Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Neuropathy peripheral, Visual impairment
Clinical narrative: Neuropathy in fingers and toe and all over body; Diabetic symptoms; Loss close up vision;  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-163-4450912-00.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, on 06Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 12Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (medically significant) with onset Jan2021, outcome "not recovered", described as "Loss close up vision"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy in fingers and toe and all over body"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetic symptoms". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "neuropathy in fingers and toe and all over body", "diabetic symptoms" and "loss close up vision" with the suspect product(s) 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. Humira (Solution for injection in prefilled pen) (Adalimumab) Causality for Humira (Adalimumab) The reporter's causality for the event(s) of loss close up vision, neuropathy in fingers and toes and all over body and diabetic symptoms was not provided.   Causality 1)Visual impairment (Visual impairment). Action(s) taken with drug : Unknown. Causality as per reporter (Drug/Vaccine) : Not Reported. Dechallenge : N/A. Neuropathy peripheral (Neuropathy peripheral). Action(s) taken with drug : Unknown. Causality as per reporter (Drug/Vaccine) : Not Reported. Dechallenge : N/A. Diabetic (Diabetes mellitus). Action(s) taken with drug : Unknown. Causality as per reporter (Drug/Vaccine) : Not Reported. Dechallenge : N/A. Causality 1)Visual impairment (Visual impairment). Action(s) taken with drug : Unknown. Causality as per reporter (Drug/Vaccine) : Not Reported. Dechallenge : N/A 2)Neuropathy peripheral (Neuropathy peripheral). Action(s) taken with drug : Unknown. Causality as per reporter (Drug/Vaccine) : Not Reported. Dechallenge : N/A 3)Diabetic (Diabetes mellitus). Action(s) taken with drug : Unknown. Causality as per reporter (Drug/Vaccine) : Not Reported. Dechallenge : N/A. Did Event Abate After Stopping Drug: NA Study No: FACILITATED COLLECT  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 in the case report and a plausible temporal relationship, a possible causal association between the events 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.