正打算问这是个神马东西呢。
12月13日至10月3日安省疫苗不良反应报告，共737例严重不良反应，10万分之3.4。423例mRNA疫苗心肌炎/心包炎报告，比上周增加15例，233例需要住院。
- 主题发起人 lindamy
- 开始时间
总体看来，moderna 最糟糕。
不过，没比效果，光看不良反应。
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
安省疫苗不良反应报告：12月13日至4月24日
接种疫苗总数：4,629,149；
严重不良反应：63例，每10万分之1.4，其中辉瑞：1.4，莫德纳：1.8，两种阿斯利康分别为：5.4和0.5；
血小板减少症：共3例，全部为50岁以上的男性，莫德纳十万分之0.4，阿斯利康：1.5，症状发生在接种疫苗之后11 - 20 天，都需要住院治疗；
总共7例死亡可能与疫苗有关，其中4例为养老院的老人。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to April 24, 2021
Table 1. Summary of all AEFI reports received to date by COVID-19 vaccine in Ontario, December 13, 2020 to April 24, 2021
Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia (TTS)
Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to a rare condition characterized by blood clots associated with low levels of platelets (thrombocytopenia) that has been reported following immunization with COVISHIELD/ AstraZeneca vaccine. The rate of VITT is currently estimated to be between 1 per 100,000 and 1 per 250,000 persons vaccinated with COVISHIELD/AstraZeneca vaccine, although information in this area is rapidly evolving.7 Canada’s National Advisory Committee on Immunization (NACI) has recently released a detailed benefit-risk analysis concerning the use of the vaccine in different epidemiologic contexts in Canada.7 A case finding definition proposed by the Brighton Collaboration is being used to support case finding of this new clinical syndrome by identifying individuals who present with thrombosis with thrombocytopenia (TTS) following COVID-19 vaccination.
To date, there have been three reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario. All three events occurred in males, two in the 65+ age group and one in 50-64 year age group; all followed receipt of COVISHIELD vaccine received between March 16 and March 27. The time to onset of thrombocytopenia for these cases ranged from 11 to 20 days after vaccination and all three cases required hospitalization. These three events represent a reporting rate of 0.5 per 100,000 doses of COVISHIELD/AstraZeneca vaccines administered based on doses administered as of April 24. If calculated using the number of COVISHIELD/AstraZeneca vaccine doses administered approximately three weeks ago (April 3) to account for the typical time to onset for this event (two weeks) and reporting delays (one week), the reporting rate is 1.5 per 100,000 doses administered.
Serious AEFIs In Ontario,
AEFIs that meet the serious definition are events that required hospital admission and reports of death. Please see the technical notes for a full definition of serious AEFIs. There were 63 AEFI reports classified as serious, representing 3.4% of all AEFI reports and a serious AEFI reporting rate of 1.4 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 2018.8 The serious reporting rate was 1.1 and 1.8 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the COVISHIELD and AstraZeneca vaccines were 5.4 and 0.5 per 100,000 doses administered, respectively.
AEFI Reports Requiring Hospitalization
Sixty-one of the 63 clients had a hospital admission related to the reported events. Of the 61 clients, 24 had recovered at the time of reporting, 27 were not yet recovered when the investigation was completed, but likely to recover, and six had unknown outcome at the time of reporting. Four reports had 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 events which 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 61 reports of hospitalizations, 14 reported an AESI, 16 reported a medically important event, and three reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 28 reports were:
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 April 24, 2021, there are seven 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. Four of the seven 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”.9 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.10 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.
