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 Appendix 1)

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.

The 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:

  • results in death
  • is life threatening
  • requires hospitalisation
  • results in persistent or significant disability or incapacity
  • results in a congenital anomaly/birth defect
  • does not fit in with the common reactions for that vaccine outlined in the Australian Immunisation Handbook1 (online edition).
  • An AEFI can be coincidentally associated with immunisation without being caused by the vaccine or the immunisation process2. The notification of a suspected AEFI does not imply a causal association with vaccination.
  • The time interval from vaccination to onset may be relevant to causal determination but will depend on the adverse reaction2. As the time interval between immunisation and onset of the event may not always be accurate or well established, a time interval is not included in the case definition.
  • Notification is required by doctors and hospitals. Other clinicians are able to notify suspected AEFIs with the consent of the patient.
  • Non-serious AEFIs should also be carefully monitored because they may signal a potentially larger concern with the vaccine or immunisation process or may have an impact on the acceptability of immunisation in general2. Non-serious adverse events that have been reported to the PHU, should be entered into the Notifiable Conditions Information Management System (NCIMS).

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).

  • All high level AEFIs require discussion with the PHU Director. TGA notification of these high-level adverse events should occur within 3 days, unless the event is also significant, as determined by the PHU Director, in which case reporting may be required within 24 hours.
  • Notification of the initial case information will occur via the routine automated TGA reporting process in the NCIMS. Additional supporting documentation is provided to the TGA as a full, de-identified case file using secure file transfer and may also include the use of case report forms (available upon request from MoH-AEFI@health.nsw.gov.au) and case classification. Some of these cases (See Appendix 1) will also require reporting to HPNSW Immunisation Unit via email to MoH-AEFI@health.nsw.gov.au

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 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:

  • Inadvertent administration of a vaccine contraindicated in pregnancy or giving a live attenuated viral vaccine during pregnancy or shortly before pregnancy due to the potential risk to the fetus1.

Source – https://www.health.nsw.gov.au/Infectious/controlguideline/Pages/adverse.aspx#6