Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Complement factor C3, Complement factor C4, Computerised tomogram, Computerised tomogram head
Clinical narrative: DEATH; HYPOKALEMIA; REFRACTORY POSSIBLE AUTOIMMUNE ENCEPHALITIS; TRICUSPID REGURGITATION; HYPOMAGNESEMIA; POSSIBLE AUTOIMMUNE VASCULITIS; PERSISTENT ACUTE RESPIRATORY FAILURE WITH HYPOXIA AND HYPERCAPNIA; DIFFUSE BILATERAL LOWER EXTREMITY SUPERFICIAL THROMBOSES; OLIGURIC WITH ACUTE KIDNEY INJURY; STATUS EPILEPTICUS; ENCEPHALOPATHY; LOWER RESPIRATORY CULTURE AND URINE FOR STREPTOCOCCUS PNEUMONIAE WAS POSITIVE; SEIZURES; DIFFUSE BILATERAL LOWER EXTREMITY DEEP THROMBOSES/THROMBI WITHIN COMMON FEMORAL DEEP VENOUS VEINS; THROMBI WITHIN BILATERAL COMMON ILIAC, EXTERNAL ILIAC; PULMONARY INTRAVASCULAR THROMBOEMBOLI; HEMOGLOBIN WAS LOW (6.5G/DL); POST INTUBATION HYPOTENSION/HYPOTENSIVE; BLOOD CLOT IN LIVER AND NECK; SUBACUTE MYOCARDIAL INFARCTION WITH ACUTE ISCHEMIA; This spontaneous legal report received from a parent via a company representative concerned a 24 year old female. The patient's weight was not reported and height was 60 inches. The patient's past medical history included: dental intervention, and concurrent conditions included: cardiac atrial septal defect, developmental delay since birth (limited speech and relative inability to read), no alcohol, no tobacco, alopecia (of the upper and lower extremities), and hypertelorism, and other pre-existing medical conditions included: The patient had no illicit drug abuse, no known allergies and not on any medications prior to admission. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 24 years old. Concomitant medications included heparin for coagulation, and famotidine for gastroesophageal irritation.  On 08-APR-2021, the patient had poor appetite with intermittent fatigue, malaise and not wanting to get up and out of bed. On 15-MAY-2021, the patient's family brought her to the hospital due to asymmetrical swelling of the lower extremities, left greater than right due to her mother concern of her having a covid vaccine related blood clot. At that office visit, her blood pressure was 118/80 but she was tachycardia with a heart rate of 149 beats per minutes. The oxygen saturation was 100 percent on room air. At her last doctor visit approximately 7 weeks ago (unspecified date in 2021), she was not tachycardia. It was recommended that she be taken to the emergency department for further evaluation. On 19-MAY-2021, upon arrival at the emergency department, other than the previously described listlessness and lower extremity, there was no other signs or symptoms of fever, chills, abdominal pain, back pain, dysuria, headache, nausea, vomiting, diarrhea or diaphoresis. Vital signs included a blood pressure of 88/54 with a persistent elevated heart rate at 115 beats per minute. The respiratory rate was 24 breaths per minute and oxygen saturations was 100 percent. The temperature was 97.5 degrees F. She appeared mildly pale which was normal per her mother. There was 1 plus pitting edema to the left extremity. The capillary refill was less 2 seconds. Laboratory data included: Activated partial thromboplastin time (NR: 26.2 - 37.2) 27.1 sec, Anion gap (NR: 2 - 12) 19 mmol/L, Bicarbonate (NR: 22.0 - 26.0) 29.3 mmol/L, Blood pH (NR: 7.35 - 7.45) 7.57 (units unspecified), Blood pressure 88/54, Blood urea nitrogen (NR: 7 - 25) 7 mg/dL, Body temperature (NR: not provided) 97.5 F, COVID-19 virus test Negative, CT brain scan without acute abnormality, CT scan pulmonary emboli were noted within one of the segmental pulmonary arterial branches of the left lower lobe of the lung and there was also thrombi within the bilateral common iliac, external iliac and common femoral deep venous veins, multiple small subsegmental pulmonary thromboemboli, Capillary nail refill test less than 2 seconds, Chest X-ray no acute cardiopulmonary disease, Chloride (NR: 98 - 107) 89 mmol/L, Creatinine (NR: 0.6 - 1.2) 0.57 mg/dL, Duplex ultrasound there was diffuse bilateral lower extremity superficial and deep thromboses, Electrocardiogram Tachycardia with inverted T waves, Heart rate 115 beats per minute, Hematocrit (NR: 34.3 - 45.5) 22.6 percent, Hemoglobin post hemoglobin transfusion level was 8.9, Hemoglobin (NR: 11.4 - 14.7) 6.5 g/dL, INR 1.3 reference range without medication less than 1.0, Influenza A virus infection Negative, Influenza B virus infection Negative, Troponin (NR: 0.00 - 0.05) 0.03 ng/mL (less then 0.03), CO2 (carbon dioxide) (NR: 35 - 45) 32 mmHg, Magnesium (NR: 1.9 - 2.7) 1.5 mg/dL (hypomagnesemia), Oxygen saturation (NR: not provided) 100 percent, Oxygen saturation (NR: 80 - 100) 99 mmHg, Platelet count 305 (reference range 139 to 361 10x3/microliter), Potassium (NR: 3.5 - 5.1) 2.3 mmol/L (hypokalemia), Prothrombin time (NR: 9.5 - 13.3) 15.5 sec, Respiratory rate 24 beats per minute, Respiratory syncytial virus test Negative, Sodium (NR: 136 - 145) 135 mmol/L, and Troponin less than 0.03. The patient had diffuse bilateral lower extremity