Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC)

SAEFVIC is the central reporting service in Victoria for any significant adverse event following immunisation (AEFI). It is a public health partnership initiative of the Victorian Immunisation Program and is funded by the Department of Health, Victoria.

All immunisations are medications and all medications do have minor, common or expected side effects. An AEFI is any unexpected or severe side effect that can happen following the administration of any immunisation. Such an event may be caused by the immunisation itself or may be unrelated and occur by chance after the immunisation. Severe side effects from vaccines are rare and common side effects are usually mild and short-lasting. An AEFI can also be an error related to the way a vaccine was stored, prepared or administered.

  • What should be reported?

    You should report:

    • Any event felt to be significant following immunisation, regardless of whether you think the side effect was related to the vaccine or not
    • Any expected symptoms that have not gone away after a few days
    • Any side effects following an immunisation which requires assessment by a doctor or nurse
    • Suspected shoulder injury related to vaccine administration (SIRVA)
    • Any immunisation administration errors

  • What does not need reporting?

    You do not need to routinely report:

    • Minor, common or expected side effects
      • These may include pain, redness, swelling and tenderness at the injection site, tiredness, headache, muscle pain, nausea, fever and chills, feeling unwell or joint pain
      • For further details of minor, common or expected side effects to National Immunisation Program (NIP) and influenza vaccines refer to Vaccine Side Effects
      • For further details of minor, common and expected side effects following COVID-19 vaccines refer to After your AstraZeneca Vaccine and After your Pfizer (COMIRNATY) Vaccine

  • Why report to SAEFVIC?

    • All data related to AEFI is confidentially collected and analysed as part of vaccine safety monitoring in Victoria
    • Any trends or signals in adverse events are notified and investigated quickly, in close liaison with Victorian and national health authorities (Therapeutic Goods Administration)
    • SAEFVIC provides individualised clinical assistance for patients and families affected by an AEFI. This may be done via a face-to-face appointment with a specialist, telehealth consultation with a specialist or with an immunisation nurse over the phone

  • Should a patient be referred to a specialist immunisation clinic after experiencing AEFI?

    • Although there are some adverse events which prevent individuals from having further immunisations, for the majority of people future immunisation is still recommended.
    • SAEFVIC can facilitate specialist immunisation appointments for children and adults who have experienced a severe AEFI or who have complex immunisation requirements. During these consultations, immunisation plans can be discussed and individualised, with any recommended immunisations administered under medical supervision.
    • The VicSIS Network proves specialist immunisation services for adults who have experienced a severe AEFI following a COVID-19 vaccine, or those who have are identified as at risk of an AEFI (for example, people with a history of anaphylaxis). For further information, refer to MVEC: The VicSIS Network.

Anyone who experiences a severe AEFI should first seek medical attention from a health professional. Please see your GP, local emergency department or call 000 if immediate assistance is required. NB: SAEFVIC is not an emergency contact. Hours of operation are Monday – Friday, 9am – 5pm.

Authors: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute), Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute) and Rachael McGuire (Research Nurse, SAEFVIC, Murdoch Children’s Research Institute)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: April 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Shoulder injury related to vaccine administration

Shoulder Injury Related to Vaccine Administration (SIRVA) is a rare complication of suspected incorrect vaccine administration into the shoulder and not into the correct site of the deltoid muscle. Damage to local structures within the shoulder joint can occur, including to ligaments and tendons, as well as a local inflammatory response to the vaccine components. This results in shoulder pain and limited range of movement of the affected limb. Symptoms are usually immediate and can last for days, months or as long as years. Following investigation, many affected individuals are diagnosed with bursitis, impingement syndrome or ligament tears.

Implications of SIRVA

SIRVA can be an extremely painful condition. The pain and limited range of movement can impact a patient’s ability to perform work duties, sporting activities and basic activities of daily living. When symptoms persist for months, individuals can experience impacts on their mental and emotional wellbeing. There are other implications of SIRVA to consider including the immunogenicity of the vaccine, cost of time off work, investigations and treatments, vaccine hesitancy and consumer confidence in healthcare providers.

Injection technique

Incorrect site- injection given too high                                           Correct site- in the deltoid muscle

                   

Please refer to MVEC: Administration of injected vaccines- correct technique for further information on correct injection technique.

