Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Neutrophil count, Pyrexia
Clinical narrative: she could not get up, could not walk without difficulty; blood and urine test which were all really high; blood and urine test which were all really high; fever/99.6-100.1 degrees Fahrenheit; diagnosed with seronegative rheumatoid arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 14:00 as dose 5 (booster), single (Lot number: GL0446) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immunization" (unspecified if ongoing); "Cough" (unspecified if ongoing), notes: He stated she also takes medication: one is for Thyroid and another one for constant cough; "Thyroid disorder" (unspecified if ongoing), notes: He stated she also takes medication: one is for Thyroid and another one for constant cough. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot ER2613, Jul2021. Injected in left arm), administration date: 16Mar2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot EW0153, Jul2021. Injected in left arm.), administration date: 06Apr2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot FF2593, expiration 31Dec2021. Injected in unknown left arm.), administration date: 08Nov2021, when the patient was 64-year-old, for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, 4th shot was supposed to be different so she wanted to wait for it), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 06Feb2023, outcome "unknown", described as "diagnosed with seronegative rheumatoid arthritis"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "she could not get up, could not walk without difficulty"; BLOOD TEST ABNORMAL (non-serious), URINE ANALYSIS ABNORMAL (non-serious), outcome "unknown" and all described as "blood and urine test which were all really high"; PYREXIA (non-serious), outcome "unknown", described as "fever/99.6-100.1 degrees Fahrenheit". The events "diagnosed with seronegative rheumatoid arthritis", "she could not get up, could not walk without difficulty", "blood and urine test which were all really high" and "fever/99.6-100.1 degrees Fahrenheit" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (20Dec2022) 80; Blood glucose: (06Feb2023) 110 mg/dl; Blood iron: (11Jan2023) 17 ug/dL; Body temperature: (unspecified date) 100-100.2 degrees Fahrenheit; (unspecified date) 99.6-100.1 degrees Fahrenheit; Complement factor C4: (06Feb2023) 41 mg/dl; C-reactive protein: (20Dec2022) 97.4 mg/l; (11Jan2023) 154.5 mg/l; Haematocrit: (11Jan2023) 32.9; Haemoglobin: (11Jan2023) 10.4; Lymphocyte count: (11Jan2023) 1.17 IU/l; Mean cell haemoglobin: (11Jan2023) 25.7; Mean cell haemoglobin concentration: (11Jan2023) 31.6; Neutrophil count: (unspecified date) x 10 (3) ul after WBC was normal; (11Jan2023) 6.25; (11Jan2023) 76.5; Red blood cell sedimentation rate: (06Feb2023) 83, notes: 83 mm/hour; Red cell distribution width: (11Jan2023) 16.6; Transferrin saturation: (11Jan2023) 7.1 %; Vitamin D: (06Feb2023) 53 ng/ml; White blood cell count: (unspecified date) normal; X-ray: (unspecified date) unknown results. Therapeutic measures were taken as a result of rheumatoid arthritis, gait disturbance, blood test abnormal, urine analysis abnormal, pyrexia. Clinical course: Reporter was a caregiver for his wife, who was diagnosed with seronegative rheumatoid arthritis. The wife's doctor believed this was related to the Pfizer COVID-19 Bivalent Vaccine because of the timeline, so reporter wanted to know if there was any information reported or any resources that could be helpful for them. Reporter added her wife 3rd dose of steroids, they gave her methylprednisolone tablets, 6 the first day, then 5, 4, 3, 2, 1, and it helped a lot, but the next day it came back, the swelling came back. Then they gave her a 9-day dose of regular prednisone, which was 3-3-3, 2-2-2, then 1-1-1. The rheumatologist told her to stop taking it, because it took out the swelling, but the pain continued on the joint, fingers, ankles and knees. So, she would start again methylprednisolone and methotrexate 2.5 mg 4 tablets every Monday. He then mentioned her wife's doctor told them that this condition couldn't be cured, it couldn't go away, but it could possibly be controlled. But that the doctor she wasn't sure because the vaccine was new, so they don't know much. She had severe pain, and the swelling was severe. Reporter added at the end that they had an appointment to the (Clinic name withheld) on 25Apr2023 in (place withheld). Reporter called regarding his wife who had really bad reaction to the COVID shot.  He confirmed it was the Pfizer COVID Vaccine Bivalent booster. The Rheumatologist said it kicked off seronegative rheumatoid arthritis. Primary sent her to another rheumatologist who said her symptoms did not give her evidence of Rheumatoid Arthritis. Went to this Rheumatoid doctor who prescribed Methylprednisolone 6 first day, 5, 4, 3 2, then 1. Really helped and was 95% better by day 3, but the day after when she stopped taking it, it came back with a vengeance. She went to see a different rheumatologist and had more blood and urine test which were all really high and said she had the seronegative Rheumatoid Arthritis. She gave her a 9-day dose of Prednisone 10 mg tablet. It did not do as good. The swelling came down some, but the pain was still there. She had 1 pill left. It was in a pharmacy vial with no manufacturer, lot or expiration. Neither of them had had COVID. He stated she was also taking medication: one was for Thyroid and another one for constant cough. Both were started prior to taking the 4th dose. She was taking during and still to this day. No further details provided. Labs: WBC was normal. ABS Neutrophil had x 10 (3) ul after it. The rheumatologist does not know if this was something that would be forever. She believed it was possible it came from COVID shot. Doesn't know if it would get worse or stay same. As of yesterday, she took another drug. Once a week drug. Methotrexate 2.5 mg once a week 4 tablets by mouth every 7 days for the next 4 weeks. This was supposed to be her long-term correction. Also, to get swelling and pain down, they gave another dose Methylprednisolone. 21 tablets 6 first day, 5 next, 4, 3, 2, 1. Then it if was not correcting they gave another refill and said to take 1-2 day until she would see Rheumatologist next. They wanted to knock swelling down and avoid joint damage. Also had fingers, toes, elbows, arms, shoulders etc. X-rayed. It hit everywhere. It was like her own body was attacking itself. Prior Vaccinations (within 4 weeks) was yes. Flu vaccine. Unknown date, manufacturer, lot and expiration. He believed it was 8-10 days prior to the last COVID vaccine. She ran a slight fever after that flu vaccine. It was 100-100.2 degrees Fahrenheit that lasted about 4 days. Then she had COVID shot, and fever jumped up again and stayed elevated for about a month 99.6-100.1 degrees Fahrenheit. It was every day, morning, noon and night. Then she started swelling and joints started, and she could not get up, could not walk without difficulty. It would take like 20 minutes to walk 2 feet. He had to open medicine bottles for her. Her hands swelled up and arms, and ankles. Ankles were twice normal size.