After vaccination

Immediately after vaccine administration:

1. Dispose of clinical waste, including sharps and vaccine vials, at the point of use. See your state or territory management guidelines for how to safely dispose of clinical waste. Also see the National Health and Medical Research Council’s Australian Guidelines for the Prevention and Control of Infection in Healthcare.¹
2. Cover the injection site quickly with a dry cotton ball and tape or an adhesive bandage as needed.
3. Gently apply pressure for 1 or 2 minutes as needed. Do not rub the site — rubbing will encourage the vaccine to leak back up the needle track, which can cause pain and local irritation.
4. To distract the vaccinated person and reduce distress, immediately change their position after completing the vaccination. For example, ask the parent/carer to put the infant over their shoulder and move around.²
5. Remove the cottonwool after a few minutes and leave the injection site exposed to the air.
6. Record the relevant details of the vaccines given — see Documenting vaccination.
7. Keep the person under observation for at least 15 minutes to ensure that they do not experience an immediate adverse event, and to provide rapid medical care if needed. They should not drive or operate machinery during this time.
8. Inform the vaccinated person or their parent/carer, preferably in writing, of any expected adverse events following immunisation, and of the date of the next scheduled vaccination(s).

Take the opportunity to check the vaccination status of other family members (as appropriate), and discuss any catch-up vaccination requirements and options available. This can also be done earlier in the visit.

Paracetamol or ibuprofen may be recommended, as required, for fever or pain after vaccination. Paracetamol is not recommended prophylactically, except for MenB (meningococcal B) vaccine in infants <2 years of age (see Meningococcal disease). See Common adverse events following immunisation and how to manage them.

Immunisation providers must document all vaccinations. This includes:

• documenting the vaccination in the person’s medical record
• notifying the vaccination to the relevant immunisation register

Documentation of National Immunisation Program vaccines, COVID-19 vaccines and influenza vaccines on the Australian Immunisation Register is mandated.

Document all vaccines administered to children in the child’s clinical file and the individual child health record. The parent or carer keeps this record and presents it every time the child sees a health professional.

Record vaccines administered to adolescents and adults in both the vaccinated person’s clinical file and the personal health record, or individual record of vaccination.

For all people being vaccinated, record the following details:

• the person’s full name and date of birth
• Medicare number (if applicable)
• details of the vaccine given, including the brand name, batch number and dose number
• date and time of vaccination
• site of administration
• name of the person providing the vaccination
• date the next vaccination is due

See also Reporting to immunisation registers.

Healthcare workers or students

Healthcare workers or healthcare students doing work or clinical placement in state or territory health facilities may have specific requirements for documenting their vaccinations. Contact your state or territory health department for specific requirements.

See also Reporting to immunisation registers.

The Australian Immunisation Register (AIR) is a national register that records all vaccines given to all people in Australia since 1996. This includes vaccines received from recognised immunisation providers in general practice, community clinics and school programs.

All people of all ages who are enrolled in Medicare are automatically included on the AIR. People not enrolled in Medicare are included when an immunisation provider sends details of a vaccination to the register. Immunisation providers other than general practitioners need to register with the AIR before they can send data to it.

The Australian Immunisation Register Act 2015 came into effect on 1 January 2016, and provides the legal authority for the expansion and ongoing administration and keeping of the immunisation registers.

Mandatory reporting of vaccinations to the AIR commenced in February 2021 for COVID-19 vaccines given on or after 20 February 2021 and influenza vaccinations given on or after 1 March 2021. From 1 July 2021, mandatory reporting to the AIR was also required for all NIP vaccines.³

Vaccination details can be submitted to the AIR:

• using Practice Management Software
• through the AIR site

More details about reporting to the AIR for health professionals can be found on the Australian Government Services Australia website.

