Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Heart rate, Intensive care, Laboratory test, Mechanical ventilation
Clinical narrative: Tachypnoea; Use of accessory respiratory muscles; Blood pressure decreased; Intensive care; Mechanical ventilation; Serum ferritin increased; Blood creatinine increased; Anticoagulant therapy; Blood gases; Platelet count decreased; Endotracheal intubation; Culture; Ultrasound Doppler normal; Troponin increased; SARS-CoV-2 test positive; Fibrin D dimer; Positive airway pressure therapy; Oxygen saturation decreased; Sedation; Cough; Pyrexia; Dyspnoea; COVID-19; Decreased appetite; Asthenia; Death; Acute kidney injury; Thrombocytopenia; Acute respiratory distress syndrome; Acute respiratory failure; Atrial fibrillation; Myocardial ischaemia; Cardiac failure congestive; COVID-19 pneumonia; Gastrointestinal haemorrhage; Syncope; Renal impairment; Respiratory distress; Dyspnoea at rest; Confirmed clinical vaccination failure; This spontaneous report received from a patient by a Regulatory Authority (VAERS ID: 1951755) concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: COPD, diabetes mellitus type 2, hypertension, pulmonary hypertension, (a regulatory authority) class 2 chronic kidney disease III, sleep apnea, and heart failure with preserved ejection fraction diastolic heart failure. The patient was previously treated with tetanus vaccine.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1,suspension for injection, intramuscular, batch number: 205A21A) dose was not reported, 1 total administered to left arm on 14-MAY-2021 for unspecified indication. No concomitant medications were reported.  On 28-OCT-2021, the patient was admitted with weakness lack of appetite mild non-productive cough for 1 week duration with syncopial episode. On admission the patient's COVID-19 test was found to be positive with right atrial oxugen saturation of 88 percent and was placed on 2 LNC (nasal cannula), respiratory rate was 26-27, heart rate 90 and the patient was afebrile. The patient was admitted with acute hypoxemic respiratory failure with multilobular COVID PNA (Peptide Nucleic Acid) and mild acute kidney injury. The patient was started on intravenous remdesivir, intravenous decadron, intravenous ceftriaxone, intravenous doxy cycline, combivent and subcutaneous heparin. On the same day experienced acute respiratory distress syndrome, acute respiratory failure, atrial fibrillation, covid-19 pneumonia, cardiac failure congestive, death, dyspnoea at rest, gastrointestinal haemorrhage, myocardial ischaemia, renal impairment, respiratory distress, syncope, thrombocytopenia, anticoagulant therapy, asthenia, blood creatinine increased, blood gases, blood pressure decreased, covid-19, cough, decreased appetite, dyspnea, platelet count decreased, pyrexia, sedation, endotracheal intubation, mechanical ventilation, confirmed clinical vaccination failure, culture,  intensive care, ultrasound doppler normal, serum ferritin increased, troponin increased, sars-cov-2 test positive, fibrin d dimer, positive airway pressure therapy, oxygen saturation decreased. The patient was hospitalized for 31 days. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 29-OCT-2021, the patient was desatting, tachypnic and on accessory muscle use and was placed on 15L HFNC (high flow nasal cannula) and NRBM (Non-rebreather mask). On the same day, oxygen saturation was 87 percent. On 30-OCT-2021, renal function improved. The patient was started on baricitinib. On the same day, d-dimer was 877, ferritin was 1090. On 31-OCT-2021, d-dimer was 902, ferritin was 3500 and doppler ultrasound negative for DVT (deep vein thrombosis). The patient  was started on lovenox and was placed on high flow nasal cannula on 40 percent.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from acute kidney injury, acute respiratory distress syndrome, acute respiratory failure, asthenia, atrial fibrillation, blood creatinine increased, blood gases, covid-19, covid-19 pneumonia, cardiac failure congestive, cough, death, decreased appetite, dyspnoea, dyspnoea at rest, gastrointestinal haemorrhage, myocardial ischaemia, pyrexia, renal impairment, respiratory distress, sedation, serum ferritin increased, syncope, tachypnoea, thrombocytopenia, anticoagulant therapy, blood creatinine increased, blood gases, blood pressure decreased, platelet count decreased, endotracheal intubation, mechanical ventilation, culture, intensive care, ultrasound doppler normal, serum ferritin increased, troponin increased, sars-cov-2 test positive, fibrin d dimer, positive airway pressure therapy and oxygen saturation decreased and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000208918. 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 evaluation/investigation performed.  Additional information received from a regulatory authority on 04-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V1: Follow up information in this version updated Product quality complaint investigation result. The follow up information does not change the causality of the previous reported events.   20211255718- covid-19 vaccine ad26.cov2.s - acute kidney injury, cardiac failure congestive, renal impairment, blood creatinine increased. 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: MEDICAL HISTORY 20211255718- covid-19 vaccine ad26.cov2.s -death, thrombocytopenia, acute respiratory distress syndrome, acute respiratory failure, atrial fibrillation, myocardial ischaemia, covid-19 pneumonia, gastrointestinal haemorrhage, syncope,  respiratory distress, dyspnoea at rest, tachypnoea,  sedation,  cough,  pyrexia, dyspnoea, covid-19,  decreased appetite,  asthenia,  blood pressure decreased, mechanical ventilation, serum ferritin increased, blood creatinine increased,  anticoagulant therapy, blood gases, platelet count decreased, endotracheal intubation, culture, intensive care,  ultrasound doppler normal,  troponin increased,  sars-cov-2 test positive,  fibrin d dimer,  positive airway pressure therapy ,oxygen saturation decreased. 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). 20211255718-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: ACUTE KIDNEY INJURY; ACUTE RESPIRATORY DISTRESS SYNDROME; ACUTE RESPIRATORY FAILURE; ASTHENIA; ATRIAL FIBRILLATION; COVID-19; COVID-19 PNEUMONIA; CARDIAC FAILURE CONGESTIVE; COUGH; DEATH; DECREASED APPETITE; DYSPNOEA; DYSPNOEA AT REST; GASTROINTESTIN