Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Carpal tunnel syndrome, Corrective lens user, Gingival disorder, Inappropriate schedule of product administration
Clinical narrative: Carpal tunnel syndrome; Therapeutic procedure; Eyeglasses wearer; Gum disorder; Vaccination site pain; Joint pain; 2nd dose: 03May2021; Booster: 27Oct2021; 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 27Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till Nov2021 for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Admin: Subcutaneous), administration date: 12Apr2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Carpal tunnel syndrome", "Therapeutic procedure", "Eyeglasses wearer", "Gum disorder", "Vaccination site pain", "Joint pain"; Bnt162b2 (Dose 2, Route of Admin: Subcutaneous), administration date: 03May2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Carpal tunnel syndrome", "Therapeutic procedure", "Eyeglasses wearer", "Gum disorder", "Vaccination site pain", "Joint pain". 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), outcome "recovering", described as "Gum disorder"; VACCINATION SITE PAIN (medically significant), outcome "recovered", described as "Vaccination site pain"; ARTHRALGIA (medically significant), outcome "recovered", described as "Joint pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "2nd dose: 03May2021; Booster: 27Oct2021".  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. The reporter's assessment of the causal relationship of reported adverse event with the suspect product 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 limited information in the case , a possible causal association between  the reported  events Carpal tunnel syndrome , Therapeutic procedure , Corrective lens user , Gingival disorder , Vaccination site pain , Arthralgia , Inappropriate schedule of product administration and the suspect drug BNT162B2 cannot be excluded.