When required, exemptions to immunisation can be given for medical contraindications or natural immunity to certain diseases. Immunisation medical exemptions can only be given by:

• general practitioners
• general practice registrars on an approved training placement
• paediatricians
• public health physicians
• infectious diseases physicians
• clinical immunologists

Medical exemptions can be reported using the AIR site.

An individual’s vaccination record can be updated with vaccination details where there is documentation that the vaccination was given by another immunisation provider (including vaccines given while the individual was overseas) by taking the record of vaccination to a recognised vaccination provider. The vaccination provider can check if the immunisations administered match the National Immunisation Program, help you to catch up if you’re missing any immunisations and add your overseas immunisations to the AIR.

Why report to the register?

The AIR provides an important means of ensuring accountability of, and evaluating, Australia’s funded National Immunisation Program. The AIR is the primary means of determining vaccination coverage at national, state and territory, and local levels.

The AIR provides a central record of the vaccination history of every Australian. It is accessible by Australian immunisation providers to assess a person’s vaccination history and plan vaccination needs for themselves and their children.

AIR data are used to determine a family’s entitlement to government family assistance payments.

Immunisation requirements for eligibility for these payments include all people up to 20 years of age.

It is therefore important that immunisation providers promptly submit vaccination data to the AIR.

The Australian Government Services Australia website has more details about immunisation requirements for family assistance payments.

Resources on the AIR website

The Australian Government Services Australia website has information and resources about the AIR. The website has:

• a general information area for individuals and families
• a general information area for health professionals
• a secure area for immunisation providers only

The AIR site allows immunisation providers to obtain a range of statistical and identified reports. Depending on the provider’s access level, they can view an individual's vaccination details; record vaccination information; and access a range of other reports.

All recognised immunisation providers (including general practitioners) are automatically given access to the AIR site.

For more details or for assistance on any reporting issues, call the AIR Internet Helpline on 1300 650 039.

Proof of vaccination

The Immunisation History Statements (IHS) displays all vaccinations that an individual has had that are recorded on the AIR. The IHS can be used to provide evidence of an individual’s vaccination status for education, employment, or travel purposes, or to determine vaccine history during pregnancy. The IHS is automatically generated when a child completes the childhood vaccination schedule (usually at around 4 years of age). The IHS is mailed to the address most recently recorded by Medicare for that person.

The COVID-19 and Influenza IHS displays all COVID-19 and influenza vaccination information (including medical contraindications) on the AIR for an individual. The COVID-19 and Influenza IHS provides people with more privacy as it does not display full vaccination history.

Parents and carers of children <14 years of age, adolescents ≥14 years of age and adults can get a copy of their IHS at any time:

• using their Medicare online account through myGov
• through the myGov mobile app
• by calling 1800 653 809 (free call)

Digital versions of the COVID-19 and Influenza IHS are available for people to use and share with their digital wallets (Apple/Google).

For further information on how to access your IHS, see How to get immunisation history statements - Australian Immunisation Register - Services Australia.

Recording details of a deceased person

Medicare notifies the AIR of the death of anyone with an AIR record. Immunisation providers no longer need to provide this information to the AIR.

Individuals who have moved overseas

If an individual has moved overseas, their immunisation provider can inform the AIR by telephone or secure-site email. This prevents their name continuing to appear on AIR reports of overdue individuals.

People born overseas who have moved to Australia permanently

A person born overseas who has moved permanently to Australia will be automatically added to the AIR when they enrol with Medicare. Individuals residing temporarily in Australia are not included on the AIR until an immunisation provider notifies the register of a vaccine administered to that person.

An adverse event following immunisation (AEFI) is any negative reaction that follows vaccination. It does not necessarily have a causal relationship with the vaccine.

The adverse event may be any:⁴

• unfavourable or unintended sign
• unfavourable or unintended symptom
• disease
• abnormal laboratory finding

These events may be caused by the vaccine(s) or may occur by chance (that is, the event would have occurred regardless of vaccination).

