Manitoba Reporting Form on Causality Assessment of Adverse Event Following Immunization (CISA)

Reset All Assessment date: Final report Provisional report Elevate to full provincial AEFI causality assessment team? Yes No, because

Name of client:

Vaccine/s administered:

Adverse event/s:

Assessor/s:

Conclusion Reset Assessment Conclusion Consistent causal association to immunization

Indeterminat e

Inconsistent causal association to immunization

For details on the process of arriving at the above conclusion, see Assessment Checklist.

MB AEFI Causality Assessment Form (CISA – June 2016) 1 Checklist Reset Assessment Checklist

MB AEFI Causality Assessment Form (CISA – June 2016) 2 Steps Directions 1 Is diagnosis correct? If yes, proceed to step 2. UNCERTAI YES NO If no, indicate the new diagnosis, then proceed to step 2. N If uncertain, conclude as “Indeterminate” or proceed to step 2.

2 Is there evidence for other causes? If yes, proceed to step 2a. YES NO UNAVAILABLE If no, proceed to step 3. If unavailable, conclude as “Indeterminate” or proceed to step 3.

2a Is evidence definitive? If yes, conclude as “Inconsistent causal association.” YES NO If no, conclude as “Indeterminate” or proceed to step 3.

3 Is there known causal association with vaccine? If yes, proceed to step 3a. YES NO INDEFINITE If no, proceed to step 4. If indefinite, proceed to step 5.

3a Was event within time window of increased risk? If yes, conclude as “Consistent causal association.” YES NO If no, proceed to step 3b.

3b Are there qualifying factors? If yes, proceed to step 5. YES NO If no, conclude as “Inconsistent causal association.”

4 Is there strong evidence against causal association? If yes, conclude as “Inconsistent causal association.” UNCERTAI YES NO If no or uncertain, proceed to step 5. N

5 Is event an infection? If yes, proceed to step 6. YES NO If no, proceed to step 10.

MB AEFI Causality Assessment Form (CISA – June 2016) 3 Steps Directions 6 Was there evidence of infectious agent found in patient? If yes, proceed to step 6a. YES NO UNTESTED If no or untested, conclude as “Indeterminate.”

6a Was it the vaccine agent? If yes, proceed to step 6b. YES NO If no, proceed to step 7.

6b Was the genetic sequence confirmed to be vaccine origin? If yes, proceed to step 6c. YES NO UNTESTED If no, conclude as “Inconsistent causal association.” If untested, conclude as “Indeterminate.”

6c Is the agent expected in tissues within this time window? If yes, conclude as “Indeterminate.” YES NO If no, conclude as “Consistent causal association.”

7 Was the same agent found in residual vial? If yes, conclude as “Consistent causal association.” YES NO NO INFO If no or no information, proceed to step 8.

8 Are there other similarly affected patients? If yes, conclude as “Indeterminate.” YES NO If no, proceed to step 9.

9 Is there evidence of actual infection at injection site? If yes, conclude as “Indeterminate.” YES NO If no, conclude as “Inconsistent causal association.”

10 Is there specific laboratory test implicating vaccine in If yes, proceed to step 10a. pathogenesis? If no, proceed to step 11. YES NO

MB AEFI Causality Assessment Form (CISA – June 2016) 4 Steps Directions

10a What is the probability of a false positive? If high or not validated, conclude as “Indeterminate.” HIGH LOW UNVALIDATED If low, conclude as “Consistent causal association.”

11 Was event a nerve or joint injury near site of infection? If yes, proceed to step 11a. YES NO If no, conclude as “Indeterminate.”

11a Is there evidence of incorrect site of administration If yes, conclude as “Consistent causal association.” YES NO If no, conclude as “Indeterminate.”

MB AEFI Causality Assessment Form (CISA – June 2016) 5