Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Migraine, Ventricular fibrillation, Visual impairment
Clinical narrative: The death certificate is noted as Acute MI; Asystole was noted; Ventricular fibrillation arrest; an episode of visual disturbances; worked up for ophthalmic versus migraine diagnoses; slight confusion and some chest tightness; slight confusion and some chest tightness; This spontaneous case was reported by a pharmacist and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (The death certificate is noted as Acute MI), CARDIAC ARREST (Asystole was noted), VENTRICULAR FIBRILLATION (Ventricular fibrillation arrest), VISUAL IMPAIRMENT (an episode of visual disturbances) and MIGRAINE (worked up for ophthalmic versus migraine diagnoses) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hyperlipidaemia.    On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (The death certificate is noted as Acute MI) (seriousness criteria death, hospitalization and medically significant), CARDIAC ARREST (Asystole was noted) (seriousness criteria death, hospitalization and medically significant), VENTRICULAR FIBRILLATION (Ventricular fibrillation arrest) (seriousness criteria death, hospitalization and medically significant), VISUAL IMPAIRMENT (an episode of visual disturbances) (seriousness criterion hospitalization), MIGRAINE (worked up for ophthalmic versus migraine diagnoses) (seriousness criterion hospitalization), CONFUSIONAL STATE (slight confusion and some chest tightness) and CHEST DISCOMFORT (slight confusion and some chest tightness). The patient died on an unknown date. The reported cause of death was the death certificate is noted as acute mi. An autopsy was not performed. At the time of death, VISUAL IMPAIRMENT (an episode of visual disturbances) and MIGRAINE (worked up for ophthalmic versus migraine diagnoses) outcome was unknown and CONFUSIONAL STATE (slight confusion and some chest tightness) and CHEST DISCOMFORT (slight confusion and some chest tightness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Catheterisation cardiac: Some minor abnormalities. On an unknown date, Electrocardiogram: did not show any major concerns. and Elevated.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered ACUTE MYOCARDIAL INFARCTION (The death certificate is noted as Acute MI), CARDIAC ARREST (Asystole was noted), VENTRICULAR FIBRILLATION (Ventricular fibrillation arrest), VISUAL IMPAIRMENT (an episode of visual disturbances), MIGRAINE (worked up for ophthalmic versus migraine diagnoses), CONFUSIONAL STATE (slight confusion and some chest tightness) and CHEST DISCOMFORT (slight confusion and some chest tightness) to be related.    No concomitant and treatment medication were reported. It was reported that several days after receiving the vaccine, patient experienced an episode of visual disturbances, slight confusion and some chest tightness which resolved in 10-15 minutes. She had episodes of visual disturbances recently and was being worked up for ophthalmic versus migraine diagnoses. Following this episode, she presented to the emergency department at an outside hospital. They did a stroke workup which was negative. It was noted that her troponins were elevated and was admitted for further workup. Cardiology consult noted that the husband was concerned about COVID vaccine related myocarditis. Electrocardiogram and echocardiogram did not show any major concerns. She was transferred to another hospital for a cardiac catheterization which showed some minor abnormalities and was referred for outpatient follow up for a cardiac MRI. During transport following this procedure she was decompensated and was found to be in Ventricular fibrillation arrest. She received several doses of EPI, shocks, and CPR. Bright red blood was noted from the respiratory intubation tube. Asystole was noted. No autopsy was performed. The death certificate was noted as acute myocardial infarction. The patient's husband was concerned about the COVID vaccine as a cause of her symptoms and subsequent death.     Company Comment: This spontaneous case concerns a female patient of an unknown age with medical history of Hypertension and Hyperlipidaemia, who experienced the unexpected, serious (medically significant, hospitalization and fatal), events of acute myocardial infarction (AESI), ventricular fibrillation (AESI) and cardiac arrest; unexpected, serious (hospitalization), events of migraine and visual impairment, that occurred several days (latency not specified) after the first dose of SPIKEVAX NOS (SPIKEVAX NOS). It was reported that several days after receiving the vaccine, she experienced an episode of visual disturbances, slight confusion and some chest tightness which resolved in 10-15 minutes. She had episodes of visual disturbances recently and was being worked up for ophthalmic versus migraine diagnoses. Following this episode, she presented to the emergency department at an outside hospital. They did a stroke workup which was negative. It was noted that her troponins were elevated and was admitted for further workup. Cardiology consult noted that the husband was concerned about COVID vaccine related myocarditis. Electrocardiogram and echocardiogram didn't show any major concerns. She was transferred to another hospital for a cardiac catheterization which showed some minor abnormalities and was referred for outpatient follow up for a cardiac MRI. During transport following this procedure she was decompensated and was found to be in Ventricular fibrillation arrest. She received several doses of EPI, shocks, and CPR. Bright red blood was noted from the respiratory intubation tube. Asystole was noted. No autopsy was performed. The death certificate was noted as acute MI. No further clinical information was provided for review. The patient's medical history of Hypertension and Hyperlipidaemia could be a confounder for acute myocardial infarction. Acute myocardial infarction could be a contributory factor for ventricular fibrillation and this could lead to cardiac arrest. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.; Reported Cause(s) of Death: The death certificate is noted as Acute MI