Frequency of AEFIs and minimising risk

Frequency of AEFIs

The frequency of adverse events is classified by regulatory agencies and often reported in clinical trials as:⁵

• very common (>10% of people vaccinated)
• common (1–10%)
• uncommon (0.1 to <1%)
• rare (0.01% to <0.1%)
• very rare (<0.01%)

Minimising the risk of AEFIs

Screen each person to be vaccinated using the pre-vaccination screening checklist in Preparing for vaccination. This helps ensure that the person does not have a condition that increases the risk of an AEFI or is a contraindication to vaccination.

Also check:

• the disease-specific chapters of this Handbook, including the variations from product information
• any other relevant sources, such as state or territory guidelines

Always use correct injection procedures to help minimise adverse events. See Administration of vaccines.

Managing AEFIs

Informing the person being vaccinated about possible adverse events

Advise the person, or their parent or carer about what common adverse events are likely or expected and what they should do about them. This should be part of the consent procedure.

It is preferable to give people written advice, such as Table. Common side effects following immunisation for vaccines used in the National Immunisation Program schedule.

See also Preparing for vaccination.

Immediate AEFIs and how to manage them

Anaphylaxis

The most serious immediate AEFI is anaphylaxis. Severe anaphylactic reactions usually happen rapidly, within 15 minutes of vaccination.

Anaphylaxis after routine vaccination is very rare, but can be fatal.^6,7

All immunisation providers must be able to:

• recognise all the symptoms and signs of anaphylaxis
• distinguish between anaphylaxis, convulsions and fainting or a stress response

See:

• Table. Clinical features that may help differentiate between a vasovagal episode and anaphylaxis
• Table. Recognition and treatment of anaphylaxis
• Infographic. Managing anaphylaxis after vaccination
• Infographic. Preparing an anaphylaxis response kit
• Guidance for differentiating anaphylaxis from acute stress response for vaccine providers and Emergency Departments from the Melbourne Vaccine Education Centre

Signs and symptoms of anaphylaxis

Anaphylaxis is characterised by an acute onset illness with skin involvement, plus one or more of sudden respiratory compromise and/or circulatory collapse and/or gastrointestinal symptoms.^8,9

Early signs involve the skin — for example:

• generalised erythema
• urticaria
• angioedema

Early signs can also involve the gastrointestinal tract — for example:

• diarrhoea
• vomiting

Severe cases may have:

• circulatory collapse
• altered level of consciousness
• hypotension
• weak or absent pulse
• marked respiratory compromise from upper airway oedema or bronchospasm

Managing anaphylaxis

Rapid intramuscular administration of adrenaline is the cornerstone of anaphylaxis treatment. Adrenaline is lifesaving and must be used promptly.¹⁰

Antihistamines or hydrocortisone are not recommended to manage anaphylaxis in an emergency.

Every time vaccines are given, these things must be immediately to hand:

• a protocol for managing anaphylaxis
• adrenaline
• 1 mL syringes

Protocol for managing anaphylaxis

• Remove the allergen
• If the person is unconscious or pregnant, lie them on their left side in a lateral recumbent position and keep the airway clear.
• If the person is conscious, lie them on their back in ‘head-down and feet-up’ position, unless this causes breathing difficulties in which case they can be allowed to sit with legs extended.
• Give adrenaline by intramuscular injection into the anterolateral thigh. See Using adrenaline for dosage.
• If oxygen is available, give it to the person by facemask at a high flow rate.
• Call for help. Never leave the patient alone.
• If the person’s condition does not improve within 5 minutes, give another dose of adrenaline. Keep giving doses every 5 minutes until the person improves.
• Check the person’s breathing. If they are not breathing, start basic life support or cardiopulmonary resuscitation (CPR), according to the Australian and New Zealand Resuscitation Council Guidelines.¹¹
• In all cases, transfer the person to hospital for more observation and treatment.
• Fully document the event, including the time and dose(s) of adrenaline given.

Adrenaline is not needed for generalised non-anaphylactic reactions (such as skin rash or angioedema). If in doubt, give intramuscular adrenaline. No serious or permanent harm is likely to occur from administering adrenaline to a person who is not experiencing anaphylaxis.¹²

Dosage and administration of adrenaline

Adrenaline 1:1000 is recommended to treat anaphylaxis because it is universally available. Adrenaline 1:1000 contains 1 mg of adrenaline per mL of solution in a 1 mL glass vial.

The recommended dose is:

• 0.01 mL per kg body weight (equivalent to 0.01 mg per kg or 10 µg per kg)
• up to a maximum of 0.5 mL
• given by deep intramuscular injection, preferably in the mid-outer thigh

Use a 1 mL syringe to improve measurement accuracy when drawing up small doses of adrenaline.

Repeat the dose of 1:1000 adrenaline every 5 minutes until there is clinical improvement.

Adrenaline 1:10,000 is not recommended to treat anaphylaxis.

Also see Table. Recognition and treatment of anaphylaxis.

The mid-outer thigh is the preferred site because adrenaline disperses more predictably from this site.¹³ This also aligns with recommendations from various professional bodies in:¹⁴

• emergency medicine
• anaesthetics
• immunology

Do not give adrenaline 1:1000 intravenously.

Table. Doses of intramuscular 1:1000 adrenaline for anaphylaxis lists the dose of 1:1000 adrenaline to use if you do not know the person’s exact weight.

Using adrenaline autoinjectors

Adrenaline autoinjectors (EpiPen) are devices that administer a single, pre-measured dose of adrenaline.

They are designed for use by anyone, whether medically trained or not. Clear instructions on correct use are on the device’s barrel and in the packaging.

Autoinjectors are usually recommended or prescribed for:

• people who are at risk of anaphylaxis due to an existing allergy
• people for whom skin testing indicates a high risk of an allergic reaction on exposure to an allergen

If a person who carries an autoinjector device develops anaphylaxis after vaccination, it is appropriate to use their autoinjector to administer adrenaline.

Administer autoinjectors in the mid-outer thigh.

Autoinjectors are dose-specific:

• EpiPen Jr contains 150 µg adrenaline and is recommended for children weighing between 7.5 kg and 20 kg.
• EpiPen contains 300 µg adrenaline and is recommended for children and adults weighing more than 20 kg.
• Anapen 500 contains 500 µg adrenaline and can be used in adults weighing more than 60kg.¹⁵

Autoinjectors are not recommended for use in children weighing less than 7.5 kg.

Autoinjectors are usually not appropriate to include in first aid kits for general use. This is because:

• they are single use only
• they are dose-specific
• multiple pens would be needed to allow for repeat dosing and varying ages/weights of patients
• shelf-life is 1–2 years maximum

Vasovagal episodes

The most common immediate adverse event in adults and older children is a vasovagal episode (fainting). This can occur either immediately or soon after vaccination.

Fainting after vaccination can be serious. If a person feels giddy or light-headed before or after vaccination, advise them to lie down until they feel better.

Infants and children rarely faint. Assume that any sudden loss of consciousness in young children is anaphylaxis, particularly if there is no strong central pulse.

A key difference between anaphylaxis and vasovagal episodes is that:

• a central pulse is weak or absent in anaphylaxis
• a central pulse is strong in a vasovagal episode or convulsion

If anaphylaxis is suspected, give the person adrenaline as quickly as possible¹⁰ (see Managing anaphylaxis). Undertreatment of anaphylaxis is more harmful, and potentially life-threatening, than overtreatment of a mild or moderate allergic reaction.¹⁴

Common AEFIs and how to manage them

Most vaccine adverse events are minor. The most common adverse events are injection site reactions, such as:¹⁶

• pain
• redness
• itching
• swelling
• burning

These are to be expected, are generally mild and usually last for 1–2 days.

