VAC4EU Case definitions and data collection forms

The VAC4EU Validation Task Force (medically trained persons) developed the procedure for case definitions and ascertainment of level of certainty, which when available were based on Brighton Collaboration (BC) case definitions. The Validation Task Force used available data collection forms from SPEAC and adapted them to real world data. This document presents the final VAC4EU case definitiona and data collection forms adapted from the Birghton Collaboration and SPEAC for the following sixteen adverse events of special interest (AESIs): · Myocarditis and pericarditis · Thrombosis with thrombocytopenia syndrome (TTS) · Guillain-Barré syndrome (GBS) · Anaphylaxis · Idiopathic thrombocytopenia (ITP) · Transverse myelitis · Major congenital anomalies · Narcolepsy · Cerebral venous sinus thrombosis (CVST) · Deep vein thrombosis (DVT) · Pulmonaru embolis(PE) · Hemorrhagic stroke · Ischemic stroke · Meningoencephalitis including ADEM · Bleeding with Thrombocytopenia (BT)