Global burden of vaccine-associated hepatobiliary and gastrointestinal adverse drug reactions, 1967-2023: A comprehensive analysis of the international pharmacovigilance database.

Autor: Lee S; Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea., Lee K; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Regulatory Science, Kyung Hee University, Seoul, South Korea., Park J; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Regulatory Science, Kyung Hee University, Seoul, South Korea., Jeong YD; Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea., Jo H; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Regulatory Science, Kyung Hee University, Seoul, South Korea., Kim S; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Precision Medicine, Kyung Hee University College of Medicine, Seoul, South Korea., Woo S; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea., Son Y; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Precision Medicine, Kyung Hee University College of Medicine, Seoul, South Korea., Kim HJ; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Regulatory Science, Kyung Hee University, Seoul, South Korea., Lee K; Digestive Disease Center, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea., Ha Y; Digestive Disease Center, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea., Oh NE; Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea., Lee J; Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea., Rhee SY; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Endocrinology and Metabolism, Kyung Hee University College of Medicine, Seoul, South Korea., Smith L; Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK., Kang J; Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.; Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts, USA., Rahmati M; CEReSS-Health Service Research and Quality of Life Center, Assistance Publique-Hôpitaux de Marseille (APHM), Aix-Marseille University, Marseille, France.; Department of Physical Education and Sport Sciences, Faculty of Literature and Human Sciences, Lorestan University, Khoramabad, Iran.; Department of Physical Education and Sport Sciences, Faculty of Literature and Humanities, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran., Lee H; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea., Yon DK; Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.; Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.; Department of Precision Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.; Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
Jazyk: angličtina
Zdroj: Journal of medical virology [J Med Virol] 2024 Jul; Vol. 96 (7), pp. e29792.
DOI: 10.1002/jmv.29792
Abstrakt: Although previous studies have focused on hepatobiliary and gastrointestinal adverse drug reactions (ADRs) associated with COVID-19 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-associated 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-associated hepatobiliary and gastrointestinal ADRs from 1967 to 2023 (total reports = 131 255 418). Through global reporting counts, reported odds ratios (ROR) with 95% confidence interval (CI), and information components (IC) with IC 0.25 , the study examined the association between 16 vaccines and the incidence of hepatobiliary and gastrointestinal ADRs across 156 countries. Of the 6 842 303 reports in the vaccine-associated ADRs, 10 786 reports of liver injury, 927 870 reports of gastrointestinal symptoms, 2978 reports of pancreas and bile duct injury, and 96 reports of intra-abdominal hemorrhage between 1967 and 2023 were identified. Most hepatobiliary and gastrointestinal ADRs surged after 2020, with the majority of reports attributed to COVID-19 messenger RNA (mRNA) vaccines. Hepatitis A vaccines exhibited the highest association with liver injury (ROR [95% CI]: 10.30 [9.65-10.99]; IC [IC 0.25 ]: 3.33 [3.22]), followed by hepatitis B, typhoid, and rotavirus. Specifically, ischemic hepatitis had a significant association with both Ad5-vectored and mRNA COVID-19 vaccines. Gastrointestinal symptoms were associated with all vaccines except for tuberculosis vaccines, particularly with rotavirus (11.62 [11.45-11.80]; 3.05 [3.03]) and typhoid (11.02 [10.66-11.39]; 3.00 [2.96]). Pancreas and bile duct injury were associated with COVID-19 mRNA (1.99 [1.89-2.09]; 0.90 [0.83]), MMR (measles, mumps, and rubella), and papillomavirus vaccines. For intra-abdominal hemorrhage, inactivated whole-virus COVID-19 vaccines (3.93 [1.86-8.27]; 1.71 [0.41]) had the highest association, followed by COVID-19 mRNA (1.81 [1.42-2.29]; 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.
(© 2024 Wiley Periodicals LLC.)
Databáze: MEDLINE
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