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12月13日至6月5日，总接种将近1千万，共191例严重不良反应，10万分之1.9。其中每十万剂疫苗发生严重不良反应：辉瑞1.3，Moderna: 1.6, AZ：6.9。
191位严重不良反应患者中有187位住院治疗，在提交报告时，59位病人已经康复，91位仍在治疗。
阿斯利康疫苗共发生20例血小板减少症（TTS)，2.3 / 10万 = 1 / 43000，其中14例确诊由疫苗诱导的免疫性血小板减少症(VITT)，1.6 / 10万 = 1 / 61000, 3例待查，3例确诊与疫苗无关。一例VITT患者死亡报告，死因正在调查，尚未确定。
截止6月5日，安大略省已收到 16 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告。年龄范围在 15 至 78 岁之间（中位数为 33 岁）； 3例为 18 岁以下。
共有21人死亡暂时可能与疫苗相关，其中6人是老人院成员。4例死亡与严重不良反应有关，其中3例主要由其他基础病引起，一例为疫苗诱发血小板减少性血栓造成。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to June 5, 2021
Highlights
There are a total of 4,584 AEFI reports received following 9,996,777 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 45.9 per 100,000 doses administered (0.05% of all doses administered)
This represents an increase of 515 AEFI reports compared to previous week
Of the total 4,584 AEFI reports received to date:
4,393 AEFI reports are non-serious (95.8% of total AEFI reports)
191 AEFI reports meet the serious definition (4.2% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.6% and 23.8% of the total AEFI reports respectively
186 reports of events managed as anaphylaxis are reported, in which 17 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
176 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 84 reports also meet the serious definition (see Adverse events of special interest for more information)
20 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which 14 are vaccine-induced immune thrombotic thrombocytopenia (VITT) (see TTS/VITT section for more information)
Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration in Ontario, December 13, 2020 to June 5, 2021
Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 22 (May 30 to June 5, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.
VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)
Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no known recent exposure to heparin. A case finding definition proposed by the Brighton Collaboration is being used to support the investigation of this new clinical syndrome by identifying individuals who present with TTS following COVID-19 vaccination. Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e., anti-platelet 4 antibodies). VITT has been reported following immunization with COVID-19 adenoviral vector vaccines, including AstraZeneca/COVISHIELD vaccine.
On May 11, 2021, Ontario announced a pause on the administration of first doses of the AstraZeneca vaccine out of an abundance of caution due to an observed increase in reports of TTS/VITT. However, based on the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system, there may be additional reports of TTS/VITT reported in the coming weeks.
To date, there have been 20 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 14 are confirmed as VITT with positive anti-PF4 antibody test results and three individuals are pending test results. The remaining three TTS events that are not classified as VITT have VITT ruled out through testing (n=2) or did not have confirmatory tests ordered (n=1).
The most recent event had a vaccination date of May 6, 2021. All reports of TTS/VITT to date have occurred after receipt of the first dose of AstraZeneca/COVISHIELD vaccine. There has been one report of death recorded in CCM that has occurred in an individual with VITT. The investigation of this death is ongoing and a cause of death has not been determined at this time.
The following reporting rates are based on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 15, 2021 (861,650 doses) as the denominator, which is four days after Ontario’s announcement on the pause of the administration of first doses of the AstraZeneca vaccine. The reporting rate of TTS based on 20 reports is 2.3 per 100,000 first doses administered (approximately 1 in 43,000). The reporting rate of VITT (as a subtype of TTS) based on 14 reports is 1.6 per 100,000 first doses administered (approximately 1 in 62,000).
Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system.
MYOCARDITIS/PERICARDITIS
There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.9,10 Information to date indicates that these events occur more commonly after the second dose, within several days after vaccination, mainly in adolescents/young adults and more often in males than females.
The Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems. In Canada, there have been a small number of reports of myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines.5 Canada is not currently seeing higher rates than would be expected in the general population.5 At this time, no clear association has been established between myocarditis/pericarditis and mRNA vaccines.
As of June 5, 2021, there have been 16 reports of myocarditis or pericarditis following receipt of COVID19 mRNA vaccines in Ontario. Of these, four were diagnosed with myocarditis and nine were diagnosed with pericarditis, while three were diagnosed with perimyocarditis, myopericarditis or inflammatory cardiac reaction of unclear significance. The age range of the individuals with these events is between 15 and 78 years of age (median 33 years); three events occurred in individuals under 18. The four reports of myocarditis have been assessed using the Brighton Collaboration case definition of myocarditis.11 All four reports met Brighton levels of diagnostic certainty 1 or 2. A Brighton Collaboration case definition for pericarditis is under development and will be applied to Ontario events once available. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website.
Serious AEFIs
In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 191 AEFI reports classified as serious, representing 4.2% of all AEFI reports and a serious AEFI reporting rate of 1.9 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.
The serious reporting rate was 1.3 and 1.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the AstraZeneca/COVISHIELD vaccine was 6.9 per 100,000 doses administered.
AEFI REPORTS REQUIRING HOSPITALIZATION
187 clients of the 191 serious reports had a hospital admission related to the reported events. Of the 187 clients, 59 had recovered at the time of reporting, 91 were not yet recovered when the investigation was completed but likely to recover, and 19 had an unknown outcome at the time of reporting. Eighteen reports had an outcome reported as “residual effects”, which is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.
When a serious report contained multiple adverse events, one event that was the prominent reason for reporting was chosen to describe the serious report. Of the 187 reports of hospitalizations, 76 reported an AESI, 43 reported a medically important event, and seven reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 61 reports were:
42 reports of other severe or unusual events
five reports of severe vomiting/diarrhea
four reports of arthritis/arthralgia
three reports of convulsion/seizure
three reports of anaesthesia/paraesthesia
one report of paralysis
one report of Bell’s Palsy
one report of syncope (fainting) with injury
one report of cellulitis
AEFI REPORTS WITH FATAL OUTCOME
The remaining four serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event). One report of death occurred in a resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine. The second report of death occurred in a community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death. The third report of death occurred in a community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine. The fourth report of death was recorded in CCM in an individual with VITT (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
Reports of death temporally associated with receipt of vaccine
In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of June 5, 2021, there are 21 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Six of the 21 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.
During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.13 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.14 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
191位严重不良反应患者中有187位住院治疗，在提交报告时，59位病人已经康复，91位仍在治疗。
阿斯利康疫苗共发生20例血小板减少症（TTS)，2.3 / 10万 = 1 / 43000，其中14例确诊由疫苗诱导的免疫性血小板减少症(VITT)，1.6 / 10万 = 1 / 61000, 3例待查，3例确诊与疫苗无关。一例VITT患者死亡报告，死因正在调查，尚未确定。
截止6月5日，安大略省已收到 16 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告。年龄范围在 15 至 78 岁之间（中位数为 33 岁）； 3例为 18 岁以下。
共有21人死亡暂时可能与疫苗相关，其中6人是老人院成员。4例死亡与严重不良反应有关，其中3例主要由其他基础病引起，一例为疫苗诱发血小板减少性血栓造成。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to June 5, 2021
Highlights
There are a total of 4,584 AEFI reports received following 9,996,777 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 45.9 per 100,000 doses administered (0.05% of all doses administered)
This represents an increase of 515 AEFI reports compared to previous week
Of the total 4,584 AEFI reports received to date:
4,393 AEFI reports are non-serious (95.8% of total AEFI reports)
191 AEFI reports meet the serious definition (4.2% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.6% and 23.8% of the total AEFI reports respectively
186 reports of events managed as anaphylaxis are reported, in which 17 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
176 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 84 reports also meet the serious definition (see Adverse events of special interest for more information)
20 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which 14 are vaccine-induced immune thrombotic thrombocytopenia (VITT) (see TTS/VITT section for more information)
Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration in Ontario, December 13, 2020 to June 5, 2021
Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 22 (May 30 to June 5, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.
VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)
Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no known recent exposure to heparin. A case finding definition proposed by the Brighton Collaboration is being used to support the investigation of this new clinical syndrome by identifying individuals who present with TTS following COVID-19 vaccination. Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e., anti-platelet 4 antibodies). VITT has been reported following immunization with COVID-19 adenoviral vector vaccines, including AstraZeneca/COVISHIELD vaccine.
On May 11, 2021, Ontario announced a pause on the administration of first doses of the AstraZeneca vaccine out of an abundance of caution due to an observed increase in reports of TTS/VITT. However, based on the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system, there may be additional reports of TTS/VITT reported in the coming weeks.
To date, there have been 20 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 14 are confirmed as VITT with positive anti-PF4 antibody test results and three individuals are pending test results. The remaining three TTS events that are not classified as VITT have VITT ruled out through testing (n=2) or did not have confirmatory tests ordered (n=1).
The most recent event had a vaccination date of May 6, 2021. All reports of TTS/VITT to date have occurred after receipt of the first dose of AstraZeneca/COVISHIELD vaccine. There has been one report of death recorded in CCM that has occurred in an individual with VITT. The investigation of this death is ongoing and a cause of death has not been determined at this time.
The following reporting rates are based on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 15, 2021 (861,650 doses) as the denominator, which is four days after Ontario’s announcement on the pause of the administration of first doses of the AstraZeneca vaccine. The reporting rate of TTS based on 20 reports is 2.3 per 100,000 first doses administered (approximately 1 in 43,000). The reporting rate of VITT (as a subtype of TTS) based on 14 reports is 1.6 per 100,000 first doses administered (approximately 1 in 62,000).
Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system.
MYOCARDITIS/PERICARDITIS
There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.9,10 Information to date indicates that these events occur more commonly after the second dose, within several days after vaccination, mainly in adolescents/young adults and more often in males than females.
The Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems. In Canada, there have been a small number of reports of myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines.5 Canada is not currently seeing higher rates than would be expected in the general population.5 At this time, no clear association has been established between myocarditis/pericarditis and mRNA vaccines.
As of June 5, 2021, there have been 16 reports of myocarditis or pericarditis following receipt of COVID19 mRNA vaccines in Ontario. Of these, four were diagnosed with myocarditis and nine were diagnosed with pericarditis, while three were diagnosed with perimyocarditis, myopericarditis or inflammatory cardiac reaction of unclear significance. The age range of the individuals with these events is between 15 and 78 years of age (median 33 years); three events occurred in individuals under 18. The four reports of myocarditis have been assessed using the Brighton Collaboration case definition of myocarditis.11 All four reports met Brighton levels of diagnostic certainty 1 or 2. A Brighton Collaboration case definition for pericarditis is under development and will be applied to Ontario events once available. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website.
Serious AEFIs
In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 191 AEFI reports classified as serious, representing 4.2% of all AEFI reports and a serious AEFI reporting rate of 1.9 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.
The serious reporting rate was 1.3 and 1.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the AstraZeneca/COVISHIELD vaccine was 6.9 per 100,000 doses administered.
AEFI REPORTS REQUIRING HOSPITALIZATION
187 clients of the 191 serious reports had a hospital admission related to the reported events. Of the 187 clients, 59 had recovered at the time of reporting, 91 were not yet recovered when the investigation was completed but likely to recover, and 19 had an unknown outcome at the time of reporting. Eighteen reports had an outcome reported as “residual effects”, which is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.
When a serious report contained multiple adverse events, one event that was the prominent reason for reporting was chosen to describe the serious report. Of the 187 reports of hospitalizations, 76 reported an AESI, 43 reported a medically important event, and seven reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 61 reports were:
42 reports of other severe or unusual events
five reports of severe vomiting/diarrhea
four reports of arthritis/arthralgia
three reports of convulsion/seizure
three reports of anaesthesia/paraesthesia
one report of paralysis
one report of Bell’s Palsy
one report of syncope (fainting) with injury
one report of cellulitis
AEFI REPORTS WITH FATAL OUTCOME
The remaining four serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event). One report of death occurred in a resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine. The second report of death occurred in a community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death. The third report of death occurred in a community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine. The fourth report of death was recorded in CCM in an individual with VITT (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
Reports of death temporally associated with receipt of vaccine
In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of June 5, 2021, there are 21 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Six of the 21 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.
During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.13 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.14 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
