Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; Vaccination failure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: Citrate free, Solution for injection in prefilled pen. On 15-Oct-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.            Concomitant Drugs were not reported. On 15-Oct-2021, the patient experienced COVID-19. In 2021, the COVID-19 had resolved. No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of 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 male patient aged 42 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred 148 days after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 30 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 42 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred 148 days after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 30 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement..