背景:COVID-19大流行,由SARS-CoV-2引起的,在世界范围内产生了深远的影响,导致广泛的发病率和死亡率。针对COVID-19的疫苗接种是控制病毒传播和降低疾病严重程度的关键工具。然而,COVID-19疫苗的快速开发和部署引发了人们对免疫接种后潜在不良事件(AEFI)的担忧.了解这些AEFI的时间和空间模式对于有效的公共卫生反应和疫苗安全监测至关重要。
目的:本研究旨在分析向疫苗不良事件报告系统(VAERS)报告的美国与COVID-19疫苗相关的AEFIs的时空特征,从而提供对AEFI模式和分布的见解,COVID-19疫苗的安全性,以及与AEFI相关的潜在风险因素。
方法:我们在2020年至2022年间对疾病控制和预防中心的管理数据(n=663,822,575)和监测系统VAERS的报告(n=900,522)进行了回顾性分析。为了更广泛地了解疫苗接种后的AEFI报告,我们根据《监管活动医学词典》将它们分为系统器官类别(SOC)。此外,我们进行了时间分析,以检查所有VAERS报告中的AEFI趋势,那些与辉瑞生物技术公司和现代技术公司有关的,以及严重报告中最重要的10个AEFI趋势。我们还比较了美国不同地区症状的相似性。
结果:我们的研究结果表明,接种COVID-19疫苗后最常见的症状是头痛(n=141,186,15.68%),发热(n=122,120,13.56%),和疲劳(n=121,910,13.54%)。最常见的症状组合是寒战和发热(n=56,954,6.32%)。最初,一般疾病和给药部位疾病(SOC22)是报告的最普遍类别.与辉瑞-BioNTech相比,Moderna的AEFI报告率更高。随着时间的推移,我们观察到与COVID-19疫苗相关的AEFI报告率下降。此外,Pfizer-BioNTech和Moderna疫苗的AEFI总体发生率相当.在空间分析方面,美国中部和北部地区与COVID-19疫苗相关的AEFI报告率较高,而东南部和中南部地区在报告的症状上表现出明显的相似性。
结论:这项研究为美国与COVID-19疫苗相关的AEFI的时空格局提供了有价值的见解。这些发现强调了增加疫苗接种覆盖率的迫切需要,以及对AEFI的持续监控。实施有针对性的监控计划可以促进AEFI的有效和高效管理,增强公众对未来COVID-19疫苗宣传活动的信心。
BACKGROUND: The COVID-19 pandemic, caused by SARS-CoV-2, has had a profound impact worldwide, leading to widespread morbidity and mortality. Vaccination against COVID-19 is a critical tool in controlling the spread of the virus and reducing the severity of the disease. However, the rapid development and deployment of COVID-19 vaccines have raised concerns about potential adverse events following immunization (AEFIs). Understanding the temporal and spatial patterns of these AEFIs is crucial for an effective public health response and vaccine safety monitoring.
OBJECTIVE: This study aimed to analyze the temporal and spatial characteristics of AEFIs associated with COVID-19 vaccines in the United States reported to the Vaccine Adverse Event Reporting System (
VAERS), thereby providing insights into the patterns and distributions of the AEFIs, the safety profile of COVID-19 vaccines, and potential risk factors associated with the AEFIs.
METHODS: We conducted a retrospective analysis of administration data from the Centers for Disease Control and Prevention (n=663,822,575) and reports from the surveillance system
VAERS (n=900,522) between 2020 and 2022. To gain a broader understanding of postvaccination AEFIs reported, we categorized them into system organ classes (SOCs) according to the Medical Dictionary for Regulatory Activities. Additionally, we performed temporal analysis to examine the trends of AEFIs in all
VAERS reports, those related to Pfizer-BioNTech and Moderna, and the top 10 AEFI trends in serious reports. We also compared the similarity of symptoms across various regions within the United States.
RESULTS: Our findings revealed that the most frequently reported symptoms following COVID-19 vaccination were headache (n=141,186, 15.68%), pyrexia (n=122,120, 13.56%), and fatigue (n=121,910, 13.54%). The most common symptom combination was chills and pyrexia (n=56,954, 6.32%). Initially, general disorders and administration site conditions (SOC 22) were the most prevalent class reported. Moderna exhibited a higher reporting rate of AEFIs compared to Pfizer-BioNTech. Over time, we observed a decreasing reporting rate of AEFIs associated with COVID-19 vaccines. In addition, the overall rates of AEFIs between the Pfizer-BioNTech and Moderna vaccines were comparable. In terms of spatial analysis, the middle and north regions of the United States displayed a higher reporting rate of AEFIs associated with COVID-19 vaccines, while the southeast and south-central regions showed notable similarity in symptoms reported.
CONCLUSIONS: This study provides valuable insights into the temporal and spatial patterns of AEFIs associated with COVID-19 vaccines in the United States. The findings underscore the critical need for increasing vaccination coverage, as well as ongoing surveillance and monitoring of AEFIs. Implementing targeted monitoring programs can facilitate the effective and efficient management of AEFIs, enhancing public confidence in future COVID-19 vaccine campaigns.