Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled syringe. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. On an unknown date, the patient experienced COVID. On an unknown date, COVID resolved.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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.  CC: This spontaneous case concerns a male patient of unknown age with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with unknown event's onset date and vaccination date. A positive COVID-19 test was obtained on an unknown date. Vaccination history included one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, additional diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab could predispose him to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with unknown event's onset date and vaccination date. A positive COVID-19 test was obtained on an unknown date. Vaccination history included one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, additional diagnostics, and treatments were not reported. Patient's underlying Crohn's disease and treatment with adalimumab could predispose him to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.