{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T09:17:37Z","timestamp":1788513457408,"version":"build-2803163510"},"reference-count":53,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014440","name":"Ministerio de Ciencia, Innovaci\u00f3n y Universidades","doi-asserted-by":"publisher","award":["PID 2023\u2013153094OB-I00"],"award-info":[{"award-number":["PID 2023\u2013153094OB-I00"]}],"id":[{"id":"10.13039\/100014440","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Drug Saf. Regul."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Spontaneous reporting systems (SRSs) gather millions of reports of adverse events occurring to patients worldwide. For its volume and breadth of data, they are often regarded as the cornerstone of pharmacovigilance. However, their individual and intra-database characteristics remain incompletely described.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Four SRSs were considered, namely, the WHO global database VigiBase, the FDA Adverse Event Reporting System (FAERS), the Vaccine Adverse Event Reporting System (VAERS), and the Japanese Adverse Drug Event Report database (JADER). As of 31 December 2025, these databases contain approximately 42.4 million, 26.3 million, 2.7 million and 0.9 million reports, respectively. Following deduplication, approximately 11.1 million reports were uniquely shared between VigiBase and FAERS and close to 1.3 million between VigiBase and VAERS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We described and compared report features such as drug and adverse event reporting patterns, reporter types, geographic distribution, demographics, and medical outcomes. Most reports have been received in recent years across the four databases with up to 70% of the reports accumulated in the last 7\u201314 years, depending on the SRS. Notable patterns appeared in reporter types (consumer-dominated in FAERS versus physician-dominated in JADER), sex (female predominance in VigiBase, FAERS and VAERS, versus near-parity in JADER), and the influence of COVID-19 vaccination campaigns, which disproportionately affected VigiBase and VAERS. Time-series trends were analysed by comparing reports pre and post 1 January 2015, excluding COVID-19 vaccine reports. Changes in reporting patterns of therapeutic subgroups and adverse events since 2015 were consistent across SRSs with some region-specific variations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>By highlighting differences between SRSs, this manuscript serves as a reference for researchers and regulators.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fdsfr.2026.1919822","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T09:03:56Z","timestamp":1788512636000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Global patterns and trends in spontaneous reporting systems: VigiBase, FAERS, VAERS, and JADER"],"prefix":"10.3389","volume":"6","author":[{"given":"Nikola","family":"Panajotovikj","sequence":"first","affiliation":[{"name":"Chemotargets SL, Parc Cientific de Barcelona","place":["Barcelona, Spain"]},{"name":"Institut de Quimica Computacional i Catalisi, Universitat de Girona","place":["Girona, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordi","family":"Mestres","sequence":"additional","affiliation":[{"name":"Chemotargets SL, Parc Cientific de Barcelona","place":["Barcelona, Spain"]},{"name":"Institut de Quimica Computacional i Catalisi, Universitat de Girona","place":["Girona, Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,4]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1007\/s40264-013-0131-x","article-title":"vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues","volume":"37","author":"Bergvall","year":"2013","journal-title":"Drug Saf."},{"key":"B2","doi-asserted-by":"publisher","first-page":"1321","DOI":"10.15585\/mmwr.mm7249a2","article-title":"Progress in immunization safety monitoring \u2014 worldwide, 2020\u20132022","volume":"72","author":"Blau","year":"2023","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"B3","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1007\/s40264-025-01642-6","article-title":"VigiBase: resource profile update with a summary of global patterns and trends in adverse event reports for medicines and vaccines","volume":"49","author":"Brand","year":"2026","journal-title":"Drug Saf."},{"key":"B4","article-title":"About the vaccine adverse event reporting system (VAERS)","year":"2026","journal-title":"Vaccine Saf. Syst."},{"key":"B5","doi-asserted-by":"publisher","first-page":"421","DOI":"10.1007\/s40199-024-00508-z","article-title":"Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic review and Meta-analysis","volume":"32","author":"Cervantes-Arellano","year":"2024","journal-title":"DARU J. Pharm. Sci."