Noda Aoi, Sakai Takamasa, Tsuchiya Masami, Oyanagi Gen, Obara Taku, Mano Nariyasu
Division of Preventive Medicine and Epidemiology, Tohoku University Tohoku Medical Megabank Organization, Sendai, Miyagi 980-8573, Japan.
Division of Molecular Epidemiology, Environment and Genome Research Center, Graduate School of Medicine, Tohoku University, Sendai, Miyagi 980-8573, Japan.
Vaccines (Basel). 2020 Jul 3;8(3):357. doi: 10.3390/vaccines8030357.
The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10-19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of "death" and "did not recover" as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10-19 years, respectively. The most frequently reported vaccine-reaction pair was type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10-19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.
本研究旨在描述日本药品不良反应报告数据库（JADER）中儿童免疫接种后不良事件（AEFI）报告的趋势和特征。我们在JADER 2004年至2017年纳入的504,407份药品不良反应报告中，使用了6280份19岁以下儿童的AEFI报告。10岁以下儿童的AEFI报告数量逐渐增加，10 - 19岁儿童的报告数量在2011年最高。2011年后，10岁以下儿童每份AEFI报告中疑似疫苗的数量增加。报告的AEFI结果中，“死亡”和“未恢复”的百分比在10岁以下儿童中分别为4.3%和3.7%，在10 - 19岁儿童中分别为0.2%和21.1%。最常报告的疫苗 - 反应组合在10岁以下儿童中是b型结合疫苗和发热，在10 - 19岁儿童中是重组吸附二价人乳头瘤病毒样颗粒疫苗和意识丧失。由于日本疫苗接种的药物警戒活动不足，有必要考虑韦伯效应以了解AEFI报告的趋势和特征。
