Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, Optic neuritis, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: Atypical Optic Neuritis; This is a literature report.  A 65-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "medullary thyroid cancer" (unspecified if ongoing); "total thyroidectomy" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing), notes: on supplementation; "prediabetes mellitus" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levothyroxine for medullary thyroid cancer; Vitamin d for vitamin D deficiency. The following information was reported: OPTIC NEURITIS (medically significant), outcome "recovering", described as "Atypical Optic Neuritis". The patient underwent the following laboratory tests and procedures: Angiotensin converting enzyme: Negative; Anti-aquaporin-4 antibody: Negative; Antineutrophil cytoplasmic antibody: Negative; Antinuclear antibody: Negative; Blood immunoglobulin G: Negative; C-reactive protein: within normal limits.; Magnetic resonance imaging: showed evidence of right optic neuritis; showed no demyelinating lesions.; Magnetic resonance imaging head: showed no demyelinating lesions.; Magnetic resonance imaging neck: showed no demyelinating lesions.; Neurological examination: were otherwise normal; Ophthalmological examination: were otherwise normal; Red blood cell sedimentation rate: within normal limits.; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of optic neuritis.  Clinical course: A 65-year-old woman with a history of medullary thyroid cancer status post total thyroidectomy on levothyroxine, vitamin D deficiency on supplementation, prediabetes mellitus, and hyperlipidemia received her first dose of the Pfizer COVID-19 mRNA vaccine. Within hours after vaccination, she experienced a headache. Five days later, she developed vision loss in the right eye associated with pain with eye movements. She presented with light perception only vision and an afferent pupillary defect in her right eye, with 360-degree optic disc swelling associated with cotton wool spots and flame hemorrhages. Her ophthalmologic and neurologic examinations were otherwise normal. Magnetic resonance imaging (MRI) orbits showed evidence of right optic neuritis. MRI of the brain and cervical and thoracic spine showed no demyelinating lesions. COVID-19 polymerase chain reaction (PCR) was negative. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were within normal limits. Antinuclear antibody (ANA), antineutrophil cytoplasmic antibodies (ANCA), and angiotensin-converting enzyme were negative. Serum myelin oligodendrocyte glycoprotein (MOG) IgG and aquaporin-4 IgG were negative. She was treated with a 5-day course of methylprednisolone 1 g IV every 24 hours and intravenous immunoglobulin (IVIG) 2 g/kg administered over 3 days. Five weeks later, the visual acuity improved to 20/100 in her right eye, but she perceived minimal recovery in central vision.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Optic Neuritis and the suspect drug cannot be completely 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.