Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS/SECOND COVID VACCINE TRIGGERED PATIENT RHEUMATOID ARTHRITIS; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS/SECOND COVID VACCINE TRIGGERED PATIENT RHEUMATOID ARTHRITIS) in a 46-year-old 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 (MODERATE TO SEVERE).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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) Citrate Free,Solution for injection in pre-filled pen. In February 2021, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS/SECOND COVID VACCINE TRIGGERED PATIENT RHEUMATOID ARTHRITIS) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS/SECOND COVID VACCINE TRIGGERED PATIENT RHEUMATOID ARTHRITIS) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Rheumatoid arthritis flare up was  assessed as No reasonable possibility for cosuspect humira. No treatment medications were reported. 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 a 46-year-old female 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, which occurred on the same month of the second mRNA-1273 vaccination. Latency cannot be properly assessed since the exact vaccination date nor the exact 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.   This case was linked to MOD-2022-620298 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case, reported by a consumer concerning a 46-year-old female 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, which occurred on the same month of the second mRNA-1273 vaccination. Latency cannot be properly assessed since the exact vaccination date nor the exact 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.