},{"key":"B6","doi-asserted-by":"publisher","first-page":"1349","DOI":"10.1007\/s11096-023-01592-y","article-title":"Factors associated with underreporting of adverse drug reactions by patients: a systematic review","volume":"45","author":"Costa","year":"2023","journal-title":"Int. J. Clin. Pharm."},{"key":"B7","doi-asserted-by":"publisher","first-page":"959","DOI":"10.1007\/s40264-025-01548-3","article-title":"Interplay of spontaneous reporting and longitudinal healthcare databases for signal management: position statement from the real-world evidence and big data special interest group of the international society of pharmacovigilance","volume":"48","author":"Crisafulli","year":"2025","journal-title":"Drug Saf."},{"key":"B8","doi-asserted-by":"publisher","first-page":"1323057","DOI":"10.3389\/fdsfr.2023.1323057","article-title":"Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems","volume":"3","author":"Cutroneo","year":"2024","journal-title":"Front. Drug Saf. Regul."},{"key":"B9","doi-asserted-by":"publisher","first-page":"3389","DOI":"10.1002\/bcp.70182","article-title":"Completeness of spontaneously reported adverse drug reactions in 4 databases","volume":"91","author":"Dedefo","year":"2025","journal-title":"Br. J. Clin. Pharmacol."},{"key":"B10","doi-asserted-by":"publisher","first-page":"203","DOI":"10.1007\/s40266-025-01275-5","article-title":"Pharmacist-led deprescribing interventions for older adults with polypharmacy: a retrospective cohort study of community pharmacy practice in Japan","volume":"43","author":"Fujita","year":"2026","journal-title":"Drugs Aging"},{"key":"B11","doi-asserted-by":"publisher","first-page":"1704","DOI":"10.1111\/jgs.19360","article-title":"Medication use quality and safety in older adults: 2023 update","volume":"73","author":"Hart","year":"2025","journal-title":"J. Am. Geriatr. Soc."},{"key":"B12","doi-asserted-by":"publisher","first-page":"2338","DOI":"10.3390\/healthcare12232338","article-title":"Understanding the landscape of cancer care in Europe: evaluating clinical and comprehensive cancer centers","volume":"12","author":"Horgan","year":"2024","journal-title":"Healthcare"},{"key":"B13","doi-asserted-by":"publisher","first-page":"e5768","DOI":"10.1002\/pds.5768","article-title":"Adverse drug reaction signal detection methods in spontaneous reporting system: a systematic review","volume":"33","author":"Jiao","year":"2024","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"B14","doi-asserted-by":"publisher","first-page":"761607","DOI":"10.3389\/fphar.2021.761607","article-title":"Evaluation of the direct costs of managing adverse drug events in all ages and of avoidable adverse drug events in older adults in Japan","volume":"12","author":"Katsuno","year":"2021","journal-title":"Front. Pharmacol."},{"key":"B15","doi-asserted-by":"publisher","first-page":"1428831","DOI":"10.3389\/fdsfr.2024.1428831","article-title":"Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review","volume":"4","author":"Kim","year":"2024","journal-title":"Front. Drug Saf. Regul."},{"key":"B16","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1016\/j.therap.2022.10.002","article-title":"Sex differences in adverse drug reactions: are women more impacted?","volume":"78","author":"Lacroix","year":"2023","journal-title":"Therapie"},{"key":"B17","doi-asserted-by":"publisher","first-page":"409","DOI":"10.1177\/009286150804200501","article-title":"VigiBase, the WHO global ICSR database system: basic facts","volume":"42","author":"Lindquist","year":"2008","journal-title":"Drug Inf. J. DIJ Drug Inf. Assoc."},{"key":"B18","doi-asserted-by":"publisher","first-page":"1760208","DOI":"10.3389\/fphar.2026.1760208","article-title":"Cross-national pharmacovigilance of drug-induced intestinal obstruction: disproportionality signals in FAERS and external validation in JADER","volume":"17","author":"Liu","year":"2026","journal-title":"Front. Pharmacol."},{"key":"B19","doi-asserted-by":"publisher","first-page":"1485190","DOI":"10.3389\/fphar.2024.1485190","article-title":"A real-world pharmacovigilance analysis of adverse events associated with irbesartan using the FAERS and JADER databases","volume":"15","author":"Liu","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B20","doi-asserted-by":"publisher","first-page":"20420986241228119","DOI":"10.1177\/20420986241228119","article-title":"Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation","volume":"15","author":"Lomeli-Silva","year":"2024","journal-title":"Ther. Adv. Drug Saf."