目的 分析2010-2021年陕西省疑似预防接种异常反应(adverse event following immunization,AEFI)监测情况及发生特征.方法 通过中国免疫规划信息管理系统和AEFI信息管理系统,收集2010-2021年陕西省各类疫苗接种数据和AEFI个案信息,并进行描述性分析.结果 2010-2021年陕西省共报告24057例AEFI,2014-2021年均AEFI报告发生率为18.998/10万剂次,其中一般反应17.998/10万剂次、异常反应0.702/10万剂次、严重AEFI 0.112/10万剂次;5-8月AEFI发生率较高,平均为26.304/10万剂次;≤1岁的个案占69.83％;免疫规划疫苗中百白破疫苗(无细胞)AEFI报告发生率最高(57.948/10万剂次),含麻类疫苗异常反应报告发生率最高(1.875/10万剂次);非免疫规划疫苗中百白破-Hib联合疫苗AEFI报告发生率最高(37.073/10万剂次),ACYW135流脑多糖疫苗异常反应报告发生率最高(2.392/10万剂次);一般反应分类中临床诊断主要为高热/局部红肿/局部硬结(22.481/10万剂次),异常反应分类中临床诊断主要为过敏性皮疹(0.473/10万剂次).结论 陕西省AEF1监测系统敏感性逐年上升,各疫苗安全性良好,以一般反应为主,严重异常反应罕见,不同地市AEFI监测水平存在差异,仍需加强培训.
Surveillance of adverse events following immunization in Shaanxi Province,2010-2021
Objective To analyze the surveillance quality and characteristics of adverse events following immunization(AEFIs)in Shaanxi Province,from 2010 to 2021.Methods The vaccine doses administered data and AEFI data reported from 2010 to 2021 in Shaanxi Province were collected through the National Immunization Program Information Management System and AEFI information management system,and descriptive epidemiological methods were used for analysis.Results A total of 24 057 AEFIs were reported from 2010 to 2021 in Shaanxi Province.The average annual reported incidence of AEFI in 2014-2021 was 18.998 per 100 000 doses,with 17.998,0.702,and 0.112 per 100 000 doses for common vac-cine reactions,rare vaccine reactions,and serious rare vaccine reactions,respectively.The incidence of AEFI was high from May to August,with an average of 26.304 per 100 000 doses.There were 69.83％of the cases reported by the children younger than 1 year old.In Expanded Program on Immunization vaccines,the incidence of AEFI in DTaP(diphtheria,teta-nus and acellular pertussis combined vaccine)was the highest(57.948 per 100 000 doses),and the incidence of rare vac-cine reactions in MR,MMR and MM(measles and rubella vaccine,measles mumps and rubella vaccine,measles and mumps combined vaccine)was the highest(1.875 per 100 000 doses).In non-Expanded Program on Immunization vac-cines,the incidence of AEFI in DTaP-Hib(diphtheria,tetanus and acellular pertussis,inactivated poliomyelitis and hae-mophilus influenzae type b conjugate combined vaccine)was the highest(37.073 per 100 000 doses),and the incidence of rare vaccine reactions in MPV-ACYW135(group A,C,Y and W123 meningococcal polysaccharide vaccine)was the highest(2.392 per 100 000 doses).In common vaccine reactions,the fever/local redness and swelling/local induration were the main clinical diagnosis(22.481 per 100 000 doses).In rare vaccine reactions,allergic rash was the main clinical diagnosis(0.473 per 100 000 doses).Conclusion The sensitivity of AEFI surveillance system in Shaanxi Province is increasing year by year,and the vaccines have good safety,with common vaccine reactions as the main ones and serious rare vaccine reac-tions as the rare ones.There were differences in AEFI surveillance levels in different prefecture-level cities,so it is still necessary to strengthen the training.
Adverse event following immunization(AEFI)SurveillanceCharacteristics of occurrence
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