Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue, Pain in extremity, Papule, Peripheral swelling
Clinical narrative: Rheumatoid arthritis flare up; Swollen hands; Bumps on joints of fingers; Painful hands/ sore arm; Pain in hips; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen hands), PAPULE (Bumps on joints of fingers), PAIN IN EXTREMITY (Painful hands/ sore arm), ARTHRALGIA (Pain in hips) and FATIGUE (Fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), PERIPHERAL SWELLING (Swollen hands), PAPULE (Bumps on joints of fingers), PAIN IN EXTREMITY (Painful hands/ sore arm) and ARTHRALGIA (Pain in hips) had not resolved and FATIGUE (Fatigue) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter.  The causality for Rinvoq was reported as no reasonable possibility for pain in extremity and reasonable possibility for all other events.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult 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 up), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of 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 adult 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 up), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of 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.