- What is an adverse event
- Managing AEFI
- Vaccination of children who have had a serious AEFI
- Importance of reporting an AEFI
- How to report an AEFI
- What happens when an AEFI is received by the TGA?
- The Database of Adverse Event Notifications (DAEN)
- Review of the management of adverse events associated with Panvax and Fluvax (Horvath Review)
Immunisation has repeatedly been demonstrated to be one of the most effective medical interventions to prevent disease and is estimated to save three million lives world-wide each year. Modern vaccines provide a high level of protection against several serious diseases, which have resulted in them becoming much less common.
Serious reactions to immunisation are rare. It is not unusual that local reactions related to a vaccine injection may produce some uncomfortable side effects, such as pain, swelling and redness, however most reactions are mild and resolve quickly.
An adverse event is any unwanted medical reaction in a patient who has been administered a medicine or vaccine. An adverse event is any unfavourable and unintended symptom, disease or sign (for example, an abnormal laboratory finding), associated with the use of the medicine or vaccine. The medicine or vaccine does not necessarily have to have caused the adverse event.
Observation after vaccination
Recipients of vaccines should remain under observation for a short interval to ensure that they do not experience an immediate adverse event. It is recommended that recipients remain in the vicinity of the place of vaccination for at least 15 minutes. Severe anaphylactic reactions usually have a rapid onset; most life-threatening adverse events begin within 10 minutes of vaccination.
The most serious immediate AEFI is anaphylaxis. However, in adults and older children, the most common immediate adverse event is a vasovagal episode (fainting), either immediately or soon after vaccination. Because fainting after vaccination can lead to serious consequences, anyone who complains of giddiness or light-headedness before or after vaccination should be advised to lie down until free of symptoms. Most faints following vaccination occur within 5 minutes, and 98% occur within 30 minutes. Adults should, therefore, be warned of the risk of driving or operating machinery for at least 30 minutes after vaccination.
What to do to manage injection site discomfort
Many vaccine injections may result in soreness, redness, itching, swelling or burning at the injection site for 1 to 2 days. Paracetamol might be required to ease the discomfort. Sometimes a small, hard lump may persist for some weeks or months. This should not be of concern and requires no treatment.
Managing fever after immunisation
Give extra fluids to drink. Do not overdress an infant if hot. Although the routine use of paracetamol at the time of vaccination is no longer necessary, it may be required if, for example, an infant or child has a high fever following vaccination. The dose of paracetamol is 15 mg/kg of paracetamol liquid, up to a maximum daily dose of 90 mg/kg per day.
Children who have had a serious AEFI (other than a contraindication, such as anaphylaxis) may be subsequently vaccinated under close medical supervision. Not all States and Territories offer an adverse event immunisation clinic. However, in States or Territories where there are no clinics, there is often a paediatrician or infectious diseases specialist who will review families who have concerns regarding future vaccinations following a previous adverse event. For more information about adverse event services contact your State or Territory Health Department.
Reporting an AEFI is important as it provides a better understanding of the safety issues around vaccines. The ongoing reporting of adverse events following immunisation allows the Therapeutic Goods Administration (TGA) to monitor rates and trends across Australia and assist in identifying issues such as incorrect vaccine administration, manufacture, storage and delivery.
The management of adverse events following immunisation is an important component of the TGA’s adverse events safety, information and education strategy. Further information can be obtained by visiting the TGA Safety Information web page.
Immunisation providers should report adverse events following immunisation to their relevant state/territory health authority where there are mandatory reporting requirements. If there are no mandatory requirements in place, immunisation providers should report directly to the TGA. You can confirm the mandatory requirements in your state and territory by contacting your local health authority. Notifications received by state/territory health authorities are referred to the TGA which manages the Australian Adverse Drug Reactions System (ADRS) which houses all adverse reaction reports related to medicines and vaccines.
Consumers can report adverse events following immunisation to the TGA or to their relevant state/territory health authority. Information on how to report an AEFI is available by visiting the TGA Safety Information web page.
Report adverse events to:
- ACT - ACT Health Department - 026205 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 available at Queensland Government - Immunisation website
- SA - Immunisation Section, Department of Health - 1300 232 272
- TAS - Direct to TGA - 1800 044 114
- VIC - SAEFVIC - 03 9345 4143 or SAEFVIC
- WA - State Health Department - WAVSSS - 08 9321 1312
Each report of an adverse event to a vaccine that the TGA receives is entered into the Australian Adverse Drug Reactions System (ADRS). The information in ADRS is analysed by TGA staff to identify safety signals - a flag for a possible safety concern. If the TGA identifies a signal against a reported adverse event, it undertakes an assessment to establish whether the vaccine was in any way responsible and where required takes appropriate actions to manage the risks.
Three months after an adverse event report is first entered in ADRS, the checked and analysed information is transferred to the publically accessible Database of Adverse Event Notifications (DAEN).
The DAEN contains information from reports of adverse events that the TGA has received in relation to medicines, including vaccines, used in Australia. These reports come from a wide range of sources, including members of the public, GPs, other health professionals and from the therapeutic goods industry. The DAEN can be accessed by visiting the TGA DAEN web page.
Following the suspension of Fluvax for children in 2010, the former Chief Medical Officer Professor John Horvath AO was asked to review the management of Australia's seasonal influenza vaccine program, and our system for reporting adverse events following vaccination.
Outcomes and Implementation of the Review of the management of adverse events associated with Panvax and Fluvax (Horvath Review)
The implementation of recommendations arising from the Review, managed by the Office of Health Protection (OHP) and the Therapeutic Goods Administration (TGA), under the leadership of the Chief Medical Officer (CMO), has seen the AEFI surveillance system in Australia strengthened. A report providing an overview on the implementation of the recommendations of the Review and identifying further work to be progressed, is now available for viewing.
- Review of the management of adverse events associated with Panvax and Fluvax (Horvath Review) Outcomes of Recommendations (PDF 139 KB)
- Review of the management of adverse events associated with Panvax and Fluvax (Horvath Review) Outcomes of Recommendations (Word 49 KB)
- Review of the management of adverse events associated with Panvax and Fluvax, Appendix 1- Principles and Objectives of the National Adverse Event Following Immunisation Surveillance System (PDF 64 KB)
- Review of the management of adverse events associated with Panvax and Fluvax, Appendix 1- Principles and Objectives of the National Adverse Event Following Immunisation Surveillance System (Word 33 KB)
Should you encounter issues in accessing the information contained either on the web page or within the downloadable documents please email Immune Coord (email@example.com) or call the Immunise Australia Information Line on 1800 671 811.