Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; On 21 Apr 2021, patient received 1st dose and  on 06 May 2021, patient received 2nd dose; COVID vaccine made feel bad/run down/achy; COVID vaccine made feel bad/run down/achy; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 38-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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 21 Apr 2021, patient received 1st dose and  on 06 May 2021, patient received 2nd dose). In 2021, the patient experienced IMMUNISATION REACTION (COVID vaccine made feel bad/run down/achy) and PAIN (COVID vaccine made feel bad/run down/achy). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2021, IMMUNISATION REACTION (COVID vaccine made feel bad/run down/achy) and PAIN (COVID vaccine made feel bad/run down/achy) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved with sequelae and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 21 Apr 2021, patient received 1st dose and  on 06 May 2021, patient received 2nd dose) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant product reported by reporter. No treatment medication reported by reporter.  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 38-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with co-suspect Adalimumab, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) after receiving a dose of mRNA-1273 vaccine. The onset date of event was not reported. Patient received 1st and 2nd doses of mRNA-1273 vaccine 15 days apart. Clinical course and treatment details were not reported. The outcome of event was reported as resolved with sequelae. Concurrent rheumatoid arthritis and co-suspect Adalimumab could be confounders as the disease flares. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with co-suspect Adalimumab, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) after receiving a dose of mRNA-1273 vaccine. The onset date of event was not reported. Patient received 1st and 2nd doses of mRNA-1273 vaccine 15 days apart. Clinical course and treatment details were not reported. The outcome of event was reported as resolved with sequelae. Concurrent rheumatoid arthritis and co-suspect Adalimumab could be confounders as the disease flares. The benefit-risk relationship of mRNA-1273 is not affected by this report.