Mills Kale, Tri Anna, Nilsen Kari
University of Kansas School of Medicine-Wichita, Wichita, KS.
Wichita State University, Wichita, KS.
Kans J Med. 2022 Feb 9;15(1):39-47. doi: 10.17161/kjm.vol15.15825. eCollection 2022.
Coronavirus disease 2019 (COVID-19) is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and has spread rapidly throughout the world since its discovery in 2019. Three vaccines (Pfizer-BioNTech, Moderna/NIAID/BARDA, and Johnson & Johnson's Janssen) have been developed for use in the U.S. to aid in the fight against this virus, but have been scrutinized intensely for their efficacy and safety. It is important to understand and interpret the adverse events or reactions (AERs) associated with these vaccines in an objective and analytical manner. The goal of this descriptive study was to provide a resource outlining AERs associated with the three available vaccines in Kansas.
Reports were obtained from the Vaccine Adverse Event Reporting System (VAERS), representing AERs observed in Kansas from December 11, 2020 to May 13, 2021. All data were screened and coded, and descriptive statistics were used to describe AERs based on vaccine manufacturer, patient age and biological sex, and reported deaths.
Only 0.00068% of COVID-19 vaccine doses given in Kansas were associated with an AER (1,445/2,120,350). There were 4,297 individual AERs reported, and the most common were fatigue/tiredness (266; 6.2%), tingling/itching (251; 5.9%), fever (226; 5.3%), hives (223; 5.2%), and muscle/joint pain (209; 4.9%). Only 0.002% of COVID-19 vaccine doses in Kansas were associated with a death (38/2,120,350). The majority of VAERS reports were by females (1,139; 78.8%) and those aged 30 to 39 years (297; 20.6%).
No reported AERs were unexpected compared to national data, and no VAERs report provided a causal relationship between vaccine administration and death. Vaccines are, and will continue to be, essential tools to fight COVID-19 in the quest to reach herd immunity. Providing a resource of potential AERs could aid in individual decisions to receive a vaccine and may help in the control of COVID-19. Future studies may include describing reported AERs for children under age 12 as the vaccines become available for those age groups, as well as reporting AERs for those who have received the vaccine after our study time period.
2019冠状病毒病（COVID-19）由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起，自2019年发现以来已在全球迅速传播。美国已研发出三种疫苗（辉瑞-生物科技、莫德纳/美国国立过敏与传染病研究所/生物医学高级研究与发展局，以及强生公司的杨森疫苗）用于抗击这种病毒，但这些疫苗的有效性和安全性受到了严格审查。以客观和分析的方式理解和解读与这些疫苗相关的不良事件或反应（AER）非常重要。这项描述性研究的目的是提供一份资源，概述堪萨斯州三种可用疫苗相关的AER。
报告来自疫苗不良事件报告系统（VAERS），代表2020年12月11日至2021年5月13日在堪萨斯州观察到的AER。所有数据都经过筛选和编码，并使用描述性统计来描述基于疫苗制造商、患者年龄和生物学性别以及报告的死亡情况的AER。
在堪萨斯州接种的COVID-19疫苗中，只有0.00068%与AER相关（1445/2120350）。共报告了4297起个体AER，最常见的是疲劳/疲倦（266起；6.2%）、刺痛/瘙痒（251起；5.9%）、发热（226起；5.3%）、荨麻疹（223起；5.2%）和肌肉/关节疼痛（209起；4.9%）。在堪萨斯州，只有0.002%的COVID-19疫苗接种与死亡相关（38/2120350）。VAERS的大多数报告来自女性（1139起；78.8%）和年龄在30至39岁之间的人群（297起；20.6%）。
与全国数据相比，没有报告的AER是意外情况，也没有VAERS报告提供疫苗接种与死亡之间的因果关系。疫苗过去是、将来也仍将是在实现群体免疫的努力中抗击COVID-19的重要工具。提供潜在AER的资源可能有助于个人做出接种疫苗的决定，并可能有助于控制COVID-19。未来的研究可能包括在疫苗可供12岁以下儿童使用时描述报告的AER，以及报告在我们的研究时间段之后接种疫苗者的AER。
