Contraindications and precautions: Canadian Immunization Guide

For health professionals

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Notice

This CIG chapter has not been completely updated to contain information regarding COVID-19 vaccines. For more information, refer to the COVID-19 vaccine chapter.

Last partial chapter revision: February 2023

This chapter was updated with guidance on contraindications and precautions associated with allergies to a vaccine component or its container.

This information is captured in the table of updates.

Last complete chapter revision: November 2021

On this page

• Introduction
• Contraindications and precautions
• Contraindications and precautions associated with specific conditions
  • Acute illness
  • Adverse events following a previous immunization
  • Allergies
  • Concurrent or recent medication including biologics
  • Other situations, underlying condition or illness
• Close contacts of immunocompromised or pregnant individuals
• Table 1: Contraindications and precautions associated with conditions that may be present in vaccine candidates
• Chapter revision process
• Acknowledgements
• Selected References

Introduction

Sometimes vaccines cannot be given or need to be delayed due to contraindications or precautions. Other times people have concerns that lead to hesitation or refusal to get vaccinated. It is important that vaccine providers correctly identify contraindications, distinguish them from precautions, and seek expert advice as needed.

Contraindications and precautions

A contraindication is a situation in which a drug, such as a vaccine, should not be used because the risk outweighs any potential therapeutic benefit.

A precaution is a condition that may increase the risk of an adverse reaction following immunization or that may compromise the ability of the vaccine to produce immunity. In general, vaccines are deferred when a precaution is present. However, there may be circumstances when the benefits of giving the vaccine outweigh any potential risks, or when reduced vaccine immunogenicity may still result in significant benefit to an immunocompromised host.

Contraindications and precautions are determined by a person's past immunization experience(s), known allergies, current health status (for example: acute illness, immunocompromised status, chronic disease, pregnancy and breastfeeding) and presence of close contacts who might be affected by the use of live attenuated vaccines.

Some precautions and contraindications depend on whether a vaccine is a live attenuated product or non-live product. For information on types of vaccines, refer to Contents of Immunizing Agents Authorized for Use in Canada in Part 1. For complete vaccine-specific contraindications and precautions, consult the relevant vaccine-specific chapter in Part 4, the product leaflet, or information contained within the vaccine's product monograph available through Health Canada's Drug Product Database.

Vaccine providers should question all clients about their past immunization experience(s), known allergies, current health, and any chronic conditions to identify contraindications and precautions to the vaccine before each dose of vaccine is given. Checklists and routine screening questions are useful and can be found in Vaccine Administration Practices in Part 1.

The following is a general discussion of the key categories of events or underlying illness or conditions that may result in a contraindication and/or precaution to immunization. Table 1 features a summary of the contraindications and precautions associated with conditions that may be present in vaccine candidates.

Contraindications and precautions associated with specific conditions

Acute illness

Moderate to severe acute illness

The risks and benefits of vaccinating a severely ill person need to be assessed. The benefits of protection in a high risk exposure situation or when the window of opportunity is short (i.e., when travel or use of immunocompromising medications are imminent) need to be assessed against the risks of a vaccine-related adverse event. It is possible that systemic adverse events may complicate the medical management of an acute illness or that events associated with the acute illness may be misperceived as vaccine-related adverse events. Expert opinion is recommended in this situation.

Situations with specific contraindications or precautions include:

• Gastroenteritis
  • Postpone oral typhoid, cholera and travellers' diarrhea vaccines until the illness has resolved.
  • Defer rotavirus vaccine until condition improves unless deferral results in scheduling the first dose beyond the recommended age limit.
• Inflammatory eye disease treated with steroids
  • Defer first-generation smallpox vaccine, if a non-outbreak situation, until condition resolves or course of steroids is completed.
• Measles
  • Delay varicella-containing vaccines for 6 weeks (a minimum of 4 weeks delay can be applied if needed).
• Medically attended wheezing in the 7 days prior to vaccination
  • Live Attenuated Influenza Vaccine (LAIV) is contraindicated.
• Tuberculosis, active, untreated
  • Tuberculosis may be exacerbated by natural measles infection. Although there is no evidence that measles or varicella-containing vaccines have such an effect, measles-mumps-rubella (MMR), measles-mumps-rubella-varicella (MMRV), and monovalent varicella vaccines are contraindicated as a precautionary measure.

Mild acute illness

Mild illnesses, with or without fever (e.g., upper respiratory tract infection, otitis media) do not increase the risk of adverse events following immunization or interfere with the response to vaccines. There are no associated contraindications or precautions and these should not be used as a reason to withhold or delay immunization.

The single exception is when nasal congestion is present that could impede the delivery of LAIV to the nasopharyngeal mucosa. In such cases, non-live influenza vaccines can be offered.

Adverse events following a previous immunization

There are numerous adverse events following a previous immunization that may lead to concern regarding subsequent immunization.

Anaphylactic reaction to a vaccine or a component of a vaccine

A vaccine is contraindicated in a person with a documented history of confirmed anaphylaxis after previous administration of the same vaccine although exceptions may apply (i.e., Imvamune^® and mRNA COVID-19 vaccines). Refer to the vaccine-specific chapters in Part 4 for more information. If there is uncertainty regarding the diagnosis of anaphylaxis or which vaccine or vaccine component may have triggered it, consultation with an expert is recommended.

Febrile seizure following immunization

There are no contraindications or precautions associated with a history of a febrile seizure after a previous immunization. Children with a history of febrile seizures have no increased risk of developing a seizure disorder.

