Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: he was asystolic upon arrival of the ambulance; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC ARREST (he was asystolic upon arrival of the ambulance) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     Patient was good about getting his testing done. Pretty active, had no other major surgeries with no known allergies.  The patient's past medical history included COVID-19 (went on a cruise at the end of August-2022 and came one and were sick with Covid-19.) in August 2022 and Quadruple vessel bypass graft in 2015. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose with lot 011L20A) on 18-Jan-2021, Moderna COVID-19 Vaccine (2nd dose with lot 012M20A) on 20-Feb-2021, Moderna COVID-19 Vaccine (1st booster with lot 025D21A) on 26-Oct-2021 and Moderna COVID-19 Vaccine (2nd booster with lot 045L21A) on 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Coronary artery disease, Blood pressure high, High cholesterol (not 100 percent) and Type II diabetes mellitus.    On 22-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CARDIAC ARREST (he was asystolic upon arrival of the ambulance) (seriousness criteria death and medically significant). The patient was treated with EPINEPHRINE on 22-Nov-2022 for Asystolic, at an unspecified dose and frequency. The patient died on 22-Nov-2022. The reported cause of death was he was asystolic upon arrival of the ambulance. An autopsy was not performed.            No concomitant product use was reported.  The patient had not received any other vaccines in the 4 weeks prior to his Covid-19 vaccine booster dose.  Patient received Moderna doses included - 1st dose on 18-Jan-2021 Lot#011L20A, 2nd dose on 20-Feb-2021 Lot#012M20A, 1st booster on 26-Oct-2021 Lot#025D21A,2nd booster on 27-Apr-2022 Lot#045L21A and 3rd booster on 22-Nov-2022 Lot#014H22A.  Reporter stated that patient passed away the same day patient received the Moderna Covid19 Bivalent booster. Reporter was not saying it was definitely because of the booster but wanted to make sure they reported it to Moderna. Reporter said patient was already cremated so there was not any autopsy done. Reporter was also assuming it was an adverse event or related to one of the health issues. Within 12 hours of the patient getting the vaccine, patient was asystolic upon arrival of the ambulance. The ambulance gave epinephrine, CPR and was pronounce at home. The patient did not suffer.  Company comment: This spontaneous case concerns an elderly 79-year-old male patient with relevant medical history of Coronary artery disease, Blood pressure high, High cholesterol and Type II diabetes mellitus, who experienced the unexpected serious (fatal and medical significant) event of Cardiac arrest which occurred on the same day after administration of fifth dose of mRNA-1273.222 bivalent vaccine. Patient died on the same day. An autopsy was not performed. Medical history of Coronary artery disease, Blood pressure high, High cholesterol and Type II diabetes mellitus remains confounding for the event and the fatal outcome. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2022: Live follow up received. Updated narrative.; Sender's Comments: This spontaneous case concerns an elderly 79-year-old male patient with relevant medical history of Coronary artery disease, Blood pressure high, High cholesterol and Type II diabetes mellitus, who experienced the unexpected serious (fatal and medical significant) event of Cardiac arrest which occurred on the same day after administration of fifth dose of mRNA-1273.222 bivalent vaccine. Patient died on the same day. An autopsy was not performed. Medical history of Coronary artery disease, Blood pressure high, High cholesterol and Type II diabetes mellitus remains confounding for the event and the fatal outcome. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report; Reported Cause(s) of Death: he was asystolic upon arrival of the ambulance