Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cardiac arrest, Feeling abnormal, Loss of personal independence in daily activities, Vomiting
Clinical narrative: heart stopped; throwing up; felt funny; Couldn't do anything; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (heart stopped) and VOMITING (throwing up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 039A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    Concurrent medical conditions included AFib (Patient had a history of Afib), Cardiomegaly (an enlarged heart), Critical illness (she was critically ill) and Stubbornness (a stubborn "X" who would not get help).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient received dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced VOMITING (throwing up) (seriousness criterion medically significant), FEELING ABNORMAL (felt funny) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't do anything). On 05-Dec-2021, the patient experienced CARDIAC ARREST (heart stopped) (seriousness criteria death and medically significant). On 05-Dec-2021, VOMITING (throwing up), FEELING ABNORMAL (felt funny) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't do anything) outcome was unknown. The patient died on 05-Dec-2021. The reported cause of death was heart stopped. It is unknown if an autopsy was performed.            No concomitant medication details was reported.  No treatment medication details was reported.  Patient was found in her chair getting dressed, as she was trying to seek medical attention. Her son was called as he lives out of state, and she was taken to the hospital. Patient son said Moderna vaccine killed his mom. Her son had spoke to her 2-3 times between receiving the booster dose of the vaccine and her death. Her death was listed as natural causes on her death certificate.  Company Comment: This fatal case concerns a 72-year-old female patient with a history of atrial fibrillation, cardiomegaly and critically ill, with concurrent flu vaccination (on the same day as booster), who experienced the unexpected non- serious event of feeling abnormal and Loss of personal independence in daily activities, with unexpected serious event of vomiting (she vomited for 3 days), approximately on the same day after the booster dose of mRNA-1273 vaccine. Three days after vaccination, she experienced a fatal cardiac arrest. Her death was listed as "natural causes" on her death certificate, autopsy was not provided. The mentioned medical history and concurrent flu vaccination remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal case concerns a 72-year-old female patient with a history of atrial fibrillation, cardiomegaly and critically ill, with concurrent flu vaccination (on the same day as booster), who experienced the unexpected non- serious event of feeling abnormal and Loss of personal independence in daily activities, with unexpected serious event of vomiting (she vomited for 3 days), approximately on the same day after the booster dose of mRNA-1273 vaccine. Three days after vaccination, she experienced a fatal cardiac arrest. Her death was listed as "natural causes" on her death certificate, autopsy was not provided. The mentioned medical history and concurrent flu vaccination remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: heart stopped