Key facts

  • Vaccines are held to a higher safety standard than other medications.  
  • Vaccine safety evaluation is included in every step of the vaccine development process.
  • Vaccine safety monitoring continues even after a vaccine is approved and begins to be used in the community.
  • In Australia, two national surveillance systems continually monitor vaccine safety: the Therapeutic Goods Administration through spontaneous reports and AusVaxSafety by actively soliciting potential side effects following vaccination in select vaccinated individuals.

Like all medications, vaccines have potential side effects, sometimes called ‘adverse events following immunisation’ (AEFI) by healthcare professionals.

However, unlike other medications that are given to a small number of people to treat a disease, vaccines are given to a large proportion of healthy people to prevent a disease. 

Therefore, vaccines are held to a very high safety standard as there is a lower tolerance for side effects compared with other medications.

To find out more about how safety monitoring works at each stage of a vaccine’s lifecycle, see:

How are vaccines developed 

Vaccine safety after vaccine approval 

Vaccine safety monitoring 

Last updated October 2025