Reported side effects following COVID-19 vaccination in Canada
We update this page every second Friday at noon Eastern Time. A summary and background information are available.
Changes to the update schedule
Please note that due to the holidays, the May 27 report will be published on May 30, 2022.
This report was last updated on MMM DD, YYYY with data up to and including MMM DD, YYYY.
On this page
- What you need to know
- Safety signals
- Other safety updates
- Definitions
- How to report an adverse event
- Summary of adverse event following immunization reports
- Adverse event following immunization reports by vaccine name
- Adverse event following immunization reports by age and sex
- Serious and non-serious adverse events reported
- Adverse events of special interest
- Detailed information on safety signals, other safety updates, and deaths
- Data notes
- Acknowledgements, suggested citation, and related links
What you need to know up to and including MMM DD, 2021
- Evidence indicates that the benefits of COVID-19 vaccines continue to outweigh the risks of the disease.
- 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 individual reports ( of all doses administered), were considered serious ( of all doses administered).
Safety signals
- No new safety signals have been identified this week. To align with standard reporting practices, Guillain-Barré Syndrome (GBS) reports are being adjusted to Brighton Collaboration level of certainty (BCD) 1 to 3. Level 4 reports with insufficient information to confirm diagnosis won’t be presented here. With this adjustment, GBS is no longer a safety signal (see note above Table 1).
- PHAC and Health Canada are actively monitoring ongoing safety signals:
- Reports of thrombosis with thrombocytopenia syndrome following vaccination with the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine. Health Canada has updated the AstraZeneca Vaxzevria COVID-19 vaccine product monograph (PDF) and the COVISHIELD COVID-19 vaccine product monograph (PDF) to include information about these very rare events of blood clots associated with low levels of platelets following immunization. For more information, please refer to the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine public advisory.
- Reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines. Data in Canada now indicate a higher number of cases in younger people (less than 40 years of age) than would normally be expected in this age group in the general population. Health Canada updated the Moderna Spikevax COVID-19 vaccine product monograph (PDF) and the Pfizer-BioNTech Comirnaty COVID-19 vaccine product monograph (PDF) to include information around these risks. For more information, please refer to the Moderna Spikevax and Pfizer-BioNTech Comirnaty COVID-19 vaccines public advisory.
- Please refer to detailed information on safety signals, other safety updates, and deaths.
Other safety updates
- PHAC and Health Canada continue to closely monitor Canadian and international reports, including:
- Capillary leak syndrome following vaccination with the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine. Health Canada has updated the AstraZeneca Vaxzevria COVID-19 vaccine product monograph (PDF) and the COVISHIELD COVID-19 vaccine product monograph (PDF) to include information on capillary leak syndrome, including a contraindication for patients who have previously experienced this syndrome. For more information, please refer to the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine public advisory.
- Facial paralysis/Bell's Palsy following vaccination with COVID-19 mRNA vaccines. Health Canada has updated the the Moderna Spikevax COVID-19 vaccine product monograph (PDF) and the Pfizer-BioNTech Comirnaty COVID-19 vaccine product monograph (PDF) to include information on facial paralysis/Bell’s Palsy.
- Immune thrombocytopenia (ITP) and venous thromboembolism (VTE) following vaccination with the Janssen COVID-19 vaccine. Health Canada has updated the Janssen vaccine product monograph (PDF) to include information on ITP and VTE. For more information, please refer to the Janssen and AstraZeneca Vaxzevria COVID-19 vaccines public advisory.
- Thrombocytopenia including ITP following vaccination with AstraZeneca Vaxzevria COVID-19 vaccine. Health Canada has updated the AstraZeneca Vaxzevria COVID-19 vaccine product monograph (PDF) to include information on thrombocytopenia including ITP. For more information, please refer to the AstraZeneca Vaxzevria COVID-19 vaccine public advisory
- Reports of Guillain-Barré Syndrome (GBS) in Canada following AstraZeneca COVID-19 vaccination. Health Canada has updated the product monographs for AstraZeneca Vaxzevria COVID-19 vaccine (PDF) and COVISHIELD COVID-19 vaccine (PDF) to include information on GBS. For more information, please refer to the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccination product description.
Definitions
Adverse Event Following Immunization (adverse event)
An adverse event is any untoward medical occurrence that 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. Report of CIOMS/WHO Working group on Vaccine Pharmacovigilance.
