Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody negative, Apolipoprotein, Apolipoprotein A-I, Aspartate aminotransferase
Clinical narrative: ACUTE RENAL FAILURE; SEPTIC SHOCK; PERICARDITIS; VASCULITIS; STAPHYLOCOCCUS AUREUS INFECTION; SEPSIS; PERICARDIAL EFFUSION; POSSIBLE EPSTEIN BARR INFECTION; DEATH; AUTOPSY; HISTOLOGY; This spontaneous report received from a health care professional via a Regulatory Authority (VAERS ID: 1459756) concerned a 55 year old white female of unspecified ethnic origin. The patient's weight was 212 pounds, and height was 69 inches. The patient's concurrent conditions included: diabetes, hypertension, dyslipidemia, obesity, and tobacco abuser. The patient had no allergies to medications, food, or other products. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: Unknown) dose was not reported, with frequency 1 total administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-APR-2021, after vaccination, the patient admitted to the hospital with complaints of sharp pain which started one week prior to the admission and it was worse with deep breath. The patient also had no appetite and chills. On certain tests such as d-dimer, computed tomography of chest, it was diagnosed the patient had probable aortitis. The cause of aortitis was not clear during the admission period. The patient tested also identified with inflammatory response of the great vessels. No pulmonary embolism was identified. The patient was discharged from the hospital on 24-APR-2021 with steroid medication (prednisone 20 mg). The patient also diagnosed with pericarditis, possible staphylococcus aureus infection, uncontrolled type 2 diabetes mellitus with hyperglycemia, and possible Epstein Barr infection. Laboratory data included: ECG (NR: not provided) sinus rhythm, inferior infract, acute anteroseptal infract., Fibrin D dimer (NR: not provided) elevated, and Gram stain (NR: not provided) clusters of gram positive cocci. CT scan (NR: not provided) and results came as Heart: trace pericardial fluid thickening. calcification is present within the visualized coronary arteries. size is normal and position. Mediastinum: moderate to marked increased attenuation in the area around the great vessel origins and the descending aorta to the mid arch. This extends superiorly to the superior mediastinum along the course of the right brachiocephalic artery and to a lesser extend to the left common carotid artery. Nonspecific lymph nodes are present in the adjacent superior mediastinum. Nonspecific lymph nodes present also in the aorticopulmonary window. Thyroid: Nonspecific areas of decreased attenuation unable to be further characterized in the thyroid left greater than right. Largest measure approximately 1.5 cm. Vasculature, aorta: The thoracic aorta demonstrates no evidence of aneurysm or rupture as visualized. Minimal vascular calcification. Pulmonary arteries: No evidence of pulmonary embolus is demonstrated in the central or pulmonary arteries. Lymph nodes: no pathologically enlarged lymph nodes. On 21-APR-2021 14:49, Laboratory data included: Anion gap (NR: not provided) 9, Creatinine clearance (NR: not provided) 59.5, Glucose (NR: 74 - 106) 306 mg/dL, and Troponin (NR: 0.00 - 0.040) less than 0.006 ng/ml. On 21-APR-2021 15:49, Laboratory data included: GFR (NR: not provided) greater than 60 ml/min, Hematocrit (NR: 35 - 45) 49.4 %, Hemoglobin (NR: 12.0 - 16.0) 16.6 g/dL, Lymphocytes (NR: not provided) 10 %, MCH (NR: 27 - 31) 29.8 pg, MCHC (NR: 31 - 36.5) 33.6 g/dL, MCV 89 fL, Monocytes (NR: not provided) 10 %, Neutrophils (NR: 2 - 8.1) 14.6 10*3/uL, Platelet count (NR: 150 - 400) 224 10*3/uL, Red blood cell count (NR: 4.20 - 5.40) 5.57 10*6/uL, Red blood cell sedimentation rate (NR: 0 - 20) 28 mm/h, and WBC (NR: 4 - 10.8) 17.0 10*3/uL. On 21-APR-2021 16:09, Laboratory data included: Fibrin D dimer (NR: 215 - 500) 814 ng/mL, INR (NR: not provided) 1.15 (units unspecified), and Prothrombin time (NR: 9.4 - 12.5) 13.1 sec. On 21-APR-2021 17:54, Laboratory data included: Blood culture (NR: not provided) positive for staphylococcus aureus. On 21-APR-2021 20:09, Laboratory data included: Anti-cyclic citrullinated peptide antibody, HIV antibody, Hepatitis A antibody, Hepatitis B antibody and Hepatitis C antibody as Negative, non-reactive. On 21-APR-2021 20:46, Laboratory data included: Urine culture (NR: not provided) positive for staphylococcus aureus. On 21-APR-2021 22:26, Laboratory data included: Glucose (NR: 60 - 69) 204 mg/dL. On 22-APR-2021, Laboratory data included: Anti-SCL 70 (NR: not provided) less than 1.2 RLU, Antinuclear antibody (NR: not provided) positive, Double stranded DNA antibody (NR: not provided) Negative, Jo-1 antibody negative (NR: not provided) less than 2.2 RLU, Ribonucleoprotein antibody (NR: not provided) less than 3.5 RLU, and SM antibody (NR: not provided) less than 3.3 RLU. On 22-APR-2021 06:17, Laboratory data included: Glucose 131 mg/dL. On 22-APR-2021 09:42, Laboratory data included: MRI angiography (NR: not provided): Patent aorta and proximal branches. No stenosis identified. The significant surrounding inflammation of the proximal thoracic great vessels and aortic arch better demonstrated on the prior day CT. Findings remain concerning for large vessel vasculitis versus infectious etiology. On 22-APR-2021 10:55, Laboratory data included: Glucose 149 mg/dL. On 22-APR-2021 15:19, Laboratory data included: Anti-cyclic citrullinated peptide antibody (NR: not provided) less than16 units, Immunoglobulin G (NR: not provided) reported, and Rheumatoid factor (NR: not provided) positive. On 22-APR-2021 16:00, Laboratory data included: Troponin less than 0.006. On 22-APR-2021 18:36, Laboratory data included: Glucose 292 mg/dL. On 22-APR-2021 20:21, Laboratory data included: Glucose 302 mg/dL. On 23-APR-2021 04:17, Laboratory data included: Anion gap (NR: not provided) 8, Bicarbonate 23 mmol/L, Calcium 9.3 mg/dL, Chloride 108 mmol/L, Creatinine clearance (NR: not provided) 72.3, GFR (NR: not provided) greater than 60 ml/min, Glucose 104 mg/dL, Hematocrit 46.8 %, Hemoglobin 15.5 g/dL, Platelet count 234 10*3/uL, Potassium 3.9 mmol/L, Sodium 139 mmol/L, Troponin less than 0.006 ng/ml, and WBC 15.4 10*3/uL. On 23-APR-2021 06:07, Laboratory data included: Glucose 115 mg/dL. On 23-APR-2021 10:58, Laboratory data included: Glucose 228 mg/dL. Other laboratory data (dates unspecified) included: Creatinine (NR: not provided) 0.96, and GFR (NR: not provided) 60. On 1-MAY-2021, the patient again admitted to the hospital with complaints of chest pain, sepsis with septic shock and acute renal failure. On admission the patient admitted to emergency room covered in feces. The patient also had multiple scratches and excoriations covered entire body as a part of different stages