Lawrence Glenda, Menzies Robert, Burgess Margaret, McIntyre Peter, Wood Nicholas, Boyd Ian, Purcell Patrick, Isaacs David
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Children's Hospital at Westmead, and the University of Sydney, New South Wales.
Commun Dis Intell Q Rep. 2003;27(3):307-23.
The Adverse Drug Reactions Advisory Committee (ADRAC) database collates notifications of adverse events following immunisation (AEFI) from across Australia. The data were analysed for vaccines received between 1 January 2000 and 30 September 2002. Dose-based AEFI reporting rates were calculated using denominator data from the Australian Childhood Immunisation Register and annual national influenza vaccination coverage surveys. The majority of the 2,409 AEFI records analysed described non-serious events, principally injection site reactions; 10.5 per cent (n = 253) described AEFIs with outcomes defined as 'serious'. Ten deaths were recorded but only one, following yellow fever vaccine, was causally related to immunisation. The average annual population-based reporting rate was 4.5 per 100,000 population. Vaccine dose-based AEFI reporting rates were 2.2 per 100,000 doses of influenza vaccine for adults aged 40 years and over and 14.6 per 100,000 doses of all scheduled vaccines for children aged less than 7 years. The most frequently reported type of adverse event was injection site reaction following receipt of an acellular pertussis-containing vaccine, particularly among children in the age groups scheduled to receive their fourth or fifth doses of the vaccine (overall reporting rate 67 per 100,000 doses). The data highlight the safety of vaccines in Australia, and illustrate both the utility of available immunisation coverage data to estimate dose-based AEFI reporting rates and the value of the ADRAC database as a surveillance tool for monitoring AEFIs nationally.
药物不良反应咨询委员会（ADRAC）数据库收集了来自澳大利亚各地的免疫接种后不良事件（AEFI）报告。对2000年1月1日至2002年9月30日期间接种的疫苗数据进行了分析。基于剂量的AEFI报告率是使用澳大利亚儿童免疫登记册的分母数据和年度全国流感疫苗接种覆盖率调查来计算的。分析的2409条AEFI记录中，大多数描述的是非严重事件，主要是注射部位反应；10.5%（n = 253）描述的AEFI结局被定义为“严重”。记录了10例死亡，但只有1例在接种黄热病疫苗后与免疫接种有因果关系。基于人群的年平均报告率为每10万人4.5例。40岁及以上成年人流感疫苗基于剂量的AEFI报告率为每10万剂2.2例，7岁以下儿童所有常规疫苗基于剂量的AEFI报告率为每10万剂14.6例。报告最频繁的不良事件类型是接种含无细胞百日咳疫苗后的注射部位反应，特别是在计划接种第四剂或第五剂该疫苗的年龄组儿童中（总体报告率为每10万剂67例）。这些数据突出了澳大利亚疫苗的安全性，并说明了可用的免疫接种覆盖率数据在估计基于剂量的AEFI报告率方面的实用性，以及ADRAC数据库作为全国监测AEFI的监测工具的价值。
