Event Definition Forms
VAC4EU was a consortium member of EMA-funded project ACCESS (vACCine COVID-19 readinESS). One of the objectives of ACCESS was to create event definition forms for 27 different adverse events of special interest (AESIs) in addition to a blueprint for how to identify the event retrospectively from electronic healthcare data sources. Each of the 27 event definition forms can be accessed on the VAC4EU Zenodo Community, and with quick links provided on the side bar on this page.
The contents of each form are the same, first featuring the clinical definition of the AESI according to the Brighton Collaboration, along with clinical characteristics at three levels of diagnostic certainty. Next, the forms list any diagnoses which must be excluded and any laboratory tests which can either exclude these other diagnoses or confirm the diagnosis of the AESI in question. The forms also list pharmacological and surgical treatments for the AESI, if any, in addition to treatment setting. Another key feature of the event definition forms is a table of diagnostic codes across multiple systems and any algorithms used in existing published reports or papers extracting the AESI. The forms also contain a summary of all known synonyms and lay terms for the AESI.
These AESIs included sudden death, transverse myelitis, vaccine-associated enhanced covid disease, multi-inflammatory syndrome in children, anaphylaxis, anosmia / ageusia, chilblain like lesions, erythema multiforma, acute respiratory distress syndrome, (meningo)encephalitis, generalized convulsions, acute kidney injury, acute liver injury, single organ cutaneous vasculitis, coagulation disorders, arrhythmia, coronary artery disease, stress cardiomyopathy, narcolepsy, heart failure, myocarditis and pericarditis, microangiopathy, thrombocytopenia, diabetes mellitus type 1, acute aseptic arthritis, acute disseminated encephalomyelitis, and Guillian Barré syndrome.