Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lumbar puncture, Magnetic resonance imaging, Visual impairment
Clinical narrative: A week later, vision was off a bit which lasted for about 5 minutes.; A week later, her right eye deviated to right  which lasted for about 5 minutes.; Short term disability from late April to 21Sep2021; felt slightly intoxicated for a week or so; Within a few hours of her shot, she was  extremely tired; Within a few hours of her shot, she had some dizziness; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (A week later, vision was off a bit which lasted for about 5 minutes.), EYE MOVEMENT DISORDER (A week later, her right eye deviated to right  which lasted for about 5 minutes.) and DISABILITY (Short term disability from late April to 21Sep2021) in a 42-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.     The patient's past medical history included COVID-19 in November 2020.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Within a few hours of her shot, she had some dizziness) and FATIGUE (Within a few hours of her shot, she was  extremely tired). In April 2021, the patient experienced DISABILITY (Short term disability from late April to 21Sep2021) (seriousness criteria hospitalization, disability and medically significant). On 09-Sep-2021, the patient experienced FEELING ABNORMAL (felt slightly intoxicated for a week or so). On an unknown date, the patient experienced VISUAL IMPAIRMENT (A week later, vision was off a bit which lasted for about 5 minutes.) (seriousness criteria hospitalization, disability and medically significant) and EYE MOVEMENT DISORDER (A week later, her right eye deviated to right  which lasted for about 5 minutes.) (seriousness criteria hospitalization, disability and medically significant). On 21-Sep-2021, DISABILITY (Short term disability from late April to 21Sep2021) had resolved. At the time of the report, VISUAL IMPAIRMENT (A week later, vision was off a bit which lasted for about 5 minutes.) and EYE MOVEMENT DISORDER (A week later, her right eye deviated to right  which lasted for about 5 minutes.) outcome was unknown and DIZZINESS (Within a few hours of her shot, she had some dizziness), FEELING ABNORMAL (felt slightly intoxicated for a week or so) and FATIGUE (Within a few hours of her shot, she was  extremely tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal and normal (normal) normal. On an unknown date, Lumbar puncture: normal (normal) normal. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) MRI showed demyelinating lesion in the thalamus and abnormal (abnormal) brain lesion improving.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The neurologist started treated her for MS.  Reported that a week later, she was admitted to hospital for blood work which was normal however the MRI showed demyelinating lesion in the thalamus. About a week later she was hospitalized for 3 days in Hospital listed as 3rd contact.Her diagnosis is still unclear. No history of MS in family.  Company comment This case concerns a 42-year-old female patient with no relevant medical history, who experienced the unexpected, serious events of visual impairment, eye movement disorder and disabling. The events occured approximately one week after first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.; Sender's Comments: This case concerns a 42-year-old female patient with no relevant medical history, who experienced the unexpected, serious events of visual impairment, eye movement disorder and disabling. The events occured approximately one week after first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.