Reported side effects following COVID-19 vaccination in Canada

Summary Detailed report Understanding the data Archived reports

This is the last regular posting of Reported side effects following COVID-19 vaccination in Canada. We will no longer be updating this online report. Instead, COVID-19 vaccine safety data will be shared in a surveillance report that will include data on all vaccines approved in Canada. We will provide a link to this new report as soon as it is available. In the meantime, recent reports and technical publications on vaccine safety are available.

This decision was made because the COVID-19 response has evolved from managing a global pandemic to an ongoing health issue and extensive evidence on COVID-19 vaccine safety has been gathered globally.

Robust vaccine safety monitoring efforts continue. If any COVID-19 vaccine safety concerns are detected, we will communicate them promptly.

This page was last updated on January 19, 2024 with data up to and including January 5, 2024.

What you need to know
How to report an adverse event
Reporting trends
Adverse event following immunization reports by vaccine name
Adverse event following immunization reports by age and sex
Most common adverse events reported following immunization
Adverse events of special interest, safety signals and deaths
Acknowledgements, suggested citation, and related links

What you need to know up to and including January 5, 2024

No new safety signals have been identified in Canada

105,016,456

Total doses administered up to and including December 3, 2023

58,712

Total adverse event following immunization reports

(0.056% of all doses administered)

47,010

Total adverse event following immunization reports that were non-serious

(0.045% of all doses administered)

11,702

Total adverse event following immunization reports that were serious

(0.011% of all doses administered)

No new safety signals have been identified during this reporting period.
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 58,712 individual reports (0.056% of all doses administered), 11,702 were considered serious (0.011% of all doses administered).
A total of 105,016,456 vaccine doses have been administered in Canada as of December 3 2023, including 5,694,993 of XBB.1.5 vaccines and 9,948,907 bivalent vaccines. Among all adverse events reports:
- 1,044 were following bivalent vaccines, of which 783 were considered non-serious (0.008% of bivalent vaccine doses administered) and 261 (0.003% of bivalent vaccine doses administered) were considered serious.
- 278 were following XBB.1.5 vaccines, of which 251 were considered non-serious (0.004% of XBB.1.5 vaccine doses administered) and 27 (0.0005% of XBB.1.5 vaccine doses administered) were considered serious.
On July 26, 2023, Health Canada cancelled the Drug Identification Number (DIN) for JCOVDEN (previously Janssen COVID-19 vaccine) at the request of the manufacturer pursuant of the Food and Drug Regulations.
On December 19, 2023, Health Canada cancelled the DIN of Vaxzevria previously (Astrazeneca COVID-19 vaccine) at the request of the manufacturer pursuant of the Food and Drug Regulations.

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.

Reporting trends

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 58,712 reports (55.9 reports per 100,000 doses administered) up to and including January 5, 2024. Of the 58,712 reports, 11,702 were considered serious (11.1 reports per 100,000 doses administered). Overall, the rate of serious reports has remained low. Figure 1 below shows the number and rate of COVID-19 adverse event reports by reporting period, as well as the cumulative number of reports.

Figure 1. Choose a measure: of COVID-19 vaccine adverse event reports received for and total doses administered per reporting period, up to and including January 5, 2024 (n=58,712)

Notes

Quarterly reporting rates are not provided after May 26, 2023, due to data quality issues introduced by the processing of a backlog of reports from jurisdictions.
As of December 3, 2023, some jurisdictions are only submitting data on doses administered for XBB.1.5 vaccines.
A minimum 5-week reporting lag period is used to account for time lags between someone experiencing an adverse event since vaccine administration and the event being reported to CAEFISS or Canada Vigilance. To align the numerator and denominator for rate calculations, we restrict reports to those with a date vaccine administered as of December 3, 2023. This change is due to changes in the provincial and territorial reporting frequency of data on doses administered, and ongoing data improvement initiatives.
Although the cumulative number of adverse event reports continues to increase over time, so does the number of doses administered. Up to and including January 5, 2024 all adverse event reports represented 0.056% of all doses administered.
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.
Information on doses administered by age group was only available starting April 23, 2021 for those aged 12 and older, starting November 27, 2021 for those aged 5 to 11 years, and starting July 17, 2022 for those under the age of 5. Rates of adverse event reports and doses administered by age group are not reported before these dates.

Figure 1: Text Description

Number of COVID-19 adverse event reports received for all people up to and including January 5, 2024 (n=58,712)

