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Vaccine safety

All vaccines registered for use in Australia and included in the National Immunisation Program must pass stringent pre-licensure vaccine clinical trials before they are approved. The Therapeutics Goods Administration (TGA) continuously monitors the safety of vaccines once they are registered.
 
To learn more about vaccine safety visit:
 

Vaccine safety surveillance

Vaccine safety surveillance in Australia aims to monitor vaccine and immunisation program safety and to detect population-specific, rare, late-onset or unexpected adverse events that may not be detected in pre-licensure vaccine trials.
 
Immunisation providers play an important role in vaccine safety surveillance by reporting serious adverse events to the local public health unit (passive surveillance) and participating in active surveillance systems such as AusVaxSafety.
 
AusVaxSafety is an active vaccine safety surveillance system that monitors the safety of vaccines in Australia. AEFI data relating to a range of vaccines including influenza, pertussis including pertussis in pregnancy, HPV and zoster vaccine  is available through the AusVaxSafety vaccine safety surveillance system​.​
 
Australia-wide annual reports on AEFI surveillance are published by the Australian Government. Annual reports on surveillance of AEFIs in NSW are available for the years:
 
To search for reported AEFIs related to specific vaccines, visit the Therapeutic Goods Administration’s (TGA) Database of Adverse Event Notifications (DAEN)
 
Other vaccine safety surveillance reports
 

 

NSW passive AEFI surveillance data

Figure 1: Total monthly counts of adverse events following immunisation (AEFIs) reported to NSW Health, YTD 2020 compared with the previous year, by month of vaccination.
 
Note: AEFI notifications increase in April/May following the commencement of the seasonal influenza vaccination program.
 
Figure 2: Reports of adverse events following immunisation, NSW, 2019 to 2020, by month of vaccination and age group in years
 

What is an AEFI?

An adverse event following immunisation (AEFIs) is defined in The Australian Immunisation Handbook as "any untoward medical occurrence that follows immunisation. It does not necessarily have a causal relationship with the vaccine". AEFIs are notifiable conditions under the NSW Public Health Act (Schedule 1).
 
Most reactions, such as fever, pain or redness at the site of injection, commonly occur after vaccination with some vaccines. There reactions are mild, short lived and should be expected.
 
The Australian Immunisation Handbook has useful information about common side effects following immunisation which should be discussed with patient’s during the consent process. To ensure patients are aware of what to expect following vaccination, immunisation providers should also provide patients with the Australian Department of Health information sheet ‘Following vaccination— what to expect and what to do’ after vaccinating a patient.
 
Serious reactions are rare. Anaphylaxis is the most severe form of allergic reaction and is potentially life threatening. Anaphylaxis is an allergic reaction involving more than one body system (for example skin, respiratory, gastro-intestinal and cardiovascular systems).
 

Reducing the risk of AEFIs

Immunisation providers can minimise the risk of serious AEFIs by performing the pre-vaccination screening checklist for all patients prior to vaccination. The checklist identifies any person with a condition which increases the risk of an adverse event or is a contraindication to vaccination. Previous AEFI which are reported at the time of the pre-vaccination screening should be investigated. It is also important for immunisation providers:
 
A pre-vaccination screening checklist and advice for avoiding shoulder injury related to vaccine administration is available in the Australian Immunisation Handbook. A short 10 minute presentation on SIRVA, correct vaccination techniques and how to avoid this injury is available on The National Centre for Immunisation Research & Surveillance education and training webpage.
 
The Australian Government Department of Health has also developed a pre-vaccination checklist to assist immunisation providers in screening for contraindications to shingles (zoster) vaccination.
 

How do I report an AEFI?

Report all uncommon, serious or unexpected AEFI or any event felt to be significant following immunisation to your local public health unit.
 

To report a suspected AEFI, please download the National Adverse Events Following Immunisation (AEFI) Reporting Form and contact your local Public Health Unit on 1300 066 055.​ 

Specialist Immunisation Services

Immunisation providers can contact the NSW Immunisation Specialist Service (NSWISS) telephone advice line on 1800 679 477 for clinical advice and support on immunisation for patients with complex or unusual medical backgrounds or who have had an adverse event following immunisation.  The phone line operates between 9-5pm Monday to Friday for immediate advice or callers can leave a message.​
 
The Australian Society of Clinical Immunology and Allergy (ASCIA) has useful information for adults who have had an adverse event following immunisation and require specialist consultation including guidelines for the Vaccination of the Egg Allergic Individual.
 
 

Resources

Current as at: Monday 28 September 2020
Contact page owner: Immunisation