Reactogenicity to COVID-19 vaccination in the United States of America

A. Sanyaolu, A. Marinkovic, S. Prakash, P. Desai, N. Haider, A. Abbasi, Nasima Mehraban, Isha Jain, Amarachi Ekeh, Omar Shazley, C. Okorie, V. Orish
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引用次数: 5

Abstract

Purpose In the United States, Pfizer-BioNTech, Moderna, and Janssen’s coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States. Materials and Methods We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis. Results Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%). Conclusion Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination.
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美利坚合众国对新冠肺炎疫苗接种的反应原性
目的在美国,Pfizer-BioNTech、Moderna和Janssen的2019冠状病毒病(新冠肺炎)疫苗已获得紧急使用授权(EUA),目前已获得美国食品和药物管理局批准的PfizerBioNTech疫苗。本研究的目的是分析美国新冠肺炎疫苗不良反应的被动监测数据。材料和方法我们分析了从疫苗不良事件报告系统数据库中检索的新冠肺炎疫苗不良反应被动监测数据。从最近报告的200例病例中提取并评估了检索到的人口统计信息记录以及10大常见疫苗不良事件,用于研究分析。结果本研究报告了局部和全身不良反应。前10种全身反应按年龄组(0.041)和性别(0.002)记录有显著差异(p<0.05)。对前5种全身反应的分析,按疫苗类型分层,得出寒战的显著差异(p=0.044),按年龄组和接种疫苗类型分层时,总的来说,辉瑞公司有182人(91.0%)报告不良事件,莫德纳公司有13人(6.5%),杨森公司有5人(2.5%)报告不良反应。因此,建议对所有不良事件进行持续监测和报告,以确保疫苗接种的安全性。
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来源期刊
CiteScore
3.70
自引率
3.70%
发文量
29
审稿时长
8 weeks
期刊介绍: Clin Exp Vaccine Res, the official English journal of the Korean Vaccine Society, is an international, peer reviewed, and open-access journal. It covers all areas related to vaccines and vaccination. Clin Exp Vaccine Res publishes editorials, review articles, special articles, original articles, case reports, brief communications, and correspondences covering a wide range of clinical and experimental subjects including vaccines and vaccination for human and animals against infectious diseases caused by viruses, bacteria, parasites and tumor. The scope of the journal is to disseminate information that may contribute to elaborate vaccine development and vaccination strategies targeting infectious diseases and tumors in human and animals. Relevant topics range from experimental approaches to (pre)clinical trials for the vaccine research based on, but not limited to, basic laboratory, translational, and (pre)clinical investigations, epidemiology of infectious diseases and progression of all aspects in the health related issues. It is published printed and open accessed online issues (https://ecevr.org) two times per year in 31 January and 31 July. Clin Exp Vaccine Res is linked to many international databases and is made freely available to institutions and individuals worldwide
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