{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T16:40:20Z","timestamp":1768322420806,"version":"3.49.0"},"reference-count":44,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,7,11]],"date-time":"2024-07-11T00:00:00Z","timestamp":1720656000000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Although previous studies have focused on hepatobiliary and gastrointestinal adverse drug reactions (ADRs) associated with COVID\u201019 vaccines, literature on such ADRs with other vaccines is limited, particularly on a global scale. Therefore, we aimed to investigate the global burden of vaccine\u2010associated hepatobiliary and gastrointestinal ADRs and identify the vaccines implicated in these occurrences. This study utilized data from the World Health Organization (WHO) international pharmacovigilance database to extract reports of vaccine\u2010associated hepatobiliary and gastrointestinal ADRs from 1967 to 2023 (total reports\u2009=\u2009131\u2009255\u2009418). Through global reporting counts, reported odds ratios (ROR) with 95% confidence interval (CI), and information components (IC) with IC<jats:sub>0.25<\/jats:sub>, the study examined the association between 16 vaccines and the incidence of hepatobiliary and gastrointestinal ADRs across 156 countries. Of the 6\u2009842\u2009303 reports in the vaccine\u2010associated ADRs, 10\u2009786 reports of liver injury, 927\u2009870 reports of gastrointestinal symptoms, 2978 reports of pancreas and bile duct injury, and 96 reports of intra\u2010abdominal hemorrhage between 1967 and 2023 were identified. Most hepatobiliary and gastrointestinal ADRs surged after 2020, with the majority of reports attributed to COVID\u201019 messenger RNA (mRNA) vaccines. Hepatitis A vaccines exhibited the highest association with liver injury (ROR [95% CI]: 10.30 [9.65\u201310.99]; IC [IC<jats:sub>0.25<\/jats:sub>]: 3.33 [3.22]), followed by hepatitis B, typhoid, and rotavirus. Specifically, ischemic hepatitis had a significant association with both Ad5\u2010vectored and mRNA COVID\u201019 vaccines. Gastrointestinal symptoms were associated with all vaccines except for tuberculosis vaccines, particularly with rotavirus (11.62 [11.45\u201311.80]; 3.05 [3.03]) and typhoid (11.02 [10.66\u201311.39]; 3.00 [2.96]). Pancreas and bile duct injury were associated with COVID\u201019 mRNA (1.99 [1.89\u20132.09]; 0.90 [0.83]), MMR (measles, mumps, and rubella), and papillomavirus vaccines. For intra\u2010abdominal hemorrhage, inactivated whole\u2010virus COVID\u201019 vaccines (3.93 [1.86\u20138.27]; 1.71 [0.41]) had the highest association, followed by COVID\u201019 mRNA (1.81 [1.42\u20132.29]; 0.77 [0.39]). Most of these ADRs had a short time to onset, within 1 day, and low mortality rate. Through a global scale database, the majority of ADRs occurred within 1 day, emphasizing the importance of healthcare workers' vigilant monitoring and timely management.<\/jats:p>","DOI":"10.1002\/jmv.29792","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T06:45:26Z","timestamp":1720766726000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Global burden of vaccine\u2010associated hepatobiliary and gastrointestinal adverse drug reactions, 1967\u20132023: A comprehensive analysis of the international pharmacovigilance database"],"prefix":"10.1002","volume":"96","author":[{"given":"Sooji","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Medicine Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyeongmin","family":"Lee","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Regulatory Science Kyung Hee University Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaeyu","family":"Park","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Regulatory Science Kyung Hee University Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi Deun","family":"Jeong","sequence":"additional","affiliation":[{"name":"Department of Medicine Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyesu","family":"Jo","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Regulatory Science Kyung Hee University Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soeun","family":"Kim","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Precision Medicine Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Selin","family":"Woo","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yejun","family":"Son","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Precision Medicine Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyeon Jin","family":"Kim","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Regulatory Science Kyung Hee University Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwanjoo","family":"Lee","sequence":"additional","affiliation":[{"name":"Digestive Disease Center, CHA Bundang Medical Center CHA University School of Medicine Seongnam South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yeonjung","family":"Ha","sequence":"additional","affiliation":[{"name":"Digestive Disease Center, CHA Bundang Medical Center CHA University School of Medicine Seongnam South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Na\u2010eun","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering Kyung Hee University Yongin South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinseok","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering Kyung Hee University Yongin South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang Youl","family":"Rhee","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Endocrinology and Metabolism Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lee","family":"Smith","sequence":"additional","affiliation":[{"name":"Centre for Health, Performance and Wellbeing Anglia Ruskin University Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiseung","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Anesthesia, Critical Care and Pain Medicine Massachusetts General Hospital Boston Massachusetts USA"},{"name":"Division of Sleep Medicine Harvard Medical School Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masoud","family":"Rahmati","sequence":"additional","affiliation":[{"name":"CEReSS\u2010Health Service Research and Quality of Life Center, Assistance Publique\u2010H\u00f4pitaux de Marseille (APHM) Aix\u2010Marseille University Marseille France"},{"name":"Department of Physical Education and Sport Sciences, Faculty of Literature and Human Sciences Lorestan University Khoramabad Iran"},{"name":"Department of Physical Education and Sport Sciences, Faculty of Literature and Humanities Vali\u2010E\u2010Asr University of Rafsanjan Rafsanjan Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hayeon","family":"Lee","sequence":"additional","affiliation":[{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Biomedical Engineering Kyung Hee University Yongin South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1628-9948","authenticated-orcid":false,"given":"Dong Keon","family":"Yon","sequence":"additional","affiliation":[{"name":"Department of Medicine Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Regulatory Science Kyung Hee University Seoul South Korea"},{"name":"Department of Precision Medicine Kyung Hee University College of Medicine Seoul South Korea"},{"name":"Department of Pediatrics, Kyung Hee University Medical Center Kyung Hee University College of Medicine Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,7,11]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(19)30742-X"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.15968"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1912514"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2022.06.032"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines9060576"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-021-27631-8"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.54724\/lc.2022.e8"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29682"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29591"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13168"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2020-323672"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.54724\/lc.2022.e1"},{"issue":"5","key":"e_1_2_11_14_1","first-page":"389","article-title":"Autoimmunity and hepatitis A vaccine in children","volume":"21","author":"Karali Z","year":"2011","journal-title":"J Investig Allergol Clin Immunol"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10495-011-0690-1"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrmicro2490"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1128\/jvi.64.1.361-368.1990"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.32572"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1159\/000529608"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2022-328169"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2023.05.020"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1055\/a-1816-7631"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa052434"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(21)00455-2"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.060360"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.5694\/j.1326-5377.2008.tb01960.x"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00508-023-02225-0"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001609"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiaa668"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2005.07.014"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhepr.2023.100776"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jceh.2021.12.003"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.4732"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2023-014544"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2021.8523"},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/46.12.2050"},{"issue":"6","key":"e_1_2_11_37_1","first-page":"1105","article-title":"Mildly elevated liver transaminase levels in the asymptomatic patient","volume":"71","author":"Giboney PT","year":"2005","journal-title":"Am Fam Physician"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2003.01969.x"},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29185"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr6701a1"},{"key":"e_1_2_11_41_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.27214"},{"key":"e_1_2_11_42_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)31604-4"},{"key":"e_1_2_11_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.07.005"},{"key":"e_1_2_11_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajem.2022.05.044"},{"key":"e_1_2_11_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dib.2023.109287"}],"container-title":["Journal of Medical Virology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jmv.29792","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,30]],"date-time":"2024-07-30T09:40:46Z","timestamp":1722332446000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jmv.29792"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7]]},"references-count":44,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2024,7]]}},"alternative-id":["10.1002\/jmv.29792"],"URL":"https:\/\/doi.org\/10.1002\/jmv.29792","archive":["Portico"],"relation":{},"ISSN":["0146-6615","1096-9071"],"issn-type":[{"value":"0146-6615","type":"print"},{"value":"1096-9071","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7]]},"assertion":[{"value":"2024-04-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e29792"}}