Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Mechanical ventilation, Thrombosis, Ventricular fibrillation
Clinical narrative: CORONARY ARTERY THROMBOSIS; THROMBOSIS; PLATELET COUNT DECREASED; ANGINA PECTORIS; ARTERIOGRAM CORONARY ABNORMAL; ATRIAL FIBRILLATION; CARDIAC ARREST; CARDIOVERSION; CATHETERISATION CARDIAC ABNORMAL; CONDITION AGGRAVATED; Coronary angioplasty; CORONARY ARTERY OCCLUSION; ELECTROCARDIOGRAM ST SEGMENT ELEVATION; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; RESUSCITATION; THROMBECTOMY; VENTRICULAR ASSIST DEVICE INSERTION; VENTRICULAR FIBRILLATION; ACUTE MYOCARDIAL INFARCTION; CARDIOGENIC SHOCK; MECHANICAL VENTILATION; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID1229547, 1263503) concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included CAD (Coronary artery disease), cardiomyopathy, LifeVest , AFIB (atrial fibrillation), and HTN (hypertension), and concurrent conditions included non-ST-segment elevation myocardial infarction (NSTEMI), DM (diabetes mellitus), and stage III CKD. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 to left arm for drug used for unknown indication. No concomitant medications were reported.  On 15-APR-2021, 10 days after receiving the vaccine, the patient went to the emergency department with complaints of anginal symptoms found to be in rapid atrial fibrillation. An EKG showed ST elevation in later precordial leads (acute myocardial infarction) and the patient went for an emergent left heart catheterization. During the catherization he went ventricular fibrillation (V-fib) and Lung Specialist stated he was arrest sedated/intubated and placed on mechanical ventilation due to clinical condition requiring defibrillation twice. The patient was in cardiogenic shock. In addition to the cardiopulmonary resuscitation (CPR) in the catheter laboratory, the angiogram was abnormal and showed acute thrombotic occlusions of left main artery (LM), left anterior descending (LAD) and ramus intermedius (RI), thrombosis. The patient underwent mechanical thrombectomy of LM and LAD with balloon angiogram of RI (recent cardiac catheterization in March 2020 showed clearly patent stents). Placed on Impella bypass and intubated. The patient was hospitalizes for 12 days in the cardiovascular intensive care unit.  Platelet count (NR: not provided) 272 (units unspecified). On 19-APR-2021 platelet count was 76 (units unspecified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from angina pectoris, arteriogram coronary abnormal, atrial fibrillation, cardiac arrest, cardioversion, catheterization cardiac abnormal, condition aggravated, coronary angioplasty, coronary artery occlusion, coronary artery thrombosis, electrocardiogram st segment elevation, endotracheal intubation, intensive care, platelet count decreased, resuscitation, thrombectomy, ventricular assist device insertion, ventricular fibrillation, acute myocardial infarction, thrombosis, cardiogenic shock and mechanical ventilation. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This case is a duplicate of 20210515208.  Additional information was received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID 1229547, 1263503) on 13-OCT-2021. It was determined that [20210515208] was a duplicate of this case. All relevant information regarding this case will be submitted under [20210502221] The following information was updated and incorporated into the case narrative: (Hospitalization date and no of days hospitalized, Event - Acute myocardial infarction, Thrombosis, Cardiogenic shock, Mechanical ventilation, Batch number of added).; Sender's Comments: V1:Follow up information updates: No. of days hospitalized and hospitalization date, new events, batch number. This case obtained via VAERS (ID 1229547, 1263503) concerns a 68-year-old male of unknown race/ethnicity who was hospitalized for life-threatening acute thrombotic occlusions of the coronary arteries 10 days after receiving Janssen Covid-19 vaccine. Medical history is significant for coronary artery disease (CAD) with cardiomyopathy (CM), use of a LifeVest (wearable defibrillator), atrial fibrillation (AF), hypertension (HTN), diabetes (DM), stage III chronic kidney disease (CKD); cardiac catheterization 13 months prior (after non-ST elevation myocardial infarction) had shown patent coronary stents. Ten days post-vaccination, the patient presented to the emergency department (ED) with complaints of anginal symptoms and was found to be in rapid AF. EKG showed ST elevation in the precordial leads (Acute myocardial infarction). While in the cardiac catheterization lab, ventricular fibrillation with cardiac arrest requiring CPR and defibrillation twice occurred. He was in cardiogenic shock. Angiography showed acute thrombotic occlusions of the left main (LM), left anterior descending (LAD), and ramus intermedius (RI) coronary arteries; mechanical thrombectomy of LM & LAD with balloon angio of RI was performed. He was placed on Impella bypass. Platelet count on the day of admission was 272 and was 76 four days later. Corrective medicinal treatments, such as anticoagulation, was not reported. As of the time of the report, he was in the ICU and intubated with Impella. The patient's underlying CAD, CM, DM, HTN, CKD, & AF likely increased the risk for the events to occur. Of note, platelet count was normal at the time of presentation. However, considering the temporal relationship with vaccination (Brighton Collaboration Criteria level 1), a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.