Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Dyspnoea, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; TROUBLE BREATHING; CHEST PAINS; SWOLLEN FEET DUE TO VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 55-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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (SWOLLEN FEET DUE TO VACCINE). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), DYSPNOEA (TROUBLE BREATHING) and CHEST PAIN (CHEST PAINS). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), PERIPHERAL SWELLING (SWOLLEN FEET DUE TO VACCINE), DYSPNOEA (TROUBLE BREATHING) and CHEST PAIN (CHEST PAINS) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of swollen feet, trouble breathing, rheumatoid arthritis flare up and chest pains with Humira was no reasonable possibility.  No treatment medications were reported.  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 55-years-old female patient with medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant)  Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to first dose of mRNA-1273 vaccine. Patient also received appropriately scheduled second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. 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 55-years-old female patient with medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to first dose of mRNA-1273 vaccine. Patient also received appropriately scheduled second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. 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.