1.5 Post-vaccination procedures

Please note: due to continuous updates being made to the Immunisation Handbook, the page number on the electronic version will not always match the hard copy version.

What are AEFI?

An adverse event following immunisation (AEFI) is an unwanted or unexpected event occurring after the administration of vaccine(s). Such an event may be caused by the vaccine(s) or may occur by chance after vaccination (ie. it would have occurred regardless of vaccination). Most vaccines cause minor adverse events such as low-grade fever, pain or redness at the injection site and these should be anticipated3 (see the table Comparison of the effects of diseases and the side effects of vaccines on the back cover of this Handbook).

The frequency of adverse events can be classified as follows: very common (>10%), common (1–10%), uncommon (0.1–1%), rare (0.01–0.1%) and very rare (<0.01%).⁴

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Common adverse events

The following common adverse events should be anticipated following vaccination.⁵ They can be distressing for parents/carers, but they do not contraindicate further vaccination. In general, unless these adverse events are significant, they do not need to be reported by immunisation service providers to the Adverse Drug Reaction Advisory Committee (ADRAC) (see Table 1.5.3, Contact details for notification of AEFI).

Parents/carers should be given advice (preferably written) as part of the consent procedure on what common adverse events are likely and what they should do about them (the table inside the back cover of this Handbook, Commonly observed adverse events following immunisation with vaccines used in the National Immunisation Program (NIP) schedule and what to do about them, can be used for this purpose).

• DTPa, dTpa, hepatitis B, Hib, IPV and their various combinations may cause transient minor adverse events including swelling, redness or soreness at the injection site, and low-grade fever, crying and irritability (in infants).
• There is an increased risk of more extensive local adverse events after booster doses of DTPa and DTPa-combination vaccines.⁶ A local adverse event that involves extensive limb swelling should be reported. For the definition of extensive limb swelling, see Appendix 6, Definitions of adverse events following immunisation.
• MMR vaccine may be followed 5 to 12 days later by a fever lasting 2 or 3 days, malaise and/or rash. This is not infectious. Fever >39.4oC is very common, occurring in 5 to 15% of vaccinees, 5 to 12 days after vaccination.
• Human papillomavirus vaccine may cause mild injection site adverse events (pain, swelling and erythema) and, occasionally, headache, fever and nausea.
• Influenza vaccine may cause soreness at the injection site. Fever, malaise, and myalgia occur less commonly.
• The 7vPCV causes low-grade fever and/or mild pain at the injection site in about 10% of infant recipients. The 23-valent pneumococcal polysaccharide vaccine (23vPPV) causes mild local adverse events in up to half the adult recipients.
• MenCCV is generally well tolerated. Very common (>10%) adverse events are pain, redness and swelling at the injection site, fever, irritability, anorexia and headache.
• Varicella vaccine may cause mild local soreness and swelling. A mild maculopapular or papulovesicular rash occurs in up to 5% of vaccinated children (see also Chapter 3.24, Varicella).
• Zoster vaccine may cause injection site reactions (including erythema, pain, swelling and/or itch). VZV-like rashes occur rarely. (See also Chapter 3.26, Zoster.)
• Injection site nodules are not uncommon. They are fibrous remnants of the body’s interaction with the vaccine components (usually an adjuvant) in the muscle, and they may remain for many weeks after the vaccination. Injection site nodules do not require any specific treatment.
• Oral rotavirus vaccine may cause mild fever and/or diarrhoea (see Chapter 3.18, Rotavirus).

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Managing common adverse events

Advice to parents on common adverse events

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.

Managing fever after vaccination

Routine use of paracetamol at the time of vaccination is no longer recommended. If an infant or child has a fever of >38.5ºC following vaccination, paracetamol can be given. The dose of paracetamol is 15 mg/kg/dose of paracetamol liquid, up to a maximum daily dose of 90 mg/kg per day in 4 to 6 divided doses for up to 48 hours.

Preventing AEFI

The key to preventing uncommon or rare adverse events is to screen each person to be vaccinated using pre-vaccination screening (Tables 1.3.1 and 1.3.2) to ensure that the person does not have a condition which either increases the risk of an adverse event or is a contraindication to vaccination. The correct injection technique is also important. Immunisation service providers should also check the relevant chapters of this Handbook or the product information supplied with the vaccine for more details on precautions and contraindications for each vaccine they are to administer.

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Uncommon and rare AEFI

Some vaccines have been shown to cause uncommon or rare adverse events, although the rate is always hundreds to thousands times less frequent than the disease complications. Examples are given below.

Rare, late events shown to be causally related to some vaccines

The use of oral poliomyelitis vaccine (OPV) in Australia was discontinued in 2005. OPV can rarely cause vaccine-associated paralytic poliomyelitis (VAPP). The incidence is 1 in 2.4 million doses of OPV, which means that Australia would have expected 1 case of VAPP every 3 years when OPV was in use. However, the reported incidence of VAPP was only 1 case every 8 to 9 years in Australia.⁷ VAPP does not occur from vaccination with IPV or IPV-containing vaccines.

Vaccines containing diphtheria and tetanus have been described as causing brachial neuritis, with an incidence of approximately 1 in 100 000 (adults).

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Events where evidence demonstrates no causal link with immunisation

There is epidemiological evidence which indicates that there is no causal association between immunisation and the following events:

• sudden infant death syndrome (SIDS) and any vaccine,^8-10
• autism and MMR vaccine,^11-14
• multiple sclerosis and hepatitis B vaccine,^15-18
• inflammatory bowel disease and MMR vaccine,¹⁹
• diabetes and Hib vaccine,^20-22
• asthma and any vaccine.²³

Management of an immediate AEFI

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.²⁴

Children who have had a serious adverse event (other than a contraindication, such as anaphylaxis) to a previous vaccine may subsequently be vaccinated under close medical supervision. Check with State/Territory health authorities for more information (see Section 2.3.1, Vaccination of children who have had a serious adverse event following immunisation and Appendix 1, Contact details for Australian, State and Territory Government health authorities and communicable disease control).

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Anaphylaxis and vasovagal episodes

Anaphylaxis following routine vaccination is very rare, but can be fatal. All immunisation service providers must be able to distinguish between anaphylaxis, convulsions and fainting.

Fainting (vasovagal episode) is relatively common after vaccination of adults and adolescents, 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 (eg. carotid) persists during a faint or convulsion.

The features listed in Table 1.5.1 may be useful in differentiating these 2 conditions. If the diagnosis is unclear and anaphylaxis is considered, management for this should be instituted with the prompt administration of adrenaline.

Table 1.5.1: Clinical features which may assist differentiation between a vasovagal episode and anaphylaxis

		Vasovagal episode	Anaphylaxis
ONSET		Immediate, usually within minutes of or during vaccine administration.	Usually within 15 minutes, but can occur within hours, of vaccine administration.
Symptoms/Signs	Skin	Generalised pallor, cool, clammy skin.	Skin itchiness, generalised skin erythema (redness), urticaria (wheals) or angioedema (localised oedema of the deeper layers of the skin or subcutaneous tissues).
	Respiratory	Normal respiration; may be shallow, but not laboured.	Cough, wheeze, stridor, or signs of respiratory distress (tachypnoea, cyanosis, rib recession).
	Cardiovascular	Bradycardia, weak/absent peripheral pulse, strong carotid pulse. Hypotension – usually transient and corrects in supine position.	Tachycardia, weak/absent peripheral and carotid pulse. Hypotension – sustained and no improvement without specific treatment.
	Neurological	Feels faint, light-headed. Loss of consciousness – improves once supine or head down position.	Sense of severe anxiety and distress. Loss of consciousness – no improvement once supine or head down position.

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Signs of anaphylaxis

Anaphylaxis is a severe adverse event of rapid onset, characterised by sudden respiratory compromise and/or circulatory collapse. Early signs include involvement of the skin, eg. generalised erythema, urticaria and/or angioedema (swelling), and/or gastrointestinal tract, eg. diarrhoea, vomiting. In severe cases, there is circulatory collapse with alteration in the level of consciousness, hypotension and weak or absent pulses, and/or marked respiratory compromise from upper airway oedema or bronchospasm.

Immunisation service providers should be able to recognise all the following symptoms and signs of anaphylaxis:

• cutaneous, such as the rapid development of widespread urticarial lesions (circumscribed, intensely itchy weals with erythematous, raised edges and pale, blanched centres) and/or erythema and/or angioedema (soft tissue swelling usually affecting the face and/or limbs),
• upper airway obstruction, such as hoarseness and stridor, resulting from angioedema of the hypopharynx, epiglottis and larynx,
• lower airway obstruction, such as subjective feelings of retrosternal tightness, and dyspnoea with audible expiratory wheeze from bronchospasm,
• limpness and pallor, which are signs of hypotension in infants and young children,
• profound hypotension in association with other signs of cardiovascular disturbance, such as sinus tachycardia or severe bradycardia, absent central pulses and reduced peripheral circulation, and/or
• abdominal cramps, diarrhoea and/or vomiting.

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Management of anaphylaxis

Rapid IM administration of adrenaline is the cornerstone of treatment of anaphylaxis.

Anaphylaxis occurs without warning, usually within 15 minutes of giving a vaccine. A protocol for the management of anaphylaxis, adrenaline, and 1 mL syringes must always be immediately at hand whenever vaccines are given.

