Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation test, Computerised tomogram, Computerised tomogram head, Computerised tomogram thorax, Coombs indirect test
Clinical narrative: CEREBRAL SINUS VEIN THROMBOSIS; LOW PLATELET; STROKE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a company representative concerned a 43 year-old female. Initial information received on 20-APR-2021, processed along with information receive on 23-APR-2021, via telephone communication.  The patient's weight and height were not reported. The patient's medical history included obesity. The patient was not on birth control. The patient did not have autoimmune disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, frequency 1 total, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patients symptoms started on 13-APR-2021 (also reported as 05-APR-2021), with headache, dizziness and mild shortness of breath.  On 16-APR-2021, the patient developed cerebral venous sinus thrombosis (CVST), had stroke, bilateral lobar pulmonary embolism and had low platelet. On the same day, the patient was admitted to the hospital and was still hospitalized at the time of reporting. The patient's platelet count was 17,000, anti platelet factor 4 was positive (the physician reported as 2.5 or 2.7 OD). The patient started on Intravenous immunoglobulin (IVIG) and responded well. Anticoagulation was not mentioned. A repeat scan, 4 days later did not show a venous thrombosis. Hemoglobin was 12.5, platelets increased to 137. The patient was discharged after approximately 4 days on 22-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral sinus vein thrombosis, stroke, pulmonary embolism, and low platelet. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: This case concerns a 43-year-old female who experienced cerebral venous sinus thrombosis (CVST), platelet count decreased, bilateral pulmonary embolism, and stroke 8 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient's medical history included obesity. The patient does not have autoimmune disease and was not taking birth control. Her symptoms started as headache, dizziness, and mild dyspnea. After seeking medical attention, she was found to have a CVST and bilateral lobar pulmonary embolism. Her platelet count was noted to be 17,000 and the anti-PF-4 antibody was positive. She was treated with IVIG. A repeat scan 4 days later did not show the venous thrombosis. The platelet count was noted to increase to 137,000. The patient was discharged after approximately 4 days. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from a non-profit global vaccine safety research network) and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.