Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-aquaporin-4 antibody, Anti-thyroid antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood immunoglobulin G
Clinical narrative: Left optic neuritis; This literature-non-study case was reported in a literature article and describes the occurrence of OPTIC NEURITIS (Left optic neuritis) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Episcleritis. Concurrent medical conditions included Prediabetes, Hyperlipidemia and Glaucoma.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced OPTIC NEURITIS (Left optic neuritis) (seriousness criterion medically significant). The patient was treated with PHENYLEPHRINE (intravitreal) at an unspecified dose and frequency and METHYLPREDNISOLONE (intravenous) at a dose of 1 gram once a day. At the time of the report, OPTIC NEURITIS (Left optic neuritis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-aquaporin-4 antibody: Aquaporin-4 IgG was negative. On an unknown date, Anti-thyroid antibody: were normal. On an unknown date, Antineutrophil cytoplasmic antibody: Negative. On an unknown date, Antinuclear antibody: Negative. On an unknown date, Blood immunoglobulin G: Serum MOG IgG was negative. On an unknown date, Blood thyroid stimulating hormone: was normal. On an unknown date, C-reactive protein: 57.2 milligram per litre. On an unknown date, Magnetic resonance imaging: MRI orbits showed evidence of left optic neuritis. On an unknown date, Magnetic resonance imaging head: was normal. On an unknown date, Neurological examination: were normal. On an unknown date, Ophthalmological examination: were normal. On an unknown date, Red blood cell sedimentation rate: within normal limits. On an unknown date, Rheumatoid factor: Negative. On an unknown date, SARS-CoV-2 test: Negative. On an unknown date, Visual acuity tests: was 20/40 in right eye and was 20/20 in right eye with a normal visual field, six weeks later.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. One day after receiving the second dose of Moderna vaccine, patient experienced bilateral eye redness and chemosis with blurred vision. Few hours later patient experienced rapidly progressive vision loss in the left eye associated with pain, eye movements, ocular surface irritation. Patient denied orbital or boring pain. Patient presented with no light perception in the left eye and a left afferent pupillary defect. Patient also had temporal chemosis and injection in both eyes which improved but did not completely blanch with phenylephrine. Patient ocular ductions were full. Six weeks later patient's visual acuity was improved but continued to have no light perception in the left eye. It was reported that patient did not had rapid improvement in visual acuity with steroids.  Company comment: This is a literature non-study case concerning a 67-year-old man, with a history of glaucoma and episcleritis, who received the second dose of the mRNA-1273 vaccine, and on the following day, he developed bilateral eye redness and chemosis with blurred vision. Hours later, he noted rapidly progressive vision loss in the left eye associated with pain with eye movements along with ocular surface irritation. He denied deep orbital or boring pain. He presented with visual acuity of 20/40 in the right eye, no light perception in the left eye, and a left afferent pupillary defect. He also had temporal chemosis and injection in both eyes that improved but did not completely blanch with phenylephrine. His ocular ductions were full, and ophthalmologic and neurologic examinations were otherwise normal. A magnetic resonance imaging of the orbits showed evidence of left optic neuritis and the brain magnetic resonance was normal. The COVID-19 PCR was negative. The red blood cell sedimentation rate was within normal limits. C-reactive protein was elevated to 57.2 mg/L, but ANA, ANCA, rheumatoid factor, serum MOG IgG and aquaporin-4 IgG were negative. Thyroid stimulating hormone (TSH) and thyroid antibodies were normal. He was given a 5-day course of methylprednisolone (1 g IV every 24 hours) and six weeks later, visual acuity improved to 20/20 in the right eye with a normal visual field, but he continued to have no light perception in the left eye. No details of previous doses were provided. Patient´s glaucoma and episcleritis could be confounders for the event. No further clinical information was available for medical review.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Live follow up received by safety on 09-Dec-2022 has an email with full text article and contains significant information. Authors information, literature information, medical history, lab data, treatment medications and event details were updated.; Sender's Comments: This is a literature non-study case concerning a 67-year-old man, with a history of glaucoma and episcleritis, who received the second dose of the mRNA-1273 vaccine, and on the following day, he developed bilateral eye redness and chemosis with blurred vision. Hours later, he noted rapidly progressive vision loss in the left eye associated with pain with eye movements along with ocular surface irritation. He denied deep orbital or boring pain. He presented with visual acuity of 20/40 in the right eye, no light perception in the left eye, and a left afferent pupillary defect. He also had temporal chemosis and injection in both eyes that improved but did not completely blanch with phenylephrine. His ocular ductions were full, and ophthalmologic and neurologic examinations were otherwise normal. A magnetic resonance imaging of the orbits showed evidence of left optic neuritis and the brain magnetic resonance was normal. The COVID-19 PCR was negative. The red blood cell sedimentation rate was within normal limits. C-reactive protein was elevated to 57.2 mg/L, but ANA, ANCA, rheumatoid factor, serum MOG IgG and aquaporin-4 IgG were negative. Thyroid stimulating hormone (TSH) and thyroid antibodies were normal. He was given a 5-day course of methylprednisolone (1 g IV every 24 hours) and six weeks later, visual acuity improved to 20/20 in the right eye with a normal visual field, but he continued to have no light perception in the left eye. No details of previous doses were provided. Patient´s glaucoma and episcleritis could be confounders for the event. No further clinical information was available for medical review.  The benefit-risk relationship of mRNA-1273 is not affected by this report.