccine products
Is there evidence in the literature that this vaccine(s) may cause
the reported event even if administered correctly?
REMARKS:
Did a specific test demonstrate the causal role of the vaccine or
any of the ingredients?
REMARKS:
Immunization error
Was there an error in prescribing or non-adherence to
recommendations for use of the vaccine (eg, expired product,
wrong recipient)?
REMARKS:
Was the vaccine (or any of its ingredients) administered
unsterile?
REMARKS:
Was the vaccine’s physical condition (eg, color, turbidity)
abnormal at the time of administration?
REMARKS:
Was there an error in vaccine constitution/preparation by the
immunization provider (eg, wrong product, improper mixing)?
REMARKS:
MB AEFI Causality Assessment Form (WHO – June 2016)
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Steps
Responses/Directions
Was there an error in vaccine handling (eg, break in cold
chain)?
REMARKS:
Was the vaccine administered incorrectly (eg, wrong dose, site
or route)?
REMARKS:
Immunization anxiety
Could the event have been caused by anxiety about the
immunization (eg, vasovagal response, hyperventilation)?
REMARKS:
II
(time)
Was the event within the time window of increased
risk?
If yes, conclude as “Consistent causal association.”
Otherwise, proceed to Step III.
Did the event occur within an appropriate time window after
vaccine administration?
REMARKS:
III
Is there strong evidence against a causal association?
If yes, conclude as “Inconsistent causal association.”
Otherwise, proceed to Step IV.
Is there strong evidence against a causal association?
REMARKS:
IV
Other qualifying factors for classification
If yes to any question in Step IV, make a decision as to
classification.
Otherwise, conclude as “Unclassifiable.”
Could the event occur independently of vaccination
(background rate)?
REMARKS:
Could the event be a manifestation of another health condition?
REMARKS:
MB AEFI Causality Assessment Form (WHO – June 2016)
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Steps
Responses/Directions
Did a comparable event occur after a previous dose of a similar
vaccine?
REMARKS:
Was there exposure to a potential risk factor or toxin prior to the
event?
REMARKS:
Was there acute illness prior to the event?
REMARKS:
Did the event occur in the past independently of vaccination?
REMARKS:
Was the patient taking any medication prior to vaccination
REMARKS:
Is there a biological plausibility that the vaccine could cause the
event?
REMARKS:
MB AEFI Causality Assessment Form (WHO – June 2016)
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