Quarterly reporting period	Quarterly non-serious reports - all	Quarterly serious reports - all	Cumulative non-serious reports - all	Cumulative serious reports - all	Cumulative number of doses administered - all¹	Quarterly number of doses administered - all¹	Quarterly non-serious reporting rate - all²	Quarterly serious reporting rate - all²	Quarterly reporting rate - all²	Cumulative non-serious rate - all	Cumulative serious rate - all	Cumulative total rate - all	Quarterly non-serious reports - 18+	Quarterly serious reports - 18+	Cumulative non-serious reports - 18+	Cumulative serious reports - 18+	Cumulative number of doses administered - 18+¹	Quarterly number of doses administered - 18+¹	Quarterly non-serious reporting rate - 18+²	Quarterly serious reporting rate - 18+²	Quarterly reporting rate - 18+²	Cumulative non-serious rate - 18+	Cumulative serious rate - 18+	Cumulative total rate - 18+	Quarterly non-serious reports - 12 to 17	Quarterly serious reports - 12 to 17	Cumulative non-serious reports - 12 to 17	Cumulative serious reports - 12 to 17	Cumulative number of doses administered - 12 to 17¹	Quarterly number of doses administered - 12 to 17¹	Quarterly non-serious reporting rate - 12 to 17²	Quarterly serious reporting rate - 12 to 17²	Quarterly reporting rate - 12 to 17²	Cumulative non-serious rate - 12 to 17	Cumulative serious rate - 12 to 17	Cumulative total rate - 12 to 17	Quarterly non-serious reports - 5 to 11	Quarterly serious reports - 5 to 11	Cumulative non-serious reports - 5 to 11	Cumulative serious reports - 5 to 11	Cumulative number of doses administered - 5 to 11¹	Quarterly number of doses administered - 5 to 11¹	Quarterly non-serious reporting rate - 5 to 11²	Quarterly serious reporting rate - 5 to 11²	Quarterly reporting rate - 5 to 11²	Cumulative non-serious rate - 5 to 11	Cumulative serious rate - 5 to 11	Cumulative total rate - 5 to 11	Quarterly non-serious reports - 0 to 4	Quarterly serious reports - 0 to 4	Cumulative non-serious reports - 0 to 4	Cumulative serious reports - 0 to 4	Cumulative number of doses administered - 0 to 4¹	Quarterly number of doses administered - 0 to 4¹	Quarterly non-serious reporting rate - 0 to 4²	Quarterly serious reporting rate - 0 to 4²	Quarterly reporting rate - 0 to 4²	Cumulative non-serious rate - 0 to 4	Cumulative serious rate - 0 to 4	Cumulative total rate - 0 to 4
05-Feb-21	606	149	606	149	82,512	82,512	N/A	N/A	N/A	N/A	N/A	N/A	605	122	605	122	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	0	1	0	1	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
28-May-21	7,639	2,024	8,245	2,173	12,168,261	12,085,749	63.21	16.75	79.95	67.76	17.86	85.62	7,599	1,779	8,204	1,901	12,139,192	12,139,192	62.60	14.66	77.25	67.58	15.66	83.24	15	6	15	7	17,172	17,172	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
20-Aug-21	12,466	2,702	20,711	4,875	45,599,060	33,430,799	37.29	8.08	45.37	45.42	10.69	56.11	11,977	2,445	20,181	4,346	43,216,285	31,077,093	38.54	7.87	46.41	46.70	10.06	56.75	478	116	493	123	2,344,480	2,327,308	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
12-Nov-21	8,451	1,901	29,162	6,776	56,910,322	11,311,262	74.71	16.81	91.52	51.24	11.91	63.15	7,994	1,641	28,175	5,987	52,792,626	52,792,626	15.14	3.11	18.25	53.37	11.34	64.71	428	128	921	251	3,996,925	3,996,925	10.71	3.20	13.91	23.04	6.28	29.32	N/A	N/A	N/A	N/A	15,456	15,456	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
04-Feb-22	5,882	1,391	35,044	8,167	68,539,708	11,629,386	50.58	11.96	62.54	51.13	11.92	63.05	5,466	1,192	33,641	7,179	62,731,442	9,938,816	55	11.99	66.99	53.63	11.44	65.07	161	41	1,082	292	4,357,657	360,732	44.63	11.37	56	24.83	6.70	31.53	259	50	259	50	1,436,482	1,421,026	18.23	3.52	21.74	18.03	3.48	21.51	3	0	3	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
27-May-22	4,932	1,089	39,976	9,256	82,687,295	14,147,587	34.86	7.70	42.56	48.35	11.19	59.54	4,492	895	38,133	8,074	74,715,815	11,984,373	37.48	7.47	44.95	51.04	10.81	61.84	143	56	1,225	348	4,904,279	546,622	26.16	10.24	36.41	24.98	7.10	32.07	288	34	547	84	3,001,801	1,565,319	18.40	2.17	20.57	18.22	2.80	21.02	1	0	4	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
19-Aug-22	1,350	485	41,326	9,741	86,218,467	3,531,172	38.23	13.73	51.97	47.93	11.30	59.23	1,253	396	39,386	8,470	78,019,705	3,303,890	37.92	11.99	49.91	50.48	10.86	61.34	34	8	1,259	356	5,002,038	97,759	34.78	8.18	42.96	25.17	7.12	32.29	52	15	599	99	3,134,820	133,019	39.09	11.28	50.37	19.11	3.16	22.27	4	0	8	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
09-Dec-22	1,612	658	42,938	10,399	93,343,515	7,125,048	22.62	9.24	31.86	46	11.14	57.14	1,421	424	40,807	8,894	84,565,448	6,545,743	21.71	6.48	28.19	48.25	10.52	58.77	58	7	1,317	363	5,156,763	154,725	37.49	4.52	42.01	25.54	7.04	32.58	56	11	655	110	3,362,470	227,650	24.60	4.83	29.43	19.48	3.27	22.75	71	7	79	7	238,429	194,119	36.58	3.61	40.18	33.13	2.94	36.07
03-Mar-23	890	307	43,828	10,706	97,199,533	3,856,018	23.08	7.96	31.04	45.09	11.01	56.11	787	244	41,594	9,138	88,052,716	3,487,268	22.57	7	29.56	47.24	10.38	57.62	32	12	1,349	375	5,294,639	137,876	23.21	8.70	31.91	25.48	7.08	32.56	24	4	679	114	3,472,657	110,187	21.78	3.63	25.41	19.55	3.28	22.84	26	0	105	7	268,617	30,188	86.13	0	86.13	39.09	2.61	41.70
26-May-23	318	203	44,146	10,909	98,094,051	894,518	35.55	22.69	58.24	45	11.12	56.12	263	162	41,857	9,300	88,861,625	808,909	32.51	20.03	52.54	47.10	10.47	57.57	18	4	1,367	379	5,315,605	20,966	85.85	19.08	104.93	25.72	7.13	32.85	11	1	690	115	3,496,461	23,804	46.21	4.20	50.41	19.73	3.29	23.02	16	1	121	8	295,447	26,830	59.63	3.73	63.36	40.95	2.71	43.66
15-Sep-23	2,336	337	46,482	11,246	98,948,662	854,611	N/A	N/A	N/A	46.94	11.36	58.29	2,199	289	44,056	9,589	89,692,635	831,010	N/A	N/A	N/A	49.12	10.69	59.81	78	14	1,445	393	5,321,330	5,725	N/A	N/A	N/A	27.15	7.39	34.54	45	1	735	116	3,503,091	6,630	N/A	N/A	N/A	20.98	3.31	24.29	13	4	134	12	342,512	47,065	N/A	N/A	N/A	39.12	3.50	42.63
05-Jan-24	528	456	47,010	11,702	105,016,456	6,067,794	N/A	N/A	N/A	44.76	11.14	55.91	464	330	44,520	9,919	95,431,101	5,738,466	N/A	N/A	N/A	46.65	10.39	57.05	18	41	1,463	434	5,445,268	123,938	N/A	N/A	N/A	26.87	7.97	34.84	17	5	752	121	3,613,703	110,612	N/A	N/A	N/A	20.81	3.35	24.16	23	0	157	12	416,566	74,054	N/A	N/A	N/A	37.69	2.88	40.57

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.
Higher rates of non-serious adverse event reports are observed for each vaccine. Serious report rates remain low. Currently, rates of adverse event reports following the first dose are higher than after subsequent doses.
The data for subsequent 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.
A total of 105,016,456 vaccine doses have been administered in Canada as of January 5, 2024, including 5,694,993 vaccine doses with the XBB.1.5 strain and 9,948,907 bivalent doses. Among all adverse event reports:
- 1,044 were following bivalent vaccines, of which 783 were considered non-serious (0.008% of bivalent vaccine doses administered) and 261 (0.003% of bivalent vaccine doses administered) were considered serious.
- 278 were following XBB.1.5 vaccines, of which 251 were considered non-serious (0.004% of XBB.1.5 vaccine doses administered) and 27 (0.0005% of XBB.1.5 vaccine doses administered) were considered serious.
544 of the 58,712 COVID-19 adverse event reports (0.93%), involved people who received an influenza vaccine and a COVID-19 vaccine on the same day. These events have been closely monitored, and no new safety concerns have been identified.

