Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Carpal tunnel syndrome, Corrective lens user, Gingival disorder, Therapeutic procedure
Clinical narrative: Carpal tunnel syndrome; Therapeutic procedure; Eyeglasses wearer; Joint pain; issues with gums/Gum disorder; Vaccination site pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4171254-00 (Agency).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 03May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 27Oct2021 (Batch/Lot number: unknown) as booster 3, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARPAL TUNNEL SYNDROME (medically significant), outcome "recovered", described as "Carpal tunnel syndrome"; THERAPEUTIC PROCEDURE (medically significant), outcome "recovered", described as "Therapeutic procedure"; CORRECTIVE LENS USER (medically significant), outcome "not recovered", described as "Eyeglasses wearer"; GINGIVAL DISORDER (medically significant) with onset 2021, outcome "recovering", described as "issues with gums/Gum disorder"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain"; ARTHRALGIA (medically significant), outcome "recovered", described as "Joint pain". The action taken for adalimumab was unknown.  Clinical : The patient was wearing reading glasses. She had carpal tunnel and received surgery on both hands. She stopped taking HUMIRA for a couple weeks because of taking antibiotics. She was taking the antibiotic as a preventative. While off HUMIRA, she had experienced some joint pain. She reported the weather was getting colder, which also caused joint pain. She had an unknown Procedure. She also had issues with gums and a sore arm after one of her two Pfizer vaccinations or booster but could not remember which one. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CARPAL TUNNEL ON BOTH HANDS, WEARS READING GLASSES and ISSUE WITH GUMS was not provided. The reporters causality for the event(s) of UNKNOWN PROCEDURE and JOINT PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporters causality for the event(s) of SORE ARM AFTER ONE OF THE PFIZER VACCINATIONS OR BOOSTER with HUMIRA(ADALIMUMAB) was no reasonable possibility. Agency's opinion was that there was no reasonable possibility that the events of CARPAL TUNNEL ON BOTH HANDS, UNKNOWN PROCEDURE, WEARS READING GLASSES, SORE ARM AFTER ONE OF THE PFIZER VACCINATIONS OR BOOSTER and JOINT PAIN are related to HUMIRA(ADALIMUMAB). Agency's opinion was that the event of ISSUE WITH GUMS is not assessable. The reporter's assessment of the causal relationship of the Carpal tunnel syndrome, therapeutic procedure, eye glasses wearer, gum disorder, vaccination site pain and joint pain 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and CARPAL TUNNEL SYNDROME, THERAPEUTIC PROCEDURE,CORRECTIVE LENS USER, GINGIVAL DISORDER, VACCINATION SITE PAIN, ARTHRALGIA  cannot be completely 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.