Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Septic shock, Toxic encephalopathy, Viral sepsis
Clinical narrative: ACUTE KIDNEY INJURY; PULMONARY HYPERTENSION; SARS-COV-2 TEST POSITIVE; ACUTE RESPIRATORY DISTRESS SYNDROME; PULMONARY HYPERTENSION; SEPTIC SHOCK; GRAM STAIN POSITIVE; ACUTE RESPIRATORY FAILURE; ACUTE RESPIRATORY DISTRESS SYNDROME; HYPOKALAEMIA; LUNG OPACITY; BACTERAEMIA; HYPOKALAEMIA; COVID-19 PNEUMONIA; PULMONARY OEDEMA; LACTIC ACIDOSIS; RIGHT ATRIAL ENLARGEMENT; PULMONARY OEDEMA; BLOOD CULTURE POSITIVE; TOXIC ENCEPHALOPATHY; ANGIOGRAM PULMONARY NORMAL; VIRAL SEPSIS; PO2 DECREASED; COVID-19; LACTIC ACIDOSIS; CANDIDA INFECTION; TOXIC ENCEPHALOPATHY; HAEMATURIA; HYPERNATRAEMIA; HYPERGLYCAEMIA; LEUKOCYTOSIS; HYPERNATRAEMIA; LUNG INFILTRATION; LEUKOCYTOSIS; RIGHT VENTRICULAR ENLARGEMENT; LUNG INFILTRATION; ANTICOAGULANT THERAPY; LUNG OPACITY; CENTRAL VENOUS CATHETERISATION; MALNUTRITION; INTENSIVE CARE; RIGHT ATRIAL ENLARGEMENT; PROCALCITONIN; RIGHT VENTRICULAR ENLARGEMENT; CULTURE; ANTICOAGULANT THERAPY; ACUTE RESPIRATORY FAILURE; CENTRAL VENOUS CATHETERISATION; VIRAL SEPSIS; INTENSIVE CARE; MALNUTRITION; CHEST X-RAY ABNORMAL; COVID-19; ECHOCARDIOGRAM ABNORMAL; HAEMATURIA; SARS-COV-2 TEST POSITIVE; BLOOD GASES ABNORMAL; BLOOD CULTURE POSITIVE; BACTERAEMIA; PROCALCITONIN; ECHOCARDIOGRAM ABNORMAL; CULTURE; CANDIDA INFECTION; BLOOD GASES ABNORMAL; COVID-19 PNEUMONIA; GRAM STAIN POSITIVE; HYPERGLYCAEMIA; ANGIOGRAM PULMONARY NORMAL; SEPTIC SHOCK; PO2 DECREASED; CHEST X-RAY ABNORMAL; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 2562206) on 27-JAN-2023 concerned an 85 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer, and normocytic anemia. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection,, route of admin, batch number not reported expiry: UNKNOWN) dose was not reported, 1 total administered for an unspecified indication. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-NOV-2021 for an unspecified indication. Age at time of vaccination 85 years old. No concomitant medications were reported.  On 07-DEC-2022, the patient experienced acute kidney injury, acute respiratory distress syndrome, acute /hypoxic respiratory failure. Initial O2 (Oxygen) saturation was around 70% on 5 L nasal cannula. He was placed on 15 L nonrebreather and O2 (Oxygen) saturation corrected to just above 90. The patient met signs and symptoms of septic shock with viral sepsis. The patient was started was on Levophed therapy and found to have a PO2 (Partial pressure of oxygen) of 38. Chest x-ray revealed abnormal multifocal opacities (Lung opacity) infiltrates (Lung infiltration). He was started on dexamethasone broad spectrum antibiotics and breathing treatments. Initial admission was to intensive care unit started on broad-spectrum antibiotics including vancomycin and cefepime. Cultures were obtained as well as procalcitonin and antibiotics were de-escalated Confirmed COVID-19 infection required aggressive steroid therapy. His acute renal failure on presentation was prohibitive of Remdesivir therapy. Echocardiogram was obtained with preserved ejection fraction (Abnormal). The patient was noted to have right ventricular enlargement and right atrial enlargement with moderate pulmonary hypertension. A CTA (Angiogram) was obtained and negative for pulmonary embolism. Initially the patient was treated with heparin infusion pending rule out of pulmonary embolism. A left femoral central venous line was removed (central venous catheterisation) following 3 of 4 blood cultures positive for gram stain positive cocci Vancomycin was continued throughout his inpatient stay based on this patient was adequately fluid resuscitated with improvement in his lactic acidosis and his AKI. Because of his leukocytosis and bacteremia he was not an appropriate candidate for baricitinib therapy. Ultimately patient had failed to respond to aggressive broad-spectrum antibiotics with O2 (Oxygen) support and Decadron therapy. Nebulizer therapies have been provided scheduled and as needed throughout his stay without significant improvement in his pulmonary function and was hospitalized for 11 days. The patient has been followed by pulmonary service Discharge diagnosis was Acute respiratory failure with hypoxia, Viral sepsis, Septic shock, ARDS, COVID-19 pneumonia, Possible superimposed bacterial pneumonia, Acute toxic metabolic encephalopathy due to sepsis and hypoxia. Pulmonary Edema on exam Blood culture contamination Pulmonary hypertension, Acute Hypernatremia, AKI, Lactic acidosis, Hypokalemia, Thrush Hematuria, Hyperglycemia Severe protein calorie (malnutrition) (Dose number in series 2). Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 70 %, and Oxygen saturation 90 (Dose number in series 2). Treatment medications (dates unspecified) included: vancomycin, cefepime, heparin, Levophed and dexamethasone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, acute respiratory distress syndrome, acute respiratory failure, angiogram pulmonary normal, anticoagulant therapy, bacteraemia, blood culture positive, blood gases abnormal, covid-19, covid-19 pneumonia, candida infection, central venous catheterisation, chest x-ray abnormal, culture, echocardiogram abnormal, gram stain positive, haematuria, hyperglycaemia, hypernatraemia, hypokalaemia, intensive care, lactic acidosis, leukocytosis, lung infiltration, lung opacity, malnutrition, po2 decreased, procalcitonin, pulmonary hypertension, pulmonary oedema, right atrial enlargement, right ventricular enlargement, sars-cov-2 test positive, septic shock, toxic encephalopathy and viral sepsis was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000269107. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from department on 10-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events.  20230161674- Acute kidney injury, pulmonary hypertension, septic shock, hypokalaemia, bacteraemia, lactic acidosis, pulmonary oedema,  toxic encephalopathy, candida infection, haematuria, hyperglycaemia, hypernatraemia, leukocytosis, lung infiltration, lung opacity, malnutrition, right atrial enlargement, right ventricular enlargement, anticoagulant therapy, central venous catheterisation, intensive care, chest x-ray abnormal, echocardiogram abnormal, blood culture positive, procalcitonin, culture,  blood gases abnormal, gram stain positive, angiogram pulmonary normal, po2 decreased. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.  V0: 20230161674- acute respiratory distress syndrome, acute respiratory failure, covid-19 pneumonia, viral sepsis, covid-19, sars-cov-2 test positive. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.