Last updated 24 May 2021 (AEFI reporting flow chart updated to reflect latest ATAGI advice)
A serious adverse event following immunisation is an event that:
This does not need to be reported to your local Public Health Unit This includes common, expected temporary reactions
1, such as:
These AEFIs can be reported directly to the
This is a notifiable condition.
Contact your local Public Health Unit on 1300 066 055.
A serious adverse event includes:
If specialist advice is needed, for example in relation to management of the second dose, contact the National Centre for Immunisation Research and Surveillance (NCIRS) NSW Immunisation Specialist Service (NSWISS).
Phone: 1800 679 477 (Monday-Friday 9am-5pm) or email:
For urgent after-hours clinical support, contact NSWISS via The Children’s Hospital at Westmead switchboard on 02 9845 0000 (ask for Immunisation Specialist Service).
Significant (rare) syndromes reported to date internationally include
Note: Many conditions can arise during normal life, whether or not a vaccine is administered. It remains important to report any new or unexpected events so that safety can be appropriately monitored.
The TGA is responsible for assessing COVID-19 vaccines before they are used in Australia. For information on this process, you can visit the
The TGA is also responsible for regulating and monitoring the use of COVID-19 vaccines in Australia. Monitoring involves detecting and responding to any emerging safety concerns related to COVID-19 vaccines, particularly any adverse events following immunisation (AEFI), which includes adverse events of special interest (AESI) where there is a temporal association with vaccination (usually within around six weeks).
The TGA works closely with state and territory health departments and expert bodies such as the National Centre for Immunisation Research and Surveillance (NCIRS) and AusVaxSafety to monitor and respond to safety concerns.
An adverse event following immunisation (AEFI) is any untoward medical event that occurs after a vaccination has been given which may be related to the vaccine itself or to its handling or administration. A conclusion regarding a causal relationship with the vaccine is not necessary to suspect or report an AEFI.
Common reactions, such as low-grade fever or pain at the injection site, do not need to be reported unless they are worsening or there are specific concerns. Check the vaccine product information for a full list of common reactions.
An AEFI is a
notifiable condition under the NSW Public Health Act (2010).
All uncommon, unexpected or serious AEFI or any event considered by the clinician to be significant following immunisation must be notified by medical practitioners or other health professionals to the local Public Health Unit (PHU) on
1300 066 055 or by email to
MOHemail@example.com or by using the
National Adverse Events Following Immunisation (AEFI) reporting form, or for emergency departments, the
NSW Heath AEFI case notification form. Routine notifications can be made during business hours. If using a mobile to notify by phone, the number will prompt the reporter to key in the patient’s postcode of residence and connect to the local PHU. For urgent advice after hours, see
clinical and immunisation expert support.
An AEFI is considered serious if it:
Any medical event that requires intervention to prevent one of the outcomes above may also be considered serious. Examples of serious adverse events following COVID-19 vaccination that should be immediately reported can be found at Table 1 on the following page.
A temporally associated death is defined as occurring within 6 weeks of vaccination where it is plausible that vaccination contributed to, or caused, the conditions resulting in death. This timeframe is a guide only, and if a death occurs outside this timeframe and meets criteria for a serious AEFI it should still be reported.
Frequency Dose 1
Frequency Dose 2
Frequency Dose 1 (>55y)
Frequency Dose 2 (>55y)
Injection site pain
Does not require mandatory notification unless concerned, more serious, persistent or not resolving.
Severe persistent lymphadenopathy or injection site pruritis lasting longer than one week, pain not at the injection site (excluding headache or muscle/joint pain)
(≥1/1,000 to <1/100))
These and any other rare, unusual or unexpected events leading to hospitalisation, disability or death must be reported urgently
Acute peripheral facial paralysis (Bell's palsy)
(≥1/10,000 to <1/1,000))
Anaphylaxis or other hypersensitivity
Australian Product Information - COMIRNATY™(BNT162b2 [mRNA]) COVID-19 Vaccine.
TesRequires mandatory notification.
These and any other rare, unusual or unexpected events leading to hospitalisation, disability or death must be reported urgently.
Non-serious adverse events known to be associated with COVID-19 vaccination (see table 1) that do not pose a potential risk to the health of the patient, do not need to be reported by immunisation providers. Any event that is considered by the immunisation provider to be significant, of concern, or affect confidence in future immunisations and may not fit in with the criteria for a serious AEFI can be reported.
If a patient would like to report a non-serious adverse event (see Table 1), healthcare professionals can provide the following guidance:
Clinicians providing care to vulnerable people, including those living in residential aged or disability care facilities, are encouraged to report on behalf of those who may be unable to report for themselves.
AEFI are monitored through a combination of passive and active surveillance systems.