},{"key":"B21","doi-asserted-by":"publisher","first-page":"991","DOI":"10.1111\/jcpt.13122","article-title":"Polypharmacy in elderly patients in Japan: analysis of Japanese real-world databases","volume":"45","author":"Mabuchi","year":"2020","journal-title":"J. Clin. Pharm. Ther."},{"key":"B22","first-page":"371","article-title":"FDA adverse event reporting system: recruiting doctors to make surveillance a little less passive","volume":"70","author":"Mann","year":"2015","journal-title":"Food Drug Law J."},{"key":"B23","doi-asserted-by":"publisher","first-page":"1287","DOI":"10.1007\/s00228-025-03862-2","article-title":"Trends in adverse drug reaction reporting in eight selected countries after the implementation of new pharmacovigilance regulation in 2012: a joinpoint regression analysis","volume":"81","author":"Masili\u016bnien\u0117","year":"2025","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"B24","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1007\/s10147-025-02939-3","article-title":"PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; encorafenib for colorectal cancer, daratumumab for multiple myeloma, repotrectinib for NTRK-Fusion positive solid tumors, and venetoclax for leukemia","volume":"31","author":"Matsumura","year":"2026","journal-title":"Int. J. Clin. Oncol."},{"key":"B25","doi-asserted-by":"publisher","first-page":"208","DOI":"10.3390\/pharma3020013","article-title":"Adverse drug reactions in multimorbid older people exposed to polypharmacy: epidemiology and prevention","volume":"3","author":"McGettigan","year":"2024","journal-title":"Pharmacoepidemiology"},{"key":"B26","doi-asserted-by":"publisher","first-page":"1497116","DOI":"10.3389\/fdsfr.2024.1497116","article-title":"Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors","volume":"4","author":"Mestres","year":"2024","journal-title":"Front. Drug Saf. Regul."},{"key":"B27","doi-asserted-by":"publisher","first-page":"471","DOI":"10.1016\/S0140-6736(23)01381-8","article-title":"HIV epidemiology, prevention, treatment, and implementation strategies for public health","volume":"403","author":"Mody","year":"2024","journal-title":"Lancet"},{"key":"B28","doi-asserted-by":"publisher","first-page":"18817","DOI":"10.1038\/s41598-023-46275-w","article-title":"Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events","volume":"13","author":"Montes-Grajales","year":"2023","journal-title":"Sci. Rep."},{"key":"B29","doi-asserted-by":"publisher","first-page":"e617","DOI":"10.1016\/S2352-3018(23)00150-9","article-title":"Global HIV control: is the glass half empty or half full?","volume":"10","author":"Nachega","year":"2023","journal-title":"Lancet HIV"},{"key":"B30","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1007\/s10147-021-02099-0","article-title":"Treatments for elderly cancer patients and reforms to social security systems in Japan","volume":"27","author":"Nagashima","year":"2022","journal-title":"Int. J. Clin. Oncol."},{"key":"B31","doi-asserted-by":"publisher","first-page":"1756","DOI":"10.1158\/1055-9965.EPI-23-0754","article-title":"Cancer prevalence projections in Japan and decomposition analysis of changes in cancer burden, 2020\u20132050: a statistical modeling study","volume":"32","author":"Nguyen","year":"2023","journal-title":"Cancer Epidemiol. Biomarkers Prev."},{"key":"B32","article-title":"Health at a glance: Asia\/Pacific 2024","year":"2024"},{"key":"B33","volume-title":"Obesity, diet and physical activity","year":"2026"},{"key":"B34","doi-asserted-by":"publisher","first-page":"1633","DOI":"10.3390\/medicina60101633","article-title":"Association between polypharmacy and adverse events in patients with alzheimer\u2019s disease: an analysis of the Japanese adverse drug event report database (JADER)","volume":"60","author":"Otani","year":"2024","journal-title":"Med. (Mex.)"},{"key":"B35","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1038\/s41514-025-00220-5","article-title":"Drug safety in healthy aging","volume":"11","author":"Panajotovikj","year":"2025","journal-title":"Npj Aging"},{"key":"B36","doi-asserted-by":"publisher","first-page":"e5743","DOI":"10.1002\/pds.5743","article-title":"Descriptive analysis on disproportionate medication errors and associated patient characteristics in the food and drug Administration\u2019s adverse event reporting system. Pharmacoepidemiol","volume":"33","author":"Pera","year":"2024","journal-title":"Drug Saf."},{"key":"B37","doi-asserted-by":"publisher","first-page":"59","DOI":"10.1007\/s40264-024-01478-6","article-title":"Disproportionality analysis and characterisation of medication errors in EudraVigilance: exploring findings on sexes and age groups","volume":"48","author":"Pera","year":"2025","journal-title":"Drug Saf."