Last updated on 22 February 2021:
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.
AEFIs are notifiable under the Public Health Act 2010 (NSW).
All uncommon, unexpected or serious AEFI or any event considered to be significant following immunisation must be notified by medical practitioners or other health professionals to the local Public Health Unit on 1300 066 055 or by email to
MOHfirstname.lastname@example.org using the
National Adverse Events Following Immunisation (AEFI) reporting form, or for emergency departments, the
NSW Heath AEFI case notification form.
An AEFI is considered serious when it:
Any medical event that requires intervention to prevent one of the outcomes above may also be considered serious. AEFIs may include temporally associated serious adverse events of special interest (AESI) for COVID-19 vaccine. A list of potential AESIs following COVID-19 vaccination can be found at Appendix 1.
The Coroners Act 2009 (NSW) specifies deaths reportable to the Coroner.
Deaths occurring in temporal relationship to COVID-19 vaccination may be reportable to the 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.
A death reportable to the Coroner, such as a sudden death without a known cause or a death that is not the reasonably expected outcome of a health-related procedure, will consider whether threre was a temporal association with COVID-19 vaccination. If a temporal relationnship exists, the forensic pathologist will conduct relevant investigations to assist in the assessment of potential AEFI or other causes as contributing factors, with support from the NSW Health vaccine safety expert panel.
All COVID-19 vaccines will be registered to the AIR including the vaccine type and date of administration. This information should be routinely gathered at the triage assessment for any death notified to the Coroner.
If COVID-19 vaccination is found to have been administered proximate to the time of death and the condition leading to death is plausibly linked to vaccination, clinical support and advice should be sought 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 (Monday-Friday 9am-5pm) or email:
SCHN-NSWISS@health.nsw.gov.au. After hours support should be reserved for advice on the immediate investigation and management of serious AEFI. Clinicians may contact NCIRS through The Children's Hospital at Westmead switchboard on
02 9845 0000 for urgent after hours clinical support.
Depending on the discussion with the NSWISS clinician, further investigations may be recommended.
An expert panel of adult and paediatric medical subspecialists will review adverse events of special interest, serious AEFI and
temporally associated deaths* following COVID-19 vaccination to provide guidance on and interpretation of investigations. In the case of a temporally associated death, the expert panel may recommend further investigation to the forensic pathologist, such as those investigations used to rule out other potential causes of death.
These investigations will be provided by the expert panel to the National Vaccine Safety Investigation Group (VSIG), to assist in causality assessment, if required. The expert panel will also provide a report of findings to support the Coroner in their determination of the cause of death, where this is unclear.
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.
*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 causing 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.
All after hours calls should be directed to the Sydney (Lidcombe) number.
*Make a mandatory AEFI report, or for advice on whether an event is notifiable.
Advice on the investigation or clinical management of a serious AEFI
*urgent advice on the investigation or clinical management of serious AEFI
Through the Children's Hospital Westmead switchboard:
02 9845 0000.
Except where indicated, these are not recognised adverse events for COVID-19 vaccination but will be monitored as a component of the broader vaccine safety surveillance strategy.
Therapeutic Goods Administration (TGA) provisional AESI list. As new information emerges, this list will be updated.