Adverse event report
One adverse event report, which represents 1 person, may report on more than 1 symptom (i.e a serious or non serious adverse event following immunization, or AEFI).
Serious adverse event
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 that may not be immediately life-threatening but requires intervention to prevent 1 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:
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 the 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, such as:
- a possible increase in the severity or frequency of expected adverse events following immunization, or
- one or more unexpected events (such as an event that is not consistent with Canadian product information or labelling).
Brighton Collaboration diagnostic level of certainty
Brighton Collaboration case definitions are standardized for adverse events following immunization (AEFI). They allow AEFIs to be compared across different data sources. Clinical information on the AEFI is reviewed and categorized into 1 of 5 categories. AEFIs that meet levels 1-3 have enough information to confirm that they are a case. AEFIs that meet level 4 lack sufficient information to meet the case definition. AEFIs categorized as level 5 do not meet the case definition.
How to report an adverse event
If you experience an adverse event following immunization with a COVID-19 vaccine in Canada, please contact your healthcare provider. Learn more about reporting adverse events.
Summary of adverse event following immunization 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 (CAEFISS) and Health Canada’s Canada Vigilance program. Doses administered used for reporting rate calculations have been adjusted to account for the delay between vaccination and reporting. The data on this page may undergo changes as more information about cases becomes available.
There have been a total of reports ( reports per 100,000 doses administered) up to and including . Of the reports, were considered serious ( reports per 100,000 doses administered). Overall, the rate of serious reports has remained low. The cumulative and biweekly number of reports, as well as the biweekly reporting rate, are shown in Figure 1.
Figure 1. of COVID-19 vaccine adverse event reports for and total doses administered biweekly up to and including MMM DD, 2021 (n=)
Data notes: The shaded area represents a period of time (lag time) where there may be delays in receiving and processing reporting forms. There may also be delays in receiving data on doses administered.
Please note that as of April 29, 2022, this figure reflects biweekly counts and rates. This is due to changes in reporting schedules.
Information on doses administered by age group was only available starting April 23, 2021 for those aged 12 and older, and starting November 27, 2021 for those under the age of 12. Rates of adverse event reports and doses administered by age group are not reported before these dates.
Reports of 11-year-olds who received the Pfizer-BioNTech Comirnaty COVID-19 vaccine dose for individuals 12 years of age and older before the pediatric dose was authorized are included in the 5 to 11 age group. The 5 to 11 year age group also includes reports of individuals born in 2017 who had not yet turned 5 years old at the time of vaccination.
Figure 1: Text Description
Number of COVID-19 adverse event reports for all people up to and including (n=45,111)
| Week report received | Biweekly non-serious reports-all | Biweekly serious reports-all | Cumulative non-serious reports-all | Cumulative serious reports-all | Cumulative number of doses administered-all1 | Biweekly number of doses administered-all1 | Biweekly non-serious reporting rate-all2 | Biweekly serious reporting rate-all2 | Biweekly reporting rate-all2 | Biweekly non-serious reports-18plus | Biweekly serious reports-18plus | Cumulative non-serious reports-18plus | Cumulative serious reports-18plus | Cumulative number of doses administered-18plus1 | Biweekly number of doses administered-18plus1 | Biweekly non-serious reporting rate-18plus2 | Biweekly serious reporting rate-18plus2 | Biweekly reporting rate-18plus2 | Biweekly non-serious reports-12to17 | Biweekly serious reports-12to17 | Cumulative non-serious reports-12to17 | Cumulative serious reports-12to17 | Cumulative number of doses administered-12to171 | Biweekly number of doses administered-12to171 | Biweekly non-serious reporting rate-12to172 | Biweekly serious reporting rate-12to172 | Biweekly reporting rate-12to172 | Biweekly non-serious reports-5to11 | Biweekly serious reports-5to11 | Cumulative non-serious reports-5to11 | Cumulative serious reports-5to11 | Cumulative number of doses administered-5to111 | Biweekly number of doses administered-5to111 | Biweekly non-serious reporting rate-5to112 | Biweekly serious reporting rate-5to112 | Biweekly reporting rate-5to112 |
|---|
1 Doses administered used for rate calculations have been adjusted to account for the delay between vaccination and reporting.
2 Reporting rate per 100,000 doses administered.
Adverse event following immunization reports by vaccine name
Figure 2 shows the breakdown of reports by vaccine name. For doses administered by vaccine type, please visit the vaccination coverage report.
