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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

A 59-year-old woman developed thrombosis and thrombocytopenia following an administration of COVID-19 vaccine. Additionally, her cerebral venous sinus thrombosis was unresponsive to immune-globulin and methylprednisolone treatment.

The woman presented with thrombolysis after waking up with reduced grip strength in her left hand and a 2 day history of mild headache (NIHSS 1, GCS 15). Two weeks earlier, she had received the first dose of COVID-19 vaccine [dose and route not stated]. Initial head CT was normal. A brain MRI revealed a signal change in the right parietal lobe. Later, she developed a self-terminating focal seizure leaving a dense left hemiparesis, left-sided inattention and left hemisensory loss. Blood tests showed severe thrombocytopenia (platelet count:25×10 9/L) and deranged liver function (alanine aminotransferase:144 IU/L). MR venography revealed thrombosis in the superior sagittal and right transverse sinuses, significant frontal haematoma and midline shift. She was diagnosed with cerebral venous sinus thrombosis secondary to vaccine-induced immune thrombosis and thrombocytopenia (VITT).

The woman received IV immune-globulin [IVIg] and IV methylprednisolone [dosages not stated]. Anti-PF4 ELISA was positive. Despite the treatment, she continued to deteriorate and she became unresponsive (GCS 7). She was admitted and underwent urgent neurosurgical intervention. Subsequently, she recovered with ongoing left-sided neurological deficit.