目的 基于美国疫苗不良事件报告系统数据，分析人用狂犬病疫苗（rabies vaccine for human use，RVFHU）相关不良事件，评估其安全性。方法 选取美国疫苗不良事件报告系统中2019年1月1日至2023年9月15日的RVFHU相关报告，采用描述性统计方法分析不良事件分布特征，应用不相称测定法检测疫苗安全性信号。结果 共纳入794例不良事件报告（2 606例次临床症状）。临床症状以产品使用问题最多，系统器官分类中全身性疾病及给药部位症状占比最高。一般不良事件和严重不良事件构成比方面，接种剂次的构成比差异有统计学意义（χ²=10.25，P<0.05），而性别、年龄、发生时间的构成比差异均无统计学意义（χ²=0.32、2.58、2.02，P>0.05）。安全性信号检测发现59条阳性信号，涉及产品使用、免疫系统异常、精神病类反应等方面。结论 RVFHU相关不良事件多为产品使用问题或一过性轻度反应；检测出的阳性信号数据较少，尚需进一步研究验证。

Objective To analyze adverse events associated with rabies vaccine for human use (RVFHU) based on data from the US Vaccine Adverse Event Reporting System (VAERS) and to evaluate the safety profile of RVFHU.Methods RVFHU-related reports were retrieved from the VAERS database for the period from January 1, 2019 to September 15, 2023. Descriptive statistical analysis was employed to characterize the distribution of adverse events, and disproportionality analysis was applied to detect vaccine safety signals.Results A total of 794 adverse event reports (comprising 2 606 clinical symptoms) were included. Product use issues were the most frequently reported clinical symptoms. In terms of System Organ Class, symptoms related to general disorders and administration site conditions accounted for the highest proportion. Regarding the composition ratios of general adverse events and serious adverse events by vaccination dose, the difference was statistically significant (χ²=10.25, P<0.05), whereas no statistically significant differences were observed for gender, age, or time of occurrence (χ²=0.32, 2.58, 2.02, respectively; P>0.05). Disproportionality analysis identified 59 positive safety signals, involving product use issues, immune system disorders, psychiatric disorders, and other aspects.Conclusions Adverse events associated with RVFHU are predominantly product use issues or transient and mild reactions. The positive safety signals detected are limited in number and require further investigation and validation.