superficial and deep thromboses (blood clot in leg). On an unspecified date, the patient experienced persistent acute respiratory failure with hypoxia and hypercapnia. It was decided that she needed to be transferred to the intensive care unit. While awaiting transfer, she experiences several seizures (epileptic intractable seizure) lasting up to 2 minutes for which she started on intravenous levetiracetam and Ativan. In light of low hemoglobin, she was transfused with 2 units of packed red blood cells. The post hemoglobin transfusion level was 8.9. She was also started on argatroben for deep vein thrombosis. Potassium and magnesium were replaced. Despite being given Ativan and a second dose of levetiracetam, she continued to be confused and was not protecting her airway and therefore emergent intubation was required at 23:55 hours. She did experience post-intubation hypotension but otherwise tolerated the procedure well. Hematology was consulted and agreed with the administration of the anticoagulant argatroban. Neurology was also consulted due to persistent seizure-type activities such as right upper extremity twitching. For this fosphenytoin was administered. A versed drip was started due to epileptiform movements. She was also on telemetry monitoring. The patient also had pulmonary intravascular thromboemboli/parenchymal hemorrhage (blood clot in chest and lungs). On an unspecified date, the patient also experienced blood clot in liver and neck. On 21-MAY-2021, hematology/oncology was consulted and it was their opinion that she did not meet the criteria for vaccine induced thrombotic thrombocytopenia as she was outside the window of 5 to 30 days and had a normal platelet level. Laboratory data included: Glucose (NR: 65 - 100) 155 mg/dL, blood pressure hypotensive 79/46 mmHg and despite potassium replacement it was remain at 3.3, Heparin-induced platelet antibody Negative, Vasopressors were administered to support her blood pressure. Additional potassium replacement was given and also insulin was provided. It was decided to transfer her to critical care unit. A magnetic resonance imaging study of the brain was also done with and without contrast which was also negative for acute stroke or hemorrhage or cerebral venous thrombosis. Therefore, levetiracetam (keppra) was given in efforts to stop the intermittent twitching of her right arm. She was loaded with fosphenytoin. Versed was given for sedation. Her mother denied any prior history of seizures. On 22-MAY-2021, infectious diseases were also consulted, due to concern for meningoencephalitis. The other differential diagnosis included a possible metabolic encephalitis. Laboratory data included: Blood culture Negative (negative for organism), Brain natriuretic peptide (NR: 0 - 100) 28 ng/mL, C-reactive protein (NR: not provided) 91.2 mg/dL (reference range less than 10), CSF (cerebrospinal fluid) culture Negative (for growth of other organisms.), CSF glucose (NR: 40 - 70) 135 mg/dL, CSF protein (NR: 15 - 45) 25 mg/dL, Echocardiogram the ejection fraction (EF) was 34 percent to 39 percent with severe global hypokinesis and moderate tricuspid regurgitation but there were no vegetations. ST changes were persistent and there was a prolonged QT; Erythrocyte sedimentation rate (NR: 0 - 20) 20 mm/h, CSF test clear and colorless, Neuron-specific enolase Negative, (meningitis-encephalitis) PCR panel (polymerase chain reaction) Negative for all organism, Syphilis test non-reactive, and Troponin 0.03. Levophed was continued to support her blood pressure. Heaprin infusion had been on hold prior to planned lumbar puncture. Arixtra was to be given 4 hours after the lumbar puncture. All other cultured including a Methicillin-resistant staphylococcal aureus was Negative. However, a lower respiratory culture for streptococcus csfpneumonia and yeast, not crutpococcus become positive. Streptococcus pneumonia was also positive in the urine. Therefore, vancomycin and ceftriaxone were continued and dexamethasone was also administered. Blood cultured however reported as negative for organism. Arixtra was transitioned to heparin for anticoagulation. She remained critically ill, intubated and sedated. The left lower extremity become swollen from the thigh to the foot. Continued neurological evaluation with electroencephalogram (EEG) for epileptiform type activity was done. Then by the EEG on day 9 of monitoring, there continued to be encephalopathy of moderate to severe intensity but the etiology remained elusive. There was a diffuse background polymorphic wave slowing. The triphasic waves were thought not to be epileptic in nature. It was thought that there was some improvement when compared to previous EEG tracings. She was maintained on keppra, versed and vimpat. Fosphenytoin was discontinued. Depakote was added. Eventually vancomycin was discontinued and rocephin was added for more 10 days. On an unspecified date, Laboratory data (dates unspecified) included: ANA (antinuclear antibody) Positive, Beta-2 