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

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 3.55per 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%) admitted to an intensive care unit. Outcomes 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 lower reporting rate and different demographic characteristics for the two cases following mRNA-based COVID-19 vaccines suggest a potentially different pathogenesis or background occurrence.

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Cerebral Venous Sinus Thrombosis With Severe Thrombocytopenia: A Fatal Adverse Event Following Johnson & Johnson COVID-19 Vaccination

Neurology Clinical Practice ◽

10.1212/cpj.0000000000001137 ◽

2021 ◽

pp. 10.1212/CPJ.0000000000001137

Author(s):

Murtaza Ali ◽

Christopher Goshgarian ◽

Andrew Jameson

Keyword(s):

Adverse Event ◽

Reporting System ◽

Sinus Thrombosis ◽

Adverse Event Reporting System ◽

Adenovirus Vector ◽

Cerebral Venous Sinus Thrombosis ◽

Adverse Event Reporting ◽

Venous Sinus ◽

Severe Thrombocytopenia ◽

Venous Sinus Thrombosis

Approximately 7.98 million doses of the Johnson and Johnson adenovirus vector SARS-CoV-2 vaccine (J&J vaccine) have been administered since EUA authorization by the FDA on February 27, 20211, 2. On April 13th, the CDC/FDA recommended a pause in administration after 6 cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia were identified through the vaccine adverse event reporting system in women aged 18-48. To date, 15 cases of thrombosis with thrombocytopenia syndrome (TTS) have been reported following vaccination with J&J, with three reported fatalities2. Here we report one of those fatalities in a 35-year-old woman who developed CVST with thrombocytopenia following vaccination with the J&J vaccine.

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Cerebral Venous Thrombosis Developing after COVID-19 Vaccination: VITT, VATT, TTS, and More

Seminars in Thrombosis and Hemostasis ◽

10.1055/s-0041-1736168 ◽

2021 ◽

Author(s):

Giuseppe Lippi ◽

Emmanuel J. Favaloro

Keyword(s):

Sinus Thrombosis ◽

Severe Disease ◽

Fatal Outcome ◽

Cerebral Venous Sinus Thrombosis ◽

Young Female ◽

Enzyme Linked Immunosorbent Assay ◽

Platelet Factor ◽

Viral Spread ◽

Thrombotic Complications ◽

Respiratory Coronavirus

AbstractDespite the huge efforts globally underway for preventing or limiting the spread of severe acute respiratory coronavirus disease 2 (SARS-CoV-2), the coronavirus disease 2019 (COVID-19) pandemic outbreak appears still virtually unstoppable. As for many other infectious diseases, COVID-19 vaccination has now become crucial for limiting viral spread, especially for averting hospitalizations, need for intensive care, and fatal outcome. Nonetheless, as for other vaccines, COVID-19 vaccination is not completely free from side effects. Among the adverse events that have been reported after receiving COVID-19 vaccination, special emphasis has been given to an unexpected number of thrombocytopenic episodes with or without thrombotic complications, especially in recipients of adenovirus-based COVID-19 vaccines. Along with a specific clinical presentation, encompassing “atypical” thrombosis (especially cerebral venous [sinus] thrombosis, CVT) more prevalent in young female subjects, this new syndrome called vaccine-induced thrombocytopenia and thrombosis (VITT) is characterized by, and thereby diagnosed for, the presence of three paradigmatic laboratory abnormalities, i.e., low platelet count (<150 × 109/L), elevated plasma D-dimer levels (>0.5 mg/L), accompanied by a positive test for anti-PF4 (platelet factor 4) antibodies assayed with ELISA (enzyme-linked immunosorbent assay) techniques. Timely identification of these important abnormalities by both clinicians and laboratory professional is essential for early diagnosis and management of VITT, since the outcome of this condition may be fatal in half or even more of effected patients with severe disease. Therefore, this narrative review aims to review here the epidemiology, pathogenesis, clinical, and laboratory characteristics of VITT and other COVID-19 vaccine-associated thrombocytopenias.

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Syndrome of cerebral venous sinus thrombosis and thrombocytopenia after vaccination for COVID-19

10.21203/rs.3.rs-439289/v1 ◽

2021 ◽

Author(s):

Babak Soleimani ◽

Sanchit Turaga ◽

Dalia Khan ◽

Claire Davies ◽

Yaw Duodu ◽

...

