Quality Assessment of Adverse Event Reports on Vaccines in the Japanese Adverse Drug Event Report Database

Quality Assessment of Adverse Event Reports on Vaccines in the Japanese Adverse Drug Event Report Database | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 31 October 2025 V1 Latest version Share on Quality Assessment of Adverse Event Reports on Vaccines in the Japanese Adverse Drug Event Report Database Authors : Kentaro Kawashima 0009-0008-4209-4929 [email protected] and Mamoru Narukawa Authors Info & Affiliations https://doi.org/10.22541/au.176188155.56234394/v1 183 views 97 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Purpose The quality of adverse event (AE) reports plays a critical role in detecting safety signals and evaluating causal relationships with drugs. Although various methods have been used to assess AE report quality, comprehensive evaluations of vaccine data in the Japanese Adverse Drug Event Report (JADER) database remain limited. This study aimed to assess the quality of vaccine-related AE reports in the JADER using the vigiGrade completeness score. Method AE reports from the JADER, covering April 2004 to January 2022, were analyzed using the vigiGrade completeness score. Logistic regression analysis was performed to identify factors associated with ”well-documented reports” (i.e., reports with a completeness score >0.8). Results Among the 12,759 vaccine-related AE reports analyzed, 8,472 (66.0%) were classified as well-documented. Higher report quality was associated with submissions from healthcare professionals, reports originating from pharmaceutical companies, and cases reported under mandatory reporting requirements of the Immunization Act. Conversely, lower quality was observed in reports involving vaccine-specific AEs. Conclusion The quality of vaccine-related AE data in the JADER is generally sufficient for safety signal analysis and may exceed that of other pharmacovigilance databases. Nonetheless, reports from medical institutions and non-healthcare professionals demonstrated lower completeness, indicating a need for improved reporting practices. Enhancing accuracy and completeness is crucial for effective pharmacovigilance. Supplementary Material File (pds-25-0910-file001.docx) Download 111.66 KB Information & Authors Information Version history V1 Version 1 31 October 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords adverse drug reaction reporting system japanese adverse drug event report database pharmacovigilance vaccine Authors Affiliations Kentaro Kawashima 0009-0008-4209-4929 [email protected] Kitasato Daigaku Yakugakubu Daigakuin Yakugaku Kenkyuka View all articles by this author Mamoru Narukawa Kitasato Daigaku Yakugakubu Daigakuin Yakugaku Kenkyuka View all articles by this author Metrics & Citations Metrics Article Usage 183 views 97 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Kentaro Kawashima, Mamoru Narukawa. Quality Assessment of Adverse Event Reports on Vaccines in the Japanese Adverse Drug Event Report Database. Authorea . 31 October 2025. DOI: https://doi.org/10.22541/au.176188155.56234394/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. 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