Vaccines are rigorously tested for safety during the research phase of development and undergo strict assessment by the TGA before approval for use in Australia. Like other medicines, vaccines can have side effects. However, all vaccines used in Australia provide benefits that greatly outweigh their risks.
Health professionals have a duty to ensure appropriate and safe administration of vaccines to the public. This includes being well informed of potential side effects and how to manage these in patients.
NSW Health: What is a serious adverse event?
Reporting AEFIs
Health professionals are required to report all uncommon, serious or unexpected AEFI or any event felt to be significant following immunisation to the relevant health authorities.
All AEFIs or suspected AEFIs must be reported to both the Therapeutic Goods Administration (TGA) and the Public Health Unit (PHU):
AEFI resource for parents
COVID-19 vaccine safety
General vaccine safety & resources
AusVaxSafety: Safety Surveillance data for NIP scheduled vaccines
AusVaxSafety: Vaccine Safety Summary report 2022
AusVaxSafety: Safety Surveillance data for various vaccines
Minimum requirements for an anaphylaxis kit:
The ASCIA anaphylaxis e-training course for health professionals 2024
VAE can occur as a result of errors in vaccine preparation, handling, storage or administration and can be associated with immunisation error-related reactions. Identification and follow-up of vaccine administration errors can identify and correct immunisation error-related reactions in a timely manner.
It is responsibility of the immunisation provider to manage VAE and seek advice from the local public health unit (PHU) if required. VAE resulting in a suspected adverse event following immunisation (AEFI) must be reported to the PHU. VAEs that pose a safety risk to the patient must be reported to the PHU and Therapeutic Goods Administration (TGA) via the National AEFI reporting form.
For instance, if Trumenba, a meningococcal B vaccine (registered for use in children aged 10 years and over) is dispensed and subsequently administered inadvertently to children aged less than 10 years, it will be considered a VAE. The provider is required to report the VAE to the PHU and TGA by completing the National AEFI report form and submitting to the PHU and TGA.
Further information about AEFI and VAE is available on NSW Health webpages at AEFIs and VAEs.
To reduce the risk of VAEs, always remember to follow AIH – Preparing for vaccination and the 7 rights of vaccine administration.
1) Right person/patient
2) Right vaccine/diluent
3) Right time
4) Right dosage
5) Right route, needle length and technique
6) Right injection site
7) Right documentation
NCIRS resource on clinical guidance on RSV immunisation product administration errors
ATAGI guidelines on the management of a range of possible vaccine administration errors, including when a replacement (repeat) dose is recommended.
Communicating with people who are unvaccinated against COVID-19
This NCIRS report summarises perspectives on COVID-19 vaccines of unvaccinated adults living in Australia who were interviewed in late 2021.
Recommendations for immunisation providers:
SKAI: Sharing Knowledge About Immunisation, is an excellent resource which empowers you with evidence-based information, helps answer common questions and supports your conversations with healthcare professionals about vaccination. This includes how to address vaccine misinformation.
mRNA vaccine misinformation: The TGA has released an article addressing the misinformation about excessive DNA in the mRNA vaccines.