Guillain-Barré syndrome (GBS) with onset within 6 weeks of immunization

Cases of GBS have been reported following immunization but the evidence only supports a causal association for two vaccines: influenza and tetanus toxoid-containing vaccines. For influenza vaccines, the evidence suggests that the absolute risk of GBS in the period following seasonal or A(H1N1)pdm09 influenza vaccination is about one excess case per 1 million vaccine doses. However, the risk is higher following wild type influenza infection with approximately 17 cases of GBS per million influenza coded health care encounters (proxy measure for influenza infection). Thus, the risk of GBS associated with influenza vaccination must be balanced against the risk of GBS associated with influenza infection itself.

The evidence for a causal association between tetanus toxoid-containing vaccines and GBS is informed by a single individual who developed GBS following each of three doses of tetanus toxoid given years apart. There are no confirmatory epidemiologic studies and, at most, it is a very rare event.

As a precaution, it is recommended that persons who develop GBS within 6 weeks of receipt of a tetanus or influenza vaccines should not receive further doses of that specific vaccine. If there is a history of both Campylobacter infection (which has been associated with GBS) and immunization within 6 weeks before the onset of GBS, consultation with an infectious disease specialist is advised. Those who develop GBS outside the 6-week interval may receive subsequent doses of the vaccine.

Hypotonic-hyporesponsive episode (HHE) following immunization

HHE is the sudden onset of hypotonia, hyporesponsiveness and pallor or cyanosis that may follow immunization in the first 2 years of life. It is thought to be a pain response. There are no contraindications or precautions associated with a history of HHE. There is evidence that there are no adverse consequences to these events. The risk of recurrence with subsequent vaccinations is low (<5%).

Persistent crying following immunization

There are no contraindications or precautions associated with a history of persistent crying following immunization. Such reactions, which may be accompanied by an unusual high-pitched cry, are likely to be responses to pain at the site of injection in young infants. There are no associated sequelae. For information on techniques to decrease injection site pain, refer to Vaccine Administration Practices in Part 1.

Oculorespiratory syndrome (ORS)

Oculorespiratory syndrome is defined as bilateral conjunctivitis plus one or more respiratory symptoms: cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat, with or without facial edema that starts within 24 hours of influenza vaccination. It is usually transient, resolving within 48 hours of onset. The only associated precaution is when lower respiratory symptoms accompany ORS, in which case expert review is required prior to subsequent immunization. For more information, refer to Influenza Vaccine in Part 4.

Severe injection site reaction

Most injection site reactions are simply a normal inflammatory response to the vaccine. They are common and generally mild. These inflammatory reactions are not indicative of an allergy to the vaccine and patients can receive subsequent vaccinations.

An injection site reaction can be considered severe based on its size or location (e.g., ≥10cm, crossing the adjacent joint), duration (e.g., ≥4days) or impact on daily activities (e.g., required a consultation or hospitalization, prevented daily activities, resulted in missing work/school/daycare). There are specific types of severe injection site reactions like extensive limb swelling (ELS) or Arthus-type injection site reaction. A severe injection site reaction to one vaccine is not associated with an increased risk of injection site reactions to other vaccines. Repeating a dose of a vaccine that was previously associated with a large injection site reaction may result in a similar reaction; however, there is no increased risk of anaphylaxis. The presence of a large injection site reaction to a previous dose is not a contraindication to continuing the recommended schedule.

Severe Arthus-type injection site reactions are occasionally reported following receipt of diphtheria toxoid or tetanus toxoid-containing vaccines. There may be extensive painful swelling around the injection site, often involving the arm from shoulder to elbow and generally beginning 2 to 8 hours after injection. Persons who have experienced a previous Arthus-type injection site reaction should not receive further routine doses of Td/Tdap vaccine for at least 10 years. A pregnant person with a history of Arthus-type injection site reaction within the past 10 years should be referred to a specialist prior to re-vaccination with Tdap.

For information on wound prophylaxis following a tetanus-prone injury, refer to the post-exposure prophylaxis section of the Tetanus toxoid chapter in Part 4.

Extensive limb swelling (ELS) following immunization

There are no contraindications or precautions associated with a history of ELS, which is defined as swelling with or without redness that extends at least to the joints immediately above and below the injection site and that may cross one or both joints or involve the entire limb where the vaccine was administered. The reaction is often painless. It is commonly (2-6%) seen in children receiving the 4th or 5th dose of DTaP containing vaccine and has also been reported after non-live influenza vaccination. For children who have had an episode of ELS, repeat episodes with the next dose of vaccine are very common (>10%). However, ELS resolves spontaneously within a few days, is not associated with any other complications, and repeat episodes are generally of less or the same intensity as the first episode.

Syncope

There are no contraindications or precautions associated with a history of syncope (fainting) after a previous immunization. The likelihood of fainting can be reduced by measures that lower stress in those awaiting immunization, such as short waiting times, comfortable room temperature, preparation of vaccines out of view of recipients, and privacy during the procedure. People should be immunized while seated or lying down.

For more information, refer to Anaphylaxis and other Acute Reactions following Vaccination.

Allergies

A history of allergies is one of the most common concerns that people have about receiving vaccines. There are many types of allergic reactions and it is important to differentiate among them when considering implications for immunization.

