Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rheumatoid arthritis
Clinical narrative: Two bad flare ups of rheumatoid arthritis; Experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Two bad flare ups of rheumatoid arthritis) in a 73-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.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced COVID-19 (Experienced COVID). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Two bad flare ups of rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Two bad flare ups of rheumatoid arthritis) outcome was unknown and COVID-19 (Experienced COVID) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  Treatment medication were not reported. Moderna COVID-19 vaccine was reported.  Company Comment: This spontaneous case concerns a 73-year-old female patient, treated with co-suspect drug Adalimumab indicated for Rheumatoid arthritis moderate to severe (onset date of adalimumab was not provided and no relevant medical history was reported), who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) at an unknown date. The patient received a dose of mRNA-1273 vaccine on an unknown date. Latency between the vaccine and the event could not be assessed (due to lack of information about vaccination and event onset dates). The outcome of event was unknown. Adalimumab indicated for Rheumatoid arthritis moderate to severe is suggestive of underlying rheumatoid arthritis which could be a confounder for the case since this disease can have flares. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient, treated with co-suspect drug Adalimumab indicated for Rheumatoid arthritis moderate to severe (onset date of adalimumab was not provided and no relevant medical history was reported), who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) at an unknown date. The patient received a dose of mRNA-1273 vaccine on an unknown date. Latency between the vaccine and the event could not be assessed (due to lack of information about vaccination and event onset dates). The outcome of event was unknown. Adalimumab indicated for Rheumatoid arthritis moderate to severe is suggestive of underlying rheumatoid arthritis which could be a confounder for the case since this disease can have flares. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.