Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess limb, Cancer fatigue, Inappropriate schedule of product administration, Joint range of motion decreased, Mobility decreased
Clinical narrative: Chemotherapy fatigue; Neck pain; Joint range of motion decreased; Neck injury; lack of mobility; RHEUMATOID ARTHRITIS; Abscess of toe; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS) in a 64-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.    The patient's past medical history included Breast cancer female in 1992. Concurrent medical conditions included Rheumatoid arthritis.   On 15-Nov-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In September 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On 15-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In August 2021, the patient experienced ABSCESS LIMB (Abscess of toe). In October 2021, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS) (seriousness criterion medically significant). On an unknown date, the patient experienced CANCER FATIGUE (Chemotherapy fatigue), NECK PAIN (Neck pain), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), NECK INJURY (Neck injury) and MOBILITY DECREASED (lack of mobility). In 2021, ABSCESS LIMB (Abscess of toe) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and CANCER FATIGUE (Chemotherapy fatigue), NECK PAIN (Neck pain), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), NECK INJURY (Neck injury) and MOBILITY DECREASED (lack of mobility) had not resolved.            The patient experienced different fatigue than just tiredness and compared it to chemotherapy fatigue. In Aug-2021, she started Rinvoq but therapy was discontinued for four weeks due to toe infection and abscess. In Aug-2021, she had symptoms of rheumatoid arthritis towards the end of the three weeks due to missed dose. Her infection was resolved. She took another call from sick child and then hung up mild assessment. Rheumatoid arthritis was diagnosed and dose was 15 milligram tablet once daily by mouth per pharmacy notes, she did not verify. She stopped taking Rinvoq after she took Covid booster for one week. She experienced neck pain, had ongoing neck injury and had to stop being a physician due to lack of mobility to examine patients.  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 is a spontaneous case concerning a 64-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis, approximately 9 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. Inappropriate schedule of vaccine administered was also reported as an additional event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-624397 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis, approximately 9 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. Inappropriate schedule of vaccine administered was also reported as an additional event. The benefit-risk relationship of mRNA-1273 is not affected by this report.