Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Balanoposthitis, COVID-19, Drug ineffective, Dysuria, Erythema
Clinical narrative: Contracted Covid-19; Contracted Covid-19, " i still have Covid"; Right eye pain; Urinary retention; Patient described the Pain " it was an unbelievable pain and unrelenting pain; Urinary incontinence; Difficulty urinating; Weak urine stream; Tip of my penis was swollen; Really red penis; Right eye blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (Urinary retention) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) for COVID-19.    The patient's past medical history included Vision abnormal. Concurrent medical conditions included Crohn's disease (Male patient with crohn disease takes budesonide pill for this condition.) and Penicillin allergy (Allergic to pencillin). Concomitant products included BUDESONIDE for Crohn's disease.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient started FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) (unknown route) at an unspecified dose. On 11-Jul-2021, the patient experienced COVID-19 (Contracted Covid-19) and DRUG INEFFECTIVE (Contracted Covid-19, " i still have Covid"). In July 2021, the patient experienced URINARY RETENTION (Urinary retention) (seriousness criterion medically significant), PAIN (Patient described the Pain " it was an unbelievable pain and unrelenting pain), URINARY INCONTINENCE (Urinary incontinence), DYSURIA (Difficulty urinating), URINE FLOW DECREASED (Weak urine stream), BALANOPOSTHITIS (Tip of my penis was swollen), ERYTHEMA (Really red penis), VISION BLURRED (Right eye blurred vision) and EYE PAIN (Right eye pain). The patient was treated with FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) from 23-Jul-2021 to 31-Jul-2021 for COVID-19, at an unspecified dose and frequency. In July 2021, EYE PAIN (Right eye pain) had resolved. At the time of the report, URINARY RETENTION (Urinary retention), COVID-19 (Contracted Covid-19), PAIN (Patient described the Pain " it was an unbelievable pain and unrelenting pain), URINARY INCONTINENCE (Urinary incontinence), DYSURIA (Difficulty urinating), URINE FLOW DECREASED (Weak urine stream), BALANOPOSTHITIS (Tip of my penis was swollen), ERYTHEMA (Really red penis), VISION BLURRED (Right eye blurred vision) and DRUG INEFFECTIVE (Contracted Covid-19, " i still have Covid") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Laboratory test: negative (Negative) Lab results were negative for infection.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were provided by reporter On 25-Jul-2021 that includes antibiotics. Patient was told he might have a urinary tract infection but lab results came negative for infection.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up received on 12-Nov-2021 Updated Lab test, Treatment drug, Concomitant drug and co-suspect product, Medical history, Event start date, Event outcome are added.; Sender's Comments: This is a case of drug ineffective concerning a 57-year-old, male patient, with Crohn's disease, who experienced the serious, unexpected event of Covid-19 (AESI) and urinary retention. The event Covid-19 occurred  3 months after second dose of mRNA 1273 vaccine. The patient was diagnosed to have Covid -19 and prescribed with Trelegy (co-suspect drug), and that's when his urinary retention and other urologic symptoms (red penis, pain when urinating, weak urine stream, and urnary incontinence) occurred. The rechallenge is not applicable as patient received treatment for events. The patient's history of Crohn's disease may have increased his risk of getting Covid-19 infection. The co-suspect medication Trelegy, and the close temporal relationship between trelegy and urinary symptoms, remain as confounders to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.