Adverse Events Following Immunization Guidance and Recommendations
August 20, 2020
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To: Local Health System Partners
FOR IMMEDIATE ATTENTION
Reporting AEFIs in Ontario
The Health Protection and Promotion Act (HPPA) Section 38 and Reg. 569 requires all health care providers to report Adverse Events following Immunizations (AEFIs). At the local level, Public Health Sudbury & Districts receives reports of AEFIs from multiple sources. Reports are submitted using the Ontario AEFI reporting form.
AEFI Reporting Guidance
Health providers (i.e. physicians, nurses, and pharmacists) are required by law to report AEFIs. Vaccine recipients or their caregivers may also voluntarily report AEFIs to public health.
The Infectious Diseases Protocol for AEFIs: Appendix B (PDF) and the Adverse Events of Special Interest (AESIs) for COVID-19 Vaccines Surveillance document (PDF) provide reporting criteria, provincial surveillance case classifications as well as types of adverse events which are reportable. This is required for all AEFIs classified as a “Confirmed Case” for provincial surveillance and reporting purposes.
In general, any adverse event following immunization should be reported to your local public health unit for further follow-up and investigation if:
- It has a temporal association with immunization (i.e. the event follows immunization); and
- Has no other clear cause at the time of reporting.
A causal relationship does not need to be proven and submitting a report does not imply causality.
The AEFI Fact Sheet for Health Care Providers also contains information on the types of adverse events that should be reported. If there is any doubt as to whether or not an event should be reported, a conservative approach should be taken and the event should be reported.
Reporting adverse events following immunization:
- Call Public Health Sudbury & Districts at 705.522.9200, ext. 458 (toll-free 1.866.522.9200) during business hours or after-hours at 705.688.4366.
- Complete the Adverse Events Following Immunization (AEFI) Report Formavailable from Public Health Ontario. Fax the completed form to Public Health Sudbury & Districts’ confidential fax line at 705.677.9618 or email us at AEFI@phsd.ca.
Public Health Investigation of AEFIs
AEFI reports received by Public Health Sudbury & Districts are investigated, assessed, and documented according to provincial surveillance guidelines, as required by the Ontario Public Health Standards (OPHS).
Information gathered during the investigation should provide enough detail to:
- Determine if the adverse event(s) meet case definition according to Section 3.0 “Case Classification” in Appendix B.
- Determine which adverse event(s) should be selected for the case as outlined in Appendix B Section 5.0 “Types of Adverse Events”.
- Provide advice/support to the client (case) and/or clinician following the client, and the Medical Officer of Health recommendations regarding future immunizations or additional follow-up.
Recommendations are provided verbally by a public health nurse to the reporting client or health care provider. Written recommendations will only be provided on a case-by-case basis.
Public Health Sudbury & Districts reviews all reported adverse events following immunization. To ensure maximum protection against COVID-19 and the Delta variant, anyone born in 2009 or earlier should get their first dose and anyone eligible for a second dose should attend a walk-in, pop-up, or mobile clinic or book their second dose as soon as possible. Select groups at highest-risk are eligible for a third dose of the COVID-19 vaccine based on the recommendation of the Chief Medical Officer of Health and other health experts.
Please visit Public Health Sudbury & District’s vaccination clinics for COVID-19 site for more information. Select primary care providers and pharmacies are also offering COVID-19 vaccination.
For additional information on adverse events following immunization, visit our Vaccine Related Adverse Events web page.
For more information on the COVID-19 vaccines, as well as for specific answers to your frequently asked questions visit our FAQ web page.
Original Signed By
Dr. Penny Sutcliffe
Medical Officer of Health and Chief Executive Officer
NOTE: All Advisory Alerts are found on our website.
This item was last modified on August 20, 2021