Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Learning disorder, Loss of personal independence in daily activities, Nausea, Reading disorder
Clinical narrative: Vestibular neuritis; Could not walk by herself without help; No energy; Didn't feel good; The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill; The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill; The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill; The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill; unable to drive; unable to shower by herself; Nausea; She woke up and couldn't see, everything was completely black, She didn't know what's wrong or what to. Vision came back after 5-10 minutes; Skin sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (She woke up and couldn't see, everything was completely black, She didn't know what's wrong or what to. Vision came back after 5-10 minutes) and VESTIBULAR NEURONITIS (Vestibular neuritis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038CZ11A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy (but it was well controlled by medication and she has no problem for 40 years). Concomitant products included CARBAMAZEPINE (TEGRETOL) and PHENOBARBITAL for an unknown indication.    On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced BLINDNESS TRANSIENT (She woke up and couldn't see, everything was completely black, She didn't know what's wrong or what to. Vision came back after 5-10 minutes) (seriousness criterion medically significant), GAIT INABILITY (Could not walk by herself without help), ASTHENIA (No energy), FEELING ABNORMAL (Didn't feel good), VISUAL IMPAIRMENT (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), HYPOACUSIS (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), LEARNING DISORDER (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), READING DISORDER (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), IMPAIRED DRIVING ABILITY (unable to drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to shower by herself) and NAUSEA (Nausea). In 2021, the patient experienced SENSITIVE SKIN (Skin sensitivity). In June 2021, the patient experienced BLINDNESS TRANSIENT (She woke up and couldn't see, everything was completely black, She didn't know what's wrong or what to. Vision came back after 5-10 minutes) (seriousness criterion medically significant), GAIT INABILITY (Could not walk by herself without help), ASTHENIA (No energy), FEELING ABNORMAL (Didn't feel good), VISUAL IMPAIRMENT (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), HYPOACUSIS (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), LEARNING DISORDER (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), READING DISORDER (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), IMPAIRED DRIVING ABILITY (unable to drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to shower by herself) and NAUSEA (Nausea). On an unknown date, the patient experienced VESTIBULAR NEURONITIS (Vestibular neuritis) (seriousness criterion medically significant). The patient was treated with Physical therapy (for 3 months) for Gait inability; Physical therapy (for 3 months) for Visual impairment; Physical therapy (for 3 months) for Hypoacusis; Physical therapy (for 3 months) for Learning disorder and Physical therapy (for 3 months) for Reading disorder. In June 2021, BLINDNESS TRANSIENT (She woke up and couldn't see, everything was completely black, She didn't know what's wrong or what to. Vision came back after 5-10 minutes) had resolved. At the time of the report, VESTIBULAR NEURONITIS (Vestibular neuritis), GAIT INABILITY (Could not walk by herself without help), ASTHENIA (No energy), FEELING ABNORMAL (Didn't feel good), VISUAL IMPAIRMENT (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), HYPOACUSIS (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), LEARNING DISORDER (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), READING DISORDER (The side effects have affected her vision and hearing, work recognition, spelling skill, and reading skill), SENSITIVE SKIN (Skin sensitivity), IMPAIRED DRIVING ABILITY (unable to drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to shower by herself) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient was also taking thyroid pill and high cholesterol medications Patient  was  on a walker and doing physical therapy for 3 months. Patient did not take any medication as treatment. Patient had epilepsy when was young child.  She was unable to go up and down the stairs. Patient had no energy to make coffee or do anything else. . Patient did not take any medication as treatment. Patient had been doing physical therapy for 3 months and the side effects are still ongoing.   This case was linked to MOD-2021-410011 (Patient Link).; Sender's Comments: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected events of Blindness Transient and Vestibular Neuronitis. The events occurred approximately 2 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. This patient's medical condition remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.