Sex: M
Vaccine: COVID19
Symptoms: Optic ischaemic neuropathy, Optical coherence tomography, Red blood cell sedimentation rate, SARS-CoV-2 test, Scan
Clinical narrative: left anterior ischemic optic neuropathy; The initial case was missing the following minimum criteria: specified product. Upon receipt of follow-up information on 29Jul2022, this case now contains all required information to be considered valid.  This is a literature report.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes mellitus" (unspecified if ongoing), notes: for 7 years treated by oral hypoglycemic drugs and diet. His last HbA1C was 7.8%. The patient took concomitant medications. The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), 4 days after the suspect product(s) administration, outcome "recovering", described as "left anterior ischemic optic neuropathy". The patient underwent the following laboratory tests and procedures: Angiogram: revealed optic disc leakage with staining and, notes: scattered capillary microaneurysms; showed peripapillary flow void areas with, notes: decreased vascular density indicating mild ischemia; Antineutrophil cytoplasmic antibody: normal; Antinuclear antibody: normal; Chest X-ray: normal; C-reactive protein: normal; Double stranded DNA antibody: normal; Full blood count: normal; Fundoscopy: revealed optic disc swelling with pallor together, notes: with blurred edges and splinter hemorrhages; Glycosylated haemoglobin: 7.8 %; Intraocular pressure test: normal in both eyes; angiotensin converting enzyme levels: normal; normal in both eyes; normal; normal; Lumbar puncture: revealed a normal cerebrospinal fluid opening, notes: pressure with normal analysis; Magnetic resonance imaging head: were unrevealing; Magnetic resonance imaging spinal: were unrevealing; Ophthalmological examination: normal in both eyes; revealed improvement of the optic disc swelling, notes: with pallor and minimal visual field improvement; normal in both eyes; Examination revelated a best corrected visual, notes: acuity of 20/20 in the right eye (OD) and 20/40 in the left eye (OS); Optical coherence tomography: revealed left optic disc elevation with retinal, notes: nerve fiber layer thickening; Red blood cell sedimentation rate: normal; SARS-CoV-2 test: negative; Scan: were unrevealing; Treponema test: normal; Venogram: were unrevealing; Visual acuity tests: 20/20 in the right eye (OD) and 20/40 in the left, notes: eye (OS); Visual field tests: showed an inferior altitudinal field defect with, notes: enlargement of the blind spot. Therapeutic measures were taken as a result of optic ischaemic neuropathy. Additional information: Present illness: A 40-year-old male patient presented to authors with acute-onset diminution of vision in his left eye of stationary course for 5 days. He also complained of an inferior visual field defect. Nine days earlier, he had received his first dose of the BNT162b2 COVID-19 vaccination (Pfizer-BioNTech), which was followed by mild constitutional symptoms including mild fever and myalgias which were treated with acetaminophen. Outcome: The patient was diagnosed with left anterior ischemic optic neuropathy secondary to COVID-19 vaccination. He was prescribed low dose aspirin and referred for more strict control of his blood sugar levels and cardiovascular systemic risk factors. Follow-up over 2 months revealed improvement of the optic disc swelling with pallor and minimal visual field improvement.  The reporter considered "left anterior ischemic optic neuropathy" related to BNT162b2.  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 temporal association, a possible contributory role of BNT162B2 in the onset of event optic ischaemic neuropathy cannot be fully excluded. This case will be reassessed should additional information become 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.