Sex: F
Vaccine: COVID19
Symptoms: Heart rate, International normalised ratio, Liver function test, Lymphocyte count, Oxygen saturation
Clinical narrative: pacemaker FAILURE; ASYSTOLE; NSTEMI; SEPTIC SHOCK; CARDIOGENIC SHOCK; PERICARDIAL EFFUSION; SUSPECTED MULTIFOCAL PNEUMONIA; This spontaneous report received from a consumer concerned a 62 year old female. The patient's weight was 57 kilograms, and height was 160 centimeters. The patient's past medical history included melanoma, immunotherapy (2years ago) ,essential thrombocytosis ,surgical removal of melanoma and family history of chronic kidney disease, and concurrent conditions included chronic thrombocytosis (7to 8 years) , no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no allergies and no known drug allergies. patient had no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, frequency 1 total administered on 04-APR-2021 for prophylactic vaccination. Concomitant medications included anagrelide hydrochloride for chronic thrombocytosis. On 05-APR-2021, patient felt unwell with malaise, generalized weakness and body aches with subjective fevers, nausea and 1 episode of non bilious vomiting. She suffered severe pain that did not improved with ibuprofen, as well as increased fatigue, anorexia and had been unable to drink or eat any food for the past couple of days. As per her husband patient also developed shortness of breath with exertion on 07-APR-2021 (yesterday). On an unspecified day in APR-2021, Covid-19 test was negative. The patient was admitted to emergency department on 08-APR-2021 at 01:20 with chief complaint of left sided abdominal pain associated with generalized weakness, malaise, and fatigue for 3 days. Physical Exam on 08-APR-2021 at 01:28 am: Blood pressure 110/58, pulse 120, body Temperature 97 Fahrenheit (36.1 degree Celsius), respiratory rate 34, SpO2 97%, BMI (Body mass index) 22.27 kg/m². Normal physical exam (PE) in emergency department (ED): Constitutional. Patient appeared well, well-developed, well-nourished and appeared stated age. Non-toxic appearing, no nystagmus or gaze deviation, no meningismus or rigidity, 2 plus equal pulses in all extremities, tachycardic, regular. Computed tomography angiography (CTA) in all lung fields, no hypoxia or tachypnea on room air. Non tender in all quadrants, no peritoneal signs. No pedal edema or tenderness bilaterally. CTA was negative for PE, revealed multiple pulmonary nodules largest measuring 1 cm in the left upper lobe and additional nodules 0.9 cm in the lateral right middle lobe and 0.9 cm in the inferior lingula. 0.9 nodule in the inferior linear surrounding tree in bud opacity suggestive of atypical infectious process. Differential diagnosis for acute coronary syndrome (ACS), gastroenteritis, diabetic ketoacidosis (DKA), small bowel obstruction (SBO), mesenteric ischemia and adverse reaction. Electrocardiogram on 08-APR-2021 at 01:13: rate: 121, rhythm: sinus tachycardia, no ST elevation. QTC 462, QRS 72. Repeat Electrocardiogram read at 03:41 Rate: 124, Rhythm: sinus tachycardia, no ST elevation, unchanged from prior. Laboratory tests on 08-APR-2021 at 01:20 - hemoglobin (18.5), hematocrit (56.9), platelet (940), Immgrans (1.7), lymphocytes (4.4); Sodium (132), Carbon dioxide (20), Blood urea (32.0), Creatinine GFR (1.12), Estimated glomerular filtration rate (GFR) (49), Calcium (8.6). Liver functions tests normal except Aspartate aminotransferase (59), International normalised ratio 1.1, Blood creatine phosphokinase (1,109) and Troponin (4.7). Code sepsis was called at 02:50. Blood work on 08-APR-2021 at 07:55 showed elevated troponin (6.272). No ST-Elevation Myocardial Infarction (STEMI) criteria, never with chest pain (CP) or shortness of breath (SOB) evaluated by cardiology, started on Dual Antiplatelet Therapy (DAPT) and heparin, CT pulmonary angiogram (CTPA) obtained due to high risk factors for PE with melanoma in the past, recent travel and possible adverse reaction/coagulopathy with vaccine, no PE possible infectious/malignant features in lungs. Blood work on 08-APR-2021; 05:32 showed elevated white blood cell (WBC) 22.88. Lactic acid (7.8 at 06:04; 8.5 at 07:55). Negative beta hydroxy but with a very low pH, toxicology screen positive for opiates, Tylenol and aspirin levels unremarkable. On 08-APR-2021 at 08:30, creatinine phosphokinase (CPK): 1,781 and SARS coronavirus-2 RNA (COVID-19) test negative at 02:12. Laboratory tests at 08:30 - WBC count (30.30), Hemoglobin (17.5), Hematocrit (54.4), Platelet (884), Sodium (136), Carbon dioxide (14.3), Blood urea (33.4), Creatinine GFR (1.05), Calcium (7.7), CPK (1,781), Troponin (3.973, 4.031), Echocardiogram at 08:46 - depress ejection fraction (EF) between 30-40%, with pericardial fluids, possible pericardial tamponade. At 09:00, ordered CTA chest/abdomen/pelvis for aortic dissection, the risk of contrast-induced nephropathy (CIN) was considered but the benefit outweigh the complication. Medications included acetyl salicylic acid (ASA), Brilinta and heparin drip. Patient was started on cefepime, vancomycin and azithromycin (D1) for suspected multifocal pneumonia. Patient became hypotensive in the course of the morning and was transferred to the cath lab for urgent cardiac catheterization that showed non-obstructive coronary artery disease (CAD), elevated filling pressures, normal cardiac output (CO) on (norepinephrine bitartrate) Levophed. Echocardiogram showed left ventricular ejection fraction (LVEF) 29%, biventricular failure, global hypokinesis. No valve disease. Cardiothoracic Surgery was scheduled at 10:12. Physical Exam was positive for Constitutional: Patient