Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac death, Contusion, Electrocardiogram
Clinical narrative: Patient was flying back home, while in mid-air, experienced cardiac death. She was told by the airline that she had a cardiac death experience in flight.; She had bruising from CPR; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DEATH (Patient was flying back home, while in mid-air, experienced cardiac death. She was told by the airline that she had a cardiac death experience in flight.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 036C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (She had bruising from CPR). At the time of the report, CARDIAC DEATH (Patient was flying back home, while in mid-air, experienced cardiac death. She was told by the airline that she had a cardiac death experience in flight.) and CONTUSION (She had bruising from CPR) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient does not have a medical history of any heart problems. No concomitant medication was reported.  Patient was told by the airline that she had a cardiac death experience in flight. They shocked her with AED and had an emergency landing. She ended up in CCU. Patient stated that she never had COVID Disease and she was totally healthy and she is still healthy. They did all types of genetic testing and EKG had nothing out of normal. No treatment information was reported. Company comment: This spontaneous case concerns a 60-year-old female with no reported medical history who experienced the unexpected, serious (hospitalization, life threatening and medically significant) event of cardiac death which occurred approximately 13 months after receiving a dose of mRNA-1273 as a 2nd dose in the COVID-19 vaccine series; 1st dose of mRNA-1273 was administered 28 days prior to current vaccination. The event was accompanied by non-serious event of contusion (reported as bruising after CPR). It was reported that the patient was informed by the airline that she had a cardiac death experience in flight. They shocked her with AED and had an emergency landing which was followed by hospitalization in CCU. Patient stated that she never had COVID disease and was totally healthy and is still healthy. Diagnostic work up included genetic testing and EKG which did not reveal any abnormalities. Flight itself can be considered as risk factor for the event however further details on the potential alternative causalities and additional risk factors, etiologic and diagnostic work up results with inclusion of laboratory testing and heart imaging tests, any concomitant medications and concurrent diseases, treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment.