COVID-19: Vaccine Allergy

Key Messages

This referral pathway is for patients with a history of allergic disease that raises concerns about receiving COVID vaccination.

All referrals will be reviewed by the allergy department and advice and guidance will be provided as soon as possible to avoid unnecessary delays in receiving vaccination.

A very small number of individuals have experienced anaphylaxis when vaccinated with the Pfizer BioNTech vaccine. Following close national surveillance, the MHRA is no longer advising that individuals with a history of anaphylaxis to any vaccine, medicine or food do not get the vaccine. Anyone with a previous history of allergic reactions to the ingredients of the vaccine should not receive it, but those with any other allergies (such as a food allergy) can now have the vaccine.

All recipients of the Pfizer BioNTech and Moderna mRNA COVID-19 vaccines should be kept for observation and monitored for a minimum of 15 minutes. Facilities for management of anaphylaxis should be available at all vaccination sites.

Most recent advice in the Green Book is that:

  • Individuals with undiagnosed PEG allergy often have a history of immediate onset-unexplained anaphylaxis or anaphylaxis to multiple classes of drugs. Such patients should not be vaccinated with the Pfizer BioNTech or Moderna mRNA vaccines, except on the expert advice of an allergy specialist. The AstraZeneca vaccine can be used as an alternative (if not otherwise contraindicated), particularly if they have previously tolerated an injected influenza vaccine. The vaccine should be administered in a setting with full resuscitation facilities (e.g., a hospital), and a 30-minute observation period is recommended.
  • Individuals with an immediate localised urticarial (itchy) skin reaction (without systemic symptoms) or delayed urticaria/angioedema not requiring medical attention to the first dose of a COVID-19 vaccine should receive the second dose of the same vaccine with prolonged observation (30 minutes) in any vaccination setting: see flow chart on page 18 here.
  • Individuals with non-allergic reactions (vasovagal episodes, non-urticarial skin reaction or non-specific symptoms) to the first dose of a COVID-19 vaccine can receive the second dose of vaccine in any vaccination setting.

Assessment

Devon COVID Vaccine Allergy Referral form – please ensure the form is completed as fully as possible. Failure to do so may result in the referral being returned and a delay in patient assessment.

All referrals without a Devon COVID Vaccine Allergy Referral form attached will be returned.

Please note these need to be sent by the referring clinician and not directly from the patient.

​Red Flags

Patients that experience red flag symptoms should receive emergency management and be admitted to hospital via ambulance (even if symptoms have settled):

Amended criteria for the diagnosis of anaphylaxis, proposed by the WAO Anaphylaxis Committee, 2019.

Anaphylaxis is highly likely when any one of the following 2 criteria are fulfilled:

1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives, pruritus or flushing, swollen lips-tongue-uvula)

AND AT LEAST ONE OF THE FOLLOWING:

a. Respiratory compromise (e.g., dyspnoea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)

b. Reduced BP or associated symptoms of end-organ dysfunction (e.g., hypotonia [collapse], syncope, incontinence)

c. Severe gastrointestinal symptoms (e.g., severe crampy abdominal pain, repetitive vomiting), especially after exposure to non-food allergens

2. Acute onset of hypotension* or bronchospasm or laryngeal involvementa after exposure to a known or highly probable allergenb for that patient (minutes to several hoursc), even in the absence of typical skin involvement.

PEF, Peak expiratory flow; BP, blood pressure.

*Hypotension defined as a decrease in systolic BP greater than 30% from that person's baseline, OR.

i. Infants and children under 10 years: systolic BP less than (70 mmHg + [2 x age in years])

ii. Adults: systolic BP less than 90 mmHg.

aLaryngeal symptoms include: stridor, vocal changes, odynophagia.

ballergen is a substance (usually a protein) capable of triggering an immune response that can result in an allergic reaction. Most allergens act through an IgE-mediated pathway, but some non-allergen triggers can act independent of IgE (for example, via direct activation of mast cells).

cThe majority of allergic reactions occur within 1–2 hours of exposure, and usually much quicker. Reactions may be delayed for some food allergens (e.g., alpha-gal) or in the context of immunotherapy, occurring up to 10 hours after ingestion.”

Investigations

Patients with suspected anaphylaxis reactions should have:

  • Mast Cell Tryptase taken at least 24 hours after acute anaphylaxis, and also ideally during the reaction in line with RCUK and NICE anaphylaxis management guidelines (as soon as possible; and 1-2 hours but no later than 4 hours after onset of symptoms).

Management

The following groups of people can receive any of the available vaccines without prior allergy assessment:

  • People with no history of allergy or anaphylaxis
  • People with a history of non-allergic reactions (e.g. vasovagal episodes, non-urticarial skin reactions, non-specific symptoms)
  • People with local skin reactions at the site of injection
    • (these individuals can have a second dose of the same vaccine in any setting with observation for 30 minutes; those with delay (over 2 hours) in onset of symptoms can consider premedicating with a non-sedating antihistamine 30 minutes prior to vaccination)
  • People with delayed-onset (over 2 hours) symptoms following vaccination that didn’t require medical attention
  • People with allergic diseases such as hayfever, eczema, or asthma
  • People with spontaneous urticaria and angioedema, without features of anaphylaxis
    • (these individuals can have a second dose of the same vaccine in any setting with observation for 30 minutes)
  • People with a history of allergy or anaphylaxis to foods or venom
  • People with a history of allergy or anaphylaxis to a single drug class (e.g., penicillins)
  • People with a history of anaphylaxis to any non-COVID vaccine
    • (as long as they are not known to be allergic to any component (excipient) of the vaccine)

Details of the excipients of the vaccines can be found at the following links:

Referral

Referral Criteria

  • Anaphylaxis following COVID vaccination
  • Anaphylaxis to a COVID vaccine excipient (e.g. PEG, polysorbate 80)
  • Anaphylaxis to multiple classes of drugs or vaccinations
  • Anaphylaxis to biologic medications
  • Spontaneous or unexplained anaphylaxis
  • Cutaneous or systemic mastocytosis
  • People with delayed-onset (over 2 hours) symptoms following vaccination that did require medical attention

Referral Instructions

e-Referral Service Selection

Specialty: Allergy

Clinic Type: Allergy

Service: Covid-19 Vaccine Allergy Service-Devon CCG-15N

Referral Forms

Devon COVID Vaccine Allergy Referral form

Please ensure the form is completed as fully as possible. Failure to do so may result in the referral being returned and a delay in patient assessment.

All referrals without a Devon COVID Vaccine Allergy Referral form attached will be returned.

Please note these need to be sent by the referring clinician and not directly from the patient.

Supporting Information

GP Information:

Green Book Chapter 14a Gov.UK

Patient Information:

Allergy UK - (Allergy and the coronavirus (COVID-19) Vaccine)

  • MHRA statement on the Oxford/Astra Zeneca vaccine and update on the Pfizer/BioNTech Vaccine

Publication date: March 2021

Publication date: March 2021

 

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