Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Keratitis, Ophthalmological examination, Ultrasound eye
Clinical narrative: marginal keratitis; This literature-non-study case was reported in a literature article and describes the occurrence of KERATITIS (marginal keratitis) in a 66-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   The patient's past medical history included Hemangioma cavernous (surgical removal of a cavernous hemangioma of the left orbit six years prior.), Aortic ectasia (abdominal), Thyroidectomy, Partial lung lobectomy, Hernia repair and Knee arthroscopy. Family history included Hypertension since an unknown date and Retinal detachment since an unknown date. Concurrent medical conditions included Thyroid cancer (thyroid cancer in remission), Lung mass and Nonsmoker (lifetime nonsmoker). Concomitant products included LEVOTHYROXINE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced KERATITIS (marginal keratitis) (seriousness criterion medically significant). At the time of the report, KERATITIS (marginal keratitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ophthalmological examination: The external exam showed best-corrected visual acuity of 20/25 and 20/30 in the right and left eyes, respectively. Pupils were 3 mm and reactive bilaterally. Intraocular pressure was 14 mmHg in the right eye and 13 mmHg in the left eye. Extraocular movements and visual fields were full bilaterally. On an unknown date, Ultrasound eye: Anterior segment exam of the right eye showed 1-2 + blepharitis and 3 + injection, 1 + chemosis. There was no discharge noted in the fornix. There were 5-6 small, flat infiltrates in the inferior cornea, 1-2 mm from the limbus, and several raised infiltrates superiorly with adjacent peripheral vascularization. The epithelium was intact, without overlying epithelial defects. The anterior chamber was deep and quiet, the iris round and reactive, and the lens showed trace nuclear sclerosis. The anterior segment exam in the left eye was remarkable for 1 + blepharitis. The posterior segment exam was unremarkable bilaterally. The patient was diagnosed with marginal keratitis of the right eye..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered KERATITIS (marginal keratitis) to be related.    Patient had no current or past history of illicit drug use. The patient was diagnosed with marginal keratitis of the right eye 2.5 weeks after the first dose and started on an antibiotic and corticosteroid combination ophthalmic drop. Patient also started an antibiotic ointment at bedtime. She was evaluated several days later with significant improvement in discomfort and injection of the right eye. Over the following two weeks, she was slowly tapered off her drops, during which time she also received her second dose of the Moderna COVID-19 vaccine. The patient completed her medication taper and was found at her follow-up visit to have a resolution of her corneal infiltrates and ocular symptoms.  Company Comment: This is a literature-non-study case concerning a elderly female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of marginal keratitis. The event occurred 2.5 weeks after the first dose of mRNA-1273 vaccine administration. Allegedly the event was described as, patient presented to the clinic with gradually worsening of right eye pain and redness. Patient described the pain as 5/10 in severity, constant, and unremitting. Symptoms were associated with intermittent blurred vision, tearing, and mild discharge. Patient denied any history of similar episodes, eye trauma, contact lens wear, or allergies. Patient denies recent infections and has had no recent sick contacts. Patient has used antibiotic eye drops without significant improvement in right eye symptoms. On examination, anterior segment of the right eye showed 1-2 + blepharitis and 3 + injection, 1 + chemosis. There was no discharge noted in the fornix. There were 5-6 small, flat infiltrates in the inferior cornea, 1-2 mm from the limbus, and several raised infiltrates superiorly with adjacent peripheral vascularization. The epithelium was intact, without overlying epithelial defects. The anterior chamber was deep and quiet, the iris round and reactive, and the lens showed trace nuclear sclerosis. The anterior segment exam in the left eye was remarkable for 1 + blepharitis. The patient was diagnosed with marginal keratitis of the right eye and started on an antibiotic and corticosteroid combination ophthalmic drop. Patient also started an antibiotic ointment at bedtime. Patient was evaluated several days later with significant improvement in discomfort and injection of the right eye. Over the following two weeks, patient was slowly tapered off her drops, during which time patient also received her second dose of the mRNA-1273 vaccine. The patient completed her medication taper and was found at her follow-up visit to have a resolution of her corneal infiltrates and ocular symptoms. The rechallenge was not applicable since the patient received the second dose of mRNA-1273 vaccine without the complete resolution of the event. The presence of 1-2 blepharitis on the right eye upon examination remain confounder for the event marginal keratitis of the right eye. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow up received by safety on 07-Jul-2022 has Email and article propagated which contains significant information: Reporter information, citation details (author details, year), lab data, suspect product dosage information, concomitant, treatment drugs information and events details were updated.; Sender's Comments: This is a literature-non-study case concerning a elderly female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of marginal keratitis. The event occurred 2.5 weeks after the first dose of mRNA-1273 vaccine administration. Allegedly the event was described as, patient presented to the clinic with gradually worsening of right eye pain and redness. Patient described the pain as 5/10 in severity, constant, and unremitting. Symptoms were associated with intermittent blurred vision, tearing, and mild discharge. Patient denied any history of similar episodes, eye trauma, contact lens wear, or allergies. Patient denies recent infections and has had no recent sick contacts. Patient has used antibiotic eye drops without significant improvement in right eye symptoms. On examination, anterior segment of the right eye showed 1-2 + blepharitis and 3 + injection, 1 + chemosis. There was no discharge noted in the fornix. There were 5-6 small, flat infiltrates in the inferior cornea, 1-2 mm from the limbus, and several raised infiltrates superiorly with adjacent peripheral vascularization. The epithelium was intact, without overlying epithelial defects. The anterior chamber was deep and quiet, the iris round and reactive, and the lens showed trace nuclear sclerosis. The anterior segment exam in the left eye was remarkable for 1 + blepharitis. The patient was diagnosed with marginal keratitis of the right eye and started on an antibiotic and corticosteroid combination ophthalmic drop. Patient also started an antibiotic ointment at bedtime. Patient was evaluated several days later with significant improvement in discomfort and injection of the right eye. Over the following two weeks, patient was slowly tapered off her drops, during which time patient also received her second dose of the mRNA-1273 vaccine. The patient completed her medication taper and was found at her follow-up visit to have a resolution of her corneal infiltrates and ocular symptoms. The rechallenge was not applicable since the patient received the second dose of mRNA-1273 vaccine without the complete resolution of the event. The presence of 1-2 blepharitis on the right eye upon examination remain confounder for the event marginal keratitis of the right eye. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.