Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lysozyme, Maculopathy, Ophthalmological examination, Optical coherence tomography, Treponema test
Clinical narrative: mild vitritis; maculopathy; choroidal lesions; This literature-non-study case was reported in a literature article and describes the occurrence of VITRITIS (mild vitritis), MACULOPATHY (maculopathy) and CHORIORETINAL DISORDER (choroidal lesions) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   The patient's past medical history included Vitiligo.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VITRITIS (mild vitritis) (seriousness criterion medically significant), MACULOPATHY (maculopathy) (seriousness criterion medically significant) and CHORIORETINAL DISORDER (choroidal lesions) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) at a dose of 60 milligram once a day. In 2021, MACULOPATHY (maculopathy) and CHORIORETINAL DISORDER (choroidal lesions) had resolved. At the time of the report, VITRITIS (mild vitritis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiotensin converting enzyme: normal/negative. In 2021, Fundus autofluorescence: resolution of the lesions after treatment with oral prednisone. and showed hyperautofluorescent lesions throughout the fundus with staining on fluorescein angiography, no anterior segment inflammation but showed evidence of trace anterior vitreous cells, trace vitreous haze, macular retinal pigment epithelium (RPE) changes, and peripheral yellow choroidal lesions. In 2021, HLA marker study: normal/negative. In 2021, Intraocular pressure test: normal in both eyes.. In 2021, Lysozyme: normal/negative. In 2021, Ophthalmological examination: the right eye was normal without evidence of inflammation.. In 2021, Optical coherence tomography: Restoration of the subfoveal architecture after treatment with oral prednisone and Subfoveal hyperreflective focus with disruption of the ellipsoid zone at initial presentation. In 2021, Treponema test: normal/negative and (Negative) Negative. In 2021, Visual acuity tests: with correction of 20/20 in the right eye and 20/40-2 in the left eye and At 1.5 months treatment with oral prednisone visual acuity improved to 20/20-1 in the left eye with restoration of his subfoveal macular architecture.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  Patient presented to clinic between March 2021 and August 2021 and were subsequently followed in an outpatient setting.  Patient had no known prior history of COVID-19 and denied any prior ocular or medical history. Patient was first seen in the eye clinic 2 weeks after symptom onset.  Unilateral Blurred vision was assessed as ocular symptom. The patient had visual acuity with correction of 20/20 in the right eye and 20/40-2 in the left eye. His intraocular pressure was normal in both eyes. The ocular exam in the right eye was normal without evidence of inflammation. The left eye had no anterior segment inflammation but showed evidence of trace anterior vitreous cells, trace vitreous haze, macular retinal pigment epithelium (RPE) changes, and peripheral yellow choroidal lesions. It was reported that QuantiFERON-TBGold was reported as normal and Fluorescent treponemal antibody absorption (FTA-ABS) was minimally reactive, but follow-up Treponema pallidum particle agglutination (TP-PA) and direct Treponema pallidum antibodies were negative. Patient was treated with oral prednisone 60 milligrams (mg) daily with taper over the following 1.5 months. At 1.5 months following presentation, his visual acuity improved to 20/20-1 in the left eye with restoration of his subfoveal macular architecture resolution of intraocular inflammation, and resolution of the peripheral choroidal lesions which were best seen on FAF .At most recent follow-up 3.5 months after presentation, his exam remained stable without recurrent inflammation or chorioretinal findings.  Company comment: This literature non study case concerns a 48-year-old, male patient with no relevant prior ocular or medical history, who experienced the unexpected serious (medically significant) events of vitritis, maculopathy and chorioretinal disorder (described as choroidal lesion). The events occurred approximately 1 day after the second dose of mRNA-1273. As reported, patient was first seen in the eye clinic 2 weeks after symptom onset with unilateral Blurred vision as ocular symptom. The patient had visual acuity with correction of 20/20 in the right eye and 20/40-2 in the left eye. His intraocular pressure was normal in both eyes. The ocular exam in the right eye was normal without evidence of inflammation. The left eye had no anterior segment inflammation but showed evidence of trace anterior vitreous cells, trace vitreous haze, macular retinal pigment epithelium (RPE) changes, and peripheral yellowchoroidal lesions. Fundus autofluorescence (FAF) of the left eye showed hyperautofluorescent lesions throughout the fundus with staining on fluorescein angiography (FA). Optical coherence tomography (OCT) of the macula demonstrated central ellipsoid zone disruption with a hyperreflective subfoveal lesion. Patient was treated with oral prednisone daily with tapper for 1.5 months and the symptoms resolved with restoration of the visual acuity. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non study case concerns a 48-year-old, male patient with no relevant prior ocular or medical history, who experienced the unexpected serious (medically significant) events of vitritis, maculopathy and chorioretinal disorder (described as choroidal lesion). The events occurred approximately 1 day after the second dose of mRNA-1273. As reported, patient was first seen in the eye clinic 2 weeks after symptom onset with unilateral Blurred vision as ocular symptom. The patient had visual acuity with correction of 20/20 in the right eye and 20/40-2 in the left eye. His intraocular pressure was normal in both eyes. The ocular exam in the right eye was normal without evidence of inflammation. The left eye had no anterior segment inflammation but showed evidence of trace anterior vitreous cells, trace vitreous haze, macular retinal pigment epithelium (RPE) changes, and peripheral yellowchoroidal lesions. Fundus autofluorescence (FAF) of the left eye showed hyperautofluorescent lesions throughout the fundus with staining on fluorescein angiography (FA). Optical coherence tomography (OCT) of the macula demonstrated central ellipsoid zone disruption with a hyperreflective subfoveal lesion. Patient was treated with oral prednisone daily with tapper for 1.5 months and the symptoms resolved with restoration of the visual acuity. The benefit-risk relationship of mRNA-1273 is not affected by this report.