Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Paraesthesia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Tingling feet/hands; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 57-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third 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 an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), PARAESTHESIA (Tingling feet/hands), CHILLS (Chills) and MYALGIA (Muscle ache). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and PARAESTHESIA (Tingling feet/hands) had not resolved and CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The formulation for Humira was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of chills and muscle aches was not provided. the reporter's causality for the event(s) of tingling in hands and feet with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of rheumatoid arthritis flare up with Humira(adalimumab) was a reasonable possibility.  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 female patient aged 57 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on unknown dates (in 2021) in the context of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event was not resolved at the time of report. Patient had received initial two doses of same vaccine at an interval of 1 month and third dose 6 months later in 2021. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 57 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on unknown dates (in 2021) in the context of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event was not resolved at the time of report. Patient had received initial two doses of same vaccine at an interval of 1 month and third dose 6 months later in 2021. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.