Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injury associated with device, Visual impairment
Clinical narrative: Vision decreased; Needle injury; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4346345-00 (Agency).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 03Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk, single (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history included: "Moderate to severe chronic plaque psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (medically significant), outcome "not recovered", described as "Vision decreased"; INJURY ASSOCIATED WITH DEVICE (non-serious), outcome "unknown", described as "Needle injury". The action taken for adalimumab was unknown. Solicited report from a consumer of an elderly female with an event of non-serious loosing vision pricking fingers with sewing needles because it was becoming harder to see with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced loosing vision pricking fingers with sewing needles because it was becoming harder to see. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB). The reporter's causality for the event(s) of loosing vision pricking fingers with sewing needles because it was becoming harder to see unknown onset and loosing vision pricking fingers with sewing needles because its becoming harder to see unknown onset was not provided. Drug:  Humira (Solution for injection in pre-filled pen) (Adalimumab), Route of Administration: 1) Subcutaneous, Indications for Use: Moderate to severe chronic plaque psoriasis, Therapy Dates/ Duration: 1) UNK. Causality:1) Vision decreased (Visual impairment)Causality as per reporter (Drug/Vaccine):  Not reported, Dechallenge: N/A. Needle injury (Injury associated with device), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine):  Not reported, Dechallenge: N/A. Causality: Vision decreased (Visual impairment), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine):  Possible, Dechallenge: N/A. Needle injury (Injury associated with device), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine):  Possible, Dechallenge: N/A.  The reporter considered "vision decreased" and "needle injury" related to BNT162b2. 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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.