MMWR Morb Mortal Wkly Rep. 2021 Jan 15;70(2):46-51. doi: 10.15585/mmwr.mm7002e1.
As of January 3, 2021, a total of 20,346,372 cases of coronavirus disease 2019 (COVID-19) and 349,246 associated deaths have been reported in the United States. Long-term sequalae of COVID-19 over the course of a lifetime currently are unknown; however, persistent symptoms and serious complications are being reported among COVID-19 survivors, including persons who initially experience a mild acute illness.* On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine (1); initial doses were recommended for health care personnel and long-term care facility residents (2). As of December 23, 2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered in the United States, and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours (3). Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2-150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home. Of the remaining case reports that were determined not to be anaphylaxis, 86 were judged to be nonanaphylaxis allergic reactions, and 61 were considered nonallergic adverse events. Seven case reports were still under investigation. 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 Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (4) and interim considerations for preparing for the potential management of anaphylaxis (5). In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the necessary supplies available to manage anaphylaxis, should implement postvaccination observation periods, and should immediately treat persons experiencing anaphylaxis signs and symptoms with intramuscular injection of epinephrine (4,5).
截至 2021 年 1 月 3 日，美国共报告 20346372 例 2019 年冠状病毒病（COVID-19）病例和 349246 例相关死亡。目前尚不清楚 COVID-19 一生中的长期后遗症；然而，COVID-19 幸存者中报告了持续症状和严重并发症，包括最初经历轻度急性疾病的人。* 2020 年 12 月 11 日，美国食品和药物管理局（FDA）发布了辉瑞-生物科技 COVID-19 疫苗的紧急使用授权（EUA），以预防 COVID-19，两剂疫苗间隔 21 天。2020 年 12 月 12 日，免疫实践咨询委员会（ACIP）发布了使用辉瑞-生物科技 COVID-19 疫苗的临时建议（1）；最初建议为卫生保健人员和长期护理机构居民接种（2）。截至 2020 年 12 月 23 日，在美国已接种 1893360 剂辉瑞-生物科技 COVID-19 疫苗，向疫苗不良事件报告系统（VAERS）报告了 4393 例（0.2%）不良事件。其中，有 175 例病例报告被确定为可能的严重过敏反应（包括过敏反应），需要进一步审查。过敏反应是一种罕见的疫苗接种后发生的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（3）。有 21 例被确定为过敏反应（每百万剂接种 11.1 例），其中 17 例有过敏史或过敏反应史，其中 7 例有过敏反应史。从疫苗接种到症状发作的中位数间隔为 13 分钟（范围为 2-150 分钟）。在 20 名可获得随访信息的人中，所有患者均已康复或出院回家。在其余被确定为非过敏反应的病例报告中，86 例被判定为非过敏反应，61 例被认为是非过敏不良事件。7 例病例报告仍在调查中。本报告总结了 2020 年 12 月 14 日至 23 日期间在美国接种第一剂辉瑞-生物科技 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 发布了关于当前在美国授权使用的 mRNA COVID-19 疫苗的最新临时临床考虑因素（4）和准备管理过敏反应（包括过敏反应）的临时考虑因素（5）。除了在接种 COVID-19 疫苗前筛查禁忌症和注意事项外，疫苗接种点还应备有必要的用品，以管理过敏反应，应实施接种后观察期，并应立即使用肾上腺素肌内注射治疗出现过敏反应症状和体征的患者（4、5）。