Allergic reactions can be either immediate or delayed. Anaphylaxis is a serious, potentially life-threatening allergic reaction to foreign antigens; it has been causally associated with vaccines with an estimated frequency of 1.3 episodes per million doses of vaccine administered. In anaphylaxis, signs and symptoms have a sudden onset and progress rapidly over several minutes and involves two or more body systems. This immediate hypersensitivity reaction is IgE mediated (Type 1) and usually occurs within minutes up to 4 hours after injection; most within 2 hours.

The mechanisms of delayed reactions to vaccines are not fully understood. These may appear several hours to days after immunization. These reactions include an Arthus-type or Type 3 reaction (a local vasculitis due to deposition of IgG-based immune complexes in dermal blood vessels), a cell-mediated, delayed hypersensitivity or Type 4 reaction, or other unknown mechanisms.

On close questioning, it may become evident that people think they have an allergy to a vaccine or vaccine component but it is not a true allergy. People can be reassured that it is highly unlikely that they are allergic to a vaccine or vaccine component if they have a delayed, localized reaction.

People with a suspected moderate to severe hypersensitivity reaction, should seek expert advice. Suspected hypersensitivity should not be an ongoing reason to not administer vaccine. It should be investigated by an expert to clarify whether the person may proceed with vaccination or not. For more information, refer to Anaphylaxis and other Acute Reactions following Vaccination.

Allergy to a vaccine component or its container

Vaccine is contraindicated in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine (with the exception of egg allergy) or its container (e.g., latex). Assessment by an allergist is warranted if further vaccine doses are needed. There is general evidence that some individuals with proven immediate or anaphylactic hypersensitivity to vaccine component(s) or with immediate allergic reactions to vaccines can safely receive a subsequent dose of the same vaccine with low risk of a systemic reaction under the supervision of an allergist. For guidance on specific vaccine(s), consult the relevant vaccine-specific chapter in Part 4.

Precaution is warranted in situations of suspected hypersensitivity or non-anaphylactic allergy to a vaccine or its components. Investigation is indicated which may involve immunization in a controlled setting. Consultation with an expert may be advised. For guidance on specific vaccine(s), consult the relevant vaccine-specific chapter in Part 4.

People may report an allergy to a number of vaccine components including:

• Gelatin - Patients with a history of anaphylaxis to gelatin need to be assessed by skin testing to gelatin before vaccine with gelatin component is given. Most gelatin allergies are non-anaphylactic.
• Latex - Anaphylactic allergy to latex is very rare but if confirmed would pose a contraindication to the use of vaccines that come in vials with latex stoppers or that include syringes with latex components. For non-anaphylactic latex allergies (e.g., history of contact dermatitis to latex gloves), vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex may be given.
• Neomycin - Neomycin allergy is most often a contact dermatitis (i.e., a delayed hypersensitivity reaction) which is not a contraindication for administration of vaccines containing neomycin.
• Thimerosal - Even if there is a documented history of a delayed hypersensitivity reaction to thimerosal (such as a large local reaction or contact dermatitis), immunization with thimerosal-containing vaccines can proceed. In the rare instance of individuals with proven delayed hypersensitivity to thimerosal, they should be advised that long-lasting local or systemic cutaneous reactions can occur. They should report any reaction of concern following immunization so that it can be managed appropriately.

For a list of potential allergens, refer to Contents of Immunizing Agents Authorized for Use in Canada in Part 1.

Egg allergy

Egg allergy is one of the most common food allergies of childhood, with a prevalence of approximately 2% in children. It is often associated with eczema in infants and asthma in young children. However, allergic diseases are not a contraindication to immunization with egg protein-containing vaccine.

As most children outgrow their egg allergy, the prevalence of egg allergy in adulthood is lower and is estimated at 0.7%. The most common egg allergy is to egg white. Anaphylaxis to egg is possible.

In Canada, there are several vaccines manufactured by processes involving hens' eggs or their derivatives, such as chick cell cultures. This manufacturing process may result in the following vaccines containing trace amounts of residual egg and chicken protein:

• measles-mumps-rubella (MMR) vaccines
• measles-mumps-rubella-varicella (MMRV) vaccines
• influenza vaccines grown in eggs or chick cell cultures
• RABAVERT^® rabies vaccine
• yellow fever (YF) vaccine
• Imvamune^® Smallpox Vaccine

Previous concerns about immunizing egg-allergic individuals with vaccines that contain egg protein have been allayed by several studies resulting in clear changes to expert recommendations for some, but not all, of the above vaccines. A known egg allergy is not a contraindication to MMR, MMRV, Imvamune^® or influenza vaccines. Refer to vaccine-specific chapters in Part 4 for additional information.

Measles and mumps-containing vaccines

MMR or MMRV vaccine can be administered in the routine manner to people who have a history of anaphylactic hypersensitivity to egg. Numerous studies of egg-allergic subjects have shown that there is no increased risk of allergic reaction to MMR vaccine in those with egg allergy. The trace amount of egg protein in both MMR and MMRV vaccines are insufficient to cause an allergic reaction in egg-allergic individuals. Skin testing is not recommended prior to vaccination as it does not predict reaction to the vaccine. Hypersensitivity reactions that do occur following MMR and MMRV vaccines are usually due to other components of the vaccine, such as gelatin or neomycin.

Influenza vaccines

Studies have clearly demonstrated that egg-allergic persons can receive influenza vaccines. All egg-allergic individuals may be vaccinated against influenza using any of the vaccines authorized for use in Canada. Although the egg albumin (egg protein) content in influenza vaccines manufactured in eggs may vary from year to year, vaccines marketed in Canada are approved with a maximum allowable egg albumin content that is associated with low risk of adverse events.

