Adverse event following immunisation (AEFI)

Introduction

An adverse event following immunisation (AEFI) is defined by the World Health Organization as any 'untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the use of the vaccine. The adverse event may be any unfavourable or unintended sign, an abnormal laboratory finding, a symptom or a disease'.¹ Adverse events may also occur following the incorrect handling or administration of a vaccine. Most AEFI are common, expected side effects, and vaccination can usually continue without special precautions.

In Western Australia, there is a legislative requirement for medical and nurse practitioners to report AEFI under the Public Health Act 2016² and the Public Health Regulations 2017.³

A serious adverse event is any AEFI that¹

• results in death, or
• is life threatening, or
• requires in-patient hospitalisation or prolongation of existing hospitalisation, or
• results in persistent or significant disability/incapacity, or
• results in a congenital anomaly/birth defect.

Primary care providers have been demonstrated to be the most trusted source of vaccine safety advice for parents.⁴ Clear discussions from primary care providers can manage concerns about common expected adverse events and provide advice about implications for future vaccination.

Most AEFI are not a contraindication to continued vaccination.

Pre-referral management

• Discussion regarding AEFI and further vaccination advice can generally be managed in the primary care setting.
• See the useful resources section below for links to materials that are useful in these discussions.

Any significant or serious AEFI events should be reported to the Western Australian Vaccine Safety Surveillance System (WAVSS) via the SAFEVAC online portal at www.safevac.org.au. All immunisation providers including pharmacists, nurses and midwives are required under their respective Structured Administration and Supply Arrangements (SASAs) to report AEFI to WAVSS and the patient’s primary healthcare provider.

When to refer

The family must consent to the referral and be willing to engage with the service.

• All children who have had a serious adverse event following immunisation should be referred for discussion about the adverse event and implications for future vaccination.
• Children who have had an adverse event following immunisation where there are ongoing concerns about future vaccination despite comprehensive discussions in the primary care setting.

Immunisation Medical Exemptions are governed by federal regulations. These can only be issued for specific reasons as outlined by Services Australia - Immunisation Exemptions. Our service cannot provide exemptions outside of those criteria.

Referrals requesting consideration of exemptions outside those criteria will not be accepted.

How to refer

• Routine non-urgent referrals from a GP or a Consultant should go to the Central Referral Service
• Routine non-urgent referrals from a nurse practitioner, non-medical referrers or private hospitals PCH Referral Office via fax: (08) 6456 0097 or email

Essential information to include in referral

• Details of the adverse event experienced including
  • date of vaccination
  • vaccines administered
  • time to onset
  • details of the adverse event
  • any investigation results
  • details on ED presentation or hospitalisation
• Other specific concerns or questions raised by the family
• The child’s immunisation history as per Australian Immunisation Register (including next due vaccinations)
• WAVSS ID number
• Relevant medical history, especially immunodeficiency, allergy, asplenia, and other medical risk factors pertinent to vaccination
• Details of any family court orders relevant to consent for vaccination

Useful resources

1. The Melbourne Vaccine Education Centre has many useful resources on vaccination and specific AEFI.
2. Sharing Knowledge About Immunisation (SKAI) has information for health professionals, and consumer resources on vaccine preventable diseases and adverse events following immunisation.
3. We recommend SKAI’s 90-minute eLearning module to develop clinical communication skills for vaccination discussions.
4. The Federal Government Your Questions Answered site addresses common concerns regarding vaccination.
5. The National Centre for Immunisation Research and Surveillance (NCIRS) has many useful resources on immunisation and vaccine safety for both health professionals and families.
6. AusVaxSafety has National data on commonly reported AEFI following NIP vaccines at each scheduled time point.
7. The Western Australian Vaccine Safety System produce an annual report with AEFI data specific to WA.
8. The Australian Immunisation Handbook is regularly updated with comprehensive vaccine related information.

References

1. World Health Organization, Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification, 2nd ed., 2019 update (2021), https://www.who.int/publications/i/item/9789241516990
2. “Public Health Act 2016”, Government of Western Australia, https://www.legislation.wa.gov.au/legislation/statutes.nsf/main_mrtitle_13791_homepage.html
3. “Public Health Regulations 2017:, Government of Western Australia, https://www.legislation.wa.gov.au/legislation/statutes.nsf/law_s49088.html
4. Gary L. Freed, Sarah J. Clark, Amy T. Butchart, Dianne C. Singer, Matthew M. Davis; Sources and Perceived Credibility of Vaccine-Safety Information for Parents. Pediatrics May 2011; 127 (Supplement_1): S107–S112. 10.1542/peds.2010-1722P
   
   

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