국내 허가 백신의 이상사례 보고현황과 실마리정보 분석

Trends in Adverse Event Reports and Signal Detection of Adverse Event Following Vaccination

As vaccines are administered to many people, the management of adverse reactions to vaccines should be a priority. This study aims to detect signals of adverse events following immunization to provide information on the events requiring attention. The Korean Adverse Event Reporting System database from 2010 to 2019 was used. Time series, status, and signal analyses were performed. The number of adverse events following immunization from 2010 to 2019 was determined. A comparison group was established considering the main vaccination targets for each vaccine. Signal information was detected that satisfies all four signal detection methods: proportional reporting ratio, reporting odds ratio, information component, and TreeScan. From 2010 to 2019, the number of adverse events following immunization reported was 37,688. The vaccines having the most reported adverse events were influenza (17,290 cases, 45.9%). Because of identifying the signal information of the top-10 vaccines based on adverse events, 74 adverse events were identified in 6 vaccines. The results are expected to contribute to the prevention of adverse events by providing information on adverse events following immunization requiring attention.