COVID-19 mRNA 疫苗在短期内通常是安全的：一项疫苗监测真实世界研究称。

COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says.

机构信息

Nephrology Department, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.

Pharmacy Department, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.

出版信息

Front Immunol. 2021 May 21;12:669010. doi: 10.3389/fimmu.2021.669010. eCollection 2021.

DOI:10.3389/fimmu.2021.669010

PMID:34093567

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8177815/

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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% 49.62%, OR = 1.88, ). History of anxiety or depression was more common in subjects reporting severe neurological AEFIs than those reporting other AEFIs (18.37% 7.85%, OR = 2.64, ). Cases reporting death were significantly older (79.36 ± 10.41-year-old 42.64 ± 12.55-year-old, , 95% CI 29.30-44.15) and more likely experienced hypertension (50.00% 11.42%, OR = 7.76, ) and neurological disorders (50.00% 5.36%, OR = 17.65, ) 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.

CONCLUSION

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.

摘要

背景

COVID-19 mRNA 疫苗的预防性接种是人类首次大规模应用这种疫苗。截至 2020 年 12 月，美国已经接种了超过 180 万剂 COVID-19 疫苗，约有 0.2%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 COVID-19 疫苗接种后的不良事件（AEFIs），并根据 VAERS 数据库中的信息分析潜在的相关性。

方法

我们搜索了 2020 年 12 月 VAERS 数据库中记录的 COVID-19 疫苗接种后的 AEFIs。在数据映射后，我们总结了报告病例的人口统计学和临床特征。Fisher 确切检验用于比较有过敏反应、神经系统疾病和死亡的 AE 组之间的临床特征。

结果

VAERS 在 2020 年 12 月报告了 3908 例 COVID-19 疫苗的 AEFIs。大多数（79.68%）是在疫苗接种第一针后报告的。在报告的病例中，我们发现一般疾病（48.80%）、神经系统疾病（46.39%）和胃肠道疾病（25.54%）是最常见的 AEFIs。有过敏反应的疫苗接种者过敏史比没有过敏反应的更常见（64.91% 49.62%，OR=1.88，）。报告严重神经系统 AEFIs 的受试者焦虑或抑郁史比报告其他 AEFIs 的更常见（18.37% 7.85%，OR=2.64，）。报告死亡的病例明显年龄较大（79.36±10.41 岁 42.64±12.55 岁，，95%CI 29.30-44.15），更可能患有高血压（50.00% 11.42%，OR=7.76，）和神经系统疾病（50.00% 5.36%，OR=17.65，）比其他疫苗接种者（，）。AEFIs 的门诊和急诊就诊率分别为 11.92%和 22.42%，需要住院的病例为 2.53%。