Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic diet, Dyspnoea, Fall, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: Cardiac failure acute; Acute left ventricular failure; Atrial fibrillation; Pulmonary embolism; Acute respiratory failure; Prostate cancer metastatic; Chronic kidney disease; TYPE 2 DIABETES MELLITUS; Type 1 diabetes mellitus; Critical illness; Hypoxia; SUSPECTED CLINICAL VACCINATION FAILURE; Anaemia; Anticoagulant therapy; Bone lesion; COVID-19; Cardiac telemetry; Chronic left ventricular failure; Condition aggravated; Coronary artery disease; Diabetic diet; Dyspnoea; Fall; Fibrin D dimer increased; Gastrooesophageal reflux disease; Haemoglobin; Haemoptysis; Hyperlipidaemia; Hypertension; Intensive care; Oxygen saturation decreased; SARS-CoV-2 test positive; Tachycardia; Asthenia; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS_ID:1658902) concerned an 86 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: closed fracture of nasal bone, aortic valve replacement, cellulitis, (MVA) motor vehicle accident and generalized weakness and concurrent conditions included: physical deconditioning, (AKI) acute kidney injury, prostate cancer, Barrett's esophagus, colon polyps, aortic stenosis, allergic to pollen, tremor, pulmonary arterial hypertension, pressure ulcer in sacral region, memory impairment, hearing loss, dyslipidemia, actinic keratosis, lumbago (pain in joint of right shoulder), impacted cerumen of left ear, anemia of chronic disease, arthritis, at risk for falls, shortness of breath, myocardial infarction, acute kidney injury and pulmonary edema. The patient was previously treated with donepezil hydrochloride, hydrocodone, Vicodin [hydrocodone bitartrate/paracetamol] and experienced drug allergy and myalgia when treated with ezetimibe, sulfa drugs and other statins [Hmg-coa-r Inhibitors] for drug used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A and expiry: unknown) dose was not reported, frequency time 1 total was administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, alprazolam, donepezil hydrochloride, ezetimibe, hydrocodone bitartrate/paracetamol, alendronate sodium, paracetamol, salbutamol, salbutamol sulfate for drug used for unknown indication. On 27-AUG-2021, the patient experienced acute left ventricular failure, acute respiratory failure, anaemia (hx iron deficient), (AFIB) atrial fibrillation, covid-19, cardiac failure acute, cardiac telemetry, (CKD) chronic kidney disease, chronic left ventricular failure, condition aggravated, (CAD) coronary artery disease, critical illness, diabetic diet, dyspnea, fall, fibrin d dimer increased with sudden (SOB) shortness of breathe hypoxia and tachycardia, (GERD) gastrooesophageal reflux disease, haemoglobin, haemoptysis, hyperlipidaemia, (HTN) hypertension, intensive care, oxygen saturation decreased, prostate cancer metastatic with right rib(bone lesion), pulmonary embolism, type 1 diabetes mellitus, type 2 diabetes mellitus insulin dependent, asthenia, sars-cov-2 test positive and had suspected clinical vaccination failure. Patient was admitted to (ICU) Intensive care unit but he refused transfer. Patient with diabetic diet and continue basal insulin, (PPI) protein pump inhibitor, heparin (sq) subcutaneously. The patient denies falling and refused (SNF) skilled nursing facility. In the (ER) emergency room patient was completing his workup when he suddenly dropped his oxygen (O2) status and thus required (HFNC) high flow nasal canula. Patient he also had reports of scant blood in his sputum. With family at bedside and help of the ER doctor an advance care planning was discussed. The patient was guarded and very critically ill. Family was in agreement for comfort care however the patient wishes for FULL code and does not want transfer. Other concomitant therapy include anticoagulant therapy. On 27-AUG-2021 Laboratory data included: Cardiac telemetry (NR: not provided) not reported and sars-cov-2 test (NR: not provided) positive. Laboratory data (dates unspecified) included: Fibrin D dimer (NR: not provided) elevated, Haemoglobin(Hgb) (NR: not provided) less than 8, Liver function test (LFT) (NR: not provided) elevated, oxygen saturation (NR: not provided) greater than 88%, Troponin (NR: not provided) elevated, and ventilationperfusion (VQ) scan (NR: not provided) not reported. Treatment medications (dates unspecified) included: heparin, and furosemide. The patient was admitted to hospital on 24-AUG-2021 and he was hospitalized for 5 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute left ventricular failure, acute respiratory failure, anaemia, anticoagulant therapy, asthenia, atrial fibrillation, bone lesion, covid-19, cardiac failure acute, cardiac telemetry, chronic kidney disease, chronic left ventricular failure, condition aggravated, coronary artery disease, critical illness, diabetic diet, dyspnoea, fall, fibrin d dimer increased, gastrooesophageal reflux disease, haemoglobin, haemoptysis, hyperlipidaemia, hypertension, hypoxia, intensive care, oxygen saturation decreased, prostate cancer metastatic, pulmonary embolism, sars-cov-2 test positive, tachycardia, type 1 diabetes mellitus, and type 2 diabetes mellitus insulin dependent and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint : 90000193654. 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 from Central Complaint Vigilance department on 21-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Additional information updated includes: Product quality complaint investigation result. This updated information does not alter the causality of previously reported event. 20210920467-Covid-19 vaccine ad26.cov2.s:  acute respiratory failure,  covid-19,  sars-cov-2 test positive, dyspnea,  haemoptysis,  Hypoxia, oxygen saturation decreased,  pulmonary embolism,  atrial fibrillation,  tachycardia, cardiac telemetry, intensive care, anticoagulant therapy, asthenia,  bone lesion  condition aggravated,  critical illness,  diabetic diet,  fibrin d dimer increased,  haemoglobin,  type 1 diabetes mellitus,  type 2 diabetes mellitus,  Hypertension. 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). 20210920467-Covid-19 vaccine ad26.cov2.s: acute left ventricular failure, chronic left ventricular failure, cardiac failure acute, anaemia, prostate cancer metastatic, chronic kidney disease, coronary artery disease, fall,  gastrooesophageal reflux disease, Hyperlipidaemia. 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: MEDICAL HISTORY 20210920467-Covid-19 vaccine ad26.cov2.s-suspected 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