Azd-1222

Author Information

An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

In a case series, three women aged 22−46 years were described, who developed thrombocytopenia and intracranial venous sinus thrombosis following administration of AZD-1222 [covid-19 vaccine astrazeneca].

Patient 1: A 22-year-old woman, who had no significant previous medical history presented with shivering, fever and headaches for two days, with spontaneous resolution following the first AZD-1222 vaccination [covid-19 vaccine AstraZeneca]. On day 4 after the vaccination, she developed new frontally accentuated headaches. Later, on day 7, she developed a self-limited generalised epileptic seizure. Her pronator drift test was positive for her left arm. MRI revealed blood in the subarachnoid space adjacent to the falx cerebri on both the sides. The superior sagittal sinus, the left-hand transverse sinus, and the sigmoid sinus were thrombosed. Laboratory examinations showed thrombocytopenia with a platelet count of 75,000/L. The SARS-CoV-2-XPCR was negative. The test for heparin-induced thrombocytopenia (HIT) with clivarin, heparin sodium, enoxaparin and danaparoid was also negative. Digital subtraction angiography (DSA) confirmed the occlusion of the ascending cerebral veins and the said sinuses. Endovascular rheolysis (i.e., flushing with an aspiration of a 50% sodium chloride [saline] solution and contrast medium mixture inside the concerning sinuses via a large-caliber catheter resulted in a complete recanalization of the sinuses. She received levetiracetam daily for three months and enoxaparin sodium daily for ten days, followed by direct oral anticoagulation with dabigatran for six months. On day 5 and day 10 after the endovascular procedure, follow-up MRI confirmed the intracranial venous sinuses' recanalization with neither new haemorrhage nor oedema. Thereafter, she was transferred to a rehabilitation facility. Her clinical status was rated 0 according to the modified Rankin scale (mRS). Follow-up laboratory examinations revealed a spontaneous increase in the platelet count and complete normalisation was confirmed after two weeks.

Patient 2: A 46-year-old woman presented with severe headaches eight days following her first AZD-1222 vaccination [covid-19 vaccine astrazeneca]. Five days later, she developed focal neurologic symptoms with mild aphasia and hemianopia to the right. Upon admission, she was somnolent. MRI revealed a thrombotic occlusion of the superior sagittal sinus and the left-hand transverse sinus and sigmoid sinus. An acute intracerebral haematoma with a diameter of 30mm was noted in the left occipital lobe. Laboratory examinations revealed thrombocytopenia with a platelet count of 60,000/L. The SARS-CoV-2-XPCR was negative. The test for HIT with clivarin, heparin sodium, enoxaparin, and danaparoid was also negative. DSA showed the occlusion of the superior sagittal sinus and the left transverse sinus and the sigmoid sinus. Partial thrombus removal was performed by endovascular rheolysis in two separate sessions. She was treated with enoxaparin sodium for two days. Since a HIT was suspected, her therapy was changed to danaparoid, which did not achieve a sufficient factor Xa inhibition. Direct oral anticoagulation with dabigatran was given on day 14 after the clinical onset. Follow-up MRIs on days 3, 5, and 12 after the endovascular procedure confirmed the complete recanalization of the superior sagittal sinus and partial recanalization of the left transverse sinus and sigmoid sinus, without new haemorrhage nor progressive oedema. On day 27 after the vaccination and on day 14 after the endovascular treatment, she was transferred to a rehabilitation facility. Her clinical status was rated mRS 1. Follow-up laboratory examinations revealed a spontaneous increase in the platelet count.

Patient 3: A 36-year-old woman presented with severe headaches seven days after the first AZD-1222 vaccination [covid-19 vaccine astrazeneca], followed by three days of fever and headache. Initially, she was suspected to have sinusitis, but the examination was unrevealing. After ten days of headache (day 17 after vaccination), she developed acute somnolence with a right-hand hemiparesis. MRI revealed a thrombotic occlusion of the straight sinus and a non-occlusive thrombus in the superior sagittal sinus. Congestive oedema of both the thalami was more pronounced on the left side. She received danaparoid and was transferred to different hospital. Laboratory examinations revealed thrombocytopenia with a platelet count of 92,000/L. The SARS-CoV-2-XPCR was negative. The test for HIT with clivarin, heparin sodium, enoxaparin and danaparoid was negative. DSA revealed the occlusion of the straight sinus and a non-occlusive thrombus of the superior sagittal sinus. Significant thrombus was removed by endovascular rheolysis and she received enoxaparin sodium for one week, followed by direct oral anticoagulation with dabigatran for six months. After the endovascular procedure, follow-up MRIs on days 1 and 3 confirmed the intracranial venous sinuses' recanalization and neither new haemorrhage nor progressive oedema. Later, she was transferred to a rehabilitation facility. Follow-up laboratory examinations revealed a spontaneous increase in the platelet count.