Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Pulmonary embolism, Thrombosis with thrombocytopenia syndrome
Clinical narrative: VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; PULMONARY EMBOLISM; CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report was received from literature:  of Ad26.COV2.S-associated VITT and specific detection of VITT antibodies. Journal of Hematology.  This report concerned a 51 year old female. The objective of this study was to assess vaccine induced immune thrombotic thrombocytopenia (VITT) antibody persistence using currently available functional and antigen-based assays and to develop new laboratory tools for the specific detection of VITT that would allow its differentiation from classical and spontaneous HIT (Heparin-induced thrombocytopenia). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after 7 days of vaccination , the patient experienced vaccine induced thrombotic thrombocytopenia, pulmonary embolism, and cerebral venous sinus thrombosis. The patient was hospitalized on an unspecified date. Number of days of hospitalization were not reported.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, PF4 Polyanion Enzyme Linked Immunosorbent Assays (ELISA) was positive (there were persistent anti-PF4 antibodies for 6 months during follow ups), Fibrin D dimer was greater than 20, 000 ng/mL (elevated), Platelet count 55000 /uL, and Serotonin release assay result was not reported.  Treatment medications during episode included: high dose intravenous immunoglobulin G, argatroban, and prednisone. The subsequent treatment was apixaban. The patient was alive as on report time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, cerebral venous sinus thrombosis and vaccine induced thrombotic thrombocytopenia was not reported. The authors emphasized that the associated VITT antibodies persisted for greater than 5 months in platelet factor 4 (PF4) polyanion enzyme linked immunosorbent assays (ELISA) while the PEA became negative earlier. Thus, it was concluded that the patients with VITT demonstrate long term ELISA positivity, although functional assays become seronegative earlier during the course of recovery. The data suggested that the un-complexed PF4 ELISA is sensitive and significantly more specific for the detection of VITT than currently available tests. This report was serious (Hospitalization Caused / Prolonged). This case, from the same literature article is linked to 20220237634, 20210448310, 20210444498, 20210415297, 20220249472, 20220249417, 20220249430 and 20220249503.; Sender's Comments: V0: 20220249398- COVID-19 VACCINE AD26.COV2.S- vaccine induced thrombotic thrombocytopenia,  pulmonary embolism, cerebral venous sinus thrombosis. This event(s) is labeled per RA and is therefore considered potentially related.