Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Fever; Chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 61-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.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In July 2021, the patient experienced COVID-19 (COVID-19). In November 2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In November 2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and COVID-19 (COVID-19) had resolved.            No Medical History information was reported. Humira (solution for injection in pre-filled pen) was used for the indication of moderate to severe rheumatoid arthritis. Action taken with Humira in response to the event COVID-19 was unknown. On unknown date Humira was discontinued. No treatment drug was reported. Causality for Humira(adalimumab): the reporter's causality for the event(s) of chills, covid and fever was not provided. the reporter's causality for the event(s) of rheumatoid arthritis flare up with Humira(adalimumab) was a 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 spontaneous case reported by a consumer, concerns a 61 year old female patient, with no relevant medical history, who experienced the unexpected, serious (medically significant) event of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) , the unexpected,  non serious AESI event of Covid 19, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of pyrexia and chills. Patient had previously received the 2 primary doses with Pfizer vaccines without any adverse events reported. Interchange of vaccine products was noted. On an unknown date patient also received Adalimumab for Rheumatoid Arthritis, which along with covid 19 infection and pyrexia remain as confounders for the flare up. The event had resolved.  No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 61 year old female patient, with no relevant medical history, who experienced the unexpected, serious (medically significant) event of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) , the unexpected,  non serious AESI event of Covid 19, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of pyrexia and chills. Patient had previously received the 2 primary doses with Pfizer vaccines without any adverse events reported. Interchange of vaccine products was noted. On an unknown date patient also received Adalimumab for Rheumatoid Arthritis, which along with covid 19 infection and pyrexia remain as confounders for the flare up. The event had resolved.  No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.