Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Acute respiratory failure, Anticoagulant therapy, COVID-19 pneumonia
Clinical narrative: COVID-19 pneumonia; Acute respiratory failure; Acute respiratory distress syndrome; Acute kidney injury; Hypoxia; SUSPECTED CLINICAL VACCINATION FAILURE; Pulse absent; Death; Fungal test; Thrombosis; Ultrasound Doppler normal; Vascular catheterisation; Dialysis; Echocardiogram abnormal; Right ventricular dilatation; Anticoagulant therapy; Cardiac arrest; Endotracheal intubation; Haemofiltration; Computerised tomogram thorax abnormal; Mechanical ventilation; General physical health deterioration; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1736821), concerned a 42 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown) with frequency as 1 total, dose was not reported, administered on 26-AUG-2021 for an unspecified indication. The batch number was not reported. Per Procedure, no follow up will be requested for this case.  No concomitant medications were reported.  The patient recently admitted to outside hospital with COVID-19 pneumonia and associated complications including acute hypoxemic, respiratory failure, acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI). During the course of her hospitalization she was treated with Dexamethasone, Remdesivir, Tofacitinib, Plaquenil and Ivermectin. She required intubation (Endotracheal intubation) on 10-Sep-2021 and developed cardiac arrest after a prolonged period of hypoxia on 12-Sep-2021. She was transferred for higher level care and treatment with continuous renal replacement therapy (CRRT) (Haemofiltration).  On 15-SEP-2021, she had a vascular catheter (Vascular catheterisation) placed, initiated dialysis that same night. She had an echocardiogram (Echocardiogram abnormal) on 15-SEP-2021 that most notably showed right ventricular (RV) was mildly dilated (Right ventricular dilatation) with moderately reduced function therefore she was started on therapeutic heparin (anticoagulant therapy) given the concern for possible pulmonary embolism (PE) in the setting of Covid. Laboratory data included: Echocardiogram (NR: not provided) abnormal.  On 16-SEP-2021, Lower extremity Dopplers (Ultrasound Doppler normal) were negative for deep vein thrombosis (DVT) (Thrombosis). Laboratory data included: Ultrasound Doppler (NR: not provided) normal.  On 17-SEP-2021, the patient underwent dialysis again. From a respiratory standpoint she was treated with flolan and has been continued on Zosyn and Zyvox since admission. She was started on Voriconazole on 17-SEP-2021 and fungal labs (fungal test) fungitel galactomannan blaso histo Ag were ordered for concern of possible underlying fungal infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. Laboratory data included: Fungal test (NR: not provided) unknown. Computed tomography Pulmonary Embolus (CT PE) study (Computerised tomogram thorax abnormal) showed two right ventricular (RV) thrombus. Laboratory data included: Computerised tomogram thorax (NR: not provided) abnormal. Therapeutic heparin was changed to Argatroban to reduce fluid intake.  Unfortunately, despite best efforts including maximizing ventilator settings and multiple rounds of hemodialysis (Mechanical ventilation) patient continued to decline without improvement (General physical health deterioration). After discussion with family on 22-SEP-202 decision was made to transition patient to comfort care but to keep her on the ventilator.  On the morning of 23-SEP-2021 06:55, patient lost pulse (Pulse absent) and was pronounced dead due to an unknown cause. Laboratory data included: Pulse rate (NR: not provided) absent. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19 pneumonia, acute respiratory failure, acute respiratory distress syndrome, acute kidney injury, cardiac arrest, hypoxia, thrombosis, endotracheal intubation, haemofiltration, vascular catheterisation, dialysis, echocardiogram abnormal, right ventricular dilatation, anticoagulant therapy, ultrasound doppler normal, fungal test, computerised tomogram thorax abnormal, mechanical ventilation, general physical health deterioration and pulse absent on 23-SEP-2021 06:55, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Life Threatening). This report is associated with product quality compliant:90000197404.  The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 18-Oct-2021. The following information was updated and incorporated into the case narrative: Product quality complaint result was added.; Sender's Comments: V2: Additional information in this version updates: Product quality complaint result. This additional information does not alter the causality of the previously reported events. 20211017574-covid-19 vaccine ad26.cov2.s- Death, covid-19 pneumonia, acute respiratory failure, acute respiratory distress syndrome, acute kidney injury, cardiac arrest, hypoxia, thrombosis, endotracheal intubation, haemofiltration, vascular catheterisation, dialysis, echocardiogram abnormal, right ventricular dilatation, anticoagulant therapy, ultrasound doppler normal, fungal test, computerised tomogram thorax abnormal, mechanical ventilation, general physical health deterioration, pulse absent. This event(s) is considered unassessable. 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). 20211017574-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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: SPECIAL SITUATIONS; Reported Cause(s) of Death: DEATH