Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Rheumatoid arthritis, Sinusitis
Clinical narrative: Rheumatoid arthritis worse; Sinus infection; Nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis worse) in a 69-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 (Moderate to severe).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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. On 04-May-2022, the patient experienced EPISTAXIS (Nose bleed). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis worse) (seriousness criterion medically significant) and SINUSITIS (Sinus infection). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis worse) had resolved, EPISTAXIS (Nose bleed) had not resolved and SINUSITIS (Sinus infection) was resolving.            No relevant concomitant medications were reported. No treatment medication reported.   The reporters causality in aspect of Humira for the events of nose bleed with Humira was a reasonable possibility. The reporters causality in aspect of Humira for the events of sinus infection and rheumatoid arthritis worse was not 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 69-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 worse) 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 69-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 worse) 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.