Figure 2. Choose a measure: of adverse event reports received for by vaccine name and up to and including January 5, 2024 (n=59,174)

Notes

An asterisk (^*) indicates a vaccine product that is no longer authorized.
As of December 3, 2023, some jurisdictions are only submitting data on doses administered for XBB.1.5 vaccines.
The "all doses" / total option includes reports that did not specify dose number.
A minimum 5-week reporting lag period is used to account for time lags between someone experiencing an adverse event since vaccine administration and the event being reported to CAEFISS or Canada Vigilance. To align the numerator and denominator for rate calculations, we restrict reports to those with a date vaccine administered as of June 18, 2023. This change is due to changes in the provincial and territorial reporting frequency of data on doses administered, and ongoing data improvement initiatives.

Figure 2: Text Description

Number and rate (per 100,000 doses administered) of adverse event reports received for all people by vaccine name and dose number, up to and including January 5, 2024 (n=54,843)

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	Non-serious reports-0to4²	Serious reports-0to4²	Total reports-0to4²	Non-serious reporting rate-0to4³	Serious reporting rate-0to4³	Total reporting rate-0to4³	Total number of doses administered-0to4
Pfizer-BioNTech Comirnaty (Total)¹	26,177	7,739	33,916	43.03	12.72	55.76	60,827,463	23,951	6,428	30,379	45.85	12.30	58.15	52,242,976	1,419	418	1,837	28.06	8.27	36.33	5,057,066	744	118	862	21.64	3.43	25.08	3,437,563	14	0	14	35.44	N/A	35.44	39,506
Pfizer-BioNTech Comirnaty (Dose 1)	15,684	3,438	19,122	65.38	14.33	79.71	23,990,549	14,360	2,997	17,357	72.42	15.11	87.53	19,828,816	799	164	963	35.04	7.19	42.24	2,280,010	497	60	557	27.10	3.27	30.37	1,833,788	10	0	10	42.66	N/A	42.66	23,440
Pfizer-BioNTech Comirnaty (Dose 2)	7,541	2,491	10,032	34.45	11.38	45.83	21,891,064	6,810	2,068	8,878	37.32	11.33	48.65	18,247,393	501	211	712	22.66	9.54	32.21	2,210,607	213	39	252	15.21	2.79	18	1,400,292	4	0	4	N/A	N/A	N/A	11,715
Pfizer-BioNTech Comirnaty (Dose 3)	1,706	805	2,511	15.48	7.31	22.79	11,019,119	1,613	598	2,211	15.73	5.83	21.56	10,254,826	71	21	92	12.85	3.80	16.65	552,406	18	7	25	8.88	N/A	12.33	202,815	0	0	0	N/A	N/A	N/A	4,344
Pfizer-BioNTech Comirnaty (Dose 4+)	317	259	576	8.07	6.60	14.67	3,926,731	315	237	552	8.05	6.06	14.11	3,911,941	0	3	3	N/A	N/A	N/A	14,043	0	0	0	N/A	N/A	N/A	668	0	0	0	N/A	N/A	N/A	7
Pfizer-BioNTech Comirnaty (Original and Omicron BA.4/BA.5) Bivalent (Total)¹	368	164	532	6.55	2.92	9.47	5,615,222	346	139	485	6.47	2.60	9.07	5,349,627	19	5	24	8.77	N/A	11.08	216,565	2	0	2	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Pfizer-BioNTech Comirnaty (Original and Omicron BA.4/BA.5) Bivalent (Dose 1)	14	6	20	28.68	N/A	40.98	48,810	13	5	18	28.84	N/A	39.93	45,081	0	0	0	N/A	N/A	N/A	2,172	1	0	1	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Pfizer-BioNTech Comirnaty (Original and Omicron BA.4/BA.5) Bivalent (Dose 2)	1	4	5	N/A	N/A	N/A	17,442	1	2	3	N/A	N/A	N/A	14,725	0	1	1	N/A	N/A	N/A	1,209	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Pfizer-BioNTech Comirnaty (Original and Omicron BA.4/BA.5) Bivalent (Dose 3)	31	10	41	9.04	2.91	11.95	343,062	24	6	30	10.57	N/A	13.21	227,034	7	0	7	N/A	N/A	N/A	77,821	1	0	1	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Pfizer-BioNTech Comirnaty (Original and Omicron BA.4/BA.5) Bivalent (Dose 4+)	307	129	436	5.90	2.48	8.38	5,205,908	294	114	408	5.81	2.25	8.06	5,062,787	11	4	15	8.13	N/A	11.08	135,363	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Comirnaty Omicron XBB.1.5 (Total)¹	98	35	133	3.45	1.23	4.68	2,843,047	92	30	122	3.36	1.10	4.46	2,737,737	3	2	5	N/A	N/A	N/A	81,107	1	1	2	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Comirnaty Omicron XBB.1.5 (Dose 1)	7	30	37	N/A	11.26	13.89	266,402	5	25	30	N/A	9.85	11.82	253,702	0	2	2	N/A	N/A	N/A	10,267	0	1	1	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Comirnaty Omicron XBB.1.5 (Dose 2)	0	0	0	N/A	N/A	N/A	11,568	0	0	0	N/A	N/A	N/A	9,930	0	0	0	N/A	N/A	N/A	544	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Comirnaty Omicron XBB.1.5 (Dose 3)	2	0	2	N/A	N/A	N/A	48,605	1	0	1	N/A	N/A	N/A	32,274	0	0	0	N/A	N/A	N/A	8,823	1	0	1	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Comirnaty Omicron XBB.1.5 (Dose 4+)	69	5	74	2.74	N/A	2.94	2,516,472	66	5	71	2.70	N/A	2.91	2,441,831	3	0	3	N/A	N/A	N/A	61,473	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Total)¹	15,900	2,391	18,291	62.12	9.34	71.47	25,594,019	15,722	2,122	17,844	62.34	8.41	70.75	25,219,975	16	9	25	32.78	N/A	51.23	48,803	2	0	2	N/A	N/A	N/A	N/A	126	12	138	41.01	3.91	44.92	307,242
Moderna Spikevax (Dose 1)	8,519	760	9,279	136.33	12.16	148.49	6,248,823	8,397	688	9,085	139.31	11.41	150.73	6,027,512	14	1	15	59.47	N/A	63.72	23,540	1	0	1	N/A	N/A	N/A	N/A	96	10	106	50.50	5.26	55.76	190,109
Moderna Spikevax (Dose 2)	4,410	931	5,341	50.39	10.64	61.02	8,752,551	4,374	819	5,193	50.82	9.52	60.33	8,607,052	2	6	8	N/A	N/A	N/A	18,819	1	0	1	N/A	N/A	N/A	N/A	28	2	30	23.97	N/A	25.68	116,818
Moderna Spikevax (Dose 3)	2,058	340	2,398	24.51	4.05	28.56	8,395,660	2,052	312	2,364	24.46	3.72	28.18	8,388,793	0	1	1	N/A	N/A	N/A	6,123	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	307
Moderna Spikevax (Dose 4+)	319	137	456	14.52	6.24	20.76	2,196,985	316	124	440	14.39	5.65	20.03	2,196,618	0	1	1	N/A	N/A	N/A	321	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	8