},{"key":"B38","year":"2026","journal-title":"Pharm. Med. Devices Agency."},{"key":"B39","doi-asserted-by":"publisher","first-page":"567","DOI":"10.1002\/cpt.3701","article-title":"FDA adverse event reporting system (FAERS) essentials: a guide to understanding, applying, and interpreting adverse event data reported to FAERS","volume":"118","author":"Potter","year":"2025","journal-title":"Clin. Pharmacol. Ther."},{"key":"B40","unstructured":"2026"},{"key":"B41","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1016\/j.jjcc.2025.07.008","article-title":"Temporal and geographical trends in anticoagulant therapy and catheter ablation for atrial fibrillation in Japan, 2014\u20132022","volume":"86","author":"Sato","year":"2025","journal-title":"J. Cardiol."},{"key":"B42","doi-asserted-by":"publisher","first-page":"8","DOI":"10.3390\/pharma4020008","article-title":"Timing matters: exploring the role of the time to onset in recall bias for adverse events following immunization (AEFIs) of COVID-19 vaccines from spontaneous reports","volume":"4","author":"Scholl","year":"2025","journal-title":"Pharmacoepidemiology"},{"key":"B43","doi-asserted-by":"publisher","first-page":"687","DOI":"10.1007\/s40264-013-0075-1","article-title":"Choosing thresholds for statistical signal detection with the proportional reporting ratio","volume":"36","author":"Slattery","year":"2013","journal-title":"Drug Saf."},{"key":"B44","doi-asserted-by":"publisher","first-page":"682","DOI":"10.18553\/jmcp.2018.24.7.682","article-title":"Serious adverse drug events reported to the FDA: analysis of the FDA adverse event reporting system 2006-2014 database","volume":"24","author":"Sonawane","year":"2018","journal-title":"J. Manag. Care Spec. Pharm."},{"key":"B45","doi-asserted-by":"publisher","first-page":"1397291","DOI":"10.3389\/fphar.2024.1397291","article-title":"Sex and gender differences and pharmacovigilance: a knot still to be untied","volume":"15","author":"Sportiello","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B46","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.thromres.2024.04.009","article-title":"Oral anticoagulant therapy in older adults","volume":"238","author":"Stuby","year":"2024","journal-title":"Thromb. Res."},{"key":"B47","doi-asserted-by":"publisher","first-page":"10","DOI":"10.5582\/ddt.2024.01090","article-title":"Characteristics and patterns of adverse event reports in the Japanese adverse drug event report database over two decades (2004-2023): exploring findings on sexes and age groups","volume":"19","author":"Tanaka","year":"2025","journal-title":"Drug Discov. Ther."},{"key":"B48","doi-asserted-by":"publisher","first-page":"46","DOI":"10.1016\/j.jcjq.2024.10.005","article-title":"Methodological approaches for analyzing medication error reports in patient safety reporting systems: a scoping review","volume":"51","author":"Tchijevitch","year":"2025","journal-title":"Jt. Comm. J. Qual. Patient Saf."},{"key":"B49","doi-asserted-by":"publisher","first-page":"riaf084","DOI":"10.1093\/ijpp\/riaf084","article-title":"Changes in the trend and quality of adverse drug reaction reports in the Japanese adverse drug event report database and the impact of COVID-19-related reports","volume":"34","author":"Tsuchiya","year":"2025","journal-title":"Int. J. Pharm. Pract."},{"key":"B50","doi-asserted-by":"publisher","first-page":"515","DOI":"10.1002\/bcp.70291","article-title":"Comparative analysis of the characteristics and trends of adverse drug reaction reports from patients in Japan and the Japanese adverse drug event report database","volume":"92","author":"Tsuchiya","year":"2026","journal-title":"Br. J. Clin. Pharmacol."},{"key":"B51","unstructured":"2026"},{"key":"B52","unstructured":"2025"},{"key":"B53","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1016\/j.pedhc.2025.07.016","article-title":"Monitoring vaccine safety: united States vaccine safety surveillance systems","volume":"40","author":"Zauche","year":"2026","journal-title":"J. Pediatr. Health Care Off. Publ. Natl. Assoc. Pediatr. Nurse Assoc. Pract."}],"container-title":["Frontiers in Drug Safety and Regulation"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdsfr.2026.1919822\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T09:03:57Z","timestamp":1788512637000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdsfr.2026.1919822\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,4]]},"references-count":53,"alternative-id":["10.3389\/fdsfr.2026.1919822"],"URL":"https:\/\/doi.org\/10.3389\/fdsfr.2026.1919822","relation":{},"ISSN":["2674-0869"],"issn-type":[{"value":"2674-0869","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,4]]},"article-number":"1919822"}}