Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Oral herpes, Rheumatoid arthritis
Clinical narrative: Cold sores; Rheumatoid arthritis; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 46-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) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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) Citrate free. In February 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant) and IMMUNISATION REACTION (Vaccination adverse reaction). On an unknown date, the patient experienced ORAL HERPES (Cold sores). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), IMMUNISATION REACTION (Vaccination adverse reaction) and ORAL HERPES (Cold sores) had not resolved.            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 information was  provided.  It was reported that In February 2021, the patient experienced covid vaccine reaction/second covid vaccine triggered rheumatoid arthritis.     Suspect drug daily dose was reported as citrate free.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.  Company comment: This spontaneous case concerns a 46-years-old female patient with medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. 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 46-years-old female patient with medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. 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.