Moderna Spikevax (Original and Omicron BA.1) Bivalent (Total)¹	351	69	420	8.64	1.70	10.34	4,060,577	350	57	407	8.63	1.41	10.04	4,055,577	0	0	0	N/A	N/A	N/A	3,852	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.1) Bivalent (Dose 1)	10	4	14	53.98	N/A	75.57	18,527	10	4	14	55.80	N/A	78.13	17,920	0	0	0	N/A	N/A	N/A	84	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.1) Bivalent (Dose 2)	3	0	3	N/A	N/A	N/A	7,123	3	0	3	N/A	N/A	N/A	6,635	0	0	0	N/A	N/A	N/A	51	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.1) Bivalent (Dose 3)	13	4	17	9.70	N/A	12.69	133,975	13	3	16	9.81	N/A	12.07	132,529	0	0	0	N/A	N/A	N/A	1,285	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.1) Bivalent (Dose 4+)	315	43	358	8.07	1.10	9.18	3,900,952	315	39	354	8.08	1	9.08	3,898,493	0	0	0	N/A	N/A	N/A	2,432	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.4/5) Bivalent (Total)¹	64	28	92	23.43	10.25	33.69	273,108	53	20	73	19.70	7.43	27.13	269,103	0	0	0	N/A	N/A	N/A	125	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.4/5) Bivalent (Dose 1)	1	5	6	N/A	N/A	N/A	3,046	1	5	6	N/A	N/A	N/A	1,182	0	0	0	N/A	N/A	N/A	10	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.4/5) Bivalent (Dose 2)	1	0	1	N/A	N/A	N/A	2,102	1	0	1	N/A	N/A	N/A	583	0	0	0	N/A	N/A	N/A	0	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.4/5) Bivalent (Dose 3)	0	2	2	N/A	N/A	N/A	5,228	0	1	1	N/A	N/A	N/A	4,721	0	0	0	N/A	N/A	N/A	41	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Moderna Spikevax (Original and Omicron BA.4/5) Bivalent (Dose 4+)	48	12	60	18.27	4.57	22.84	262,732	48	11	59	18.28	4.19	22.47	262,617	0	0	0	N/A	N/A	N/A	74	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Spikevax XBB.1.5 (Total)¹	167	29	196	5.83	1.01	6.84	2,864,357	143	27	170	5.36	1.01	6.37	2,667,140	3	0	3	N/A	N/A	N/A	36,624	4	1	5	N/A	N/A	N/A	N/A	16	0	16	25.09	N/A	25.09	63,783
Spikevax XBB.1.5 (Dose 1)	26	7	33	5.66	N/A	7.18	459,322	18	5	23	4.50	N/A	5.76	399,623	0	0	0	N/A	N/A	N/A	10,790	1	1	2	N/A	N/A	N/A	N/A	6	0	6	N/A	N/A	N/A	25,307
Spikevax XBB.1.5 (Dose 2)	4	0	4	N/A	N/A	N/A	20,889	0	0	0	N/A	N/A	N/A	8,142	0	0	0	N/A	N/A	N/A	286	1	0	1	N/A	N/A	N/A	N/A	3	0	3	N/A	N/A	N/A	8,343
Spikevax XBB.1.5 (Dose 3)	9	0	9	N/A	N/A	N/A	87,320	2	0	2	N/A	N/A	N/A	29,682	0	0	0	N/A	N/A	N/A	4,457	0	0	0	N/A	N/A	N/A	N/A	7	0	7	N/A	N/A	N/A	29,685
Spikevax XBB.1.5 (Dose 4+)	107	18	125	4.66	0.78	5.44	2,296,826	102	18	120	4.57	0.81	5.38	2,229,693	3	0	3	N/A	N/A	N/A	21,091	2	0	2	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	448
AstraZeneca Vaxzevria/COVISHIELD (Total)¹	3,712	1,006	4,718	132.01	35.78	167.79	2,811,892	3,706	895	4,601	131.81	31.83	163.64	2,811,627	0	0	0	N/A	N/A	N/A	86	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
AstraZeneca Vaxzevria/COVISHIELD (Dose 1)	3,318	618	3,936	148.53	27.66	176.19	2,233,943	3,317	579	3,896	148.50	25.92	174.42	2,233,734	0	0	0	N/A	N/A	N/A	80	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
AstraZeneca Vaxzevria/COVISHIELD (Dose 2)	214	122	336	37.15	21.18	58.32	576,120	210	110	320	36.45	19.10	55.55	576,064	0	0	0	N/A	N/A	N/A	6	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
AstraZeneca Vaxzevria/COVISHIELD (Dose 3)	1	15	16	N/A	837.05	892.86	1,792	1	13	14	N/A	725.45	781.25	1,792	0	0	0	N/A	N/A	N/A	0	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
AstraZeneca Vaxzevria/COVISHIELD (Dose 4+)	1	8	9	N/A	N/A	N/A	37	1	8	9	N/A	N/A	N/A	37	0	0	0	N/A	N/A	N/A	0	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Janssen JCOVDEN (Total)¹	48	40	88	201.24	167.70	368.94	23,852	46	34	80	193.10	142.73	335.82	23,822	0	0	0	N/A	N/A	N/A	13	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Janssen JCOVDEN (Dose 1)	37	22	59	161.18	95.84	257.01	22,956	37	19	56	161.37	82.86	244.23	22,929	0	0	0	N/A	N/A	N/A	11	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Janssen JCOVDEN (Dose 2)	5	2	7	N/A	N/A	N/A	578	5	1	6	N/A	N/A	N/A	577	0	0	0	N/A	N/A	N/A	0	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Janssen JCOVDEN (Dose 3)	1	3	4	N/A	N/A	N/A	262	1	3	4	N/A	N/A	N/A	261	0	0	0	N/A	N/A	N/A	1	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Janssen JCOVDEN (Dose 4+)	0	3	3	N/A	N/A	N/A	56	0	3	3	N/A	N/A	N/A	55	0	0	0	N/A	N/A	N/A	1	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Novavax Nuvaxovid (Total)¹	46	11	57	127.38	30.46	157.84	36,112	46	8	54	128	N/A	150.26	35,938	0	0	0	N/A	N/A	N/A	106	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Novavax Nuvaxovid (Dose 1)	24	4	28	202.14	N/A	235.83	11,873	24	4	28	203.25	N/A	237.13	11,808	0	0	0	N/A	N/A	N/A	39	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Novavax Nuvaxovid (Dose 2)	16	2	18	143.45	N/A	161.38	11,154	16	2	18	143.96	N/A	161.96	11,114	0	0	0	N/A	N/A	N/A	28	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Novavax Nuvaxovid (Dose 3)	1	1	2	N/A	N/A	N/A	2,866	1	1	2	N/A	N/A	N/A	2,838	0	0	0	N/A	N/A	N/A	12	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Novavax Nuvaxovid (Dose 4+)	4	0	4	N/A	N/A	N/A	10,219	4	0	4	N/A	N/A	N/A	10,178	0	0	0	N/A	N/A	N/A	27	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Unknown vaccine (Total)¹	90	641	731	N/A	N/A	N/A	N/A	69	535	604	N/A	N/A	N/A	N/A	3	10	13	N/A	N/A	N/A	N/A	0	2	2	N/A	N/A	N/A	N/A	1	0	1	N/A	N/A	N/A	N/A
Unknown vaccine (Dose 1)	21	75	96	N/A	N/A	N/A	N/A	15	62	77	N/A	N/A	N/A	N/A	1	0	1	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Unknown vaccine (Dose 2)	13	146	159	N/A	N/A	N/A	N/A	12	104	116	N/A	N/A	N/A	N/A	1	8	9	N/A	N/A	N/A	N/A	0	2	2	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Unknown vaccine (Dose 3)	9	66	75	N/A	N/A	N/A	N/A	6	49	55	N/A	N/A	N/A	N/A	1	1	2	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A
Unknown vaccine (Dose 4+)	7	94	101	N/A	N/A	N/A	N/A	7	90	97	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A	0	0	0	N/A	N/A	N/A	N/A

