Thrombocytopenia and Intracranial Venous Sinus Thrombosis after “COVID-19 Vaccine AstraZeneca” Exposure

Abstract

Background: As of 8 April 2021, a total of 2.9 million people have died with or from the coronavirus infection causing COVID-19 (Corona Virus Disease 2019). On 29 January 2021, the European Medicines Agency (EMA) approved a COVID-19 vaccine developed by Oxford University and AstraZeneca (AZD1222, ChAdOx1 nCoV-19, COVID-19 vaccine AstraZeneca, Vaxzevria, Covishield). While the vaccine prevents severe course of and death from COVID-19, the observation of pulmonary, abdominal, and intracranial venous thromboembolic events has raised concerns. Objective: To describe the clinical manifestations and the concerning management of patients with cranial venous sinus thrombosis following first exposure to the “COVID-19 vaccine AstraZeneca”. Methods: Patient files, laboratory findings, and diagnostic imaging results, and endovascular interventions of three concerning patients were evaluated in retrospect. Results: Three women with intracranial venous sinus thrombosis after their first vaccination with “COVID-19 vaccine AstraZeneca” were encountered. Patient #1 was 22 years old and developed headaches four days after the vaccination. On day 7, she experienced a generalized epileptic seizure. Patient #2 was 46 years old. She presented with severe headaches, hemianopia to the right, and mild aphasia 13 days after the vaccination. MRI showed a left occipital intracerebral hemorrhage. Patient #3 was 36 years old and presented 17 days after the vaccination with acute somnolence and right-hand hemiparesis. The three patients were diagnosed with extensive venous sinus thrombosis. They were managed by heparinization and endovascular recanalization of their venous sinuses. They shared similar findings: elevated levels of D-dimers, platelet factor 4 antiplatelet antibodies, corona spike protein antibodies, combined with thrombocytopenia. Under treatment with low-molecular-weight heparin, platelet counts normalized within several days. Conclusion: Early observations insinuate that the exposure to the “COVID-19 vaccine AstraZeneca” might trigger the expression of antiplatelet antibodies, resulting in a condition with thrombocytopenia and venous thrombotic events (e.g., intracranial venous sinus thrombosis). These patients’ treatment should address the thrombo-embolic manifestations, the coagulation disorder, and the underlying immunological phenomena.

COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis

“…Finally, several international reports have been published highlighting the possibility of thrombohemorrhagic complications within the time interval of 5 to 16 days after the first dose of the adenoviral vector vaccine ChAdOx1-19 against COVID-19 [7][8][9]18]: these data confirmed that the analyzed cases may be definitively classified as AEFI caused by vaccination.…”

“…Moreover, in order to develop specific evidence-based items, an exhaustive review of the pertinent literature was performed. To date, several reports have been published reporting severe adverse effects (thrombosis and thrombocytopenia) after COVID-19 vaccination [7][8][9][16][17][18][19]. Each report was analyzed independently by each author of this article in order to identify specific items.…”

“…The second step is to analyze the temporal proximity to confirm that the symptoms occurred within a plausible time window after vaccine administration. According to the literature, three weeks after administration represent an ideal period that should be monitored to evaluate the AEFI after COVID-19 vaccination [8,9]. • If there are any suspicious causes other than those listed above, write the details below.…”

“…For this reason, the scientific community is working to support the concept of safer COVID-19 vaccinations. Moreover, researchers worldwide are focusing their attention on the so-called "thrombosis and thrombocytopenia after ChAdOx1 nCoV-19 vaccination", producing several studies and publications [7][8][9]. Furthermore, after a precautionary stop, on April 20, 2021, the COVID-19 vaccine Janssen received the authorization for its use by EMA that provided updated guidance, confirming that the overall benefit-risk profile remains positive.…”

Extending the clinical spectrum of thrombotic thrombocytopenic syndrome attributable to adenovirus-based vaccines for Covid-19

“…The ChAdOx1-nCoV 19 is another adenovirus-based vaccine for which data on VITT have been published in the medical literature. There are data on 58 cases(45 females) of whom 48 were aged <60 [ [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] ]. The twin derangements of thrombocytopenia and raised D-dimer levels were documented in 51 cases.…”