Case Series of Thrombosis with Thrombocytopenia Syndrome following COVID-19 vaccination—United States, December 2020–August 2021

  1. Isaac See
  2. Allison Lale
  3. Paige Marquez
  4. Michael B. Streiff
  5. Allison P. Wheeler
  6. Naomi K. Tepper
  7. Emily Jane Woo
  8. Karen R. Broder
  9. Kathryn M. Edwards
  10. Ruth Gallego
  11. Andrew I. Geller
  12. Kelly A. Jackson
  13. Shashi Sharma
  14. Kawsar R. Talaat
  15. Emmanuel B. Walter
  16. Imo J. Akpan
  17. Thomas L. Ortel
  18. Shannon C. Walker
  19. Jennifer C. Yui
  20. Tom T. Shimabukuro
  21. Adamma Mba-Jonas
  22. John R. Su
  23. David K. Shay
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Abstract

Background

Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. TTS presents similarly to autoimmune heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis following Janssen/Johnson & Johnson (Ad26.COV2.S) COVID-19 vaccination have been described.

Objective

Describe surveillance data and reporting rates of TTS cases following COVID-19 vaccination.

Design

Case series.

Setting

United States

Patients

Case-patients reported to the Vaccine Adverse Event Reporting System (VAERS) receiving COVID-19 vaccine from December 14, 2020 through August 31, 2021, with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction). If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for anti-platelet factor 4 antibody was required.

Measurements

Reporting rates (cases/million vaccine doses) and descriptive epidemiology.

Results

52 TTS cases were confirmed following Ad26.COV2.S (n=50) or mRNA-based COVID-19 (n=2) vaccination. TTS reporting rates were 3.55 per million (Ad26.COV2.S) and 0.0057 per million (mRNA-based COVID-19 vaccines). Median age of patients with TTS following Ad26.COV2.S vaccination was 43.5 years (range: 18–70); 70% were female. Both TTS cases following mRNA-based COVID-19 vaccination occurred in males aged >50 years. All cases following Ad26.COV2.S vaccination involved hospitalization including 32 (64%) with intensive care unit admission. Outcomes of hospitalizations following Ad26.COV2.S vaccination included death (12%), discharge to post-acute care (16%), and discharge home (72%).

Limitations

Under-reporting and incomplete case follow-up.

Conclusion

TTS is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the two cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate.

Funding Source

CDC

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