The full recommended dose can be used and there is no need for a prior influenza vaccine skin test irrespective of a past severe reaction to egg. The vaccine may be given in any setting where vaccines are routinely administered. Refer to the Additional Vaccine Safety Considerations in the Statement on Seasonal Influenza Vaccine for 2018-2019 for safety data supporting this recommendation for inactivated influenza vaccine (IIV) and LAIV.

Imvamune^® vaccine

Imvamune^® vaccine is prepared from virus grown in chicken embryo fibroblast cells. However, the risk associated with the trace amounts contained in the vaccine is thought to be low. The full recommended dose can be used and there is no need for a prior vaccine skin test irrespective of a past severe reaction to egg. The vaccine may be given in any setting where vaccines are routinely administered. Prolonged observation (30 minutes) may be considered.

Rabies vaccines

RABAVERT^® rabies vaccine is grown in chick embryo cell culture. Imovax^® rabies vaccine is manufactured using human diploid cell cultures and therefore egg protein contamination is not an issue. For pre-exposure vaccination, Imovax^® rabies vaccine should be given to persons with a history of hypersensitivity reactions to egg or egg products as a precautionary measure. For post-exposure prophylaxis, the use of Imovax^® vaccine is preferred for persons with a history of hypersensitivity to egg. If Imovax^® vaccine is not available, RABAVERT^® vaccine should be administered with strict medical monitoring and facilities for emergency treatment of anaphylactic reactions readily available.

Yellow fever vaccine

Yellow fever (YF) vaccine is prepared from virus grown in chick embryos and is the vaccine most likely to contain sufficient amounts of egg or chicken proteins to cause an allergic reaction in egg-allergic or chicken-allergic individuals. There have been several reports of anaphylactic reactions to YF vaccine in egg-allergic or chicken-allergic individuals; therefore, Yellow fever vaccine should not be routinely administered to egg-allergic or chicken-allergic individuals. Referral of egg-allergic or chicken-allergic individuals to an allergy specialist is recommended, as YF vaccination may be possible after careful evaluation, skin testing and graded challenge or desensitization.

Individuals should be asked about allergies to egg or chicken prior to vaccination with Yellow fever or RABAVERT^® rabies vaccines.

Concurrent or recent medication including biologics

Antibiotic therapy

Antibiotic therapy does not interfere with response to non-live vaccines or most live vaccines with the following exceptions:

• The Typh-O vaccine series should be finished at least 3 days before commencing, or initiated at least 3 days after completing, treatment with sulphonamides or other antibiotics active against S. typhi, or antimalarials. Exceptions include chloroquine, mefloquine and atovaquone/proguanil (Malarone^®), as these antimalarials do not affect the immune response to Typh-O vaccine and can be administered at the same time as, or at any interval before or after Typh-O vaccine.
• Bacille Calmette-Guérin (BCG) vaccine should not be administered to individuals receiving drugs with anti-tuberculous activity, including fluoroquinolones.

Anticoagulation

Individuals receiving long-term anticoagulation with either warfarin or heparin are not considered to be at higher risk of bleeding complications following immunization and may be immunized through either the intramuscular or subcutaneous route (as recommended for the vaccine product) without discontinuation of anticoagulation therapy. For intramuscular injection, use a small gauge needle (23 gauge or smaller) and apply firm pressure to the injection site for ≥ 2 minutes. There is a paucity of evidence on whether there is an increased risk of bleeding complications following immunization with the other types of anticoagulants, such as antiplatelet agents, but there is no reason to believe that persons receiving these anticoagulants need to be treated any differently from those receiving other anticoagulants.

Antiviral therapy

Antiviral therapy does not interfere with response to non-live vaccines or most live vaccines with the following exceptions:

• Varicella-containing vaccines may have reduced effectiveness if given concurrently with antivirals active against varicella zoster virus (such as acyclovir, valacyclovir, famciclovir). People taking long-term antiviral therapy should discontinue these drugs, if possible, from at least 24 hours before administration of varicella-containing vaccine and should not restart antiviral therapy until 14 days after vaccination.
• LAIV should not be administered until 48 hours after antiviral agents active against influenza (e.g., oseltamivir) are stopped, and antiviral agents should not be administered until at least 14 days after receipt of LAIV unless medically indicated. If antiviral agents are administered within this time frame (from 48 hours before to 14 days after LAIV), revaccination should take place at least 48 hours after the antivirals are stopped.

Recent administration of blood products containing antibodies

Passive immunization with human immunoglobulin or receipt of most blood products can interfere with the immune response to MMR, MMRV and monovalent varicella vaccines. Measles-containing or varicella vaccines should be given at least 14 days prior to administration of an immunoglobulin preparation or blood product, or delayed until the antibodies in the immunoglobulin preparation or blood product have degraded. Respiratory syncytial virus monoclonal antibody (RSVAb) does not interfere with live vaccines because RSVAb contains only antibody to respiratory syncytial virus. For more information, refer to Table 1 in Blood Products, Human Immunoglobulin and Timing of Immunization in Part 1.

A risk-benefit assessment is needed for post-partum women who have received Rh immunoglobulin (RhIg) and require MMR or varicella-containing vaccines. For more information, refer to Blood Products, Human Immunoglobulin and Timing of Immunization in Part 1.

Salicylates

While it is generally safe to be immunized when taking salicylates (acetylsalicylic acid, aspirin, or ASA) there are some exceptions:

• LAIV is contraindicated in children and adolescents (2-17 years of age) currently receiving salicylates (e.g., ongoing treatment with aspirin-containing therapy) because of the association of Reye's syndrome with ASA and wild-type influenza infection. Non-live influenza vaccines should be used instead. ASA-containing products should be delayed for 4 weeks after receipt of LAIV in children aged 2 - 17 years, unless a risk assessment deems that the benefits outweigh the potential risks for the individual (e.g., treatment of Kawasaki disease).
• Varicella-containing vaccine manufacturers recommend avoidance of salicylate therapy for 6 weeks after varicella immunization because of an association between wild-type varicella, salicylate therapy and Reye's syndrome. Health care providers should weigh the theoretical risks associated with varicella-containing vaccine against the known risks associated with wild-type varicella. Because adverse events have not been reported with the use of salicylates after varicella immunization, people with conditions requiring chronic salicylate therapy should be considered for immunization, with close subsequent monitoring.

Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional information.

Other Situations, Underlying Condition or Illness

Chronic conditions with no contraindications or precautions are not included in the list below. However, it is important to ensure that individuals with chronic conditions are immunized appropriately since they are often at higher risk of complications due to vaccine-preventable diseases. For detailed recommendations on the use of live and non-live vaccines in individuals with asplenia or hyposplenia, endocrine/metabolic disease, heart disease, non-malignant hematologic disorders, inflammatory diseases, renal disease and dialysis, liver disease, lung disease and neurologic disorders, refer to Immunization of Persons with Chronic Diseases in Part 3.

Asthma, severe

Live attenuated influenza vaccine (LAIV) is contraindicated in individuals with severe asthma (defined as currently on oral or high dose inhaled glucocorticosteroids or active wheezing) or those with medically-attended wheezing in the 7 days prior to vaccination. LAIV can be used in stable, non-severe asthmatics.

Bleeding disorders

People with bleeding disorders should receive all recommended immunizations according to routine schedules when appropriate safety measures have been taken. Control of bleeding disorders should be optimized prior to immunization. Vaccine providers should ensure that there are no symptoms or signs compatible with an undiagnosed bleeding disorder (e.g., unexplained bruising). If such indicators are present before immunization, a diagnosis should be established before commencing immunization. When administering a parenteral vaccine, consider the use of a small gauge needle (23 gauge or smaller) and apply firm pressure for ≥ 2 minutes after the immunization.

For more information, refer to Immunization of Persons with Chronic Diseases in Part 3.

Congenital malformation of gastrointestinal tract or history of intussusception

Rotavirus vaccines are contraindicated in infants with a history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.

Immunocompromised persons

For contraindications and precautions regarding immunization of individuals with primary immunodeficiencies, hematopoietic stem cell transplant candidates/recipients, solid organ transplant candidates/recipients and HIV-infected persons, refer to Immunization of Immunocompromised Persons in Part 3. Contraindications and precautions are also provided for individuals slated for, or on, immunosuppressive therapy including infants of mothers treated during pregnancy.

Positive Tuberculin skin test

BCG vaccine is contraindicated for individuals with a positive tuberculin skin test, although immunization of tuberculin reactors has occurred frequently without complications.

Pregnancy and Breastfeeding

For contraindications and precautions regarding immunization during pregnancy and breastfeeding, refer to Immunization in Pregnancy and Breastfeeding in Part 3.

Preterm infants

Healthy preterm infants weighing 1,500 grams or more at birth generally tolerate immunizations well, with rates of adverse events similar to the low rates of full-term infants. Hospitalized premature infants should have continuous cardiac and respiratory monitoring for 48 hours after their first immunization. For more information, refer to Immunization of Infants Born Prematurely in Part 3.

Skin Disorders

Vaccines are generally safe for people with skin disorders. For comfort, administer vaccine into a non-affected area. Some smallpox vaccines and BCG are exceptions to this. Imvamune^® vaccine can be safely administered in people with eczema (atopic dermatitis). BCG vaccine is contraindicated when there is extensive skin disease or burns.

For more information, refer to the Smallpox Vaccine and Bacille Calmette-Guerin Vaccine chapters in Part 4.

Thymus disease

For individuals with a past history of thymus disease with abnormal immune function (e.g., thymoma, thymectomy, myasthenia gravis), Yellow fever vaccine is contraindicated because of an increased risk of viscerotropic disease.

Close Contacts of Immunocompromised or Pregnant Individuals

Vaccination provides protection at both an individual and population level. Some people may have conditions that preclude vaccination, but they can be protected by having the people around them vaccinated. Immunization of household contacts of immunosuppressed persons, pregnant women, and neonates provides important protection against transmission of disease in the household.

Up-to-date routine immunizations are recommended for household contacts of pregnant women, immunocompromised persons, and neonates with the following exceptions:

• Non-live influenza vaccines are preferred over LAIV for those in close contact with severely immunocompromised persons.
• Oral polio vaccine (OPV): OPV is not used in Canada but individuals may receive it in other countries. Household contacts who are vaccinated with OPV should not have contact with immunocompromised persons for six weeks after receipt of OPV.
• Following MMRV or monovalent varicella vaccines, if a vaccine recipient develops a varicella-like rash, the rash should be covered and the vaccinee should avoid direct contact with the immunocompromised person for the duration of the rash.
• First-generation smallpox vaccine should not be administered to household contacts of an immunocompromised person in a non-emergency situation.
• First-generation smallpox vaccine: Vaccinees with household and other close contacts with active eczema or a history of eczema or other exfoliative skin conditions, immunosuppressive disorders, or with close contact with infants or pregnant women, should take special precautions in order to prevent viral transfer to these contacts.

