Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Feeling abnormal, Immunisation reaction, Pyrexia
Clinical narrative: Rheumatoid arthritis flare up; Feeling bad with chills; Second COVID vaccine had reaction; Fatigue; Low grade fever / Fever; Feeling bad with chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-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.    No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FEELING ABNORMAL (Feeling bad with chills), IMMUNISATION REACTION (Second COVID vaccine had reaction), FATIGUE (Fatigue), PYREXIA (Low grade fever / Fever) and CHILLS (Feeling bad with chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and FEELING ABNORMAL (Feeling bad with chills), IMMUNISATION REACTION (Second COVID vaccine had reaction), FATIGUE (Fatigue), PYREXIA (Low grade fever / Fever) and CHILLS (Feeling bad with chills) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  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 a 65-years-old female patient with medical history of Rheumatoid Arthritis that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) event of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis treated with HUMIRA remains a confounder to the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up received as events and narrative description was updated.; Sender's Comments: This spontaneous case concerns a 65-years-old female patient with medical history of Rheumatoid Arthritis that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) event of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis treated with HUMIRA remains a confounder to the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.