Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Joint swelling, Tendonitis
Clinical narrative: He has since developed reactive arthritis / think it might be reactive arthritis infection, or something related; swelling in elbow/ starting maybe a week or 2 after that injection / swelling is in the right elbow; was tendinitis; some pain in elbow before the injection; Lost range of motion 2 weeks, maybe a week after the injection/ had full range of motion and no swelling. Range of motion has significantly reduced and had taken months to figure this out; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS REACTIVE (He has since developed reactive arthritis / think it might be reactive arthritis infection, or something related) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INFLUENZA VACCINE for an unknown indication.    Concomitant products included VITAMIN D3 for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 23-Nov-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS REACTIVE (He has since developed reactive arthritis / think it might be reactive arthritis infection, or something related) (seriousness criterion medically significant), JOINT SWELLING (swelling in elbow/ starting maybe a week or 2 after that injection / swelling is in the right elbow), TENDONITIS (was tendinitis), ARTHRALGIA (some pain in elbow before the injection) and JOINT RANGE OF MOTION DECREASED (Lost range of motion 2 weeks, maybe a week after the injection/ had full range of motion and no swelling. Range of motion has significantly reduced and had taken months to figure this out). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, ARTHRITIS REACTIVE (He has since developed reactive arthritis / think it might be reactive arthritis infection, or something related), TENDONITIS (was tendinitis) and ARTHRALGIA (some pain in elbow before the injection) outcome was unknown, JOINT SWELLING (swelling in elbow/ starting maybe a week or 2 after that injection / swelling is in the right elbow) had not resolved and JOINT RANGE OF MOTION DECREASED (Lost range of motion 2 weeks, maybe a week after the injection/ had full range of motion and no swelling. Range of motion has significantly reduced and had taken months to figure this out) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: showing there is kind of some auto immune thing going on. All major auto immune diseases, he tested negative for.. On an unknown date, Blood test: Test confirmed markers still high, 3 weeks apart. Did not have lupus or anything like that. and 3 weeks apart. Did not have lupus or anything like that..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was 95.25 kg. Patient was really flustered with that mismatched information. The pharmacy gave him a lot number on his patient card for that dose of GJ9733 and when he spoke with Pfizer Medical Information, he found out it was not a valid lot number so he called the pharmacy back and they said in their system the lot for that dose was FR2583 so customer service confirmed that was a Pfizer covid vaccine for that lot number but it was a grey cap monovalent and is not the bivalent Patient believed he had Pfizer dose 4 vaccine on its arm, but does not remember which one. He was saw to rheumatologist and had to take medications.  They were  doing a procedure with a needle, the end of the month, to find out what the fluid was. It was reported as once it got into full swing of being swollen, it has been about the same. Patient was trying to wait for his physical, saw orthopedist in Jan2023. They tried using Cortisone shot, nothing happened. It might had been in the wrong spot.  He did physical therapy for about 6 or 7 weeks. Patient had MRI after that, physical therapy did not work. After MRI, orthopedist said he needed to see a rheumatologist. Subsequently, they took a lot of blood tests at the rheumatologist. Patient had cortisone injection, that did not hit the right area where the swelling occurred. she stated the manufacture date (Pfizer)of FR2583 was January 7, 2022  Company Comment: This is a spontaneous case concerning a 32 year-old, male patient with no reported medical history and No family history of rheumatoid arthritis, who experienced the serious (due to medically significant) unexpected, AESI of Arthritis reactive, which occurred approximately 1 year after the mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. The patient received the Tozinameran vaccine as the fourth dose of COVID-19 vaccination schedule and developed 1 to 2 weeks after swelling in right elbow and lost range of motion. Patient thought it was tendinitis. Patient received a cortisone shot without results and Physical Therapy for about 6 or 7 weeks. Had an MRI and several blood tests performed that ruled out lupus and all major autoimmune diseases. However, ANA test was reported as showing a probable autoimmune disorder thus the Rhemothologist considered it could be a reactive arthritis. A needle puncture of fluid will be performed, results not provided. Company causality was assessed as not related to the mRNA-1273 vaccine since there is long latency (over 1 year) and the reporter links the events to the Pfizer vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.