Pharmacovigilance analysis of spondyloarthritis following HPV vaccination based on the VAERS database

基于疫苗不良事件报告系统(VAERS)数据库的人乳头瘤病毒(HPV)疫苗接种后脊柱关节炎药物警戒分析

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Abstract

HPV vaccine is an important biological product that contributes to disease prevention and control and public health system construction, and it shows an increasing vaccination rate year by year. Based on this high vaccination rate, it has brought about many adverse events. The aim of this study was to investigate the association between real world HPV vaccine and spondyloarthritis. Data from Vaccine Adverse Event Reporting System (VAERS) through January 1, 2025 were included in the study. Four pharmacovigilance analysis methods and bonferroni corrected P-values were utilized to uncover associations between HPV vaccines and spondyloarthritis. In addition, subgroup analyses were utilized to explore populations with different characteristics. Complementarily, time to induction analysis and Weibull distribution analysis were utilized to expand the research horizons. Of the 60,840 HPV vaccine-related adverse events recorded in the VAERS database during the study period, 141 could be attributed to spondyloarthritis. Of these, juvenile idiopathic arthritis and reactive arthritis were monitored for warning signs of positive significance. The results of the subgroup analysis showed that the gender was female and the age group was lower was found to have higher positive signals for adverse events. Weibull distribution analysis showed that the vaccine had an early-onset profile, HPV vaccine-induced spondyloarthritis was progressive and decreasing over time. This study suggests an association between HPV vaccine and spondyloarthritis with different predisposing risks in different patient populations and treatment stages. Patients should be closely monitored for spondyloarthritis-related markers and assessed for risk during HPV vaccination. This study provides more comprehensive insights into HPV vaccine safety and the understanding of spondyloarthritis.

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