Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare; Covid vaccine issue/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, 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) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) (seriousness criterion medically significant) and FATIGUE (Covid vaccine issue/fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) and FATIGUE (Covid vaccine issue/fatigue) outcome was unknown.            No concomitant medication information was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up and an expected, non-serious event. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not provided and the event onset dates were not reported, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19 vaccine issue/fatigue and rheumatoid arthritis flare. No further details were provided. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The co-suspect product Humira (adalimumab) also remains a confounder for the event rheumatoid arthritis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up and an expected, non-serious event. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not provided and the event onset dates were not reported, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19 vaccine issue/fatigue and rheumatoid arthritis flare. No further details were provided. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The co-suspect product Humira (adalimumab) also remains a confounder for the event rheumatoid arthritis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.