Vaccine errors can occur when a vaccine is incorrectly stored, prepared or given outside the current clinical guidelines, potentially resulting in an Adverse Event Following Immunisation (AEFI).
Examples of vaccine error include administration of:
- an expired vaccine
- vaccine compromised by a cold chain breach
- diluent only component of a vaccine
- vaccine that is contraindicated for an individual or outside recommended age.
Vaccine errors should be reported to , the Victorian vaccine safety service.
Prepare your health service to prevent vaccine errors
All vaccine errors are preventable.
Keeping up to date with your knowledge of vaccines, cold chain management, national and state immunisation programs, the professional standards of your registration and your relevant authority to immunise, will provide the framework for safe practice.
Review and check:
- Ensure all staff receiving and storing vaccines have completed the department’s eLearning Cold Chain .
- Read the National Vaccine Storage Guidelines: Strive for .
- Develop a vaccine management for your health service to manage cold chain requirements, including a back-up plan in the event of power outage.
- Ensure staff providing the vaccination have adequate training and current knowledge of the Victorian Immunisation Schedule and National Immunisation (NIP) schedule.
- Ensure staff have access to the online Australian Immunisation .
- Download the Australian Immunisation Handbook Mobile . The app enables access to all content even when you do not have access to the internet.
- Ensure staff are practicing within their individual scope of practice and the conditions associated with their Approval to administer vaccines, including exclusion criteria and specified ages of approved client groups.
- Medical practitioners and nurse practitioners are authorised via Victorian drugs and poisons legislation to administer vaccines without the need for additional authorisation.
- Nurse immunisers and pharmacist immunisers are authorised to administer specified vaccines via Secretary Approvals. It's important that immunisers know the requirements of the Approvals and how meet their legal and professional obligations.
- Nurse immunisers can access the Secretary Approvals and Approved Client Groups information.
- Pharmacist immunisers can access the Secretary Approvals and Victorian Pharmacist-Administered Vaccination Program Guidelines.
- All health professionals can access free immunisation training through the department’s immunisation eLearning .
- Stay up to date with changes and subscribe to the Department of Health’s Immunisation newsletter.
Six steps to prevent vaccine errors
- Identify the right person by checking their full name and date of birth.
- Identify any medical risk factors or contraindications by using the pre-vaccination screening from the Australian Immunisation Handbook.
- For live zoster vaccines (Zostavax), always use the screening for contraindications to the live vaccine.
- Thoroughly check the vaccine name, and expiry date.
- Confirm the cold chain of the vaccine has been maintained.
- Look for any abnormalities such as the wrong colour or a cracked vial. Report concerns to the Immunisation Unit, Department of Health via email to firstname.lastname@example.org.
- Vaccine dosage is based on the person’s age, so ensure you are using the correct age formulation.
- Always check any existing vaccine immunisation records before vaccinating, for example the Australian Immunisation (AIR), My Health, Learning and Development book (Green book), medical records or contact a previous immunisation provider. Client recall is not always reliable.
- Check the Victorian Immunisation Schedule and National Immunisation Program (NIP) for correct schedules and the Australian Immunisation for the correct age eligibility and vaccine information.
- Check the correct dose intervals from the same or different vaccines.
- Confirm route of administration. Route of administration may vary by vaccine type. Most vaccines available in Australia are given intramuscularly. Only a few vaccines are given subcutaneously, orally or intradermally.
- Rotavirus vaccines are only available for oral administration and must never be injected.
- Immunisation providers need special training for intradermal administration.
- Review the Administration of vaccines in the Australian Immunisation Handbook for correct site, technique and needle lengths for age and how to avoid shoulder injury related to vaccine
- Always document vaccines given in the My Health, Learning and Development book (Green book), medical records, and/or heatlh service software.
- Ensure you are entering the correct vaccine name, and batch number to your health service software.
- Ensure you report all NIP, state program, influenza, and COVID-19 vaccines to the Australian Immunisation .
Managing vaccine errors
Vaccine errors can occur when a vaccine is incorrectly stored, prepared or given outside the current clinical guidelines potentially resulting in AEFI.
A review of the error should always be undertaken to:
- investigate and identify the cause of the vaccine error
- identify how to prevent a similar error occurring in the future
- identify actions required to resolve the situation including an appropriate response to the affected person/family
- follow health service protocols for recording the error and providing the appropriate support for the staff and individual/s involved.
Health services must follow the requirement for open disclosure to inform the client of vaccine error. The Australian Open Disclosure Framework developed by the Australian Commission on Safety and Quality in Health Care outlines the key principles of open disclosure. Refer to Open Disclosure Framework for details.
Support for immunisation providers
SAEFVIC is Victoria’s vaccine safety service and assist the department to ensure safe and effective immunisation programs and maintain community confidence in vaccines. SAEFVIC will support and guide immunisation providers to respond to vaccine errors and facilitate clinical response and education as required.
Vaccine errors can be reported via the SAEFVIC 24 hours a day, 7 days a week.
Alternatively, you can call SAEFVIC on 1300 882 924 (Option 1). Hours of operation are Monday - Friday 9.00am - 4.30pm.
Common vaccine errors and management
Administration of live attenuated vaccines are contraindicated in pregnancy or shortly before pregnancy due to a potential risk to the foetus. Refer to the Vaccination for women who are planning pregnancy, pregnant or in the Australian Immunisation Handbook for further details.
