Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Prone position, Pulmonary embolism, Pyrexia, Vaccination failure
Clinical narrative: DEATH; CARDIOVERSION; EXTUBATION; ANGIOGRAM PULMONARY ABNORMAL; ELECTROCARDIOGRAM ABNORMAL; PULMONARY EMBOLISM; VENTRICULAR TACHYCARDIA; HYPOTENSION; PYREXIA; LABORATORY TEST NORMAL; PRONE POSITION; VASOPRESSIVE THERAPY; ENDOTRACHEAL INTUBATION; MECHANICAL VENTILATION; ACUTE RESPIRATORY FAILURE; HYPOXIA; DYSPNOEA; MENTAL STATUS CHANGES; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1765357) concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anxiety, depression, and chronic back pain, and concurrent conditions included: insulin-dependent diabetes mellitus 2, obstructive sleep apnea, postural orthostatic tachycardia syndrome, lumbar spinal stenosis, morbid obesity, and hyperlipidemia. The patient experienced drug allergy when treated with prochlorperazine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1082068 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for an unspecified indication. Concomitant medications included acetylsalicylic acid, alprazolam, bisacodyl, citalopram, gabapentin, gemfibrozil, latanoprost, linaclotide, metformin, midodrine, oxycodone hydrochloride/paracetamol, timolol maleate, venlafaxine, vitamins nos, and zolpidem.  On 03-SEP-2021, the patient had laboratory test normal and COVID-19 infection (suspected clinical vaccination failure). On 04-SEP-2021, the patient presented from clinic with acute respiratory failure due to COVID-19 infection. The patient required intubation secondary to refractory hypoxemia (Hypoxia) with worsening mental status (Mental status changes) and increased work of breathing (Dyspnoea). On 06-SEP-2021, the patient was initially on paralytics and intermittently in prone position following intubation (Endotracheal intubation). The hospital course complicated by persistent fevers (Pyrexia) up to 103.9, multiple infectious workups were negative. On 06-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 103.9, and Laboratory test (NR: not provided) normal. On 16-SEP-2021, the patient had acute decompensation with hypotension, hypoxia and ventricular tachycardia, requiring defibrillation (cardioversion). The CTPA (Angiogram pulmonary) revealed pulmonary embolism, and EKG (Electrocardiogram) with anterior leads concerning for ischemia. Laboratory data included: Angiogram pulmonary (NR: not provided) abnormal, and Electrocardiogram (NR: not provided) abnormal. The on-call cardiologist notified, stat echo ordered. The patient continued to decompensate despite maximal support from vasopressors (Vasopressive therapy) and mechanical ventilation. The patient's husband expressed wished to transition to home care. The code status changed to DN RCC sic. The patient compassionately extubated (Extubation) with time of death at 20:51 on 16-SEP-2021. On an unspecified date, the patient was hospitalized for 14 days. On 16-SEP-2021, the patient died from acute respiratory failure, covid-19, dyspnoea, hypotension, hypoxia, mental status changes, pulmonary embolism, pyrexia, and ventricular tachycardia. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, prone position, cardioversion, endotracheal intubation, mechanical ventilation, extubation, vasopressive therapy, angiogram pulmonary abnormal, electrocardiogram abnormal and laboratory test normal on 16-SEP-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: 90000198436.  Additional information was received from Complaint department on 20-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint number added. Upon review following information was amended: Start dates for cause of death added in patient tab, Onset date for laboratory test normal and cardioversion corrected.; Sender's Comments: V1: This follow up adds information about Product quality complaint number.  Start dates for cause of death, Onset date for laboratory test normal and cardioversion amended. This information does not alter the previous causality assessment of the reported events.  20211031409-covid-19 vaccine ad26.cov2.s-Death, acute respiratory failure, covid-19, dyspnoea, hypotension, hypoxia, mental status changes, pulmonary embolism, pyrexia, ventricular tachycardia, prone position, cardioversion, endotracheal intubation, mechanical ventilation, extubation, vasopressive therapy, angiogram pulmonary abnormal, electrocardiogram abnormal and laboratory test normal. 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). 20211031409-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: ACUTE RESPIRATORY FAILURE; COVID-19; DYSPNOEA; HYPOTENSION; HYPOXIA; MENTAL STATUS CHANGES; PULMONARY EMBOLISM; PYREXIA; VENTRICULAR TACHYCARDIA