Injection site nodules are also fairly common. They are fibrous remnants of the body’s interaction with vaccine components (usually an adjuvant) in the muscle. Nodules may last for many weeks after vaccination and do not need any specific treatment.

Low-grade fever and tiredness (malaise) are also common after many vaccines. These responses are usually mild and self-limiting, and generally do not need specific treatment.

Commonly occurring AEFIs are described in Table. Comparison of the effects of diseases and the side effects of National Immunisation Program vaccines.

Details about the adverse events that are known to occur after vaccination are in the ‘Adverse events’ section of each disease-specific chapter.

Using medications to manage pain or fever

Using paracetamol or ibuprofen at the time of, or immediately after, vaccination to reduce the risk of fever is not recommended.

An exception is the specific recommendation to give prophylactic paracetamol with Men B vaccine in infants <2 years of age (see Meningococcal disease).

Infants, children or adults can receive paracetamol or ibuprofen if they have:

• fever of >38.5°C following vaccination
• pain at the injection site

The dose of paracetamol for an infant or child up to 12 years of age is 15 mg per kg per dose, up to a maximum dose of 60 mg per kg per day in 4 divided doses.

Adults and children aged ≥12 years can receive 500–1000 mg of paracetamol every 4–6 hours. The dose must not exceed 4 g in 24 hours.

The dose of ibuprofen for an infant or child up to 12 years of age is 10 mg per kg per dose, up to a maximum dose of 40 mg per kg per day in 4 divided doses.

Adults and children aged ≥12 years can receive 200–400 mg of ibuprofen every 4–6 hours. The dose must not exceed 1200 mg in 24 hours.

People should not take paracetamol or ibuprofen for more than 48 hours without seeking medical advice.¹⁷

Seeking medical advice for adverse events

People should seek medical advice if they have unexpected, serious or prolonged adverse symptoms or signs after vaccination.

The symptoms and signs from illness that is unrelated to vaccination can sometimes be attributed to a recent vaccination. These should be investigated and managed.

Uncommon and rare AEFIs

Some vaccines can cause uncommon or rare serious adverse events. The rate of vaccine adverse events is usually hundreds to thousands times less than the rate of disease complications.

The benefits and risks of immunisation are always taken into account when making recommendations for vaccine use.

It is important to advise the person being vaccinated or their parent/carer about known, but rare, AEFIs. Place the advice in the context of the benefits of vaccination. See Vaccination for people who have had an adverse event following immunisation.

If a person has had a serious, uncommon or rare AEFI, it is important that they or their immunisation provider seek advice from a specialist immunisation clinic, or contact their state or territory health authorities for more details. This advice is important to:

• determine the relationship of the adverse event to vaccination
• consider the benefits and risks of further vaccination
• plan for receiving additional doses of that vaccine or other vaccines, as appropriate

People who have had a serious AEFI can usually still receive vaccines under close medical supervision. This does not include people who have a contraindication, such as anaphylaxis to a vaccine component whose identity has been confirmed. For more details, see Vaccination for people who have had an adverse event following immunisation.

Examples of uncommon and rare adverse events are below. Although uncommon or rare, these events are not necessarily causally related to vaccination, even if they occur after vaccination.

Febrile convulsions

Febrile convulsions are a fairly common response to fever of any cause in young children, particularly in those aged <3 years. Incidence peaks at 14–18 months of age. Overall, by the age of 5 years, around 3% of all children will have had a febrile convulsion, regardless of vaccination.

Febrile convulsions are rare after vaccination. They do occur more commonly after some vaccines, but still at a low rate.

For example, MMR (measles-mumps-rubella) and MMRV (measles-mumps-rubella-varicella) vaccines are associated with an increased risk of febrile convulsions around 7–12 days after the 1st vaccine dose (see Measles for more details).

Co-administration of inactivated influenza vaccine and 13vPCV (13-valent pneumococcal conjugate vaccine) may also be associated with an increased risk of febrile convulsions. See Influenza and Pneumococcal disease.

