Vaccine safety

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.

AEFI

Adverse Events Following Immunisation (AEFI)

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):

TGA: Submit National AEFI reporting form to adr.reports@tga.gov.au OR complete the online form
PHU: Notify Public Health Unit on 1300 066 055

AEFI resource for parents

Following vaccination – what to expect – download of order from DOH

Vaccine safety

COVID-19 vaccine safety

TGA: COVID-19 vaccine weekly safety report
AusVaxSafety: COVID-19 vaccine safety surveillance

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

Anaphylaxis

Anaphylaxis Kit

Minimum requirements for an anaphylaxis kit:

Preparing an anaphylaxis response kit – requirements as per Handbook
Managing anaphylaxis after vaccination – poster from Handbook
Anaphylaxis vs Vasovagal Episode – Pharmaceutical Society of Australia

Anaphylaxis e-Training

The ASCIA anaphylaxis e-training course for health professionals 2024

This course was developed by the Australasian Society of Clinical Immunology and Allergy (ASCIA).
This free anaphylaxis course takes approximately 1.5 hours to complete and is suitable for all health professionals, including medical practitioners and nurses.

GP requirement: Basic Life Support

BLS training requirements – and how often does this need to be renewed? RACGP

CPR requirements

Frequently asked questions for cardiopulmonary resuscitation (CPR) requirements in general practices

Vaccine administration errors (VAE)

Vaccine administration error (VAE)

Vaccine administration errors include but are not limited to the inadvertent administration of a wrong or unintended vaccine and/or the inadvertent administration of a vaccine that is incorrectly stored, prepared or given outside the Australian Immunisation Handbook’s advice.

Some examples include the supply and administration of:

a vaccine compromised by a cold chain breach or exposed to light
an expired vaccine
a diluent only component of a vaccine
a vaccine that is contraindicated for an individual (due to pregnancy, immuno-compromised conditions or other reasons) or outside recommended age.

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 the responsibility of all NSW immunisation providers including pharmacist immunisers to manage and report VAE to the PHU by calling 1300 066 055 irrespective of the outcome of the VAE.

VAEs that pose a safety risk to the patient or result in AEFI must be reported to the PHU and Therapeutic Goods Administration (TGA) via the National AEFI reporting form.

For example, 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.

7 rights of vaccine administration

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

RSV vaccine administration errors

NCIRS resource on clinical guidance on RSV immunisation product administration errors.

COVID-19 vaccine administration errors

ATAGI guidelines on the management of a range of possible vaccine administration errors, including when a replacement (repeat) dose is recommended.

General advice on vaccine errors

Advice relating to patient
- Open disclosure of the incident to the patient/parents of the patient.
- Inform patient of any expected side effects and possible remedies to help with side effects.
- Arrange follow up appointment for patient with GP – mainly as a health check, but also to maintaining the GP/patient relationship.
- Give the Patient/Parents HCCC contact details in case they want to report a complaint:
  - Email: hccc@hccc.nsw.gov.au
  - Phone: 92197444
Advice relating to practice
1. - Usual incident reporting process within the practice
  - Inform the practice Insurer
  - Review practice policies/process to avoid error in future
Clinical advice
- Send patient to Emergency Department if patient clinically unwell
- Contact NSWISS if clinical advice is required (eg revaccination advice)
  - Email: SCHN-NSWISS@health.nsw.gov.au
  - Phone: 1800 679 477 or 9845 1414
- For accidental overdose see below.
Reporting
- Complete an AEFI reporting form and
- contact your local public health unit on 1300 066 055
- For COVID-19 vaccinations, send an error report to Vaccine Operations Centre (VOC): COVID19VaccineOperationsCentre@Health.gov.au

Accidental overdose

If an accidental overdose occurs, it is recommended to observe vital signs and, if symptomatic, to treat the symptoms. There are no specific overdose symptoms to be aware of.
Follow the above Advice on Vaccine Errors – This error must be recorded through your normal jurisdictional medication error reporting systems.
For more information, the Poisons Information Centre may be contacted on 131 126.

Vaccine hesitancy

Sharing Knowledge About Immunisation (SKAI) is an excellent resource to support conversations with patients who may be hesitant about vaccinating themselves or their children. There are a range of factsheets, eLearning programs and answers to common questions.

Parents who do not intend to vaccinate their child

The goals for a consultation with a declining parent are to maintain trust and engagement, and to keep the consultation brief.

Conversations can be kept short. Engaging declining parents in debate about the validity of their beliefs can result in extended, unproductive consultations and should be avoided; it an increase their risk of disengaging from the healthcare system all together.

Resources for health professionals:

Parents who are feeling hesitant about vaccinating their child

The goals for a consultation with a hesitant parent are to increase vaccine confidence, and ultimately to vaccinate.

Most hesitant parents will decide to accept vaccination but want to actively participate in the process of decision-making. This sense of agency is important. They primarily have questions or concerns about vaccine safety, and may have had a bad past experience or heard or read something frightening.

Resources for health professionals:

Adult patients who have questions

The goals for a consultation with a hesitant patient are to increase vaccine confidence and to vaccinate.

Studies have shown that a patient is more likely to vaccinate if they get a strong recommendation from a healthcare professional. It’s important for healthcare professionals to elicit and acknowledge concerns, share their knowledge, and ultimately recommend vaccination.

Resources for health professionals:

Addressing vaccine misinformation

As a healthcare professional and a trusted source of information for patients, you have an important role in dispelling vaccine misinformation. Vaccine misinformation can undermine vaccine confidence and increase vaccine hesitancy. Your role is especially significant given the threat misinformation has posted to people’s acceptance and uptake of COVID-19 vaccines and routine vaccination.

Resources for health professionals:

Resources to provide to patients with questions

Co-administration of vaccines

Co-administration of vaccines for adults

The National Centre for Immunisation Research and Surveillance has released an updated guide to support immunisation providers in identifying vaccines that can be co-administered for people aged 18 years and over.

Co-administration of vaccines for adults: a guide for immunisation providers – March 2025