Action required – report error immediately to for assessment and clinical advice.
Vaccine errors include the administration of:
- Live attenuated vaccine to a person with severe immunocompromise or on immune suppressive therapy.
- Live zoster vaccine (Zostavax) to a person with immunocompromise due to the risk of disseminated disease from the Oka vaccine virus
Refer to Vaccination for people who are in the Australian Immunisation Handbook for a description of conditions leading to immunocompromise and examples of immunosuppressive therapy.
Action required - report error immediately to for assessment and clinical advice.
All cold chain breaches must be reported to the department using the process detailed in Cold chain reporting.
Action required - Incidents where compromised vaccines have been inadvertently administered must be reported immediately to for assessment and clinical advice.
Where a vaccine has been administered to the wrong person, the vaccine immunisation provider must follow the requirements for open disclosure, as outlined in the Open Disclosure Framework.
Action required - provide immediate reassurance and report error to for assessment and clinical advice.
All vaccines have an expiry date determined by the manufacturer or a revised expiry date following removal from deep freeze storage (thaw date) for distribution and storage at +2°C to +8°C. Vaccines stored appropriately can be used up until the last day of the month indicated on the expiration date.
Action required - report error to for assessment and clinical advice.
The diluent supplied with Infanrix hexa contains the DTPa-hepB-IPV (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus) components as liquid in a syringe. If this is administered without reconstituting the vial pellet, the individual would not receive the Hib (Haemophilus influenzae type b) component.
Action required - On discovering this error, administer a dose of NIP funded monovalent Hib (Haemophilus influenzae type b) immediately or recall client to provide the vaccine at the earliest convenience.
Some vaccines are manufactured in either powder or pellet form and must be mixed with a diluent to reconstitute the vaccine before being administered.
Diluents may contain an antigen, or an adjuvant needed for vaccine effectiveness. Even if the diluent is composed of sterile water or saline, use only the diluent supplied with the vaccine to reconstitute it.
Action required - report error to for assessment and clinical advice.
There are specific vaccine formulations and schedules for different age groups (e.g. Hep B vaccines) or vaccines registered for use in certain ages only (e.g. influenza vaccines). Larger than recommended doses may result in excessive local or systemic concentrations of antigens or other vaccine constituents. Administration of a lower dose may result in inadequate protection.
Check the disease chapters of the Australian Immunisation Handbook for correct vaccine formulation for age.
Action required - report error to , for assessment and clinical advice.
The Australian Immunisation table provides guidance on the minimum acceptable age for the first dose of scheduled vaccines in infants contained in the National Immunisation Program .
Action required - Refer to the table and remedial actions to be taken if a vaccine dose is inadvertently given before the recommended minimum age.
Except for the rotavirus vaccine, (when the first dose should not be given above 15 weeks of age and the second dose not above 24 weeks of age) it is never too late to start vaccination. Refer to the Australian Immunisation Handbook for further information for rotavirus .
In the absence of a documented history of previous immunisations, a person should be assumed to be unimmunised and offered catch up vaccines as per the National Immunisation Program , using catch up contained in the Handbook.
If the process of administering an injectable vaccine is interrupted (such as by syringe–needle disconnection) and most of the dose has not been given, repeat the whole dose as soon as practicable.
If an infant spits out or vomits most of an oral rotavirus vaccine dose within minutes of administration, they can receive a single repeat dose during the same visit.
If an infant spits out or vomits only a small part of an oral rotavirus vaccine dose, there is no need to repeat the dose. The regurgitated (and incomplete volume) dose is still considered as the valid dose.
The Australian Immunisation Handbook contains a series of tables providing guidance on the minimum acceptable dose intervals for vaccines. This includes guidance for children <10 years of , and people ≥ 10years of , for catch up schedules. These are not the routinely recommended intervals between vaccine doses and are intended to be used for catch-up vaccination. Catch-up using a combination vaccine must also meet the minimum intervals for all antigens.
Action required - For administration of vaccines earlier than the recommended dosing intervals report to for assessment and clinical advice.
For incomplete or overdue vaccinations, develop a catch-up schedule based on the previous documented doses the person has received. In almost all cases do not start the schedule again, regardless of the interval since the last dose and count previous doses as part of the schedule. One exception to this rule is for oral cholera vaccine (see in the Australian Immunisation Handbook).
When completing a schedule, ensure you refer to the catch up resources and the disease chapters of the Australian Immunisation Handbook to administer the age appropriate vaccine dose and schedule.
If the needle intended for intramuscular administration is too short, the vaccine may be inadvertently injected into the subcutaneous tissue. This may lead to more severe local reactions such as the development of nodules or cellulitis. Some intramuscular vaccines may still be immunogenic when given by the subcutaneous route. These vaccine doses do not need to be repeated.
Action required - refer to Vaccine injection for recommended actions.
Incorrect identification of the deltoid muscle may lead to shoulder injury related to vaccine administration (SIRVA). SIRVA occurs when an intramuscular injection intended for the deltoid muscle has been administered too high (i.e. in the shoulder joint), which initiates an inflammatory process, causing damage to the bursae, tendons, and ligaments. Refer to Melbourne Vaccine Education Centre for further details.
Action required - SIRVA is an AEFI and must be reported to .
For other vaccine errors or assistance to interpret this guidance, contact the Immunisation Unit at email@example.com.
Reviewed 17 May 2023