Vaccine safety

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: Vaccine Safety Summary report 2022
AusVaxSafety: Safety Surveillance data for various vaccines

Anaphylaxis Kit

Minimum requirements for an anaphylaxis kit:

• Anaphylaxis response kit – requirements as per Handbook
• Adrenaline dosage card – Order form
• Managing anaphylaxis after vaccination – poster from Handbook

Anaphylaxis e-Training

The ASCIA anaphylaxis e-training course for health professionals 2021

• 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 error (VAE)

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. VAE that poses a safety risk to the patient must be reported to the PHU and Therapeutic Goods Administration (TGA) by using 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 the NSW Health webpages at https://www.health.nsw.gov.au/immunisation/Pages/aefi.aspx and https://www.health.nsw.gov.au/Infectious/controlguideline/Pages/adverse.aspx#7

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

1. 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
2. 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
3. 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: 1800679477 or 98451414
   • For accidental overdose see below.
4. Reporting
   • If patient develops any symptoms:
     • 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

1. 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.
2. Follow the above Advice on Vaccine Errors – This error must be recorded through your normal jurisdictional medication error reporting systems.
3. For more information, the Poisons Information Centre may be contacted on 131 126.

Vaccine Hesitancy training

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:

1. Seek out training to build confidence and skills around having conversations with vaccine-hesitant people such as the SKAI eLearning module and Addressing vaccine hesitancy webinar.
2. Use the “It’s worth the shot” Benefits and Decision cards to help engage and encourage discussions, and tip sheet on how to start the conversation
3. Use resources to support conversations: COVID-19 Decision Aid, Vaccination glossary
4. Make a positive recommendation to vaccinate
5. Be ready to tailor conversations to a range of positions on vaccination, from refusing to hesitant about the COVID-19 vaccines (including receiving a booster vaccine)