Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Right Shoulder pain; First dose was on 20-Jul-21,Second dose on 8-Aug-21,Third dose on 21-Nov-21; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ARTHRALGIA (Right Shoulder pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 20-Jul-21,Second dose on 8-Aug-21,Third dose on 21-Nov-21) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Jul-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-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 experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ARTHRALGIA (Right Shoulder pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 20-Jul-21,Second dose on 8-Aug-21,Third dose on 21-Nov-21). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and ARTHRALGIA (Right Shoulder pain) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 20-Jul-21,Second dose on 8-Aug-21,Third dose on 21-Nov-21) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Rheumatoid arthritis on Upadacitinib (RINVOQ), who experienced the unexpected non-serious AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine. The event was associated with non-serious event of Arthralgia (right shoulder pain). The outcome was reported as not resolved. Details of investigations and treatment of the flare-up of Rheumatoid arthritis was not provided. Elderly age of the patient could be a risk factor. Medical history of Rheumatoid arthritis remains a confounder. The interval between the 1st and 2nd doses is 38 days  inappropriate schedule of vaccination. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Rheumatoid arthritis on Upadacitinib (RINVOQ), who experienced the unexpected non-serious AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine. The event was associated with non-serious event of Arthralgia (right shoulder pain). The outcome was reported as not resolved. Details of investigations and treatment of the flare-up of Rheumatoid arthritis was not provided. Elderly age of the patient could be a risk factor. Medical history of Rheumatoid arthritis remains a confounder. The interval between the 1st and 2nd doses is 38 days  inappropriate schedule of vaccination. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.