Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Computerised tomogram thorax, Computerised tomogram thorax abnormal, Coronary artery thrombosis, Deep vein thrombosis
Clinical narrative: TACHYCARDIA; ACUTE RESPIRATORY FAILURE; PNEUMONIA; HEMIPARESIS; BRAIN OEDEMA; IMMUNOGLOBULIN THERAPY; THROMBECTOMY; COMPUTERISED TOMOGRAM THORAX ABNORMAL; ULTRASOUND DOPPLER ABNORMAL; CEREBROVASCULAR ACCIDENT; CAROTID ARTERY THROMBOSIS; CORONARY ARTERY THROMBOSIS; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; THROMBOSIS; THROMBOCYTOPENIA SYNDROME; PLATELET COUNT DECREASED; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 48 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-AUG-2021 for drug use for unknown indication. No concomitant medications were reported.  On unspecified date, patient was hospitalized. On 15-AUG-2021, patient sustained an acute stroke and developed blood clot in right internal carotid. Thrombectomy was performed irregular intraluminal thrombus along the anterior aspect of the proximal descending thoracic aorta was noted at time of intervention. The patient experienced brain oedema post CVA, carotid artery thrombosis, cerebrovascular accident, computerised tomogram thorax abnormal, coronary artery thrombosis, deep vein thrombosis, hemiparesis, pneumonia and platelet count was decreased. The patient experienced pneumonia, pulmonary embolism, thrombectomy, thrombosis and thrombocytopenia syndrome and abnormal ultrasound doppler. On 20-AUG-2021,the patient developed acute respiratory failure and tachycardia. On unspecified date, computed tomography of chest revealed acute bilateral pulmonary embolism and lower extremity venous doppler revealed acute bilateral DVT(deep vein thrombosis) also upper extremity DVT(deep vein thrombosis) and the patient had developed VITT(vaccine induced thrombotic thrombocytopenia which was concluded by oncology and IV Immunoglobulin was administered twice with patient and improvement platelets at lowest point were at 32. The patient had dense Left hemiparesis since 15-8-2021 and requires extensive PT O T and speech therapy). The patient discharged to acute care rehabilitation facility on 31-8-2021 and then transferred to a skilled nursing facility on 28-sep-2021 for further rehabilitation and patient still had left hemiparesis. The patient undergone Multiple labs and Computed tomography scans. On 15-AUG-2021, Laboratory data included: CT angiography (NR: not provided) acute thrombotic stroke, Computerised tomogram thorax (NR: not provided) Abnormal, Platelet count (NR: not provided) decreased, and Ultrasound Doppler (NR: not provided) abnormal. On 18-AUG-2021, Laboratory data included: CT scan (NR: not provided) worsening cerebral edema. On 20-AUG-2021, the patient experienced acute respiratory failure. On 20-AUG-2021, the patient experienced tachycardia. Laboratory data included: CT scan (NR: not provided) pulmonary embolism. Laboratory data (dates unspecified) included: CT scan (NR: not provided) pulmonary embolism, not reported, Laboratory test (NR: not provided) not reported, Platelet count (NR: not provided) 32, and Venous Doppler (NR: not provided) acute bilateral DVT, upper extremity DVT.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory failure, brain oedema, carotid artery thrombosis, cerebrovascular accident, computerised tomogram thorax abnormal, coronary artery thrombosis, deep vein thrombosis, hemiparesis, immunoglobulin therapy, platelet count decreased, pneumonia, pulmonary embolism, tachycardia, thrombectomy, thrombocytopenia syndrome, ultrasound doppler abnormal, and thrombosis. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).  Version created to amend previously reported information on 08-Oct-2021. Upon review following information was amended: changed the Labeling of Event (Cerebrovascular accident) label to unlabeled.; Sender's Comments: V1: This version was created  to amend - Labeling of Event (Cerebrovascular accident) label to unlabeled. MAC is amended as per updated labeling. 20211017368-COVID-19 VACCINE AD26.COV2.S- CAROTID ARTERY THROMBOSIS, CORONARY ARTERY THROMBOSIS, PULMONARY EMBOLISM, DEEP VEIN THROMBOSIS,  THROMBOSIS, THROMBOCYTOPENIA SYNDROME, PLATELET COUNT DECREASED, TACHYCARDIA, THROMBECTOMY, COMPUTERISED TOMOGRAM THORAX ABNORMAL, ULTRASOUND DOPPLER ABNORMAL. This event(s) is labeled per RSI and is therefore considered potentially related.  20211017368-COVID-19 VACCINE AD26.COV2.S- CEREBROVASCULAR ACCIDENT, ACUTE RESPIRATORY FAILURE, PNEUMONIA, HEMIPARESIS, BRAIN OEDEMA, IMMUNOGLOBULIN THERAPY. 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).