Adverse events following immunisation (AEFI) must be managed and reported.
What is an adverse event following immunisation (AEFI)?
Vaccines, like any medication or natural therapy, can have side effects. An AEFI is any negative reaction that follows immunisation.
It can be either expected or unexpected, and may not be triggered by the vaccine or only coincidentally occurs after getting a vaccine.
When to report AEFIs
Most reactions to vaccines are like a low grade fever and pain at the spot where the needle went in. They are mild and usually only last a little while. These reactions do not require special treatment or reporting. You should report to the state and territory AEFI contacts below if you have concerns about a reaction that:
- appears to be getting worse
- does not fit the common reactions for that vaccine.
On very rare occasions, a severe allergic reaction may occur. Anaphylaxis is the most severe form of allergic reaction and is life threatening if it is not treated immediately. Anaphylaxis is an allergic reaction involving more than one body system, for example skin, respiratory, gastro-intestinal and cardiovascular systems.
Why report an AEFI
By providing all information relevant to a specific adverse event, you can help TGA to assess the possible role of the product in causing the adverse event.
Reporting an AEFI assists in:
- identifying or better understanding the safety issues relating to newly introduced vaccines
- monitoring AEFI rates and trends across Australia
- identifying problems with manufacture, storage, delivery or administration
The Therapeutic Goods Administration (TGA) monitors AEFIs as an important component of the TGA’s strategy for adverse events safety, information and education. See the TGA Safety Information for more.
How to report an AEFI
Vaccination providers can report an AEFI or a defect with a vaccine by contacting the TGA on 1800 020 653
An AEFI should also be reported to State and Territory AEFI contacts:
- ACT: ACT Health Department 02 6205 2300
- NSW: 1300 066 055 (to connect to your local public health unit)
- NT: NT Department of Health 08 8922 8044
- Qld: Queensland Health 07 3328 9888, or complete an AEFI initial report form on the Queensland Health website
- SA: Immunisation Section, Department of Health 1300 232 272
- Tas.: report direct to the TGA 1800 020 653
- Vic.: SAEFVIC 03 9345 4143 or the SAEFVIC website
- WA: WAVSSS 08 9321 1312
Consumers can report an AEFI:
- directly to the TGA using the National Adverse Event Following Immunisation (AEFI) reporting form
- online to the Report a Side Effect of a Medicine form.
Consumers wanting to report a side effect to a vaccine by telephone are encouraged to speak to a pharmacist from NPS Medicinewise on 1300 134 237. The pharmacist can both lodge the report and provide further advice on how to manage the side effect.
Consumers can also report AEFIs to their state or territory health service.
Records of AEFI
The TGA enters each report of an AEFI into the Australian Adverse Drug Reactions System (ADRS). TGA staff review the information in ADRS to identify any possible safety signals or concerns. Safety signals may arise from individual reports or clusters of reports.
If the TGA identifies a safety signal from a reported event, it assesses if there is a possible or likely causal link. It also looks at the potential causes such as a manufacturing error for a particular batch. This information helps enable the TGA take appropriate actions to manage the risks.
Three months after an adverse event report is first entered in the ADRS, the TGA transfers the checked and analysed information to the publicly accessible Database of Adverse Event Notifications (DAEN).
Managing immediate AEFIs
Keep all patients under observation for at least 15 minutes to ensure that they do not experience an immediate AEFI. Most life-threatening adverse events usually begin within 10 minutes of vaccination.
Anaphylaxis is very rare, but it can be fatal. Patients with anaphylaxis need immediate treatment.
All immunisation service providers must be able to recognise all the symptoms and signs of anaphylaxis and know the difference between anaphylaxis, convulsions and fainting.
See the Australian Immunisation Handbook for details on managing anaphylaxis.
In addition, the Australasian Society of Clinical Immunology and Allergy has anaphylaxis e-training for health professionals.
A vasovagal episode (fainting) is relatively common after the vaccination of adults and teenagers, but infants and children rarely faint. Sudden loss of consciousness in young children should be presumed to be an anaphylactic reaction, particularly if a strong central pulse is absent. A strong central pulse (for example, carotid) persists during a vasovagal episode or convulsion.
Most faints following vaccination occur within five minutes, and 98% occur within 30 minutes.
Make sure the patient is safe:
- Lay the patient flat on his or her back.
- Elevate his or her legs to restore blood flow to the brain.
- Loosen tight clothing.
See the Australian Immunisation Handbook for details on managing fainting, and distinguishing between anaphylaxis and fainting.
A febrile convulsion is a fit or seizure caused by a fever. Febrile convulsions are a relatively common response to fever of any cause in young children. It is particularly common in those aged less than 3 years with a peak occurrence at 14 to 18 months of age. Overall, by the age of 5 years, approximately 3% of all children will have experienced a febrile convulsion, irrespective of vaccination. Febrile convulsions are rare following immunisation. They do, however, occur more commonly, but still at a low rate, after some vaccines. For example, measles, mumps and rubella and measles, mumps, rubella and varicella vaccines are associated with an increased risk of febrile convulsions approximately 7 to 12 days after the first vaccine dose.
See the Australian Immunisation Handbook for details on managing febrile convulsions.
Managing other AEFIs
Please see the Australian Immunisation Handbook for rare AEFIs that can occur with particular vaccines.
Injection site discomfort
Local reactions to a vaccine injection are relatively common and may result in soreness, redness, itching, swelling or burning at the injection site for 1 to 2 days. Most reactions are mild and resolve quickly. Paracetamol will help some patients ease the discomfort. Sometimes a small, hard lump may persist for some weeks or months. This generally requires no treatment.
Some vaccines are associated with fever. This can be managed by:
- giving extra fluids to drink
- not overdressing an infant if they are hot
- giving paracetamol.
Vaccinating people who have previously had a serious AEFI
A serious AEFI is one that is considered life-threatening. The most serious immediate adverse AEFI is a severe allergic reaction known as anaphylaxis. A contraindication to any particular vaccine is previous anaphylaxis to that vaccine or one of its ingredients.
Generally, people who have had other serious AEFIs may be subsequently vaccinated under close medical supervision. Most states and territories offer an adverse event immunisation clinic where parents or carers can get advice regarding revaccination and receive supervised vaccinations if required. Where there is no clinic, there is often a paediatrician or infectious diseases specialist who will assist families with vaccination concerns.
Contact your state or territory health department for more information about adverse event immunisation services