Global burden of vaccine-associated kidney injury using an international pharmacovigilance database

Abstract

Abstract 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 (IC025) 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; IC025, 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; IC025, 2.90) and hepatitis B vaccines (ROR, 11.35; IC025, 3.18). Disproportionate TIN reporting was significant for COVID-19 mRNA (ROR, 2.43; IC025, 0.99) and human papillomavirus (ROR, 1.75; IC025, 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.

Keywords

• Acute kidney injury
• Glomerulonephritis
• Pharmacovigilance
• Tubulointerstitial nephritis
• Vaccines