Sex: F
Vaccine: COVID19
Symptoms: Device issue, Dysgeusia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Taste metallic; Misfire/patient did injection/not puncture skin, fluid ran down skin; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult 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 an unknown indication.  No Medical History information was reported.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-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) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), DYSGEUSIA (Taste metallic) and DEVICE ISSUE (Misfire/patient did injection/not puncture skin, fluid ran down skin). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown and DYSGEUSIA (Taste metallic) and DEVICE ISSUE (Misfire/patient did injection/not puncture skin, fluid ran down skin) had resolved.  No concomitant medication was reported. No treatment medication was reported. The reporter causality for the events of misfire/patient did injection/not puncture skin, fluid ran down skin, rheumatoid arthritis flare and metal taste with HUMIRA was not provided.  Company comment. This spontaneous case concerns an adult female patient (5-decade-old) with no reported medical history, who received two doses of mRNA-1273 vaccine, and experienced the unexpected, serious medically significant AESI of rheumatoid arthritis (described as "Rheumatoid arthritis flare up"), among other non  serious events. Event onset date was not reported; hence latency and temporal association cannot be properly assessed. Patient was in treatment with co  suspect product Adalimumab (Humira). No further details were provided for medical review. Rheumatoid arthritis flare is suggestive of underlying Rheumatoid arthritis and flaring of symptoms is part of the natural course (but diagnosis is not available). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient (5-decade-old) with no reported medical history, who received two doses of mRNA-1273 vaccine, and experienced the unexpected, serious medically significant AESI of rheumatoid arthritis (described as "Rheumatoid arthritis flare up"), among other non  serious events. Event onset date was not reported; hence latency and temporal association cannot be properly assessed. Patient was in treatment with co  suspect product Adalimumab (Humira). No further details were provided for medical review. Rheumatoid arthritis flare is suggestive of underlying Rheumatoid arthritis and flaring of symptoms is part of the natural course (but diagnosis is not available). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.