Public health priority: Routine.
Many adverse events following immunisation (AEFIs) are common and expected. For the purpose of this guideline, AEFIs (see
Case Definition) include low level events, high level events and high-level events of significance. (See
PHU response time: Respond to reportable low level AEFIs within 7 working days following notification. Respond to suspected high level AEFIs or adverse events of special interest (AESIs) within 3 days. Respond to suspected high level AEFIs of significance within 1 day. Follow up a suspected case as required.
Case management: Responsibility of the treating doctor. PHUs investigate using the
Adverse Event Following Immunisation Form [PDF]. Advise on further immunisations if requested or facilitate specialist referrals as required.
Contact management: Nil.
An adverse event following immunisation (AEFI) is any untoward medical occurrence that follows immunisation. It does not necessarily have a causal relationship with the vaccine.
An AEFI may be related to the vaccine itself or to its handling or administration.
Australian Immunisation Handbook1 (online edition) provides information about the frequency, types and management of AEFIs such as anaphylaxis.
A serious adverse event following immunisation that includes any of the following2:
Any clinical event that requires intervention to prevent one of the outcomes above may also be considered as serious2.
Detailed definitions of conditions classified as serious AEFIs are available in the
Australian Immunisation Handbook1 (online edition).
A non-serious adverse event following immunisation is a common/expected adverse event known to be associated with the vaccine as described in the
Australian Immunisation Handbook1(online edition) or product information and does not pose a potential risk to the health of the patient2. Any event that is considered by the immunisation provider or immunisation recipient 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.
A suspected case is any adverse event, either serious or non-serious, that occurs after vaccination and is considered to be possibly related to that vaccination.
AEFIs are notifiable conditions under the NSW Public Health Act (2010). Notification is required by doctors and hospitals.
Suspected cases should be entered onto the NCIMS by the PHU.
Serious AEFIs and those reported to a school-based immunisation team on the day of vaccination should be reported directly to the NSW Health Immunisation Unit as well as being entered onto the NCIMS.
Follow-up information of the notification will be obtained from the treating clinicians, medical records and/or patients/carers as appropriate.
The expected timeframe to report AEFIs is aligned with the level, likely causality and significance of the adverse event.
Suspected AEFI (see
Case Definition) may be:
Low level adverse events are adverse events which have a low level of concern in relation to immunisation. Low level adverse events include common and expected (non-serious) reactions for the vaccine (as outlined in the
Australian Immunisation Handbook1 (online edition) or that are described in the product information), and other acute clinical events occurring in proximity to immunisation, but which are not considered as adverse events of special interest (AESI) and are not known to be causally linked to immunisation.
Information in relation to low level events should be gathered and reported to the TGA within 7 working days.
Notification to the TGA should occur via the routine automated TGA reporting process in the NCIMS. Data transmitted to the TGA should be de-identified.
High level adverse events are conditions which are known or suspected to be causally related to immunisation and have resulted in death and/or critical care admission and/or are of special interest (AESIs).
For all cases collect information about the case using the
Adverse Event Following Immunisation Form [PDF].
The response to a notification will normally be carried out in collaboration with the medical practitioner caring for the patient. But regardless of who does the follow-up, PHU staff should ensure that action has been taken to:
The Adverse Events of Special Interest (AESI) vaccine follow up form must also be completed for monitored events of special interest that have been reported in association with vaccination. The AESI vaccine follow up forms have been developed by the TGA with reference to the Brighton Collaboration Case Definitions and Guidelines for vaccine safety and include:
The AESI Vaccine follow up forms are available from the Immunisation Unit, Health Protection NSW.
Appendix 1 for some examples of COVID-19 vaccine specific AEFIs/AESIs under each classification level.
The attending medical practitioner is responsible for treatment. The PHU should provide advice to the doctor regarding further immunisation if requested according to the recommendations of the latest
Australian Immunisation Handbook1 (online edition).
Additional specialist advice and facilitation of future vaccination through specialist services may be obtained from the NSW Immunisation Specialist Service on 1800 679 477 or SCHN-NSWISS@health.nsw.gov.au.
Ensure feedback has been given to the immunisation provider using the AEFI standard response letters in the
Suspected cases of AEFI are reported to the TGA safety monitoring program daily via the NCIMS. The TGA enters all suspected AEFI to the TGA Adverse Events Management System (AEMS). Reports are then transferred to the publicly accessible
Database of Adverse Event Notifications – medicines 90 days after they have been reported to AEMS.
The TGA may refer safety concerns to the Australian Committee on Medicines (ACM) for independent advice.
Vaccine failure is when a disease occurs in a person even though they have received the recommended number of vaccines.
Surveillance of vaccine failures is important to monitor overall vaccine effectiveness and to identify specific problems with vaccine manufacturing or program delivery, such as cold chain breaches.
Surveillance for vaccine failures occurs through disease surveillance processes rather than AEFI surveillance processes. Public Health Units should refer to the relevant
NSW Control Guidelines for management of vaccine preventable disease notifications.
The vaccination failure AESI vaccine follow up form must be completed and submitted to the TGA safety monitoring program for assessment and surveillance and the Immunisation Unit, Health Protection NSW at
MOH-AEFI@health.nsw.gov.au when a vaccine failure is identified.
Vaccination administration errors can occur as a result of errors in vaccine preparation, handling, storage or administration and can be associated with immunisation error-related reactions2. Identification and follow-up of vaccine administration errors can identify and correct immunisation error-related reactions in a timely manner.
It is the responsibility of the immunisation provider to manage vaccine administration errors and seek advice from the PHU if required. Vaccine administration errors resulting in a suspected adverse event following immunisation must be reported to the PHU and reported in the NCIMS.
Vaccination administration errors that may pose a safety risk to the patient, regardless of whether an adverse event following immunisation has occurred, must be reported to the TGA such as:
Vaccine administration errors that pose a safety risk to the patient must be reported to the PHU using the
National Adverse Event Following Immunisation reporting form [PDF]. The notification form should be submitted to the TGA safety monitoring program and the Immunisation Unit, Health Protection NSW at
MoH-AEFI@health.nsw.gov.au. An NCIMS entry is not required unless the vaccine administration error has resulted in an AEFI.
Additional information and resources about vaccine safety and avoiding adverse events following immunisation are available on the NSW Health Immunisation program
Adverse Events Following Immunisation (AEFI).
Routine priority (within 3 days)
PHU Director to inform Ministry of Health.
PHU director to inform Ministry of Health if case meets CDC criteria for
confirmed and probable myocarditis, and confirmed pericarditis, and critical care admission or leads to death
PHU director to inform the Ministry of Health if case meets
Brighton Level 1, 2 or 3 and requires critical care admission or leads to death
PHU Director to inform Ministry of Health if case results in critical care admission, or major impairment.
PHU director to inform the Ministry of Health if case results in critical care admission or major impairment.
High priority (within 1 day)
PHU director to inform the Ministry of Health, Health Protection NSW, Immunisation Team.
TGA classifications for possible, probable, and confirmed TTS cases.
Remain as probable even if PF4 antibodies are negative or unknown.
Presence of ≥ 2 new or worsening of the following clinical features: