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

To quantify and describe urologic adverse events and symptoms after vaccination with the Pfizer-BioNTech and Moderna COVID-19 vaccines. 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. 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. 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.