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UPJ INSIGHT Short-Term Reported Urologic Adverse Events Following COVID-19 Immunization
By: Owais M. Aftab, BS, New Jersey Medical School, Newark; Matthew Davis, MD, MBA, Vattikuti Urology Institute, New Jersey Medical School, Newark; Aisha Obeidallah, BA, New Jersey Medical School, Newark; Alexandra Rogers, BS, Vattikuti Urology Institute—Center for Outcomes Research, Analysis, and Evaluation, Detroit, Michigan; Laurence Hou, MD, Hackensack University Medical Center, Hackensack Meridian School of Medicine, New Jersey; Firas Abdollah, MD, Vattikuti Urology Institute—Center for Outcomes Research, Analysis, and Evaluation, Detroit, Michigan; Mutahar Ahmed, MD, Hackensack University Medical Center, Hackensack Meridian School of Medicine, New Jersey; Mubashir Shabil Billah, MD, Hackensack University Medical Center, Hackensack Meridian School of Medicine, New Jersey | Posted on: 18 Mar 2024
Aftab OM, Davis M, Obeidallah A, et al. Short-term reported urologic adverse events following COVID-19 immunization: a VAERS analysis. Urol Pract. 2024;11(2):312-323.
Study Need and Importance
There is a need for the present study due to medical misinformation and public concern about the safety of different COVID-19 vaccinations. Previous studies have been limited in size or in the statistical methods used to examine potential urologic side effects experienced by patients following COVID-19 vaccination. Due to the nature of the data within the Vaccine Adverse Events Reporting System (VAERS) database, it is important to use the proper statistical methods.
What We Found
Lower urinary tract symptoms were the most commonly reported potential urologic side effect following COVID-19 vaccination (Figure). On our disproportionality analysis, no potential urologic side effect produced a positive safety signal for all COVID-19 vaccinations. When broken down by manufacturer, some potential urologic side effects produced positive safety signals for the Janssen vaccination.
Limitations
The limitations of the study include its retrospective nature. Further, the VAERS database can be subject to reporting biases as well as underreporting. Change in medical terminology over time also has the potential to limit the study as the data span approximately half a century. It has also been demonstrated that potential side effects are more likely to be reported in the first 2 years after approval by the Food and Drug Administration. Most importantly, there is no randomized control group within the VAERS database, which makes comparing to other vaccinations necessary.
Interpretation for Patient Care
The study results provide a better understanding of potential urologic side effects following COVID-19 vaccination. While safety monitoring remains ongoing, efforts ought to be made by physicians to voluntarily report potential urologic side effects experienced following COVID-19 vaccination, or any vaccine, to VAERS. Additionally, potential urologic side effects experienced following use of a drug can be reported to the Food and Drug Administration Adverse Event Reporting System database.
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