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

Age differences

The rate of adverse event reports was highest among the 40 to 49 year age group (84.6 reports per 100,000 doses administered), followed by those in the 30 to 39 year age group (72.3 reports per 100,000 doses administered).
The rate of adverse event reports was lowest in the 5 to 11 year age group.

Sex differences

Overall, most adverse event reports were from females (72.4%). The reporting rate for females was 75.9 reports per 100,000 doses administered, compared to 31.5 per 100,000 doses administered for males. However, within the youngest age groups (<18 years of age) the reporting rate is similar in males and females, or slightly higher in males.
- This may be due to differences in health care seeking behaviour (for example, reporting adverse events) as well as 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, Israel, 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 received by up to and including January 5, 2024 (n=58,712)

Notes

As of December 3, 2023, some jurisdictions are only submitting data on doses administered for XBB.1.5 vaccines.
A minimum 5-week reporting lag period is used to account for time lags between someone experiencing an adverse event since vaccine administration and the event being reported to CAEFISS or Canada Vigilance. To align the numerator and denominator for rate calculations, we restrict reports to those with a date vaccine administered as of December 3, 2023. This change is due to changes in the provincial and territorial reporting frequency of data on doses administered, and ongoing data improvement initiatives.

Figure 3: Text Description

Number and rate (per 100,000 doses administered) of adverse event reports received by age group and sex up to and including January 5, 2024 (n=58,712)

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
0 to 4	169	82	79	1	7	416,566	213,409	202,980	416,389	40.57	38.42	38.92	38.67
5 to 11	873	431	423	1	18	3,613,703	1,841,588	1,769,690	3,611,278	24.16	23.40	23.90	23.65
12 to 17	1,897	970	899	6	22	5,445,268	2,744,991	2,695,028	5,440,019	34.84	35.34	33.36	34.36
18 to 29	6,980	2,460	4,400	17	103	13,482,841	6,600,340	6,857,610	13,457,950	51.77	37.27	64.16	50.97
30 to 39	9,504	2,345	7,024	8	127	13,146,961	6,359,745	6,771,366	13,131,111	72.29	36.87	103.73	71.35
40 to 49	11,072	2,450	8,506	12	104	13,084,416	6,292,532	6,781,486	13,074,018	84.62	38.94	125.43	83.80
50 to 59	10,705	2,445	8,114	9	137	15,344,707	7,391,719	7,942,766	15,334,485	69.76	33.08	102.16	68.86
60 to 69	8,600	2,215	6,252	8	125	18,226,891	8,721,784	9,496,366	18,218,150	47.18	25.40	65.84	46.48
70 to 79	5,119	1,461	3,576	5	77	14,149,145	6,706,074	7,437,090	14,143,164	36.18	21.79	48.08	35.61
80+	2,459	650	1,768	1	40	7,996,140	3,277,442	4,707,834	7,985,276	30.75	19.83	37.55	30.28
Unknown	1,334	289	493	1	540	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

¹Reports not identified as male or female were removed due to small numbers.

²Reporting rate per 100,000 doses administered.

Most common adverse events reported following immunization

The 58,712 individual reports represent 58,712 people who reported 1 or more adverse events. Among the 58,712 reports, the most frequently reported adverse events are presented in Figure 4. Most of these adverse events are non-serious and are captured in the product monographs.
The most common report adverse event for all COVID-19 vaccines combined was paraesthesia with a rate of 7.64 per 100,000 doses administered.

Figure 4. of the most frequently reported adverse events by vaccine type () up to and including January 5, 2024 (n=150,208)

Notes

An asterisk (^*) indicates a vaccine product that is no longer authorized.
As of December 3, 2023, some jurisdictions are only submitting data on doses administered for XBB.1.5 vaccines.
Please note that 1 report represents 1 person and may contain information on more than 1 adverse event.
A minimum 5-week reporting lag period is used to account for time lags between someone experiencing an adverse event since vaccine administration and the event being reported to CAEFISS or Canada Vigilance. To align the numerator and denominator for rate calculations, we restrict reports to those with a date vaccine administered as of December 3, 2023. This change is due to changes in the provincial and territorial reporting frequency of data on doses administered, and ongoing data improvement initiatives.