Keyword(s):

Sinus Thrombosis ◽

Case Series ◽

Multidisciplinary Care ◽

Intravenous Immunoglobulins ◽

Cerebral Venous Sinus Thrombosis ◽

Venous Sinus ◽

Laboratory Findings ◽

Platelet Factor ◽

Venous Sinus Thrombosis ◽

Decompressive Hemicraniectomy

Abstract Experience in the management of COVID-19 vaccine induced thrombosis and thrombocytopenia is currently lacking. In this case series we report the presentation and our experience in the management of cerebral venous sinus thrombosis and thrombocytopenia post ChAdOx1 nCoV-19 vaccination. Two of the three cases had confirmed anti-platelet factor 4 antibodies and extracranial thrombosis. In all the cases, plasma exchange, intravenous immunoglobulins and steroids normalised the platelet count and intravenous argatroban was used for initial anticoagulation. Two cases received a platelet transfusion and required decompressive hemicraniectomy due to raised intracranial pressure, secondary to cerebral oedema and haemorrhage. Prompt assessment of a new persistent headache occurring between 5 and 28 days of receiving the ChAdOx1 nCoV-19 vaccine is warranted irrespective of age. In cases with venous thrombosis on imaging or abnormal laboratory findings (thrombocytopenia, abnormal clotting or elevated D-dimer), urgent transfer to a tertiary centre is recommended for multidisciplinary care and prevention of life-threatening complications from this rare syndrome.

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Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽

10.1016/j.vaccine.2019.08.087 ◽

2019 ◽

Vol 37 (44) ◽

pp. 6760-6767 ◽

Cited By ~ 2

Author(s):

Michael M. McNeil ◽

Iwona Paradowska-Stankiewicz ◽

Elaine R. Miller ◽

Paige L. Marquez ◽

Srihari Seshadri ◽

...

Keyword(s):

United States ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adenovirus Type ◽

Adverse Event Reporting ◽

Event Reporting

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74 BEVACIZUMAB-ASSOCIATED ESOPHAGEAL PERFORATIONS: A CASE SERIES FROM THE FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) DATABASE

Gastroenterology ◽

10.1016/s0016-5085(21)00789-7 ◽

2021 ◽

Vol 160 (6) ◽

pp. S-16

Author(s):

Thomas Adam Wichelmann ◽

Mandy Weaver ◽

Sufyan AbdulMujeeb ◽

Eli D. Ehnrenpreis

Keyword(s):

Adverse Event ◽

Reporting System ◽

Adverse Event Reporting System ◽

Case Series ◽

Adverse Event Reporting ◽

Event Reporting ◽

Esophageal Perforations

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Cerebral venous sinus thrombosis after ChAdOx1 nCov-19 vaccination with a misleading first cerebral MRI scan

Stroke and Vascular Neurology ◽

10.1136/svn-2021-001095 ◽

2021 ◽

pp. svn-2021-001095

Author(s):

Benno Ikenberg ◽

Antonia Franziska Demleitner ◽

Thomas Thiele ◽

Benedikt Wiestler ◽

Katharina Götze ◽

...

Keyword(s):

Sinus Thrombosis ◽

Intravenous Immunoglobulins ◽

Cerebral Venous Sinus Thrombosis ◽

Venous Sinus ◽

Pathological Findings ◽

Mri Scan ◽

Platelet Factor ◽

Venous Sinus Thrombosis ◽

Activation Assay ◽

Cerebral Mri

Vaccine-induced immune thrombotic thrombocytopenia (VITT) and cerebral venous sinus thrombosis (CVST) have been recently described as rare complications following vaccination against SARS-CoV-2 with vector vaccines. We report a case of a young woman who presented with VITT and cerebral CVST 7 days following vaccination with ChAdOx1 nCov-19 (AstraZeneca). While the initial MRI was considered void of pathological findings, MRI 3 days later revealed extensive CVST of the transversal and sigmoidal sinus with intracerebral haemorrhage. Diagnostic tests including a platelet-factor-4-induced platelet activation assay confirmed the diagnosis of VITT. Treatment with intravenous immunoglobulins and argatroban resulted in a normalisation of platelet counts and remission of CVST.

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