Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Blood test abnormal, Rheumatoid arthritis
Clinical narrative: Blood test abnormal; RHEUMATOID ARTHRITIS FLARE UP / RHEUMATOID ARTHRITIS FLARE UPS THAT AFFECTED LEFT SHOULDER/Frozen shoulder/LEFT SHOULDER FREEZE UP; RHEUMATOID ARTHRITIS FLARE UPS; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) and RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP / RHEUMATOID ARTHRITIS FLARE UPS THAT AFFECTED LEFT SHOULDER/Frozen shoulder/LEFT SHOULDER FREEZE UP) in a 62-year-old female patient who received mRNA-1273 (Spikevax) 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis flare up.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2022, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) (seriousness criterion medically significant). In July 2022, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP / RHEUMATOID ARTHRITIS FLARE UPS THAT AFFECTED LEFT SHOULDER/Frozen shoulder/LEFT SHOULDER FREEZE UP) (seriousness criterion medically significant). On an unknown date, the patient experienced BLOOD TEST ABNORMAL (Blood test abnormal). The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2022, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) had resolved. In July 2022, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP / RHEUMATOID ARTHRITIS FLARE UPS THAT AFFECTED LEFT SHOULDER/Frozen shoulder/LEFT SHOULDER FREEZE UP) had resolved. At the time of the report, BLOOD TEST ABNORMAL (Blood test abnormal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: something was not right with blood work.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of LEFT SHOULDER FREEZE UP, RHEUMATOID ARTHRITIS FLARE UPS THAT AFFECTED LEFT SHOULDER and RHEUMATOID ARTHRITIS FLARE UPS with HUMIRA (Solution for injection in pre-filled syringe) (ADALIMUMAB) was no reasonable possibility (Not Related). The reporter's causality for the event(s) of SOMETHING WAS NOT RIGHT WITH BLOOD WORK with HUMIRA(ADALIMUMAB) was not provided (Not Reported).  Company Comment: This spontaneous case concerns a 62-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious AESI of Rheumatoid arthritis flare up and Rheumatoid arthritis flare up (Rheumatoid arthritis flare up that affected the left shoulder) and non-serious event of Periarthritis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Blood work done on an unknown date was abnormal. The Clinical course, Concomitant medication, treatment details were not provided, and the outcome of events reported as resolved. The medical history of Rheumatoid Arthritis remains a confounder to the events Rheumatoid arthritis flare up and Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious AESI of Rheumatoid arthritis flare up and Rheumatoid arthritis flare up (Rheumatoid arthritis flare up that affected the left shoulder) and non-serious event of Periarthritis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Blood work done on an unknown date was abnormal. The Clinical course, Concomitant medication, treatment details were not provided, and the outcome of events reported as resolved. The medical history of Rheumatoid Arthritis remains a confounder to the events Rheumatoid arthritis flare up and Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.