MP67-03 UROLOGIC SIDE EFFECTS FOLLOWING COVID19 VACCINATION: AN ANALYSIS OF THE FDA VACCINE ADVERSE EVENT REPORTING SYSTEM

Abstract

INTRODUCTION AND OBJECTIVE: Large scale efforts are underway to vaccinate the majority of the population against COVID-19 in an effort to achieve herd immunity, but there is little known about potential urologic complications from the vaccinations. Given that the number of vaccinations will continue to dramatically increase in the following months, urologists should be aware of potential genitourinary side effects of the vaccine. In this study, we investigated the FDA Vaccine Adverse Event Reporting System (VAERS) to quantify and describe reported urologic symptoms following COVID-19 vaccination with the Pfizer-BioNTech and Moderna vaccines. METHODS: The FDA VAERS is an early warning system that can detect potential issues with licensed vaccines. We queried the VAERS for all reported symptoms following the Pfizer-BioNTech and Moderna vaccines that have been processed as of February 12th, 2021. The list of unique symptoms was then reviewed separately by two physicians and all urology-specific symptoms were isolated and the associated adverse events were reviewed. Patient demographics and adverse event description free text were reviewed and compiled. RESULTS: Our query generated a list of 15,785 adverse event reports with 73,867 symptoms. Out of 15,785 adverse event reports, only 0.7% (113) described a urologic symptom. Urologic complaints made up 0.2% (156/73,867) of all the symptoms reported following vaccination. The median age of the patients reporting urologic symptoms was 63 years (IQR 44-79, Range: 19-96). 54% of the reports were about female patients. We categorized the urologic symptoms into five different categories: Lower Urinary Tract Symptoms (n=34, 22%), Hematuria (n=22, 14%), Urinary Infection (n=41, 26%), Skin/Soft Tissue (n=16, 10%), and Other (n=43, 28%). CONCLUSIONS: These results can provide reassurance and help counsel providers and patients, especially as vaccination efforts continue to grow. To our knowledge, this is the first study to investigate urologic symptoms after COVID-19 vaccination as these details were not reported from the Pfizer-BioNTech and Moderna trial results. [4,5] While the current literature suggests that there may be urologic manifestations of COVID-19 infections, our investigation of the VAERS finds that urologic symptoms reported after COVID-19 vaccination are rare.