In 2010, 1 brand of seasonal influenza vaccine (bioCSL Fluvax and Fluvax Junior) was associated with high fevers and febrile convulsions in children aged <5 years in Australia. Incidence was estimated at 4.4 per 1000 doses in Western Australia.¹⁸ This vaccine is no longer registered for use in this age group. Other influenza vaccines for children have not been associated with an excess risk of fever and febrile convulsions.^18,19

Brachial neuritis

Brachial neuritis is inflammation of a nerve in the arm, causing weakness or numbness. It can occur after receiving a tetanus toxoid–containing vaccine. The estimated excess risk is around 0.5–1 in 100,000 doses in adults.^5,20

Case reports of brachial neuritis following administration of other vaccines are rare, and a causal relationship has not been established.²¹ This includes HPV (human papillomavirus) vaccines.²²

Intussusception

Oral rotavirus vaccines are associated with a small increased risk of intussusception. This a rare form of bowel blockage caused when the intestine telescopes into itself. The risk appears to be particularly in the 7 days following the 1st vaccine dose. However, a smaller increased risk in the week after the 2nd dose has also been reported.^23-25

The increased risk represents around 6 additional cases of intussusception for every 100,000 infants vaccinated, or 14 additional cases per year in Australia.²⁵

Children who have had intussusception are not recommended to receive rotavirus vaccine (see Rotavirus).

Hypotonic-hyporesponsive episode

A hypotonic-hyporesponsive episode (HHE) is the sudden onset of:

• pallor or cyanosis
• limpness (muscle hypotonia)
• reduced responsiveness or unresponsiveness

This can occur after vaccination where no other cause is evident, such as a vasovagal episode or anaphylaxis.

The episode usually occurs 1–48 hours after vaccination and resolves spontaneously.

There are no known long-term side effects from an HHE.^26,27

In Australia during 2011, 3 HHEs were reported per 100,000 doses of DTPa (diphtheria-tetanus-acellular pertussis)–containing vaccine given to children <1 year of age.²⁸

Myocarditis or pericarditis

Myocarditis refers to inflammation of the muscle of the heart, and pericarditis refers to inflammation of the lining around the heart. They can occur separately or together (myopericarditis). COVID-19 vaccines are associated with a small increased risk of myocarditis and/or pericarditis. These conditions have been reported more frequently in males under 40, and most frequently after the second dose of COVID-19 vaccine.^29,30 See COVID-19 chapter for further information.

Myocarditis has also rarely been reported following receipt of mpox vaccines.³¹ See Mpox chapter for further information.

Symptoms and signs of myocarditis or pericarditis are summarised in the table below. Myocarditis symptoms typically start within a few days after vaccination (median 2 days).³²

Symptoms and signs of myocarditis or pericarditis

Assessment of possible myocarditis or pericarditis following vaccination

Patients with significant clinical suspicion of myocarditis and/or pericarditis should immediately be referred to ED.

Initial investigations can be performed in the primary care setting, based on clinical judgement, if

• the patient is not acutely unwell, and has mild symptoms
• the referring practice can obtain and review all the results of initial investigations within 12 hours. If required, contact your local pathology service to ensure this before sending the patient for blood tests.

It is important to consider other causes of chest pain and to refer to local guidance on investigation and management.

Patients with confirmed myocarditis should be admitted to hospital for cardiac monitoring. Referral to a cardiologist for advice regarding acute management may be appropriate (depending on location, telehealth consultation and or/medical retrieval may be required). Treatment of myocarditis and pericarditis is determined on a case-by-case basis. In many cases, supportive care is adequate.

Following diagnosis, follow up with cardiology is required for at least 12 months.

