Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Erectile dysfunction, Fatigue
Clinical narrative: Erectile dysfunction after 2nd vaccine, Both doctors stated the ED is not vaccine related; Felt a little run down after 2nd primary vaccine; This spontaneous case was reported by a patient and describes the occurrence of ERECTILE DYSFUNCTION (Erectile dysfunction after 2nd vaccine, Both doctors stated the ED is not vaccine related) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN for Migraine.   On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt a little run down after 2nd primary vaccine). In December 2021, the patient experienced ERECTILE DYSFUNCTION (Erectile dysfunction after 2nd vaccine, Both doctors stated the ED is not vaccine related) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (Erectile dysfunction after 2nd vaccine, Both doctors stated the ED is not vaccine related) and FATIGUE (Felt a little run down after 2nd primary vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, Blood testosterone: 330 ng/dL. In April 2022, Blood testosterone: 410 ng/dL. In June 2022, Blood testosterone: 310 ng/dL.         The patient reported that he did not have side effects really.  In Dec-2021 and Jan-2022 started with Erectile dysfunction. Patient went to 2 different doctors. Both physician stated the Erectile dysfunction was not vaccine related.  No treatment medication details reported.  Company comment: This spontaneous case reported by a patient, concerns a 54 year old male patient, with relevant medical history of Migraine , who experienced the unexpected, serious (medically significant) event of Migraine, unknown days after receiving the 2 dose of mRNA1273 vaccine in the covid 19 vaccination series, along with other non serious event of fatigue. Patient previously had the 1 dose of Moderna vaccine about 28 days prior to the 2 dose. Concomitant products included SUMATRIPTAN for Migraine, which could be considered as a confounder. No information was provided about the other comorbidities and treatment medication. It was reported that the doctors had stated that the event was not vaccine related. Blood tests revealed Low Blood Testosterone levels at 330 ng/dL, 410 ng/dL and 310 ng/dl. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient, concerns a 54 year old male patient, with relevant medical history of Migraine , who experienced the unexpected, serious (medically significant) event of Migraine, unknown days after receiving the 2 dose of mRNA1273 vaccine in the covid 19 vaccination series, along with other non serious event of fatigue. Patient previously had the 1 dose of Moderna vaccine about 28 days prior to the 2 dose. Concomitant products included SUMATRIPTAN for Migraine, which could be considered as a confounder. No information was provided about the other comorbidities and treatment medication. It was reported that the doctors had stated that the event was not vaccine related. Blood tests revealed Low Blood Testosterone levels at 330 ng/dL, 410 ng/dL and 310 ng/dl. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.