Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Pyrexia, Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: Rheumatoid arthritis flare up; Systemic lupus erythematosus syndrome aggravated/lupus worsened; SLIGHT HIGH TEMPERATURE; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated/lupus worsened) 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) tablet for Rheumatoid arthritis.    The patient's past medical history included COVID-19 since October 2020. Concurrent medical conditions included Migraine, Lupus erythematosus, Drug allergy (Codeine allergy manifested by skin crawling and itching) and Blood pressure high. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) for Blood pressure high, FOLIC ACID for Folic acid supplementation, TOPIRAMATE for Migraine, TRAMADOL for Pain, GABAPENTIN for Trapped nerve.   In August 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated/lupus worsened) (seriousness criterion medically significant) and PYREXIA (SLIGHT HIGH TEMPERATURE). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated/lupus worsened) and PYREXIA (SLIGHT HIGH TEMPERATURE) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test:. In March 2021, Body temperature (97-99): 100 (High) 100F. On an unknown date, Blood test: fine (normal) fine and normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated/lupus worsened) and PYREXIA (SLIGHT HIGH TEMPERATURE) to be probably related.    The patient had first dose of covid19 vaccine which threw her into a rheumatoid arthritis flare with lots of joint pain and lupus causing muscle pain as well. She had blood tests done and everything was fine and normal. She clarified that in the first shot of Covid 19 vaccine she experienced a slight flare-up which caused the signs and symptoms of severe joint pain, slight high temperature, joint and muscle stiffness, high inflammation, and muscle pain and her lupus worsened. Her migraines seemed to be getting better on RINVOQ. RINVOQ worked better than the Topimax that was prescribed for the migraines. On second Covid 19 vaccine shot, she experienced bad and severe flare-up that caused the same signs and symptoms. The lupus originally started 20 years ago and it did not worsen while taking RINVOQ. She mentioned that only Rinvoq treats the reported adverse events and no other managements and interventions done. She used to get 18 to 21 a month but getting 1 to 8 a month as of 26 May 2021. RINVOQ was working great on her lupus. She had flare up which was causing by stress. The alternative etiology for the event worsened lupus, flare-up, severe joint pain, joint and muscle stiffness, high inflammation, muscle pain, slight high temperature was covid 19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was treated with TOPIMAX.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-214503 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.