Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sepsis, Tidal volume, Tracheostomy, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONDITION AGGRAVATED; DEATH; GASTROSTOMY; TRACHEOSTOMY; MECHANICAL VENTILATION; POSITIVE END-EXPIRATORY PRESSURE; RESUSCITATION; TIDAL VOLUME; CHEST TUBE INSERTION; ECHOCARDIOGRAM ABNORMAL; EJECTION FRACTION DECREASED; FRACTION OF INSPIRED OXYGEN; ACUTE KIDNEY INJURY; CARDIAC ARREST; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; RENAL TUBULAR NECROSIS; SEPSIS; COVID-19 PNEUMONIA; PNEUMONIA PSEUDOMONAL; PNEUMONIA NECROTISING; PNEUMOTHORAX; PULSELESS ELECTRICAL ACTIVITY; COVID-19; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System concerned a 74 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 02-DEC-2021. The patient's height, and weight were not reported. The patient's past medical history included: cholecystectomy, and right knee replacement, and concurrent conditions included: chronic obstructive pulmonary disease, pulmonary embolism, hyperlipidemia, gastroesophageal reflux disease, and hypothyroidism. The patient's son passed away from COVID-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 01-MAY-2021 for an unspecified indication. (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 05-OCT-2021, the patient tested positive for COVID-19 virus test and experienced covid-19 infection, and was hospitalized (date unspecified). On an unspecified date, patient experienced confirmed clinical vaccination failure. Patient was unable to be weaned off of the ventilator and underwent a tracheostomy on 27-OCT-2021 and gastrostomy placement on 29-OCT-2021. The patient was transferred to bigger hospital from a smaller Hospital with COVID-19 pneumonia and sepsis on 03-NOV-2021. When the patient arrived to bigger hospital the patient had a pulseless electrical activity cardiac arrest requiring chest compressions and 1 dose of epinephrine prior to returning to spontaneous circulation. The patients post cardiac echocardiogram showed an ejection fraction decreased to 23%, the patient also developed acute kidney injury related to acute tubular necrosis. The patient was given tocilizumab, remdesivir and steroids The patient's hospital course was further complicated by deep vein thrombosis and pulmonary embolism. Patient was noted to also have right upper lobe necrotizing pneumonia due to Pseudomonas and was on Meropenem. The patient's family met with palliative care and they wanted to continue current care. On admission the patient was on assit-control mode of ventilation with a tidal volume of 380, Positive end-expiratory pressure of 5 respiratory rate of 14 and FiO2 (Fraction of inspired oxygen) of 40%. The patient also had pneumothoraxes and 2 right sided chest tubes and a chest tube on the left. Patient's condition worsened and on 11-NOV-2021. The surgical additional chest tube placement needed but family decided on comfort cares at that time. Patient was placed on comfort cares. On 12-NOV-2021, at 15:00 the patient died from unknown cause of death. The number of hospitalization days was 36 days. It was unknown whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of from unknown cause of death on 12-NOV-2021, and the outcome of cardiac arrest, pulmonary embolism, acute kidney injury, deep vein thrombosis, renal tubular necrosis, sepsis, covid-19 pneumonia, pneumonia pseudomonal, pneumonia necrotising, pneumothorax, pulseless electrical activity, condition aggravated, covid-19, sars-cov-2 test positive, chest tube insertion, echocardiogram abnormal, ejection fraction decreased, fraction of inspired oxygen, gastrostomy, mechanical ventilation, positive end-expiratory pressure, resuscitation, tidal volume and tracheostomy was fatal, 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: 90000205240. 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 RA department on 06-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1 Additional information in this version updates of Product quality complaint investigation result. This updated information does not change the prior causality assessment of reported events.  20211201285- Covid-19 vaccine ad26.cov2.s- Death, cardiac arrest, acute kidney injury, deep vein thrombosis, renal tubular necrosis, sepsis, covid-19 pneumonia, pneumonia pseudomonal, pneumonia necrotising, pneumothorax, pulseless electrical activity, condition aggravated, covid-19, sars-cov-2 test positive, chest tube insertion, echocardiogram abnormal, ejection fraction decreased, fraction of inspired oxygen, gastrostomy, mechanical ventilation, positive end-expiratory pressure, resuscitation, tidal volume, tracheostomy. 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). 202111201285-Covid-19 vaccine ad26.cov2.-Pulmonary embolism. 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 20211201285-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: UNKNOWN CAUSE OF DEATH