Causality assessment for Adverse Events Following Immunisation (AEFI)

Dr Matt Butler, Dr Arina Tamborska, and co-authors

Criteria for defining causality in vaccine-related adverse events adapted from WHO criteria and from Bradford Hill criteria

This publication outlines the principles of causality assessment of neurological events following vaccination, in the context of COVID-19 vaccines. We propose categorisation of events into probable, possible and unlikely, where previous evidence is limited.  See Table 3 below taken from the publication to be used as a tool.

Table 3 taken from the Causality Vaccine publication

Download a pdf version of Table 3: Suggested criteria for labelling causality in neurological AEFI to zoom in and read the tool more clearly.

This categorisation has been successfully applied in the study of Guilian- Barré syndrome following vaccination in group publication.

Download the full text version of the article 'Considerations for causality assessment of neurological and neuropsychiatric complications of SARS-CoV-2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder' published in the Journal of Neurology, Neurosurgery and Psychiatry by clicking on the link to the right. 

When to use?

As a companion to the vaccination clinical record forms and in clinical assessment of links between immunisation and neurological events. 

 

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