Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound scan normal, Venogram, Venogram abnormal
Clinical narrative: Cerebral venous sinus thrombosis; Pulmonary embolism; PLATELET COUNT DECREASED; Activated partial thromboplastin time shortened; Rash erythematous; Dizziness; Headache; ALANINE AMINOTRANSFERASE INCREASED; ANGIOGRAM PULMONARY ABNORMAL; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD ALKALINE PHOSPHATASE DECREASED; BLOOD ELECTROLYTES NORMAL; HAPTOGLOBIN NORMAL; THROMBIN TIME PROLONGED; ULTRASOUND SCAN NORMAL; VENOGRAM ABNORMAL; This spontaneous report received from a patient, concerned a 40-year-old. This case was described in a literature article, reference: outcomes of bivalirudin therapy for thrombotic thrombocytopenia and cerebral venous sinus thrombosis after vaccination:   The patient's height, and weight were not reported. The patient's concurrent conditions included tonsil exudate, seasonal allergies, strain of cervical portion of right trapezius muscle, and migraine headaches. There was no history of thrombosis, clotting disorders, inflammatory bowel disease, collagen vascular disorders or cancers. The patient was not pregnant at the time of reporting, was not using estrogen-containing medications or tobacco and had no recent surgical history.  On 01-APR-2021, the patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, once total administered on left arm for prophylactic vaccination.   Concomitant medications included cyanocobalamin, menatetrenone, and paracetamol.   On post-vaccination day 5, 06-APR-2021, the patient developed a headache, sinus pressure, myalgias and sore throat with tonsillar exudate. On day 8, she presented to urgent care and was prescribed amoxicillin/clavulanate potassium, a methyl-prednisolone taper and methocarbamol. No laboratory evaluation was performed. She continued to have worsening headaches (different to her normal headaches), especially with movement, associated photophobia and intermittent dizziness prompting her presentation at the Emergency Department on post-vaccination day 12, 13-APR-2021. She denied fever, weakness, numbness, vision changes, speech difficulty, gait instability, seizure. Her initial vital signs were within normal limits, except blood pressure was 141/96 mmHg. Physical examination revealed small areas of petechiae on her chest and right cheek of the face and mild tonsillar exudate without cervical lymphadenopathy. A detailed neurological examination was normal, and she had no leg swelling or pain. She was admitted to the hospital for further testing and management.  The patient was found to have thrombocytopenia, an elevated D-dimer, normal fibrinogen, and mild elevation of the serum transaminases. Laboratory data on 13-APR-2021  included: alanine aminotransferase was 87 U/L, aspartate aminotransferase was 65 U/L, blood alkaline phosphatase was 25 U/L, other blood electrolytes were normal, haptoglobin was 208 mg/dL, partial thromboplastin time prolonged was 26.4 sec, platelet count was 20x10*9/L, and thrombin time was 14.9 sec, D-dimer was 27,150 to 47,570 FEU. Peripheral smear did not reveal schistocytes or other evidence of hemolysis. The patient's nasopharyngeal swab tested negative for SARS-CoV-2 RNA by reverse-transcriptasepolymerase-chain-reaction assay. An initial heparin induced thrombocytopenia antibody test, HIT IGG PF4, (HemosIL LIA assay) was negative. A confirmatory HIT PF4 ELISA resulted positive.  While the patient did show a transient drop in hemoglobin (nadir of 12.3 g/dL on 15-APR-2021), there was no clinical evidence of bleeding. Mild transaminitis was present on time of admission; investigation for causes such as autoimmune hepatitis did not reveal an etiology.   A CT angiogram of the chest showed a mild burden of acute pulmonary embolism with subsegmental filling defects in the right lower lobe. No right heart strain or lung infarct.   A CT venography of the head/brain showed occlusive dural venous sinus thrombosis involving the left transverse and sigmoid sinuses extending into the left internal jugular vein. There is no associated infarct. There was possible additional nonocclusive thrombus in the right internal jugular vein.   A lower extremity ultrasound was negative for DVT. A right upper quadrant ultrasound confirmed no portal vein thrombosis.  The patient was treated with bivalirudin, a direct thrombin inhibitor with a short half-life. Infusion was started at 0.15 mg/kg/hr with titration parameters to target a PTT goal of 50-80 seconds. Additional pharmacologic interventions to aid in platelet recovery included intravenous globulin 1 g/kg/day for 12 days and prednisone 1 mg/kg daily.  The patient demonstrated steady improvement until discharge on hospital day 6 and continued to show improvement. Platelet count was 115 x 10^9/L (at discharge on hospital day 6/post-vaccination day 18) and was 182 x 10^9/L (during outpatient follow-up on post-vaccination day 21).  The patient did not demonstrate any sequelae of thrombosis.   The patient was recovering well from the events of cerebral venous sinus thrombosis, pulmonary embolism, low platelet count, activated partial thromboplastin time shortened, dizziness, and rash erythematous, and vision changes  was not reported. The event of headache resolved on an unspecified date.   This report was serious (Hospitalization Caused / Prolonged).  This case, from the same reporter is linked.  Additional information was received from traditional media and the literature via a company representative on 07-MAY-2021. The following information was updated and incorporated into the case narrative: Literature citation, author details, company representative added as reporter, patient race, medical history, platelet count, clinical progression, lab data, corrective treatment, and outcome.; Sender's Comments: V2: Follow up from literature provided clinical details; company assessment remains the same. This case initially obtained concerns a 40-year-old White female who was hospitalized for cerebral venous sinus thrombosis, pulmonary embolism (PE) and thrombocytopenia 12 days after receiving covid-19 vaccine. Medical history included migraine headaches. There was no history of thrombosis, clotting disorders, inflammatory bowel disease, collagen vascular disorders or cancers. She was not pregnant, was not using estrogen-containing medications or tobacco, & had no recent surgical history. Concomitant medications included cyanocobalamin, menatetrenone, & paracetamol. Post-vaccination day 5 (PVD5), she developed a headache, sinus pressure, myalgias & sore throat with tonsillar exudate. PVD8, she went to urgent care & was prescribed amoxicillin/clavulanate, methylprednisolone taper & methocarbamol. PVD12, headaches worsened, prompting Emergency Department visit. She was hospitalized for further testing and management. Labs showed: Platelets (PLT) 20k/uL, peripheral smear without schistocytes or hemolysis, d-dimer 47K, normal fibrinogen, negative Covid-19 PCR swab, positive HIT PF4 ELISA. CTV of brain showed occlusive dural venous sinus thrombosis involving left transverse & sigmoid sinuses extending into left internal jugular vein. CTA showed PE in right lobe. Ultrasound did not show deep vein thrombosis of lower extremity or portal vein. Treatment included bivalirudin, IVIG, & prednisone. Patient improved and was discharged on PVD18 with PLT 115; PLT 182 on PVD21. She was recovering without sequelae of thrombosis. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination.