Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Computerised tomogram thorax, Computerised tomogram thorax normal, Confusional state, Echocardiogram
Clinical narrative: VENOGRAM NORMAL; MAGNETIC RESONANCE IMAGING HEAD NORMAL; SARS-COV-2 TEST NEGATIVE; ANTINUCLEAR ANTIBODY NEGATIVE; BLOOD CREATINE PHOSPHOKINASE NORMAL; BLOOD GASES NORMAL; PYREXIA; SCAN WITH CONTRAST NORMAL; URINE ANALYSIS NORMAL; HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES); RENAL FUNCTION TEST NORMAL; BLOOD CULTURE POSITIVE; EMBOLISM VENOUS; CEREBRAL ARTERY OCCLUSION; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; ACUTE MYOCARDIAL INFARCTION; ENDOCARDITIS; SEPSIS; RHABDOMYOLYSIS; SEPTIC ENCEPHALOPATHY; ALTERED STATE OF CONSCIOUSNESS; HYPOXIA; LACTIC ACIDOSIS; BASAL GANGLIA INFARCTION; ENTEROCOCCAL BACTERAEMIA; LACUNAR INFARCTION; MENTAL STATUS CHANGES; METABOLIC ACIDOSIS; CONFUSIONAL STATE; HYPERTENSION; HYPOMAGNESAEMIA; HYPOVOLAEMIA; FALL; WHITE MATTER LESION; TACHYCARDIA; AORTIC VALVE REPLACEMENT; TROPONIN INCREASED; BLOOD MAGNESIUM DECREASED; RESPIRATORY RATE INCREASED; ANTI-PLATELET ANTIBODY; CHEST X-RAY NORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; COMPUTERISED TOMOGRAM THORAX NORMAL; ECHOCARDIOGRAM; ELECTROCARDIOGRAM NORMAL; LABORATORY TEST ABNORMAL; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (reference number 1286545), in addition to information received via literature and concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included transcatheter aortic valve replacement, and concurrent conditions included atrial fibrillation, peanut allergy, hypertension, aortic stenosis, and diabetes, and other pre-existing medical conditions included oranges allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included insulin for diabetes, atorvastatin, furosemide, and glipizide.  Patient was on the ground in the room for 3 days. The patient was found covered in feces. The patient was unable to know how she was on ground and denied fall or syncope. On 28-APR-2021, the patient was feeling slightly tachycardic and febrile, slightly hypertensive, had an exam without any significant acute findings. There were no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Electrocardiogram was appearing to be normal with no signs of ischemia or arrhythmia. Lab test had shown slightly elevated troponin, low magnesium, metabolic acidosis and lactic acidosis. Venous blood gas was relatively normal. Urine analysis was found to be negative for infection. The chest x-ray was found to be normal without evidence of pneumonia. There were no clinical signs or symptoms to identify source of infection. Computerised Tomogram of head was found to be negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remained hemodynamically stable with no hypotension. The patient was feeling slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. Computerised Tomogram of chest (thorax) was having no evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status was possibly related to compensation for metabolic acidosis that was likely due to lack of fluid intake due to being on the ground. Blood Creatine phosphokinase and kidney function both were normal. The patient consulted for medicine for admission for further evaluation and treatment. On 28-APR-2021, the patient also experienced embolism venous, acute myocardial infarction, cerebral small vessel ischaemic disease, cerebral artery occlusion, rhabdomyolysis, hypomagnesemia, altered mental status, septic encephalopathy, sepsis, enterococcal bacteremia, altered state of consciousness, basal ganglia infarction, confusional state, endocarditis, hypovolaemia, lacunar infarction, mental status changes and white matter lesion was hospitalized. On 28-APR-2021, the patient has done laboratory tests such as Anti-platelet antibody which was found to be negative, Blood culture which was found to be positive for enterococcal bacteremia, Echocardiogram was found to be normal, hepatic enzyme was increased, laboratory test was abnormal, Scan with contrast was normal. On 29-APR-2021, the patient underwent magnetic resonance imaging head which was normal, sars-cov-2 test which was found to be negative and antinuclear antibody which was negative. On 03-MAY-2021, patient had undergone for venogram which was normal. For non-ST elevated myocardial infarction the patient was told to start argatroban drip until cerebral