Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erectile dysfunction
Clinical narrative: erectile dysfunction; This spontaneous case was reported by a patient and describes the occurrence of ERECTILE DYSFUNCTION (erectile dysfunction) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L21A and 041B21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 17-May-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022 at 3:45 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced ERECTILE DYSFUNCTION (erectile dysfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (erectile dysfunction) had not resolved.            No concomitant medication was reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Reportedly, patient started experiencing erectile dysfunction since Pfizer booster. Patient did not have the problem on 04-Jan-2022. As of 31-Mar-2022, patient was still having the same problem which never happened before 04-Jan-2022. Patient did not have COVID related or any health problems. Patient was not tested positive for COVID. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No treatment information was provided.  Device date was reported as 31-Jan-2022.  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 is a Spontaneous case reported by a patient, concerning a 43-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Erectile dysfunction, which occurred 1 day after the third dose of Pfizer vaccine against COVID-19, and after primary vaccination with mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a patient, concerning a 43-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Erectile dysfunction, which occurred 1 day after the third dose of Pfizer vaccine against COVID-19, and after primary vaccination with mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.