接种疫苗总数：4,629,149；
12月13日至4月24日，共63例严重不良反应，10万分之1.4，共3例血小板减少症，全部为50岁以上男性。
严重不良反应：63例，每10万分之1.4，其中辉瑞：1.4，莫德纳：1.8，两种阿斯利康分别为：5.4和0.5；
血小板减少症：共3例，全部为50岁以上的男性，莫德纳十万分之0.4，阿斯利康：1.5，症状发生在接种疫苗之后11 - 20 天，都需要住院治疗；
总共7例死亡可能与疫苗有关，其中4例为养老院的老人。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to April 24, 2021
Table 1. Summary of all AEFI reports received to date by COVID-19 vaccine in Ontario, December 13, 2020 to April 24, 2021
Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia (TTS)
Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to a rare condition characterized by blood clots associated with low levels of platelets (thrombocytopenia) that has been reported following immunization with COVISHIELD/ AstraZeneca vaccine. The rate of VITT is currently estimated to be between 1 per 100,000 and 1 per 250,000 persons vaccinated with COVISHIELD/AstraZeneca vaccine, although information in this area is rapidly evolving.7 Canada’s National Advisory Committee on Immunization (NACI) has recently released a detailed benefit-risk analysis concerning the use of the vaccine in different epidemiologic contexts in Canada.7 A case finding definition proposed by the Brighton Collaboration is being used to support case finding of this new clinical syndrome by identifying individuals who present with thrombosis with thrombocytopenia (TTS) following COVID-19 vaccination.
To date, there have been three reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario. All three events occurred in males, two in the 65+ age group and one in 50-64 year age group; all followed receipt of COVISHIELD vaccine received between March 16 and March 27. The time to onset of thrombocytopenia for these cases ranged from 11 to 20 days after vaccination and all three cases required hospitalization. These three events represent a reporting rate of 0.5 per 100,000 doses of COVISHIELD/AstraZeneca vaccines administered based on doses administered as of April 24. If calculated using the number of COVISHIELD/AstraZeneca vaccine doses administered approximately three weeks ago (April 3) to account for the typical time to onset for this event (two weeks) and reporting delays (one week), the reporting rate is 1.5 per 100,000 doses administered.
Serious AEFIs In Ontario,
AEFIs that meet the serious definition are events that required hospital admission and reports of death. Please see the technical notes for a full definition of serious AEFIs. There were 63 AEFI reports classified as serious, representing 3.4% of all AEFI reports and a serious AEFI reporting rate of 1.4 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 2018.8 The serious reporting rate was 1.1 and 1.8 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the COVISHIELD and AstraZeneca vaccines were 5.4 and 0.5 per 100,000 doses administered, respectively.
AEFI Reports Requiring Hospitalization
Sixty-one of the 63 clients had a hospital admission related to the reported events. Of the 61 clients, 24 had recovered at the time of reporting, 27 were not yet recovered when the investigation was completed, but likely to recover, and six had unknown outcome at the time of reporting. Four reports had 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 events which 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 61 reports of hospitalizations, 14 reported an AESI, 16 reported a medically important event, and three reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 28 reports were:
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 April 24, 2021, there are seven 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. Four of the seven 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”.9 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.10 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.
最后编辑:
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
12月13日至5月8日，共86例严重不良反应，10万分之1.4。
阿斯利康疫苗共发生11例血小板减少症（TTS)，1.7 / 10万 = 1 / 6万，其中8例由疫苗诱导的免疫性血小板减少症(VITT)，1.2 / 10万 = 1 / 8万。截止到上次报告，（一周前，5月1日）TTS仅3例，全部为50岁以上的男性。
共有10人死亡暂时可能与疫苗相关，其中5人是老人院成员。
Highlights
There are a total of 2,684 AEFI reports received following 6,147,144 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 43.7 per 100,000 doses administered
This represents an increase of 404 AEFI reports compared to previous week
Of the total 2,684 AEFI reports received to date:
2,598 AEFI reports are non-serious (96.8% of total AEFI reports)
86 AEFI reports meet the serious definition (3.2% 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 25.7% of the total AEFI reports respectively
113 reports of events managed as anaphylaxis are reported, in which 11 reports also meet the serious definition (see Events Managed As Anaphylaxis for description of events)
60 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 25 reports also meet the serious definition (see Adverse events of special interest for description of events)
Eleven reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of COVISHIELD/AstraZeneca vaccine, of which eight are vaccine-induced immune thrombotic thrombocytopenia (VITT)
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 18 (May 2 to 8, 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.7 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.7 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 COVISHIELD/AstraZeneca vaccine. The rate of VITT is currently estimated to be approximately 1 per 100,000 persons vaccinated with COVISHIELD/AstraZeneca vaccine, although information in this area is rapidly evolving.
To date, there have been 11 reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario; of these, eight are VITT. The two most recent events had a vaccination date of April 23, 2021. The following reporting rates are based on the number of doses of COVISHIELD/AstraZeneca vaccines administered in Ontario as of April 24, 2021 (643,714 doses) as the denominator, which accounts for the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system. The reporting rate of TTS based on 11 reports is 1.7 per 100,000 (approximately 1 in 60,000) doses administered. The reporting rate of VITT (as a subtype of TTS) based on eight reports is 1.2 per 100,000 (approximately 1 in 80,000) doses administered. Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 86 AEFI reports classified as serious, representing 3.2% of all AEFI reports and a serious AEFI reporting rate of 1.4 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 2018.9 The serious reporting rate was 1.2 and 1.5 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the COVISHIELD and AstraZeneca vaccines were 6.4 and 1.2 per 100,000 doses administered, respectively.
AEFI Reports Requiring Hospitalization
Eighty-three clients of the 86 serious reports had a hospital admission related to the reported events. Of the 83 clients, 30 had recovered at the time of reporting, 38 were not yet recovered when the investigation was completed, but likely to recover, and nine had an unknown outcome at the time of reporting. Six 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. Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 8 When a serious report contained multiple adverse events, one event that was the pro
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 83 reports of hospitalizations, 19 reported an AESI, 22 reported a medically important event, and six reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 36 reports were:
24 reports of other severe or unusual events
four reports of severe vomiting/diarrhea
three reports of convulsion/seizure
two reports of anaesthesia/paraesthesia
one report of syncope (fainting) with injury
one report of arthritis/arthralgia
one report of paralysis
AEFI Reports with Fatal Outcome
The remaining three 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.
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 May 8, 2021, there are ten 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. Five of the ten 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 Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 9 in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.10 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.11 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.
阿斯利康疫苗共发生11例血小板减少症（TTS)，1.7 / 10万 = 1 / 6万，其中8例由疫苗诱导的免疫性血小板减少症(VITT)，1.2 / 10万 = 1 / 8万。截止到上次报告，（一周前，5月1日）TTS仅3例，全部为50岁以上的男性。
共有10人死亡暂时可能与疫苗相关，其中5人是老人院成员。
Highlights
There are a total of 2,684 AEFI reports received following 6,147,144 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 43.7 per 100,000 doses administered
This represents an increase of 404 AEFI reports compared to previous week
Of the total 2,684 AEFI reports received to date:
2,598 AEFI reports are non-serious (96.8% of total AEFI reports)
86 AEFI reports meet the serious definition (3.2% 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 25.7% of the total AEFI reports respectively
113 reports of events managed as anaphylaxis are reported, in which 11 reports also meet the serious definition (see Events Managed As Anaphylaxis for description of events)
60 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 25 reports also meet the serious definition (see Adverse events of special interest for description of events)
Eleven reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of COVISHIELD/AstraZeneca vaccine, of which eight are vaccine-induced immune thrombotic thrombocytopenia (VITT)
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 18 (May 2 to 8, 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.7 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.7 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 COVISHIELD/AstraZeneca vaccine. The rate of VITT is currently estimated to be approximately 1 per 100,000 persons vaccinated with COVISHIELD/AstraZeneca vaccine, although information in this area is rapidly evolving.
To date, there have been 11 reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario; of these, eight are VITT. The two most recent events had a vaccination date of April 23, 2021. The following reporting rates are based on the number of doses of COVISHIELD/AstraZeneca vaccines administered in Ontario as of April 24, 2021 (643,714 doses) as the denominator, which accounts for the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system. The reporting rate of TTS based on 11 reports is 1.7 per 100,000 (approximately 1 in 60,000) doses administered. The reporting rate of VITT (as a subtype of TTS) based on eight reports is 1.2 per 100,000 (approximately 1 in 80,000) doses administered. Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 86 AEFI reports classified as serious, representing 3.2% of all AEFI reports and a serious AEFI reporting rate of 1.4 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 2018.9 The serious reporting rate was 1.2 and 1.5 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the COVISHIELD and AstraZeneca vaccines were 6.4 and 1.2 per 100,000 doses administered, respectively.
AEFI Reports Requiring Hospitalization
Eighty-three clients of the 86 serious reports had a hospital admission related to the reported events. Of the 83 clients, 30 had recovered at the time of reporting, 38 were not yet recovered when the investigation was completed, but likely to recover, and nine had an unknown outcome at the time of reporting. Six 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. Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 8 When a serious report contained multiple adverse events, one event that was the pro
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 83 reports of hospitalizations, 19 reported an AESI, 22 reported a medically important event, and six reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 36 reports were:
24 reports of other severe or unusual events
four reports of severe vomiting/diarrhea
three reports of convulsion/seizure
two reports of anaesthesia/paraesthesia
one report of syncope (fainting) with injury
one report of arthritis/arthralgia
one report of paralysis
AEFI Reports with Fatal Outcome
The remaining three 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.
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 May 8, 2021, there are ten 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. Five of the ten 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 Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 9 in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.10 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.11 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.
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
12月13日至5月15日，共111例严重不良反应，10万分之1.6。其中每十万剂疫苗发生严重不良反应：辉瑞1.1，Moderna: 1.5, AZ：4.2。
阿斯利康疫苗共发生14例血小板减少症（TTS)，1.8 / 10万 = 1 / 57000，其中11例由疫苗诱导的免疫性血小板减少症(VITT)，1.4 / 10万 = 1 / 72000。
共有12人死亡暂时可能与疫苗相关，其中5人是老人院成员。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to May 15, 2021
Highlights
There are a total of 3,092 AEFI reports received following 7,068,229 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 43.7 per 100,000 doses administered
This represents an increase of 408 AEFI reports compared to previous week
Of the total 3,092 AEFI reports received to date:
2,981 AEFI reports are non-serious (96.4% of total AEFI reports)
111 AEFI reports meet the serious definition (3.6% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.3% and 25.6% of the total AEFI reports respectively
124 reports of events managed as anaphylaxis are reported, in which 11 reports also meet the serious definition (see Events Managed As Anaphylaxis for description of events)
83 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 40 reports also meet the serious definition (see Adverse events of special interest for description of events)
14 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which eleven are vaccine-induced immune thrombotic thrombocytopenia (VITT)
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 19 (May 9 to 15, 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.7Vaccine-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 14 reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario; of these, 11 are VITT, two have VITT ruled out by confirmatory testing but still meet the definition of TTS and one is pending results of confirmatory testing. The most recent event had a vaccination date of April 25, 2021. The following reporting rates are based on the number of doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 1, 2021 (796,014 doses) as the denominator, which accounts for the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system. The reporting rate of TTS based on 14 reports is 1.8 per 100,000 (approximately 1 in 57,000) doses administered. The reporting rate of VITT (as a subtype of TTS) based on 11 reports is 1.4 per 100,000 (approximately 1 in 72,000) doses administered. Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 111 AEFI reports classified as serious, representing 3.6% of all AEFI reports and a serious AEFI reporting rate of 1.6 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 2018.9 The serious reporting rate was 1.1 and 1.5 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 4.2 per 100,000 doses administered.
AEFI Reports Requiring Hospitalization
108 clients of the 111 serious reports had a hospital admission related to the reported events. Of the 108 clients, 37 had recovered at the time of reporting, 52 were not yet recovered when the investigation was completed but likely to recover, and ten had an unknown outcome at the time of reporting. Nine 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 108 reports of hospitalizations, 30 reported an AESI, 25 reported a medically important event, and ten reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 43 reports were:
30 reports of other severe or unusual events
four reports of severe vomiting/diarrhea
three reports of convulsion/seizure two reports of arthritis/arthralgia
two reports of paralysis one report of syncope (fainting) with injury
one report of anaesthesia/paraesthesia
AEFI Reports with Fatal Outcome
The remaining three 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.
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 May 15, 2021, there are 12 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. Five of the 12 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”.10 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.11 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.
