Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Blindness, Cerebrovascular accident, Laboratory test, SARS-CoV-2 test
Clinical narrative: Stroke; the nuisance on the eye; lost the sight; a sensation that something burst in the corner of the right eye; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS (lost the sight) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient said that had COVID-19 back in April. It started in April 5th with symptoms and on April 7th got the results back. Since April 7th was isolated on the household. It was negative to the rapid check and positive to the PCR.  Just had fever, chills, and lots of head ache on the first day. 14 days of quarantine. Started having lots of cough and the doctors said that had nodules on the lungs due to COVID.) on 05-Apr-2021 and Lung nodule (the doctors said that had nodules on the lungs due to COVID. In 6 months needs to check it's lungs again.). Concurrent medical conditions included Migraine (The patient said that usually has migraine). Concomitant products included METFORMIN for an unknown indication.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced BLINDNESS (lost the sight) (seriousness criterion medically significant) and ABNORMAL SENSATION IN EYE (a sensation that something burst in the corner of the right eye). On 17-Jun-2021, the patient experienced VITREOUS FLOATERS (the nuisance on the eye). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 23-Jun-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), BLINDNESS (lost the sight), ABNORMAL SENSATION IN EYE (a sensation that something burst in the corner of the right eye) and VITREOUS FLOATERS (the nuisance on the eye) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: fine from the heart (normal) fine from the heart. On an unknown date, SARS-CoV-2 test: positive (Positive) positive to the PCR and negative (Negative) It was negative to the rapid check.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CEREBROVASCULAR ACCIDENT (Stroke) to be related. No further causality assessments were provided for BLINDNESS (lost the sight), ABNORMAL SENSATION IN EYE (a sensation that something burst in the corner of the right eye) and VITREOUS FLOATERS (the nuisance on the eye).    No treatment information was provided.  The patient said that usually had migraine and thought that was a migraine. The patient had a scan of the head, an MRI, and Blood test - No  results were provided.  The patient also received oxygen due to the eye problem while being on ER. The patient said on Friday was transferred to a hospital room where it stayed until June 23rd at 12:00 due to a Stroke which the doctors said could have been related to the vaccine.  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.