SUSPECTED CLINICAL VACCINATION FAILURE; AGITATION; ATRIAL FLUTTER; CONDITION AGGRAVATED; CORONARY ARTERY DISEASE; DISORIENTATION; DISTURBANCE IN ATTENTION; DYSLIPIDAEMIA; DYSPNOEA; DYSSTASIA; FALL; HYPERTENSION; HYPOMAGNESAEMIA; HYPOPHAGIA; LUNG OPACITY; PLEURAL EFFUSION; NOTHING BY MOUTH ORDER; INTENSIVE CARE; ANTICOAGULANT THERAPY; ELECTROLYTE SUBSTITUTION THERAPY; ALANINE AMINOTRANSFERASE INCREASED; ANGIOGRAM PULMONARY ABNORMAL; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD CREATINE PHOSPHOKINASE INCREASED; BLOOD POTASSIUM DECREASED; CREATININE RENAL CLEARANCE DECREASED; ECHOCARDIOGRAM ABNORMAL; ELECTROCARDIOGRAM ABNORMAL; FLUID BALANCE POSITIVE; HEART RATE INCREASED; TROPONIN INCREASED; BLOOD GASES; BRONCHOGRAM; COMPUTERISED TOMOGRAM HEAD NORMAL; COMPUTERISED TOMOGRAM SPINE; GLYCOSYLATED HAEMOGLOBIN NORMAL; SARS-COV-2 TEST NEGATIVE; URINE ANALYSIS NORMAL; ASTHENIA; FATIGUE; COVID-19 PNEUMONIA; ACUTE RESPIRATORY FAILURE; PNEUMONIA BACTERIAL; MYOCARDIAL INFARCTION; ATRIAL FIBRILLATION; DELIRIUM; HYPOXIA; HYPOKALAEMIA; COVID-19; MALNUTRITION; RHABDOMYOLYSIS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System [ID 1761883] concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included: fatigue, short of breath, right coronary artery stent/ drug eluting stent (RCA/DES), pneumonia due to organism, endoscopy colon/ colonoscopy, adenoidectomy, carpal tunnel release, cataract removal bilateral, cervical fusion, colonoscopy polypectomy, and tonsillectomy, and concurrent conditions included: tobacco use, atrial fibrillation, atrial flutter, coronary artery disease, dyslipidemia, type 2 diabetes mellitus, hypertension, arthritis, benign prostatic hyperplasia, non-ST-elevation myocardial infarction (NSTEMI), chronic obstructive pulmonary disease, emphysema, depression, diabetic neuropathy, non-alcohol user, systolic and diastolic heart failure, cancer and protein-calorie malnutrition. The patient had no known allergies and is widowed. The patient has four children. The patient had no substance and sexual activity history. The patient had a family history of cancer (mother, cause of death), Colon Polyps (brother at 72 years), transluminal coronary angioplasty, heart failure (father, cause of death). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, 1 total administered on 09-MAR-2021 for an unspecified indication. The drug start period was 201 days. Concomitant medications included metformin for non insulin dependent diabetes mellitus, acetylsalicylic acid (Aspirin), amlodipine besilate (Norvasc), apixaban (Eliquis), lisinopril, paracetamol (Tylenol), salbutamol (albuterol HFA), spiriva and salbutamol sulfate.  On 07-JUN-2018, Laboratory data included: Colonoscopy (NR: not provided) not reported. On 2019, Laboratory data included: Computerised tomogram head (NR: not provided) small meningioma which was stable in appearance. On 03-MAR-2021, Laboratory data included: Colonoscopy (NR: not provided) not reported. On SEP-2021, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) negative, Creatine kinase (NR: not provided) 8094, Echocardiogram (NR: not provided) stable ejection fraction and showed inferior infarct normal right ventricular (RV) size, systolic function and no significant valvular dysfunction. Cardiology recommended to continue metoprolol, and up titrate as needed. Amlodipine and lisinopril were held to allow further up titration of metoprolol. Renal function test (NR: not provided) normal. On 16-SEP-2021, the patient experienced rhabdomyolysis. On 17-SEP-2021, the patient experienced mild protein-malnutrition. On 26-SEP-2021, the patient was presented to the emergency department with hypoxia and shortness of breath. Emergency room (ER) workup showed positive for COVID-19 pneumonia and also with atrial fibrillation (AFib), Rapid ventricular rate (RVR). The Intensive care unit was contacted by ER air in agreement with CC2 level bed and would consult on patient. The patient denied having fevers or chills. The resting history was provided by daughter of the patient at bedside given his inattentiveness and disorientation She states that over the last few days he has become more fatigued and short of short of breath since discharge from recent hospitalization. On 26-SEP-2021, the patient experienced acute respiratory failure secondary to severe COVID-19 pneumonia, covid-19, agitation, atrial fibrillation, atrial flutter, condition aggravated, coronary artery disease, creatinine renal clearance decreased, delirium, dyslipidaemia, dysstasia, fall (in his apartment and was unable to get up for about 12 hours), hypertension, hypokalaemia, hypomagnesaemia, hypophagia, lung opacity, myocardial infarction, nothing by mouth order, pleural effusion, pneumonia bacterial, asthenia and fatigue and was hospitalized (dates unspecified). The patient was treated with electrolyte substitution therapy. Laboratory data included: Alanine aminotransferase (NR: not provided) increased, Angiogram pulmonary (NR: not provided) abnormal, Aspartate aminotransferase (NR: not provided) increased, Blood creatine phosphokinase (NR: not provided) increased, Blood potassium (NR: not provided) decreased, Bronchogram (NR: not provided) not reported, Computerised tomogram head (NR: not provided) normal, Computerised tomogram spine (NR: not provided) no acute pathology, Creatinine renal clearance (NR: not provided) decreased, Echocardiogram (NR: not provided) abnormal, Electrocardiogram (NR: not provided) atrial fibrillation, Fluid balance assessment (NR: not provided) positive, Glycosylated haemoglobin (NR: not provided) normal, Heart rate (NR: not provided) increased, SARS-CoV-2 test (NR: not provided) negative, Troponin (NR: not provided) increased (elevated at 32 and 30), and Urine analysis (NR: not provided) normal. On an unspecified date, the patient experienced suspected clinical vaccination failure. Laboratory data (dates unspecified) included: Computed Tomogram Angiography Thorax (NR: not provided) No evidence of acute pulmonary embolism noting that the sub segmental branches in the lower lobes are sub optimally opacified due to artifact, right upper lobe-predominant patchy ground glass airspace disease as seen with COVID-19 infection, volume loss in the lower lobes with small right greater than left pleural effusions, no consolidative lobar pneumonia, findings suggestive of mild positive fluid balance, question chronic pulmonary arterial hypertension, Creatinine clearance (NR: not provided) 89.3 mL/min (milliliter/minute), HbA1C (glycated hemoglobin) (NR: not provided) 5.4, and Serum creatinine (NR: not provided) 67 mg/dL (milligram/deciliter). Treatment medications (dates unspecified) included: diltiazem, metoprolol, remdesivir, dexamethasone, furosemide, vancomycin, cefepime, precedex and enoxaparin sodium. The patient was planned to start with very low dose insulin sliding scale given that he would be on steroids for covid-19 treatment. It was reported that the patient was unable to tolerate oral intake, hence Eliquis was kept on hold for now and started on Lovenox protocol for COVID-19 and transition back to Eliquis was thought of when patient was able to tolerate orally. The patient was at high risk of clinical deterioration and death due to severe COVID pneumonia requiring high amount of oxygen supplementation, wean oxygen as tolerated to maintain saturations greater than 92%, cardizem drip and metoprolol titration was planned to control heart rate to less than 120. The patient was on nil per oral (NPO) diet. He was evaluated by Physical therapist (PT) and Occupational therapist (OT) and recommendation was for home health therapy. He had no other acute issues and was discharged home in stable condition. The duration of hospitalization were 9 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood creatine phosphokinase increased, and heart rate increased, and the outcome of acute respiratory failure, agitation, alanine aminotransferase increased, angiogram pulmonary abnormal, aspartate aminotransferase increased, asthenia, atrial fibrillation, atrial flutter, blood potassium decreased, covid-19, covid-19 pneumonia, condition aggravated, coronary artery disease, creatinine renal clearance decreased, delirium, disorientation, disturbance in attention, dyslipidaemia, dyspnoea, dysstasia, echocardiogram abnormal, electrocardiogram abnormal, fall, fatigue, fluid balance positive, hypertension, hypokalaemia, hypomagnesaemia, hypophagia, hypoxia, lung opacity, malnutrition, myocardial infarction, nothing by mouth order, pleural effusion, pneumonia bacterial, rhabdomyolysis, troponin increased, suspected clinical vaccination failure, anticoagulant therapy, blood gases, bronchogram, computerised tomogram head normal, computerised tomogram spine, electrolyte substitution therapy, glycosylated haemoglobin normal, intensive care, sars-cov-2 test negative and urine analysis normal was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case was associated with a Quality Complaint 90000198177. 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 Quality Complaint evaluation/investigation performed.  Additional information received from Complaint Vigilance department on 22-OCT-2021. The following information was updated and incorporated into the case narrative: quality complaint investigation result was added. Upon review following information was amended: The family history of cause of death of 3 diseases (cancer, heart failure and transluminal coronary angioplasty) was deleted in disease tab and added in pre-existing medical history tab.; Sender's Comments: V1:F/U-PQC result.This does not alter previous causality. 20211031440-covid-19 vaccine ad26.cov2.sRhabdomyolysis,Covid19 Pneumonia,Acute respiratory failure,Pneumonia bacterial,Deliruim,Hypoxia,Hypokalemia,blood creatine phosphokinase increased,Covid19,Agitation,Condition aggravated,Disorientation,Disturbance in attention,Dysstasia, Fall,Hypomagnesaemia,Hypophagia,Lung opacity,Pleural effusion,Nothing by mouth order,Intensive care,Anticoagulant Therapy,electrolyte substitution therapy,angiogram pulmonary abnormal,blood K+ decreased,creatinine renal clearance decreased,fluid balance positive,blood gases,bronchogram,CT head normal,CT spine,glycosylated Hb normal,sars-cov-2 test negative,urine analysis.This event(s) is considered unassessable.The event(s) has a compatible/suggestive temporal relationship,is unlabeled,& has unknown scientific plausibility.There is no information on any other factors potentially associated with the event(s). 20211031440-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,& has unknown scientific plausibility.There are other factors more likely to be associated with the event than the drug.Specifically: SPECIAL SITUATIONS 20211031440-covid-19 vaccine ad26.cov2.s-Myocardial infarction,Atrial fibrillation,Atrial flutter,Coronary artery disease,Dyslipidemia,Hypertension,heart rate increased,Dyspnoea,Echocardiogram abnormal,EKG abnormal,Troponin increased,ALT increased,AST increased,Malnutrition.This event(s) is considered not related.The event(s) has a compatible/suggestive temporal relationship, is unlabeled,& has unknown scientific plausibility.There are other factors more likely to be associated with the event(s) than the drug.Specifically:MEDICAL HISTORY,UNDERLYING DISEASE 20211031440-covid-19 vaccine ad26.cov2.sFatigue,Asthenia.This event(s) is labeled per Regulatory Authority & therefore considered potentially related