Reporting on Adverse Clinical Events

J. Dill, T. Mcevoy
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Abstract

A retrospective review was performed regarding the possible relationship between hearing disorders and the administration of the COVID vaccine. Data were used from the US Vaccine Adverse Event Reporting System (VAERS) between January 2020 and November 2021. A total of 14 956 and 151 reports of hearing-related adverse events were identified related to the COVID and influenza vaccines, respectively. The incidence of hearing disorder following COVID vaccination was 6.66/100 000. Further analysis revealed that reports of COVID vaccine–related hearing impairment was higher for both mRNA (reporting odds ratio [ROR] = 2.37, 95% confidence interval [CI] = 2.20-2.55) and virus vector vaccines (ROR = 2.50, 95% CI = 2.28-2.73). Reports of hearing dysfunction associated with the influenza vaccine were lower (ROR = 0.36, 95% CI = 0.30-0.42). Based on this retrospective review of VAERS database reports, the authors identified an increased risk for hearing disorder following administration of both mRNA and virus vector COVID vaccines compared with influenza vaccination. COVID Vaccine [COVID Vaccine] Chen C et al (Jie Xiao: Department of Pharmacy, Xiamen Cardiovascular Hospital of Xiamen University, 2999 Jinshan Road, Huli District, Xiamen, China; e-mail: yfxjbz666@163.com) Hearing disorder following COVID-19 vaccination: a pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. J Clin Pharm Ther 47:1789–1795 (Nov) 2022
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不良临床事件报告
对听力障碍与COVID疫苗接种之间可能存在的关系进行了回顾性研究。数据来自2020年1月至2021年11月期间的美国疫苗不良事件报告系统(VAERS)。共发现与COVID和流感疫苗相关的听力相关不良事件报告14 956例和151例。新冠疫苗接种后听力障碍发生率为6.66/10万。进一步分析显示,mRNA(报告优势比[ROR] = 2.37, 95%可信区间[CI] = 2.20-2.55)和病毒载体疫苗(ROR = 2.50, 95% CI = 2.28-2.73)中与COVID疫苗相关的听力损伤报告均较高。与流感疫苗相关的听力障碍报告较低(ROR = 0.36, 95% CI = 0.30-0.42)。基于对VAERS数据库报告的回顾性回顾,作者发现与流感疫苗接种相比,接种mRNA和病毒载体COVID疫苗后听力障碍的风险增加。陈超等肖洁:厦门市湖里区金山路2999号,厦门大学厦门心血管医院药剂科;电子邮件:yfxjbz666@163.com) COVID-19疫苗接种后的听力障碍:使用疫苗不良事件报告系统的药物警戒分析。中华临床医学杂志,47 (11):1789 - 1795
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