Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Poliomyelitis, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS RELAPSED AFTER COVID-19 VACCINE/Rheumatoid arthritis flare up; Muscle pain; Poliomyelitis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS RELAPSED AFTER COVID-19 VACCINE/Rheumatoid arthritis flare up) and POLIOMYELITIS (Poliomyelitis) in a 45-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.    The patient's past medical history included Glaucoma surgery from 2001 to 2002. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROCHLOROTHIAZIDE for Diuretic therapy, SULFADIMIDINE (SULFADINE), AZATHIOPRINE (IMURAN [AZATHIOPRINE]), MELOXICAM (MOBIC) and BUTALBITAL, PARACETAMOL (TENCON [BUTALBITAL;PARACETAMOL]) for Rheumatoid arthritis, AMLODIPINE BESILATE (NORVASC) for an unknown indication.   In 2007, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. In June 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced POLIOMYELITIS (Poliomyelitis) (seriousness criterion medically significant). In September 2021, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS RELAPSED AFTER COVID-19 VACCINE/Rheumatoid arthritis flare up) (seriousness criterion medically significant) and MYALGIA (Muscle pain). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS RELAPSED AFTER COVID-19 VACCINE/Rheumatoid arthritis flare up) and MYALGIA (Muscle pain) had not resolved and POLIOMYELITIS (Poliomyelitis) outcome was unknown.            The concomitant medication included sulphadine was started over 18 years ago. The Humira drug was available as Solution for injection in pre-filled pen and syringe. The reporter causality for the events of Rheumatoid arthritis flare up, Poliomyelitis was not Reported for cosuspect humira. The reporter causality for the event of muscle pain was  assessed as Not related for cosuspect humira. 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 45 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) events of Rheumatoid arthritis (AESI) (reported as Rheumatoid arthritis flare up in Sep. 2021) and Poliomyelitis (in 2021) on unknown dates in the context of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine at an interval of 28 days in 2021. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event Rheumatoid arthritis flare up was not resolved and Poliomyelitis was not known at the time of report. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient aged 45 years with reported concurrent condition of rheumatoid arthritis on Humira, experienced unexpected serious (medically significant) events of Rheumatoid arthritis (AESI) (reported as Rheumatoid arthritis flare up in Sep. 2021) and Poliomyelitis (in 2021) on unknown dates in the context of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine at an interval of 28 days in 2021. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event Rheumatoid arthritis flare up was not resolved and Poliomyelitis was not known at the time of report. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.