Sex: F
Vaccine: COVID19
Symptoms: ADAMTS13 activity assay, Blood pressure measurement, Fibrin D dimer, Heparin-induced thrombocytopenia test, Imaging procedure
Clinical narrative: VACCINE-INDUCED THROMBOCYTOPENIA AND THROMBOCYTOSIS; VACCINE-INDUCED THROMBOCYTOPENIA AND THROMBOCYTOSIS; This is a literature report for the following literature source(s).  A 68-year-old female patient received BNT162b2 (COMIRNATY), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, SINGLE, Unknown manufacturer), for COVID-19 immunisatio; Covid-19 vaccine (DOSE:2, SINGLE, Unknown manufacturer), for COVID-19 immunisatio; Covid-19 vaccine (DOSE:3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunisatio; Covid-19 vaccine (DOSE:4 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunisatio; Covid-19 vaccine (DOSE:5 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunisatio. The following information was reported: THROMBOCYTOPENIA (medically significant), THROMBOCYTOSIS (medically significant), outcome "recovering" and all described as "VACCINE-INDUCED THROMBOCYTOPENIA AND THROMBOCYTOSIS". Clinical course: A 68-year-old female with history of asthma, hypertension, hyperlipidemia, diabetes, and no prior documented heparin exposure presented with stroke-like symptoms and confusion. On arrival, she was hypertensive at 210/100s. Blood work revealed severe thrombocytopenia (<2000/ml), mild normocytic anemia (10.9g/dl). Imaging revealed left transverse and sigmoid sinus thrombosis with scattered subarachnoid and subdural hemorrhage. Thrombocytopenia and non-life-threatening bleeding were unresponsive to multiple platelet transfusions. Heparin was initiated for anticoagulation. Work up for hypercoagulable states including ADAMTS13 were unremarkable. On further questioning, she was reported to having received the 6th dose of Pfizer vaccine (Comirnaty vaccine) 4weeks prior to presentation. Further workup revealed markedly elevated D-dimer, positive Heparin platelet factor-4 (PF-4) with optical density of 0.97U and negative serotonin release assay suggesting VITT. She was switched to argatroban and started on intravenous immunoglobulin with significant improvement of thrombocytopenia (200-300k/ml). Discussion: While cerebral venous thrombosis was the primary clinical presentation in our patient, VITT often times affects both venous and arterial circulations. Additional research is required to understand and develop an appropriate diagnostic tool for detecting VITT-like anti-PF4 antibodies. In the midst of a successful vaccination program to conquer COVID-19, VITT has emerged as a rare but expected complication.  No follow-up possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Thrombocytopenia and Thrombocytosis occurred after the administration with multiple COVID 19 vaccines including BNT162b2.    More epidemiologic and accumulative clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the events occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate