Self Reporting

Health Canada – Adverse Event Following immunization (AEFI)

Anyone can report a side effect to a health product, including vaccines. You should make a report  even if you are not sure if a particular health product was the cause.

A side effect (also known as adverse reaction) is a harmful and unintended response to a health product. Health products include prescription and non-prescription medications; natural health products; biologics (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues and organs) radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims. You may report any undesirable effect suspected to be associated with health product use. An unintended effect, health product abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable side effects.

A temporal (happens shortly after receiving the product) or a possible association is sufficient for a report to be made. Reporting of a side effect does not imply a definitive causal link.

All suspected side effects should be reported, especially those that are:

• unexpected, regardless of their severity (i.e. not consistent with product information or labelling;
• serious, whether expected or not;
• reactions to recently marketed health products (on the market less than five years), regardless of their nature or severity.

A serious side effect is one that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Side effects that result in significant medical intervention to prevent one of these listed outcomes are also considered to be serious.

To document your AEFI, you may complete an online form or download and mail a completed PDF form to the address printed on this postage paid label.

How to complete the Side Effect Reporting Form

• All sections of the form should be filled in as completely as possible. Use a separate form for each person. Attach an additional form if there is more than one suspected health product. Additional pages may be attached if more space is required. Please provide the product label where possible.
• Follow-up information for a side effect that has already been reported can be submitted using a new form, indicating that it consists of follow-up information, including, if known, the date of the original report and the report number provided in the acknowledgement.

• Questions? Call: 1-866-234-2345

  [Text modified from Health Canada website.]