Report an adverse reaction to a vaccine: industry
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- a domestic serious adverse reaction
- a foreign unexpected serious adverse reaction
- a domestic unusual failure in efficacy for new drugs involving their marketed health products, including vaccines
Industry must report within 15 calendar days of receiving information about or becoming aware of an adverse reaction.
What are vaccines
Vaccines are products that produce immunity to a specific disease. Most vaccines are given by injection (needle) but some are given orally (by mouth) or nasally (sprayed into the nose).
They protect people against serious and potentially deadly diseases, such as diphtheria, measles, polio and tetanus.
Tracking adverse events following immunization
Health Canada and the Public Health Agency of Canada (PHAC) share the monitoring of the safety of vaccines in Canada.
PHAC manages the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS). This post-market vaccine safety surveillance system collects CAEFISS reports submitted by public health authorities in provinces and territories, which in turn receive them from local public health units. Nurses, doctors or pharmacists who provide immunizations or care for people who experience an adverse event from a vaccine generate most of the reports.
Once aware, manufacturers (market authorization holders) of all drugs, including vaccines, must report:
- serious adverse reactions in Canada
- unexpected serious adverse reactions in other countries
- unusual failures in efficacy for new drugs in Canada
- Vaccines and immunization
- MedEffect Canada
- Drugs and health products
- Adverse reaction database
- Reporting Adverse Events Following Immunization (AEFI) in Canada: User Guide to Completion and Submission of the AEFI Reports
- Overview of the reporting of adverse reactions to marketed health products - guidance
- Drug and health product register
- Advisories, warnings and recalls
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