Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis, Stress, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Stress; Patient had moderna COVID-19 vaccination/sorearm afterwards; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 60-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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-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) UNK, Citrate Free. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), STRESS (Stress) and VACCINATION SITE PAIN (Patient had moderna COVID-19 vaccination/sorearm afterwards). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and STRESS (Stress) had not resolved and VACCINATION SITE PAIN (Patient had moderna COVID-19 vaccination/sorearm afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            It was reported that daily dose of Humaira as citrate free. Reporter's causality for events vaccination site pain and stress was reported as not related with respect to Humira drug. Reporter's causality for event rheumatoid arthritis flare up was reported as probable with respect to Humira drug. It was unknown if the patient was part of clinical trial. Treatment and concomitant medications were not 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 spontaneous case concerns 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.