中国药物警戒 ›› 2024, Vol. 21 ›› Issue (5): 572-579.
DOI: 10.19803/j.1672-8629.20230771

• 安全与合理用药 • 上一篇    下一篇

基于美国VAERS数据库的肝、肾移植受者接种新型冠状病毒疫苗不良事件分析

武一1,何金阳2,王晓剑1,周效竹1,3,刘冉佳1,郭明星1,赵莹1,代文迪4#,崔向丽1*   

  1. 1首都医科大学附属北京友谊医院药学部,北京,100050;
    2北京航空航天大学数学科学学院,北京,100191;
    3首都医科大学药学院,北京,100069;
    4首都医科大学附属北京友谊医院肾内科,北京 100050
  • 收稿日期:2023-12-08 出版日期:2024-05-15 发布日期:2024-05-13
  • 通讯作者: *崔向丽,女,博士,主任药师,临床药学。E-mail：cui10@163.com #为共同通信作者。
  • 作者简介:武一,男,博士,药师,临床药学。
  • 基金资助:
    北京市通州区科技计划项目（KJ2022CX039）; 国家卫生健康委医院管理研究所医院药学高质量发展研究项目（NIHAYS2302）

Adverse events of COVID-19 vaccination in recipients of liver and kidney transplant based on US VAERS database

WU Yi1, HE Jinyang2, WANG Xiaojian1, ZhOU Xiaozhu1,3, LIU Ranjia1, GUO Mingxing1, ZHAO Ying1, DAI Wendi4#, CUI Xiangli1,*   

  1. 1Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China;
    2School of Mathematical Sciences, Beihang University, Beijing 100191, China;
    3Capital Medical University, Beijing 100069, China;
    4Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2023-12-08 Online:2024-05-15 Published:2024-05-13

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摘要： 目的 通过对美国疫苗不良反应事件报告系统（vaccine adverse event reporting system,VAERS）中肝、肾移植受者接种新型冠状病毒疫苗后的不良反应数据进行挖掘,分析其具体特征,为器官移植受者接种新型冠状病毒疫苗提供安全性数据参考。方法 提取2020年12月18日到2023年5月24日VAERS数据库中肝、肾移植患者新型冠状病毒疫苗相关不良事件数据,用比例失衡法统计分析不良事件报告基本情况,对例数大于3的不良事件进行筛选和系统-器官分类分析。结果 共收集接种新型冠状病毒疫苗13个系统-器官分类的不良反应报告,肝移植253例,肾移植817例,常见不良反应为头痛、疲劳、发热、寒战、肢体疼痛、头晕、咳嗽、腹泻等。其中临床需关注新的不良反应有急性肾损伤、心房纤颤、丙氨酸转氨酶升高、移植排斥反应、病情加重、血氧饱和度降低等。结论 通过VAERS系统对肝、肾移植患者接种疫苗后不良反应数据挖掘,检测出多个值得关注的新的不良反应,为进一步开展移植患者接种新型冠状病毒疫苗提供参考。

关键词: 新型冠状病毒, 疫苗, 肝移植受者, 肾移植受者, 疫苗不良反应事件报告系统, 不良事件, 系统-器官

Abstract: Objective To mine and analyze data on adverse events among liver or kidney transplant recipients following COVID-19 vaccination based on the Vaccine Adverse Event Reporting System (VAERS). Methods The data on adverse events related to COVID-19 vaccines among liver or kidney transplant patients and collected between December 18, 2020 and May 24, 2023 was retrieved before being analyzed using disproportionality methods. Adverse events involving more than 3 cases were screened and analyzed via system organ classification. Results 253 and 817 adverse events related to COVID-19 vaccines were respectively collected among recipients of liver and kidney transplant. The common adverse reactions were headache, fatigue, fever, chills, limb pain, dizziness, cough and diarrhea, involving 13 system organ classifications of both liver and kidney transplant recipients. New adverse event signals that deserved clinical attention included deterioration of conditions, acute renal injury, elevated serum creatinine, atrial fibrillation, elevated alanine aminotransferase, transplant rejection, and decrease of blood oxygen saturation. Conclusion A number of new adverse event signals have been detected, which can provide reference for subsequent development of COVID-19 vaccines for liver and kidney transplant patients.

Key words: COVID-19, vaccine, liver transplant patient, recipients of kidney transplant, Vaccine Adverse Event Reporting System(VAERS), adverse event, system organ

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