Event Definition Forms

In a pharmacoepidemiology study involving secondary use of electronic healthcare databases, researchers need standardised definitions of the adverse events of special interests (AESI) they are assessing in the study. One of the objectives of EMA-funded project ACCESS (vACCine COVID-19 readinESS) was to create event definition forms for different AESI in addition to a blueprint for how to identify the event retrospectively from electronic healthcare data sources. As a member of this project, VAC4EU developed 27 event definition forms, which can be accessed on the VAC4EU Zenodo Community. Each form has the following structure:

The Brighton Collaboration clinical definition of the AESI along with clinical characteristics at three levels of diagnostic certainty

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

Pharmacological and surgical treatments for the AESI, if any, in addition to treatment setting

A table of diagnostic codes across multiple systems and any algorithms used in existing published reports or papers extracting the AESI

A summary of all known synonyms and lay terms for the AESI.

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

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