Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Ventilation/perfusion scan normal
Clinical narrative: DEATH; RESPIRATORY FAILURE; ACUTE RESPIRATORY FAILURE; PULMONARY EMBOLISM; FAT EMBOLISM; FEMUR FRACTURE; HIP FRACTURE; RENAL IMPAIRMENT; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; EMPHYSEMA; CONDITION AGGRAVATED; OXYGEN SATURATION DECREASED; ANTICOAGULANT THERAPY; FALL; BILEVEL POSITIVE AIRWAY PRESSURE; CHEST X-RAY NORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; VENTILATION PERFUSION SCAN NORMAL; COVID-19; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1663606) concerned an 87 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: acute onychomadesis, middle cerebral artery cerebrovascular accident, and intertrochanteric fracture of right femur closed initial encounter, and concurrent conditions included: chronic obstructive pulmonary disease, diabetes mellitus type 2, atherosclerosis of native artery of both lower extremities with intermittent claudication, hyperlipidemia, hypertension, acute kidney injury, acute respiratory failure with hypoxia, and vascular dementia, and patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: unknown) dose was not reported, 1 total, administered on 18-JUN-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine besilate, atorvastatin calcium, hydrochlorothiazide, lisinopril, metformin, and omeprazole. On 20-AUG-2021, the patient was tested positive for covid-19 (sars-cov-2 test positive) and experienced confirmed clinical vaccination failure, after an exposure at nursing facility. On 25-AUG-2021, the patient was admitted to the orthopedic service for right comminuted hip fracture (femur fracture) that occurred after a fall at his living facility. At the time of hospitalization, patient was fairly asymptomatic from covid- 19 infection. Patient was initially stable with no significant chest x-ray findings (normal results). Patient was scheduled for operating room on 26-AUG-2021, but overnight, on 25-AUG-2021, patient had rapid escalation in his oxygen needs going from room air to requiring 5-6 liters nasal cannula (oxygen saturation decreased) and later to high-flow nasal cannula. It was unable to obtain computed tomography angiography thorax due to patient's kidney function (renal impairment), so, computed tomography thorax without contrast performed only showed severe emphysema. Ventilation perfusion (VQ) scan was obtained which was not suspicious for pulmonary embolism. Patient was started on a heparin drip (anticoagulant therapy) due to concern for pulmonary embolism versus fat embolism. As VQ scan came back negative for pulmonary embolism, heparin drip was discontinued. After that, orthopedic team transferred service to hospitalist team and was waiting for improvement in respiratory status before proceeding with surgery. On 25-AUG-2021, patient experienced chronic obstructive pulmonary disease. Patient was then started on decadron (dexamethasone). As patient's oxygen requirements increased (condition aggravated), he was placed on continuous (bilevel) positive airway pressure (BiPAP) to help with workup breathing. Code status was confirmed with patient's son and he wanted patient to remain as and not to resuscitate. Patient was made incapacitated at nursing facility. Due to worsening oxygen requirements, pulmonology was also consulted. Patient was continued on BiPAP with worsening respiratory status (respiratory failure) and eventually died. On 30-AUG-2021, the patient died from covid-19. Patient was hospitalized for 6 days. 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, respiratory failure, acute respiratory failure, pulmonary embolism, fat embolism, femur fracture, hip fracture, renal impairment, chronic obstructive pulmonary disease, emphysema, sars-cov-2 test positive, condition aggravated, oxygen saturation decreased, anticoagulant therapy, fall, bilevel positive airway pressure, chest x-ray normal, computerised tomogram thorax abnormal and ventilation perfusion scan normal on 30-AUG-2021, 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: 90000193363. 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 20-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: Previously Suspected clinical vaccination failure event was updated with Confirmed clinical vaccination failure.; Sender's Comments: V1:This version is created to update the information regarding Product quality complaint investigation result, this does not change the causality of the previously reported events. Mac amended from the previous version (Suspected clinical vaccination failure event updated to Confirmed clinical vaccination failure.). 20210920902- COVID-19 VACCINE AD26.COV2.S-Death, Respiratory failure, Acute respiratory failure, Pulmonary embolism, Fat embolism, Femur fracture, Hip fracture, Renal impairment, Chronic obstructive pulmonary disease, Emphysema, COVID-19, Sars-cov-2 test positive, Condition aggravated, Oxygen saturation decreased, Anticoagulant therapy, Fall,  Bilevel positive airway pressure, Chest x-ray normal, Computerised tomogram thorax abnormal, Ventilation perfusion scan normal. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210920902- 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: COVID-19