Page 3: Health Product InfoWatch – August 2017

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Vaccine safety quarterly summary

Report for October 1, 2016 to December 31, 2016

Post-market surveillance is essential to monitor the safety and effectiveness of vaccines and other health products. The monitoring of the safety of vaccines is a shared responsibility between Health Canada and the Public Health Agency of Canada (PHAC). Market authorization holders are required to report serious adverse events following immunization (AEFIs) to the Canada Vigilance Program in the Marketed Health Products Directorate at Health Canada. The Canada Vigilance Program also receives voluntary AEFI reports from healthcare professionals and consumers. Provincial and territorial public health authorities report AEFIs from publicly funded vaccine programs to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) in PHAC to monitor the safety of immunization programs.

This Vaccine Safety Quarterly Summary includes AEFI reports received by the Canada Vigilance Program between October 1, 2016 and December 31, 2016. To access reports published by CAEFISS, please visit the CAEFISS Web site.

  • From October 1, 2016 to December 31, 2016, the Canada Vigilance Program received 167 reportsFootnote * of adverse events following immunization (AEFIs) for which vaccines were the suspected cause.
  • There were 86 (52%) serious reports. Most of these involved patients with underlying medical conditions and were unlikely related to the vaccination.
  • The largest proportion of reports (serious and non-serious) involved influenza vaccines (46%) followed by herpes zoster vaccine (22%) and pneumococcal vaccines (9%).
  • The most frequently reported AEFIs (serious and non-serious) included injection site erythema, pruritus, headache, aggravated condition, and hypotonic-hyporesponsive episode.
    • Five of the serious reports with the event of aggravated condition were from a patient who received multiple vaccines and 13 of the serious reports of hypotonic-hyporesponsive episode were from 4 patients who received one or more vaccines.
    • All of these reports lacked sufficient information for adequate assessment. The other AEFIs are common following vaccination and are captured in the respective Canadian product monographs.
  • No new safety signals (potential safety issues) were identified during this period.
  • The benefits of vaccines authorized in Canada continue to outweigh the risks.
  • Health Canada, in collaboration with PHAC, will continue to closely monitor the safety of vaccines authorized in Canada.


Reference *

Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database

Note that because of updated information received by the Canada Vigilance Program, there may be differences in the number of AEFI reports and adverse events retrieved at different dates.

This summary may contain duplicate reports. Duplicate reports are reports related to the same patient and event received from more than one source (e.g. pharmacist and consumer).Therefore, the sum of all reports in the line listing may exceed the total number of individual patient cases.

For additional information, contact the Marketed Health Products Directorate.

Return to footnote * referrer

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