Page 3: Canadian Immunization Guide: Part 2 - Vaccine Safety

Contraindications, Precautions and Concerns

Introduction

There are a number of reasons for not giving vaccines. Sometimes vaccines cannot be given or need to be delayed due to contraindications or precautions. Other times people have unfounded concerns that lead to hesitation to get vaccination when there is no increased risk for vaccination. It is critical for vaccine providers to distinguish among these different reasons.

This chapter defines contraindications and precautions and highlights contraindications and precautions contained in other chapters in the Canadian Immunization Guide. It also identifies common concerns and provides information to assist vaccine providers in responding to those concerns. In most cases, these concerns can be addressed with information and reassurance. This chapter is meant to be a user friendly guide to aid in determining whether a particular condition is a contraindication to vaccination, a precaution or a common concern that need not postpone or prevent vaccination.

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 the potential harm, or when reduced vaccine immunogenicity may still result in significant benefit to a susceptible, immunocompromised host.

Some precautions and contraindications depend on whether a vaccine is an attenuated live product or an inactivated product. Refer to the Contents of Immunizing Agents Available for Use in Canada in Part 1 . For complete vaccine-specific contraindications and precautions, consult the relevant chapter in the Canadian Immunization Guide, the product leaflet, or information contained within the vaccine's product monograph available through Health Canada's Drug Product Database.

Contraindications and precautions

Vaccine providers should question all clients about their 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. Refer to Vaccine Administration Practices in Part 1 for additional information.

The following is a summary of some of the common contraindications and precautions.

Anaphylactic reaction to a vaccine or a component of a vaccine

A vaccine is contraindicated in a person with a history of anaphylaxis after previous administration of the same vaccine and in a person with proven immediate or anaphylactic hypersensitivity to any component of the vaccine (with the exception of egg allergy) or its container. 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 allergist is advised.

Asthma, severe

Asthma should be optimized before giving any vaccine. LAIV should not be administered to individuals with severe asthma (defined as currently on oral or high dose inhaled glucocorticosteriods or active wheezing) or those with medically attended wheezing in the seven days prior to vaccination. LAIV can be used in stable, non-severe asthmatics.

Congenital malformation of gastrointestinal tract or history of intussusception

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

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

Cases of GBS or polyneuritis have been reported following administration of tetanus toxoid-containing vaccine and there has been one case report of relapsing GBS following each of three doses of vaccine. However, population studies have not supported a causal association. Cases of GBS or polyneuritis have also been reported following receipt of diphtheria toxoid-containing vaccine. While some evidence favours a causal relationship between tetanus toxoid and GBS, there is little evidence to support an independent association between receipt of diphtheria toxoid and GBS. Persons who develop GBS within 6 weeks of receipt of tetanus toxoid-containing vaccine should not receive a further dose. Those who develop GBS outside the 6-week interval may receive subsequent doses of the vaccine. If there is a history of both Campylobacter infection (which has been associated with GBS) and receipt of a tetanus and diphtheria toxoid-containing vaccine within the 6 weeks before the onset of GBS, consultation with an infectious disease specialist is advised.

In a review of studies between 1976 and 2005, the United States Institute of Medicine concluded that the 1976 swine flu vaccine was associated with an elevated risk of Guillain-Barré Syndrome (GBS). However, evidence was inadequate to accept or reject a causal relation between GBS in adults and seasonal influenza vaccination. More recent studies suggest that the absolute risk of GBS in the period following seasonal and A(H1N1)pdm09 influenza vaccination is about one excess case per 1 million vaccines. The risk of GBS associated with influenza vaccination must be balanced against the risk of GBS associated with influenza infection itself. In general, it is recommended to avoid subsequent influenza vaccination of persons known to have had GBS within six weeks of a previous influenza vaccination.

Immunocompromised persons

Refer to Immunization of Immunocompromised Persons in Part 3 for further information.

