Report an adverse reaction to a vaccine: hospitals

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There are new mandatory reporting requirements for hospitals. Hospitals must report, in writing, within 30 days of documenting the serious adverse drug reaction within the facility. We encourage hospitals to report sooner, if possible.

Health care professionals who work in a hospital should check with their hospital administration to learn about any new requirements and internal procedures.

However, hospitals do not have to report for vaccines if they have submitted an Adverse Events Following Immunization (AEFI) report to their local public health unit. Learn more about reporting adverse events following an immunization.

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 these reports.

Once aware, manufacturers (market authorization holders) of all drugs, including vaccines, must report:

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

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