197. Are health professionals familiar with or trained in causality assessment of individual adverse events following immunisation for the purposes of vaccine safety monitoring? If not, shouldn’t they be?

Question Number: 306
PDR Number: SQ22-000682
Date Submitted: 21/11/2022
Department or Body: Department of Health

All medicines have potential adverse reactions (side effects). Australian health professionals are trained to recognise and respond to these as part of their everyday management of individual patients. Managing adverse events is however different from causality assessment. This diagnostic process considers the likelihood of whether or not a medicine may be responsible for the patient’s symptoms, although the level of skill and experience an individual health professionals in causality assessment is variable. In a number of cases specialist medical training e.g. in neurology may be required. In the case of vaccine adverse events, health professionals are supported by jurisdictional immunisation coordinators and specialist immunisation services who can provide some advice on individual cases. However, it is not a pre-requisite for health professionals to conduct their own formal causality assessment to be able to report adverse events to the Therapeutic Goods Administration (TGA). It is usually not possible to establish a definite causal relationship between a particular adverse event following immunisation and a particular vaccine on the basis of an individual case. Reporters are encouraged to report all suspected adverse reactions, even when they are not certain that there is a link between a vaccine and an event, so that their reports can be included in the TGA’s analyses of reporting data to look for potential new safety information.