Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Rheumatoid RA factor came back at 125.was extremely elevated/entire body started to swell up, arthritis took over whole body, from mouth, all the way down; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid RA factor came back at 125.was extremely elevated/entire body started to swell up, arthritis took over whole body, from mouth, all the way down) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032218) for COVID-19 prophylaxis.     The patient's past medical history included Congestive heart failure. Previously administered products included for Product used for unknown indication: RSV, Influenza and Pneumococcal vaccine. Past adverse reactions to the above products included No adverse event with Influenza, Pneumococcal vaccine and RSV. Concurrent medical conditions included COPD.    On 30-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid RA factor came back at 125.was extremely elevated/entire body started to swell up, arthritis took over whole body, from mouth, all the way down) (seriousness criterion medically significant). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid RA factor came back at 125.was extremely elevated/entire body started to swell up, arthritis took over whole body, from mouth, all the way down) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rheumatoid factor: Rheumatoid RA factor came back at 125.         No concomitant medication was reported.   Patient's left shoulder started hurting, knot on it like half a tennis ball, it was painful, started spreading to hands and knees. Patient went to another doctor when symptoms were not getting better and the doctor recommended that she took OTC allergy medication and she 'might be allergic to something in the vaccine' Medication did not help, went again and got 'steroid for pain'. After all of these doctor visits, everyday pain and different medications taken, she had an appt with a rheumatologist. At that point the patient stated that she was 'almost in a wheelchair due to how painful her body was feeling. The rheumatologist started the patient on a 'steroid shot' to calm down the pain and reduce the swelling. Patient had chest x-rays done and blood tests done. Rheumatoid RA factor came back at 125. Which as per HCP, was extremely elevated. Rheumatologist decided to put patient on TB med and a hep b shot so that 'nothing flares up'. Patiently currently waiting for medication for Rheumatoid Arthritis (does not know the name). Patient had to get an ultrasound on the back of the knee before getting this medication. MD said they won't put her on medication 'methotrexate' because they don't want anything messing with her liver. Patient currently still has symptoms in her shoulder, behind left leg - got shots (cortisone) in the knees 3 weeks ago, doing better. Patient's hands were kind of painful - but progress being made, as per patient. Patient had chest X-ray done however the results were unknown.  Company Comment: This is a spontaneous case concerning a 69 year-old, female patient with no relevant medical history, who experienced the serious (due to medically significant) unexpected, AESI of Rheumatoid arthritis, which occurred 1 day after the Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula (Pre-filled Syringe), received as the sixth dose of COVID-19 vaccination schedule. The patient reported left shoulder knot and pain that spread to hands and knees. Steroids were prescribed for the pain. Her entire body started to swell up and patient reported arthritis took over her whole body. Patient had several doctor visits, had pain everyday, took different medications and went to a rheumatologist. The rheumatologist started the patient on a steroid shot to calm down the pain and reduce the swelling. Had chest x-rays done and blood tests done but results not provided. Rheumatoid RA factor came back at 125 (no units nor reference range). Rheumatologist decided to put patient on TB medication and a hepatitis b shot (no further information provided). Patiently currently waiting for medication for Rheumatoid Arthritis (exact product unknown). Patient currently has symptoms in her shoulder, behind left leg and her hands are painful. No further clinical information was available for medical review. The benefit-risk relationship of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula (Pre-filled Syringe) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761263 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761263:Same Reporter Different Patient