of healing (the patient had 10 cats). On first day of admission, the patient was in shock and she had taken to intensive care unit (ICU) and on two vasopressors(unspecified). The patient's respiratory failure worsened at night and kept her on intubation and was later placed on ventilator. The patient also had profound metabolic acidosis which was unresponsive to medical therapy. The patient was presented with a pH of 7.2 and she was placed on bicarb drip with additional pushes and her pH continued to deteriorate. From nephrology she had instructed to start dialysis. The patient consulted with vascular surgery foe placement of a dialysis catheter. The patient also consulted with pulmonary critical care and infectious disease. The patient had large pericardial effusion. The patient had mild thrombocytosis and platelets were normal in morphology without significant platelet anisocytosis. Thrombocytosis might have accompanied along with reactive neutrophilia that are secondary to acute stress. Laboratory data included: Chest X-ray revealed cardiomegaly, Upper limb X-ray (NR: not provided) No acute bony abnormality identified in the right forearm, and pH (NR: not provided) 7.2. On 01-MAY-2021 04:49, Laboratory data included: Arterial blood gases (NR: not provided) pH art: 7.03 (normal- 7.35-7.45), pCO2 art: 33 mmHg(35-45), pO2 art: 77 mmHg(80-102 ), HCO3 art: 9mmol/l(22-26), O2Hb%:88%(95-100), % saturation, arterial: 90%(95-100), base excess art:-21.1mmol/l(-2-2), O2 cont. art: 16.4 vol. % (16-20), Hemoglobin art: 13.1 gm/dl(12-18), carboxy hemoglobin: 0.6%(0.0-0.2), met HB, arterial:0.7%(0.0-3.0), reduced HB: 10.4(2.5-9.3), NA level-art: 132mmol/l(135-145), K level: 5.8mmol/l(3.5-5.0), Cl level-art: 99mmol/l(98-106), Ion Ca level-art: 0.87mmol/l(1.05-1.30), arterial lactate: 1.6mmol/l(0.3-1.3), arterial glucose:373mg/dl(60-99), FIO2-arterial:90. On 01-MAY-2021 06:37, Laboratory data included: Albumin 2.2 g/dL, Alkaline phosphatase 185 U/L, Anion gap (NR: not provided) 22, BUN 115 mg/dL, Bicarbonate 10 mmol/L, Bilirubin total less than 0.2 mg/dl, Blood alcohol (NR: not provided) less than 12 mg/dl, C-reactive protein (NR: not provided) greater than 30.4 mg/dl, CK MB (NR: not provided) 1.71 ng/mL, CPK (NR: 34 - 145) 199 U/L, Calcium 7.5 mg/dL, Chloride 98 mmol/L, Creatinine 5.48 mg/dL, GFR (NR: not provided) 8 mL/min, Glucose 126 mg/dL, Hemoglobin 12.7 g/dL, Magnesium (NR: 1.6 - 2.6) 2.4 mg/dL, Phosphate (NR: 2.4 - 5.1) 12.5 mg/dL, Platelet count 477 10*3/uL, Potassium 5.3 mmol/L, Red blood cell sedimentation rate 69 mm/h, Sodium 130 mmol/L, and WBC 35.2 10*3/uL. On 01-MAY-2021 07:00, Laboratory data included: COVID-19 virus test (NR: not provided) Presumptive negative. On 01-MAY-2021 08:10, Laboratory data included: Antimicrobial susceptibility test resistant, Candida test, Cryptococcus test, Enterococcus test, Klebsiella test, Listeria test, Streptococcus test and Salmonella test as not detected, Staphylococcus test and staphylococcus aureus were detected. On 01-MAY-2021 09:17, Laboratory data included: Glucose (NR: 60 - 99) 464 mg/mL. On 01-MAY-2021 12:22, Laboratory data included: Epstein-Barr virus antibody (NR: not provided) less than 36 units/ml, 729 U/mL, and Epstein-Barr virus test (NR: not provided) greater than 600 units/ml. On 01-MAY-2021 13:15, Laboratory data included: Arterial blood gases (NR: not provided) pH art: 7.07 (normal- 