• If the patient is unconscious, lie him/her on the left side and position to keep the airway clear. If the patient is conscious, lie supine in ‘head down and feet up’ position (unless this results in breathing difficulties).
• Give adrenaline by IM injection (see below for dosage) for any signs of anaphylaxis with respiratory and/or cardiovascular symptoms or signs. Adrenaline is not required for generalised non-anaphylactic reactions (such as skin rash or angioedema). If in doubt, IM adrenaline should be given.
• If there is no improvement in the patient’s condition by 5 minutes, repeat doses of adrenaline every 5 minutes until improvement occurs.
• If oxygen is available, administer by facemask at a high flow rate.
• Call for assistance. Never leave the patient alone.
• Begin expired air resuscitation for apnoea, check for a central pulse. If pulse is not palpable, commence external cardiac massage (ECM).
• All cases should be admitted to hospital for further observation and treatment.
• Document the time and dose of adrenaline given.

Experienced practitioners may choose to use an oral airway if the appropriate size is available, but its use is not routinely recommended unless the patient is unconscious.

Antihistamines and/or hydrocortisone are not recommended for the emergency management of anaphylaxis.

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Adrenaline dose

Adrenaline 1:1000 (one in one thousand)

Adrenaline 1:1000 contains 1 mg of adrenaline per mL of solution in a 1 mL glass vial. Adrenaline 1 in 10 000 is no longer recommended for the treatment of anaphylaxis. The use of 1:1000 adrenaline is recommended because it is universally available. Use a 1 mL syringe to improve the accuracy of measurement when drawing up small doses.

The recommended dose of 1:1000 adrenaline is 0.01 mL/kg body weight (equivalent to 0.01 mg/kg or 10 µg/kg) up to a maximum of 0.5 mL, given by deep IM injection (not the deltoid). Adrenaline 1:1000 must not be administered intravenously. Table 1.5.2 lists the dose of 1:1000 adrenaline to be used if the exact weight of the individual is not known.

Table 1.5.2: Doses of intramuscular 1:1000 (one in one thousand) adrenaline for anaphylaxis

Less than 1 year	0.05–0.1 mL
1–2 years (approx. 10 kg)	0.1 mL
2–3 years (approx. 15 kg)	0.15 mL
4–6 years (approx. 20 kg)	0.2 mL
7–10 years (approx. 30 kg)	0.3 mL
11–12 years (approx. 40 kg)	0.4 mL
13 years and over (over 40 kg)	0.5 mL

The dose of 1:1000 (one in one thousand) adrenaline may be repeated every 5 minutes as necessary until there is clinical improvement.

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Reporting AEFI

Surveillance for adverse events following immunisation is an integral part of a national vaccination program. Through surveillance, it is hoped to detect changes in the rates of known adverse events and any adverse events that either were previously undocumented, or result from program errors, such as incorrect vaccine schedule, delivery or storage.

Any serious or unexpected adverse event following immunisation should be reported. Providers should use clinical judgement and common sense in deciding which adverse events to report, and parents/carers should be encouraged to notify the immunisation service provider or health authorities of an AEFI.

Any of the adverse events listed in Appendix 6, Definitions of adverse events following immunisation should be reported. No time limit has been set to report AEFI. Notification of an adverse event does not necessarily imply a causal association with vaccination, as some events may occur coincidentally following vaccination.

Immunisation service providers are also advised to report any adverse events of concern that do not fit into any of the categories listed in Appendix 6. They should be reported as ‘other reactions’ with a full description of the adverse event. This will enable new and unexpected AEFI to be identified.

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How should AEFI be reported?

AEFI are notifiable directly to the relevant health authority in Australian Capital Territory, New South Wales, Northern Territory, Queensland, South Australia, Victoria and Western Australia. In Tasmania, AEFI should be reported using the Adverse Drug Reactions Advisory Committee (ADRAC) blue card.

AEFI are notifiable conditions in Australian Capital Territory, New South Wales, Northern Territory, Queensland, South Australia, Victoria and Western Australia and must be reported direct to the relevant health authority (see Table 1.5.3 below). These State and Territory health authorities then forward AEFI notifications to ADRAC.

The Adverse Drug Reactions Advisory Committee (ADRAC) receives reports of unexpected and serious adverse events for all medicines, including vaccines. Any person (medical or non-medical) can report an AEFI to ADRAC by telephoning the numbers listed in Table 1.5.3 below, or by filling in a blue card or completing a web-based report (https://www.tgasime.health.gov.au/SIME/ADRS/ADRSLodg.nsf/wNotification?OpenForm).

