MEMO: Adverse Events Following Immunizations

TO: Health Care Professionals in the Niagara region

FROM: Vaccine Preventable Disease program

REFERENCE: Adverse Events Following Immunizations

DATE: April 9, 2021

Health care professionals within Ontario are mandated under the Health Protection and Promotion Act (HPPA), R.S.O. 1990, c. H.7 Section 38 to report adverse events following immunization (AEFI) to their local public health unit. Reporting AEFIs is an essential component of vaccine safety and supports the success of immunization programs within Ontario.

To ensure best practice and help support vaccine safety, Niagara Region Public Health (NRPH) strongly recommends the following:

Prioritize follow-up office appointments for patients who experienced an AEFI, especially for individuals who experience an AEFI associated with multi-dose vaccines and the series is incomplete
Do not direct your clients to call NRPH to self-report AEFIs. It is the responsibility of the health care provider to report an AEFI. Often, reporting an AEFI requires information from a health care provider’s perspective that the client may not have.

Niagara health care professionals should report AEFIs using the Report of Adverse Event Following Immunization (AEFI) form and fax it to 905-688-8225.

Completion of the AEFI form is required whether you were the vaccine administrator or not
As a reminder, if an asterisk (*) is present beside an AEFI term, this specific event should be diagnosed by a physician, which may require an in-person physical exam

Reportable Adverse Events

An AEFI is an unexpected health effect that happens after an individual receives a vaccine, which may or may not be caused by the vaccine. A casual relationship with the administration of the vaccine does not need to be proven. Health professionals should report adverse events when there is:

A temporal association with a vaccine
Urgent medical attention required or severe outcomes
Unusual or unexpected effects

Not all reactions are AEFIs. Events that are not reportable include the following:

Expected side effects of vaccination:
- Fever or chills not accompanied by another reportable adverse event
- Headache
- Muscle or joint pain
- Fatigue
- Pain, redness or swelling at the injection site lasting less than 4 days
Has been clearly attributed to other causes
Vasovagal syncope (without injury)
Adverse events related to administration of passive immunizing agents (eg. Immune globulin), tuberculin skin tests, or other drug products
Immunization program errors (eg. wrong dose) not associated with an adverse event

AEFI Reporting Form

The Ministry of Health mandated the collection of AEFIs for COVID-19 vaccines in addition to all other non-COVID-19 vaccines
In accordance to the new mandate, PHO has updated the AEFI Reporting Form to reflect the collection of several COVID-19-specific AEFIs
When completing the AEFI reporting form it is critical that sections 1 – 6 are completed and legible; if sections are incomplete or illegible, our nurses may have to follow-up directly with you

Additional Information

Refer to Appendix B: Provincial Case Definitions for Diseases of Public Health Significance or Adverse Event Following Immunization Reporting for Health Care Providers in Ontario Fact Sheet for guidance on AEFI reporting and case definitions
Visit NRPH’s Frequently Asked Questions on Novel Coronavirus (COVID-19) webpage to learn more about the new provincial vaccine Allergy/Immunology eConsult service
Review PHO’s, Adverse Events of Special Interest (AESI) for COVID-19 Vaccines Surveillance document for information on AESI
For most updates on COVID-19 vaccine side effects, visit Government of Canada’s Reported Side Effects COVID-19 Vaccinations webpage
Refer to PHAC’s, Reporting AEFIs in Canada User Guide
For any questions, please call the Vaccine Preventable Disease program at 905-688-8248 or 1-888-505-6074 ext. 7396