Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Ejection fraction, Mitral valve prolapse, Prostatic disorder, Urinary retention
Clinical narrative: He could not go to the bathroom and had surgery on his prostate; Diagnosed with Mitral valve prolapse; Congestive Heart Failure and went to Emergency Room; Had prostate problems and went to Emergency; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive Heart Failure and went to Emergency Room), MITRAL VALVE PROLAPSE (Diagnosed with Mitral valve prolapse), URINARY RETENTION (He could not go to the bathroom and had surgery on his prostate) and PROSTATIC DISORDER (Had prostate problems and went to Emergency) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive Heart Failure and went to Emergency Room) (seriousness criterion hospitalization). On 04-Jun-2021, the patient experienced PROSTATIC DISORDER (Had prostate problems and went to Emergency) (seriousness criterion medically significant). On 14-Jun-2021, the patient experienced MITRAL VALVE PROLAPSE (Diagnosed with Mitral valve prolapse) (seriousness criterion hospitalization). On 23-Aug-2021, the patient experienced URINARY RETENTION (He could not go to the bathroom and had surgery on his prostate) (seriousness criterion hospitalization). The patient was hospitalized from 19-May-2021 to 22-May-2021 due to CARDIAC FAILURE CONGESTIVE, then from 18-Jun-2021 to 26-Jun-2021 due to MITRAL VALVE PROLAPSE, and then on 23-Aug-2021 due to URINARY RETENTION. The patient was treated with TORSEMIDE for Adverse event, at a dose of 20 milligram; Surgery (had a catheterization done and on 22 JUN 2021 had Mitral Valve Repair surgery) for Mitral valve prolapse and Surgery (had surgery on his prostate) for Urinary retention. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive Heart Failure and went to Emergency Room), MITRAL VALVE PROLAPSE (Diagnosed with Mitral valve prolapse), URINARY RETENTION (He could not go to the bathroom and had surgery on his prostate) and PROSTATIC DISORDER (Had prostate problems and went to Emergency) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ejection fraction: low (Low) Heart beats only 34% of his blood, as opposed to 60 or above.         No concomitant medication information was provided. Treatment included  diuretics. On an unknown date, patient had a Foley catheter insertion. Patient had several tests performed, treated and was discharged on 22 MAY2021  Patient was admitted to Hospital, ICU and then moved to Hospital on 18 JUN 2021.  On 22 JUN 2021 patient had Mitral Valve Repair surgery and was discharged 26 JUN 2021 and stayed home.  On 30 JUL 2021, patient had a Cardio-conversion procedure (electro-pads). Company comment:This is a spontaneous case concerning a 63-year-old, male patient with no medical history reported, who experienced the unexpected serious events of Mitral valve prolapse, congestive heart failure and prostatic disorder with urinary retention. It started about 1 month after the second dose of mRNA-1273, where the patient was hospitalized for 4 days due to congestive heart failure. Despite being reported that several tests were performed, no results were disclosed, but the reporter does mention an EF of 34%. Thirteen days after hospital discharge the patient had a visit to the ER requiring a Foley catheter insertion due to a unknown prostate disorder. Ten days later the patient was diagnosed with mitral valve prolapse being admitted to the ICU. This time, he stayed 13 days hospitalized where he was submitted to a cardiac catheterization and later a mitral valve repair. Four days after being discharged home the patient underwent a cardioversion with electro-pads, but the cause was not reported. Finally, around 4 months after the second dose of the vaccine, the patient presented urinary retention requiring a prostate surgery. Currently patient receives Torsemide and Diuretics as treatment. It is unknown if the cardiac and prostatic problems are new in onset or an aggravation of previous comorbidities. It is important to highlight, though, that urinary retention due to prostatic issues are very common in the patient's age group, where surgery is a common treatment. Also, mitral valve prolapse usually has long latency and only in some fewcases are malignant, leading to several complications that when untreated can lead to congestive cardiac failure, rarely in an acute fashion. Queries were raised to try to clarify any possible confounders for the events reported. The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2021-395689 (Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up information received and contains no new information; Sender's Comments: This is a spontaneous case concerning a 63-year-old, male patient with no medical history reported, who experienced the unexpected serious events of Mitral valve prolapse, congestive heart failure and prostatic disorder with urinary retention. It started about 1 month after the second dose of mRNA-1273, where the patient was hospitalized for 4 days due to congestive heart failure. Despite being reported that several tests were performed, no results were disclosed, but the reporter does mention an EF of 34%. Thirteen days after hospital discharge the patient had a visit to the ER requiring a Foley catheter insertion due to a unknown prostate disorder. Ten days later the patient was diagnosed with mitral valve prolapse being admitted to the ICU. This time, he stayed 13 days hospitalized where he was submitted to a cardiac catheterization and later a mitral valve repair. Four days after being discharged home the patient underwent a cardioversion with electro-pads, but the cause was not reported. Finally, around 4 months after the second dose of the vaccine, the patient presented urinary retention requiring a prostate surgery. Currently patient receives Torsemide and Diuretics as treatment. It is unknown if the cardiac and prostatic problems are new in onset or an aggravation of previous comorbidities. It is important to highlight, though, that urinary retention due to prostatic issues are very common in the patient's age group, where surgery is a common treatment. Also, mitral valve prolapse usually has long latency and only in some fewcases are malignant, leading to several complications that when untreated can lead to congestive cardiac failure, rarely in an acute fashion. Queries were raised to try to clarify any possible confounders for the events reported. The benefit-risk relationship of mRNA-1273 in not affected by this report.