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Adverse Event Following Immunisation

Queensland Health guidelines for public health units

Description

An adverse event following immunisation (AEFI) refers to any untoward medical occurrence that follows immunisation, whether expected or unexpected, and whether triggered by the vaccine or only coincidentally occurring after receiving a vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.

Notification criteria

Clinical evidence

An AEFI may be caused by the vaccine(s) or may occur by chance (i.e. it would have occurred regardless of vaccination). Most vaccine adverse events are minor, such as low-grade fever, and pain or redness at the injection site; these should be anticipated. Refer to the latest edition of the Australian Immunisation Handbook for further information regarding AEFI.

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Notification procedure

Under the Public Health Act 2005, all immunisation providers are required to report any adverse events following immunisation.

It is very important that all immunisation service providers report AEFI, particularly if serious or unexpected, as this will enable vaccine safety issues to be identified and managed appropriately as soon as possible.

No time limit has been set to report AEFI; however, timely notification of adverse events, particularly rapid reporting of serious events, is important to identify any potential concerns.

This is done by completing the Adverse Event Following Immunisation (AEFI) Reporting Form (PDF, 4.5MB) and returning it by emailing to CDIS-NOCS-Support@health.qld.gov.au or facsimile to (07) 3328 9434.

Note: Individuals/caregivers should be informed of common or expected mild events and should be encouraged to notify their vaccine service provider of any other adverse events following immunisation.

Public health significance and occurrence

Surveillance for AEFI is an integral part of the Australian Immunisation Program and underpins the safe use of all vaccines in Australia.

Surveillance of AEFI aims to detect changes in the rates of known adverse events, any unrecognised or unexpected adverse events, or adverse events that result from program errors, such as incorrect vaccine schedule, delivery or storage.

All reported AEFI are included in the Adverse Drug Reactions System (ADRS) database of the Therapeutic Goods Administration (TGA). From time to time, reports are published in Communicable Diseases Intelligence accessible at the Australian Government Department of Health website by searching for CDI.

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Latent period

No time limit has been set to report AEFI; however, timely notification of adverse events, particularly rapid reporting of serious events, is important to identify any potential concerns. Notification does not necessarily imply a causal association with vaccination, as some events may occur coincidentally following vaccination.

Prevention and management of adverse events

Important factors in reducing the likelihood of an adverse event occurring is to:

  • screen each person to be vaccinated using the pre-vaccination checklist in the current edition of the Australian Immunisation Handbook to ensure that the person to be vaccinated does not have a condition which either increases the risk of an adverse event or has a contraindication to vaccination
  • check the relevant chapters in the Australian Immunisation Handbook for details on precautions and contraindications for each vaccine to be administered
  • parents and/or carers and persons to be vaccinated should be given advice (preferably written) on common or expected side effects and what they should do about them as part of the consent procedure
  • use correct injection technique.

Vaccine or immunoglobulin injections commonly result in soreness, redness, itching, swelling or burning at the injection site for one to two days. Routine use of paracetamol at the time of, or immediately after, vaccination is not recommended. However, if an infant, child, or adult has a fever of 38.5 degrees Celsius following vaccination or has pain at the injection site, paracetamol can be given.

The Australian Technical Advisory Group on Immunisation has recommended a recent exception to the use of paracetamol with the introduction of Bexsero® 4CMenB in March 2014 as follows: Paracetamol should be administered with every dose of Bexsero® 4CMenB administered to children under two years of age to reduce the probability and severity of fever.

Check the information sheet Comparison of the effects of diseases and the side effects of National Immunisation Program vaccines in the latest edition of  the Australian Immunisation Handbook

All recipients of vaccines should be observed for at least 15 minutes following immunisation to ensure that they do not experience an immediate adverse event after vaccination.  Most life-threatening adverse events begin within 10 minutes of vaccination. Children and adults who have had a serious adverse event (other than a contraindication, such as anaphylaxis) following a previous vaccine may subsequently be vaccinated under close medical supervision. Some major hospitals may have a special clinic and some paediatricians and GPs may admit the child for immunisation. The public health unit should provide advice on future vaccination with the vaccine service provider if requested.

Notification and follow-up of adverse events

  • The vaccine service provider completes and emails or faxes the Adverse Events Following Immunisation (AEFI) Initial Report Form to the Communicable Diseases Unit, Queensland Health.
  • The AEFI will be recorded in the Notifiable and Other Conditions (NOCS) database.
  • The public health unit will access the NOCS notification report and undertake any follow-up or investigation in consultation with the vaccine service provider who notified the adverse event (and may follow-up with the patient or their parent) in order to gather further information.
  • The public health unit will complete further information that may be requested by the TGA for inclusion on the national database.

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Feedback

NOCS report AEFIs to TGA daily. If TGA requires further follow-up of any AEFI, the request will be received by the Communicable Diseases Unit and forwarded to the appropriate public health unit.

Summary

The public health unit may be required to prepare a summary report of the investigation for the Communicable Diseases Unit, on request.

References

National Health and Medical Research Council.  The Australian Immunisation Handbook, 10th edition 2013.

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Last updated: 23 June 2015