key: cord-0738706-6r106ztz
authors: Zhao, Hanson; Souders, Colby; Carmel, Maude; Anger, Jennifer T.
title: Low Rates of Urologic Side Effects Following COVID Vaccination: An Analysis of the FDA Vaccine Adverse Event Reporting System
date: 2021-04-20
journal: Urology
DOI: 10.1016/j.urology.2021.04.002
sha: 3cd6ef68eb939cc5d3a045c966db62dfd644e33a
doc_id: 738706
cord_uid: 6r106ztz

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/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 VAERS is needed.

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/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 VAERS is needed.

The COVID-19 pandemic has had a dramatic impact on urologic providers and patients.

[1] Currently, large scale efforts are underway to vaccinate the majority of the population in an effort to achieve herd immunity. The United States Food and Drug Administration (FDA) issued Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020 and the Moderna COVID-19 vaccine on December 18, 2020. [2] As of February 12 th 2021, over 54 million doses have been administered to the United States population. [3] While common and serious adverse events following vaccination have been widely reported and are carefully monitored, there is little known about potential organ-specific complications. [2, 4, 5] 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.

The FDA VAERS is an early warning system that can detect potential issues with licensed vaccines by recording and analyzing adverse events following vaccinations. [6] These adverse events can be submitted by health care professionals, vaccine manufacturers, and the public. Raw VAERS data can be directly downloaded or accessed through the CDC WONDER (Center for Disease Control and Prevention Wide-ranging OnLine Data for Epidemiologic Research) search tool (https://wonder.cdc.gov/vaers.html).

We first queried the CDC WONDER tool for all reported symptoms following the Pfizer-BioNTech and Moderna vaccines that have been processed as of February 12th, 2021.

Each adverse event report can contain multiple symptoms related to the patient's clinical presentation or laboratory and imaging findings.

The list of unique symptoms was then reviewed separately by two physicians and all urology-specific symptoms were isolated. Nephrology-related side effects or symptoms (e.g. acute kidney injury, abnormal urine studies not related to infection or hematuria) were excluded from further analysis. Obstetrical and gynecological symptoms were also excluded. Each urologic symptom was then queried through the CDC WONDER tool to obtain specific details about the related adverse event report. Patient demographics and adverse event description free text were reviewed and compiled. The vaccine manufacturer and the associated dose number was recorded. Nonspecific complaints of pain including flank pain (n=19), groin pain (n=4), pelvic pain (n=5), and suprapubic pain 

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] The FDA VAERS is a passive reporting system designed to help monitor the safety of vaccines. [6] It cannot determine causality but it can allow for earlier detection of unexpected or unusual patterns of adverse events or "safety signals", leading to further safety investigation using the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. [6] Because of the limitations with report submissions and event descriptions, we cannot create a direct connection between the vaccination and the symptom. For example, although we identified 22 reported symptoms related to hematuria, we do not often know the details of the patient's past medical history and cannot establish a causal link between vaccination and hematuria. In addition, many of the symptoms we identified are common in the general population. Thus, it is difficult to determine what is a true side effect. Nevertheless, some of these reported patient complaints, like lower urinary tract symptoms, could plausibly result from the immune response generated by the vaccine. Interestingly, 75% of the adverse events with urologic symptoms were reported after the first dose. This may represent a reporting bias as patients with severe symptoms after the first dose may have reported their side effects right away while those with milder symptoms after the first dose may have chosen not to report any side effects with either dose. Since the VAERS contains adverse events from voluntary reporters, it may not capture the entire spectrum or quantity of urologic side effects.

Other symptoms reported in the VAERS included laboratory and imaging findings that may not be related to the actual vaccination. For example, three adverse events reported a symptom of "Renal Cyst" because the patients were incidentally found to have renal cysts on abdominal imaging following vaccination. While these findings likely do not have any clinical implications, we chose to include them in this study to represent the entire spectrum of urologic symptoms reported in the VAERS.

Finally, it is also important to note that a narrow population of individuals has been vaccinated to date in the United States: healthcare workers, older individuals, and those with significant comorbidities. The patient demographics identified in our study correlate to the demographics of those who had been vaccinated. According to the CDC, in the first month of vaccination, 63% of the patients were women and 55% were 50 years old or older. [7] As the vaccination criteria expands to a healthier, younger cohort, the types of reported adverse events may also change. In addition, vaccines with different 

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