Sex: F
Vaccine: COVID19
Symptoms: Acute macular neuroretinopathy, Fundoscopy, Intraocular pressure test, Ophthalmological examination, Optical coherence tomography
Clinical narrative: Acute macular neuroretinopathy; This is a literature report for the following literature source(s): "Acute macular neuroretinopathy following Pfizer-BioNTech COVID-19 vaccination", Journal of Ophthalmology Case Reports, 21; Vol:24, DOI:10.1016/j.ajoc.2021.101200.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "vaginal ring" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Etonogestrel/ethinyl estradiol for birth control, notes: only significant for use of etonogestrel/ethinyl estradiol 0.12-0.015 mg/24 hr vaginal ring for birth control. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: ACUTE MACULAR NEURORETINOPATHY (hospitalization, medically significant), outcome "recovered", described as "Acute macular neuroretinopathy". The event "acute macular neuroretinopathy" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: fundoscopy: unrevealing; unrevealing, with no hemorrhages, retinal vascular, notes: sheathing, retinal or choroidal lesions, and normal appearance of the optic nerve head; revealed hyporeflective foci typical for acute, notes: macular neuroretinopathy (AMN); intraocular pressure test: physiologic; ophthalmological examination: there was no relative afferent pupillary defect or, notes: dyschromatopsia; both eyes were white and quiet and there was no, notes: evidence of anterior chamber or vitreous inflammation; optical coherence tomography: demonstrated corresponding parafoveal foci of, notes: outer nuclear layer hyperreflectivity with granularity of the underlying ellipsoid (There are triangular dark lesions in the superior macula with corresponding bilateral focal ellipsoid zone loss worse in the right eye.); slit-lamp examination: unrevealing; visual acuity tests: 20/20, notes: in both eyes; remained 20/20, notes: in both eyes; visual field tests: confirmed the presence of bilateral paracentral, notes: scotomata; showed stable bilateral paracentral scotomata. Therapeutic measures were taken as a result of acute macular neuroretinopathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event Acute macular neuro-retinopathy cannot be excluded. 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.