Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) in an adult male 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 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-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) Discontinued. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of RHEUMATOID ARTHRITIS FLARE UP with respect to Humira was not provided.  Company Comment:  This spontaneous case concerns an adult male patient with relevant medical history of Rheumatoid arthritis treated with Adalimumab , who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as the date of event onset was not provided. Outcome of the event at the time of report was unknown. Patient received 2 doses of mRNA-1273 vaccine as primary series given 14 days apart. Inappropriate schedule of product administration was noted. Relevant medical history of Rheumatoid arthritis could be considered as confounding to the case as Rheumatoid arthritis  itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Rheumatoid arthritis treated with Adalimumab , who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as the date of event onset was not provided. Outcome of the event at the time of report was unknown. Patient received 2 doses of mRNA-1273 vaccine as primary series given 14 days apart. Inappropriate schedule of product administration was noted. Relevant medical history of Rheumatoid arthritis could be considered as confounding to the case as Rheumatoid arthritis  itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.