Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Cardiac failure, Catheterisation cardiac, Catheterisation cardiac abnormal
Clinical narrative: CORONARY ARTERY BYPASS; CONDITION AGGRAVATED; CORONARY ARTERY DISEASE; CORONARY ARTERY BYPASS; DYSPNOEA; HAEMODIALYSIS; INTENSIVE CARE; INTENSIVE CARE; CATHETERISATION CARDIAC ABNORMAL; CATHETERISATION CARDIAC ABNORMAL; ISCHAEMIC CARDIOMYOPATHY; EJECTION FRACTION DECREASED; HAEMODIALYSIS; SARS-COV-2 TEST POSITIVE; ACUTE KIDNEY INJURY; CARDIAC FAILURE; DIABETES MELLITUS INADEQUATE CONTROL; DIABETES MELLITUS INADEQUATE CONTROL; CORONARY ARTERY DISEASE; ISCHAEMIC CARDIOMYOPATHY; EJECTION FRACTION DECREASED; COVID-19; CARDIAC FAILURE; CHEST PAIN; COVID-19; CONDITION AGGRAVATED; CHEST PAIN; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 2517993) concerned a 62 year old female of an unspecified race and ethnic origin. Initial information was processed along with additional information on 13-DEC-2022. The patient's height, and weight were not reported. The patient's past medical history included: constipation, backache (uncontrolled Low back pain), history of mammogram pap smear for cervical cancer, and screening history of bone density study diabetic nephropathy, and concurrent conditions included: acute kidney injury (AKI) (Hospital), hepatocellular carcinoma (HCC), non-hospital hypothyroidism, type I diabetes mellitus with neurological manifestations, hyperlipidemia mixed (272.2), tobacco use disorder (305.1), depressive disorder (311.) Depression, major, single episode, moderate), restless leg syndrome, diabetic polyneuropathy, diabetes mellitus with background retinopathy, essential hypertension, asthma, gastrooesophageal reflux disease (GERD) (530.11), vitiligo, urinary incontinence, proteinuria (791.0), cervical cancer, right carpal tunnel syndrome, trigger finger, obesity (Body mass index 30-39.9), diabetes type 1, hypercholesterolemia (hypercholesterolemia with LDL (low density lipoprotein) greater than 190 mg/dL), chronic kidney disease, stage iv (severe), hyperparathyroidism, covid-19 virus infection, acute systolic congestive heart failure, acute respiratory failure with hypoxia, coronary artery disease (Coronary artery disease involving native coronary artery of native heart), myocardial infarction (MI), cardiorenal syndrome, ischemic cardiomyopathy, and drug allergy (Codeine, Morphine, Tuberculin, PPD (Purified protein derivative)). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, 1 total administered on 22-DEC-2021 for an unspecified indication. Age at time of vaccination 62 years old. No concomitant medications were reported.  On 25-OCT-2022, Patient was admitted to hospital with Covid detected with PCR (polymerase chain reaction) test and with shortness of breath and chest pain. Patient experienced acute kidney injury, cardiac failure and condition aggravated. The patient was found to have severe CAD (Coronary Artery Disease), decompensated severe ischemic cardiomyopathy and acute on chronic renal failure. Cardiac catheterization revealed 3 vessel CAD with EF (Ejection fraction) of 25%. Laboratory data included: Catheterisation cardiac Abnormal (3 vessel CAD with EF of 25), Ejection fraction (NR: not provided) 25 % (Decreased), and SARS-CoV-2 test Positive. She was recommended for CABG (coronary artery bypass graft). After a period of optimal medical management including initiation of hemodialysis the patient was brought to the operating room and underwent CABG x 4 on 14-NOV-2022. She tolerated the surgery well. The patient was monitored in the ICU (Intensive care unit) and PCU (progressive care unit) setting. She continued to undergo hemodialysis. The patient worked with therapy on a daily basis. On an unspecified date, she was discharged home with HHC (sic) and therapies in stable condition on postoperative day 12. The patient had difficult to control DM (diabetes mellitus) type I and had adjustments to her insulin regimen throughout the hospital course (diabetes mellitus inadequate control). She will follow up with endocrinology as an outpatient. Patient was hospitalized for 31 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute kidney injury, cardiac failure, diabetes mellitus inadequate control, ischaemic cardiomyopathy, covid-19, chest pain, condition aggravated, coronary artery bypass, coronary artery disease, dyspnoea, haemodialysis, intensive care, catheterisation cardiac abnormal, ejection fraction decreased, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint 90000262958. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 12-JAN-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up adds information about Product quality complaint investigation result. This does not alter the previous causality assessment of the reported events.  20221224530- Acute kidney injury, Cardiac failure, Diabetes mellitus inadequate control, Ischaemic cardiomyopathy, Chest pain, Condition aggravated, Coronary artery bypass, Coronary artery disease, Dyspnoea, Haemodialysis, Intensive care, Catheterisation cardiac abnormal, Ejection fraction decreased. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.   20221224530- Sars Cov 2 test positive, Covid 19- The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine