Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Increased tendency to bruise, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Increased tendency to bruise/bruises easily; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 60-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Jul-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 01-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-May-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and INCREASED TENDENCY TO BRUISE (Increased tendency to bruise/bruises easily). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and INCREASED TENDENCY TO BRUISE (Increased tendency to bruise/bruises easily) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Bruises easily with Rinvoq(Upadacitinib) was no reasonable possibility. The reporter's causality for the event of rheumatoid arthritis flare up with Rinvoq(Upadacitinib) was a reasonable possibility.  Company Comment: This is a spontaneous case concerning  a  60-year-old, female patient with Concurrent medical conditions of Rheumatoid arthritis. and co-suspect product included non-company product Upadacitinib for Rheumatoid arthritis., who experienced the unexpected serious (medically significant) event of Rheumatoid arthritis and unexpected non-serious event of Increased tendency to bruise. The exact date of the onset of the events was not specified, hence latency could not be assessed. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events had not resolved at the time of report. Reporter's causality for the event of rheumatoid arthritis flare up with Rinvoq(Upadacitinib) was a reasonable possibility. The Concurrent medical conditions of Rheumatoid arthritis and co-suspect product included non-company product Upadacitinib remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  60-year-old, female patient with Concurrent medical conditions of Rheumatoid arthritis. and co-suspect product included non-company product Upadacitinib for Rheumatoid arthritis., who experienced the unexpected serious (medically significant) event of Rheumatoid arthritis and unexpected non-serious event of Increased tendency to bruise. The exact date of the onset of the events was not specified, hence latency could not be assessed. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events had not resolved at the time of report. Reporter's causality for the event of rheumatoid arthritis flare up with Rinvoq(Upadacitinib) was a reasonable possibility. The Concurrent medical conditions of Rheumatoid arthritis and co-suspect product included non-company product Upadacitinib remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.