Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: OCCASIONAL FLARE UPS ASSOCIATED WITH RHEUMATOID ARTHRITIS; Moderna vaccine 1st dose taken on 24-Mar-2021 and 2nd dose taken on 14-Apr-2021; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (OCCASIONAL FLARE UPS ASSOCIATED WITH RHEUMATOID ARTHRITIS) in a 58-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 an unknown indication.    No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-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) CF. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine 1st dose taken on 24-Mar-2021 and 2nd dose taken on 14-Apr-2021). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (OCCASIONAL FLARE UPS ASSOCIATED WITH RHEUMATOID ARTHRITIS) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (OCCASIONAL FLARE UPS ASSOCIATED WITH RHEUMATOID ARTHRITIS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine 1st dose taken on 24-Mar-2021 and 2nd dose taken on 14-Apr-2021) outcome was unknown.            No concomitant drugs were taken.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the event of occasional flare ups associated with rheumatoid arthritis with Humira (Adalimumab) was no reasonable possibility.  No treatment medication information provided Company comment: This spontaneous case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Rheumatoid arthritis. Inappropriate schedule of product administration was also reported. The exact date of onset of the event was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The interval between the first and second dose of mRNA-1273 is 21 days. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Rheumatoid arthritis. Inappropriate schedule of product administration was also reported. The exact date of onset of the event was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The interval between the first and second dose of mRNA-1273 is 21 days. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.