Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 54-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SULFASALAZINE for an unknown indication.   On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2022, 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) at an unspecified dose. In January 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved.            Swelling in fingers and Trouble using hands were the reported symptoms of Rheumatoid arthritis flare up.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Swelling in fingers and Trouble using hands was not provided.  No treatment information was 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 a 54-year-old female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as rheumatoid arthritis flare up), which occurred the same month related to the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. Patient experienced swelling of fingers and trouble using hands. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 54-year-old female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as rheumatoid arthritis flare up), which occurred the same month related to the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. Patient experienced swelling of fingers and trouble using hands. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.