Sex: M
Vaccine: COVID19
Symptoms: Coagulation test, Computerised tomogram head, Cryoglobulins, Echocardiogram, Electrocardiogram
Clinical narrative: combined central retinal vein and artery occlusion; combined central retinal vein and artery occlusion; ischemic optic neuropathy; This is a literature report.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 01Mar2021, for COVID-19 immunisation. The following information was reported: RETINAL VEIN OCCLUSION (medically significant), RETINAL ARTERY OCCLUSION (medically significant) all with onset Apr2021, outcome "recovered with sequelae" (2021) and all described as "combined central retinal vein and artery occlusion"; OPTIC ISCHAEMIC NEUROPATHY (medically significant) with onset Apr2021, outcome "recovered with sequelae" (2021), described as "ischemic optic neuropathy". The patient underwent the following laboratory tests and procedures: activated protein c resistance: (Apr2021) unremarkable.; angiogram: (Apr2021) negative, notes: for acute pathology; (Apr2021) negative for acute pathology; angiogram retina: (10Apr2021) about the same with comparable blot hemorrhages, notes: and delayed filling time of the central retinal vein; (Apr2021) demonstrated delayed central retinal vein filling,, notes: and the retina was mildly thickened on OCT, but frank cystoid macular edema was not present. There is also delayed arterial filling, particularly in the more distant branches even after 50 seconds, which is consistent with partial obstruction of the central retinal artery. The few blot hemorrhages are highlighted by the FA; angiotensin converting enzyme: (Apr2021) unremarkable.; antibody test: (Apr2021) unremarkable; antinuclear antibody: (Apr2021) unremarkable.; (Apr2021) unremarkable; antiphospholipid antibodies: (Apr2021) unremarkable.; (Apr2021) unremarkable.; antithrombin iii: (Apr2021) unremarkable.; blood cholesterol: (Apr2021) 227; blood pressure measurement: (08Apr2021) 117/70; (Apr2021) 160/77; (Apr2021) 126/79; cardiolipin antibody: (Apr2021) unremarkable.; chest x-ray: (Apr2021) showed no acute cardiopulmonary process; coagulation factor viii level: (Apr2021) unremarkable.; coagulation factor xi level: (Apr2021) unremarkable.; coagulation test: (Apr2021) were all unremarkable; computerised tomogram head: (Apr2021) negative, notes: for acute pathology; c-reactive protein: (Apr2021) normal; cryoglobulins: (Apr2021) unremarkable.; echocardiogram: (Apr2021) was normal; electrocardiogram: (Apr2021) showed no ischemic changes or evidence of cardiac, notes: arrhythmia; electrophoresis: (Apr2021) unremarkable.; factor v leiden carrier: (Apr2021) unremarkable.; fibrin d dimer: (Apr2021) unremarkable.; full blood count: (Apr2021) were all unremarkable; glycosylated haemoglobin: (Apr2021) 5.4, notes: normal; heparin-induced thrombocytopenia test: (10Apr2021) negative; international normalised ratio: (Apr2021) unremarkable; investigation: (Apr2021) 93, notes: um OD; (Apr2021) 153, notes: um OS; low density lipoprotein: (Apr2021) 159; lymphocyte count: (Apr2021) unremarkable.; lysozyme: (Apr2021) unremarkable.; metabolic function test: (Apr2021) were all unremarkable; ophthalmological examination: (Apr2021) based on the fundus appearance of, notes: dilated and tortuous retinal veins, a few scattered blot hemorrhages in all 4 quadrants, disc edema, and exudative macular detachment on the macular OCT; optical coherence tomography: (08Apr2021) 153, notes: unit: um Day1; (09Apr2021) 176, notes: unit: um Day2; (11Apr2021) 214, notes: unit: um Day4; (12Apr2021) 219, notes: unit: um Day5; (13Apr2021) 233, notes: unit: um Day6; (14Apr2021) 252, notes: unit: um Day7; (21Apr2021) 190, notes: unit: um Day14; (23Apr2021) 186, notes: unit: um Day16; (28Apr2021) 167, notes: unit: um Day21; (05May2021) 139, notes: unit: um Day28; (27May2021) 95, notes: unit: um Day50; (08Apr2021) 321, notes: unit: um Day1; (09Apr2021) 358, notes: unit: um Day2; (10Apr2021) 354, notes: unit: um Day3; (11Apr2021) 353, notes: unit: um Day4; (12Apr2021) 352, notes: unit: um Day5; (13Apr2021) 348, notes: unit: um Day6; (14Apr2021) 350, notes: unit: um Day7; (21Apr2021) 338, notes: unit: um Day14; (23Apr2021) 332, notes: unit: um Day16; (28Apr2021) 312, notes: unit: um Day21; (05May2021) 299, notes: unit: um Day28; (27May2021) 280, notes: unit: um Day50; (10Apr2021) showed some areas of improvement; protein c: (Apr2021) unremarkable.; protein s: (Apr2021) unremarkable.; red blood cell sedimentation rate: (Apr2021) 26, notes: mildly elevated; treponema test: (Apr2021) unremarkable.; troponin: (Apr2021) were all unremarkable; ultrasound doppler: (Apr2021) unremarkable.; vascular imaging: (Apr2021) demonstrated delayed central retinal vein filling, notes: and the retina was mildly thickened on OCT, but frank cystoid macular edema was not present. There is also delayed arterial filling, particularly in the more distant branches even after 50 seconds, which is consistent with partial obstruction of the central retinal artery. The few blot hemorrhages are highlighted by the FA; visual acuity tests: (08Apr2021) cf@2ft, notes: Day 1; (09Apr2021) cf@2ft, notes: Day 2; (10Apr2021) cf@2ft, notes: Day 3; (11Apr2021) cf@1ft, notes: Day 4; (12Apr2021) 20/400, notes: Day 5; (13Apr2021) 20/200, notes: Day 6; (14Apr2021) 20/80, notes: Day 7; (21Apr2021) 20/50, notes: Day 14; (23Apr2021) 20/50, notes: Day 16; (28Apr2021) 2/30, notes: Day 21; (05May2021) 20/40, notes: Day 28; (27May2021) 20/30, notes: Day 50 he continued to note light and color desaturation and exhibited a 2+ relative afferent pupillary defect in the left eye; (09Apr2021) further darkening; (Apr2021) remained count fingers; (27May2021) a residual inferior altitudinal visual field defe. Therapeutic measures were taken as a result of retinal vein occlusion, retinal artery occlusion, optic ischaemic neuropathy.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 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.