Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Illness, Unevaluable event, Urinary retention
Clinical narrative: COULD NOT PEE; BLOOD PRESSURE WENT LOW; VERY SICK; COULD NOT GET WATER THROUGH SYSTEM; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (COULD NOT PEE) in a 61-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Smoker from 1982 to 2022.   On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced URINARY RETENTION (COULD NOT PEE) (seriousness criterion medically significant), HYPOTENSION (BLOOD PRESSURE WENT LOW), ILLNESS (VERY SICK) and UNEVALUABLE EVENT (COULD NOT GET WATER THROUGH SYSTEM). At the time of the report, URINARY RETENTION (COULD NOT PEE), HYPOTENSION (BLOOD PRESSURE WENT LOW), ILLNESS (VERY SICK) and UNEVALUABLE EVENT (COULD NOT GET WATER THROUGH SYSTEM) had not resolved.            No concomitant medication was reported No treatment medication was reported. Patient's doctor took him off of the blood pressure medication after the blood pressure was low. Patient had just received Shingles, Flu and Pneumonia shot before COVID shot. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE  020343  Company comment  This spontaneous case reported by a consumer, concerns a 61 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious ( medically significant) event of URINARY RETENTION (COULD NOT PEE)  Unknown days after receiving  2 unspecified  doses of Moderna vaccine at an interval of 34 days apart, in the covid 19 vaccination series, along with other non serious events of Hypotension and illness. It was reported that the Patient had just received Shingles, Flu and Pneumonia shot before COVID vaccine. Also the patient had received RISANKIZUMAB for Ulcerative Colitis which is a confounder for Hypotension. It was reported that the Patient's blood pressure medications were stopped after the blood pressure was low. The outcome of the event was not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 61 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious ( medically significant) event of URINARY RETENTION (COULD NOT PEE)  Unknown days after receiving  2 unspecified  doses of Moderna vaccine at an interval of 34 days apart, in the covid 19 vaccination series, along with other non serious events of Hypotension and illness. It was reported that the Patient had just received Shingles, Flu and Pneumonia shot before COVID vaccine. Also the patient had received RISANKIZUMAB for Ulcerative Colitis which is a confounder for Hypotension. It was reported that the Patient's blood pressure medications were stopped after the blood pressure was low. The outcome of the event was not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.