Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rheumatoid arthritis
Clinical narrative: Sick after second COVID-19 vaccine; Rheumatoid arthritis flare; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) in a 57-year-old 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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, UNK. In September 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (Sick after second COVID-19 vaccine). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) and ILLNESS (Sick after second COVID-19 vaccine) had resolved. No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality with Humira for the event Rheumatoid arthritis flare up was reasonable possibility and for the event sickness was no reasonable possibility. 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 57-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), which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. 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 57-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), which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. 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.