Pfizer-BioNTech COVID-19 vaccine: Continued monitoring

Vaccines on the market in Canada are monitored continuously. Commonly reported side effects of vaccination, such as pain at the site of injection, body chills, feeling tired or feverish are not considered safety concerns to the health of Canadians. At the time of authorization, no major safety concerns have been reported in the available data submitted to Health Canada.

We are carefully monitoring the post-market (after authorization) safety and effectiveness of authorized COVID-19 vaccines. As part of our commitment to keep Canadians informed, we are publishing information about adverse events following immunization (AEFI). An AEFI is a medical incident that may occur following immunization. The cause of this occurrence isn’t necessarily related to the vaccine.

We will take prompt action should any safety concerns arise. This could include warning Canadians about potential side effects (adverse events), changing the recommended use of the product or even removing the product from the market.

Updates on post-market activities

Health Canada will provide updates on post-market activities for the Pfizer-BioNTech COVID-19 vaccine in the Post-Authorization Activity Table (PAAT), found in the vaccines and treatments regulatory portal.

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