Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electroencephalogram, Malaise, Road traffic accident, Seizure
Clinical narrative: diagnosed with ventricular tachycardia, "life or death diagnosis",Rushed to emergency room by ambulance 11Sep2021; Was unresponsive for 45 seconds; did not feel well; seizure/ Neurologist did EEG test and noted abnormal seizure activity 10Sep2021; her son fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car; fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure/ Neurologist did EEG test and noted abnormal seizure activity 10Sep2021), VENTRICULAR TACHYCARDIA (diagnosed with ventricular tachycardia, "life or death diagnosis",Rushed to emergency room by ambulance 11Sep2021), SOMNOLENCE (fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car), ROAD TRAFFIC ACCIDENT (her son fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car) and SYNCOPE (Was unresponsive for 45 seconds) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced SOMNOLENCE (fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car) (seriousness criterion medically significant). On 16-Jun-2021 at 1:30 AM, the patient experienced ROAD TRAFFIC ACCIDENT (her son fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car) (seriousness criterion medically significant). On 10-Sep-2021, the patient experienced SEIZURE (seizure/ Neurologist did EEG test and noted abnormal seizure activity 10Sep2021) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced VENTRICULAR TACHYCARDIA (diagnosed with ventricular tachycardia, "life or death diagnosis",Rushed to emergency room by ambulance 11Sep2021) (seriousness criterion medically significant), SYNCOPE (Was unresponsive for 45 seconds) (seriousness criterion medically significant) and MALAISE (did not feel well). The patient was treated with METOPROLOL for Seizure, at an unspecified dose and frequency. At the time of the report, SEIZURE (seizure/ Neurologist did EEG test and noted abnormal seizure activity 10Sep2021), VENTRICULAR TACHYCARDIA (diagnosed with ventricular tachycardia, "life or death diagnosis",Rushed to emergency room by ambulance 11Sep2021), SOMNOLENCE (fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car), ROAD TRAFFIC ACCIDENT (her son fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car), SYNCOPE (Was unresponsive for 45 seconds) and MALAISE (did not feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Electroencephalogram: abnormal (abnormal) abnormal seizure activity. On 11-Sep-2021, Electrocardiogram: abnormal (abnormal) ventricular tachycardia was detected.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VENTRICULAR TACHYCARDIA (diagnosed with ventricular tachycardia, "life or death diagnosis",Rushed to emergency room by ambulance 11Sep2021) to be related. No further causality assessments were provided for SEIZURE (seizure/ Neurologist did EEG test and noted abnormal seizure activity 10Sep2021), SOMNOLENCE (fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car), ROAD TRAFFIC ACCIDENT (her son fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car), SYNCOPE (Was unresponsive for 45 seconds) and MALAISE (did not feel well).    Concomitant medications was not reported. States her son was diagnosed with a heart condition. after receiving 2nd dose was was healthy prior to the vaccine.  Caller states on 16Jun2021 her son fell asleep behind wheel at 1:30AM driving to work and crashed and totaled his car. Doctors thought it was a seizure and her son thought he passed out. Neurologist did EEG test and noted abnormal seizure activity 10Sep2021. On 11Sep2021 caller states her son did not feel well and went to a walk in urgent care pediatric facility to get CVID-19 tested. States her son passed out at the urgent care facility before the staff. Was unresponsive for 45 seconds. On EKG, ventricular tachycardia was detected.  This case concerns a 23-year-old male patient with no medical history, who experienced the serious unexpected events of Somnolence, Seizure, and adverse event of special interest Ventricular Tachycardia. The event of Somnolence, which was medically significant, occurred approximately 3 months after receiving the third dose of mRNA-1273 Vaccine, while the events of Seizure and Ventricular Tachycardia occurred approximately 6 months after. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 23-year-old male patient with no medical history, who experienced the serious unexpected events of Somnolence, Seizure, and adverse event of special interest Ventricular Tachycardia. The event of Somnolence, which was medically significant, occurred approximately 3 months after receiving the third dose of mRNA-1273 Vaccine, while the events of Seizure and Ventricular Tachycardia occurred approximately 6 months after. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.