Report an adverse reaction to a vaccine: Industry
Industry (manufacturers) must report within 15 calendar days of receiving information about or becoming aware of an adverse reaction.
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), which is a post-market vaccine safety surveillance system. CAEFISS receives reports from public health authorities in provinces and territories, which in turn receive them from local public health units. Nurses, doctors and pharmacists who provide immunizations or care for people who experience an adverse event from a vaccine generate most of the reports.
In addition, when manufacturers are made aware of adverse reactions to a drug or vaccine, they must report to Health Canada:
- 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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