Additional blue cards are available from:
The Secretary
Adverse Drug Reactions Advisory Committee
PO Box 100
Woden ACT 2606
Telephone: 1800 044 114 or on-line at www.tga.gov.au/adr/bluecard.htm

ADRAC will forward copies of individual reports of AEFI with vaccines on the National Immunisation Program schedule to those States/Territories that have follow-up surveillance. In addition, reports from ADRAC and State/Territory Health Departments are aggregated and published in Communicable Diseases Intelligence.²⁵

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Table 1.5.3: Contact details for notification of AEFI

State/Territory	Report adverse events directly to:	Telephone number
* Australian Capital Territory	ACT Health Department	02 6205 2300
* New South Wales	NSW Public Health Units	Contact your local Public Health Unit, found under ‘ Health ' in the White Page s
* Northern Territory	NT Department of Health and Community Services	08 8922 8044
* Queensland	Queensland Health	07 3234 1500
* South Australia	Department of Health In SA, parents can also report adverse events by calling	08 8226 7177 1300 364 100 (24 hours)
Tasmania	ADRAC	Use blue card
* Victoria	Department of Human Services, SAEFVIC	1300 822 924
* Western Australia	State Health Department	08 9321 1312

* AEFI are notifiable in these States/Territories and health professionals should report directly to their respective Health Department as listed above.

References

4. Stratton KR, Howe CJ, Johnston RB, Jr., eds. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington, D.C.: National Academy Press, 1994.

5. Braun MM, Ellenberg SS. Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991–1994. Journal of Pediatrics 1997;131:529-35.

6. Rennels MB, Deloria MA, Pichichero ME, et al. Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccins. Pediatrics 2000;105:e12.

7. Burgess MA, McIntyre PB. Vaccine-associated paralytic poliomyelitis. Communicable Diseases Intelligence 1999;23:80-1.

8. Jonville-Bera AP, Autret E, Laugier J. Sudden infant death syndrome and diphtheria-tetanus-pertussis-poliomyelitis vaccination status. Fundamental & Clinical Pharmacology 1995;9:263-70.

9. Mitchell EA, Stewart AW, Clements M, Ford RP. Immunisation and the sudden infant death syndrome. Archives of Disease in Childhood 1995;73:498-501.

10. Fleming PJ, Blair PS, Platt MW, et al. The UK accelerated immunisation programme and sudden unexpected death in infancy: case-control study. BMJ 2001;322:822.

11. DeStefano F, Chen RT. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Journal of Pediatrics 2000;136:125-6.

12. Taylor B, Miller E, Farrington CP, et al. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 1999;353:2026-9.

13. Halsey NA, Hyman SL, Conference Writing Panel. Measles-mumps-rubella vaccine and autistic spectrum disorder: report from the New Challenges in Childhood Immunizations Conference convened in Oak Brook, Illinois, June 12–13, 2000. Pediatrics 2001;107:e84.

14. Global Advisory Committee on Vaccine Safety, 16–17 December 2002. Weekly Epidemiological Record 2003;78:17-20.

15. Monteyne P, André FE. Is there a causal link between hepatitis B vaccination and multiple sclerosis? Vaccine 2000;18:1994-2001.

16. Ascherio A, Zhang SM, Hernán MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. New England Journal of Medicine 2001;344:327-32.

17. Demicheli V, Rivetti A, Di Pietrantonj C, Clements CJ, Jefferson T. Hepatitis B vaccination and multiple sclerosis: evidence from a systematic review. Journal of Viral Hepatitis 2003;10:343-4.

18. World Health Organization (WHO). The Global Advisory Committee on Vaccine Safety rejects association between hepatitis B vaccination and multiple sclerosis (MS). 2002. Available at: http://www.who.int/vaccine_safety/topics/hepatitisb/ms/en/ (accessed Aug 2006).

19. MacIntyre CR, McIntyre PB. MMR, autism and inflammatory bowel disease: responding to patient concerns using an evidence-based framework. Medical Journal of Australia 2001;175:127-8.

20. DeStefano F, Mullooly JP, Okoro CA, et al. Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitus. Pediatrics 2001;108:e112.

21. Classen JB, Classen DC. Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM. Autoimmunity 2002;35:247-53.

22. Karvonen M, Cepaitis Z, Tuomilehto J. Association between type 1 diabetes and Haemophilus influenzae type b vaccination: birth cohort study. BMJ 1999;318:1169-72.

23. Anderson HR, Poloniecki JD, Strachan DP, et al. Immunization and symptoms of atopic disease in children: results from the International Study of Asthma and Allergies in Childhood. American Journal of Public Health 2001;91:1126-9.

24. Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Archives of Pediatrics & Adolescent Medicine 1997;151:255-9.

25. Lawrence G, Boyd I, McIntyre P, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2005. Communicable Diseases Intelligence 2006;30:319-33.

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