BACKGROUND & AIMS:
:Adverse events following pandemic (H1N1) 2009 vaccines ("2009 H1N1 vaccines") in Taiwan were passively reported to the National Adverse Drug Reaction Reporting System. To evaluate the completeness of spontaneous reporting, cases of death, Guillain-Barré syndrome (GBS), convulsion, Bell's palsy, and idiopathic thrombocytopenic purpura (ITP) after 2009 H1N1 vaccination that occurred between November 1, 2009 and August 31, 2010 were selected from the National Adverse Drug Reaction Reporting System (NADRRS) database and an additionally constructed nationwide large-linked database (LLDB), and matched on a unique personal identifier, date of vaccination (within ±7 days), and date of diagnosis (within ±7 days). Overall, matches occurred between the two data sources included 21 for death, 5 for GBS, 19 for convulsion, 22 for Bell's palsy, and 5 for ITP. The Chapman capture-recapture estimated spontaneous reporting completeness within 0-42 days of vaccination was 4% for death, 71% for GBS, 3% for convulsion, 9% for Bell's palsy, and 15% for ITP. For the interval ≥43 days after vaccination, reporting completeness was 0.1% for death, 14% for GBS, 0.1% for convulsion, <0.1% for Bell's palsy, and 0% for ITP. The estimated-to-expected ratio for Bell's palsy in the interval 0-42 days after vaccination was 1.48 (95% CI 1.11-1.98). Reporting completeness was higher for GBS than other adverse events after 2009 H1N1 vaccination. Linking the NADRRS to existing data sources in a capture-recapture analysis can be considered as an alternative to enhance Taiwan's postlicensure safety assessment of other routine vaccines. Nevertheless, the possibility of an increased risk for Bell's palsy detected by capture-recapture analyses needs further evaluation by controlled studies.
背景与目标:
: 台湾大流行 (H1N1) 2009疫苗 (“2009 H1N1疫苗”) 后的不良事件被动报告给国家药品不良反应报告系统。为了评估自发报告的完整性,死亡病例,格林-巴利综合征 (GBS),惊厥,贝尔麻痹,2009年11月1日至2010年8月31日之间发生的特发性血小板减少性紫癜 (ITP) 2009年H1N1疫苗接种是从国家药品不良反应报告系统 (NADRRS) 数据库和另外构建的全国大型链接数据库 (LLDB) 中选择的,并在唯一的个人标识符上进行匹配,接种日期 (± 7天内) 和诊断日期 (± 7天内)。总体而言,两个数据源之间发生了匹配,包括死亡21例,GBS 5例,抽搐19例,贝尔麻痹22例和ITP 5例。Chapman捕获-再捕获估计的疫苗接种后0-42天内的自发报告完整性为死亡4%,GBS 71%,惊厥3%,贝尔麻痹9%,ITP 15%。对于接种后 ≥ 43天的间隔,报告完整性0.1% 为死亡,14% 为GBS,0.1% 为惊厥,<0.1% 为贝尔麻痹,0% 为ITP。1.48接种后0-42天间隔内贝尔麻痹的估计与预期的比率 (95% CI 1.11-1.98)。GBS的报告完整性高于其他2009年H1N1疫苗接种的不良事件。在捕获-再捕获分析中,将NADRRS与现有数据源链接可以被视为增强台湾对其他常规疫苗的许可后安全性评估的替代方法。然而,通过捕获-再捕获分析发现贝尔麻痹风险增加的可能性需要通过对照研究进行进一步评估。