Table 1: Contraindications and precautions associated with conditions that may be present in vaccine candidates

Condition	Contraindication	Precaution	Comments
Acute illness
Gastrointestinal illness	None	Oral typhoid, cholera and travellers' diarrhea vaccines: postpone until illness has resolved Rotavirus vaccines: if moderate to severe defer until condition improves unless deferral results in scheduling first dose beyond the recommended age limit.	Refer to the vaccine-specific chapters in Part 4 for more information.
Inflammatory eye disease treated with steroids	None	First-generation smallpox vaccine: in a non-outbreak situation defer until condition resolves or course of steroids completed.	Refer to Smallpox and Mpox (Monkeypox) Vaccines in Part 4.
Measles	None	Varicella-containing vaccine: delay vaccination for 6 weeks (a minimum of 4 weeks delay can be applied if needed).	Refer to Varicella (Chickenpox) Vaccines in Part 4.
Tuberculosis, active, untreated	MMR, MMRV, monovalent varicella vaccines	None	Refer to the vaccine-specific chapters in Part 4 for more information.
Medically attended wheezing in the 7 days prior to vaccination	LAIV	None	Refer to Influenza Vaccines in Part 4.
Other moderate to severe acute illness	None	Consider risks and benefits. Expert opinion is recommended in such situations.	Refer to the vaccine-specific chapters in Part 4 for more information.
Minor illness with or without fever	None	LAIV: if significant nasal congestion is present that might impede delivery of LAIV to the nasopharyngeal mucosa non-live influenza vaccine can be administered instead.	Refer to Influenza Vaccines in Part 4.
Adverse events following previous immunization
Anaphylaxis	Receipt of the same vaccine is often contraindicated although exceptions may apply (i.e., Imvamune® and mRNA COVID-19 vaccines). Consult an allergist if further vaccine doses are needed.	None	Refer to Anaphylaxis and Other Acute Reactions Following Vaccination.
Febrile seizure	None	None	Refer to Measles Vaccines in Part 4.
GBS within 6 weeks of receiving influenza vaccine or tetanus toxoid	Generally contraindicated to receive the same vaccine	If there is a history of both Campylobacter infection and immunization within 6 weeks before the onset of GBS, consultation with an infectious disease specialist is advised. Influenza vaccines: may need to balance the risk against that of GBS associated with influenza infection.Footnote 1	Refer to Tetanus Toxoid and Influenza Vaccines in Part 4.
Hypotonic-hyporesponsive episode (HHE)	None	None	Refer to Pertussis (whooping cough) Vaccines in Part 4.
Oculorespiratory syndrome (ORS)	None	Influenza vaccines: need expert review if ORS episode involved lower respiratory tract.	Refer to Influenza Vaccines in Part 4.
Persistent crying	None	None	None
Extensive limb swelling (ELS)	None	None	Refer to Tetanus Toxoid in Part 4.
Arthus-type injection site reaction	None	Tetanus-containing vaccines: no further routine doses for at least 10 years.	Refer to Tetanus Toxoid in Part 4.
Syncope (fainting)	None	None but reduce likelihood by taking measures to lower stress while awaiting immunization and ensure individual is seated, or if at high risk, lying down during immunization.	Refer to Anaphylaxis and Other Acute Reactions Following Vaccination.
Allergies
Egg allergy - anaphylactic or other	None	Rabies vaccination: Pre-exposure: use Imovax® Post-exposure: Imovax® preferred but if unavailable administer RABAVERT® ensuring strict medical monitoring with readily available emergency treatment for anaphylaxis YF vaccine: should not be routinely given to egg- or chicken-allergic individuals. If required, allergy specialist referral recommended.	Refer to Rabies Vaccines and Yellow Fever Vaccine in Part 4.
Anaphylactic hypersensitivity to a specific component of the vaccine (other than egg) or its container (e.g., latex)	History of a confirmed reaction to a specific component of the vaccine or its container. Exceptions may apply (i.e., Imvamune® and mRNA COVID-19 vaccines). Refer to the vaccine-specific chapters in Part 4 for more information.	History of a suspected reaction; consultation with an expert is advised. Exceptions may apply (i.e., Imvamune® and mRNA COVID-19 vaccines). Refer to the vaccine-specific chapters in Part 4 for more information.	Refer to Anaphylaxis and other Acute Reactions following Vaccination. Refer to Contents of Immunizing Agents Authorized for Use in Canada in Part 1.
Thimerosal - delayed hypersensitivity	None	Advise that long-lasting local or systemic cutaneous reactions can occur and should report any such reaction so appropriate management can be given.
Concurrent or recent medication including biologics
Antibiotic therapy	None	Live oral typhoid vaccine: delay until at least 3 days after last dose of antibiotic active against Salmonella typhi. BCG: do not give while individuals are on anti-tuberculous drugs including fluoroquinolones.	Refer to Typhoid Vaccines in Part 4. Refer to Bacille Calmette-Guérin Vaccine in Part 4.
Antiviral therapy	None	LAIV and varicella-containing vaccines: consider timing of administration if antiviral drug active against vaccine strain.	Refer to Influenza Vaccines and Varicella (Chickenpox) Vaccines in Part 4.
Anti-coagulation	None	Intramuscular injections: use a 23 gauge or smaller needle; apply firm pressure to the injection site for ≥ 2 minutes.	Refer to Immunization of Persons with Chronic Diseases in Part 3.
Blood products containing antibodies	None	MMR, MMRV and monovalent varicella vaccines: should be given at least 14 days prior to blood product. If product already given recommended interval between blood product and these vaccines are vaccine and blood product specific Risk benefit assessment is needed for post-partum women who have received Rh immunoglobulin (RhIg) and require MMR or monovalent varicella vaccine.	Refer to Blood Products, Human Immunoglobulin and Timing of Immunization in Part 1. Refer to Immunization in Pregnancy and Breastfeeding in Part 3.
Salicylates Chronic Intermittent	1. LAIV 2. None	1. Varicella-containing vaccines: can be considered with close monitoring 2. Children and adolescents should avoid salicylates followingFootnote 2: LAIV for 4 weeks Varicella-containing vaccines for 6 weeks Unless a risk assessment deems that the benefits outweigh the potential risks for the individual.	Refer to Immunization of Persons with Chronic Diseases in Part 3. Refer to Influenza Vaccines and Varicella (Chickenpox) Vaccines in Part 4.
Other situations, underlying condition or illness in vaccinee
Asthma, severeFootnote 3	LAIV	None	Refer to Immunization of Persons with Chronic Diseases in Part 3. Refer to Influenza Vaccines in Part 4.
Bleeding disorder	None	Ensure optimal control of bleeding prior to immunization; use a 23 gauge or smaller needle and apply pressure for ≥ 2 minutes at the injection site after immunization.	Refer to Immunization of Persons with Chronic Diseases in Part 3.
Congenital malformation of gastro-intestinal tract, uncorrected or history of intussusception	Rotavirus vaccines due to increased risk of intussusception	None	Refer to Rotavirus Vaccines in Part 4.
Immuno-compromised persons	Live vaccines contraindicated if severely immunocompromised.	Can give all non-live vaccines but should consider ability to mount an immune response to vaccine For milder degrees of immunosuppression may consider live vaccines.	Refer to Immunization of Immunocompromised Persons
Positive tuberculin test	BCG	None	Refer to Bacille Calmette-Guérin Vaccine in Part 4.
Preterm infants	None	Hepatitis B vaccines for infants with a birth weight <1,500 grams If hospitalized, continuous respiratory and cardiac monitoring for 48 hours after 1st immunization.	Refer to Hepatitis B Vaccines in Part 4.
Skin disorder	First and second generation smallpox vaccines are contraindicated in those with eczema (atopic dermatitis) in non-outbreak situation; Imvamune® (third generation) is not contraindicated and can be administered safely BCG vaccine is contraindicated if extensive skin disease or burns	For comfort, administer vaccine into non-affected area.	Refer to Bacille Calmette-Guérin Vaccines and Smallpox and Mpox (Monkeypox) Vaccines in Part 4.
Thymus disease	YF vaccine is contraindicated in persons with a history of thymus disease with abnormal immune function (e.g., thymoma, thymectomy, myasthenia gravis)Footnote 4		Refer to Yellow Fever Vaccine in Part 4.
Those in Close Contact of the Following Individuals
Immuno-compromised (severe) persons	First-generation smallpox vaccine is contraindicated in non-emergency situations OPVFootnote 5	Influenza vaccines: use non-live influenza vaccines rather than LAIV. LAIV recipients should avoid close contact for at least two weeks after immunization OPV: avoid direct contact with immunocompromised person(s) for 6 weeks after receipt of OPV in another country Varicella-containing vaccine recipients with varicella-like rash: ensure that rash is covered and avoid direct contact with the immunocompromised person for the duration of the rash First-generation smallpox vaccine: If required in an emergency situation must ensure isolation of vaccinee from affected household contacts until scab falls off.	Refer to Immunization of Immunocompromised Persons in Part 3. Refer to the vaccine-specific chapters in Part 4 for more information.
Pregnant women, infants, eczema or other exfoliative skin condition		First-generation smallpox vaccine: Defer if non-outbreak situation. If required in an emergency situation must ensure isolation of vaccinee from affected household contacts until scab falls off.	Refer to Smallpox and Mpox (Monkeypox) Vaccines in Part 4.
Footnote 1 Those who develop GBS outside the 6 week interval may receive subsequent doses of the vaccine. Return to footnote 1 referrer Footnote 2 Salicylates are avoided in these instances to decrease the risk of Reye's syndrome. Return to footnote 2 referrer Footnote 3 Severe asthma: defined as currently on oral or high dose inhaled glucocorticosteroids or active wheezing. Return to footnote 3 referrer Footnote 4 Because of an association between a history of thymus disease and acute viscerotropic disease. Return to footnote 4 referrer Footnote 5 Oral polio vaccine is neither recommended nor available in Canada. Return to footnote 5 referrer Table 1 - Abbreviations BCG Bacille Calmette-Guérin vaccine ELS extensive limb swelling GBS Guillain-Barré syndrome HHE hypotonic-hyporesponsive episode Ig immunoglobulin LAIV live attenuated influenza vaccine MMR measles-mumps-rubella vaccine MMRV measles-mumps-rubella-varicella vaccine OPV oral polio vaccine ORS oculorespiratory syndrome RV rotavirus vaccine Tdap tetanus toxoid, diphtheria toxoid (reduced), acellular pertussis (reduced) vaccine VZV varicella-zoster virus YF yellow fever

