Age: 46.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Herpes zoster, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Leg pain; Shingles; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer (patient), based on the information received by Pfizer (manufacturer control number: 21K-163-3837356-00).   A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on an unspecified date (lot/batch number not reported) at dose 1, single, second dose on an unspecified date (lot/batch number not reported) at dose 2, single, third dose on an unspecified date (lot/batch number not reported) at dose 3 (booster), single; all via intramuscular at the age of 46-years-old for COVID-19 immunisation; upadacitinib (RINVOQ), via oral from an unspecified date to an unspecified date at unknown dose and frequency for moderate to severe rheumatoid arthritis; and flutamide (FLUTAMIDE), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included persistent cough (for two years now and would not go away) from an unspecified date in 2019, and ongoing moderate to severe rheumatoid arthritis from an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced rheumatoid arthritis flare up, leg pain, and shingles. The patient stated that after the third dose of COVID-19 vaccination, she got sick. The patient also stated that the patient had rheumatoid arthritis flare ups here and there with upadacitinib (RINVOQ). In 2019, the patient had persistent cough. It was also reported that the patient did arts and crafts and her hands got tired and started hurting when she made her crafts. She did have flare ups here and there. She had gotten to the point when she knew when to stop. She had a cough for two years that would not go away. One of the medications she was taking  which was flutamide did cause coughing. She got the third dose of COVID-19 vaccination and got sick off the vaccination and was off RINVOQ for a week. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. On unknown dates, the patient received the first, second and third dose of COVID-19 vaccine manufactured by Pfizer/BioNTech. The reporter's causality for the events persistent cough and rheumatoid arthritis flare ups here and there with upadacitinib (RINVOQ) was no reasonable possibility. The action taken in response to the events for BNT162B2 was not applicable, and for the other suspect drugs was unknown. Outcome of the event rheumatoid arthritis flare up was not recovered, and for other events was recovering.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided the role of the vaccine in triggering/contributing to the events rheumatoid arthritis, leg pain and shingles with the usage of the vaccine BNT162B2 cannot be completely excluded. Also the role of the patient relevant medical history needs to be taken into consideration for the reported events. The case will be reassessed once additional information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.