Event Definition Forms

VAC4EU was a consortium member of EMA-funded project ACCESS. One of the major outputs of this project was to produce event definition forms. All of these forms are publicly available.

   Event Definition Forms

Sturkenboom M, et al. ACCESS-Background rate of adverse events-definition –Sudden death. Zenodo.
Sturkenboom M, et al. ACCESS-Background rate of adverse events-definition –transverse myelitis. Zenodo.
van Wijngaarden, et al. ACCESS-Background rate of adverse events-definition –Vaccine Associated Enhanced covid disease. Zenodo.
Engelen R, et al. ACCESS-Background rate of adverse events-definition –Multi-Inflammatory Syndrome (in Children). Zenodo.
Kelters I, et al. ACCESS-Background rate of adverse events-definition –Anaphylaxis. Zenodo.
Egbers T, et al. ACCESS-Background rate of adverse events-definition –Anosmia & Ageusia. Zenodo.
van Wijngaarden, et al. ACCESS-Background rate of adverse events-definition –Chilblain Like lesions. Zenodo.
Villaescusa R, et al. ACCESS-Background rate of adverse events-definition –Erythema Multiforma. Zenodo.
Villaescusa R, et al. ACCESS-Background rate of adverse events-definition –Acute Respiratory Distress Syndrome. Zenodo.
van Wijngaarden, et al. ACCESS-Background rate of adverse events-definition –(Meningo)encephalitis. Zenodo.
van Wijngaarden, et al. ACCESS-Background rate of adverse events-definition – Generalized Convulsions. Zenodo.
Kelters I, et al. ACCESS-Background rate of adverse events-definition –Acute Kidney Injury. Zenodo.
Villaescusa R, et al. ACCESS-Background rate of adverse events-definition –Acute Liver Injury. Zenodo.
Engelen R, et al. ACCESS-Background rate of adverse events-definition –Single Organ Cutaneous Vasculitis. Zenodo.
Egbers T, et al. ACCESS-Background rate of adverse events-definition –Coagulation disorders. Zenodo.
Engelen R, et al. ACCESS-Background rate of adverse events-definition –Arrhythmia. Zenodo.
Kelters I, et al. ACCESS-Background rate of adverse events-definition –Coronary Artery Disease. Zenodo.
Kelters I, et al. ACCESS-Background rate of adverse events-definition –Stress Cardiomyopathy. Zenodo.
Villaescusa R, et al. ACCESS-Background rate of adverse events-definition –Narcolepsy. Zenodo.
Kelters I, et al. ACCESS-Background rate of adverse events-definition –Heart Failure. Zenodo.
Sturkenboom M, et al. ACCESS-Background rate of adverse events-definition –Myocarditis and pericarditis. Zenodo.
Kelters L, et al. ACCESS-Background rate of adverse events-definition –Microangiopathy. Zenodo.
Sturkenboom M, et al. ACCESS-Background rate of adverse events-definition -thrombocytopenia. Zenodo.
Sturkenboom M, et al. ACCESS-Background rate of adverse events-definition -Diabetes mellitus type1. Zenodo.
Sturkenboom M, et al. ACCESS-Background rate of adverse events-definition -Acute Aseptic Arthritis. Zenodo.
Sturkenboom M, et al. ACCESS: Background rates of AESI to monitor vaccine safety- definition Acute disseminated encephalomyelitis. Zenodo.
Sturkenboom M, et al. ACCESS: Background rates of AESI to monitor vaccine safety- GBS definition. Zenodo.

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.