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 January 5, 2024 (n=150,208)

Most frequently reported events¹	Number of Pfizer-BioNTech Comirnaty events	Number of Pfizer-BioNTech Comirnaty Bivalent (Original/Omicron BA.4/BA.5) events	Number of Moderna Spikevax events	Number of Moderna Spikevax (Original/OmicronBA.1) Bivalent events	Number of Moderna Spikevax (Original/OmicronBA.4/5) Bivalent events	Number of AstraZeneca Vaxzevria/COVISHIELD events	Number of Janssen JCOVDEN events	Number of Novavax Nuvaxovid events	Number of Unspecified events	Total number of events	Rate of Pfizer-BioNTech Comirnaty events (per 100,000 doses administered)	Rate of Pfizer-BioNTech Comirnaty Bivalent (Original/Omicron BA.4/BA.5) events (per 100,000 doses administered)	Rate of Moderna Spikevax events (per 100,000 doses administered)	Rate of Moderna Spikevax (Original/OmicronBA.1) Bivalent 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)
Paraesthesia (tingling and prickling)	5,069	59	1,990	48	3	772	18	15	22	8,027	8.33	1.05	7.78	1.18	27.45	75.47	7.64
Vaccination site pain	3,296	63	3,644	58	16	609	6	5	39	7,780	5.42	1.12	14.24	1.43	21.66	N/A	7.41
Headache	3,708	34	1,840	40	1	1,212	10	8	74	6,916	6.10	0.61	7.19	0.99	43.10	41.93	6.59
Dyspnoea (laboured breathing)	4,173	48	1,889	33	4	459	7	9	89	6,690	6.86	0.85	7.38	0.81	16.32	N/A	6.37
Pruritus (itching)	3,922	60	2,091	68	8	393	14	15	24	6,638	6.45	1.07	8.17	1.67	13.98	58.70	6.32
Fatigue	3,620	30	1,891	35	2	722	9	6	123	6,421	5.95	0.53	7.39	0.86	25.68	N/A	6.11
Chest pain	3,741	31	1,684	22	3	243	10	9	60	5,764	6.15	0.55	6.58	0.54	8.64	41.93	5.49
Urticaria (hives)	2,953	42	1,609	54	8	285	7	3	10	4,998	4.85	0.75	6.29	1.33	10.14	N/A	4.76
Hypoaesthesia (numbness)	2,971	37	1,110	27	5	516	5	8	32	4,717	4.88	0.66	4.34	0.66	18.35	N/A	4.49
Dizziness	2,885	44	1,247	31	4	411	7	9	52	4,689	4.74	0.78	4.87	0.76	14.62	N/A	4.47
Fever ≥ 38°C	2,216	26	1,596	23	3	737	6	5	55	4,668	3.64	0.46	6.24	0.57	26.21	N/A	4.45
Nausea	2,585	41	1,344	30	3	489	11	5	51	4,559	4.25	0.73	5.25	0.74	17.39	46.12	4.34
Vaccination site erythema (redness)	1,049	25	3,017	24	10	294	4	0	10	4,466	1.72	0.45	11.79	0.59	10.46	N/A	4.25
Vaccination site swelling	1,088	17	2,421	23	6	263	4	0	7	3,859	1.79	0.30	9.46	0.57	9.35	N/A	3.67
Chest discomfort	2,436	23	1,083	21	3	199	3	11	26	3,799	4.00	0.41	4.23	0.52	7.08	N/A	3.62
Erythema (redness)	2,148	34	1,182	28	2	276	6	5	15	3,715	3.53	0.61	4.62	0.69	9.82	N/A	3.54
Pain	1,849	25	924	20	3	400	4	4	82	3,312	3.04	0.45	3.61	0.49	14.23	N/A	3.15
Palpitations	2,170	24	891	13	3	108	2	4	21	3,228	3.57	0.43	3.48	0.32	3.84	N/A	3.07
Arthralgia (joint pain)	1,842	27	838	24	2	323	3	4	55	3,115	3.03	0.48	3.27	0.59	11.49	N/A	2.97
Rash generalized (non-allergic)	1,728	28	988	34	2	212	7	7	0	3,029	2.84	0.50	3.86	0.84	7.54	N/A	2.88
Swollen lymph nodes	1,853	26	942	10	3	115	0	4	5	2,954	3.05	0.46	3.68	0.25	4.09	N/A	2.81
Vomiting	1,532	20	865	13	1	288	5	2	27	2,761	2.52	0.36	3.38	0.32	10.24	N/A	2.63
Chills	1,185	9	834	22	3	526	9	4	18	2,602	1.95	N/A	3.26	0.54	18.71	N/A	2.48
Rash	1,514	20	793	19	5	197	6	2	30	2,595	2.49	0.36	3.10	0.47	7.01	N/A	2.47
Diarrhea	1,455	22	740	18	3	287	4	4	44	2,584	2.39	0.39	2.89	0.44	10.21	N/A	2.46
Vaccination site warmth	505	16	1,768	15	4	185	1	0	3	2,517	0.83	0.28	6.91	0.37	6.58	N/A	2.40
Pain in extremity	1,461	23	580	10	0	392	6	3	61	2,514	2.40	0.41	2.27	0.25	13.94	N/A	2.39
Myalgia (muscle pain)	1,154	15	726	16	3	352	3	3	20	2,282	1.90	0.27	2.84	0.39	12.52	N/A	2.17
Asthenia (weakness)	1,248	15	602	20	2	211	5	2	42	2,143	2.05	0.27	2.35	0.49	7.50	N/A	2.04
Vaccination site pruritus (itching)	453	8	1,340	4	3	97	0	0	3	1,923	0.74	N/A	5.24	N/A	3.45	N/A	1.83
Throat tightness	1,216	10	417	11	0	68	8	5	2	1,743	2.00	0.18	1.63	0.27	2.42	N/A	1.66
Tachycardia (fast heartbeat)	1,071	18	493	10	1	101	5	4	7	1,716	1.76	0.32	1.93	0.25	3.59	N/A	1.63
Cough	962	6	429	14	1	93	4	1	45	1,544	1.58	N/A	1.68	0.34	3.31	N/A	1.47
Abdominal pain	885	10	343	16	1	168	6	1	47	1,480	1.45	0.18	1.34	0.39	5.97	N/A	1.41
Malaise (discomfort)	800	20	422	11	3	162	1	2	54	1,465	1.32	0.36	1.65	0.27	5.76	N/A	1.40
Dysphagia (difficulty swallowing)	959	11	335	2	2	69	3	2	2	1,392	1.58	0.20	1.31	N/A	2.45	N/A	1.33
Swelling face	892	14	335	12	0	76	0	0	6	1,336	1.47	0.25	1.31	0.30	2.70	N/A	1.27
Peripheral swelling	724	11	340	11	0	168	1	2	45	1,294	1.19	0.20	1.33	0.27	5.97	N/A	1.23
Vaccination site rash	364	8	799	5	1	66	2	0	2	1,255	0.60	N/A	3.12	N/A	2.35	N/A	1.20
Feeling hot	761	8	355	6	0	100	2	0	8	1,241	1.25	N/A	1.39	N/A	3.56	N/A	1.18
Myocarditis²/pericarditis	725	5	465	4	1	18	1	1	8	1,231	1.19	N/A	1.82	N/A	0.64	N/A	1.17
Vaccination site cellulitis	137	10	894	7	2	116	0	0	2	1,184	0.23	0.18	3.49	N/A	4.13	N/A	1.13
Hyperhidrosis (excessive sweating)	656	5	345	10	1	104	4	1	17	1,142	1.08	N/A	1.35	0.25	3.70	N/A	1.09
Burning sensation	672	9	294	7	0	90	1	1	6	1,082	1.10	N/A	1.15	N/A	3.20	N/A	1.03
Hypertension	699	7	228	12	0	103	0	2	10	1,058	1.15	N/A	0.89	0.30	3.66	N/A	1.01
Hypersensitivity	577	6	325	6	0	72	0	1	14	1,017	0.95	N/A	1.27	N/A	2.56	N/A	0.97
Oropharyngeal pain	611	3	276	6	1	63	4	0	21	981	1.00	N/A	1.08	N/A	2.24	N/A	0.93
Lip swelling	647	6	247	3	0	58	3	1	1	968	1.06	N/A	0.97	N/A	2.06	N/A	0.92
Swollen tongue	626	4	242	3	0	49	2	0	1	930	1.03	N/A	0.95	N/A	1.74	N/A	0.89
Cardiac arrhythmias	539	10	269	14	1	44	1	1	0	884	0.89	0.18	1.05	0.34	1.56	N/A	0.84