Health Canada authorized booster doses of Pfizer-BioNTech Comirnaty on November 9, 2021 and Moderna Spikevax on November 12, 2021. Booster doses are administered in the muscle (intramuscularly) to adults at least 6 months after they complete their primary series.
On November 19, 2021, the authorization of the Pfizer-BioNTech Comirnaty was extended to children 5 to 11 years of age (10 mcg dose). On March 17, 2022, the authorization of the Moderna Spikevax COVID-19 vaccine was extended to children 6 to 11 years of age (50 mcg dose). Health Canada authorized the AstraZeneca Vaxzevria COVID-19 vaccine on November 19, 2021, the Janssen COVID-19 vaccine on November 23, 2021, and the Novavax Nuvaxovid COVID-19 vaccine on February 17, 2022.
While the Medicago Covifenz COVID-19 vaccine was approved for use in Canada on February 24, 2022, it was not distributed during this reporting period.
Get more information about the authorized vaccines:
-
Pfizer-BioNTech Comirnaty COVID-19 vaccine
- information on Pfizer-BioNTech Comirnaty boosters
- information on the Pfizer-BioNTech Comirnaty vaccine for children 5 to 11 years of age
-
Moderna Spikevax COVID-19 vaccine
- information on Moderna Spikevax boosters
- information on the Moderna Spikevax COVID-19 vaccine for children 6 to 11 years of age
-
AstraZeneca Vaxzevria COVID-19 vaccine
- information on AstraZeneca Vaxzevria authorization
-
Janssen (Johnson & Johnson) COVID-19 vaccine
- information on Janssen authorization
-
Novavax Nuvaxovid COVID-19 vaccine
- information on Novavax Nuvaxovid authorization
-
Medicago Covifenz COVID-19 vaccine
- information on Medicago Covifenz authorization
For all COVID-19 vaccines being used in Canada, the rate of serious adverse event reports remains lower than that of non-serious adverse event reports. As well, rates of adverse event reports are lower after the second and third doses than after the first dose. The data for second, third, and fourth doses do not take into account which vaccine an individual received for previous doses. Generally, non-serious adverse event reports are consistent with information provided in the vaccine product pages.
Note: 72 of the 45,111 COVID-19 adverse event reports (0.16%), involved people who received an influenza vaccine and a COVID-19 vaccine on the same day.
Figure 2. of adverse event reports for by vaccine name and dose number up to and including MMM DD, 2021 (n=)
Data notes: Reports of 11-year-olds who received the Pfizer-BioNTech Comirnaty COVID-19 vaccine dose for individuals 12 years of age and older before the pediatric dose was authorized are included in the 5 to 11 age group. The 5 to 11 year age group also includes reports of individuals born in 2017 who had not yet turned 5 years old at the time of vaccination.
Total includes reports that did not specify dose number.Figure 2: Text Description
Number and rate (per 100,000 doses administered) of adverse event reports for all people by vaccine name and dose number, up to and including MMM DD, 2021 (n=45,204)
| Vaccine name | Non-serious reports-all2 | Serious reports-all2 | Total reports-all2 | Non-serious reporting rate-all3 | Serious reporting rate-all3 | Total reporting rate-all3 | Total number of doses administered-all | Non-serious reports-18plus2 | Serious reports-18plus2 | Total reports-18plus2 | Non-serious reporting rate-18plus3 | Serious reporting rate-18plus3 | Total reporting rate-18plus3 | Total number of doses administered-18plus4 | Non-serious reports-12to172 | Serious reports-12to172 | Total reports-12to172 | Non-serious reporting rate-12to173 | Serious reporting rate-12to173 | Total reporting rate-12to173 | Total number of doses administered-12to17 | Non-serious reports-5to112 | Serious reports-5to112 | Total reports-5to112 | Non-serious reporting rate-5to113 | Serious reporting rate-5to113 | Total reporting rate-5to113 | Total number of doses administered-5to11 |
|---|
1Includes reports that did not specify dose number.
2Includes reports that contain information on more than one vaccine name.
3Reporting rate per 100,000 doses administered.
Adverse event following immunization reports by age and sex
- The rate of adverse event reports was highest among the 40 to 49 year age group (76.9 reports per 100,000 doses administered), followed by those in the 50 to 59 year age group (66.4 reports per 100,000 doses administered).
- The rate of adverse event reports was lowest in the 5 to 11 year age group.
- There are 24 adverse event reports in 11 year olds who likely received the Pfizer-BioNtech Comirnaty COVID-19 vaccine dose for individuals 12 years of age and older. These reports are included in the 5 to 11 year age group.
