Adverse events of acute nephrotoxicity reported to EudraVigilance and VAERS after COVID-19 vaccination

The present study aimed to estimate the reporting rates (RRs) of acute kidney injury (AKI) and renal failure (RF) after COVID-19 vaccination in the European Economic Area (EEA) and the United States. We retrieved and analyzed pharmacovigilance data on suspected AKI and RF cases and fatalities post C...

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Bibliographic Details
Published in:Vaccine 2023-11, Vol.41 (48), p.7176-7182
Main Authors: Anastassopoulou, Cleo, Boufidou, Fotini, Hatziantoniou, Sophia, Vasileiou, Konstantinos, Spanakis, Nikolaos, Tsakris, Athanasios
Format: Article
Language:English
Subjects:
Acute kidney injury (AKI)
Acute Kidney Injury - chemically induced
Acute Kidney Injury - epidemiology
Ad26COVS1
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Aged
Case reports
COVID-19
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Disease
Economic analysis
EudraVigilance
Fatalities
Female
Humans
Immunization
Kidneys
Licenses
Male
Middle Aged
Mortality
mRNA
mRNA vaccines
Pharmacovigilance
Renal failure
Side effects
Statistical analysis
United States - epidemiology
Vaccination - adverse effects
Vaccines
VAERS
Vectored vaccines
Young Adult
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Summary:The present study aimed to estimate the reporting rates (RRs) of acute kidney injury (AKI) and renal failure (RF) after COVID-19 vaccination in the European Economic Area (EEA) and the United States. We retrieved and analyzed pharmacovigilance data on suspected AKI and RF cases and fatalities post COVID-19 vaccination with licensed vaccines reported to EudraVigilance and VAERS between week 52/2020 and week 52/2022 or week 1/2023, respectively. Reporting rates with 95% confidence intervals were estimated per million administered vaccine doses. In total, 4,244 AKI and 1,557 RF suspected cases were notified to EudraVigilance (1,692 AKI/971 RF) and VAERS (2,552 AKI/586 RF) during the study period following the administration of >1.6 billion COVID-19 vaccine doses (EEA: 970,934,453/US: 666,511,603). The overall RRs were 3.03 (95 % CI: 2.94–3.12) for AKI and 1.11 (95 % CI: 1.06–1.17) for RF per million administered vaccine doses. Indices for statistically significant increased risks were found in subjects, especially males, ≥65 years compared to 18–64 years old (AKI: OR = 7.23, 95 % CI: 6.63–7.88, p = 0.000, and RF: OR = 4.74, 95 % CI: 3.99–5.63, p 
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2023.10.030