Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: DEATH; ACUTE RESPIRATORY DISTRESS SYNDROME; COVID-19 PNEUMONIA; CAROTID ARTERY OCCLUSION; CAROTID ARTERY THROMBOSIS; ELECTROCARDIOGRAM ST SEGMENT ELEVATION; GAZE PALSY; HEMIPARESIS; HYPOXIA; ISCHAEMIC STROKE; PNEUMONIA; PULMONARY OEDEMA; UNRESPONSIVE TO STIMULI; ANGIOGRAM CEREBRAL ABNORMAL; APHASIA; COUGH; ENDOTRACHEAL INTUBATION; EXPOSURE TO SARS-COV-2; HAEMATOCRIT NORMAL; INTENSIVE CARE; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; MECHANICAL VENTILATION; NEUROLOGICAL EXAMINATION ABNORMAL; PERFUSION BRAIN SCAN ABNORMAL; PRONE POSITION; RESPIRATORY SYMPTOM; SUSPECTED CLINICAL VACCINE FAILURE; CEREBROVASCULAR ACCIDENT; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1947958) on 24-DEC-2021 and concerned a 66 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 respiratory failure, acute systolic heart failure, and acute right middle cerebral artery stroke, and concurrent conditions included: cardiomyopathy, ischemic coronary artery disease, essential hypertension, peripheral vascular disease, carotid artery disease, anemia, chronic kidney disease, kidney disorder stage iii, renal osteodystrophy, gout, diabetes mellitus, and tobacco user, and other pre-existing medical conditions included: Patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered at right arm on 08-APR-2021 for an unspecified indication. Concomitant medications included amlodipine, amlodipine besilate, atorvastatin, atorvastatin calcium, clopidogrel, clopidogrel bisulfate, glipizide, metoprolol succinate, omeprazole, Aspirin and pantoprazole. On 26-NOV-2021, the patient experienced cerebrovascular accident, acute respiratory distress syndrome, covid-19 pneumonia, carotid artery occlusion, carotid artery thrombosis, electrocardiogram st segment elevation, gaze palsy, hemiparesis, hypoxia, ischaemic stroke, pneumonia, pulmonary oedema, unresponsive to stimuli, angiogram cerebral abnormal, aphasia, cough, endotracheal intubation, exposure to sars-cov-2, haematocrit normal, intensive care, magnetic resonance imaging head abnormal, mechanical ventilation, neurological examination abnormal, perfusion brain scan abnormal, prone position, respiratory symptom and suspected clinical vaccine failure. Patient was hospitalized on 26-NOV-2021, patient had COVID-19 exposure (unclear if test done) patient was fully vaccinated. Patient had acute right MCA stroke, Ischemic stroke. Patient had recent COVID exposure and was admitted to Medical Intensive care unit (ICU)from Emergency department (ED) for concern of stroke in the presence of COVID pneumonia. Neuro ICU was consulted for stroke to review patient was found unresponsive on 26-NOV-2021. He was last known well on the evening of 25-NOV-2021 down time is unknown. Patient has multiple family members at home who are COVID positive Per ED report patient was having some cough and respiratory symptoms while at home emergency medical services (EMS) reportedly found patient unresponsive with a right sided gaze and left sided weakness. Patient was hypoxic with O2 saturation in the 60 and a respiratory rate in the 40. On arrival to outside ED patient's exam was documented as nonverbal but following commands patient was stroke coded at 1130 on 26-NOV-2021. Initial NIH 32 Stat (hematocrit)HCT was negative for hemorrhage due to unknown down time patient was outside the window for Tissue plasminogen activator (TPA) Computed tomography angiography (CTA) shows a l eft cervical internal carotid artery (ICA) occlusion and a incompletely occlusive right cervical ICA thrombus no intracranial occlusions reported (Computed Tomography Perfusion) CTP showed a 7 ml core and 5 ml penumbra patient was showing some ST elevation in V1 V2 and lead 3 concerning for ST-elevation myocardial infarction (STEMI) He was given rectal aspirin per outside report ED physician contacted both BW cardiology and stroke neurology for recommendations per cardiology did not feel this was a STEMI, no acute need for heparin from cardiac standpoint at this time. Stroke neurology recommended STAT MRI brain there was no documented discussion regarding