US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021.
Abstract | 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. A mechanism similar to autoimmune heparin-induced thrombocytopenia (HIT) has been proposed. In the US, the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson), which uses a human adenoviral vector, received Emergency Use Authorization (EUA) on February 27, 2021. By April 12, 2021, approximately 7 million Ad26.COV2.S 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. Objective: Design, Setting, and Participants: Case series of 12 US patients with CVST and thrombocytopenia following use of Ad26.COV2.S vaccine under EUA reported to the Vaccine Adverse Event Reporting System (VAERS) from March 2 to April 21, 2021 (with follow-up reported through April 21, 2021). Exposures: 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. Results: Patients' ages ranged from 18 to younger than 60 years; all were White women, reported from 11 states. 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. Time from Ad26.COV2.S vaccination to symptom onset ranged from 6 to 15 days. Eleven patients initially presented with headache; 1 patient initially presented with back pain and later developed headache. Of the 12 patients with CVST, 7 also had intracerebral hemorrhage; 8 had non-CVST thromboses. After diagnosis of CVST, 6 patients initially received heparin treatment. Platelet nadir ranged from 9 ×103/µL to 127 ×103/µL. All 11 patients tested for the heparin- platelet factor 4 HIT antibody by enzyme-linked immunosorbent assay (ELISA) screening had positive results. All patients were hospitalized (10 in an intensive care unit [ICU]). 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). Conclusions and Relevance:
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Authors | Isaac See, John R Su, Allison Lale, Emily Jane Woo, Alice Y Guh, Tom T Shimabukuro, Michael B Streiff, Agam K Rao, Allison P Wheeler, Suzanne F Beavers, Anna P Durbin, Kathryn Edwards, Elaine Miller, Theresa A Harrington, Adamma Mba-Jonas, Narayan Nair, Duong T Nguyen, Kawsar R Talaat, Victor C Urrutia, Shannon C Walker, C Buddy Creech, Thomas A Clark, Frank DeStefano, Karen R Broder |
Journal | JAMA
(JAMA)
Vol. 325
Issue 24
Pg. 2448-2456
(06 22 2021)
ISSN: 1538-3598 [Electronic] United States |
PMID | 33929487
(Publication Type: Case Reports, Journal Article, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- COVID-19 Vaccines
- ChAdOx1 nCoV-19
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Topics |
- Adolescent
- Adult
- COVID-19 Vaccines
(adverse effects)
- ChAdOx1 nCoV-19
- Critical Care
- Fatal Outcome
- Female
- Headache
(etiology)
- Humans
- Middle Aged
- Platelet Count
- Sinus Thrombosis, Intracranial
(etiology, therapy)
- Thrombocytopenia
(etiology, therapy)
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