As of April 21, 2021, outcomes were death (n = 3), continued ICU care (n = 3), continued non-ICU hospitalization (n = 2), and discharged home (n = 4).Ĭonclusions and Relevance The initial 12 US cases of CVST with thrombocytopenia after vaccination represent serious events. All patients were hospitalized (10 in an intensive care unit ). All 11 patients tested for the heparin-platelet factor 4 HIT antibody by enzyme-linked immunosorbent assay (ELISA) screening had positive results. After diagnosis of CVST, 6 patients initially received heparin treatment. Of the 12 patients with CVST, 7 also had intracerebral hemorrhage 8 had non-CVST thromboses. Eleven patients initially presented with headache 1 patient initially presented with back pain and later developed headache. Time from vaccination to symptom onset ranged from 6 to 15 days. Seven patients had at least 1 CVST risk factor, including obesity (n = 6), hypothyroidism (n = 1), and oral contraceptive use (n = 1) none had documented prior heparin exposure. Results Patients’ ages ranged from 18 to younger than 60 years all were White women, reported from 11 states. Main Outcomes and Measures Clinical course, imaging, laboratory tests, and outcomes after CVST diagnosis obtained from VAERS reports, medical record review, and discussion with clinicians. Objective To describe reports of CVST with thrombocytopenia following vaccine receipt.ĭesign, Setting, and Participants Case series of 12 US patients with CVST and thrombocytopenia following use of vaccine under EUA reported to the Vaccine Adverse Event Reporting System (VAERS) from March 2 to Ap(with follow-up reported through April 21, 2021).Įxposures Receipt of vaccine. By April 12, 2021, approximately 7 million vaccine doses had been given in the US, and 6 cases of CVST with thrombocytopenia had been identified among the recipients, resulting in a temporary national pause in vaccination with this product on April 13, 2021. In the US, the COVID-19 vaccine (Janssen/Johnson & Johnson), which uses a human adenoviral vector, received Emergency Use Authorization (EUA) on February 27, 2021. A mechanism similar to autoimmune heparin-induced thrombocytopenia (HIT) has been proposed. Importance Cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare and serious condition, has been described in Europe following receipt of the ChAdOx1 nCoV-19 vaccine (Oxford/AstraZeneca), which uses a chimpanzee adenoviral vector. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.
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