Control Guideline for Public Health Units

Public health priority: Routine.

PHU response time: Respond to and notify suspected serious cases within 1 working day following notification and update within 5 working days of receipt of updated information (see Data Management). Enter suspected non-serious cases on NCIMS within 7 working days of notification.  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.

 

​VersionDate​​Revised by ​Changes​Approval
​1.0​14/01/2021​Immunisation Branch​Revision​Chief Health Officer
Last updated: 22 January 2021

On this page

  1. Adverse Events Following Immunisation
  2. Surveillance objectives
  3. Data management
  4. Case definition
  5. Notification criteria and procedure
  6. Managing single notifications
  7. Vaccination failures
  8. Vaccine administration errors
  9. References and additional sources of information
  10. Further information

1. Adverse Events Following Immunisation

An adverse event following immunisation (AEFI) is any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of 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.

Serious adverse events

An adverse event following immunisation that2:

  • 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).
  • Any medical 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).

Non-serious adverse event

A non-serious adverse event 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. These events do not need to be reported by immunisation providers however 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.

https://immunisationhandbook.health.gov.au/resources/handbook-tables/table-common-side-effects-following-immunisation-for-vaccines-used-in-the

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2. Surveillance objectives

    To monitor the safety of vaccines post-licensure to:
    • rapidly detect and respond to changes in the rates of known adverse events following immunisation (AEFIs), and
    • rapidly detect and respond to AEFIs which were previously undocumented
  • To maintain public confidence in vaccines and the National Immunisation Program (NIP)

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3. Data management

Suspected serious cases (see case definition) should be entered onto the notifiable diseases database within 1 working day following notification. The initial notification should include details available at the time of notification to allow early identification of any safety signals. Any updated information should be entered within 5 working days or as required (see data entry).

Suspected non-serious cases (see case definition) should be entered onto the notifiable diseases database within 7 working days following notification.

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4. Case definition

Suspected case

A suspected case is any adverse event that occurs any time after receiving a vaccination and is considered by the immunisation provider to be possibly related to that vaccination and is either a:

Factors to be considered in case identification

    An AEFI can be coincidentally associated with the timing of immunisation without necessarily being caused by the vaccine or the immunisation process2. The notification of a suspected AEFI does not imply a causal association with vaccination but should be investigated.
  • The time interval from vaccination to onset will depend on the antigen and 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. Detailed information on antigen or adverse reaction-specific onset intervals are available in the Brighton Collaboration case definitions.
  • Medical practitioners or other health professionals are free to report any AEFI that concerns them, whether or not it is clear that a vaccine caused the adverse event.
  • Non-serious AEFI 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 are considered by the immunisation provider to be significant and of concern and have been reported to the PHU, should be entered into NCIMS.
  • Immunisation providers may seek advice from the PHU regarding non-serious AEFI. It is at the discretion of the PHU to determine if the AEFI should be notified.

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5. Notification criteria and procedure

AEFIs are notifiable conditions under the NSW Public Health Act (2010). Suspected cases are to be notified by medical practitioners or other health professionals and hospital CEOs on diagnosis to the public health unit.

Suspected cases should be entered onto NCIMS (see Case definition and Data management).

Serious AEFIs including hospitalisation/deaths and those 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.

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6. Managing single notifications

Response Times

Investigation

On same day of notification (during business hours) of a suspected serious case, begin follow-up investigation using the Adverse Event Following Immunisation Form [PDF].

Within 3 working days of notification of a suspected non-serious case begin follow-up investigation using the Adverse Event Following Immunisation Form [PDF] if required.

Contact the doctor caring for the patient to obtain follow-up information as required.

Data entry

Within 1 working day of notification enter suspected serious cases on the notifiable diseases database with information available at the time of notification. The purpose of the initial report is to notify suspected serious AEFI to the TGA. A report must be made as quickly as possible, even if not all details have been obtained, so that an immediate decision can be made on the need for action and investigation. Updated information should be entered within 5 working days or as required.

Within 7 working days enter suspected non-serious cases on the notifiable diseases database.

Response Procedure

Case Investigation

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 doctor or specialist caring for the patient. 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
  • Seek the doctor's permission to contact the case or relevant care-giver
  • Review case management including if appropriate follow up has been arranged for advice regarding future vaccinations, if required
  • Confirm the date of resolution of symptoms and outcome of adverse reaction

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:

  • Anaphylaxis
  • Bell's Palsy
  • Encephalitis, Myelitis or Acute Disseminated Encephalomyelitis (ADEM)
  • Guillain-Barre Syndrome (GBS) including Fisher Syndrome
  • Hypotonic-Hyporesponsive episode (HHE)
  • Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS)
  • Neuritis
  • Optic Neuritis
  • Seizures
  • Serum Sickness
  • Vasculitis

The AESI Vaccine follow up forms are available from the Immunisation Unit, Health Protection NSW.

Case management

In general, 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.

Ensure feedback has been given to the immunisation provider using the AEFI standard response letters in NCIMS.

TGA response procedure

Suspected cases of AEFI are forwarded by the Immunisation Unit, Health Protection NSW to the Therapeutics Goods Administration (TGA) safety monitoring program daily. 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.

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7. Vaccination Failures

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 forwarded to MOH-Vaccreports@health.nsw.gov.au when a vaccine failure is identified.

The AESI Vaccine follow up form is available from the Immunisation Unit, Health Protection NSW. Vaccination failures are forwarded to the Therapeutics Goods Administration (TGA) safety monitoring program for assessment and surveillance.

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8. Vaccine Administration Errors

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 NCIMS.

Vaccination administration errors that may pose a safety risk to the patient, regardless of whether an adverse event following immunisation has occurred, must also 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, and Inadvertent administration of zoster vaccine to an immunocompromised patient due to the risk of disseminated disease from the Oka vaccine virus1
  • 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 then be forwarded to the Immunisation Unit, Health Protection NSW (MOH-Vaccreports@health.nsw.gov.au) for submission to the Therapeutics Goods Administration (TGA) safety monitoring program.

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9. References and additional sources of information

Resources

References

1 Australian Technical Advisory Group on Immunisation (ATAGI). Australian Immunisation Handbook (online edition), Australian Government Department of Health, Canberra, 2018, https://immunisationhandbook.health.gov.au.

2 World Health Organisation (WHO).Global Manual on Surveillance of Adverse Events Following Immunization, World Health Organisation, Geneva, 2016, https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/

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10. Further information

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) webpage.

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Current as at: Friday 22 January 2021
Contact page owner: Communicable Diseases