Miao Liang, Lu Li, Wu Jiang, Suo Luo-dan, Liu Dong-lei, Sun Mei-ping, Pang Xing-huo, Deng Ying, Wang Xiao-li
Department of Immunization and Prevention, Beijing Center for Disease Prevention and Control, Beijing, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2010 Oct;44(10):884-7.
To evaluate the safety of 2009 influenza A (H1N1) vaccine based on mass immunization initiative in Beijing.
There were 2 113 280 people were vaccinated during September to December 2009. The information of adverse events following immunization (AEFI) was collected through surveillance system, and descriptive methodology was used for data analysis.
A Total of 612 AEFI cases were reported, among which there were 321 vaccine reaction cases following immunization, 203 coincidental illness cases, 82 psychogenic reaction cases, and 6 pending cases. The rates of rare reactions and common reactions associated with vaccination were respectively 5.54/100 000 (117/2 113 280) and 9.65/100 000 (204/2 113 280). The rate of serious rare reaction was 0.19/100 000 (4/2 113 280). The rates of vaccine reactions in urban, suburb and county were 16.87/100 000 (36/213 519), 17.81/100 000 (187/1 049 817) and 11.53/100 000 (98/849 944), respectively. The rates of rare reaction and common reaction in different age groups were between 3.65/100 000 (6/164 604) to 8.99/100 000 (27/300 176), and between 0.61/100 000 (1/164 604) to 22.06/100 000 (85/385 275). The 117 rear vaccine reaction cases were mainly allergic reaction (107 cases), and the 204 common vaccine reaction cases were mainly fever (176 cases). There were 91.90% (295/321) vaccine reactions occurred within 24 hours of administration, and all cases had improved consequence.
The mostly symptoms of AEFI cases during the period of 2009 influenza A (H1N1) vaccinoprophylaxis were anaphylaxis and fever. The types of adverse reactions and the level of serious events are consistent with the anticipation. There were no rear or new events occurred.
基于北京大规模免疫接种计划评估2009年甲型H1N1流感疫苗的安全性。
2009年9月至12月期间有2113280人接种了疫苗。通过监测系统收集免疫接种后不良事件（AEFI）信息，并采用描述性方法进行数据分析。
共报告612例AEFI病例，其中免疫接种后疫苗反应病例321例，偶合病症病例203例，心因性反应病例82例，待定病例6例。与疫苗接种相关的罕见反应和常见反应发生率分别为5.54/10万（117/2113280）和9.65/10万（204/2113280）。严重罕见反应发生率为0.19/10万（4/2113280）。城区、郊区和农村的疫苗反应发生率分别为16.87/10万（36/213519）、17.81/10万（187/1049817）和11.53/10万（98/849944）。不同年龄组的罕见反应和常见反应发生率在3.65/10万（6/164604）至8.99/10万（27/300176）之间，以及0.61/10万（1/164604）至22.06/10万（85/385275）之间。117例疫苗罕见反应病例主要为过敏反应（107例），204例疫苗常见反应病例主要为发热（176例）。91.90%（295/321）的疫苗反应发生在接种后24小时内，所有病例预后均有改善。
2009年甲型H1N1流感疫苗预防接种期间AEFI病例的主要症状为过敏反应和发热。不良反应类型及严重事件程度与预期一致。未发生罕见或新的事件。
