向疫苗不良事件报告系统报告HPV疫苗接种后的不良事件
Adverse events following HPV vaccine reported to the Vaccine Adverse Event Reporting System.
摘要(中文译文)
针对高危型HPV的疫苗接种是一项关键预防措施。然而，对疫苗安全性的担忧可能阻碍疫苗接种工作。本研究旨在评估2006年至2024年HPV疫苗接种后向疫苗不良事件报告系统（VAERS）报告的不良事件（AEs），为其安全性特征提供见解。我们分析了VAERS数据，这是一个包含去标识化AE报告的自发性报告系统。应用了四种不相称性分析方法（ROR、PRR、BCPNN和MGPS），仅当四种方法同时满足阳性标准时才定义不良事件信号。使用R软件和Microsoft Excel进行统计分析，显著性阈值设为p < 0.05。共分析了77,909份HPV疫苗相关AE报告，其中68.4%涉及女性，48.7%影响18岁以下个体。严重AE占11,659份报告，头痛和疲劳最为常见。晕厥是最常见的信号，而体位性直立性心动过速综合征（POTS）表现出最强的信号强度。约90%的AE发生在接种后30天内。在疫苗类型中，HPV4的报告数量最多，肌内注射是最常见的接种途径。本研究提供了对HPV疫苗接种后报告的不良事件的更新药物警戒评估，突出了可能值得进一步调查的报告模式和统计信号。
Abstract
Vaccination against high-risk HPV types is a key preventive measure. However, concerns regarding vaccine safety may hinder vaccination efforts. This study aims to evaluate adverse events (AEs) reported in the Vaccine Adverse Event Reporting System (VAERS) following HPV vaccination from 2006 to 2024, providing insights into its safety profile. We analyzed VAERS data, a spontaneous reporting system containing de-identified AE reports. Four disproportionality analyses (ROR, PRR, BCPNN, and MGPS) were applied, and adverse event signals were defined only when the positive criteria were simultaneously met across all four methods. Statistical analyses were performed using R software and Microsoft Excel, with a significance threshold of p < 0.05. A total of 77,909 HPV vaccine-related AE reports were analyzed, with 68.4% involving females and 48.7% affecting individuals under 18. Serious AEs accounted for 11,659 reports, with headache and fatigue being the most common. Syncope was the most frequent signal, while postural orthostatic tachycardia syndrome (POTS) exhibited the strongest signal strength. Approximately 90% of AEs occurred within 30 days post-vaccination. Among vaccine types, HPV4 had the highest number of reports, and intramuscular injection was the most common administration route. This study offers an updated pharmacovigilance assessment of adverse events reported following HPV vaccination, highlighting reported patterns and statistical signals that may warrant further investigation.
如何引用
AMA
Siqi Zhang, Yu Li, Miaomiao Liu, Jiajia Yang, Xiong Wang, Mingshan Wang. Adverse events following HPV vaccine reported to the Vaccine Adverse Event Reporting System.. PloS one. 2026; doi:10.1371/journal.pone.0351652.
APA
Siqi Zhang, Yu Li, Miaomiao Liu, Jiajia Yang, Xiong Wang, Mingshan Wang (2026). Adverse events following HPV vaccine reported to the Vaccine Adverse Event Reporting System.. PloS one. https://doi.org/10.1371/journal.pone.0351652
GB/T 7714
Siqi Zhang, Yu Li, Miaomiao Liu, Jiajia Yang, Xiong Wang, Mingshan Wang. Adverse events following HPV vaccine reported to the Vaccine Adverse Event Reporting System.[J]. PloS one, 2026 doi:10.1371/journal.pone.0351652.
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