- Overall, most adverse event reports were from females (72.6%). The reporting rate for females was 73.4 reports per 100,000 doses administered, compared to 29.3 per 100,000 doses administered for males. However, within the 12 to 17 age group, the proportion and reporting rate in males was slightly higher.
- It is unclear if this is due in part to health care seeking behaviour (for example, reporting adverse events) or biological differences between females and males.
- The higher proportion and rate of adverse event reports for females has been observed in the United States, the United Kingdom, and other countries.
- Health Canada, PHAC, and provincial and territorial public health authorities will continue to monitor but have not identified this as a safety issue.
Figure 3. of adverse event reports by up to and including MMM DD, 2021 (n=)
Data notes: Reports of 11-year-olds who received the Pfizer-BioNtech Comirnaty COVID-19 vaccine dose for individuals 12 years of age and older before the pediatric dose was authorized were previously included in the 12 to 17 age group. As of December 17, 2021, they are included in the 5 to 11 age group, regardless of dosage amount. The 5 to 11 year age group also includes reports of individuals born in 2017 who had not yet turned 5 years old at the time of vaccination.
Figure 3: Text Description
Number and rate (per 100,000 doses administered) of adverse event reports by age group and sex up to and including (n=)
| Age group | Total | Male | Female | Other | Unknown | Number of doses administered by age group | Number of doses administered to males | Number of doses administered to females | Total number of doses administered1 | Reporting rate by age group | Male reporting rate2 | Female reporting rate2 | Total reporting rate (males and females)1,2 |
|---|
1Reports not identified as male or female were removed due to small numbers.
2Reporting rate per 100,000 doses administered.
3The 5 to 11 year age group also includes reports of individuals born in 2017 who had not yet turned 5 years old at the time of vaccination.
Serious and non-serious adverse events reported
- All reports of adverse events following immunization received by Health Canada and PHAC are included in this report, regardless of whether they have been linked to the vaccines. This is because we need to look at all the data available to us so we can detect any early signals of an issue.
- Health Canada, PHAC, the provinces and territories, and manufacturers continue to closely monitor the safety of COVID-19 vaccines. Serious events will be reviewed to determine if there is a new safety signal.
- If a new safety issue is found to be related to immunization, Health Canada will take appropriate action. This could include updating the product information, communicating new risks to healthcare providers and the general population or changing the recommended use of the product.
- The individual reports represent people who reported 1 or more adverse events. Among the reports, the most frequently reported adverse events are presented in Figure 4. Most of these adverse events are non-serious.
Figure 4. of the most frequently reported adverse events by vaccine type () up to and including MMM DD, 2021 (n=)
Figure 4: Text Description
Number and rate (per 100,000 doses administered) of the most frequently reported adverse events by vaccine type up to and including MMM DD, 2021 (n=)
| Most frequently reported events1 | Number of Pfizer-BioNTech Comirnaty events | Number of Moderna Spikevax events | Number of AstraZeneca Vaxzevria/COVISHIELD events | Number of Janssen events | Number of Unspecified events | Total number of events | Rate of Pfizer-BioNTech Comirnaty events (per 100,000 doses administered) | Rate of Moderna Spikevax events (per 100,000 doses administered) | Rate of AstraZeneca Vaxzevria/COVISHIELD events (per 100,000 doses administered) | Rate of Janssen events (per 100,000 doses administered) | Total rate of events (per 100,000 doses administered) |
|---|
1Includes both serious and non-serious adverse events.
2Includes adverse events meeting levels 1-3 of the Brighton Collaboration level of diagnostic certainty.
Adverse events of special interest
Adverse events of special interest (AESI) are pre-specified medically significant events that have the potential to be causally associated with a vaccine product. They must be carefully monitored and confirmed by further special studies. AESI can be serious or non-serious and can include:- events of interest due to their association with COVID-19 infection.
- events of interest for vaccines in general (e.g. to the specific vaccine type or adjuvants).
The list of AESIs below takes into consideration the lists of AESIs from these expert groups, manufacturers and regulatory authorities:
The AESI list changes based on the evolving safety profile of vaccines. Although adverse events may occur after being vaccinated with a COVID-19 vaccine, they are not necessarily related to the vaccine. Health Canada and PHAC review the reports to determine whether the vaccine may have played a role.
Up to and including , the most commonly reported AESIs were myocarditis/pericarditis and anaphylaxis (Table 1).
