COVID-19 vaccine safety in Canada
This page provides information about any adverse events following immunization (AEFI) that individuals have reported after receiving a COVID-19 vaccine in Canada. Even though an adverse event is reported, it is not necessarily related to the vaccine. We update this page every Friday at 12:00 PM Eastern Time.
On this page
- What you need to know
- Definitions
- Summary of AEFI reports
- AEFI reports by age and sex
- Serious and non-serious adverse events reported
- Data notes
- Related links
What you need to know up to and including MMM DD, 2021
No safety signals
(potential safety issues) have been identified
{New AEFIs reported since last report}
New AEFI reports since last update
({New non-serious AEFIs} new non-serious and {New serious AEFIs} new serious)
{Total AEFIs}
Total AEFI reports
({Percent non-serious (total)}% of all doses administered)
{Total non-serious AEFIs}
Total AEFI reports were non-serious
({Percent non-serious (total)}% of all doses administered)
{Total serious AEFIs}
Total AEFI reports were serious
({Percent serious (total)}% of all doses administered)
{Total doses administered}
Total doses administered as of
- The benefits of vaccines authorized in Canada continue to outweigh the risks.
- Health Canada, the Public Health Agency of Canada (PHAC), the provinces and territories, and manufacturers continue to closely monitor the safety of COVID-19 vaccines. We’ll respond to any safety issues right away and will inform Canadians about any risks that arise in Canada.
- Of the AEFI reports (% of all doses administered), were considered serious (% of all doses administered).
- The number of AEFI reports was highest among the age group where age was known.
- There were more AEFI reports among than , where sex was known.
Definitions
Adverse Event Following Immunization (AEFI)
An AEFI is any untoward medical occurrence which follows immunization. It isn’t necessarily causally related to the usage of the vaccine. The adverse event may be any:
- unfavourable or unintended sign (for example: skin rash)
- abnormal laboratory finding
- symptom or
- disease
For more information, please refer to the Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO). Definition and Application of Terms for Vaccine Pharmacovigilance. Report of CIOMS/WHO Working group on Vaccine Pharmacovigilance. Geneva: CIOMS and WHO; 2012
AEFI report
Please note that one AEFI report, which represents one person, may report on more than one symptom (i.e a serious or non serious adverse event following immunization, or AEFI).
Serious AEFI
An event is considered serious if it:
- results in death
- is life-threatening (an event/reaction in which the patient was at real, rather than hypothetical, risk of death at the time of the event/reaction)
- requires in-patient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity, or
- results in a congenital anomaly/birth defect
Medically important event
An event which may not be immediately life-threatening but requires intervention to prevent one of the outcomes listed above and may also be considered as serious. This is based on the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. See:
International Council on Harmonisation (ICH). Support Documentation. Medical Dictionary for Regulatory Activities. https://www.meddra.org/how-to-use/support-documentation
Adverse Events of Special Interest (AESI)
This is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product. It must be carefully monitored and confirmed by further special studies.
For more information, please refer to World Health Organization. COVID-19 Vaccines: Safety Surveillance Manual.Safety signal
Information indicating a new and potentially causal association between a vaccine and an event that could affect health. The event is either unknown or incompletely documented. It could also indicate a new aspect of a known association. The primary purpose of vaccine post-market surveillance is to detect safety concerns. These concerns include a possible increase in the severity or frequency of expected AEFIs, or one or more unexpected events (i.e., an event that is not consistent with Canadian product information or labelling).
For more information, please refer to World Health Organization: Investigation of safety signals.Summary of AEFI reports
The information on this page reflects detailed case information data from the Public Health Agency of Canada’s Canadian Adverse Events Following Immunization Surveillance System and Health Canada’s Canada Vigilance program. The data may undergo changes as more information about cases becomes available.
There have been AEFI reports up to and including , of which were considered serious. The weekly and total numbers of AEFI reports are shown in Figure 1.
Figure 1. number of COVID-19 vaccine AEFI reports up to and including MMM DD, 2021 (n=)
Figure 1: Text Description
| Week report received | Weekly non-serious AEFI reports | Weekly serious AEFI reports | Total non-serious AEFI reports | Total serious AEFI reports |
|---|
AEFI reports by age and sex
Among people where age was known, those aged years reported the most AEFIs (Figure 2). Most of the AEFI reports involved where sex was known (Figure 2), up to and including .
Figure 2. AEFI reports by up to and including MMM DD, 2021 (n=)
Figure 2: Text Description
| Age group | Total AEFI reports | Male | Female | Other | Unknown |
|---|
Serious and non-serious adverse events reported
- The individual AEFI reports represent people who reported one or more adverse events.
- Among the 90 AEFI reports, the most frequently reported adverse events were vaccination site reactions, paraesthesia, pruritis, urticaria, headache, hypoaesthesia, nausea and anaphylaxis.
Figure 4. Classification of serious AEFIs as of MMM DD, 2021
Data notes
The data presented in this report are estimates and may not accurately represent national COVID-19 vaccine AEFIs for the following reasons:
- There may be delays in receiving reporting forms. These delays may be due to jurisdictions investigating and reviewing each AEFI prior to submitting the information to PHAC. There are also limitations to reporting practices such as underreporting, missing information, and differing AEFI reporting practices accross jurisdictions in Canada.
- Information is collected on individuals for whom an AEFI report was submitted, not on the total number of individuals who experience an adverse event as not every adverse event is reported.
- New information contained in this report is not comprehensive but rather represents preliminary results of data received on a weekly basis.
- Note that reporting jurisdictions may refer to gender as opposed to sex.
Related links
- Canadian Adverse Events Following Immunization and Surveillance System (CAEFISS)
- Immunization Monitoring Program ACTive (IMPACT)
- Canadian National Vaccine Safety Network (CANVAS)
- Canada Vigilance Program
- Drug Product Database
- Approved COVID-19 Vaccine list
- COVID-19 vaccines and treatments portal
- COVID-19 vaccination in Canada
- Date modified: