Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received first 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) CF. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The formulation for Humira was reported as Solution for injection in pre-filled pen.  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 elderly, male patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported and the vaccination date of the second dose of the mRNA-1273 vaccine was reported as unspecified date in May2021 while the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19. No symptoms were reported and treatment information was not provided. However, the event was resolving at the time of the report. The history of co-suspect administration of Humira, a tumor necrosis factor-alpha blocker that can lower the ability of the immune system to fight infections, remains a confounder. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an elderly, male patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported and the vaccination date of the second dose of the mRNA-1273 vaccine was reported as unspecified date in May2021 while the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19. No symptoms were reported and treatment information was not provided. However, the event was resolving at the time of the report. The history of co-suspect administration of Humira, a tumor necrosis factor-alpha blocker that can lower the ability of the immune system to fight infections, remains a confounder. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.