Reported side effects following COVID-19 vaccination in Canada

Report summary updated March 17, 2023

• A total of 97,597,702 vaccine doses have been administered in Canada as of March 3, 2023, including 8,191,329 bivalent doses. Adverse events (side effects) have been reported by 54,569 people. That’s about 6 people out of every 10,000 people vaccinated who have reported 1 or more adverse events.
  • Of the 54,569 individual reports, 43,884 were considered non-serious (0.045% of all doses administered) and 10,685 were considered serious (0.011% of all doses administered).
  • Of the 54,569 individual reports, 627 were following a bivalent vaccine. 482 were considered non-serious (0.006% of bivalent COVID-19 doses administered) and 145 (0.002% of bivalent COVID-19 doses administered) were considered serious.
  • Most adverse events are mild and include soreness at the site of injection or a slight fever.
  • Serious adverse events are rare, but do occur. They include anaphylaxis (a severe allergic reaction), which has been reported 776 times (1 report per 100,000 doses administered) for all COVID-19 vaccines across Canada. That’s why you may need to wait for a period of time after you receive a vaccination so that you can receive treatment in case of an allergic reaction.
• All serious adverse event reports undergo medical review to see if there are any safety issues needing further action. These processes include meeting regularly to review the data with provincial and territorial partners, the regulator, research networks and medical advisors. Any unexpected safety concerns are detected quickly and acted upon immediately.
• Health Canada and PHAC are aware of an updated report released on Monday February 6, 2023 by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) on findings from the Vaccine Safety Datalink. This preliminary safety signal has prompted additional investigation into whether there is a safety concern between the Pfizer-BioNTech bivalent COVID-19 vaccine and ischemic stroke in people 65 years of age and over. The signal has not been found in other vaccine safety monitoring systems in the USA nor in other countries, including Canada. Health Canada and PHAC will continue to monitor this issue closely.
• Adverse events may occur after being vaccinated with a COVID-19 vaccine, but they are not necessarily related to the vaccine.
• Evidence indicates that the benefits of COVID-19 vaccines continue to outweigh the risks of the disease.

Adverse events of interest

• Thrombosis with thrombocytopenia syndrome following vaccination with AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine.
• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.