vein sinus thrombosis is excluded then the patient will switch to heparin drip and also aspirin and statin. HCP had also told patient to check fasting lipid panel and monitor on telemetry. For Rhabdomyolysis, patient was told to stay hydrated and recheck CPK. For Elevated liver enzymes, the patient was told to check hepatitis panel and monitor levels. For fever, the patient was told to follow up on blood cultures, check CT of the abdomen and pelvis and to start empiric antibiotics Vancomycin and Zosyn. For hypomagnesemia, the patient was told start with magnesium sulfate and repeat magnesium level in the morning. For diabetes, the patient was told to start with sliding scale insulin, monitor fingersticks and check hemoglobin A1c. For hypertension, as patient was hemodynamically stable, the patient will have to cautiously start metoprolol and adjust antihypertensives to optimal blood pressure control. For lactic acidosis the patient was told to stay hydrated. For altered mental status and septic encephalopathy due to sepsis the patient was told to continue antibiotics. For Enterococcal bacteremia and endocarditis, the patient was told to repeat blood cultures which were pending. Patient was currently on Unasyn for Enterococcal bacteremia and will need 4 weeks of IV antibiotics The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from embolism venous, cerebral artery occlusion, cerebral small vessel ischaemic disease, acute myocardial infarction (non-st elevated myocardial infarction), endocarditis, sepsis, rhabdomyolysis, septic encephalopathy, altered state of consciousness, lacunar infarction, mental status changes, hypoxia, lactic acidosis, metabolic acidosis, basal ganglia infarction, confusional state, enterococcal bacteraemia, hypertension, hypomagnesaemia, hypovolaemia, fall, white matter lesion, tachycardia, aortic valve replacement, troponin increased, blood magnesium decreased, respiratory rate increased, anti-platelet antibody, chest x-ray normal, computerised tomogram head abnormal, computerised tomogram thorax normal, echocardiogram, electrocardiogram normal, laboratory test abnormal, magnetic resonance imaging head normal, hepatic enzyme increased (elevated liver enzymes), renal function test normal, sars-cov-2 test negative, scan with contrast normal, urine analysis normal, venogram normal, blood culture positive, antinuclear antibody negative, blood creatine phosphokinase normal, blood gases normal, and pyrexia. This report was serious (Hospitalization Caused / Prolonged).  Additional information was received via literature on 07-SEP-2021.  The following information was updated and incorporated into the case narrative: a literature citation was added to this case, as the patient involved was quoted in a table of similar events contained within the article.; Sender's Comments: V1: Follow up information updated includes literature citation, which doesn't alter causality of previously reported events. 20210528129-COVID-19 VACCINE AD26.COV2.S - Acute Myocardial Infarction (Non-St Elevated Myocardial Infarction), Endocarditis, Hypertension, Tachycardia, Aortic Valve Replacement, Respiratory Rate Increased. 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, UNDERLYING DISEASE 20210528129-COVID-19 VACCINE AD26.COV2.S  Embolism Venous, Cerebral Artery Occlusion, Cerebral Small Vessel Ischaemic Disease, Sepsis, Rhabdomyolysis,  Lacunar Infarction, Basal Ganglia Infarction, Septic Encephalopathy, Altered State Of Consciousness, Mental Status Changes, Hypoxia, Lactic Acidosis, Metabolic Acidosis, Confusional State, Enterococcal Bacteraemia, Hypomagnesaemia, Hypovolaemia, Fall, White Matter Lesion, Troponin Increased, Blood Magnesium Decreased, Anti-Platelet Antibody, Chest X-Ray Normal, Computerised Tomogram Head Abnormal, Computerised Tomogram Thorax Normal, Echocardiogram, Electrocardiogram Normal, Laboratory Test Abnormal, Magnetic Resonance Imaging Head Normal, Hepatic Enzyme Increased, Renal Function Test Normal, Sars-Cov-2 Test Negative, Scan With Contrast Normal, Urine Analysis Normal, Venogram Normal, Blood Culture Positive, Antinuclear Antibody Negative, Blood Creatine Phosphokinase Normal, Blood Gases Normal. 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). 20210528129-COVID-19 VACCINE AD26.COV2.S -Pyrexia. This event(s) is labeled per Resource and is therefore considered potentially related.