7.35-7.45), pCO2 art: 23 mmHg(35-45), pO2 art: 62 mmHg(80-102 ), HCO3 art: 6mmol/l(22-26), O2Hb%:79%(95-100), % saturation, arterial: 80%(95-100), base excess art:-23.4mmol/l(-2-2), O2 cont. art: 15.2 vol. % (16-20), Hemoglobin art: 13.7 gm/dl(12-18), carboxy hemoglobin: -0.2%(0.0-0.2), met HB, arterial:1%(0.0-3.0), reduced HB: 20(2.5-9.3), NA level-art: 131mmol/l(135-145), K level: 5.6mmol/l(3.5-5.0), Cl level-art: 105mmol/l(98-106), Ion Ca level-art: 0.96mmol/l(1.05-1.30), arterial lactate: 1.4mmol/l(0.3-1.3), arterial glucose:185mg/dl(60-99),. On 01-MAY-2021 14:46, Laboratory data included: Glucose 318 mg/mL. On 01-MAY-2021 16:14, Laboratory data included: Glucose 226 mg/mL. On 01-MAY-2021 17:13, Laboratory data included: Arterial blood gases (NR: not provided) pH art: 7.09 (normal- 7.35-7.45), pCO2 art: 21 mmHg(35-45), pO2 art: 108 mmHg(80-102 ), HCO3 art: 6mmol/l(22-26), O2Hb%:96%(95-100), % saturation, arterial: 96%(95-100), base excess art:-21.8mmol/l(-2-2), O2 cont. art: 18 vol%(16-20), Hemoglobin art: 13.3 gm/dl(12-18), carboxy hemoglobin: 0.3%(0.0-0.2), met HB, arterial:0.5%(0.0-3.0), reduced HB: 3.7(2.5-9.3), NA level-art: 132mmol/l(135-145), K level: 5.6mmol/l(3.5-5.0), Cl level-art: 104mmol/l(98-106), Ion Ca level-art: 0.82mmol/l(1.05-1.30), arterial lactate: 1.6mmol/l(0.3-1.3), arterial glucose:241mg/dl(60-99), FIO2-arterial:70. On 01-MAY-2021 20:08, Laboratory data included: Amphetamines, Barbiturates, Benzodiazepine, Opiates, and Cannabinoids drug level as negative. Chlamydia test, Polymerase chain reaction were not detected, Legionella test and Streptococcus test was negative. On 02-MAY-2021 04:26, Laboratory data included: Antimicrobial susceptibility test resistant (NR: not provided) Amoxicillin/clavulanate, cefazolin, Clindamycin, erythromycin, gentamycin, levofloxacin, tetracycline, oxacillin, and trimethoprim/sulfa -susceptible, ampicillin and penicillin- resistant. On 02-MAY-2021 04:28, Laboratory data included: BUN 124 mg/dL, Bicarbonate less than 10 mmol/l, Calcium 6.5 mg/dL, Chloride 99 mmol/L, Creatinine 5.39 mg/dL, Creatinine clearance (NR: not provided) 10.6, GFR (NR: not provided) 8 mL/min, Glucose 395 mg/dL, Hematocrit 36.5 %, Hemoglobin 12 g/dL, MCH 29.9 pg, MCHC 32.9 g/dL, MCV 91 fL, Platelet count 476 10*3/uL, Potassium 5.5 mmol/L, Red blood cell count 4.02 10*6/uL, Red cell distribution width 15.3 %, Sodium 134 mmol/L, and WBC 34.8 10*3/uL. On 02-MAY-2021 04:56, Laboratory data included: Chest X-ray revealed cardiomegaly CHF and increasing pulmonary edema. On 02-MAY-2021 08:11, Laboratory data included: Echocardiogram (NR: not provided) Normal left ventricular systolic function. LV ejection fraction was 74%. The left ventricular ejection fraction was an estimation. mild left ventricular hypertrophy. Moderate to large pericardial effusion. The pericardial effusion was circumferential to the heart. No echocardiographic evidence to suggest cardiac tamponade. On 02-MAY-2021 10:56, Laboratory data included: Acetaminophen (NR: 10 - 20) less than 4 mcg/ml, Hepatitis B antibody, Hepatitis B antigen, and Hepatitis C antibody as non-reactive, and Salicylate (NR: 2.8 - 20) less than 3 mg/ml. On 02-MAY-2021 11:30, Laboratory data included: Apo A1 (NR: 0.2 - 0.3) 0.8 g/dL, Apo lipoprotein (NR: 0.5 - 0.9) 1.2 g/dL, Beta 2 globulin (NR: 0.2 - 0.5) 0.4 g/dL, Beta globulin (NR:.4 - 0.6) 0.4 g/dL, Complement factor C3 (NR: 83 - 193) 