Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Pyrexia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Burning sensation of upper limb; Low grade fever; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 57-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.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-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 BURNING SENSATION (Burning sensation of upper limb), PYREXIA (Low grade fever) and PAIN IN EXTREMITY (Pain in arm). 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 BURNING SENSATION (Burning sensation of upper limb), PYREXIA (Low grade fever) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not 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.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter. Company comment: This spontaneous case concerns a 57-years-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI 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. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. 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.; Sender's Comments: This spontaneous case concerns a 57-years-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI 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. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. 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.