Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Intentional dose omission, Loss of consciousness, Loss of personal independence in daily activities, Urinary incontinence
Clinical narrative: cannot control bladder; Could not move her feet to get over to the counter, and someone put her into bed; Lost all capabilities/She could not unlock her telephone/She says she is not enjoying this part of her life; It felt like spiders crawling down the side of head/it felt like spiders crawling down the side of ears/Her body got messed up/Could not get brain to work right; Has been having problems getting oxygen into her lungs; felt dizzy; Memory loss; She can't taste food anymore, she forces herself to eat; felt like spiders crawling down the side of head and ears; Now that so many months have gone by, can I get; Collapsed; Everything went dark; Stroke; Unconscious for a day and half; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), CIRCULATORY COLLAPSE (Collapsed), BLINDNESS TRANSIENT (Everything went dark) and LOSS OF CONSCIOUSNESS (Unconscious for a day and half) in a 62-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 Accident (Had an accident 20 years ago) and Alopecia. Previously administered products included for Product used for unknown indication: Prednisone. Past adverse reactions to the above products included Weight gain with Prednisone. Concurrent medical conditions included Disability (Disabled due to accident), Spinal cord disorder NOS, Neuropathy (Hurts while standing up), Hives (Hives that turn into blister in back and shoulders, for 5 years), Drug allergy and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, TRAZODONE, PREGABALIN, GABAPENTIN, PREDNISONE and METHADONE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Collapsed) (seriousness criterion medically significant), BLINDNESS TRANSIENT (Everything went dark) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Unconscious for a day and half) (seriousness criterion medically significant), URINARY INCONTINENCE (cannot control bladder), GAIT DISTURBANCE (Could not move her feet to get over to the counter, and someone put her into bed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lost all capabilities/She could not unlock her telephone/She says she is not enjoying this part of her life), FEELING ABNORMAL (It felt like spiders crawling down the side of head/it felt like spiders crawling down the side of ears/Her body got messed up/Could not get brain to work right), DYSPNOEA (Has been having problems getting oxygen into her lungs), DIZZINESS (felt dizzy), AMNESIA (Memory loss), AGEUSIA (She can't taste food anymore, she forces herself to eat), FORMICATION (felt like spiders crawling down the side of head and ears) and INTENTIONAL DOSE OMISSION (Now that so many months have gone by, can I get). The patient was treated with OXYBUTYNIN at a dose of 15 mg. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CIRCULATORY COLLAPSE (Collapsed), BLINDNESS TRANSIENT (Everything went dark), URINARY INCONTINENCE (cannot control bladder), GAIT DISTURBANCE (Could not move her feet to get over to the counter, and someone put her into bed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lost all capabilities/She could not unlock her telephone/She says she is not enjoying this part of her life), FEELING ABNORMAL (It felt like spiders crawling down the side of head/it felt like spiders crawling down the side of ears/Her body got messed up/Could not get brain to work right), DYSPNOEA (Has been having problems getting oxygen into her lungs), DIZZINESS (felt dizzy), AMNESIA (Memory loss) and AGEUSIA (She can't taste food anymore, she forces herself to eat) outcome was unknown, LOSS OF CONSCIOUSNESS (Unconscious for a day and half) and INTENTIONAL DOSE OMISSION (Now that so many months have gone by, can I get) had resolved and FORMICATION (felt like spiders crawling down the side of head and ears) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On an unknown date, diagnostic test included Brain bleed and heart monitor. Concomitant medication included Laslunomamide 20 mg.  Company Comment: This  is a spontaneous case  that concerns a 62-year-old, female patient with concurrent medical conditions of accident (20 years ago), disability, Spinal cord disorder, weight gain, Neuropathy peripheral, urticaria, Drug hypersensitivity, Alopecia, Anxiety and polypharmacy including methadone, who experienced the serious (medically significant), unexpected events of Cerebrovascular accident (AESI), Circulatory collapse, Blindness transient, Loss of consciousness, and the unexpected non serious AESI event of Ageusia along other non serious events. The event of stroke started two days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The onset dates of the rest of the events were not provided. The rechallenge was not applicable since the patient reported an Intentional dose omission. The Medical conditions of anxiety, previous disability, Spinal cord disorder and Neuropathy peripheral could be a potential confounder for the events Cerebrovascular accident, Circulatory collapse, Blindness transient, Loss of consciousness. The concomitant medication methadone, trazodone, alprazolam, gabapentin and pregabalin, specially ate the dosage reported by the patient, are co suspects for several events. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This  is a spontaneous case  that concerns a 62-year-old, female patient with concurrent medical conditions of accident (20 years ago), disability, Spinal cord disorder, weight gain, Neuropathy peripheral, urticaria, Drug hypersensitivity, Alopecia, Anxiety and polypharmacy including methadone, who experienced the serious (medically significant), unexpected events of Cerebrovascular accident (AESI), Circulatory collapse, Blindness transient, Loss of consciousness, and the unexpected non serious AESI event of Ageusia along other non serious events. The event of stroke started two days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The onset dates of the rest of the events were not provided. The rechallenge was not applicable since the patient reported an Intentional dose omission. The Medical conditions of anxiety, previous disability, Spinal cord disorder and Neuropathy peripheral could be a potential confounder for the events Cerebrovascular accident, Circulatory collapse, Blindness transient, Loss of consciousness. The concomitant medication methadone, trazodone, alprazolam, gabapentin and pregabalin, specially ate the dosage reported by the patient, are co suspects for several events. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.