<p> Manitoba Reporting Form on Causality Assessment of Adverse Event Following Immunization (CISA)</p><p>Reset All Assessment date: Final report Provisional report Elevate to full provincial AEFI causality assessment team? Yes No, because</p><p>Name of client: </p><p>Vaccine/s administered: </p><p>Adverse event/s: </p><p>Assessor/s:</p><p>Conclusion Reset Assessment Conclusion Consistent causal association to immunization</p><p>Indeterminat e</p><p>Inconsistent causal association to immunization</p><p>For details on the process of arriving at the above conclusion, see Assessment Checklist.</p><p>MB AEFI Causality Assessment Form (CISA – June 2016) 1 Checklist Reset Assessment Checklist</p><p>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.</p><p>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.</p><p>2a Is evidence definitive? If yes, conclude as “Inconsistent causal association.” YES NO If no, conclude as “Indeterminate” or proceed to step 3.</p><p>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.</p><p>3a Was event within time window of increased risk? If yes, conclude as “Consistent causal association.” YES NO If no, proceed to step 3b.</p><p>3b Are there qualifying factors? If yes, proceed to step 5. YES NO If no, conclude as “Inconsistent causal association.”</p><p>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</p><p>5 Is event an infection? If yes, proceed to step 6. YES NO If no, proceed to step 10.</p><p>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.”</p><p>6a Was it the vaccine agent? If yes, proceed to step 6b. YES NO If no, proceed to step 7.</p><p>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.”</p><p>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.”</p><p>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.</p><p>8 Are there other similarly affected patients? If yes, conclude as “Indeterminate.” YES NO If no, proceed to step 9.</p><p>9 Is there evidence of actual infection at injection site? If yes, conclude as “Indeterminate.” YES NO If no, conclude as “Inconsistent causal association.”</p><p>10 Is there specific laboratory test implicating vaccine in If yes, proceed to step 10a. pathogenesis? If no, proceed to step 11. YES NO</p><p>MB AEFI Causality Assessment Form (CISA – June 2016) 4 Steps Directions</p><p>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.”</p><p>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.”</p><p>11a Is there evidence of incorrect site of administration If yes, conclude as “Consistent causal association.” YES NO If no, conclude as “Indeterminate.”</p><p>MB AEFI Causality Assessment Form (CISA – June 2016) 5</p>