Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Intraocular pressure test, Ophthalmological examination, Optical coherence tomography, Pyrexia
Clinical narrative: branch retinal vein occlusion in the left eye; Fever; This literature-non-study case was reported in a literature article and describes the occurrence of RETINAL VEIN OCCLUSION (branch retinal vein occlusion in the left eye) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Hypertension and Dry eye syndrome. Concomitant products included FLUTICASONE, HYDROCHLOROTHIAZIDE, FEXOFENADINE and HYPROMELLOSE (ARTIFICIAL TEAR [HYPROMELLOSE]) for an unknown indication.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RETINAL VEIN OCCLUSION (branch retinal vein occlusion in the left eye) (seriousness criterion medically significant) and PYREXIA (Fever). The patient was treated with AFLIBERCEPT (intravitreal) in 2021 for Retinal vein branch occlusion, at a dose of UNK UNK, qmo. At the time of the report, RETINAL VEIN OCCLUSION (branch retinal vein occlusion in the left eye) was resolving and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 124/77 mmhg 124/77 mmHg. In 2021, Intraocular pressure test: unremarkable intraocular pressures were unremarkable; there was  no relative afferent pupillary defect; and her visual fields were full to  confrontation. In 2021, Ophthalmological examination: revealed branch retinal vein occlusion revealed a supero-temporal branch  retinal vein occlusion (BRVO) with superficial intraretinal hemorrhages  scattered along the superior arcade without macular edema and unremarkable unremarkable. In 2021, Visual acuity tests: 20/20 20/20 and 20/30 (Low) 20/30. On an unknown date, Optical coherence tomography: demonstrated persistent fovealsparingmacular edema demonstrated  persistent foveal-sparing macular edema. On an unknown date, Visual acuity tests: 20/25 20/25.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RETINAL VEIN OCCLUSION (branch retinal vein occlusion in the left eye) and PYREXIA (Fever) to be related.    The patient presented with flashes and floaters in her left eye for three weeks duration. The patient had no known allergies. Observation was recommended due to absence of macular edema and preserved visual acuity. Patient did not receive a booster vaccine.  Company Comment: This is a literature non-study case concerns a 57-year-old female patient with a medical condition of Hypertension, who experienced the unexpected serious (Medically significant) event of Retinal vein occlusion (Retinal vein branch occlusion) on an unknown date in 2021 while the second dose of mRNA-1273 Vaccine administered on 12-Apr-2021. It was reported after the second dose of Moderna vaccine patient had a fever followed by the onset of floaters, which progressively worsened prompting evaluation three weeks later. Her visual acuity was 20/20 in each eye; intraocular pressures were unremarkable; there was no relative afferent pupillary defect; and her visual fields were full to confrontation. Dilated examination of the right eye was unremarkable; dilated examination of the left eye revealed a supero-temporal branch retinal vein occlusion (BRVO) with superficial intraretinal hemorrhages scattered along the superior arcade without macular edema. Her blood pressure was 124/77 mmHg. Observation was recommended given absence of macular edema and preserved visual acuity. Macular edema developed and visual acuity declined to 20/30 at two months after initial presentation for which she was treated with intravitreal aflibercept monthly for 6 months. Visual acuity at most recent follow-up was 20/25, and OCT demonstrated persistent foveal-sparing macular edema. Patients medical condition of Hypertension is considered as risk factor for the event Retinal vein branch occlusion. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received by safety on 09-JUN-2022 has Email with FTA and contains significant information: Reporter information, Medical History, lab details, treatment and concomitant medications, Product coding and event details were updated and events (retinal hemorrhage, fever)were added.; Sender's Comments: This is a literature non-study case concerns a 57-year-old female patient with a medical condition of Hypertension, who experienced the unexpected serious (Medically significant) event of Retinal vein occlusion (Retinal vein branch occlusion) on an unknown date in 2021 while the second dose of mRNA-1273 Vaccine administered on 12-Apr-2021. It was reported after the second dose of Moderna vaccine patient had a fever followed by the onset of floaters, which progressively worsened prompting evaluation three weeks later. Her visual acuity was 20/20 in each eye; intraocular pressures were unremarkable; there was no relative afferent pupillary defect; and her visual fields were full to confrontation. Dilated examination of the right eye was unremarkable; dilated examination of the left eye revealed a supero-temporal branch retinal vein occlusion (BRVO) with superficial intraretinal hemorrhages scattered along the superior arcade without macular edema. Her blood pressure was 124/77 mmHg. Observation was recommended given absence of macular edema and preserved visual acuity. Macular edema developed and visual acuity declined to 20/30 at two months after initial presentation for which she was treated with intravitreal aflibercept monthly for 6 months. Visual acuity at most recent follow-up was 20/25, and OCT demonstrated persistent foveal-sparing macular edema. Patients medical condition of Hypertension is considered as risk factor for the event Retinal vein branch occlusion. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.