To align with standard reporting practices, for AESIs with a BCD, only those meeting the BCD level of certainty 1 to 3 are reported. BCD level 4 AESIs (indicating not enough information to confirm the diagnosis) are not included in the case counts and rate calculations. BCD level 4 is presented separately in Table 1 this week to highlight the impact of this change.
| AESI Category | AESI | Total |
|---|
*Brighton Collaboration Definition
1 Includes adverse events meeting levels 1-3 of the Brighton Collaboration level of diagnostic certainty.
2 Includes adverse events meeting level 4 of the Brighton Collaboration level of diagnostic certainty.
3 COVID-19 vaccines that are currently authorized in Canada cannot cause an infection because they do not contain the live virus. While they are all highly effective at preventing severe COVID-19 illness and death, no vaccine is 100% effective, and some COVID-19 cases will still occur. For vaccines that have a two-dose regimen, protection begins 14 days after the first dose, and 7 to 14 days after the second dose.
4 WHO guidance on pregnancy related AESIs.
Please note that 1 report represents 1 person and may contain information on more than 1 adverse event of special interest.
Detailed information on safety signals, other safety updates and deaths
These reports do not imply a causal relationship between the vaccine and the adverse event. Some unrelated medical events do occur by chance after immunization, especially when millions of people are being vaccinated.
Thrombosis with thrombocytopenia syndrome
- Thrombosis with thrombocytopenia syndrome (TTS) is characterized as blood clotting with low platelet levels. Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT), also known as Vaccine-Induced Prothrombotic Immune Thrombocytopenia (VIPIT), is characterized as TTS that seems to be vaccine-induced due to the laboratory-confirmed presence of platelet factor (PF) 4 antibodies.
- Numbers and rates have been adjusted following medical review of the data.
- Up to and including June 25, 2021, there were 102 reports of TTS that met level 1 to 3 of the Brighton Collaboration level of diagnostic certainty. Of the TTS reports:
- 63 reports followed vaccination with the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine, 28 followed vaccination with the Pfizer-BioNTech Comirnaty COVID-19 vaccine, and 11 followed vaccination with the Moderna Spikevax COVID-19 vaccine
- Of the 63 TTS reports following the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine:
- symptoms started between 3 hours and 48 days after vaccination
- median age is 57 years (age range 34 to 88 years old)
- 35 were males [median age 58 years (age range 34 to 78 years old)], and 28 were females [median age 55 years (age range 40 to 88 years old)]
- 53 followed the first vaccine dose, and the dose number for 10 were not specified
- 26 had laboratory results showing the presence of platelet factor (PF) 4 antibodies, indicating VITT (also known as VIPIT)
- 6 people died (these deaths are still under investigation)
Guillain-Barré Syndrome
- Up to and including July 9, 2021, 7 reports of GBS following vaccination with AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine met level 1 to 3 of the Brighton Collaboration level of diagnostic certainty. Of the GBS reports:
- The reporting rate of GBS following AstraZeneca/COVISHIELD COVID-19 vaccine is higher than the reporting rate of GBS following the Pfizer BioNTech Comirnaty or the Moderna Spikevax COVID-19 vaccines.
- When the BCD level 4 cases (indicating not enough information to confirm the diagnosis) are removed to align with standard reporting practices, the observed number of reports of GBS following vaccination with AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine is not higher than would normally be expected in the general population. With this adjustment, GBS is no longer a safety signal.
Myocarditis/pericarditis
- Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the lining around the heart.
