Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Endotracheal intubation, Exposure to SARS-CoV-2, Extubation, Hypercapnia
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; TROPONIN INCREASED; BLOOD GASES; BRAIN NATRIURETIC PEPTIDE INCREASED; CHEST X-RAY ABNORMAL; ECHOCARDIOGRAM ABNORMAL; EJECTION FRACTION DECREASED; ELECTROCARDIOGRAM ABNORMAL; ENDOTRACHEAL INTUBATION; ACUTE MYOCARDIAL INFARCTION; COVID-19 PNEUMONIA; CARDIOMYOPATHY; RESPIRATORY FAILURE; RESPIRATORY TRACT HAEMORRHAGE; EXPOSURE TO SARS-COV-2; RESPIRATORY TRACT INFLAMMATION; LUNG DISORDER; DYSPNOEA; HYPERCAPNIA; HYPOKINESIA; EXTUBATION; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1847178) concerned a 73-year-old female, unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: In 2008 or 2009 the patient underwent cardiac pacemaker placement and cataract extraction with intraocular lens implant bilateral. The patient underwent bilateral cataract surgery, partial hip arthroplasty, right ventricular cardiac pacemaker insertion. The patient had hypertensive disease on 09-FEB-2011. The patient had arteriosclerotic heart disease on 07-APR-2011. The patient experienced slurred speech with ischemic stroke on 07-APR-2011. The patient underwent treatment of coronary artery disease with Percutaneous coronary intervention(PCI) in 2011 with drug-eluting stent (DES) to left anterior descending artery (LAD) and D1. The patient had chronic renal impairment from 20- JUN-2011. In 2012 the patient had rethrombosis in stent which required repeat PCI and DES to LAD and D1 and was treated with (clopidogrel bisulfate), Coumadin (warfarin sodium), and Aspirin (acetylsalicylic acid). On 06-SEP-2012, the patient had congestive heart failure. On 09-FEB-2016, the patient had complex social issues. On 09-FEB-2016, it was reported that the patient had a personal history of noncompliance with medical treatment presenting hazards to health. The patient had dry eyes, had essential hypertension benign, on 09-FEB-2016, the patient developed with diabetes mellitus type 2. The patient had vertigo on 25-FEB-2016. On 28-AUG-2016, the patient had dizziness. The patient experienced urinary incontinence on 20-OCT-2016. On 22-DEC-2016, the patient had a cerebrovascular accident. The patient had a history of cerebrovascular accident (CVA) on 25-DEC-2016. On 04-JAN-2017, the patient had coronary artery disease counseling and coordination of care. The patient was advised for follow up on 05-JAN-2017. The patient also underwent proliferative diabetic retinopathy with macular edema associated with diabetes mellitus due to underlying condition on 17-JAN-2017. The patient had central scotoma on 17-JAN-2017. The patient had a cerebrovascular accident due to occlusion of left cerebellar artery on 20-JAN-2017. The patient had pain in joint of right shoulder on 20-JAN-2017. The patient had menopause. The patient experienced neuropathy on 09-FEB-2017, The patient had cerebral artery occlusion with cerebral infarction on 22-FEB-2017. On 04-MAR-2017, The patient underwent Chest X-ray in which pulmonary infiltrate were found, and Globulin were found to be elevated. The patient had fall on 04-MAR-2017. The patient experienced irritation of both eyes on 08-MAR-2017 and neuropathy feet on 21-MAR-2017. The patient had pain of right hand on 05-MARCH-2017 and had the urinary tract infection on 05-FEB-2017. The patient had a balance problem on 12-APR-2017. The patient also had carotid artery calcification on 21-MAR-2017. The patient had hematoma (traumatic SDH) on 03-AUG-2017. On 07-AUG-2017 the patient experienced gastroesophageal reflux disease without esophagitis. The patient also experienced weakness of both hips and abdominal cramping on 14-AUG-2017. The patient had anemia on 07-AUG-2017. On 08-FEB-2018, the patient had community acquired pneumonia of right lower lobe of lung. On 16-FEB-2018 the patient had hypokalemia. The carpal tunnel syndrome of left wrist on 16-FEB-2018. On 21-AUG-2018 the patient had incontinence of faeces. On 15-NOV-2019, the patient underwent right capsulotomy. On 03-JAN-2021, the patient had a hypertensive urgency. On 09-FEB-2021, the patient had frequent medical issues due to which she frequently visited the emergency department (ED). The patient had Hyperlipidemia. The patient also had penicillin allergy and allergy to Lisinopril.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: unknown) dose was not reported, 1 total, administered at left arm on 11-MAR-2021 for product use for unknown indication (dose number series 1).  On 30-AUG-2021, the patient underwent colonoscopy. The patient also underwent coronary stent placement, and esophagogastroduodenoscopy on 02-SEP-2021. Concomitant medications included atorvastatin, ISDN (isosorbide dinitrate), Aspirin (acetylsalicylic acid), Vitamin C (ascorbic acid), bisacodyl, Coreg (carvedilol), docusate, Cymbalta (duloxetine hydrochloride), Calcium or Vitamin D (ergocalciferol), hydralazine, insulin nph (isophane bovine), iron, losartan, Miralax (macrogol 3350), mirtazapine, nifedipine, omeprazole, Trileptal (oxcarbazepine) for seizures, and senna alexandrina.  