Future dose considerations following suspected vaccine-related myocarditis/pericarditis

The following people should not proceed with further doses until they have discussed the risks and benefits with a cardiologist or specialist immunisation service:

Individuals with suspected myocarditis following vaccination and no clear alternative diagnosis

Individuals with suspected pericarditis following vaccination with abnormal investigations (i.e. ECG, troponin, echocardiogram, or chest x-ray) and no clear alternative diagnosis

Individuals aged 39 years or younger with suspected pericarditis where investigations were not performed or are unavailable (i.e. ECG, echocardiogram, or chest x-ray). A normal troponin may have been performed.

The decision to administer further doses should be made on a case-by-case basis, taking into account an individual’s preferences, risk factors for severe illness from the vaccine-preventable disease, and the incremental benefit of an additional dose. Individuals should defer revaccination until they have been symptom-free for at least 6 weeks.  

Guillain–Barré syndrome

Guillain–Barré syndrome (GBS) is a rare autoimmune condition. It involves acute onset of flaccid paralysis that is:

• rapidly progressive
• ascending
• symmetrical

It may or may not involve sensory loss.

Diagnosis of GBS is complex. Only a physician can diagnose GBS. 

A small increased risk of GBS was associated with an influenza vaccine in the United States in 1976. Since then, close surveillance has shown that GBS occurs at a very low rate of up to 1 in 1 million doses of influenza vaccine, if at all.³³

Data from the United States suggest a possible but very rare risk of GBS following dose 1 of 1 Shingrix (an estimated 6 additional cases per million doses administered to adults aged ≥65 years).^34,35 There was no increased risk of GBS observed following dose 2 of Shingrix.^34,35 GBS may also be triggered by zoster itself,³⁶ and modelling data suggests that the overall benefits of vaccination outweighs the risks of GBS.³⁷

Early analysis of post-market surveillance data from the United States and United Kingdom in adults aged ≥60 years suggests that GBS may occur at higher rates than expected after vaccination.^38-41 Observed rates of excess cases differ for Abrysvo and Arexvy. For Abrysvo a rate of 9–18 excess GBS cases per million doses within 1–42 days after vaccination has been seen, whereas for Arexvy, a rate of 5–7 excess GBS cases per million doses within 1–42 days after vaccination has been seen. These are both higher compared with an expected rate of 2 GBS cases per million doses. GBS remains very rare, and these findings require ongoing monitoring and analyses.

Complex regional pain syndrome

Complex regional pain syndrome is an uncommon and poorly understood condition. It is characterised by chronic pain in one or more of the extremities, along with autonomic dysfunction in the affected limb(s). It occurs in response to trauma such as:⁴²

• injury
• stroke
• medical procedures

Rare cases of complex regional pain syndrome after vaccination have been reported. However, this may be a non-specific reaction to the minor trauma of the injection and not specific to the vaccine(s) used.²¹

Generalised (chickenpox-like) rash following varicella (chickenpox) vaccine

Chickenpox-like rashes can develop after live attenuated varicella vaccine (chickenpox) due to replication of the Oka vaccine virus. About 5% of varicella vaccine recipients develop a papulovesicular (chickenpox-like) rash within 1 to 4 weeks of vaccination. Most chickenpox-like rashes that occur within the first 2 weeks after varicella vaccination are the result of infection with wild-type varicella-zoster virus (VZV) before vaccine immunity has developed.  Rashes caused by the Oka vaccine strain occur a median of 3 weeks (range 5 days to 6 weeks) after varicella vaccination.

If the person has suspected disseminated VZV infection:

• conduct appropriate diagnostic testing
• start empirical antiviral treatment
• consult with an infectious diseases specialist
• stop immunosuppressive therapy, if relevant
• notify the relevant state or territory health authority and the Therapeutic Goods Administration (TGA) - see Reporting AEFIs

Events where evidence demonstrates no causal link with immunisation

Because vaccines are usually given to healthy people, conditions that occur after a vaccine dose may be attributed to vaccination. This is particularly so for illnesses that are complex and have an unknown or unclear cause.

