[Study on surveillance data of adverse events following immunization of seasonal influenza vaccine in China during 2015-2018 influenza season].

Objective: To analyze the occurrence features of adverse events following immunization (AEFI) of Seasonal Influenza Vaccines (InfV) used in China, 2015-2018 influenza season. Methods: InfV (including concurrent administered with other vaccines) AEFI data were collected through the Chinese national AEFI information system during 2015.9.1-2018.8.31 (excluding Chinese Hong Kong, Macao and Taiwan data). The vaccine lot release data were collected from National Institutes for Food and Drug Control published database. Time periods of three influenza season were 2015.9.1-2016.8.31, 2016.9.1-2017.8.31, 2017.9.1-2018.8.31. The vaccines used and included in this analysis were trivalent inactivated influenza vaccine (IIV3)-Split, IIV3-Split (Children) and IIV-subnit. The incidence of AEFI were calculated (per 100 000 release doses), and epidemiological characteristic were analyzed using descriptive methodology. Results: A total of 8 464 InfV AEFIs were collected in 2015-2018 influenza season from National AEFI Information System, in which 5 646 were IIV3-split, with the rate of 10.64/100 000 release doses, 2 818 were IIV3-split (Children), with the rate of 9.355/100 000 release doses. The most common symptom was fever (axillary temperature ≥37.1 ℃) within vaccine reactions, with a number of 6 207 cases. In which, there were 3 554 cases with fever (axillary temperature ≥38.6 ℃) and the estimated reporting rate was 4.274/100 000 release doses. In all rare vaccine reactions, the most common diagnosis was anaphylactic rash(442, 0.531/100 000 release doses) and angioedema (70, 0.084/100 000 release doses). Even the rates of serious rare vaccine reactions were low, febrile Convulsion (27, 0.032/100 000 release doses) and Henoch-Schönlein Purpura(HSP) (21, 0.025/100 000 release doses) were relatively common in serious rare vaccine reactions during the study period. Conclusion: The estimated rate of rare vaccine reactions related toInfV was relatively low. In all vaccine reactions, fever was the most common symptoms. The most common diagnosis of non-serious rare vaccine reaction were anaphylactic rash and angioedema. The incidence of serious rare vaccine reactions was low.目的： 分析中国2015—2018年流感季节流感疫苗（InfV）疑似预防接种异常反应（AEFI）的发生特征。 方法： 通过全国AEFI信息管理系统，收集中国（不包括中国香港、澳门和台湾数据）2015年9月1日至2018年8月31日流感季节接种InfV后发生AEFI的个案数据进行分析（含同时接种其他疫苗数据）。疫苗批签发剂次数据来源于中国食品药品检定研究院公布的批签发数据。3个流感季节分别为2015年9月1日至2016年8月31日，2016年9月1日至2017年8月31日，2017年9月1日至2018年8月31日；使用的疫苗分别为3价流感疫苗（IIV3）-Split、IIV3-Split（儿童型）、IIV3-subunit。计算AEFI发生率（/10万剂），采用描述流行病学方法分析3个流感季节AEFI的发生特征。 结果： 2015—2018年流感季节共报告InfVAEFI 8 464例，其中接种IIV3-split者为5 646例，发生率为10.645/10万剂；IIV3-split（儿童型）为2 818例，发生率为9.355/10万剂。不良反应中，报告例数最多的为发热（腋温≥37.1 ℃），共6 207例，其中3 554例出现高热（腋温≥38.6 ℃），发生率为4.274/10万剂。非严重异常反应中，报告较多的为过敏性皮疹（442例，0.531/10万剂）、血管性水肿（70例，0.084/10万剂）；严重异常反应发生率较低，其中报告较多的为热性惊厥（27例，0.032/10万剂）、过敏性紫癜（21例，0.025/10万剂）。 结论： 中国InfV接种后严重AEFI报告发生率较低；所有不良反应中，发热报告例数最多。非严重异常反应过敏性皮疹和血管性水肿报告例数较多，严重异常反应报告发生率低。.