Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Activated partial thromboplastin time, Acute respiratory failure, Alanine aminotransferase, Aspartate aminotransferase
Clinical narrative: PNEUMONIA DUE TO COVID (DYSPNEA ON EXERTION, SHORTNESS OF BREATH); ACUTE RESPIRATORY FAILURE DUE TO COVID-19; INTRACTABLE VOMITING WITH NAUSEA; ABDOMINAL DISCOMFORT; HEMATEMESIS; CONFIRMED COVID-19 INFECTION (FEVER, FATIGUE, WEAKNESS, NAUSEA, VOMITING, PERSISTENT COUGH, BODY PAIN); BINOCULAR VISION LOSS; CHRONIC LOW BACK PAIN; METABOLIC ACIDOSIS; DURAL VENOUS SINUS THROMBOSIS; SUBACUTE LEFT FRONTAL INFARCTION; ACUTE PULMONARY EMBOLISM; OCCLUSIVE AND NON OCCLUSIVE DEEP VEIN THROMBOSIS; THROMBOCYTOPENIA; SHOCK; This spontaneous report received from a health care professional concerned a 39-year-old not Hispanic or Latino, African American female. The patient's height, and weight were not reported. The patient's past medical history included acute respiratory failure, edema (leg, eyelid, abdomen), high blood pressure, hospitalization, and chest pain, and concurrent conditions included vision loss, no alcohol use, nonsmoker, type 2 diabetes mellitus, idiopathic intracranial hypertension, chronic back pain, obesity, and hyperlipidemia. The patient experienced drug allergy when treated with metformin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, frequency 1 total administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included acetazolamide for idiopathic intracranial hypertension, tramadol for pain, amlodipine, baclofen, furosemide, gabapentin, guaifenesin, hydrochlorothiazide, insulin detemir, lactulose, liraglutide, and lisinopril. Patient had multiple hospitalizations. On 23-Feb-2021 (before vaccination), patient visited emergency department for chest pain and hypertension. Eyelid edema and sinus tachycardia was noted. Platelet count was 366,000.  On 12-Mar-2021 (Day 5 after vaccination), patient was hospitalized for binocular vision loss. Patient experienced this since past 1 month and also had headache. Patient was diagnosed with chronic bilateral blurry vision likely pseudo tumor cerebri. Computed tomography (CTA) of head was done on 12-Mar-2021 at 19:30, No evidence of an acute intracranial process and no evidence of Dural venous sinus thrombosis on CTA of the head. MRI (Magnetic resonance imaging) brain done on 13-Mar-2021 showed no acute infarct, mass or hemorrhage. Patient was prescribed Diamox. Patient was discharged on 14-Mar-2021, after 2 days in hospital.  On 25-Mar-2021 (Day 18 after vaccination), patient was admitted to hospital for Covid-19 [coded as Confirmed COVID-19 infection for fever, fatigue, weakness, nausea, vomiting, persistent cough, body pain. COVID-19 PCR and IgG tests were positive. Patient was discharged on 29-Mar-2021.  Patient was readmitted to the hospital on 31-Mar-2021 (Day 24 post vaccination, Day 7 after positive Covid-19 by PCR) for Covid-19 pneumonia and acute respiratory failure.  She also had complaints of intractable vomiting with nausea, hematemesis and abdominal discomfort. The patient was noted to be have metabolic acidosis and shock.  Notable laboratory results included platelet count of 100,000,  During the hospitalization, she was further diagnosed with subacute left frontal infarct (anterior left MCA distribution), dural venous sinus thrombosis within right sigmoid sinus, pulmonary embolism and deep vein thrombosis during the hospitalization.  On 5-APR-21, the patient "coded" and was revived after 2 rounds of cardiorespiratory resuscitation. She experienced asystole and died later that day. The cause of death was Pneumonia due to Covid-19. Autopsy was not performed. Notable laboratory results during hospitalization included: D-dimer was 1,162 (date not specified). On 04-APR-2021, pulmonary embolism was diagnosed (test unknown) and head CT showed  dural venous sinus thrombosis.  