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, safety signals, and deaths

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 January 5, 2024, the most commonly reported AESI was myocarditis/pericarditis (Table 1).

To align with standard reporting practices, for AESIs with a Brighton Collaboration case definition (BCCD), only those meeting the BCCD level of certainty 1 to 3 are reported. BCCD level 4 AESIs (indicating not enough information to confirm the diagnosis) are not included in the number of reports and rate calculations for the table below.

Table 1. of reported adverse events of special interest by vaccine type () up to and including January 5, 2024 (n=6,781).
AESI Category	AESI	Total number of events
Auto-immune diseases	Guillain-Barré Syndrome¹	24
	Thrombocytopenia (low blood platelets)¹	204
	Subtotal	228
Cardiovascular system	Cardiac arrest	63
	Cardiac failure	106
	Myocardial infarction (heart attack)	160
	Myocarditis/Pericarditis¹ (inflammation of the heart muscle and lining around the heart)	1,231
	Subtotal	1,560
Circulatory system	Cerebral venous (sinus) thrombosis	35
	Cerebral thrombosis	19
	Cutaneous vasculitis	53
	Deep vein thrombosis	411
	Embolism	24
	Haemorrhage (bleeding)	323
	Pulmonary embolism	589
	Thrombosis (blood clot)	380
	Thrombosis with thrombocytopenia syndrome (blood clot with low platelets)¹	89
	Subtotal	1,923
Hepato-gastrointestinal and renal system	Acute kidney injury	82
	Glomerulonephritis (kidney inflammation) and nephrotic syndrome (kidney disorder)	27
	Liver injury	40
	Subtotal	149
Nerves and central nervous system	Bell's Palsy¹/facial paralysis	216
	Cerebrovascular accident (stroke – includes ischemic and hemorrhagic strokes)	306
	Transverse myelitis (inflammation of spinal cord)¹	24
	Subtotal	546
Other system	Anaphylaxis¹	777
	COVID-19²	1,360
	Multisystem inflammatory syndrome¹	24
	Subtotal	2,161
Pregnancy outcomes³	Fetal growth restriction	5
	Spontaneous abortion	96
	Subtotal	101
Respiratory system	Acute respiratory distress syndrome	11
Respiratory system	Subtotal	11
Skin and mucous membrane, bone and joints system	Chilblains	35
	Erythema multiforme (immune skin reaction)	67
	Subtotal	102
All AESI categories	Total	6,781

Notes

¹ Includes adverse events meeting levels 1-3 of the Brighton Collaboration level of diagnostic certainty.

² 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.

³ WHO guidance on pregnancy related AESIs.

An asterisk (^*) indicates a vaccine product that is no longer authorized.
As of December 3, 2023, some jurisdictions are only submitting data on doses administered for XBB.1.5 vaccines.
Please note that 1 report represents 1 person and may contain information on more than 1 adverse event of special interest.
A minimum 5-week reporting lag period is used to account for time lags between someone experiencing an adverse event since vaccine administration and the event being reported to CAEFISS or Canada Vigilance. To align the numerator and denominator for rate calculations, we restrict reports to those with a date vaccine administered as of June 18, 2023. This change is due to changes in the provincial and territorial reporting frequency of data on doses administered, and ongoing data improvement initiatives.

Safety signals identified and other safety updates

To date, 2 safety signals have been confirmed: Thrombosis with thrombocytopenia syndrome (TTS) and myocarditis/pericarditis. This is based on adverse events that were reported in Canada during the COVID-19 vaccination campaign, which followed their detection internationally. These reports do not imply a causal relationship between the vaccines and the adverse event. Health Canada updated the respective product monographs to include information about these adverse events. Health Canada PHAC will continue to monitor these events.

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 were adjusted following receipt of additional information by the Advisory Committee on Causality Assessment (ACCA).
Up to and including January 5, 2024, 89 reports of TTS have been reported that met level 1 to 3 of the Brighton Collaboration level of diagnostic certainty. Of the TTS reports:

56 reports followed vaccination with the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine
24 followed vaccination with the Pfizer-BioNTech Comirnaty COVID-19 vaccine
8 followed vaccination with the Moderna Spikevax COVID-19 vaccine.
The vaccine name for 1 was not specified.

For detailed information on the results of expert causality assessment for a subset of TTS reports, please visit the ACCA webpage.