Passive vaccine safety surveillance is the reporting of AEFIs by individuals, including the patient, GP, specialist doctor, immunisation provider or the vaccine manufacturing company. In NSW, all serious or unexpected AEFIs must be reported to the PHU on 1300 066 055, or by email using the
NSW Health AEFI case notification form to
MOHfirstname.lastname@example.org, as they are a
AusVaxSafety is the national active vaccine surveillance system led by the National Centre for Immunisation Research and Surveillance (NCIRS). AusVaxSafety monitors adverse events following immunisation and facilitates early detection of potential vaccine safety issues. The program uses Vaxtracker or SmartVax to send automated SMS or email at specific time points to some patients following vaccination to collect information on adverse events following immunisation.
All COVID-19 vaccines, including those administered to NSW Health staff, will be recorded in NSW specific databases that will feed into AusVaxSafety for AEFI monitoring and will also be recorded in the Australian Immunisation Register (AIR).
Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system monitoring for AEFI, multisystem inflammatory syndrome in children (MIS-C), and vaccine-associated enhanced disease (VAED) at The Children’s Hospital Westmead and the Sydney Children’s Hospital, Randwick.
Public Health Rapid, Emergency, Disease and Syndromic Surveillance (PHREDSS) system is a near real-time system that identifies changes in trends of ED presentations of specific AEFI and supports active case finding. Serious and non-serious AEFIs are monitored via PHREDSS to ensure prompt investigation and management, and to detect emerging safety signals. The expected rates of conditions which may be relevant to detecting AEFI trends have been analysed through other sources to support this approach.
NSW Health is working closely with NCIRS to ensure benchmarking and information sharing with international partners such as the Brighton Collaboration and the Safety Coalition for Epidemic Preparedness Innovations (CEPI), specifically the Safety Platform for Emergency Vaccines (SPEAC).
These collaborations ensure safety assessments and pharmacovigilance knowledge are shared rapidly and globally.
All COVID-19 vaccinations will be recorded in the
Australian Immunisation Registration (AIR) including vaccine type, date of immunisation and dose number. A patient’s vaccination history can be accessed by authorised vaccination providers through AIR, the patient’s
My Health Record or mygov account.
Clinicians can access advice regarding investigation and management of suspected AEFIs from the NSW Immunisation Specialist Service (NSWISS), supported by the National Centre for Immunisation Research and Surveillance (NCIRS). They can be reached on
1800 679 477 (Mon-Fri 9am-5pm) or email:
After hours support should be reserved for advice on the immediate investigation and management of serious AEFI. Clinicians may
contact NSWISS through The Children’s Hospital at Westmead switchboard on
02 9845 0000 for urgent after-hours clinical support.
Should further immunisation specialist consultation or assessment be required, individuals can be referred to appropriate services in consultation with the NSWISS.
To make a mandatory notification, or to seek advice on whether an event is notifiable, contact the local Public Health Unit on
1300 066 055 during business hours, through the public health officer on-call through the hospital switchboard after hours, or by email using the
NSW Health AEFI case notification form to
Deaths occurring in temporal relationship to COVID-19 immunisation may be reportable to the NSW State Coroner under certain circumstances. Clinicians should use the
Coronial Checklist to determine whether such a death is reportable to the Coroner. Where any doubt exists as to whether a death should be reported, the Duty Forensic Pathologist or the Forensic Medicine Clinical Nurse Consultant at the relevant Forensic Medicine facility can be contacted:
Business hours (8am – 4:30 pm):
All after hours calls should be directed to the Sydney (Lidcombe) number. The relevant Duty Pathologist will be notified by the Sydney Forensic Medicine staff.
The State Coroner’s Court may also be contacted for advice on 02 8584 7777.
An expert panel of adult and paediatric medical subspecialists will review adverse events of special interest, serious AEFI and temporally associated deaths with COVID-19 vaccination to provide guidance on and interpretation of investigations. The expert panel will also assist in the conduct of any causality assessment by the National Vaccine Safety Investigation Group (VSIG). In the case that a causality assessment is required, the expert panel will provide their assessment findings to the VSIG.
The panel will include the local Public Health Unit, immunisation specialist/s from the NSWISS and invited medical experts in fields relevant to the AEFI notified.
*Make a mandatory AEFI report, or for advice on whether an event is notifiable. 1300 066 055 – key in the postcode of residence for the relevant public health unit
Operating hours: Monday to Friday 8:30am – 5pm Email:
Advice on the investigation or clinical management of a serious AEFI1800 679 477
Operating hours: Monday to Friday 9:00am – 5pm
*Urgent advice on the clinical management of serious AEFI Through the Children’s Hospital Westmead switchboard:
02 9845 0000.
Participate in the AusVaxSafety surveillance system through the text message received post vaccination
Text messages inviting participation in a brief survey are sent to some individuals following immunisation if enrolled at the time of vaccination
Adverse event reporting form:
Therapeutic Goods Administration