Notable laboratory data during the complex hospital course included: On 04 APR 2021 Glucose (NR: not provided) 274 mg/dL, activated partial thromboplastin time (NR: not provided) 103.66 sec., albumin (NR: not provided) 2.1 g/dL, alkaline phosphatase (NR: not provided) 221 U/L, BNP (NR: not provided) 235 pg/mL, BUN (NR: not provided) 40 mg/dL, Bilirubin (NR: not provided) 0.5 mg/dL, Calcium (NR: not provided) 7.7 mg/dL, Carbon dioxide (NR: not provided) 24 mEq/L, Chloride (NR: not provided) 114 mEq/L, Creatinine (NR: not provided) 1.86 mg/dL, Glomerular filtration rate (NR: not provided) 39, Glucose (NR: not provided) 300 mg/dL, HIV antibody (NR: not provided) negative, HIV antigen (NR: not provided) negative, Hepatitis A antibody (NR: not provided) negative, Hepatitis B core antibody (NR: not provided) negative, Hepatitis B surface antigen (NR: not provided) negative, Hepatitis C antibody (NR: not provided) negative, Magnesium (NR: not provided) 2.3 mg/dL, Phosphorus (NR: not provided) 3.9 mg/dL, Potassium (NR: not provided) 3.7 mEq/L, Protein (NR: not provided) 5.8 g/dL, SGOT (NR: not provided) 33 U/L, SGPT (NR: not provided) 10 U/L, Sodium (NR: not provided) 144 mEq/L, and Troponin I (NR: not provided) 3.05 ng/mL, lactic acid (NR: not provided) 2.0 mmol/L, arterial blood pH (NR: not provided) 7.28, Oxygen saturation (NR: not provided) 85 %, Partial arterial pressure of carbon dioxide (NR: not provided) 58 mmHg, and Partial arterial pressure of oxygen (NR: not provided) 57 mmHg. On 05-APR-2021: Fibrin D dimer (NR: not provided) 25,989 ng/mL. On 06-APR-2021: Oxygen saturation (NR: not provided) was 73 % and the platelet count was 154,000.  Imaging studies during hospitalization included: CTA of head (03-APR-2021) showing  subacute left frontal infarction in anterior left MCA distribution, CTA of head (04-APR-2021) showing dural venous sinus thrombosis within the right sigmoid sinus as well as within the distal aspect of the left transverse sinus measuring marginally extending into the sigmoid sinus, bilateral upper extremity Doppler ultrasound (04-APR-2021) showing occlusive and non-occlusive deep venous thrombosis in the bilateral upper extremities and occlusive superficial venous thrombosis within the bilateral cephalic veins. Chest X ray (or other exam, on04-Apr-2021) showing segmental pulmonary embolus in right upper lobe, and right lower lobe, chest X-ray (06-APR-2021) showing bilateral pulmonary opacities.  Treatment medications (dates unspecified) included: zinc, ergocalciferol, ibuprofen, vancomycin, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, piperacillin sodium/tazobactam sodium, dexamethasone, and rivaroxaban.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of  acute respiratory failure due to Covid-19 pneumonia and other complications including shock, metabolic acidosis, acute pulmonary embolism, deep vein thrombosis, dural venous sinus thrombosis, thrombocytopenia,  This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report is associated with product quality Number: 90000176348; Sender's Comments: V0: This case concerns a 39-year-old female who died during a complicated hospital course that included pneumonia due to COVID infection, acute respiratory failure, shock, metabolic acidosis, pulmonary embolism, Dural venous sinus and transverse thrombosis, upper extremity venous thrombosis and thrombocytopenia 29 days after receiving covid-19 vaccine ad26.cov2.s / 12 days after PCR-confirmed Covid-19 infection.   The patient has a history of diabetes, obesity, and idiopathic intracranial hypertension and decreased vision starting prior to vaccination. The subject was presented to the emergency department 13 days prior to vaccination with eyelid edema, chest pain and hypertension. At this time her platelet count was 366,000. She was hospitalized 4 days after vaccination for vision loss. A CT angiogram (CTA) of the head and MRI were unremarkable. She was hospitalized again 17 days after vaccination with symptoms of COVID infection and tested positive for COVID. She was readmitted again 23 days after vaccination / 6 days after Covid-19 infection with pneumonia and acute respiratory failure. Her course was complicated by acidosis, hypoxia, elevated D-Dimer with a peak value of 25,989 ng/ml and thrombocytopenia. CTA of the head and chest diagnosed dural venous sinus thrombosis, right sigmoid sinus and left transverse sinus thrombosis as well as pulmonary embolus.  She died after 6 days in hospital.  The death and reported events are most likely related to the patients underlying medical conditions and the complications associated with Covid-19 infection/Covid-19 pneumonia, and are considered inconsistent with a causal association to immunization, per the WHO causality classification for adverse events following immunization.; Reported Cause(s) of Death: PNEUMONIA DUE TO COVID