- Up to and including June 25, 2021, there were 1,059 reports of myocarditis/pericarditis that met levels 1 to 3 of the Brighton Collaboration level of diagnostic certainty. Of the myocarditis/pericarditis reports:
- 635 reports followed vaccination with the Pfizer-BioNTech Comirnaty COVID-19 vaccine, 405 followed vaccination with the Moderna Spikevax COVID-19 vaccine, 17 followed vaccination with the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine and the vaccine name for 2 were not specified
- the reporting rate of myocarditis/pericarditis following vaccination with Moderna Spikevax COVID-19 vaccine is higher than that of the Pfizer-BioNtech Comirnaty COVID-19 vaccine, for all ages and sexes combined
- Among the 635 reports of myocarditis/pericarditis following vaccination with the Pfizer-BioNTech Comirnaty COVID-19 vaccine (administered to those 5 years of age and older):
- symptoms started between 1 minute and 212 days after vaccination
- median age is 23 years (age range 6 to 88 years old)
- 416 were males [median age 20 years (age range 9 to 84 years old)], 195 were females [median age 35 years (age range 6 to 88 years old)], the sex of 1 was 'other', and the sex of 23 were not specified
- 246 reports followed the first vaccine dose, 360 reports followed the second vaccine dose, 21 reports followed the third vaccine dose, and the dose number for 8 were not specified
- current analyses show the number of reports of myocarditis/pericarditis following the Pfizer-BioNTech Comirnaty COVID-19 vaccine is higher than what would be expected in the general population of males and females less than 30 years old and primarily following the second dose
- Among the 405 reports of myocarditis following vaccination with the Moderna Spikevax COVID-19 vaccine (administered to those 6 years of age and older):
- symptoms started between 5 minutes and 68 days after vaccination
- median age is 28 years (age range 14 to 95 years old)
- 309 were males [median age 27 years (age range 14 to 95 years old)], 85 were females [median age 34 years (age range 18 to 76)], the sex of 1 was 'other', and the sex of 10 were not specified
- 76 reports followed the first vaccine dose, 304 reports followed the second vaccine dose, 20 reports followed the third dose, and the dose number for 5 were not specified
- current analyses show the number of reports of myocarditis/pericarditis following the Moderna Spikevax COVID-19 vaccine is higher than what would be expected in the general population, particularly among males and females less than 40 years old and following the second dose
- Evidence is evolving and investigations into the association between myocarditis/pericarditis and mRNA vaccines continue.
Capillary leak syndrome
- Up to and including July 9, 2021, there have been 2 reports of capillary leak syndrome that have been medically reviewed to verify the diagnosis. The events occurred following a first dose of the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine.
Deaths
- Up to and including June 25, 2021, a total of 336 reports with an outcome of death were reported following vaccination. Although these deaths occurred after being vaccinated with a COVID-19 vaccine, they are not necessarily related to the vaccine. Based on the medical case review using the WHO-UMC causality assessment categories, it has been determined that:
- 181 reports of deaths could not be assessed due to insufficient information
- 106 reports of deaths are unlikely linked to a COVID-19 vaccine
- 49 reports of death are still under investigation
Data notes
The data presented in this report are estimates and may not accurately represent national COVID-19 vaccine adverse events following immunization for the following reasons:
- There may be delays in receiving reporting forms and processing reporting forms which may contribute to variations in the amount of reports presented biweekly. These delays may be due to jurisdictions investigating and reviewing each adverse event before submitting the information to PHAC. There are also limitations to reporting practices such as underreporting, missing information, and differing adverse event reporting practices across jurisdictions in Canada.
- Every second week, we update the historical data (biweekly and cumulative number of reports) to include any delayed reporting forms from earlier weeks.
- Information is collected on individuals for whom an report was submitted, not on the total number of individuals who experience an adverse event as not every adverse event is reported.
- New information in this report may not be comprehensive but rather represents preliminary results of data received on a biweekly basis.
- Reporting jurisdictions may refer to gender as opposed to sex.
- Information on COVID-19 vaccine doses administered are obtained from provincial and territorial partners or their websites. More details on the number of COVID-19 vaccine doses administered, please consult the COVID-19 vaccination coverage webpage.
- The data presented in this report represent combined numbers from both CAEFISS and the Canada Vigilance program. Canada Vigilance receives reports directly from vaccine manufacturers, healthcare professionals and consumers. CAEFISS receives reports from regional public health authorities. Although data from these 2 surveillance systems are carefully merged together, the individual programs are subject to different reporting requirements and definitions. It is also possible that the biweekly report contains duplicate reports.
- Adverse events of special interest are assessed according to the Brighton Collaboration level of diagnostic certainty (if available).
- Please note, the adverse event and AESI numbers in Figure 4 and Table 1 may be adjusted following medical case review.
- For adverse events with low counts (less than 10) or incomplete data on doses administered, rates will not be provided.
Acknowledgements
This biweekly report would not be possible without the collaboration of federal, provincial and territorial public health partners as well as everyone taking part in the COVID-19 vaccination rollout in Canada.
We would also like to thank everyone who took the time to submit an adverse event report for their contribution to vaccine safety in Canada.
Suggested citation
Public Health Agency of Canada. Canadian COVID-19 vaccination safety report. Ottawa: Public Health Agency of Canada; May 13, 2022. https://health-infobase.canada.ca/covid-19/vaccine-safety/
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: