Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cardiac stress test, Computerised tomogram head, Echocardiogram, Magnetic resonance imaging
Clinical narrative: a total central artery occlusion of the left eye cause by a blood clot which has resulted in permanent blindness of the left eye; a total central artery occlusion of the left eye cause by a blood clot which has resulted in permanent blindness of the left eye; a total central artery occlusion of the left eye cause by a blood clot which has resulted in permanent blindness of the left eye; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 09:30 (Lot number: EL9267) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Prior to vaccination the patient was not diagnosed with COVID-19. No known allergies. Concomitant medications included: CYMBALTA; ATIVAN; CELEBREX; DIAZIDE [GLICLAZIDE]; LIPITOR; LISI. Vaccination history included: Bnt162b2 (1st dose, lot EL3249, at 05:30 AM, in right arm), administration date: 26Jan2021, when the patient was 68 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: RETINAL ARTERY OCCLUSION (hospitalization, disability, medically significant, life threatening), THROMBOSIS (hospitalization, disability, medically significant, life threatening), BLINDNESS UNILATERAL (hospitalization, disability, medically significant, life threatening) all with onset 28Feb2021 21:30, outcome "recovered with sequelae" and all described as "a total central artery occlusion of the left eye cause by a blood clot which has resulted in permanent blindness of the left eye". The patient was hospitalized for retinal artery occlusion, thrombosis, blindness unilateral (hospitalization duration: 4 day(s)). The events "a total central artery occlusion of the left eye cause by a blood clot which has resulted in permanent blindness of the left eye" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures in ICU: cardiac stress test: (Feb2021) unknown results; computerised tomogram head: (Feb2021) unknown results; echocardiogram: (Feb2021) unknown results; magnetic resonance imaging: (Feb2021) unknown results. Since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of retinal artery occlusion, thrombosis, blindness unilateral. 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