Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute macular neuroretinopathy, Angiogram, Blood test, Computerised tomogram head, Magnetic resonance imaging head
Clinical narrative: Acute Macular Neuroretinopathy; This spontaneous case was reported by a patient and describes the occurrence of ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) (seriousness criterion medically significant). The patient was treated with CELECOXIB (CELEBREX) for Pain behind eyes, at a dose of 200 milligram. At the time of the report, ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: CTA and CT scans of head negative. On an unknown date, Blood test: Blood work for MS, RA, and other Autoimmune disorders negative.. On an unknown date, Computerised tomogram head: CTA and CT scans of head negative. On an unknown date, Magnetic resonance imaging head: MRI of brain, neck, spine all negative to lesions.. On an unknown date, Magnetic resonance imaging neck: MRI of brain, neck, spine all negative to lesions.. On an unknown date, Magnetic resonance imaging spinal: MRI of brain, neck, spine all negative to lesions.. On an unknown date, Scan: Scan of blood vessels behind left eye- positive for vessels not providing blood flow to left eye.. On an unknown date, Ultrasound eye: negative.         No relevant concomitant medications were reported. Patient had black eye floaters for months then loss of color, blurred vision, and large para-central scotoma. It was unknown if the patient experienced any additional symptoms/events. Company comment: This spontaneous case concerns a 64-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Acute Macular Neuroretinopathy after one dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine, dose not reported. The event onset date and the suspect start date seem to be discrepancy, hence, the company causality was conservatively retained as related. Blood tests were negative for autoimmune disorders. Computerized tomogram of the head was negative. Magnetic resonance imaging of brain, neck, spine was negative to lesions. A scan of blood vessels behind left eye revealed that vessels were not providing blood flow to left eye. An angiogram and an ultrasound were negative. No treatment medication was reported. The event had not resolved. No further clinical information was available for medical review. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.