Suspected cases of SIRVA

Any adverse event following immunisation (AEFI) should be reported to SAEFVIC. Reports can be made online via www.saefvic.org.au or by telephone on 1300 882 924 (option 1) during business hours.

Resources

Authors: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Georgie Lewis (SAEFVIC Clinical Manager, Murdoch Children's Research Institute) and Nigel Crawford (Director SAEFVIC, Murdoch Children's Research Institute)

Reviewed by: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Date: August 2020

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Special Risk Chapter in the Australian Immunisation Handbook

What is it?

Individuals that are at higher risk of vaccine preventable diseases (VPD) are classified as ‘special risk’ groups in the Australian Immunisation Handbook.

This includes populations at special risk (e.g. Aboriginal and Torres Straight Islanders) and those with additional vaccine requirements (e.g. maternal vaccination; preterm infants). It also has detailed sections on those at special risk because of immune suppression (disease and/or therapy) e.g. Asplenia, cancer/chemotherapy.

The chapter is updated online using the latest available scientific evidence

The Handbook is endorsed by:

  • The Australian Technical Advisory Group on Immunisation [ATAGI] and
  • The National Health and Medical Research Council [NHMRC]

Resources

Reviewed by: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute)

Date: September 2018

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.

 

 


Solid organ transplant recipient: pre-transplant immunisation recommendations

Background

In order to prevent the rejection of transplanted organs, people who have undergone a solid organ transplant require varying doses of immune suppressive medication. Once a patient is immune suppressed, seroprotection gained from immunisation may be suboptimal and therefore additional doses of vaccines may be recommended. Some vaccines (live-attenuated vaccines) may be contraindicated.

To overcome this and maximise immune responses it is recommended where possible that all vaccines are administered well before transplant with live-attenuated vaccines administered a minimum of 4 weeks prior to transplant.

Please refer to MVEC: Pre-solid organ transplant recipient immunisation guideline (0-18 years) for more information.

For immunisation recommendations following a solid organ transplant please refer to your immunisation specialist for specific advice.

MVEC special risk guidelines

These guidelines have been prepared by immunisation staff from the Royal Children’s Hospital and Monash Health and endorsed at a monthly immunisation meeting. Attendees at this meeting include paediatricians, infectious disease physicians, nurse immunisation specialists, infection control team members and a representative from the Immunisation Section of the Victorian Department of Health.

These guidelines are based on the latest available evidence and aim to align with recommendations in the Australian Immunisation Handbook.

Vaccine funding

Some of the recommendations in these guidelines are outside the scope of the National Immunisation Program (NIP). Different jurisdictions and individual hospitals have varying approaches to non-NIP vaccines, which should be clarified with the local health service.

We welcome any feedback on the guidelines, please email: info.mvec@mcri.edu.au

Resources

Authors: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute) and Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator) and Annie Cobbledick (Immunisation Pharmacist, the Royal Children's Hospital)

Date: March 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Science of immunisation

What is it?

‘The Science of Immunisation’ was first published in 2012 and aims to address confusion created by inconsistent information found in public sources such as searching ‘Google’. It details the current situation in immunisation science, including where there is agreement in the scientific community and where the answers aren’t clear.

This document summarises and clarifies the current understanding of immunisation around six key questions:

  1. What is immunisation?
  2. What is a vaccine?
  3. Who benefits from vaccines?
  4. Are vaccines safe?
  5. How are vaccines shown to be safe?
  6. What does the future hold for vaccination?

Is it a reputable source of information and is the information current?

Yes. It was published in November 2012 by the Australian Academy of Science.

Answers to the questions were reviewed by a committee of experts including:

  • Professor Gus Nossal who is an internationally renowned scientist and has been a significant figure in Australia's medical and scientific community. He was Director of the Walter and Eliza Hall Institute (1965-1996), Professor of Medical Biology at the University of Melbourne and President of the Australian Academy of Science.
  • Professor Fiona Stanley who is the Founding Director and Patron of the Telethon Institute for Child Health Research and Distinguished Research Professor, School of Paediatrics & Child Health at the University of Western Australia.  She was named Australian of the Year in 2003 and in 2006.

The publication has been endorsed by

  • The Royal Australasian College of Physicians
  • The Australian Medical Association

Resources

Author: Rachael McGuire (Research Nurse, SAEFVIC, Murdoch Children's Research Institute)

Date: February 2018

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.