アブストラクト | Global evidence on the association between vaccines and renal adverse events (AEs) is inconclusive. This pharmacovigilance study analyzed a total of 120,715,116 reports from VigiBase collected between 1967 and 2022. We evaluated the global reporting of acute kidney injury (AKI), glomerulonephritis (GN), and tubulointerstitial nephritis (TIN) and assessed disproportionate signals between vaccines and renal AEs using reporting odds ratios (ROR) and the lower limit of the 95% confidence interval of the information component (IC(025)) in comparison with the entire database. The number and proportion of reports on AKI, GN, and TIN gradually increased, with a substantial increase after 2020. Disproportionate reporting of AKI was significant for COVID-19 mRNA vaccines (ROR, 2.38; IC(025), 1.09). Fourteen vaccines were significantly disproportionate for higher GN reporting, and the highest disproportionality for GN reporting was observed for COVID-19 mRNA (ROR, 13.41; IC(025), 2.90) and hepatitis B vaccines (ROR, 11.35; IC(025), 3.18). Disproportionate TIN reporting was significant for COVID-19 mRNA (ROR, 2.43; IC(025), 0.99) and human papillomavirus (ROR, 1.75; IC(025), 0.19) vaccines. Significant disproportionality in the reporting of AKI, GN, and TIN was observed in patients exposed to multiple vaccines, including COVID-19 mRNA vaccines, alongside increasing global reports of vaccine-associated renal AEs. |
投稿者 | Hwang, Hyeon Seok; Lee, Hayeon; Yoon, Soo-Young; Kim, Jin Sug; Jeong, Kyunghwan; Kronbichler, Andreas; Kim, Hyeon Jin; Kim, Min Seo; Rahmati, Masoud; Shin, Ju-Young; Choi, Ahhyung; Shin, Jae Il; Lee, Jinseok; Yon, Dong Keon |
組織名 | Division of Nephrology, Department of Internal Medicine, Kyung Hee University;Medical Center, Kyung Hee University College of Medicine, Seoul, Korea.;hwanghsne@gmail.com.;Department of Nephrology, Department of Internal Medicine, College of Medicine,;Kyung Hee University, Kyung Hee University Medical Center, 23, Kyungheedae-ro,;Dongdaemun-gu, Seoul, 02447, Republic of Korea. hwanghsne@gmail.com.;Department of Electronics and Information Convergence Engineering, Kyung Hee;University, Yongin, Korea.;Department of Internal Medicine IV, Nephrology and Hypertension, Medical;University Innsbruck, Innsbruck, Austria.;Center for Digital Health, Medical Science Research Institute, Kyung Hee;University Medical Center, Kyung Hee University College of Medicine, Seoul,;Korea.;Cardiovascular Disease Initiative, Broad Institute of MIT and Harvard, Cambridge,;MA, USA.;Department of Physical Education and Sport Sciences, Faculty of Literature and;Human Sciences, Lorestan University, Khoramabad, Iran.;Human Sciences, Lorestan University, Khorramabad, Iran.;Humanities, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.;CRSMP, Center for Mental Health and Psychiatry Research - PACA, Marseille,;France.;School of Pharmacy, Sungkyunkwan University, Suwon, South Korea.;Department of Pediatrics, Yonsei University College of Medicine, Seoul, South;University, Yongin, Korea. yonkkang@gmail.com.;Korea. yonkkang@gmail.com.;Department of Pediatrics, College of Medicine, Kyung Hee University Medical;Center, Kyung Hee University, Seoul, Korea. yonkkang@gmail.com.;Center for Digital Health, Medical Science Research Institute Kyung Hee;Korea, 23, Kyungheedae-ro, Dongdaemun-gu, 02447, Seoul, Republic of Korea.;yonkkang@gmail.com. |