Sex: U
Vaccine: COVID19
Symptoms: Anti-platelet antibody, Blood fibrinogen, Fibrin D dimer, Haematoma, Jugular vein thrombosis
Clinical narrative: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; RIGHT TRANSVERSE SINUS THROMBI; RIGHT SIGMOID SINUS THROMBI; UPPER INTERNAL JUGULAR VEIN THROMBI; LARGE HEMATOMA; This spontaneous report was received from literature. This report concerned a 30 year old of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, approximately 2 weeks after vaccination the patient developed increasingly severe headaches with blurry vision, neck pain, stiffness nausea and vomiting ,vaccine induced immune thrombotic thrombocytopenia, right transverse sinus thrombi, right sigmoid sinus thrombi, upper internal jugular vein thrombi, and large hematoma, and was hospitalized for 10 days. The patient was started on IVIG (1 g/kg x 2 doses) and underwent chemical thrombolysis utilizing direct administration of TPA followed by a balloon thrombectomy. Bivalirudin was used as the anticoagulant during and after the procedure. The patient was also started on prednisone, corticosteroid and parenteral direct thrombin inhibitors briefly followed by direct oral anticoagulants. The patient made a complete neurological recovery and was discharged 10 days later with a steroid taper and on apixaban. On an unspecified date, Laboratory data included, MRI (Magnetic resonance imaging) demonstrated a large hematoma in the right posterior temporal lobe with surrounding edema and associated mass-effect with a right-to-left midline shift. Thrombi were also noted within the torcula, right transverse sinus, right sigmoid sinus, and upper internal jugular vein. At the time, the patient had a platelet count of 102 × 109/L with an elevated D-dimer of more than 40,000 ng/mL FEU and a normal fibrinogen activity (386mg/dL). Patients had oligoclonal anti-PF4 antibodies and HIT anti-PF4 antibodies were polyclonal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine induced immune thrombotic thrombocytopenia, large hematoma, right transverse sinus thrombi, right sigmoid sinus thrombi and upper internal jugular vein thrombi was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210515201, 20210514958 and 20210448310.; Sender's Comments: V0: 20221037346-covid-19 vaccine ad26.cov2.s-Large hematoma. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE(Concurrent condition of VITT considered as confounding factor). Therefore, this event(s) is considered not related.  20221037346-covid-19 vaccine ad26.cov2.s- Vaccine induced immune thrombotic thrombocytopenia, Right transverse sinus thrombi, Right sigmoid sinus thrombi, Upper internal jugular vein thrombi. This event(s) is labeled per RSI and is therefore considered potentially related.