阿斯利康疫苗共发生14例血小板减少症（TTS)，1.8 / 10万 = 1 / 57000，其中11例由疫苗诱导的免疫性血小板减少症(VITT)，1.4 / 10万 = 1 / 72000。
共有12人死亡暂时可能与疫苗相关，其中5人是老人院成员。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to May 15, 2021
Highlights
There are a total of 3,092 AEFI reports received following 7,068,229 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 43.7 per 100,000 doses administered
This represents an increase of 408 AEFI reports compared to previous week
Of the total 3,092 AEFI reports received to date:
2,981 AEFI reports are non-serious (96.4% of total AEFI reports)
111 AEFI reports meet the serious definition (3.6% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.3% and 25.6% of the total AEFI reports respectively
124 reports of events managed as anaphylaxis are reported, in which 11 reports also meet the serious definition (see Events Managed As Anaphylaxis for description of events)
83 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 40 reports also meet the serious definition (see Adverse events of special interest for description of events)
14 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which eleven are vaccine-induced immune thrombotic thrombocytopenia (VITT)
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 19 (May 9 to 15, 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.7Vaccine-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 14 reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario; of these, 11 are VITT, two have VITT ruled out by confirmatory testing but still meet the definition of TTS and one is pending results of confirmatory testing. The most recent event had a vaccination date of April 25, 2021. The following reporting rates are based on the number of doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 1, 2021 (796,014 doses) as the denominator, which accounts for the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system. The reporting rate of TTS based on 14 reports is 1.8 per 100,000 (approximately 1 in 57,000) doses administered. The reporting rate of VITT (as a subtype of TTS) based on 11 reports is 1.4 per 100,000 (approximately 1 in 72,000) doses administered. Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 111 AEFI reports classified as serious, representing 3.6% of all AEFI reports and a serious AEFI reporting rate of 1.6 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 2018.9 The serious reporting rate was 1.1 and 1.5 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 4.2 per 100,000 doses administered.
AEFI Reports Requiring Hospitalization
108 clients of the 111 serious reports had a hospital admission related to the reported events. Of the 108 clients, 37 had recovered at the time of reporting, 52 were not yet recovered when the investigation was completed but likely to recover, and ten had an unknown outcome at the time of reporting. Nine 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 108 reports of hospitalizations, 30 reported an AESI, 25 reported a medically important event, and ten reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 43 reports were:
30 reports of other severe or unusual events
four reports of severe vomiting/diarrhea
three reports of convulsion/seizure two reports of arthritis/arthralgia
two reports of paralysis one report of syncope (fainting) with injury
one report of anaesthesia/paraesthesia
AEFI Reports with Fatal Outcome
The remaining three 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.
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 May 15, 2021, there are 12 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. Five of the 12 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”.10 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.11 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.
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
安省报告第一例与AZ疫苗相关的血栓死亡病例。
死亡的男子40岁以上，4月底接种的AZ疫苗。他几周后死于疫苗引起的免疫性血小板减少症。
安省将近一百万人接种了AZ疫苗，共发生13例疫苗诱导的血小板减少症。AZ疫苗已于5月11日停止。
卫生官说：“与这种疫苗相关的风险很少，但确实存在。”
Nearly one million people in Ontario aged 40 and older have received the AstraZeneca vaccine. The province suspended the use of the vaccine in first doses on May 11, but has approved it for second doses for those who’ve already received it. There have been 13 cases of VIIT in the province so far, Yaffe said.
“The risks associated with this vaccine are rare, but they are real,” Yaffe said.
But she also said that those who received a first dose of AstraZeneca made the right choice. Experts maintain the blood-clotting syndrome associated with the AstraZeneca shot is exceedingly rare and treatable in most cases.
“I want to take this opportunity to reiterate that those who received AstraZeneca vaccine should feel very confident in their decision,” she said.
ottawacitizen.com
死亡的男子40岁以上，4月底接种的AZ疫苗。他几周后死于疫苗引起的免疫性血小板减少症。
安省将近一百万人接种了AZ疫苗，共发生13例疫苗诱导的血小板减少症。AZ疫苗已于5月11日停止。
卫生官说：“与这种疫苗相关的风险很少，但确实存在。”
COVID-19: Decision on Ontario school year coming 'soon'; Province reports 1st death from blood clot linked to AstraZeneca vaccine
Ontario also reported its first death associated with a rare blood clotting disorder linked to the Oxford-AstraZeneca vaccine. The man was in his 40s and received his vaccine at the end of April. He died a few weeks later of vaccine-induced immune thrombotic thrombocytopenia, Ontario’s associate medical officer of health, Dr. Barbara Yaffe, confirmed Tuesday.Nearly one million people in Ontario aged 40 and older have received the AstraZeneca vaccine. The province suspended the use of the vaccine in first doses on May 11, but has approved it for second doses for those who’ve already received it. There have been 13 cases of VIIT in the province so far, Yaffe said.
