Mahajan Deepika, Roomiani Ilnaz, Gold Michael S, Lawrence Glenda L, McIntyre Peter B, Menzies Rob I
National Centre for Immunisation Research and Surveillance of Vaccine Preventable, University of Sydney, The Children's Hospital, Westmead, Sydney, New South Wales.
Commun Dis Intell Q Rep. 2010 Sep;34(3):259-76.
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2009, and describes reporting trends over the 10-year period 2000 to 2009. There were 2,396 AEFI records for vaccines administered in 2009, the highest number reported, a 46% increase over the 1,638 in 2008. The increase was almost entirely due to reports related to the introduction of pandemic H1N1 (pH1N1) 2009 influenza vaccine from September 2009 (n = 1,312) largely from the members of the public. The pH1N1 AEFI reporting rate for people aged > or = 18 years was 34.2 per 100,000 administered doses compared with 2.8 for seasonal influenza vaccine. The rates in > or = 65 year-olds were 28.0, 1.6 and 13.3 for pH1N1, seasonal influenza and polysaccharide pneumococcal, respectively. The high reporting rate for pH1N1 vaccine is likely to be at least partly due to enhanced reporting seen for all new vaccines and greater levels of reporting from members of the public in response to the implementation of strategies to encourage reporting, as part of the pH1N1 program. For children < 7 years, AEFI reporting rates in 2009 (14.1 per 100,000 administered doses) were similar to previous years. There were 193 (8%) AEFI reports classified as serious; 6 deaths temporally associated with immunisation were reported but none were judged to have a causal association. As in previous years, the most commonly reported reactions were allergic reaction, injection site reaction, fever, headache, malaise, nausea and myalgia. The most commonly reported reactions following pH1N1 influenza vaccine were allergic reaction (n = 381), headache (n = 289), fever (n = 235), pain (n = 186), nausea (n = 180) and injection site reaction (n = 178). The data within the limitation of passive surveillance provide a reference point for ongoing reporting of trends in AEFI by age group, severity and vaccine type and illustrate the value of the national TGA database as a surveillance tool for monitoring AEFI nationally.
本报告总结了2009年向澳大利亚治疗用品管理局（TGA）报告的免疫接种后不良事件（AEFI）的被动监测数据，并描述了2000年至2009年这10年期间的报告趋势。2009年有2396条疫苗接种AEFI记录，为报告数量最多的一年，比2008年的1638条增加了46%。增长几乎完全归因于2009年9月引入的2009年甲型H1N1流感大流行（pH1N1）疫苗相关报告（n = 1312），主要来自公众。18岁及以上人群的pH1N1 AEFI报告率为每10万剂接种量34.2例，而季节性流感疫苗为2.8例。65岁及以上人群中，pH1N1、季节性流感和多糖肺炎球菌疫苗的报告率分别为28.0、1.6和13.3。pH1N1疫苗报告率高可能至少部分归因于所有新疫苗报告率的提高，以及公众因作为pH1N1计划一部分的鼓励报告策略的实施而增加的报告量。对于7岁以下儿童，2009年的AEFI报告率（每10万剂接种量14.1例）与前几年相似。有193份（8%）AEFI报告被归类为严重；报告了6例与免疫接种时间相关的死亡，但均未判定有因果关系。与往年一样，最常报告的反应是过敏反应、注射部位反应、发热、头痛、不适、恶心和肌痛。pH1N1流感疫苗接种后最常报告的反应是过敏反应（n = 381）、头痛（n = 289）、发热（n = 235）、疼痛（n = 186）、恶心（n = 180）和注射部位反应（n = 178）。被动监测范围内的数据为按年龄组、严重程度和疫苗类型持续报告AEFI趋势提供了参考点，并说明了国家TGA数据库作为全国监测AEFI的监测工具的价值。
