Sex: M
Vaccine: COVID19
Symptoms: Intraocular pressure test, Investigation, Magnetic resonance imaging head, Metabolic function test, Mycobacterium tuberculosis complex test
Clinical narrative: This is a literature report for the following literature source(s): "Non-arteritic Anterior Ischemic Optic Neuropathy with Macular Star following COVID-19 Vaccination", Ocular Immunology and Inflammation, 2022; pgs:1-4, DOI:10.1080/09273948.2022.2059522. A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 0.3 ml single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes mellitus" (ongoing), notes: of 15-year duration. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), 1 day after the suspect product(s) administration, outcome "recovering", described as "Non-arteritic Anterior Ischemic Optic Neuropathy with Macular Star following COVID-19". The patient underwent the following laboratory tests and procedures: Angiogram retina: normal OD and disclosed optic disc leakage OS; Angiotensin converting enzyme: normal/non-revealing; Antibody test: normal/non-revealing; normal/non-revealing; Antinuclear antibody: normal/non-revealing; normal/non-revealing; Blood glucose: normal/non-revealing; C-reactive protein: 0.45 mg/dl; Fluorescence angiogram: showed a normal choroidal and retinal vascular, notes: filling pattern; Full blood count: normal/non-revealing; Fundus auto-fluorescence: revealed subtle macular hyper, notes: auto-fluorescence underlying an area of subretinal fluid; Glycosylated haemoglobin: normal/non-revealing; Glycosylated haemoglobin: 13.1 %, notes: raised; Intraocular pressure test: 14 OD and 15 OS; Dilated fundus examination: showed normal optic disc, macula, retinal vessels, notes: and periphery OD but disclosed optic disc edema (Frisen scale grade 4) in the eft eye, peripapillary hemorrhages, and blunted foveal reflex; showed resolved optic nerve swelling OS; Magnetic resonance imaging head: showed no intracranial pathology demyelinating, notes: lesions or evidence of optic nerve enhancement; Metabolic function test: normal/non-revealing; Mycobacterium tuberculosis complex test: normal/non-revealing; Neurological examination: normal; Optic nerve cup/disc ratio: 0.2; Optical coherence tomography: showed marked thickening of the, notes: peripapillary retina, intra-retinal fluid and hyperreflective foci consistent with exudates, and sub retinal fluid under the fovea; showed a resolved SRF with mild improvement of the, notes: outer retinal layers, but diminution of the retinal nerve fiber layer; Red blood cell sedimentation rate: 4, notes: mm/hr; Rheumatoid factor: normal/non-revealing; Slit-lamp examination: normal anterior segment examination, notes: with no anterior chamber inflammation or anterior vitritis; Toxoplasma serology: normal/non-revealing; Treponema test: normal/non-revealing; Visual acuity tests: 20/25 OD, notes: and counting fingers at 3 feet OS; 20/25 OD and 20/400 OS. Therapeutic measures were taken as a result of optic ischaemic neuropathy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event optic ischaemic neuropathy 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 drug 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.