Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flare in right leg and arms/around right knee; run down after all covid shots; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis flare in right leg and arms/around right knee) in an 81-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-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) CF, Solution for injection in pre-filled pen. In 2021, the patient experienced FATIGUE (run down after all covid shots). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis flare in right leg and arms/around right knee) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis flare in right leg and arms/around right knee) had not resolved and FATIGUE (run down after all covid shots) had resolved.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for HUMIRA(ADALIMUMAB) for the event(s) of rheumatoid arthritis flare in right leg and arms/around right knee was not provided. the reporter's causality for the event(s) of run down after all covid shots with humira(adalimumab) 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 concerning an 81-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare), after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 81-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare), after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.