Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Septic shock, Thrombocytopenia
Clinical narrative: fDEATH; CARDIOGENIC SHOCK; ISCHAEMIC HEPATITIS; SEPTIC SHOCK; THROMBOCYTOPENIA; HEART RATE DECREASED; HYPOTENSION; INTENSIVE CARE; MALAISE; MEAN ARTERIAL PRESSURE; OXYGEN SATURATION DECREASED; CONFIRMED COVID-19 INFECTION; COUGH; DYSPNOEA; SARS-COV-2 TEST POSITIVE; RESPIRATORY FAILURE; SEPSIS; ENCEPHALOPATHY; COVID-19 PNEUMONIA; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 2082974) was received on 11-FEB-2022 and concerned a 70 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included End-stage renal disease, CHF (congestive heart failure), EF (ejection fraction) 15 percent, implantable cardioverter-defibrillator (ICD), kidney transplant, and partial lobectomy from lymphoma in remission, and concurrent conditions included pneumonia, AFIB (atrial fibrillation), DM (diabetes mellitus), lupus nephritis, and allergy to cephalexin and prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) dose was not reported, 1 total administered on 17-MAR-2021 for an unspecified indication. Concomitant medications included apixaban, atorvastatin, carvedilol, colecalciferol, ferrous sulfate, gabapentin, insulin detemir, and methoxy polyethylene glycol-epoetin beta. On 17-MAR-2021, patient received Pfizer Vaccine. The drug start period was 298 days. On 09-JAN-2022, the patient experienced covid-19 pneumonia, cough, dyspnea, encephalopathy, respiratory failure, sars-cov-2 test positive and sepsis. On 09-JAN-2022, the patient was presented to ED (emergency department) with complaints of SOB (shortness of breath) and cough. The patient was admitted for hypoxic, respiratory failure, covid pneumonia, sepsis and acute encephalopathy. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The patient was treated with dexamethasone, ceftriaxone and doxycycline. On 15-JAN-2022, treatment with dexamethasone, ceftriaxone and doxycycline was stopped. Then patient received vancomycin, cefepime, micafungin and 1 2 Beta D glucan as a treatment medication. On 24-JAN-2022, the patient experienced confirmed covid-19 infection, cardiogenic shock, death, heart rate decreased, hypotension, intensive care, ischaemic hepatitis, malaise, mean arterial pressure, oxygen saturation decreased, septic shock, and thrombocytopenia. Patient admitted to ICU (intensive care unit) with septic cardiogenic shock. Course complicated by shock liver thrombocytopenia and ongoing hyopoxic respiratory failure. Patient's BP (blood pressure) remained low with MAPs (mean arterial pressure) in 50-60s. DNR (do not resuscitate) status was patient's HR (heart rate) and O2 (oxygen) suddenly dropped. Laboratory data included: Heart rate (NR: not provided) decreased, mean arterial pressure (NR: not provided) 50-60s, and Oxygen saturation (NR: not provided) decreased. Laboratory data (dates unspecified) included: BP (NR: not provided) remained low. The patient visited to emergency room for all events. The patient was hospitalized for 15 days for all events. It was not reported if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of confirmed covid-19 infection, covid-19 pneumonia, cardiogenic shock, cough, death, dyspnoea, encephalopathy, heart rate decreased, hypotension, intensive care, ischaemic hepatitis, malaise, mean arterial pressure, oxygen saturation decreased, respiratory failure, sars-cov-2 test positive, sepsis, septic shock and thrombocytopenia on 24-JAN-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000217505. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. based on the PQC evaluation/investigation performed.  Additional information received from department on 17-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This version updates- Product quality complaint investigation result. This new  information does not alter prior causality assessment. 20220230459-covid-19 vaccine ad26.cov2.s -Death, Confirmed covid-19 infection, covid-19 pneumonia, cardiogenic shock, cough, dyspnoea, encephalopathy, heart rate decreased, hypotension, intensive care, ischaemic hepatitis, malaise, mean arterial pressure, oxygen saturation decreased, respiratory failure, sars-cov-2 test positive, sepsis, septic shock and thrombocytopenia. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH