Outline the expectations of all clinical staff involved in vaccinations at Grampians Health to rapidly recognise and manage an anaphylaxis response following vaccine administration.

 Anaphylaxis to any vaccine is a rare but life-threatening occurrence.
It is an expectation that all clinical staff who administer vaccines are proficient in the early recognition and immediate first-aid management of anaphylaxis and provide definitive post adverse event medical care.

Care Community residents' vaccinations must be administered by: Registered Nurse DIV 1, Endorsed Enrolled Nurse, Nurse Practitioner or an accredited Nurse Immuniser who is able to recognise the signs and symptoms of anaphylaxis. They must be competent in the administration of adrenalin and in Cardio pulmonary resuscitation (CPR). The resident's General Practitioner, when writing a vaccination on the medication chart, will also need to have written a 'PRN' order for Adrenalin 1:1,000 (contains 1mg of adrenaline per 1ml) or an adrenaline (Epinephrine) injector, for example, Anapen or Epipen.

 AEFI: Adverse Events Following Immunisation is any expected or unexpected negative reaction that follows any immunisation. This can range from mild, expected side effects through to life-threatening events such as anaphylaxis. For any vaccination all AEFI, no matter how minor, must be reported as noted in the 'Issues To Consider' section below.

Anaphylaxis: ASCIA (Australasian Society of Clinical Immunology and Allergy) defines anaphylaxis as any acute onset of hypotension or bronchospasm or upper airway obstruction, where anaphylaxis is considered possible, even if typical skin features are not present (ASCIA, 2023).

GH Vaccination Clinic: Any space managed by GH that is used to allow immunisers to provide vaccines to any person. These clinics can be located:

• Within any GH facilities as a dedicated identified clinic space

• Within any GH facilities space used for a brief period to deliver vaccination

• At a fixed, dedicated clinic space within the community.

Polyethylene glycol (PEG): is a component of mRNA COVID-19 vaccines (Pfizer of Moderna).

 The emergency treatment of anaphylaxis following the administration of a vaccine is based on the vaccine recipient's medical history and clinical features, including:

Respiratory Symptoms:

• signs of airway obstruction, such as cough, wheeze, hoarseness, stridor or signs of respiratory distress (e.g. tachypnoea, cyanosis, rib recession)

• upper airway swelling (lip, tongue, throat, uvula or larynx)

Cardiovascular Symptoms:

• tachycardia, weak/absent carotid pulse

• hypotension that is sustained and with no improvement without specific treatment

• Note: in infants and young children limpness and pallor are signs of hypotension

• loss of consciousness with no improvement once supine or in head-down position

Dermatological Symptoms:

• pruritus (itchiness), generalised erythema (redness), urticaria (weals) or angioedema (localised or general swelling of the deeper layers of the skin or subcutaneous tissue)

Gastrointestinal Symptoms:

• abdominal cramps, diarrhoea, nausea and/or vomiting

Other Symptoms:

• sense of severe anxiety and distress

 Emergency treatment of anaphylaxis using IM adrenaline is not indicated for:

• Simple allergic responses with only cutaneous features such as hives

• Vasovagal (fainting) episode

Precautions: Specific Allergies

The following individuals should be assessed for suitability for vaccination before being given a vaccine dose, if necessary in consultation with an allergist/immunologist or specialist immunisation clinic:

• people with immediate (within 4 hours) and generalised symptoms of a possible allergic reaction (e.g. urticaria/hives) to a previous vaccination.

• people with a generalised allergic reaction (without anaphylaxis) to any component of a vaccine to be administered (e.g. PEG in Comirnaty (Pfizer) and Spikevax (Moderna) or polysorbate 80 in Vaxzevria (AstraZeneca) COVID-19 Vaccines

• people with a prior history of anaphylaxis to previous vaccines and/or multiple drugs (injectable and/or oral) where ingredients such as PEG or polysorbate 80 may conceivably be the cause

• people with a known systemic mast cell activation disorder with raised mast cell tryptase that requires treatment.

 If people in these categories are vaccinated, they may require vaccination in a facility with medical staff in attendance, and to be observed for 30 minutes following administration of a vaccine dose. Refer to current ASCIA guidelines for more information.

All other vaccine recipients, including those with a history of allergy; anaphylaxis to food, drugs, venom or latex; or allergic conditions, including asthma, atopic dermatitis (eczema) or allergic rhinitis (hay fever), should be observed for at least 15 minutes following administration of the vaccine at the clinic site in accordance with the current recommendations in the Australian Immunisation Handbook. It is important that all providers are trained in anaphylaxis management.

For individuals who are suspected to have had an allergic reaction to any vaccine they should seek expert advice through the specialist immunisation service managed through notification to SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community) or a specialist allergist/immunologist. They may need a clinical assessment to make a decision regarding the subsequent vaccine doses, including potentially receiving an alternate vaccine brand.

 Before and during each vaccination session, immunisers should check that up-to-date protocols, equipment, medicines and trained staff to manage anaphylaxis are available as per the Preparing for vaccination section of the Australian Immunisation Handbook.

 As part of routine care, all vaccine recipients should be given information on adverse events following immunisation and when to seek medical attention.

 Anaphylaxis Kit

• Container to hold kit contents

• Adrenaline 1:1000 vials x 5

• 1mL syringes x 5 (Never use insulin syringes)

• 23g needles x 5

• Laminated copy of Recognition and Treatment of Anaphylaxis and Doses of IM adrenaline from the latest Australian Immunisation Handbook

• Medical record or other documentation method

• A timer/clock

If the vaccine clinic is outside a facility with ready access to a medically supported resuscitation team, additional first aid and other emergency medical care equipment such as a first aid kit, an Automatic External Defibrillator (AED), airway support adjuncts such as oropharynx and nasopharynx airways will be required.

Reliable methods of communication to an in-hospital resuscitation team (in acute health facilities) or Ambulance Victoria (outside acute health facilities) are essential.

To note: an Adrenaline (Epinephrine) Injector (Injection) S3 may be used if available. An Adrenaline (Epinephrine) Injector contains Adrenaline Injection 1:1,000 and is designed to deliver a single 300 microgram dose of 0.3 mg. To manage severe anaphylaxis, repeat Adrenaline (Epinephrine) injections may be necessary. Each Adrenaline (Epinephrine) Injector is used ONCE only. The Adrenaline (Epinephrine) injector dose may be repeated every 5 minutes if symptoms recur or have not subsided.

Anaphylaxis Management: Adrenaline

Intramuscular (IM) injection of adrenaline is THE treatment for anaphylaxis. An anaphylaxis kit must always be available when conducting any immunisation.

The recommended dose of 1:1000 adrenaline is 0.01mL/kg (0.01mg/kg) body weight up to a maximum single dose of 0.5mLs (0.5mg). Multiple doses may be required. Using 1:1000 adrenaline with a 1mL syringe ensures accurate measurement of dose and 1:1000 vials are universally available.

The IM adrenaline dose is injected deep into the anterolateral thigh. Do not administer IM adrenaline into veins (IV), fingers, hands or feet.

Vasovagal versus Anaphylaxis Recognition and Management

Recognition and management of a simple faint or vasovagal episode is important to ensure that the vaccination recipient is appropriately cared for.

Notification of AEFI

Serious AEFI situations require urgent notification. A serious AEFI is defined as a medical event that results in the following actions being taken or outcomes for the vaccinated person:

• Adrenaline administration

• Transfer to hospital care

• Defibrillator

• Life-threatening incident

• Death

If a vaccinated person has an AEFI action or outcome as above, it must be urgently reported to the Victorian Department of Health:

• Business Hours (Mon-Fri; 0900-1700): Notify SAEFVIC on 1300 882 924

  • For AEFI involving adrenaline administration, defibrillator use, transfer to hospital care, life-threatening AEFI, or death, call SAEFVIC Immunisation Hotline, AND complete SAEFVIC online report form: https://www.safevac.org.au/Home/Info/VIC .

  • For all other AEFI, complete SAEFVIC online report form: https://www.safevac.org.au/Home/Info/VIC .

• Out of Hours: Notify the Victorian Vaccine Control Centre (VVCC) on 1800 675 398 Choose Option 3.1.2)

  • For AEFI involving adrenaline administration, defibrillator use, transfer to hospital care, life-threatening AEFI, or death, call VVCC (to escalate to SAEFVIC) on call AND complete SAEFVIC online report form: https://www.safevac.org.au/Home/Info/VIC.

  • For all other AEFI, just complete SAEFVIC online report form: https://www.safevac.org.au/Home/Info/VIC .

• Reporting a delayed AEFI (outside place of vaccination)

  • If made aware of a delayed AEFI GH immunisers must advise vaccine recipients to seek medical attention from their local GP or ED.

  • Following medical attention, a treating clinician should report an AEFI as per Reporting an Immediate AEFI above.

Documentation

Clinical staff caring for a person who develops anaphylaxis following vaccine administration must complete the following documentation:

• VHIMS

AEFI notification via:

• SAEFVIC via website https://www.safevac.org.au/ 

• TGA via website https://aems.tga.gov.au/ or by calling 1800 020 653

Continued Education

An anaphylaxis competency must be completed every two years with the exception of an accredited nurse immuniser.