基于美国疫苗不良事件报告系统的新型冠状病毒肺炎疫苗相关不良事件报告分析

Analysis of COVID-19 vaccine-related adverse event reports based on the American Vaccine Adverse Event Reporting System

目的:了解新型冠状病毒肺炎(COVID-19)疫苗相关不良事件的发生情况和特点,为预防接种和科学研究提供参考。方法:调取2020年1月1日-2021年2月26日期间美国疫苗不良事件报告系统中COVID-19疫苗相关报告,对受种者一般情况、接种剂次、发生时间、临床症状等信息进行回顾性分析。结果:18184例COVID-19疫苗相关不良事件报告中,严重报告3521例(19.36%);男女比例为1∶3.26;14194例(78.06%)发生于第1剂次接种后;13675例(75.20%)发生于接种后2天之内;共涉及3092种(89694例次)临床症状,主要表现为头痛、疲劳、发热等。916例死亡报告中有767例(83.73%)为65岁及以上受种者,631例(68.89%)发生于第1剂次接种后。结论:预防接种应重点关注老年受种者;持续开展疫苗安全性监测,有助于减少疫苗犹豫、提高接种率,最终有效控制COVID-19疫情。

Objective:To investigate the occurrence and characteristics of COVID-19 vaccine-related adverse event reports in order to provide references for vaccination and scientific research.Methods:The COVID-19 vaccine-related reports from January 1st,2020 to February 26th,2021 were collected from the American Vaccine Adverse Event Reporting System(VAERS).And the general information,dose series,occurrence time,clinical symptoms and other information of COVID-19 vaccine-related adverse event reports were retrospectively analyzed.Results:There were 3521(19.36%)serious reports among 18184 cases of COVID-19 vaccine-related adverse event reports.The ratio of male to female was 1∶3.26.14194 cases(78.06%)occurred after the first inoculation;13675 cases(75.20%)occurred within 2 days after vaccination.A total of 3092 kinds of clinical symptoms(89694 cases)were involved,in which the main symptoms were headache,fatigue,fever,etc.Of the 916 death reports,767 cases(83.73%)were recipients over 65 years old and 631 cases(68.89%)occurred after the first inoculation.Conclusion:The elderly recipients should be concerned particularly when getting vaccination of COVID-19.Continuous safety monitoring of COVID-19 vaccine is helpful to reduce vaccine hesitation,improve vaccination rate,and finally effectively control the epidemic of COVID-19.