P226: Safety Profile of SARS-CoV-2 RNA Vaccines based on Adverse Event Reports in Japan
Poster Presenter
Daisuke Koide
Project Professor, Department of Biostatistics and Bioinformatics
Graduate School of Medicine, The University of Tokyo Japan
Objectives
the objective is to characterize reported adverse events from COVID-19 vaccines and determine their safety profile in Japan.
Method
The study used JADER which contains adverse events of SARS-CoV-2 RNA vaccines reported to PMDA from Jan 2021 to Sep 2024. Data were summarized in order of number of reports and highest reporting odds ratio (ROR) with Czeek V Pro (Ark Medical Solutions Inc.).
Results
The number of adverse event reports related to SARS-CoV-2 RNA Vaccines was 25,512. By gender, there were 8,650 (33.9%) male cases, 16,401 (64.3%) female cases, and 461 (1.8%) unknown cases. By age group, there were 1,471 cases (5.8%) for under 15 year old, 5,506 (21.6%) cases for 16-30 year old, 7,000 cases (27.4%) for 31-50 year old, 2,825 cases (11.1%) for 51-60 year old, 3,676 cases (14.4%) for 61-70 year old, 3,786 cases (14.8%) for over 71 year old, and 1,248 cases (4.9%) for unknown. The most frequently reported adverse event was fever (n=4,189, 16.4%), followed by anaphylactic reactions (n=3,337, 13.1%), fatigue (n=2,273, 8.9%), dyspnea (n=2,183), and nausea (n=2,160). The ROR values in order were: suspected Covid-19 189.7 (n=489), immune-related 97.4 (n=44), vaccination site discoloration 65.3 (n=10), vaccination site pruritus 62.3 (n=87), and radial nerve injury 59.7 (n=8).
Conclusion
As the safety profile of SARS-CoV-2 RNA Vaccines based on JADER in Japan, the case majority was female, and the most and least common age groups were 31-50 and under 15 year old. The top 5 frequently reported cases or the top 5 ROR values were less serious cases, except for anaphylactic reactions. It seems necessary for further research to focus on serious outcomes. This study was supported by MHLW Research Program Grant Number JPMH23KC2003.
