Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up due to covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up due to covid vaccine) 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). Concomitant products included LEFLUNOMIDE (ARAVA) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Solution for injection in pre-filled pen. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up due to covid vaccine) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up due to covid vaccine) outcome was unknown.            Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for humira for the event(s) of rheumatoid arthritis flare due to covid vaccine was not provided.  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 is a spontaneous case, reported by a consumer concerning an elderly male patient with relevant medical condition of moderate to severe Rheumatoid arthritis, who experienced the unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis, reported as Rheumatoid arthritis flare up, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The medical condition of moderate to severe Rheumatoid arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer concerning an elderly male patient with relevant medical condition of moderate to severe Rheumatoid arthritis, who experienced the unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis, reported as Rheumatoid arthritis flare up, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The medical condition of moderate to severe Rheumatoid arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.