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Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021.
Morbidity and Mortality Weekly Report ( IF 33.9 ) Pub Date : 2021-05-07 , DOI: 10.15585/mmwr.mm7018e3
Anne M Hause 1 , Julianne Gee 1 , Tara Johnson 1 , Amelia Jazwa 1 , Paige Marquez 1 , Elaine Miller 1 , John Su 1 , Tom T Shimabukuro 1 , David K Shay 1
Affiliation  

On April 7, 2021, after 5 weeks' use of the Janssen COVID-19 vaccine under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), CDC received reports of clusters of anxiety-related events after administration of Janssen COVID-19 vaccine from five mass vaccination sites, all in different states. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices. Four of the five sites temporarily closed while an investigation took place. Overall, 64 anxiety-related events, including 17 reports of syncope (fainting), an anxiety-related event, among 8,624 Janssen COVID-19 vaccine recipients, were reported from these sites for vaccines administered during April 7-9. As a follow-up to these interviews, CDC analyzed reports of syncope shortly after receipt of Janssen COVID-19 vaccine to the Vaccine Adverse Event Reporting System (VAERS), the vaccine safety monitoring program managed by CDC and FDA. To compare the occurrence of these events with those reported after receipt of other vaccines, reports of syncopal events after influenza vaccine administered in the 2019-20 influenza season were also reviewed. Syncope after Janssen COVID-19 vaccination was reported to VAERS (8.2 episodes per 100,000 doses). By comparison, after influenza vaccination, the reporting rate of syncope was 0.05 episodes per 100,000 doses. Anxiety-related events can occur after any vaccination. It is important that vaccination providers are aware that anxiety-related adverse events might be reported more frequently after receipt of the Janssen COVID-19 vaccine than after influenza vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration.

中文翻译:

Janssen COVID-19疫苗接种后与焦虑相关的不良事件群-2021年4月,美国有五个疫苗接种点。

2021年4月7日,在获得美国食品药品管理局(FDA)紧急使用授权(EUA)的许可下使用Janssen COVID-19疫苗5周后,疾病预防控制中心收到了有关服用Janssen COVID-来自五个不同州的大规模疫苗接种地点的19种疫苗。为了进一步调查这些案件,疾病预防控制中心采访了疫苗接种场所的工作人员,以收集有关所报告事件和疫苗接种场所做法的更多信息。进行调查时,五个地点中的四个暂时关闭。总体而言,从这些地点报告了4月7日至9日期间接种的8,624份Janssen COVID-19疫苗接种者中的64例与焦虑相关的事件,包括17例晕厥(晕倒)报告,这是一种与焦虑相关的事件。作为这些采访的后续活动,CDC在收到Janssen COVID-19疫苗后不久就向疫苗不良事件报告系统(VAERS)分析了晕厥的报告,该报告是由CDC和FDA管理的疫苗安全监控程序。为了将这些事件的发生与收到其他疫苗后报告的事件进行比较,还回顾了2019-20流感季节接种流感疫苗后晕厥事件的报告。VAERS报告了Janssen COVID-19疫苗接种后的晕厥(每10万剂8.2次发作)。相比之下,流感疫苗接种后,晕厥的报告率为每10万剂0.05次。接种疫苗后可能会发生与焦虑相关的事件。
更新日期:2021-05-07
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