Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Brain oedema, Central nervous system lesion, Dyspnoea, Hypertension
Clinical narrative: Legion in the brain that showed swelling; Legion in the brain that showed swelling; Only can see little bit from left eye; Had an eye stroke, affecting optic nerve; Could not see anything from right eye; Numbness in her arm and toe/developing numbness in arm and leg; Developed high blood pressure; Little bit of heavy breathing; Optic nerve split; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Could not see anything from right eye), BRAIN OEDEMA (Legion in the brain that showed swelling), CENTRAL NERVOUS SYSTEM LESION (Legion in the brain that showed swelling), VISUAL IMPAIRMENT (Only can see little bit from left eye), OPTIC NERVE DISORDER (Optic nerve split), OPTIC NEUROPATHY (Had an eye stroke, affecting optic nerve) and HYPOAESTHESIA (Numbness in her arm and toe/developing numbness in arm and leg) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 079A42A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced BLINDNESS UNILATERAL (Could not see anything from right eye) (seriousness criteria hospitalization, disability and medically significant), OPTIC NERVE DISORDER (Optic nerve split) (seriousness criteria hospitalization and disability), OPTIC NEUROPATHY (Had an eye stroke, affecting optic nerve) (seriousness criteria hospitalization, disability and medically significant) and DYSPNOEA (Little bit of heavy breathing). On an unknown date, the patient experienced BRAIN OEDEMA (Legion in the brain that showed swelling) (seriousness criteria hospitalization, disability, medically significant and life threatening), CENTRAL NERVOUS SYSTEM LESION (Legion in the brain that showed swelling) (seriousness criteria hospitalization and life threatening), VISUAL IMPAIRMENT (Only can see little bit from left eye) (seriousness criteria hospitalization and disability), HYPOAESTHESIA (Numbness in her arm and toe/developing numbness in arm and leg) (seriousness criterion hospitalization) and HYPERTENSION (Developed high blood pressure). The patient was treated with AMLODIPINE BESILATE (NORVASC) for Blood pressure high, at a dose of 10 mg; HYDROCHLOROTHIAZIDE for Blood pressure high, at a dose of 25 mg and PREDNISONE for Inflammation, at a dose of 40 mg. At the time of the report, BLINDNESS UNILATERAL (Could not see anything from right eye), VISUAL IMPAIRMENT (Only can see little bit from left eye) and OPTIC NERVE DISORDER (Optic nerve split) had not resolved and BRAIN OEDEMA (Legion in the brain that showed swelling), CENTRAL NERVOUS SYSTEM LESION (Legion in the brain that showed swelling), OPTIC NEUROPATHY (Had an eye stroke, affecting optic nerve), HYPOAESTHESIA (Numbness in her arm and toe/developing numbness in arm and leg), HYPERTENSION (Developed high blood pressure) and DYSPNOEA (Little bit of heavy breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Intraocular pressure test: pressure increased up to 26 (High) pressure increased up to 26.         Concomitant product used was not provided by the reporter.  A few days after getting second vaccination, this patient started to experience a little bit of heavy breathing. About a week later, when she got up she could not see anything from her right eye. She went to an Eye Specialist and was diagnosed with optic nerve may have split causing her pressure to increase to 26 and affecting both eyes. The doctor recommended she go to the ER. While at the ER, she developed high blood pressure (never had before), numbness in her arm and toe. It was recommended that she see her primary physician. Her primary physician prescribed Norvasc (amlodipine) and hydrochlorothiazide. The patient then traveled to see two eye specialist and was hospitalized for brain test, CAT scan and MRI. She was told she had a eye stroke affecting her optic nerve, developing numbness in arm and leg and a lesion in her brain was noticed that showed swelling. She was prescribed prednisone for the inflammation.  Treatment included MRI, brain test, CAT scan, amlodipine, hydrochlorothiazide and prednisone.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.