Title

Frequentist and Bayesian analysis of potential adverse events of the COVID-19 immunization

Document Type

Conference Proceeding

Publication Date

2-1-2023

Publication Title

Eur Urol

Abstract

Introduction & Objectives: Although there is emerging literature on the urologic side effects of COVID-19, there are few, if any, large volume studies examining the urologic side effects of immunization against COVID-19. We sought to quantify and analyze urologic adverse events and symptoms after COVID-19 immunization.

Materials & Methods: We queried the FDA Vaccine Adverse Event Reporting System (VAERS) for all reported symptoms following COVID-19 immunization for the period of December, 2020 through April 1st, 2022 as well as for all other immunizations since 1990. We identified the fifty most common adverse urologic events. Using proportional reporting ratio, reporting odds ratio, information component, and empirical Bayes geometric mean, we analyzed the reporting data in the VAERS database. In line with prior methodology, symptoms were then categorized into either haematuria, lower urinary tract symptoms, skin and/or soft tissue, urinary infection, or other.

Results: A total of 2,629,200 non-COVID immunizations and 3,679,330 COVID-19 immunizations were identified from the queried periods with 770,975 and 865,585 adverse events reported, respectively. No potential adverse event produced a positive signal across all four measures of disproportionality. Out of all adverse events reported following COVID-19 immunization, the most common adverse event was urinary tract infection, which only accounted for 2,313 adverse events. The median age of the patients reporting urologic symptoms was 50 years old (interquartile range, 22 - 64) and 66% of the patients were female.

Conclusions: Although there have been anecdotal reports of adverse events associated with the COVID-19 vaccine and urologic symptoms reported after COVID-19 immunization continue to be extremely rare, our review of the VAERS database did not produce positive signals across all four measures for any potential adverse event. Our findings suggest these adverse events are not related to the COVID-19 immunization but further evaluation and analysis of the COVID-19 immunization is ongoing.

Volume

83

First Page

S199

Last Page

S200

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