appeared well-developed and well-nourished, toxic, appearance, ill, distressed. Nasal cannula was in place. Neck: Normal range of motion. Neck supple. Jugular vein distention (JVD) present. Cardiovascular: Regular rhythm. Tachycardia present. Murmur heard. Systolic murmur was present with a grade of 2/6. Pulmonary/Chest: Effort normal. No respiratory distress. Patient had rales. Abdominal: Soft. Patient exhibited no distension. There was abdominal tenderness. There was no rebound and no guarding. Neurological: alert and had normal strength. A sensory deficit was present. Skin was dry and intact. Ecchymosis noted. Patient was not diaphoretic. There was cyanosis and pallor. Psychiatric: Judgment and thought content was normal. The patient's mood appeared anxious, speech was delayed, agitated. Cognition and memory were normal. Cardiogenic shock was discussed extensively with patient high likelihood for need for V-A ECMO, NSTEMI follow up left heart catheterization to evaluate for CAD, Essential thrombocytosis-platelets were significantly elevated and high risk of thrombus/embolism development, pericardial effusion - repeat echo in AM but no indication for intervention as there was no evidence of tamponade physiology by echo. On 08-APR-2021 at 10:40: Perioperative anesthesia evaluation: Emergent insertion of peripheral percutaneous venous and arterial ECMO cannulae, Emergent initiation of veno-arterial extracorporeal membrane oxygenation support, Emergent insertion of distal perfusion cannula, Ultrasound guided vascular access, Lower extremity angiograms, Transthoracic and/or transesophageal echocardiogram(s), Left heart catheterization with coronary angiography. On 08-APR-2021 at 12:30 - Cardiothoracic surgery noted stated that, patient evaluated at bedside with cardiology at time of cardiac cath with decision for no extracorporeal membrane oxygenation (ECMO) support as per cardiology recs secondary to shock not thought to be cardiogenic primary in nature with further management as per Medical Intensive Care Unit (MICU) and Coronary care unit (CCU) with ECMO available on standby as needed with discussion with patient's husband as to findings as well as if ECMO needed in future would require sternotomy and central cannulation secondary to inadequate vessel size for peripheral cannulation as noted on imaging during cardiac catheterization. On 08-APR-2021 at 12:54 - Coronary Care Unit note stated that, CTA abdomen and pelvis showed no acute aortic disease, no ischemic bowel, small linear filling defect in proximal celiac trunk may represent non-occlusive thrombus, stable small mildly hyperdense pericardial effusion. She was taken to the OR for cath and possible ECMO. Found to be agitated and confused. She was intubated in the OR and pressors were started (Levophed and epinephrine). IABP placed during cath, but removed due to good cardiac function. No coronary artery disease on cath. RIJ Swan Ganz placed. During the course of hours WBC increased to 30 and then to 45. Her pressors requirements increased and the acid base status woresened, with depleted bicarb and low pH. Patient was placed on broad spectrum antibiotics (cefepime, Vancomycin and azithromycin) with infusion of flis and albumin, bicarb pushes (2) and gtt, on Levophed and vasopressin. Left-sided heart catheterization (LHC) showed non obstructive CAD, LVEDP (left ventricular end-diastolic pressure) 37 mmHg (elevated left sided filling pressures) and right-sided heart catheterization (RHC) showed PA pressure 36/30 mmHg, mean 33mmHg; Sat mixed venous 79%, Ao 98%; CO Fick 5.1, CI 3.26. Currently on broad spectrum antibiotics (cefepime, Vancomycin and azithromycin) with infusion of IVF and albumin, bicarb pushes (2) and gtt, on Levophed and vasopressin. On 08-APR-2021 at 21:27 - surgery noted stated that, there was a concern for bowel ischemia. The patient was on max dose of Levophed, Vasopressin, Epinephrin with refractory hypotension and acidosis. CT (Computed Tomography) showed all mesenteric vessels were patent and no bowel thickening, stranding, or free fluid to suggest bowel ischemia. The abdomen was soft non tender and non-distended. In the setting of multi-organ failure and low flow state, non-occlusive mesenteric ischemia would be expected but would be diffuse in nature rather than focal. There was no role for surgical resection for diffuse bowel ischemia if it develops the mainstay of treatment being to improve her overall perfusion to vital organs. The patient may benefit from ionotropic support in addition to vasopressors. Code Blue was called on 09-APR-2021 at 00:45, the patient found unresponsive and asystole. The patient presented with septic shock with metabolic acidosis, intubated, sedated on pressors, levophed, epinephrine and vasopressin drip. Pertinent Lab Prior to or at Onset of Code: pH 7.12/31/133/10.1/95% 08/Apr/2021;15:00Pulse rate was 117, Respiratory rate 118,on 08/Apr/2021;10:30 blood pressure 110/58,pulse rate120,Respiratory rate 34.,08/Apr/2021;01:23 blood pressure 116/57,Body temperature 96.5,Pulse rate 123,,Respiratory rate18 ,SPO2 96%,body Height 1.6cm,weight 50kg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of  suspected multifocal pneumonia, cardiogenic shock, NSTEMI, pericardial effusion,asystole, septic shock ,biventricular failure are not reported. This report was serious (Life threatening and ,and hospitalization).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s-Asystole, NSTEMI, Biventricular failure,  Septic shock,  Cardiogenic shock,  Pericardial effusion,  Suspected multifocal pneumonia . This events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.