Report an adverse reaction to a vaccine: industry
Canada's Food and Drugs Act and Regulations set out specific reporting requirements and timelines for mandatory reports. These include requiring regulated parties to report a serious or unexpected adverse reaction to vaccines. Reports must be made within 15 calendar days of receiving or becoming aware of the information about the adverse reaction.
What is a vaccine
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.
- 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
- Canada Vigilance Program
- Drug and health product register
- Advisories, warnings and recalls
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