COVID-19mRNA疫苗的预防性接种是此类疫苗在人类世界中的首次大规模应用。截至2020年12月,美国已使用了超过180万剂COVID-19疫苗,约0.2%的人向疫苗不良事件报告系统(VAERS)提交了AE报告。本研究旨在评估免疫后的AE(AEFI),并根据VAERS数据库中的信息分析潜在的关联。
我们搜索了VAERS数据库,记录了2020年12月COVID-19疫苗接种后的AEFI。数据映射后,我们总结了报告病例的人口统计学和临床特征.Fisher精确检验用于比较具有过敏反应的AE组之间的临床特征。关于神经系统疾病和死亡。
VAERS在2020年12月报告了3908例AEFI的COVID-19疫苗。大多数(79.68%)是在第一次接种疫苗后报告的。在报告的案件中,我们发现一般疾病(48.80%),神经系统疾病(46.39%),胃肠道疾病(25.54%)是最常见的AEFI。有过敏反应的疫苗接受者的过敏史比没有过敏反应的人更频繁(64.91%vs.49.62%,OR=1.88,P<0.017)。焦虑或抑郁的病史在报告严重神经系统AEFI的受试者中比报告其他AEFI的受试者更常见(18.37%vs.7.85%,OR=2.64,P<0.017)。报告死亡的病例明显年龄较大(79.36±10.41岁vs.42.64±12.55岁,P<0.01,95%CI29.30-44.15)和更可能经历过高血压(50.00%vs.11.42%,OR=7.76,P<0.01)和神经系统疾病(50.00%vs.5.36%,OR=17.65,P<0.01)优于其他疫苗接种者。AEFI的门诊和急诊室就诊率分别为11.92%和22.42%,2.53%的病例需要住院治疗。
COVID-19mRNA疫苗的AEFIs通常是非严重的局部或全身反应。既往过敏史是过敏反应的危险因素,而焦虑病史可能与严重的神经系统不良事件有关。此类疫苗接受者需要进一步评估和监测。
The prophylactic vaccination of COVID-19 mRNA vaccines is the first large-scale application of this kind in the human world. Over 1.8 million doses of the COVID-19 vaccine had been administered in the US until December 2020, and around 0.2% submitted AE reports to the Vaccine Adverse Event Reporting System (VAERS). This study aimed to evaluate the AEs following immunization (AEFIs) and analyze the potential associations based on the information from the VAERS database.
We searched the VAERS database recorded AEFIs after COVID-19 vaccines in December 2020. After data mapping, we summarized demographic and clinical features of reported cases. Fisher exact test was used to comparing the clinical characteristics among AE groups with an anaphylactic response, concerning neurological disorders and death.
VAERS reported 3,908 AEFIs of COVID-19 vaccines in December 2020. Most (79.68%) were reported after the first dose of the vaccine. Among the reported cases, we found that general disorders (48.80%), nervous system disorders (46.39%), and gastrointestinal disorders (25.54%) were the most common AEFIs. The allergy history was more frequent in vaccine recipients with anaphylactic reactions than those without (64.91% vs. 49.62%, OR = 1.88, P <0.017). History of anxiety or depression was more common in subjects reporting severe neurological AEFIs than those reporting other AEFIs (18.37% vs. 7.85%, OR = 2.64, P <0.017). Cases reporting death were significantly older (79.36 ± 10.41-year-old vs. 42.64 ± 12.55-year-old, P <0.01, 95% CI 29.30-44.15) and more likely experienced hypertension (50.00% vs. 11.42%, OR = 7.76, P <0.01) and neurological disorders (50.00% vs. 5.36%, OR = 17.65, P <0.01) than other vaccine recipients. The outpatient and emergency room visit rates were 11.92 and 22.42% for AEFIs, and 2.53% of cases needed hospitalization.
AEFIs of COVID-19 mRNA vaccines were generally non-severe local or systemic reactions. A prior allergy history is the risk factor for anaphylaxis, while a history of anxiety may link with severe neurological AEs. Such vaccine recipients need further evaluation and monitor.