Myocarditis/pericarditis

Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the lining around the heart.
Up to and including January 5, 2024, there were 1,231 reports of myocarditis/pericarditis that met levels 1 to 3 of the Brighton Collaboration level of diagnostic certainty. Of the myocarditis/pericarditis reports:

725 reports followed vaccination with the Pfizer-BioNTech Comirnaty COVID-19 vaccine
465 followed vaccination with the Moderna Spikevax COVID-19 vaccine
18 followed vaccination with the AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine
5 followed vaccination with the Pfizer-BioNTech Comirnaty (Original and Omicron BA.4/BA.5) bivalent vaccine
4 followed vaccination with the Moderna Spikevax (Original/Omicron BA.1) bivalent vaccine
3 followed vaccination with the Moderna Spikevax XBB.1.5 vaccine
1 followed vaccination with the Moderna Spikevax (Original/Omicron BA.4/5) bivalent vaccine
1 followed vaccination with the Janssen JCOVDEN vaccine
1 followed vaccination with the Novavax Nuvaxovid vaccine
the vaccine name for 8 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.
Among the 725 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 155 days after vaccination
median age is 26 years (age range 6 to 88 years old)
474 were males [median age 21 years (age range 7 to 86 years old)], 243 were females [median age 39 years (age range 6 to 88 years old)], the sex of 2 were 'other', and the sex of 6 were not specified
286 reports followed the first vaccine dose, 392 reports followed the second vaccine dose, 41 reports followed the third vaccine dose, 5 reports followed the fourth dose, and the dose number for 1 was 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 465 reports of myocarditis following vaccination with the Moderna Spikevax COVID-19 vaccine (administered to those 6 months of age and older):

symptoms started between 5 minutes and 113 days after vaccination
median age is 29 years (age range 14 to 95 years old)
339 were males [median age 27 years (age range 14 to 95 years old)], 122 were females [median age 36 years (age range 18 to 88)], the sex of 1 was 'other', and the sex of 3 were not specified
86 reports followed the first vaccine dose, 336 reports followed the second vaccine dose, 36 reports followed the third dose, 6 reports followed the fourth dose, and the dose number for 1 was 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.

Deaths

Up to and including January 5, 2024, a total of 488 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.
Medical case review previously used the WHO-UMC causality assessment categories to classify the status of death reports. Updated WHO guidance on causality assessment specific to vaccinations has been released. This updated user guide more accurately represents causality assessments following vaccination, so all reports with an outcome of death were updated and reclassified using the new classification system.
Of the 488 death reports, it was not possible to assess causality for 131 reports due to missing information (not enough information to initiate causality assessment).
Preliminary causality assessment was possible for the remaining 357 cases where there was sufficient information. Using the available information and the WHO guidance on causality assessment specific to vaccinations, we’ve determined that:

167 reports of death were unclassifiable due to lack of available information (not enough information to complete the preliminary assessment)
109 reports of death were inconsistent with causal association to the vaccine (unlikely to be linked to the vaccine)
77 reports of death were indeterminate (insufficient definitive evidence or conflicting evidence for causality)
4 deaths were consistent with causal association to immunization (see ACCA webpage)

If additional information becomes available, cases will be re-assessed, and the causality assessment may be updated.

Acknowledgements

This quarterly 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; January 19, 2024. https://health-infobase.canada.ca/covid-19/vaccine-safety/

Did you find what you were looking for?

What was wrong?

The answer I need is missing

The information isn’t clear

I’m not in the right place

Something is broken or incorrect

Other reason

Please provide more details

(Don’t include any personal information. Note that you will not receive a reply.)
Maximum 300 characters

Date modified:: 2024-01-19

Language selection

Search

Reported side effects following COVID-19 vaccination in Canada

On this page

What you need to know up to and including January 5, 2024

How to report an adverse event

Reporting trends

Figure 1. Choose a measure: of COVID-19 vaccine adverse event reports received for and total doses administered per reporting period, up to and including January 5, 2024 (n=58,712)

Number of COVID-19 adverse event reports received for all people up to and including January 5, 2024 (n=58,712)

Adverse event following immunization reports by vaccine name

Figure 2. Choose a measure: of adverse event reports received for by vaccine name and up to and including January 5, 2024 (n=59,174)

Number and rate (per 100,000 doses administered) of adverse event reports received for all people by vaccine name and dose number, up to and including January 5, 2024 (n=54,843)

Adverse event following immunization reports by age and sex

Age differences

Sex differences

Figure 3. of adverse event reports received by up to and including January 5, 2024 (n=58,712)

Number and rate (per 100,000 doses administered) of adverse event reports received by age group and sex up to and including January 5, 2024 (n=58,712)

Most common adverse events reported following immunization

Figure 4. of the most frequently reported adverse events by vaccine type () up to and including January 5, 2024 (n=150,208)

Number and rate (per 100,000 doses administered) of the most frequently reported adverse events by vaccine type up to and including January 5, 2024 (n=150,208)

Adverse events of special interest, safety signals, and deaths

Safety signals identified and other safety updates

Acknowledgements

Suggested citation

Related links

Did you find what you were looking for?

Reported side effects following COVID-19 vaccination in Canada

On this page

What you need to know up to and including January 5, 2024

How to report an adverse event

Reporting trends

Number of COVID-19 adverse event reports received for all people up to and including January 5, 2024 (n=58,712)

Adverse event following immunization reports by vaccine name

Figure 2. Choose a measure: Number Rate of adverse event reports received for all people people 18 years and older people 12 to 17 years people 5 to 11 years people 0 to 4 years by vaccine name and all doses dose 1 dose 2 dose 3 dose 4+ up to and including January 5, 2024 (n=59,174)

Number and rate (per 100,000 doses administered) of adverse event reports received for all people by vaccine name and dose number, up to and including January 5, 2024 (n=54,843)

Adverse event following immunization reports by age and sex

Age differences

Sex differences

Figure 3. Number Rate of adverse event reports received by age group age group and sex up to and including January 5, 2024 (n=58,712)

Number and rate (per 100,000 doses administered) of adverse event reports received by age group and sex up to and including January 5, 2024 (n=58,712)

Most common adverse events reported following immunization

Number and rate (per 100,000 doses administered) of the most frequently reported adverse events by vaccine type up to and including January 5, 2024 (n=150,208)

Adverse events of special interest, safety signals, and deaths

Safety signals identified and other safety updates

Acknowledgements

Suggested citation

Related links

Did you find what you were looking for?

Figure 2. Choose a measure: of adverse event reports received for by vaccine name and up to and including January 5, 2024 (n=59,174)

Figure 3. of adverse event reports received by up to and including January 5, 2024 (n=58,712)