Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Orthopnoea, Oxygen saturation, Packed red blood cell transfusion, Platelet transfusion
Clinical narrative: DEATH; APHASIA; THROMBOCYTOPENIA; PACKED RED BLOOD CELL TRANSFUSION; PLATELET TRANSFUSION; ANAEMIA; RESPIRATORY VIRAL PANEL; VENTILATION PERFUSION SCAN NORMAL; WHEEZING; SUSPECTED CLINICAL VACCINATION FAILURE; ATRIAL FIBRILLATION; COVID-19 PNEUMONIA; RESPIRATORY FAILURE; RENAL FAILURE; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; CONDITION AGGRAVATED; COUGH; CULTURE POSITIVE; DYSPNOEA; DYSPNOEA EXERTIONAL; DYSPNOEA PAROXYSMAL NOCTURNAL; HAEMOPTYSIS; HYPOTENSION; INTENSIVE CARE; MALAISE; ORTHOPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAER reference number 1828685) concerned a 64 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease, chronic kidney disease, hepatitis c, anemia, depression, atrial fibrillation, gastrooesophageal reflux disease, hypothyroidism, hypersensitivity lung disease, and hypertension. The patient experienced anaphylaxis when treated with lisinopril.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, intramuscular, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 26-AUG-2021 for an unspecified indication. The drug start period was 37 days. Concomitant medications included amlodipine 10 mg once daily, calcitriol 0.25 mcg once daily, fluticasone propionate/salmeterol xinafoate 250/50 once daily, furosemide 40 mg twice daily, metoprolol 50 mg twice daily, mirtazapine 15 mg once daily, ondansetron 4 mg three times a day, salbutamol nebulization PRN, and simvastatin8 10 mg once daily.  On 02-OCT-2021, the patient experienced condition aggravated, culture positive, haemoptysis, hypotension, intensive care, malaise, respiratory viral panel, ventilation perfusion scan normal. Laboratory data included: Respiratory viral panel (NR: not provided) Not Reported, and Ventilation/perfusion scan (NR: not provided) Normal. The patient was presented to emergency department for shortness of breath coughing and wheezing. Patient was feeling unwell for a week and had worsening dyspnea on exertion Paroxysmal nocturnal dyspnea (PND) and orthopnea. The patient also mentioned stopped all of medications for two days because of feeling too unwell 4 days ago. The shortness of breath worsened and had been dusting and that dust made her wheezing and coughing worse. Shortness of breath became severe enough that patient needed to come to the emergency department. The patient was admitted on 03-OCT-2021 for Chronic Obstructive Pulmonary Disease (COPD) exacerbation and Covid pneumonia (Suspected clinical vaccination failure). The patient developed worsening hypoxemic respiratory failure with increasing HFNC(High flow nasal cannula)requirements and was subsequently transferred to the intensive care unit (ICU) on 11-OCT-2021. The patients renal failure worsened so a femoral quinton catheter was placed but the patient became very hypotensive and hypoxic with every attempt at hemodialysis or Continuous renal replacement therapy (CRRT). The patient decided that she would not want to pursue intubation in the setting of further respiratory deterioration. Dialysis made the patient too hypoxic while already on HFNC (High flow nasal cannula). The decision was made to not pursue further dialysis and the quinton was removed. Then the patient's pneumonia panel came back positive for pseudomonas and her respiratory culture indicated the presence of mold and was started on cefepime and cresemba. The oxygen requirements decreased and was transferred back to the floor on 19-OCT-2021. However ON 20-OCT-2021 was again brought back to the ICU(Intensive care unit) once again for worsening hypoxia requiring 60L 90% on HFNC. The patient also developed hemoptysis anemia and thrombocytopenia requiring transfusion of platelets and Packet red blood cell ( (PRBC). V/Q (Ventilation/perfusion) scan was negative for pulmonary embolism (PE). On 23-OCT-2021 the patient developed acute word finding difficulty while speaking with family member (aphasia) in the setting of a brief run of atrial fibrillation and ongoing thrombocytopenia CT (Computed tomography) brain was ordered to assess for stroke bleed. However after discussion with the patient and her daughter the decision was made to withdraw all support and was started on comfort care. On 24-OCT-2021 patient was deceased. The cause of death was unknown. It was unknown if an autopsy was performed.  Laboratory data (dates unspecified) included: Culture positive (NR: not provided) Presence of mold, Oxygen saturation (NR: not provided) 90 %, Respiratory viral panel (NR: not provided) Positive for pseudomonas, and V/Q (Ventilation/perfusion) scan (NR: not provided) Negative for pulmonary embolism.  Treatment medications (dates unspecified) included: cefepime, and isavuconazonium sulfate.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, thrombocytopenia, atrial fibrillation, covid-19 pneumonia, respiratory failure, renal failure, anaemia, aphasia, chronic obstructive pulmonary disease, condition aggravated, cough, culture positive, dyspnoea, dyspnoea exertional, dyspnoea paroxysmal nocturnal, haemoptysis, hypotension, intensive care, malaise, orthopnoea, packed red blood cell transfusion, platelet transfusion, respiratory viral panel, ventilation perfusion scan normal and wheezing on 24-OCT-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000203020. 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 29-NOV-2021. The following information was updated and incorporated into the case narrative: The product quality complaint investigation result was added.; Sender's Comments: V2: This version updates- The product quality complaint investigation result was added. This updated information does not alter the causality of previously reported events  20211129989-COVID-19 VACCINE AD26.COV2.S-death, thrombocytopenia, covid-19 pneumonia, respiratory failure, aphasia, condition aggravated, cough, culture positive, dyspnoea, dyspnoea exertional, dyspnoea paroxysmal nocturnal, haemoptysis, hypotension, intensive care, malaise, orthopnoea, packed red blood cell transfusion, platelet transfusion, respiratory viral panel, ventilation perfusion scan normal and wheezing . 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).  20211129989-COVID-19 VACCINE AD26.COV2.S-atrial fibrillation, renal failure, chronic obstructive pulmonary disease, anemia. 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  V0; 20211129989-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: UNKNOWN CAUSE OF DEATH