Low Rates of Urologic Side Effects Following Coronavirus Disease Vaccination: An Analysis of the Food and Drug Administration Vaccine Adverse Event Reporting System.

ABSTRACT

OBJECTIVE: To quantify and describe urologic adverse events and symptoms after vaccination with the Pfizer-BioNTech and Moderna COVID-19 vaccines. METHODS AND MATERIALS We queried the FDA Vaccine Adverse Event Reporting System (VAERS) for all reported symptoms following the Pfizer-BioNTech and Moderna vaccines as of February 12th, 2021. All urologic symptoms were isolated and the reported adverse events associated with each symptom were reviewed. RESULTS: Out of 15,785 adverse event reports, only 0.7% (113) described urologic symptoms. A total of 156 urologic symptoms were described amongst the 113 adverse event reports. The Pfizer-BioNTech vaccine was responsible for 61% of these reports and the Moderna vaccine was responsible for 39%. These symptoms were grouped into five different categories Lower Urinary Tract Symptoms (n = 34, 22%), Hematuria (n = 22, 14%), Urinary Infection (n = 41, 26%), Skin and/or Soft Tissue (n = 16, 10%), and Other (n = 43, 28%). The median age of the patients reporting urologic symptoms was 63 years (IQR 44-79, Range 19-96) and 54% of the patients were female. CONCLUSION: Urologic symptoms reported after COVID-19 vaccination are extremely rare. Given the common prevalence of many of these reported symptoms in the general population, there does not appear to be a correlation between vaccination and urologic symptoms, but as the vaccination criteria expands, further monitoring of the Vaccine Adverse Event Reporting System is needed.