“The risks associated with this vaccine are rare, but they are real,” Yaffe said.
But she also said that those who received a first dose of AstraZeneca made the right choice. Experts maintain the blood-clotting syndrome associated with the AstraZeneca shot is exceedingly rare and treatable in most cases.
“I want to take this opportunity to reiterate that those who received AstraZeneca vaccine should feel very confident in their decision,” she said.
COVID-19: Decision on Ontario school year coming 'soon'; Province reports 1st death from blood clot linked to AstraZeneca vaccine
Ontario reported 1,039 new COVID-19 infections Tuesday, the lowest daily count of new cases the province has seen in nearly 12 weeks.
最后编辑:
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
12月13日至5月22日，共140例严重不良反应，10万分之1.7。其中每十万剂疫苗发生严重不良反应：辉瑞1.3，Moderna: 1.4, AZ：5.4。
140位严重不良反应患者中有136位住院治疗，在提交报告时，46位病人已经康复，66位仍在治疗。
阿斯利康疫苗共发生16例血小板减少症（TTS)，2 / 10万 = 1 / 50000，其中13例由疫苗诱导的免疫性血小板减少症(VITT)，1.6 / 10万 = 1 / 61000。
共有17人死亡暂时可能与疫苗相关，其中6人是老人院成员。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to May 22, 2021
Highlights
There are a total of 3,569 AEFI reports received following 8,069,397 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 44.2 per 100,000 doses administered (0.04% of all doses administered)
This represents an increase of 477 AEFI reports compared to previous week
Of the total 3,569 AEFI reports received to date:
3,429 AEFI reports are non-serious (96.1% of total AEFI reports)
140 AEFI reports meet the serious definition (3.9% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.4% and 24.9% of the total AEFI reports respectively
143 reports of events managed as anaphylaxis are reported, in which 13 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
113 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 56 reports also meet the serious definition (see Adverse events of special interest for more information)
16 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which 13 are vaccine-induced immune
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 20 (May 16 to 22, 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.7 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.7Vaccine-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 16 reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario (including one probable TTS); of these, 13 are VITT. The most recent event had a vaccination date of April 29, 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 1, 2021 (794,065 doses) as the denominator, which accounts for the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system. The reporting rate of TTS based on 16 reports is 2.0 per 100,000 first doses administered (approximately 1 in 50,000). The reporting rate of VITT (as a subtype of TTS) based on 13 reports is 1.6 per 100,000 first doses administered (approximately 1 in 61,000).
Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 140 AEFI reports classified as serious, representing 3.9% of all AEFI reports and a serious AEFI reporting rate of 1.7 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 2018.9 The serious reporting rate was 1.3 and 1.4 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 5.4 per 100,000 doses administered.
AEFI Reports Requiring Hospitalization
136 clients of the 140 serious reports had a hospital admission related to the reported events. Of the 136 clients, 46 had recovered at the time of reporting, 66 were not yet recovered when the investigation was completed but likely to recover, and 12 had an unknown outcome at the time of reporting. Twelve 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 136 reports of hospitalizations, 38 reported an AESI, 29 reported a medically important event, and 17 reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 52 reports were:
37 reports of other severe or unusual events
four reports of severe vomiting/diarrhea
three reports of convulsion/seizure
three reports of arthritis/arthralgia
two reports of paralysis
one report of Bell’s Palsy
one report of syncope (fainting) with injury
one report of anaesthesia/paraesthesia
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 May 22, 2021, there are 17 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 17 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”.10 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.11 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.
