Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute macular neuroretinopathy, Angiogram, COVID-19, Optical coherence tomography, Visual acuity tests
Clinical narrative: Bilateral acute macular neuroretinopathy; Positive for COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MACULAR NEURORETINOPATHY (Bilateral acute macular neuroretinopathy) in a 64-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MACULAR NEURORETINOPATHY (Bilateral acute macular neuroretinopathy) (seriousness criterion medically significant) and COVID-19 (Positive for COVID-19 infection). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ACUTE MACULAR NEURORETINOPATHY (Bilateral acute macular neuroretinopathy) and COVID-19 (Positive for COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: revealed flow voids in deep capillary plexus and choriocapillaris oculus uterque, all consistent with acute macular neuroretinopathy .. On an unknown date, COVID-19: (Positive) Positive. On an unknown date, Optical coherence tomography: revealed outer nuclear layer thinning and an ellipsoid zone disruption oculus uterque.. On an unknown date, Visual acuity tests: 20/200 oculus uterque  and near-infrared reflectance revealed hypo-reflective lesions in the maculae oculus uterque..     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACUTE MACULAR NEURORETINOPATHY (Bilateral acute macular neuroretinopathy) and COVID-19 (Positive for COVID-19 infection) to be related.    No concomitants medications were reported.  Patient presented with central vision loss in both the eyes (OU). After the vaccine administration patient rapidly experienced an unspecified systemic symptoms. Treatment was provided for vision improvement and persistent scotomas. Company comment: This is a literature-non-study case concerning a 64-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant), unexpected event of Bilateral acute macular neuroretinopathy and the unexpected non-serious AESI of COVID-19. As per source document, she experienced central vision loss in both eyes. She had recently received a dose of mRNA-1273 vaccine and rapidly developed systemic symptoms. Testing revealed COVID-19 infection. Visual acuities were 20/200 and near-infrared reflectance revealed hypo-reflective lesions in the maculae, optical coherence tomography showed outer nuclear layer thinning and ellipsoid zone disruption, and an OCT-angiography showed flow voids in the deep capillary plexus and choriocapillaris, all consistent with acute macular neuroretinopathy. She was treated with oral prednisone with subsequent mild vision improvement and persistent scotomas. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a literature-non-study case concerning a 64-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant), unexpected event of Bilateral acute macular neuroretinopathy and the unexpected non-serious AESI of COVID-19. As per source document, she experienced central vision loss in both eyes. She had recently received a dose of mRNA-1273 vaccine and rapidly developed systemic symptoms. Testing revealed COVID-19 infection. Visual acuities were 20/200 and near-infrared reflectance revealed hypo-reflective lesions in the maculae, optical coherence tomography showed outer nuclear layer thinning and ellipsoid zone disruption, and an OCT-angiography showed flow voids in the deep capillary plexus and choriocapillaris, all consistent with acute macular neuroretinopathy. She was treated with oral prednisone with subsequent mild vision improvement and persistent scotomas. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.