On 09-OCT-2021, the patient had dyspnoea (acute shortness of breath (SOB)) and known exposure to sars-cov-2 (Severe acute respiratory syndrome (SARS) COVID-19) and confirmed clinical vaccination failure. The patient underwent endotracheal intubation for mixed respiratory failure in the hospital. In the emergency department the patient underwent tests taken like Arterial blood gases (ABG) with findings of 7 29 56 58 which where most consistent with a mixed hypercarbic (hypercapnia) and hypoxic respiratory failure. This was found to be the likely setting of a COVID-19 pneumonia and possible aspiration pneumonia. The Chest X-ray evidence of predominantly right-sided lung disease (lung disorder). There was also likely some contribution of echocardiography (CHF bedside echo done) by cardiology with evidence of diffuse hypokinesis, reduced ejection fraction estimated at 40 Percent, and with elevated Jugular venous pressure (JVP). Pulmonary Embolism (PE) was ruled out as there were explanations for hypoxia and Lower Extremity Non Invasive Study (LENIs) without evidence of lower extremity clots. On 12-OCT-2021, the patient was extubated with difficulty with upper airway swelling (respiratory tract inflammation) and some bleeding (respiratory tract haemorrhage). The patient had stress induced cardiomyopathy (cardiomyopathy) and acute myocardial infarction (Non-ST-Elevation Myocardial Infarction (NSTEMI) Type 2), Previously in JUL-2021, the echocardiography showed normal ejection estimated around 70 Percent. The increased Brain natriuretic peptide (BNP) value was found to be increased to 8138 and suggested stress-induced cardiomyopathy. The Troponins levels were found to be peaked 85 to 114 160 204 479 to 454 452 462 354 282. The electrocardiogram (EKG) changes included initial T-wave inversion (TWI) with resolution of TWI's but with possible ST segment elevation in lead V2 STD in leads V4-V6 as well as augmented Vector Left (1 avL) leads V1-V2. It was concluded that the patient had mostly type 2 Non-ST-Elevation Myocardial Infarction (NSTEMI) in the setting of elevated Blood pressure (BP's) thus, meeting criteria for hypertensive urgency. On 12-OCT-2021, the patient tested positive for sars-cov-2. The patient visited the emergency room and was hospitalized for 4 days.  The patient died on 13-OCT-2021 due to the acute myocardial infarction, blood gases, brain natriuretic peptide increased, covid-19, covid-19 pneumonia, cardiomyopathy, chest x-ray abnormal, dyspnoea, echocardiogram abnormal, ejection fraction decreased, electrocardiogram abnormal, endotracheal intubation, exposure to sars-cov-2, extubation, hypercapnia, hypokinesia, lung disorder, respiratory failure, respiratory tract haemorrhage, respiratory tract inflammation, sars-cov-2 test positive, and troponin increased. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events acute myocardial infarction, blood gases, brain natriuretic peptide increased, covid-19, covid-19 pneumonia, cardiomyopathy, chest x-ray abnormal, dyspnoea, echocardiogram abnormal, ejection fraction decreased, electrocardiogram abnormal, endotracheal intubation, exposure to sars-cov-2, extubation, hypercapnia, hypokinesia, lung disorder, respiratory failure, respiratory tract haemorrhage, respiratory tract inflammation, sars-cov-2 test positive, and troponin increased was fatal and outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000204482. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received on 23-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2. This follow up version was created to update PQC investigation result. This updated information doesn't alter previous causality assessment made for the events in this case.   20211144818-COVID-19 VACCINE AD26.COV2.S-acute myocardial infarction, covid-19 pneumonia, cardiomyopathy, exposure to sars-cov-2,  respiratory failure, respiratory tract haemorrhage, respiratory tract inflammation,  lung disorder, dyspnoea,  hypercapnia, hypokinesia,  extubation,  covid-19, blood gases, brain natriuretic peptide increased,  chest x-ray abnormal,  echocardiogram abnormal, ejection fraction decreased, electrocardiogram abnormal, endotracheal intubation, sars-cov-2 test positive,  troponin increased. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20211144818-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: ACUTE MYOCARDIAL INFARCTION; BLOOD GASES; BRAIN NATRIURETIC PEPTIDE INCREASED; COVID-19; COVID-19 PNEUMONIA; CARDIOMYOPATHY; CHEST X-RAY ABNORMAL; DYSPNOEA; ECHOCARDIOGRAM ABNORMAL; EJECTION FRACTION DECREASED; ELECTROCARDIOGRAM ABNORMAL; ENDOTRACHEA