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
Division of Nephrology, Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, Korea.
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.
Sci Rep. 2025 Feb 12;15(1):5177. doi: 10.1038/s41598-025-88713-x.
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) 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, 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, 2.90) and hepatitis B vaccines (ROR, 11.35; IC, 3.18). Disproportionate TIN reporting was significant for COVID-19 mRNA (ROR, 2.43; IC, 0.99) and human papillomavirus (ROR, 1.75; IC, 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.
关于疫苗与肾脏不良事件（AE）之间关联的全球证据尚无定论。这项药物警戒研究分析了1967年至2022年期间从VigiBase收集的总共120,715,116份报告。我们评估了急性肾损伤（AKI）、肾小球肾炎（GN）和肾小管间质性肾炎（TIN）的全球报告情况，并使用报告比值比（ROR）和信息成分（IC）95%置信区间的下限，与整个数据库相比，评估疫苗与肾脏AE之间的不成比例信号。AKI、GN和TIN的报告数量和比例逐渐增加，2020年后大幅增加。COVID-19 mRNA疫苗的AKI报告不成比例显著（ROR，2.38；IC，1.09）。14种疫苗的GN报告显著不成比例，GN报告的最高不成比例情况出现在COVID-19 mRNA（ROR，13.41；IC，2.90）和乙肝疫苗（ROR，11.35；IC，3.18）中。COVID-19 mRNA（ROR，2.43；IC，0.99）和人乳头瘤病毒（ROR，1.75；IC，0.19）疫苗的TIN报告不成比例显著。在接触多种疫苗（包括COVID-19 mRNA疫苗）的患者中，观察到AKI、GN和TIN报告存在显著不成比例，同时全球疫苗相关肾脏AE的报告也在增加。
