- Reason for surveillance
- Case definition
- Notification criteria and procedure
- Managing single notifications
1. Reason for surveillance
- To detect changes in the rates of known adverse events following immunisation (AEFIs)
- To detect AEFIs which were previously undocumented.
2. Case definition
A person with any condition that is serious or unexpected that occurs any time after he or she received a vaccination and is considered by the immunisation provider to be possibly related to that vaccination. Such conditions may including:
- Acute flaccid paralysis
- Allergic reaction
- Brachial neuritis
- Disseminated BCG
- Extensive limb swelling
- Fever - over 40.5°C
- Guillain-Barre Syndrome (GBS)
- Hypotonic - hyporesponsive episode (shock, collapse)
- Injection site reaction (severe)
- Lymphadenitis (includes suppurative lymphadenitis)
- Meningitis - diagnosis must be made by physician
- Rash (severe or unusual)
- Screaming (persistent)
- Subacute sclerosing panencephalitis
- Toxic-shock syndrome
- Vaccine associated paralytic poliomyelitis
- Other severe or unusual events
Detailed definitions of these AFEIs are available in Appendix 6 of The Australian Immunisation Handbook.
Factors to be considered in case identification
The inclusion of a condition in the list of suspected AEFIs does not imply a causal association with vaccination, since the condition can occur coincidentally.
Medical practitioners or other health professionals are free to report any AEFI that concerns them, even if the AEFI does not fit into any of the above categories.
3. Notification criteria and procedure
Suspected cases are to be notified by medical practitioners or other health professionals and hospital CEOs on diagnosis (reporting by fax/email to PHU).
Suspected cases should be entered onto NCIMS.
Serious AEFIs (including hospitalisation) reported to a school-based immunisation team on the day of vaccination are reported directly to the NSW Health Immunisation Unit as well as being entered onto NCIMS.
4. Managing single notifications
Within 3 working days of notification of a suspected case begin follow-up investigation using the Adverse Event Following Immunisation Form [PDF].
Contact the doctor caring for the patient to obtain follow-up information as required.
Within 7 working days of notification enter suspected cases on NCIMS. Update information as required.
The response to a notification will normally be carried out in collaboration with the case's health carers. But regardless of who does the follow-up, PHU staff should ensure that action has been taken to:
- Confirm the onset date and symptoms of the illness
- Find out if the case or relevant care-giver has been told what the diagnosis is before interviewing them
- Seek the doctor's permission to contact the case or relevant care-giver
- Review case management.
For all cases seek information about the case using the Adverse Event Following Immunisation Form [PDF] initially and as required.
Provide advice to the doctor regarding further immunisation if requested according to the recommendations of the latest The Australian Immunisation Handbook. Specialist advice may be required from the Immunisation Adverse Events Clinic at the Children's Hospital at Westmead on (02) 9845 1414.
Suspected cases of AEFI are forwarded by the Immunisation Unit to ADRAC the Australian Committee on the Safety of medicines (ACSOM) for review.