Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Protein S deficiency, SARS-CoV-2 test negative, Splenic vein thrombosis, Thrombocytopenia, Transaminases
Clinical narrative: LEFT SIGMOID SINUS VEIN THROMBOSIS; PORTAL VEIN THROMBOSIS; SPLENIC VEIN THROMBOSIS; SUPERIOR MESENTERIC VEIN THROMBOSIS; LEFT INTERNAL JUGULAR VEIN THROMBOSIS; THROMBOCYTOPENIA; ABDOMINAL PAIN; HEADACHE; This spontaneous report was received from a physician and concerned a 58-year-old white female. Initial information was received on 27-APR-2021, with additional information obtained via telephone follow up from the physician on 29-APR-2021. The patient's specific height and weight were not reported. The patient's past medical history included fatty liver, and the patient was overweight.  Family history was significant for a deep venous thrombosis treated with anticoagulants in the patient's mother, and a history of unspecified blood clots in her maternal grandmother. The patient was on no medications, including no estrogen containing pharmaceutical products or supplements. She has never been exposed to heparin. The patient had no history of COVID-19 infection. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported, batch number not reported) on 12-APR-2021. The batch number has been requested. No concomitant medications were reported. On 18-APR-2021, 6 days after receiving vaccine, the patient developed a headache. On 23-APR-2021, 11 days after receiving vaccine, the patient presented to the hospital with complaints of headache and abdominal pain. COVID test in the emergency room was negative. On 23-APR-2021, imaging of the head and abdomen revealed:  left sigmoid sinus vein thrombosis, portal vein thrombosis, splenic vein thrombosis, superior mesenteric vein thrombosis, left internal jugular vein thrombosis.  The patient also had thrombocytopenia, with platelet count on presentation 22,000 (units not provided).  D-dimer was elevated at >12.8 (units not provided), Fibrinogen was low at 103 (units not provided), HIT antibody test by ELISA was positive, and physicians made the diagnosis of Vaccine-induced Thrombotic Thrombocytopenia (VITT). The patient was hospitalized in the intensive care unit. Treatment medications included argatroban, steroids and IVIG.  Following treatment, the platelet count remained low, with a nadir of 17,000. On 27-Apr-2021, she underwent thrombectomy and thrombolysis of the intra-abdominal clots. This was performed due to the potential for portal hypertension in the future, given the extent of the thromboses. Repeat CT venogram of the head on an unknown date, revealed resolution of the sigmoid sinus vein thrombosis; the internal jugular thrombosis persisted. The patient has steadily improved since the thrombectomy. Abdominal pain and headache are improving.  Platelet count has steadily risen, to 138,000 on 29- Apr-2021. Her transaminases were slightly elevated on admission and have not worsened, and she appears to have no organ dysfunction. A dialysis catheter had been placed in the event she would require plasmapheresis, but this was never used.  Additional laboratory data included: IgG and IgM antibodies against the SARS-COVID-2 nucleocapsid protein positive; Protein C deficiency negative; Protein S deficiency negative; Homocysteine level (NR: not provided) negative.  Serotonin release assay, anticardiolipin panel and Factor V Leiden tests were pending. The plan was to transition the patient to an oral anticoagulant and remove the dialysis catheter on 30-APR-2021, with a possible discharge on 01-MAY-2021. The patient had not recovered from left sigmoid sinus vein thrombosis, portal vein thrombosis, splenic vein thrombosis, superior mesenteric vein thrombosis, and left internal jugular vein thrombosis, and was recovering from left sigmoid sinus vein thrombosis, thrombocytopenia, headache and abdominal pain.  This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).  Additional information was received from physician on 29-APR-2021. The following information was updated and incorporated into the case narrative: patient history, disease course, events, outcome, lab data, concomitant drugs.; Sender's Comments: V0:  This spontaneous report concerns a 58-year-old female patient who experienced left sigmoid sinus vein thrombosis, portal vein thrombosis, splenic vein thrombosis, superior mesenteric vein thrombosis, left internal jugular vein thrombosis, thrombocytopenia, headache and abdominal pain, 11 days after receiving COVID-19 VACCINE AD26.COV2.S.  The patient is overweight and there is a family history of clots in her mother and maternal grandmother. Imaging of the head and abdomen revealed multiple sites of thrombus formation, platelet count was 22,000, D-dimer was elevated at >12.8 (units not provided), Fibrinogen was low at 103 (units not provided),  and HIT antibody test by ELISA was positive. Physicians made the diagnosis of  Vaccine-induced Thrombotic Thrombocytopenia (VITT).  The patient was treated with argatroban, IVIG, and steroids.  Platelet counts remained low and she underwent thrombectomy of the intra-abdominal thrombi.  Following thrombectomy the platelet counts rose and abdominal pain began to improve.  Lab data included a positive test for IgG and IgM antibodies against the SARS-COVID-2 nucleocapsid protein.   Based on the evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), the low platelet count and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.