MMWR Morb Mortal Wkly Rep. 2021 Jan 29;70(4):125-129. doi: 10.15585/mmwr.mm7004e1.
As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine (1). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours (2). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1-45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020-January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (3) and interim considerations for preparing for the potential management of anaphylaxis (4).
截至 2021 年 1 月 20 日，美国共报告 24135690 例 2019 年冠状病毒病（COVID-19）病例和 400306 例相关死亡病例（https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days）。2020 年 12 月 18 日，食品和药物管理局（FDA）发布了一项紧急使用授权（EUA），允许将 Moderna COVID-19 疫苗作为两剂疫苗，每剂间隔一个月接种，以预防 COVID-19。2020 年 12 月 19 日，免疫实践咨询委员会（ACIP）发布了一项关于使用 Moderna COVID-19 疫苗的临时建议（1）。截至 2021 年 1 月 10 日，美国已报告接种 Moderna COVID-19 疫苗第一剂 4041396 剂，报告接种 Moderna COVID-19 疫苗后发生 1266 例（0.03%）不良事件，并向疫苗不良事件报告系统（VAERS）报告。其中，有 108 例病例报告被确定为进一步审查的可能严重过敏反应病例，包括过敏反应。过敏反应是一种罕见的疫苗接种后危及生命的过敏反应，通常在接种后数分钟至数小时内发生（2）。在这些病例报告中，有 10 例被确定为过敏反应（每接种百万剂 Moderna COVID-19 疫苗 2.5 例过敏反应），其中 9 例有过敏史或过敏反应史，其中 5 例有过敏反应史。从疫苗接种到症状出现的中位间隔为 7.5 分钟（范围为 1-45 分钟）。在有随访信息的 8 人中，所有患者均已康复或出院回家。在其余被确定不是过敏反应的病例报告中，有 47 例被评估为非过敏反应，47 例被认为是非过敏不良事件。对于 4 例病例报告，调查人员无法获得足够的信息来评估过敏反应的可能性。本报告总结了 2020 年 12 月 21 日至 2021 年 1 月 10 日期间，美国首次接种 Moderna COVID-19 疫苗后，过敏反应（包括过敏反应和非过敏反应）病例报告的临床和流行病学特征。CDC 发布了更新的美国目前授权使用的 mRNA COVID-19 疫苗的临时临床注意事项（3）和准备应对过敏反应（包括过敏反应）潜在管理的临时注意事项（4）。
