Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rheumatoid arthritis, SARS-CoV-2 antibody test
Clinical narrative: Rheumatoid arthritis flare up; PAIN/HURT; SICK TO STOMACH/NAUSEOUS; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ETANERCEPT (ENBREL) for Rheumatoid arthritis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Rheumatoid arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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 and ETANERCEPT (ENBREL) (unknown route) at an unspecified dose. In 2021, the patient experienced NAUSEA (SICK TO STOMACH/NAUSEOUS). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and PAIN (PAIN/HURT). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and NAUSEA (SICK TO STOMACH/NAUSEOUS) outcome was unknown and PAIN (PAIN/HURT) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: not reported.         Formulation of Humira was reported as Solution for injection in pre-filled pen. No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  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 70-years-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA) and ETANERCEPT (ENBREL), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test was performed and  result not reported. 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 70-years-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA) and ETANERCEPT (ENBREL), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test was performed and  result not reported. 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