146 mg/dL, Complement factor C4 (NR: 15 - 57) 20 mg/dL, Gamma globulin (NR: 0.8 - 1.7) 0.7 g/dL, Serum protein electrophoresis (NR: 3.8 - 4.8) 1.7 g/dL, and Serum total protein 5.2 g/dL. On 02-MAY-2021 12:22, Laboratory data included: Beta-2 glycoprotein antibody (NR: not provided) less than 1, Brucella serology (NR: not provided) 0.58, 0.08, CMV IgG antibody (NR: not provided) less than 0.6 unit/ml, CMV IgM antibody (NR: not provided) less than 30, Ehrlichia serology (NR: not provided) less than 1:20, less than 1:64, Parvovirus B19 serology (NR: not provided) 7.8, 0.2, and Tuberculosis test (NR: not provided) indeterminate. On 02-MAY-2021 15:06, Laboratory data included: Albumin 2.2 g/dL, Alkaline phosphatase 328 U/L, Anion gap (NR: not provided) 25, BUN 97 mg/dL, Bicarbonate 17 mmol/L, Bilirubin total 0.5 mg/dL, Calcium 8.6 mg/dL, Chloride 95 mmol/L, Creatinine 4.26 mg/dL, Creatinine clearance (NR: not provided) 13.4, GFR (NR: not provided) 11 mL/min, Glucose 283 mg/dL, Potassium 5.8 mmol/L, SGOT (NR: not provided) 2655 U/L, SGPT 1204 U/L, Serum total protein 5.8 g/dL, and Sodium 137 mmol/L. On 02-MAY-2021 15:13, Laboratory data included: ECG (NR: not provided) atrial fibrillation. On 02-MAY-2021 16:11, Laboratory data included: Arterial blood gases (NR: not provided) pH art: 7.12 (normal- 7.35-7.45), pCO2 art: 27 mmHg (35-45), pO2 art: 64mmHg (80-102), HCO3 art: 9mmol/l(22-26), O2Hb%:81%(95-100), % saturation, arterial: 82%(95-100), base excess art:-19.3mmol/l(-2-2), O2 cont. art: 10.6 vol. % (16-20), Hemoglobin art: 9.2 gm/dl(12-18), carboxy hemoglobin: 0.2%(0.0-0.2), met HB, arterial:1%(0.0-3.0), reduced HB: 17.6(2.5-9.3), NA level-art: 137mmol/l(135-145), K level: 4.6mmol/l(3.5-5.0), Cl level-art: 103mmol/l(98-106), Ion Ca level-art: 0.93mmol/l(1.05-1.30), arterial lactate: 11.8mmol/l(0.3-1.3), arterial glucose:230mg/dl(60-99), FIO2-arterial:100. On 02-MAY-2021, the patient died from sepsis, pericarditis, large vessel vasculitis, and staphylococcus aureus infection as per the autopsy report. On 03-MAY-2021, Laboratory data included during autopsy: Blood urea nitrogen (NR: not provided) 107 mg/dL, Chloride (NR: not provided) 105 mmol/L, Creatinine (NR: not provided) 3.5 mg/dL, Ethanol (NR: not provided) negative, Glucose (NR: not provided) 161 mg/dL, Isopropanol (NR: not provided) negative, Methanol (NR: not provided) Negative, Potassium (NR: not provided) 11.2 mmol/L, and Sodium (NR: not provided) 141 mmol/L. Laboratory data (dates unspecified) included: ANA (NR: not provided) positive 1:1280, ANCA (NR: not provided) Negative, Anti-cyclic citrullinated peptide antibody (NR: not provided) Negative and GFR (NR: not provided) 60. Treatment medications (dates unspecified) included: metformin hydrochloride/sitagliptin phosphate monohydrate, trazodone, vitamin b complex, sodium bicarbonate, diltiazem, buspirone, venlafaxine hydrochloride, canagliflozin, prednisone, atorvastatin, ascorbic acid/beta carotene/biotin/calcium/calcium pantothenate/chromium amino acid chelate/colecalciferol/copper amino acid chelate/cyanocobalamin/folic acid/magnesium citrate/magnesium oxide/manganese amino acid chelate/mecobalamin/molybdenum amino acid chelate/nicotinamide/phytomenadione/potassium iodide/pyridoxine hydrochloride/retinol palmitate/riboflavin/selenium amino acid chelate/thiamine mononitrate/tocopheryl acetate/zinc amino acid chelate, colecalciferol, losartan, momordica