Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1ST DOSE OF MODERNA ON 14-MAR-2021 AND 2ND DOSE ON 30-MAR-2021; Rheumatoid arthritis flare up; SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN; DISCOMFORT IN MORNING; SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN; PATIENT TOOK VACCINE AND ARM WAS LITTLE SORE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 68-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to Dose 2. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) Dose 1. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), PAIN (SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN), DISCOMFORT (DISCOMFORT IN MORNING), SWELLING (SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN) and VACCINATION SITE PAIN (PATIENT TOOK VACCINE AND ARM WAS LITTLE SORE). On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST DOSE OF MODERNA ON 14-MAR-2021 AND 2ND DOSE ON 30-MAR-2021). In March 2021, PAIN (SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN), SWELLING (SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN) and VACCINATION SITE PAIN (PATIENT TOOK VACCINE AND ARM WAS LITTLE SORE) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) was resolving, DISCOMFORT (DISCOMFORT IN MORNING) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST DOSE OF MODERNA ON 14-MAR-2021 AND 2ND DOSE ON 30-MAR-2021) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported. The patient had whole body swollen and was in pain, she had to go off RINVOQ. She stopped taking the RINVOQ in 2021 two weeks before and due to taking the Covid-19 vaccine on 14-Mar-2021  The reporter's causality for the events of PATIENT TOOK VACCINE AND ARM WAS LITTLE SORE, SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN onset in 2021, DISCOMFORT IN MORNING, SWOLLEN EVERY WHERE/WHOLE BODY WAS SWOLLEN AND IN PAIN onset in 2021, HARDLY WALK OR STAND onset in 2021, RHEUMATOID ARTHRITIS FLAREUP, HARDLYWALK OR STAND onset in 2021 and PATIENT STOPPED TAKING THE RINVOQ TWO WEEKS BEFORE TAKING VACCINE was not provided. She had a lot of pain in her hand because she was off RINVOQ and the physician gave her an injection for it (Treatment medication was unspecified).  The events sitting disability, dysstasia and gait disturbance were subsumed under Rheumatoid arthritis flare up. reporter stated that Patient stopped taking the rinvoq two weeks before taking vaccine.  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.  This spontaneous case concerns a 68-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the second dose of mRNA-1273. The patient describes that she had a flare up in which she experienced swelling all over her body accompanied by pain which impaired her ability to walk or stand up. Two weeks before the administration of the first dose of mRNA-1273, the patient stopped taking her rheumatoid arthritis medication (upadacitinib), which along with the disease's natural history of possible relapses, could be contributing factors for the event. It is to note that the patient also received the second dose of mRNA-1273 16 days after the first dose (inappropriate schedule of product administration) which could also contribute to the event. The patient was treated with an injection, although medication was unspecified. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the second dose of mRNA-1273. The patient describes that she had a flare up in which she experienced swelling all over her body accompanied by pain which impaired her ability to walk or stand up. Two weeks before the administration of the first dose of mRNA-1273, the patient stopped taking her rheumatoid arthritis medication (upadacitinib), which along with the disease's natural history of possible relapses, could be contributing factors for the event. It is to note that the patient also received the second dose of mRNA-1273 16 days after the first dose (inappropriate schedule of product administration) which could also contribute to the event. The patient was treated with an injection, although medication was unspecified. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.