• Isaac See, Allison Lale, Paige Marquez, Michael B Streiff, Allison P Wheeler, Naomi K Tepper, Emily Jane Woo, Karen R Broder, Kathryn M Edwards, Ruth Gallego, Andrew I Geller, Kelly A Jackson, Shashi Sharma, Kawsar R Talaat, Emmanuel B Walter, Imo J Akpan, Thomas L Ortel, Victor C Urrutia, Shannon C Walker, Jennifer C Yui, Tom T Shimabukuro, Adamma Mba-Jonas, John R Su, and David K Shay.
• Centers for Disease Control and Prevention COVID-19 Response Team, Atlanta, Georgia (I.S., A.L., P.M., N.K.T., K.R.B., R.G., A.I.G., K.A.J., S.S., T.T.S., J.R.S., D.K.S.).
• Ann. Intern. Med. 2022 Apr 1; 175 (4): 513-522.

BackgroundThrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis after vaccination with the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson) have previously been described.ObjectiveTo describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States.DesignCase series.SettingUnited States.PatientsCase patients receiving a COVID-19 vaccine from 14 December 2020 through 31 August 2021 with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction) reported to the Vaccine Adverse Event Reporting System. If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for antiplatelet factor 4 antibodies or functional heparin-induced thrombocytopenia platelet test result was required.MeasurementsReporting rates (cases per million vaccine doses) and descriptive epidemiology.ResultsA total of 57 TTS cases were confirmed after vaccination with Ad26.COV2.S (n = 54) or a messenger RNA (mRNA)-based COVID-19 vaccine (n = 3). Reporting rates for TTS were 3.83 per million vaccine doses (Ad26.COV2.S) and 0.00855 per million vaccine doses (mRNA-based COVID-19 vaccines). The median age of patients with TTS after Ad26.COV2.S vaccination was 44.5 years (range, 18 to 70 years), and 69% of patients were women. Of the TTS cases after mRNA-based COVID-19 vaccination, 2 occurred in men older than 50 years and 1 in a woman aged 50 to 59 years. All cases after Ad26.COV2.S vaccination involved hospitalization, including 36 (67%) with intensive care unit admission. Outcomes of hospitalizations after Ad26.COV2.S vaccination included death (15%), discharge to postacute care (17%), and discharge home (68%).LimitationsUnderreporting and incomplete case follow-up.ConclusionThrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the 3 cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate.Primary Funding SourceCenters for Disease Control and Prevention.

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