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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a retrospective descriptive study, 28 patients (19 women and 9 men) including 17 adults and 11 elderly patients [exact ages not stated] were described, who developed cerebral venous sinus thrombosis, pulmonary embolism, carotid artery thrombosis, peripheral artery thrombosis, thrombosis, pelvic vein thrombosis, deep vein thrombosis or thrombophlebitis following administration of AZD-1222 for prevention of COVID-19 [dosages, routes and time to reactions onsets not stated].
The patients, who received AZD-1222 [Oxford-AstraZeneca vaccine] for prevention of COVID-19 developed thrombotic events including cerebral venous sinus thrombosis and pulmonary embolism (1 patient), carotid artery thrombosis and peripheral artery thrombosis (1 patient), thrombosis (6 patients), pelvic vein thrombosis and pulmonary embolism (1 patient), deep vein thrombosis (12 patients), deep vein thrombosis and pulmonary embolism (4 patients), pelvic vein thrombosis (1 patient) or thrombophlebitis (2 patients). Out of these 28 patients, 3 patients recovered from thrombotic events, 11 patients recovering from thrombotic events, 6 patients did not recover from thrombotic events, 2 patients died due to pulmonary embolism and 1 patient died due to thrombosis. Thrombotic events outcomes in remaining 5 patients were found to be unknown.
Reference
- Tobaiqy M, et al. Analysis of thrombotic adverse reactions of covid-19 astrazeneca vaccine reported to eudravigilance database. Vaccines 9: 393, No. 4, Jan 2021. Available from: URL: 10.3390/vaccines9040393 [DOI] [PMC free article] [PubMed]