Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, SARS-CoV-2 test, SARS-CoV-2 test positive, Subclavian vein thrombosis, Urinary tract infection
Clinical narrative: DEATH; URINARY TRACT INFECTION; INTENSIVE CARE; MECHANICAL VENTILATION; ENDOTRACHEAL INTUBATION; GENERAL PHYSICAL HEALTH DETERIORATION; COVID-19 PNEUMONIA; HYPOXIA; DYSPONEA; SUBCLAVIAN VEIN THROMBOSIS; JUGULAR VEIN THROMBOSIS; ANTICOAGULANT THERAPY; SARS-COV-2 TEST POSITIVE; COVID-19; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1854042), concerned a 53-year-old female patient of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple myeloma, end stage renal dialysis (ESRD) with hemodialysis, and morbid obesity. The patient experienced drug allergy when treated with non-steroidal anti-inflammatory drugs (NSAIDs), thorazine (chlorpromazine), and Ultram (tramadol hydrochloride) when used for unknown indications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, dose series 1, administered on 16-MAR-2021 for an unknown indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was taking unspecified chemo treatment medications for multiple myeloma. On an unspecified date, the patient developed urinary tract infection (UTI). On 27-AUG-2021, the patient was admitted to the hospital with positive covid-19 [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive; confirmed clinical vaccination failure] and acute hypoxemia. On 31-AUG-2021, she was discharged with good oxygenation on dexamethasone and Levoquin (levofloxacin) for UTI. The patient was admitted again on 02-SEP-2021 due to worsening dyspnea (hypoxia) from covid-19 pneumonia and was treated with Zyvox (linezolid) and Zosyn (piperacillin sodium, tazobactam sodium) on high flow oxygen. The patient continued to decline (general physical health deterioration). On 03-SEP-2021, the patient was admitted to the intensive care unit (ICU), intubated (endotracheal intubation), put on mechanical ventilation and she received remdesivir and continued on unspecified steroids. On an unspecified date, in SEP-2021, bilateral internal jugular vein thrombosis and subclavian vein thrombosis was found following which the patient was transitioned from anticoagulant therapy Eliquis (apixaban) to Lovenox (enoxaparin sodium). The patient could not be weaned off from the ventilator. The patient's family involved in care, transitioned her to comfort care and the patient was extubated. On 11-SEP-2021, the patient died. The reported events had not recovered at the time of death. The exact cause of death was unknown. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events death, covid-19 pneumonia, hypoxia, subclavian vein thrombosis, jugular vein thrombosis, anticoagulant therapy, covid-19, sars-cov-2 test positive, dysponea, general physical health deterioration, endotracheal intubation, intensive care, mechanical ventilation, and urinary tract infection was reported as fatal, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report is associated with a product quality complaint: 90000203449. 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 (Void N).  Additional information received from Central Complaint Vigilance department on 26-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result, dose series.; Sender's Comments: V1: Additional information in this version updates Product quality complaint investigation result, dose series. This updated information does not alter the causality of the previously reported events.  20211145189- covid-19 vaccine ad26.cov2.s-Death,  covid-19 pneumonia,  hypoxia,  subclavian vein thrombosis,  jugular vein thrombosis,  Covid-19,  dysponea,  endotracheal intubation,   sars-cov-2 test positive,  general physical health deterioration,  anticoagulant therapy, intensive care,  mechanical ventilation,  urinary tract infection . 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).  20211145189- covid-19 vaccine ad26.cov2.s-Confirmed 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: ANTICOAGULANT THERAPY; CONFIRMED COVID-19 INFECTION; COVID-19 PNEUMONIA; DEATH; DYSPNOEA; ENDOTRACHEAL INTUBATION; GENERAL PHYSICAL HEALTH DETERIORATION; HYPOXIA; INTENSIVE CARE; JUGULAR VEIN THROMBOSIS; MECHANICAL VENTILATION; SARS-COV-2 TEST POSITI