Chapter revision process

The CIG Part 2 Working Group members reviewed the chapter to ensure content was up-to-date with clinical practice and evidence based. The revised guidance on the pressure time post administration of a parenteral vaccine to persons with a bleeding disorder or on an anticoagulant were based on a review of the literature, a review of guidance provided by other National Immunization Technical Advisory Groups (NITAGs) and expert opinion. For persons with a history of thymus disease with abnormal immune function, guidance regarding YF vaccine administration was changed from "generally not recommended" to "contraindicated" following a literature review. Updated guidance on contraindications and precautions associated with allergies is based on the guidance on Imvamune vaccine in those with allergic/immunocompromising conditions from the Canadian Society of Allergy and Clinical Immunology (CSACI) as of November 1, 2022.

Acknowledgements

The Public Health Agency of Canada (PHAC) would like to acknowledge Part 2 Working Group members J Bettinger (Working Group Chair), N Dayneka, S Deeks, R Warrington, K Top, B Law, B Seifert, J Gallivan, D Moore, R Pless, D Danoff, G Lacuesta, and D Fell for their contributions to the revision of this chapter. PHAC participants on the Part 2 Working Group include C Jensen, J Zafack, O Baclic, E Abrams and R Krishnan.

Selected references

• Canadian Society of Allergy and Clinical Immunology. IMVAMUNE (Monkeypox/Smallpox) vaccine in those with allergic/immunocompromising conditions: Guidance for allergists/immunologists from the CSACI. Accessed November 2022 at: https://canadiansocietyofallergyandclinicalimmunology.wildapricot.org/resources/CSACI%20Imvamune%20Statement.pdf
• Centers for Disease Control and Prevention. Chart of Contraindications and Precautions to Commonly Used Vaccines. Accessed February 2017 at: http://www.cdc.gov/vaccines/hcp/admin/contraindications-vacc.html
• Centers for Disease Control and Prevention. The Pink Book: Epidemiology and Prevention of Vaccine Preventable Diseases. 13th ed.; 2015.Accessed February 2017 at: http://www.cdc.gov/vaccines/pubs/pinkbook/genrec.html
• Clarke AE, Elliott SJ, St. Pierre Y, Soller L. La Vieille S, Ben-Shoshan M. Temporal trends in prevalence of food allergy in Canada. J Allergy Clin Immunol Pract 2019: 8(4): 1428-1430.e5.
• Committee to Advise on Tropical Medicine and Travel. Statement for yellow fever vaccine. Can Comm Dis Rep 2013;39(ACS-2). Accessed December 2019 at: https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2013-39/statement-travellers-yellow-fever.html
• Crawford NW, McMinn A, Royle J, Lazzaro T, Danchin M, Perrett KP, Buttery J, Elia S, Orr K, Wood N. Recurrence risk of a hypotonic hyporesponsive episode in two Australian specialist immunisation clinics. Vaccine 36 (2018): 6152-6157.
• Dreskin et al Interantional Consensus (ICON): allergic reactions to vaccines World Allergy Organization J (2016) 9:32.
• Greenhawt M et al. The risk of allergic reaction to SARS-CoV-2 vaccines and recommended evaluation and management: A systematic review, meta-analysis, GRADE assessment, and international consensus approach. J Allergy Clin Immunol Pract 2021;9: 3546-3567.
• Kelso JM, Greenhawt M, Li JT. Task force report: Adverse reactions to vaccines practice parameter 2012 update. J Allergy Clin Immunol. 2012; 130 (1): 25-43.
• Kessel A et al. Safe administration of the Pfizer-BioNtTech COVID-19 vaccine following an immediate reaction to the first dose. Allergy 2021;76: 3538-3540 (PMID: 34370884).
• Khakoo GA, Lack G. Recommendations for using MMR vaccine in children allergic to eggs. Br Med J 2000;320:929-32.
• Krantz MS et al. Safety evaluation of the second dose of messenger RNA COVID-19 vaccines in patients with immediate reactions to the first dose. JAMA Intern Med 2021;181: 1530-1533 (PMID:34309623).
• Krantz MS et al. Anaphylaxis to the first dose of mRNA SARS-CoV-2 vaccines: Don't give up on the second dose! Allergy 2021;76: 2916-2920 (PMID:34028041).
• Kwong JC, Vasa PP, Campitelli MA, et al. Risk of Guillain-Barré syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study. Lancet Infect Dis. 2013;13(9):769-76.
• National Advisory Committee on Immunization. Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2018-2019. Accessed December 2019 at: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2018-2019.html
• Top KA, Billard M-N, Gariepy M-C, Rouleau I, Pernica JM, Pham-Huy A, Quach C, Tran D, Vaudry W, Dobson S, Boucher FD, Carignan A, Jadavji T, Mconnell A, McNeil SA, Halperin SA, DeSerres G. Immunizing patients with adverse events after immunization and potential contraindications to immunization. Pediatric Infectious Disease Journal. 2016;35:e384-e391.
• Zafack JG, DeSerres G, Kiely M et al. Risk of recurrence of adverse events following immunization: a systematic review. Pediatrics 2017; 140(3): e320163707.
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