Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Inappropriate schedule of product administration, Urinary retention, Urine analysis
Clinical narrative: Trouble voiding urine; Blood in urine; Patient received 2nd and 3rd dose of mRNA-1273 vaccine 9 months apart; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (Trouble voiding urine) in a 60-year-old female 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 06-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd and 3rd dose of mRNA-1273 vaccine 9 months apart). On an unknown date, the patient experienced URINARY RETENTION (Trouble voiding urine) (seriousness criterion medically significant) and BLOOD URINE PRESENT (Blood in urine). The patient was treated with Surgery (surgery of urethra stretching) for Urinary retention and Surgery (surgery of urethra stretching) for Blood urine present. At the time of the report, URINARY RETENTION (Trouble voiding urine), BLOOD URINE PRESENT (Blood in urine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd and 3rd dose of mRNA-1273 vaccine 9 months apart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine analysis: Blood in urine.         No concomitant medication information was reported.  In Jun 2022, patient had out patient surgery of urethra stretching due to some blood in urine and trouble voiding. No other treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Adverse event information provided by patient was related to covid vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 60-year-old female patient, with concurrent medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Urinary retention after receiving a dose of mRNA-1273 vaccine. The onset date of the event was not provided. It was reported that patient underwent urethral dilation due to trouble voiding and bloody urine. Patient received primary series of mRNA-1273 vaccine 27 days apart, and 2nd dose was given approximately 9 months prior to the 3rd dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. Upadacitinib for rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with concurrent medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Urinary retention after receiving a dose of mRNA-1273 vaccine. The onset date of the event was not provided. It was reported that patient underwent urethral dilation due to trouble voiding and bloody urine. Patient received primary series of mRNA-1273 vaccine 27 days apart, and 2nd dose was given approximately 9 months prior to the 3rd dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. Upadacitinib for rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.