glycoprotein antibody negative or less, Cardiolipin antibodies negative or less, Complement factor C3 negative or less, Complement factor C4 negative or less, and Lab test negative or less. On 01-JUN-2021, Levopad was discontinued, low dose metoprolol was given. For volume overload, Lasix was given. Nutrition was provided via a feeding tube with some elevated liver enzymes levels. Pepcid was administered to avoid gastroesophageal irritation. It was felt that elevated glucose level was stress induced. Insulin was administered as needed. On 02-JUN-2021, arixtra was transitioned to heparin drip. Reevaluation of the positive ANA with a speckled pattern of 1:160 was not thought to be of a level high enough to cause her symptoms, but pulse steroids were started for possible autoimmune vasculitis process. On 03-JUN-2021, a tracheostomy tube was placed and a bronchoscopy was also done with Broncho alveolar lavage specimen obtained from the right lower lobe of the lung. Specialized tests included varicella zoster virus, viral atypical pneumonia, PCR panel including covid-19, fungal organisms, Acid fast bacillus organism, Cytomegalovirus virus, herpes simplex virus, and Legionella were all negative. The Broncho alveolar lavage protein level was less than 3 which was in the range of lactate dehydrogenase level at 215 units/liter. By cytology, the right lower lobe Broncho alveolar lavage specimen was negative for malignant cells. Pulmonary macrophages, bronchial cells and inflammatory cells were present. On 05-JUN-2021, the patient went into status epilepticus requiring versed drip and fycompa. Discussions for options including intravenous immunoglobulin and plamapheresis therapy for again refractory possible autoimmune encephalitis were considered. Steroids was continued. She became oliguric with kidney injury which was contributing to metabolic and lactic acidosis. On 09-JUN-2021, burst suppression was ultimately achieved with maximum doses of ketamine and versed. Fentanyl was also started as was propofol for burst suppression. On 10-JUN-2021, propofol was slowly weaned. Empiric cefepime was given for concern for right sided pneumonia. Pulseless electrical activity cardiac arrest occurred at 23:22 hours with a widened QRS. Return of spontaneous circulation was achieved after 10 minutes of cardio resuscitative efforts including 2 doses of epinephrine, 2 doses of bicarbonate, 1 dose of calcium and 1 dose of magnesium. Profound acidosis was present. Nephrology was consulted for the need of continues renal replacement therapy. A hemodialysis catheter had been placed in the interim. Levels of norepinephrine were at the maximum dosage to maintain a blood pressure. Vasopressin was also given. Sodium bicarbonate and epinephrine infusions were initiated. On 11-JUN-2021, the troponin level was 0.05. The patient had cardiac arrest despite being on maximum doses of 3 vasopressors. Again, there was return of spontaneous circulation after a dose of epinephrine, calcium and bicarbonate. The patient's parents were updated and had clear understanding of most likely imminent death, and they agreed that no further heroic measures should be attempted. On the same day at 12:32 hours, the patient was died. The cause of death was not reported. Treatment medications (dates unspecified) included: insulin, norepinephrine, sodium bitartrate, vancomycin, lacosamide, ceftriaxone sodium, potassium, ceftriaxone, fondaparinux sodium, levetiracetam, dexamethasone, valproate semisodium, fosphenytoin, lorazepam, and argatroban. The number of days of hospitalization was reported as 24 days. On 12-JUN-2021, autopsy was performed and revealed subacute myocardial infarction with acute ischemia, multiple bilateral parenchymal hemorrhages with organizing fibrin thrombi, bilateral serious pleural effusions, mucosal necrosis with acute hemorrhage, midline of the corpus callosum was thin and had vascular arteriosclerosis, blood clot in liver and capsular tear, bilateral paratubal cysts and congestive hepatomegaly.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diffuse bilateral lower extremity deep thromboses/thrombi within common femoral deep venous veins, pulmonary intravascular thromboemboli, seizures, post intubation hypotension/hypotensive, lower respiratory culture and urine for streptococcus pneumoniae was positive, oliguric with acute kidney injury, subacute myocardial infarction with acute ischemia, blood clot in liver and neck, status epilepticus, thrombi within bilateral common iliac, external iliac, diffuse bilateral lower extremity superficial thromboses, hemoglobin was low (6.5g/dl), encephalopathy, persistent acute respiratory failure with hypoxia and hypercapnia, hypokalemia, hypomagnesemia, refractory possible autoimmune encephalitis, possible autoimmune vasculitis and tricuspid regurgitation was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). This case, from the same reporter is linked to 20230129900.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH