Sex: F
Vaccine: COVID19
Symptoms: Fluorescence angiogram, Intraocular pressure test, Investigation, Optic ischaemic neuropathy, Optical coherence tomography
Clinical narrative: Sudden bilateral loss of vision; Arteritic anterior ischemic optic neuropathy; Mild cataracts in both eyes; This is a literature report.  CASE REPORT: The patient was a 79-year-old female, otherwise healthy, with a history of osteoporosis and osteoarthritis. She was presented to the author 35 days after a sudden bilateral loss of vision, which occurred two days after she received the second recombinant mRNA vaccine (Pfizer) injection. The patient did not have any other accompanying systemic or ocular symptoms. She also had no family history of autoimmune diseases. Prior to presentation at the author's clinic, the patient was hospitalized for very high erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels (i.e., ESR: 61 and CRP: 32). The patient was on 50 mg of oral prednisone for only one day. As a result of the high ESR and CRP, she underwent a right temporal artery biopsy that was compatible with AAION and was simultaneously started on high dose intravenous steroid pulse therapy (1 g) for three consecutive days. She was then administered 60 mg of oral prednisone with a slow taper. When the author eventually saw the patient, she was on oral prednisone at 40 mg/day. At presentation, the best-corrected visual acuity was measured at 20/1250 and 20/40 in the right and left eyes on the Snellen acuity chart, respectively. There was 3+ afferent pupillary defect in the right eye. The anterior segment and posterior segment exams were normal except for mild cataracts in both eyes, complete pallor of the optic nerve head in the right eye, and segmental (inferior) pallor in her left eye [Figure 1]. Intraocular pressure was normal in both eyes. Figure 1 also illustrates the macular optical coherence tomography (OCT), fluorescein angiography (FA), and indocyanine green angiography (ICG) in both eyes. These tests demonstrate generalized disc pallor in the right optic nerve head and inferior pallor in the left optic nerve head. Figure 2 illustrates the retinal nerve fiber layer (rNFL) and ganglion cell complex (GCC), and Octopus EyeSuite Static perimetry V3.6.1 in both eyes. The ganglion cell complex is thin (red area) in both eyes. The retinal nerve fiber layer thickening is within the normal limit in both eyes. The right eye visual field shows severe generalized depression and the left eye depicts superior altitudinal defect. Figure 3 illustrates the fixed luminance- (FL-) and multi luminance- (ML-) flicker electroretinography (ERG) and multifocal- (MF)ERG in both eyes, both of which are normal. Based on her diagnosis, the author started the patient on 162 mg of weekly subcutaneous tocilizumab with plans to taper the steroid slowly while monitoring her ESR, CRP, and IL-6. The efficacy of the therapy will be evaluated in three months. DISCUSSION: Most studies on vaccine-related side effects reveal symptom reduction during the analysis of the 10-20 days follow-up. This suggests that any new finding within this time range, especially in a healthy person, can be considered as vaccine-related adverse effects until proven otherwise. With reference to the case presented here, the patient developed AAION within the time frame described above, so the rule is applicable. AAION is an autoimmune disease. Based on the aforementioned discussions, neutralizing antibodies against SARS-CoV-2 spike proteins and/or activated T-helper-1 cells after vaccination can cross-react with proteins and antigens in large arteries, outer retinal layers, and retinal pigment epithelial cells, causing presentation with the typical form of AAION. Additionally, presenting symptoms early after the second COVID-19 shot (within 10-20 days period) appears to provide further evidence that supports the direct correlation between COVID- 19 vaccination and the development of this autoimmune disease. With direct reference to the case, the presentation of ocular disease in the patient after receiving the second shot, which boosts the immune system, may provide additional evidence to support the correlation between vaccinations and ocular diseases. The high ESR and CRP levels further support this assertion and can also indicate the overactivity of the immune system. In conclusion, after assessing the facts and the circumstances surrounding the case, the author conclude that there may be a correlation between ocular inflammatory diseases with autoimmune mechanism and COVID-19 vaccination. The timing of the occurrences of the autoimmune disease, AAION, in the patient coincides with the timing parameters outlined for determining possible side effects as a consequence of receiving the vaccine. In addition to which, the absence of the respective comorbidity in the patients prior to the vaccination also suggests a possible cause and effect scenario.  Figure 1. A and B are multicolored images of the right and left eyes, respectively, which illustrate generalized disc pallor in the right optic nerve head and inferior pallor in the left optic nerve head. C and D are the green reflectance images of the right and left eyes, respectively, which demonstrate generalized nerve fiber loss in the right eye and inferior nerve fiber layer loss in the left eye. E and F are the late phase of fluorescein angiography of the right and left eyes, respectively, and G and H are macular optical coherence tomography of the right and left eyes, respectively. These appear normal.  Figure 2. A and B illustrate ganglion cell complex (GCC) and retinal nerve fiber layer (rNFL) thickness of the right eye, respectively. GCC image demonstrates significant thinning (red area), and rNFL looks normal. C and D show rNFL thickness and GCC of the left eye, respectively. GCC image demonstrates thinning inferiorly (red area) and rNFL looks normal. E and F are Octopus EyeSuite TM Static perimetry V6.3.1 visual field of the right and left eyes, respectively. Right eye visual field shows severe generalized depression, and the left eye depicts a superior altitudinal defect  Figure 3. A and B illustrate fixed-luminance electroretinography (ERG) on Diopsys, which is equal to 30-Hz flicker conventional ERG. Waves have normal magnitude (amplitude) and phase (implicit time) in both eyes. Graphs show rays (blue lines) in the green area, which indicates a normal pattern. C and D show multifocal ERG of the right and left eyes, respectively. Multifocal ERG in both eyes is normal.; Sender's Comments: Based on the available information in the case, the causal association between the events blindness, optic ischemic neuropathy, cataract and the suspect drug BNT162B2 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.