Sex: F
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 an adult female 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, received third 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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID-19) was resolving and VACCINATION FAILURE (Vaccination failure) outcome was unknown.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  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 spontaneous case concerns an adult female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date in the context of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date were provided. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 31 days and 3rd dose approximately  5 months later. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolving 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 assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date in the context of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date were provided. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 31 days and 3rd dose approximately  5 months later. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolving 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 assessed as per medical judgement