{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:30:26Z","timestamp":1792798226880,"version":"4.5.0"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T00:00:00Z","timestamp":1748995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T00:00:00Z","timestamp":1748995200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Introduction<\/jats:title>\n            <jats:p>The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) receives duplicate reports of adverse events associated with drug and therapeutic biological products. Duplicate reports, defined as multiple reports of the same adverse event(s) related to the administration of the same marketed product(s) to the same individual patient at a particular point in time, may be received in FAERS for many reasons. The presence of duplicate reports can negatively impact public health surveillance efforts by impeding both safety signal identification and signal evaluation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Objectives<\/jats:title>\n            <jats:p>To characterize the features and contributing factors associated with duplicate reports in FAERS.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>We manually assessed a convenience sample of individual case safety reports (ICSRs) for duplication, resulting in two data sets: one consisting of non-duplicate reports and one with duplicate reports. We then compared key features of these two datasets, including both structured and unstructured data fields. Key comparison features included: report and reporter type, country of report origin, data source for report, and outcome. In addition, we evaluated information similarity of reports for seven data elements (e.g., age, sex, suspect products) within sets of duplicates using both structured and unstructured fields. We used pairwise sentence\u00a0bidirectional encoder representations from transformers (SBERT) cosine similarity scores to examine free-text narrative similarity.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Among the 2297 reports in the sample, 901 (39%) were classified as duplicates, consisting of 237 unique duplicate sets. Compared to non-duplicate reports, duplicates were more likely to be foreign reports (82% versus 37%), reported by healthcare professionals (89% versus 68%), mention other regulatory authority databases (42% versus 11%), describe published case reports (34% versus 11%), or have a serious outcome (97% versus 83%) (<jats:italic>p<\/jats:italic> &lt; 0.0001). Within sets of duplicates (<jats:italic>n<\/jats:italic> = 237), coded information was frequently different, with only 16% (<jats:italic>n<\/jats:italic> = 39) having concordance of all 7 data elements. The narrative was highly similar among most sets of duplicates; we found that the median similarity score for the duplicate pairs was 0.87 compared to 0.48 for non-duplicate pairs.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>We observed differences in the attributes of and potential contributors to duplicate reports in FAERS that may inform duplicate prevention, detection, and management strategies. However, further studies are needed to better understand the implications of these findings and how potential regulatory changes and technological advances can be leveraged to further address duplicate reporting in adverse event reporting systems.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s40264-025-01560-7","type":"journal-article","created":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T11:34:45Z","timestamp":1749036885000},"page":"1119-1126","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["An Evaluation of Duplicate Adverse Event Reports Characteristics in the Food and Drug Administration Adverse Event Reporting System"],"prefix":"10.1007","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-8794-9749","authenticated-orcid":false,"given":"Scott","family":"Janiczak","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Tanveer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Tom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongmei","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong","family":"Ma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7372-6051","authenticated-orcid":false,"given":"Lisa","family":"Wolf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9754-1986","authenticated-orcid":false,"given":"Monica A.","family":"Mu\u00f1oz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,6,4]]},"reference":[{"key":"1560_CR1","unstructured":"U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) public dashboard. 2023. https:\/\/www.fda.gov\/drugs\/fdas-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-public-dashboard. Accessed 26 Nov 2024."},{"issue":"4","key":"1560_CR2","doi-asserted-by":"publisher","first-page":"e081990","DOI":"10.1136\/bmjopen-2023-081990","volume":"14","author":"R Kiguba","year":"2024","unstructured":"Kiguba R, Isabirye G, Mayengo J, et al. Navigating duplication in pharmacovigilance databases: a scoping review. BMJ Open. 2024;14(4):e081990. https:\/\/doi.org\/10.1136\/bmjopen-2023-081990.","journal-title":"BMJ Open"},{"key":"1560_CR3","unstructured":"International Council for Harmonisation. Post-approval safety data: definitions and standards for management and reporting of individual case safety reports (E2D(R1)). 2024. https:\/\/database.ich.org\/sites\/default\/files\/ICH_E2D%28R1%29_Step3_Draft%20Guideline_2024_0205.pdf. 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Several data were corrected throughout the article.","order":5,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 July 2025","order":6,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":7,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":8,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s40264-025-01585-y","URL":"https:\/\/doi.org\/10.1007\/s40264-025-01585-y","order":9,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This project was supported in part by an appointment to the Research Participation Program at the US Food and Drug Administration administered by the Oak Ridge Institute for Science and Education (ORISE) through an interagency agreement between the US Department of Energy and the US Food and Drug Administration. Sarah Tanveer and Karen Tom conducted this research while they were ORISE fellows in the Office of Surveillance and Epidemiology, Center of Drug Evaluation and Research, FDA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Scott Janiczak, Sarah Tanveer, Karen Tom, Rongmei Zhang, Yong Ma, Lisa Wolf, and Monica A. Mu\u00f1oz declare that they have no conflicts of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was determined to be exempt from review by the FDA Institutional Review Board.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval\/patient consent statement"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets used in the current study contain information that cannot be disclosed such as personal identifiers. Although data archiving is not mandated, select data that is able to be disclosed will be made available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"The analytic code can be made available upon request to the corresponding author.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors read and approved the final version. Concept and design: Monica Mu\u00f1oz, Scott Janiczak, and Sarah Tanveer. Acquisition, analysis, or interpretation of data: all authors. Drafting of the manuscript: Scott Janiczak and Sarah Tanveer. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Rongmei Zhang, Yong Ma, and Sarah Tanveer. Supervision: Monica Mu\u00f1oz and Scott Janiczak.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"This article reflects the views of the authors and should not be construed to represent the FDA\u2019s views or policies.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclaimer"}}]}}