Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye pain, Scleral disorder
Clinical narrative: red spot on while of eye appeared causing pain and Overtime blindness, blind in her left eye; red spot on white of eye appeared causing pain and overtime blindness, blind in her left eye; red spot on white of eye appeared causing pain and overtime blindness, blind in her left eye; This is a spontaneous report received from an Other HCP, Program ID:.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, 0.3 ml single (Lot number: EP6955) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6199, Anatomical Location: Arm Left), administration date: 03Mar2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "blindness/ totally blind in her left eye", "Severe pain in stomach", "Burning sensation", "too sick", "Joints ached could not walk", "Joints ached could not walk", "Could not sleep due to pain and Burning", "Could not sleep due to pain and Burning/constant pain", "red spot on while of eye appeared causing pain and Overtime blindness", "red spot on white of eye appeared causing pain and Overtime blindness", "diarrhea", "Rheumatoid arthritis", "ready to commit suicide", "accused of being a druggie", "Long covid", "maybe has 10 percent vision in the right", "very angry", "stress eating", "can't sleep/no sleep", "overweight", "crabby", "often falls", "has limited use of her hands that do not bend", "heart murmur", "changes in hair/hair loss", "itchy/irritated skin", "weak", "stomach irritated". The following information was reported: SCLERAL DISORDER (disability) with onset 01Jun2021, outcome "not recovered", described as "red spot on while of eye appeared causing pain and Overtime blindness, blind in her left eye"; BLINDNESS UNILATERAL (disability, medically significant), EYE PAIN (disability) all with onset 01Jun2021, outcome "not recovered" and all described as "red spot on white of eye appeared causing pain and overtime blindness, blind in her left eye".; Sender's Comments: The events scleral disorder, and eye pain are conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. As there is limited information in the case provided, the causal association between the event blindness unilateral and the suspect 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 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.,Linked Report(s) : US-PFIZER INC-PV202400031157 same patient/product, different dose/event;US-PFIZER INC-202300334093 same patient/vaccine, different dose/events;US-PFIZER INC-202400057571 same patient/product, different dose/event;