Report an adverse reaction to a vaccine: industry

On this page

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:

Industry must report within 15 calendar days of receiving information about or becoming aware of an adverse reaction.

Report 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:

Manufacturers report to Health Canada's Canada Vigilance Program.
Text Equivalent

This diagram shows the pathway of adverse events following immunization reports:

  • from the source (vaccine recipient or market authorization holder)
  • to the Public Health Agency of Canada or Health Canada

At the top of the diagram, on the left, is a box representing the vaccine recipient. From this box, an arrow points downward to a box for the health care provider. Another arrow points from this box downward to a box for local public health units. From this box, an arrow points downward to a box for federal/provincial/territorial immunization authorities, then to a box for the Public Health Agency of Canada.

The right side of the diagram shows a box representing market authorization holders. From this box, an arrow points downward to a box for Health Canada. A dotted line with double arrows points between the Public Health Agency of Canada box and the Health Canada box.

Related links

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: