Adverse event reporting

Background

An adverse event following immunisation (AEFI) is any untoward medical occurrence that happens following the administration of a vaccine. It can be coincidentally associated with immunisation, without necessarily being caused by the vaccine. A vaccine error is also considered an AEFI and may be related to the way a vaccine was stored, prepared or administered.  

Common side effects from vaccines are usually mild and short‑lasting. Severe side effects are rare. A list of common vaccine side effects can be found in The Australian Immunisation Handbook: Table: Common side effects following immunisation for vaccines used in the National Immunisation Program schedule.

Purpose

Monitoring vaccine safety during development and through post‑licensure adverse event surveillance are important ways both to ensure safe vaccination programs and to maintain community confidence in vaccines. 

Post-licensure monitoring is conducted via a number of different mechanisms. One of which is through reporting AEFI to jurisdictional and national authorities. Reporting AEFI allows the rapid investigation of any potential vaccine or system problem and ensures vaccinees get timely medical advice and support.  

Making a report

Any vaccinated individual, parent/guardian, immunisation provider or treating medical practitioner can report an AEFI. In some states and territories, healthcare professionals have a statutory responsibility to report significant or serious AEFIs. 

AEFI reports should be made to authorities in the jurisdiction where the vaccine was administered.

It is important to note that the above services do not provide emergency care and are reporting services only.

If you require medical assistance please see your GP, local emergency department or dial 000 if immediate support is required.

Resources

• • MVEC: Allergy and immunisation
  • MVEC: Febrile seizures and vaccines
  • MVEC: Guillain–Barré syndrome
  • MVEC: Hypotonic-hyporesponsive episode (HHE)
  • MVEC: Identifying AEFI in diverse skin colour
  • MVEC: Immune thrombocytopenia (ITP)
  • MVEC: Injection site nodules
  • MVEC: Shoulder Injury related to vaccine administration (SIRVA)
  • MVEC: Vaccine-associated enhanced disease (VAED)