Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rheumatoid arthritis
Clinical narrative: COVID-19; Rheumatoid arthritis flare; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) in a 48-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 (Moderate to severe rheumatoid arthritis), Injection site itching and Injection site papule.   In April 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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) at an unspecified dose. In May 2022, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) (seriousness criterion medically significant). In 2022, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) and COVID-19 (COVID-19) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was reported.  No treatment medication information was reported.  The reporter's causality for the events of COVID, raised on Humira injection site and itchy unknown onset, rheumatoid arthritis flare and raised on Humira injection site and itchy unknown onset with Humira (adalimumab) was no reasonable possibility.  Company comment: This is a spontaneous case concerning a 48-year-old, female patient with concurrent medical condition of rheumatoid arthritis. The patient has co-suspect medication of Adalimumab (Humira) for moderate to severe rheumatoid arthritis. The patient experienced the unexpected serious (medically significant) AESI event of rheumatoid arthritis flare up, and the unexpected non-serious AESI event of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with unspecified dosage interval. The event rheumatoid arthritis flare up occurred on the same year with the third dose (booster) of mRNA-1273 vaccine administration. The event Covid-19 occurred the month after the third dose (booster) of mRNA-1273 vaccine administration. No further clinical information was available for medical review. The outcome of the events was reported as resolved. The natural course of the concurrent medical condition of rheumatoid arthritis remain confounder for the event rheumatoid arthritis flare up. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 48-year-old, female patient with concurrent medical condition of rheumatoid arthritis. The patient has co-suspect medication of Adalimumab (Humira) for moderate to severe rheumatoid arthritis. The patient experienced the unexpected serious (medically significant) AESI event of rheumatoid arthritis flare up, and the unexpected non-serious AESI event of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with unspecified dosage interval. The event rheumatoid arthritis flare up occurred on the same year with the third dose (booster) of mRNA-1273 vaccine administration. The event Covid-19 occurred the month after the third dose (booster) of mRNA-1273 vaccine administration. No further clinical information was available for medical review. The outcome of the events was reported as resolved. The natural course of the concurrent medical condition of rheumatoid arthritis remain confounder for the event rheumatoid arthritis flare up. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.