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12 Cases of CVST Reported for Ad26.COV2.S Vaccine in the U.S.

TUESDAY, May 4, 2021 -- Twelve cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia have been reported following use of the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson), which uses a human adenoviral vector, according to a study published online April 30 in the Journal of the American Medical Association.

Isaac See, M.D., from the U.S. Centers for Disease Control and Prevention COVID-19 Response Team, and colleagues describe 12 cases of CVST with thrombocytopenia following receipt of the Ad26.COV2.S vaccine that were reported to the Vaccine Adverse Event Reporting System from March 2 to April 21, 2021.

The researchers found that patients were aged 18 to younger than 60 years, and all were White women from 11 states. Seven of the patients had at least one risk factor for CVST, including obesity, hypothyroidism, and oral contraceptive use (six patients, one patient, and one patient, respectively). None of the patients had documented heparin exposure. The range of time from Ad26.COV2.S vaccination to symptom onset was six to 15 days. Initial presentation was headache (11 patients) and back pain (one patient, who later developed headache). Seven of the 12 patients with CVST also had intracerebral hemorrhage; eight had non-CVST thromboses. Six patients initially received heparin treatment after CVST diagnoses. All patients were hospitalized; the outcomes were death (three patients), continued intensive care unit care (three patients), continued hospitalization (two patients), and discharge home (four patients) as of April 21, 2021.

"This case series may inform clinical guidance as Ad26.COV2.S vaccination resumes in the United States as well as investigations into the potential relationship between Ad26.COV2.S vaccine and CVST with thrombocytopenia," the authors write.

Several authors disclosed financial ties to the pharmaceutical industry, including companies that have developed COVID-19 vaccines.

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