Standardized case definitions for global use

The Brighton Collaboration is committed to develop standardized, widely disseminated and globally accepted case definitions for an exhaustive number of AEFI complemented by guidelines facilitating their use. A common understanding of each AEFI worldwide and in all settings builds a basis for meaningful research and communication in immunization safety.

Brighton case definitions and associated guidelines are intended to enhance data comparability within and across clinical trials, surveillance systems, and post-licensure clinical studies. They neither provide a causal assessment of a given adverse event with immunization, nor are they intended to establish criteria for management of patients. The case definitions are designed to define the levels of diagnostic certainty of reported adverse events following immunization.

Working Groups

Working Groups work as multidisciplinary teams consisting of 5 - 20 volunteers with relevant experience in patient care, public health, clinical trials, safety surveillance and safety assessment from developed and developing countries. Volunteers are actively sought by the Brighton Team, can be recommended, or can volunteer themselves.

Method

Case definition development follows an established standard "Brighton method". This is based on systematic review of current evidence, consensus formation, structured peer review and scientific publication. 

Brighton case definitions

Our published case definitions are endorsed by the World Health Organization (WHO) and the UN Council for International Organizations of Medical Sciences (CIOMS), they are recommended for use by the US Food and Drug Administration (FDA), the European medicines Agency (EMA), the US Centers for Disease Control and Prevention (CDC), the European Centre for Disease Prevention and Control (ECDC).

January 9, 2017:

Download the following case definitions here:

  • Abscess
  • Anaphylaxis
  • Acute Disseminated Encephalomyelitis or ADEM (see Encephalitis)
  • Aseptic Meningitis (see Meningitis, Aseptic)
  • Cellulitis at Injection Site
  • Chronic Fatigue (see Fatigue)
  • Congenital Anomalies
  • Convulsion (see Seizure)
  • Crying, Persistent
  • Diarrhoea
  • Eczema Vaccinatum
  • Encephalitis, Myelitis, and ADEM
  • Fatigue
  • Fever
  • Generalized Convulsive Seizure (see Seizure)
  • Generalized Vaccinia
  • Guillain Barre Syndrome and Fisher Syndrome
  • Hypertensive Disorders of Pregnancy
  • Hypotonic Hyporesponsive Episode
  • Inadvertent Inoculation
  • Induration at Injection Site
  • Injection Site Pain (see Pain, Injection Site)
  • Intussusception
  • Local Reaction
  • Maternal Death
  • Meningitis, Aseptic
  • Meningoencephalitis (see Encephalitis)
  • Myelitis (see Encephalitis)
  • Narcolepsy
  • Neonatal Death
  • Neonatal infections
  • Nodule at Injection Site
  • Non-reassuring Fetal Status
  • Pain, Injection Site
  • Pathways to Preterm Birth
  • Persistent Crying (see Crying, Persistent)
  • Postpartum Haemorrhage
  • Preterm Birth
  • Progressive Vaccinia
  • Rash
  • Robust Take
  • Seizure
  • Stillbirth
  • Swelling
  • Thrombocytopenia
  • Unexplained Sudden Infant Death
  • Viscerotropic Disease

 

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