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Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination-United States, December 2020 to August 2021.
See, Isaac; Lale, Allison; Marquez, Paige; Streiff, Michael B; Wheeler, Allison P; Tepper, Naomi K; Woo, Emily Jane; Broder, Karen R; Edwards, Kathryn M; Gallego, Ruth; Geller, Andrew I; Jackson, Kelly A; Sharma, Shashi; Talaat, Kawsar R; Walter, Emmanuel B; Akpan, Imo J; Ortel, Thomas L; Urrutia, Victor C; Walker, Shannon C; Yui, Jennifer C; Shimabukuro, Tom T; Mba-Jonas, Adamma; Su, John R; Shay, David K.
  • See I; 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.).
  • Lale A; 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.).
  • Marquez P; 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.).
  • Streiff MB; The Johns Hopkins University, Baltimore, Maryland (M.B.S., K.R.T., V.C.U., J.C.Y.).
  • Wheeler AP; Vanderbilt University Medical Center, Nashville, Tennessee (A.P.W., K.M.E., S.C.W.).
  • Tepper NK; 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.).
  • Woo EJ; Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland (E.J.W., A.M.).
  • Broder KR; 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.).
  • Edwards KM; Vanderbilt University Medical Center, Nashville, Tennessee (A.P.W., K.M.E., S.C.W.).
  • Gallego R; 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.).
  • Geller AI; 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.).
  • Jackson KA; 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.).
  • Sharma S; 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.).
  • Talaat KR; The Johns Hopkins University, Baltimore, Maryland (M.B.S., K.R.T., V.C.U., J.C.Y.).
  • Walter EB; Duke University School of Medicine, Durham, North Carolina (E.B.W., T.L.O.).
  • Akpan IJ; Columbia University Irving Medical Center, New York, New York (I.J.A.).
  • Ortel TL; Duke University School of Medicine, Durham, North Carolina (E.B.W., T.L.O.).
  • Urrutia VC; The Johns Hopkins University, Baltimore, Maryland (M.B.S., K.R.T., V.C.U., J.C.Y.).
  • Walker SC; Vanderbilt University Medical Center, Nashville, Tennessee (A.P.W., K.M.E., S.C.W.).
  • Yui JC; The Johns Hopkins University, Baltimore, Maryland (M.B.S., K.R.T., V.C.U., J.C.Y.).
  • Shimabukuro TT; 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.).
  • Mba-Jonas A; Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland (E.J.W., A.M.).
  • Su JR; 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.).
  • Shay DK; 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 ; 175(4): 513-522, 2022 04.
Article in English | MEDLINE | ID: covidwho-1811218
ABSTRACT

BACKGROUND:

Thrombosis 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.

OBJECTIVE:

To describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States.

DESIGN:

Case series.

SETTING:

United States. PATIENTS Case 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. MEASUREMENTS Reporting rates (cases per million vaccine doses) and descriptive epidemiology.

RESULTS:

A 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%).

LIMITATIONS:

Underreporting and incomplete case follow-up.

CONCLUSION:

Thrombosis 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 SOURCE Centers for Disease Control and Prevention.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombocytopenia / Thrombosis / Vaccines / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Long Covid / Vaccines Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: North America Language: English Journal: Ann Intern Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombocytopenia / Thrombosis / Vaccines / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Long Covid / Vaccines Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: North America Language: English Journal: Ann Intern Med Year: 2022 Document Type: Article