Many of these illnesses are rare or manifest months to years after vaccination. This means that they are difficult to study in randomised controlled clinical trials, which are usually conducted before vaccine registration.

However, strong epidemiological evidence indicates that there is no causal association between vaccination and many diseases or conditions that were suggested to relate to vaccines. This evidence usually comes from multiple well-conducted post-marketing studies.

Examples of events unrelated to vaccination include:

• sudden infant death syndrome (SIDS) and any vaccine^43-45
• autism and MMR vaccine^46-49
• multiple sclerosis and hepatitis B vaccine^50-53
• inflammatory bowel disease and MMR vaccine⁴⁶
• diabetes and Hib (Haemophilus influenzae type b) vaccine^54-56
• asthma and any vaccine⁵⁷

People who want advice about links between vaccination and certain conditions can speak to:

• their immunisation provider
• a specialist immunisation clinic
• their state or territory health authority

Reporting AEFIs

Surveillance for AEFIs is an integral part of Australia’s National Immunisation Program. It underpins the safe use of all vaccines in Australia.

Surveillance of AEFIs aims to detect:

• changes in the rates of known adverse events
• any unrecognised or unexpected adverse events
• adverse events that result from program errors, such as incorrect vaccine schedule, delivery or storage

Australia has a vaccine safety surveillance initiative called AusVaxSafety. AusVaxSafety collects reports of AEFIs directly from the public. Software programs installed in sentinel surveillance sites (such as general practices and community immunisation clinics) send SMSs after a vaccination asking about the person’s experience. The system monitors de-identified information to detect possible safety signals for vaccines.

What to report

All immunisation providers should report AEFIs, particularly serious or unexpected AEFIs. This allows any vaccine safety issues to be identified and managed as soon as possible.

Any event that is suspected of being related to vaccination can be reported. All identifying information relating to the reporter and patient is kept strictly confidential.

For details on how to report AEFIs, see How to report AEFIs.

Notifying an adverse event does not imply a causal association with vaccination. Some events may occur coincidentally after vaccination. 

When to report AEFIs

Timely notification of adverse events — particularly rapid reporting of serious events — is important to identify any potential concerns.

However, there is no time limit for reporting AEFIs.

Who can report AEFIs

Anyone can report an AEFI, whether they are health professionals or consumers.

An immunisation provider who did not give the vaccine can report an AEFI. Include as much detail as possible in all reports.

Patients and parents should be encouraged to contact their healthcare provider if they are concerned about an adverse event occurring after vaccination, particularly if the reaction is:

• unexpected
• uncommon
• serious

As well as reporting AEFIs, immunisation providers may need to advise the person about clinical management and future vaccination. They may need expert advice. Information about specialist immunisation clinics, or the contact details for paediatricians or medical specialists with experience in managing patients with AEFIs, are usually available from state or territory health authorities. Also see Vaccination for people who have had an adverse event following immunisation.

How to report AEFIs

Details of how to report AEFIs in each state and territory are in Table. Contact information for notifying adverse events following immunisation.

Immunisation providers can also report directly to the Therapeutic Goods Administration (TGA) using the Australian Adverse Drug Reaction Reporting System.

Anyone can report adverse events directly to the TGA using the National Adverse Events Following Immunisation (AEFI) reporting form.

What happens to the reports and data

State and territory health departments forward AEFI notifications to the TGA. The TGA enters the notification into the Adverse Drug Reactions System database. This database includes all adverse reaction reports related to medicines and vaccines.

The TGA forwards copies of AEFI reports it receives from other channels to state and territory health departments.

The TGA aggregates vaccine AEFI reports from all sources. Details on rates and trends in AEFIs are published in the journal Communicable Diseases Intelligence.⁵⁸

The TGA also transfers reports of adverse events to all medicines, including vaccines, to a publicly accessible search facility, the Database of Adverse Event Notifications.

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