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VAERS 报告的 COVID-19 疫苗接种后新发癫痫与流感疫苗接种相比。

VAERS-reported new-onset seizures following use of COVID-19 vaccinations as compared to influenza vaccinations.

机构信息

Department of Neurology, University of Kentucky Medical Center, Lexington, KY, United States.

Department of Behavioral Science, University of Kentucky Medical Center, Lexington, KY, United States.

出版信息

Br J Clin Pharmacol. 2022 Nov;88(11):4784-4788. doi: 10.1111/bcp.15415. Epub 2022 Jun 3.

Abstract

The incidence of new-onset seizures, which we defined as de novo seizures occurring within 4 weeks of receiving any of the US Food and Drug Administration-approved COVID-19 vaccinations as reported in patient-reported data compiled in the US Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System Data (CDC VAERS), has not been explored. The VAERS database contains de-identified patient-reported adverse events following vaccination and represents post-marketing surveillance and analysis of vaccine safety. After adjusting for time at risk, this resulted in estimated incidence rates of 3.19 seizures per 100 000 persons per year for the COVID-19 vaccine and 0.090 seizures per 100 000 persons per year for the influenza vaccines. A data-driven, individualized dataset that is comprehensive and coupled with a longitudinal follow-up in larger numbers of vaccinated individuals is needed to expand on our preliminary findings of vaccine-related seizures.

摘要

我们将新发病例定义为在接受任何美国食品和药物管理局批准的 COVID-19 疫苗后 4 周内出现的新发癫痫,这些病例是根据美国疾病控制与预防中心疫苗不良事件报告系统数据(CDC VAERS)中汇总的患者报告数据报告的。尚未探讨新发病例的发生率。VAERS 数据库包含接种疫苗后未经识别的患者报告不良事件,代表疫苗安全性的上市后监测和分析。在调整风险时间后,这导致 COVID-19 疫苗的估计发病率为每 100000 人每年 3.19 例癫痫发作,流感疫苗的发病率为每 100000 人每年 0.090 例癫痫发作。需要一个数据驱动的、个体化的综合数据集,并对更多接种疫苗的个体进行纵向随访,以扩展我们关于疫苗相关癫痫发作的初步发现。

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