charantia, glipizide, fish oil/omega-3 fatty acids, and insulin detemir. On 03-MAY-2021, Laboratory data included: Acetone, Amphetamines, Barbiturates, Benzodiazepine drug level, cannabinoids, muscle relaxants, opioid analgesics and stimulants levels were negative. An autopsy performed on 3-MAY-2021 08:00, which revealed pericarditis with large vessel vasculitis and a fibrinous exudate coating the epicardial surface of the heart. Ascending and descending aorta grossly and histologically remarkable. A gram stain performed on tissue from the brachiocephalic and left common carotid arteries revealed numerous clusters of gram positive cocci. The radial artery histologically showed fibrinoid material with associated inflammatory cells in a vessel wall within the adventitia but no inflammation of the vessel walls. Lungs with diffuse alveolar damage and centrilobular necrosis of the liver and acute tubular necrosis of the kidneys. The heart was enlarged (cardiomegaly, 500 grams) and exhibited moderate to severe calcific coronary artery disease with up to 80% occlusion of the left anterior descending coronary artery. ventral hernia. Multiple right sided rib fractures were noted, which were likely secondary to resuscitative efforts. remote cholecystectomy and bilateral tubal ligation. Vitreous electrolytes were significant for renal failure. It was unclear vaccination played a direct role in death. Based on the circumstances surrounding the death and the findings at autopsy, the patient died as a result of sepsis with pericarditis and large vessel vasculitis due to staphylococcus aureus bacterial infection. The manner of death was natural. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, autopsy, vasculitis, septic shock, histology and staphylococcus aureus infection on 02-MAY-2021, and the outcome of possible Epstein Barr infection, pericardial effusion, acute renal failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received via company representative on 06-AUG-2021, 07-AUG-2021 and 9-AUG-2021. The following information was updated and incorporated into the case narrative: Patient's demographics added (DOB, height, weight, race), patient history added (hypertension, obesity, dyslipidemia, tobacco abuse), cause of death updated (sepsis, pericarditis, large vessel vasculitis, staphylococcal aureus infection, Date of autopsy updated, events added (septic shock, sepsis, staphylococcal aureus infection, acute renal failure, possible Epstein Barr infection), seriousness criteria added (pericarditis, vasculitis and septic shock-Hospitalization caused/prolonged), hospital address added, lab data added (from data 3 to data 302), Reporter added and narrative updated. The narrative has been abstracted to comply with E2B data limitations. Sender's Comments: V1: Follow up information received in the current version is regarding patient demographics, medical history, autopsy findings, new events with clinical course and laboratory details. 20210751395-Covid-19 vaccine ad26.cov2.s-sepsis, pericarditis, vasculitis, staphylococcus aureus infection, septic shock, death, autopsy, histology, pericardial effusion, acute renal failure. Follow-up received regarding Clinical Details. 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; Reported Cause(s) of Death: SEPSIS; PERICARDITIS; LARGE VESSEL VASCULITIS; STAPHYLOCOCCUS AUREUS INFECTION.