Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract, Impaired driving ability, Nasopharyngitis
Clinical narrative: Cataract; Impaired driving ability; Cold;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not available). The reporter is the patient. Other Case identifier(s): 22K-163-4328786-00.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous for uveitis. The patient's relevant medical history included: "Neuropathy" (unspecified if ongoing); "Spinal Stenosis" (unspecified if ongoing); "Swollen eyes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer, Route of administration: Intramascular), administration date: 02Jun2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Manufacturer: Pfizer, Route of administration: Intramascular), administration date: 23Jun2021, when the patient was 65-year-old, for COVID-19 Immunization.  The following information was reported: CATARACT (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (non-serious), outcome "recovering"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "Cold". The action taken for adalimumab was unknown. The clinical course was reported as on unknown dates, the patient experienced Cataract and could not drive, Cold and not sure if Humira was helping. In March 2022, the patient experienced Covid. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. the patient had other things that happened well before starting HUMIRA that effected, like neuropathy and spinal stenosis. He had cataract and it was bad. He could not drive and really struggled to see. In Mar 2022, he had Covid and was doing better, he was really tired and had headaches. He was not sure if HUMIRA helped with the swelling in his eyes since starting it but his eyes were no longer swollen which was fantastic. Felt like he had a cold after the booster but did not last long. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of cataract and could not drive unknown onset with Humira(Adalimumab) was no reasonable possibility. The reporters causality for the event(s) of Cold and not sure if Humira was helping was not provided. RA opinion is that there is no reasonable possibility that the events of Cataract and could not drive unknown onset are related to Humira (Adalimumab). RA opinion is that the event of COLD is not assessable. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporters causality for the event(s) of cataract and could not drive unknown onset with Pfizer BioNTech Covid-19 Vaccine(Tozinameran) was not reported. The reporters causality for the event(s) of Cold with Pfizer BioNTech Covid-19 Vaccine(Tozinameranwas) wsa possible. The reporter's assessment of the causal relationship of "cataract" and "impaired driving ability" 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. The reporter considered "cold" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per limited available information, the causal relationship between the events of "cataract" and "impaired driving ability" and the suspected drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.