Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Computerised tomogram, Computerised tomogram abnormal, Death, Embolism venous
Clinical narrative: DEATH; PULSELESS ELECTRICAL ACTIVITY; HAEMODYNAMIC INSTABILITY; HAEMOGLOBIN NORMAL; NUCLEIC ACID TEST; SARS-COV-2 TEST POSITIVE; THROMBECTOMY; TROPONIN INCREASED; ULTRASOUND DOPPLER; WHITE BLOOD CELL COUNT INCREASED; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; ANGIOGRAM ABNORMAL; CARDIAC DISORDER; CHEST X-RAY NORMAL; COMPUTERISED TOMOGRAM ABNORMAL; ENDOTRACHEAL INTUBATION; CAROTID ARTERY OCCLUSION; CEREBROVASCULAR ACCIDENT; EMBOLISM VENOUS; HEMIPARESIS; HYPOXIA; SEPSIS; This spontaneous report received from a health care professional via the Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1785490) concerned a 66 year old male of unknown race and ethnicity. The patient's past medical history included: acute otitis media, anxiety, and vitamin D deficiency, and concurrent conditions included: CAD (coronary artery disease), cataracts, CHF (congestive heart failure), chronic kidney disease, COPD (chronic obstructive pulmonary disease), DM (diabetes mellitus), enlarged thyroid, hypertension, and sleep apnea, and other pre-existing medical conditions included: The patient had no known drug allergy. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 042A21A expiry: unknown) dose was not reported, 1 total was administered to right arm on 11-APR-2021 for prophylactic vaccination.  Concomitant medications included hydroxyzine for anxiety, carvedilol for drug used for unknown indication, escitalopram for drug used for unknown indication, furosemide for drug used for unknown indication, glipizide for drug used for unknown indication, isophane insulin for drug used for unknown indication, potassium chloride for drug used for unknown indication, salbutamol for drug used for unknown indication, and simvastatin for drug used for unknown indication.  On 01-OCT-2021, patient presented to medical center with a chief complaint of cerebrovascular accident. The symptom onset was overnight and the patient woke up with complaints of left sided weakness (hemiparesis). The patient was seen by teleneurology and CTA (computed tomography angiography) showed occlusion at the right ICA (internal carotid artery) (carotid artery occlusion) origin CT (computed tomography) perfusion scan revealed at risk tissue that was felt to be amenable to reperfusion so patient was transferred to hospital (hospitalized for 11 days) emergently for cerebral thrombectomy. The patient was intubated (endotracheal intubation), the patient was covid-19 positive (confirmed clinical vaccination failure). The patient was extubated after procedure on 01-OCT-2021. On 01-OCT-2021, White blood cells were acutely elevated, Chest X-ray was stable (normal), LE (lower extremity) Doppler (ultrasound Doppler), troponin was increased (0.14 more than 0.15), heamoglobin was stable (normal). The patient was reintubated on 07-OCT-2021.  On 11-OCT-2021, the patient developed acute hemodynamic instability and worsening of hypoxemia. It was reported that the patient's etiology was unclear, acute sepsis vs venous thrombolic disease (embolism venous). The patient was progressed to PEA (pulseless electrical activity) arrest (cardiac disorder) and did not have ROSC (return of spontaneous circulation) despite ACLS (advanced cardiovascular life support).  On 11-OCT-2021, the patient passed away (died) from covid-19, cardiac disorder, carotid artery occlusion, cerebrovascular accident, embolism venous, heamodynamic instability, hemiparesis, hypoxia, pulseless electrical activity, and sepsis. It was unknown if autopsy was performed. The action taken with covid-19 vaccine was not applicable. The patient died of death, angiogram abnormal, chest x-ray normal, computerised tomogram abnormal, endotracheal intubation, heamoglobin normal, nucleic acid test, sars-cov-2 test positive, thrombectomy, troponin increased, ultrasound doppler and white blood cell count increased on 11-OCT-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000199301. 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 02-Nov-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: 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. 20211046214-COVID-19 VACCINE Death, carotid artery occlusion, cerebrovascular accident, embolism venous, hemiparesis, hypoxia, sepsis, pulseless electrical activity, covid-19, angiogram abnormal, cardiac disorder, chest x-ray normal, computerised tomogram abnormal, endotracheal intubation, haemodynamic instability, haemoglobin normal, nucleic acid test, sars-cov-2 test positive, thrombectomy, troponin increased, ultrasound Doppler, white blood cell count increased. 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).  20211046214-COVID-19 VACCINE 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; CARDIAC DISORDER; CAROTID ARTERY OCCLUSION; CEREBROVASCULAR ACCIDENT; EMBOLISM VENOUS; HAEMODYNAMIC INSTABILITY; HEMIPARESIS; HYPOXIA; PULSELESS ELECTRICAL ACTIVITY; SEPSIS