Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis, Tendonitis
Clinical narrative: flare all over her body / rheumatoid arthritis flare; tendons are purply and red and inflamed; hands and feet hurt; This is a spontaneous report from a contactable other healthcare professional (licensed practical nurse, also the patient) reporting for herself.  A 56-year-old female patient received the second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 06Feb2021 at 11:00am (batch/lot number: FS5318) at 56 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included rheumatoid arthritis from an unknown date for 12 or 13 years; high blood pressure, menopause, and hot flashes, all from an unknown date. Patient had no family history. Concomitant medications included atenolol (ATENOLOL) taken for high blood pressure, from two or three years, start and stop date were not reported and paroxetine hydrochloride (PAXIL) taken for menopause and hot flashes, start and stop date were not reported. The patient previously received prednisone for rheumatoid arthritis. Patient had previous reaction to Tetanus vaccine 25 years ago (in 1996; product details unknown). The patient previously received the first dose of BNT162B2 via an unspecified route of administration, administered in the left arm on 15Jan2021 at 11:00 (batch/lot number: EL3302) at 55 years old, as DOSE 1, SINGLE for COVID-19 immunization. There were no additional vaccines administered on same date of the Pfizer vaccine and no prior vaccinations within 4 weeks of Pfizer vaccine. On May2021, the patient experienced flare all over her body/ rheumatoid arthritis flare, tendons are purply and red and inflamed, hands and feet hurt. It was reported that the patient started to have the rheumatoid arthritis flare around mid May2021; but this time it was not just her joints but also her tendons. Patient stated that if you look at her, she looks normal, but her tendons are purple-y and red and inflamed. She just left the doctor's office and was driving. She also just saw a new primary care doctor; her hands and feet hurt, and she just wanted to make sure everything was okay, she can't miss work and she is a single mom with a son. She asked the doctor if she could go on Enbrel, but she wanted to keep her on Methotrexate. All of her symptoms are persisting. Some days she can't move, and she has been there before with the rheumatoid arthritis back when she was forty years old or maybe when she first got it. She just tried to power through. The events did not require visit to the Emergency Room; patient visited Physician Office. Therapeutic measures were taken as a result of the events which included Methotrexate 2.5mg tablets (manufacturer: Roxane; expiry date: 21Apr2022) taken at two, once weekly for the last three weeks; and now bumping up to four once weekly by mouth. The patient asked if there are any studies. Right now, she is on Methotrexate, would she qualify for a booster? Her whole body is flaring, and she doesn't' know if it is from the Methotrexate or the Pfizer COVID 19 vaccine or if it is just a coincidence. The patient has not recovered from the events.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Rheumatoid arthritis  and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.