Sex: F
Vaccine: COVID19
Symptoms: Fall, Rheumatoid arthritis
Clinical narrative: Fall; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third 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) UNK, CF Pen. On an unknown date, the patient experienced FALL (Fall) (seriousness criterion hospitalization) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, FALL (Fall) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved.            No concomitant medications were reported No treatment medications were reported It was reported that HUMIRA was not working and Rheumatoid arthritis flared up with HUMIRA. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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 female patient of an unknown age, with concurrent medical history of rheumatoid arthritis treated with co-suspect drug Adalimumab (start date not reported), who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis flare up and unexpected serious (hospitalization) event of Fall on an unknown date after receiving a dose of mRNA-1273 vaccine. Patient received 3 doses of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of events was reported as not resolved. The co-suspect Adalimumab and rheumatoid arthritis could be  confounder since the disease flares up. Patient received 2 doses of mRNA-1273 vaccine as primary series at an interval of 28 days, and the 2nd dose was given approximately 7 months prior to the 3rd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of rheumatoid arthritis treated with co-suspect drug Adalimumab (start date not reported), who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis flare up and unexpected serious (hospitalization) event of Fall on an unknown date after receiving a dose of mRNA-1273 vaccine. Patient received 3 doses of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of events was reported as not resolved. The co-suspect Adalimumab and rheumatoid arthritis could be confounder since the disease flares up. Patient received 2 doses of mRNA-1273 vaccine as primary series at an interval of 28 days, and the 2nd dose was given approximately 7 months prior to the 3rd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.