140位严重不良反应患者中有136位住院治疗，在提交报告时，46位病人已经康复，66位仍在治疗。
阿斯利康疫苗共发生16例血小板减少症（TTS)，2 / 10万 = 1 / 50000，其中13例由疫苗诱导的免疫性血小板减少症(VITT)，1.6 / 10万 = 1 / 61000。
共有17人死亡暂时可能与疫苗相关，其中6人是老人院成员。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to May 22, 2021
Highlights
There are a total of 3,569 AEFI reports received following 8,069,397 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 44.2 per 100,000 doses administered (0.04% of all doses administered)
This represents an increase of 477 AEFI reports compared to previous week
Of the total 3,569 AEFI reports received to date:
3,429 AEFI reports are non-serious (96.1% of total AEFI reports)
140 AEFI reports meet the serious definition (3.9% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.4% and 24.9% of the total AEFI reports respectively
143 reports of events managed as anaphylaxis are reported, in which 13 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
113 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 56 reports also meet the serious definition (see Adverse events of special interest for more information)
16 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which 13 are vaccine-induced immune
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 20 (May 16 to 22, 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.7 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.7Vaccine-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 16 reports of TTS following receipt of COVISHIELD/AstraZeneca vaccine in Ontario (including one probable TTS); of these, 13 are VITT. The most recent event had a vaccination date of April 29, 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 1, 2021 (794,065 doses) as the denominator, which accounts for the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system. The reporting rate of TTS based on 16 reports is 2.0 per 100,000 first doses administered (approximately 1 in 50,000). The reporting rate of VITT (as a subtype of TTS) based on 13 reports is 1.6 per 100,000 first doses administered (approximately 1 in 61,000).
Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 140 AEFI reports classified as serious, representing 3.9% of all AEFI reports and a serious AEFI reporting rate of 1.7 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 2018.9 The serious reporting rate was 1.3 and 1.4 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 5.4 per 100,000 doses administered.
AEFI Reports Requiring Hospitalization
136 clients of the 140 serious reports had a hospital admission related to the reported events. Of the 136 clients, 46 had recovered at the time of reporting, 66 were not yet recovered when the investigation was completed but likely to recover, and 12 had an unknown outcome at the time of reporting. Twelve 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 136 reports of hospitalizations, 38 reported an AESI, 29 reported a medically important event, and 17 reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 52 reports were:
37 reports of other severe or unusual events
four reports of severe vomiting/diarrhea
three reports of convulsion/seizure
three reports of arthritis/arthralgia
two reports of paralysis
one report of Bell’s Palsy
one report of syncope (fainting) with injury
one report of anaesthesia/paraesthesia
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 May 22, 2021, there are 17 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 17 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”.10 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.11 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.
- 注册
- 2005-11-23
- 消息
- 30,363
- 荣誉分数
- 7,477
- 声望点数
- 373
12月13日至5月29日，总接种将近1千万，共164例严重不良反应，10万分之1.8。其中每十万剂疫苗发生严重不良反应：辉瑞1.3，Moderna: 1.5, AZ：6.2。
160位严重不良反应患者中有160位住院治疗，在提交报告时，53位病人已经康复，76位仍在治疗。
阿斯利康疫苗共发生17例血小板减少症（TTS)，2 / 10万 = 1 / 51000，其中14例由疫苗诱导的免疫性血小板减少症(VITT)，1.6 / 10万 = 1 / 61000,一例VITT患者死亡报告，死因正在调查，尚未确定。
共有17人死亡暂时可能与疫苗相关，其中5人是老人院成员。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to May 29, 2021
Highlights
There are a total of 4,069 AEFI reports received following 8,988,502 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 45.3 per 100,000 doses administered (0.05% of all doses administered)
This represents an increase of 500 AEFI reports compared to previous week
Of the total 4,069 AEFI reports received to date:
3,905 AEFI reports are non-serious (96.0% of total AEFI reports)
164 AEFI reports meet the serious definition (4.0% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.4% and 24.2% of the total AEFI reports respectively
167 reports of events managed as anaphylaxis are reported, in which 16 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
144 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 70 reports also meet the serious definition (see Adverse events of special interest for more information)
17 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)
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 21 (May 23 to 29, 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.
Adverse events of special interest (AESIs) for COVID-19 vaccines
Several adverse events of special interest (AESIs) for COVID-19 vaccines have been identified by international health authorities based on a theoretical rationale for a possible association with COVID-19 vaccines. Reporting of AESIs for COVID-19 vaccines enables enhanced monitoring of events which may otherwise not be captured in a passive surveillance system. There were 144 reports with COVID-19 vaccine-specific AESIs, representing 3.5% of all reports.
Of the 144 reports, 70 met the definition of a serious AEFI. The number of AEFI reports and reporting rate for each AESI by vaccine product are presented in Appendix A.
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.7 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.7Vaccine-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 17 reports of TTS following receipt of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 14 are VITT. The most recent event had a vaccination date of April 29, 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 (860,949 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 17 reports is 2.0 per 100,000 first doses administered (approximately 1 in 51,000). 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 61,000).
Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 164 AEFI reports classified as serious, representing 4.0% of all AEFI reports and a serious AEFI reporting rate of 1.8 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 2018.9 The serious reporting rate was 1.3 and 1.5 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 6.2 per 100,000 doses administered.
AEFI Reports Requiring Hospitalization
160 clients of the 164 serious reports had a hospital admission related to the reported events. Of the 160 clients, 53 had recovered at the time of reporting, 76 were not yet recovered when the investigation was completed but likely to recover, and 17 had an unknown outcome at the time of reporting. Fourteen 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 160 reports of hospitalizations, 61 reported an AESI, 36 reported a medically important event, and eight reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 55 reports were:
38 reports of other severe or unusual events
five reports of severe vomiting/diarrhea
four reports of arthritis/arthralgia
three reports of convulsion/seizure
two reports of anaesthesia/paraesthesia
one report of paralysis
one report of Bell’s Palsy
one report of syncope (fainting) with injury
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 May 29, 2021, there are 17 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. Five of the 17 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”.10 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.11 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.
160位严重不良反应患者中有160位住院治疗，在提交报告时，53位病人已经康复，76位仍在治疗。
阿斯利康疫苗共发生17例血小板减少症（TTS)，2 / 10万 = 1 / 51000，其中14例由疫苗诱导的免疫性血小板减少症(VITT)，1.6 / 10万 = 1 / 61000,一例VITT患者死亡报告，死因正在调查，尚未确定。
共有17人死亡暂时可能与疫苗相关，其中5人是老人院成员。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to May 29, 2021
Highlights
There are a total of 4,069 AEFI reports received following 8,988,502 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 45.3 per 100,000 doses administered (0.05% of all doses administered)
This represents an increase of 500 AEFI reports compared to previous week
Of the total 4,069 AEFI reports received to date:
3,905 AEFI reports are non-serious (96.0% of total AEFI reports)
164 AEFI reports meet the serious definition (4.0% of total AEFI reports)
The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.4% and 24.2% of the total AEFI reports respectively
167 reports of events managed as anaphylaxis are reported, in which 16 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
144 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 70 reports also meet the serious definition (see Adverse events of special interest for more information)
17 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)
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 21 (May 23 to 29, 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.
Adverse events of special interest (AESIs) for COVID-19 vaccines
Several adverse events of special interest (AESIs) for COVID-19 vaccines have been identified by international health authorities based on a theoretical rationale for a possible association with COVID-19 vaccines. Reporting of AESIs for COVID-19 vaccines enables enhanced monitoring of events which may otherwise not be captured in a passive surveillance system. There were 144 reports with COVID-19 vaccine-specific AESIs, representing 3.5% of all reports.
Of the 144 reports, 70 met the definition of a serious AEFI. The number of AEFI reports and reporting rate for each AESI by vaccine product are presented in Appendix A.
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.7 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.7Vaccine-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 17 reports of TTS following receipt of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 14 are VITT. The most recent event had a vaccination date of April 29, 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 (860,949 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 17 reports is 2.0 per 100,000 first doses administered (approximately 1 in 51,000). 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 61,000).
Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system, as well as increases in doses administered over time.
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 164 AEFI reports classified as serious, representing 4.0% of all AEFI reports and a serious AEFI reporting rate of 1.8 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 2018.9 The serious reporting rate was 1.3 and 1.5 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 6.2 per 100,000 doses administered.
AEFI Reports Requiring Hospitalization
160 clients of the 164 serious reports had a hospital admission related to the reported events. Of the 160 clients, 53 had recovered at the time of reporting, 76 were not yet recovered when the investigation was completed but likely to recover, and 17 had an unknown outcome at the time of reporting. Fourteen 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 160 reports of hospitalizations, 61 reported an AESI, 36 reported a medically important event, and eight reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 55 reports were:
38 reports of other severe or unusual events
five reports of severe vomiting/diarrhea
four reports of arthritis/arthralgia
three reports of convulsion/seizure
two reports of anaesthesia/paraesthesia
one report of paralysis
one report of Bell’s Palsy
one report of syncope (fainting) with injury
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 May 29, 2021, there are 17 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. Five of the 17 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”.10 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.11 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.