whether or not patient's candidacy for mechanical thrombectomy was discussed. It was assumed that patient was not a candidate. Patient was setting 90% on NRB It was ultimately decided to admit to medical ICU and patient was intubated for airway protection On 27-NOV-2021. An MRI brain was obtained and showed right MCA and watershed territory strokes Left MCA ACA watershed strokes and possible small left petechial ICH Throughout his ICU course his pulmonary status continued to decline and he developed severe ARDS pneumonia and pulmonary edema despite maximum medical efforts including high dose sedation paralytics and prone positioning the patient failed to make significant improvement from a pulmonary standpoint. Given his poor neurological exam in conjunction with his multiple bihemispheric strokes seen on brain MRI as well as failure to improve on the ventilator multiple family meetings were held to discuss goals of care. It was decided that the current level of care and anticipated poor recovery did not align with the patient's prior wishes. As such the family elected to transition him to comfort measures. After all family was able to say their goodbyes. the patient was terminally extubated on 4-DEC-2021. He passed away with family at his bedside at 3:53PM. Laboratory data (dates unspecified) included: Angiogram cerebral (NR: not provided) Abnormal, CT scan (NR: not provided) Unknown, left cervical ICA, Hematocrit (NR: not provided) Normal, Intubation (NR: not provided) Unknown, MRI brain (NR: not provided) middle cerebral artery, Neurological examination (NR: not provided) Abnormal, Oxygen saturation (NR: not provided) 60 %, Perfusion brain scan (NR: not provided) Abnormal, Respiratory rate (NR: not provided) 40 (units unspecified), and ST elevated (NR: not provided) STEMI. On 04-DEC-2021, the patient died from cerebrovascular accident. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from cerebrovascular accident, acute respiratory distress syndrome, covid-19 pneumonia, carotid artery occlusion, carotid artery thrombosis, electrocardiogram st segment elevation, gaze palsy, hemiparesis, hypoxia, ischaemic stroke, pneumonia, pulmonary oedema, unresponsive to stimuli, angiogram cerebral abnormal, aphasia, cough, endotracheal intubation, exposure to sars-cov-2, haematocrit normal, intensive care, magnetic resonance imaging head abnormal, mechanical ventilation, neurological examination abnormal, perfusion brain scan abnormal, prone position, and respiratory symptom and not yet recovered from suspected clinical vaccine failure. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with a product quality complaint: 90000209186. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. based on the PQC evaluation/investigation performed.  Additional information received from Complaint Department on 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Additional information in this version updates: Product quality complaint investigation result. this updated information does not alter the company causality of previously reported events.  20211255568-COVID-19 VACCINE AD26.COV2.S-Cerebrovascular accident, Death, Acute respiratory distress syndrome, COVID-19 pneumonia, Carotid artery occlusion, Carotid artery thrombosis, Electrocardiogram ST segment elevation, Gaze palsy, Hemiparesis, Hypoxia, Ischaemic stroke, Pneumonia, Pulmonary oedema, Unresponsive to stimuli, Angiogram cerebral abnormal, Aphasia, Cough, Endotracheal intubation, Exposure to SARS-CoV-2, Haematocrit normal, Intensive care, Magnetic resonance imaging head abnormal, Mechanical ventilation, Neurological examination abnormal, Perfusion brain scan abnormal, Prone position, Respiratory symptom. 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). 20211255568-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccine 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: CEREBROVASCULAR ACCIDENT; ACUTE RESPIRATORY DISTRESS SYNDROME; COVID-19 PNEUMONIA; CAROTID ARTERY OCCLUSION; CAROTID ARTERY THROMBOSIS; ELECTROCARDIOGRAM ST SEGMENT ELEVATION; GAZE PALSY; HEMIPARESIS; HYPOXIA; ISCHAEMIC STROKE; PNEUMONIA; PULMONARY O