Pregnancy

In general, live vaccines are contraindicated in pregnancy, as there is a theoretical risk to the fetus; however, there are circumstances in which vaccination with a live vaccine may be considered.

In general, routine inactivated vaccines may be administered to pregnant women, if indicated. HPV vaccine is not recommended for use in pregnancy although no adverse outcomes of pregnancy or adverse events to the developing fetus have been reported.

Tuberculosis, active, untreated

MMR, MMRV, varicella, and herpes zoster vaccines are contraindicated in individuals with active, untreated tuberculosis as a precautionary measure. Although tuberculosis may be exacerbated by natural measles infection, there is no evidence that measles or varicella-containing vaccines have such an effect. BCG vaccine is contraindicated for individuals with a positive tuberculin skin test, although immunization of tuberculin reactors has occurred frequently without complications.

Table 1 summarizes common contraindications and selected precautions for inactivated and live vaccines. Vaccine-specific contraindications and precautions are contained in the relevant chapters in Part 4. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for a detailed list of inactivated and live vaccines and their contents.

Table 1: Contraindications and selected precautions for vaccine administration for inactivated and live vaccines
Contraindications and selected precautions Type of vaccine Comments
Inactivated Live
Anaphylaxis: Anaphylaxis after previous dose of a vaccine Contraindicated if receiving the same vaccine Contraindicated if receiving the same vaccine Refer to Early Vaccine Reactions Including Anaphylaxis in Part 2.
Anaphylaxis: ProvenTable 1 - Footnote 2 immediate or anaphylactic hypersensitivity to any component of the vaccine or its container (e.g., latex) Contraindicated if receiving vaccine containing the same componentTable 1 - Footnote 3 Contraindicated if receiving vaccine containing the same componentTable 1 - Footnote 3
Asthma, severeTable 1 - Footnote 4

No contraindication

Subjects anchored within this pageTable 1 - Footnote 1

LAIV contraindicated for individuals with severe asthmaTable 1 - Footnote 4 or those with medically attended wheezing in the 7 days prior to vaccination.

Asthma control should be optimized prior to any vaccine.

Refer to Influenza Vaccine in Part 4.

Congenital malformation of gastrointestinal tract, uncorrected No contraindication or precautionTable 1 - Footnote 1 Rotavirus vaccine contraindicated due to increased risk of intussusception.
Guillain-Barre Syndrome within 6 weeks of receiving a vaccine Generally contraindicated if receiving the same vaccine. For influenza vaccine, the risk of GBS associated with influenza vaccination must be balanced against the risk of GBS associated with influenza infection itself.Table 1 - Footnote 5 Generally contraindicated if receiving the same vaccine. For influenza vaccine, the risk of GBS associated with influenza vaccination must be balanced against the risk of GBS associated with influenza infection itself.Table 1 - Footnote 5 Refer to vaccine-specific chapters in Part 4
Immunocompromised persons Refer to Immunization of Immunocompromised Persons in Part 3

Refer to Immunization of Immunocompromised Persons in Part 3

Intussusception, past history No contraindication or precautionTable 1 - Footnote 1 Rotavirus vaccine contraindicated
Pregnancy Generally no contraindications for routine vaccinesTable 1 - Footnote 1 Generally contraindicated Refer to Immunization in Pregnancy and Breastfeeding in Part 3.
Precaution - HPV vaccine (due to lack of data)
Tuberculosis, active, untreated No contraindications for routine vaccinesTable 1 - Footnote 1 MMR, MMRV, univalent varicella, herpes zoster, and BCG vaccines contraindicated Refer to vaccine-specific chapters in Part 4.

Common conditions and concerns

There are a number of conditions that may be raised as a concern about receiving a vaccine, that in fact should not delay or preclude immunization. For example, routine administration of vaccines should not be postponed in persons with minor illnesses, such as an upper respiratory tract infection, otitis media, mild gastrointestinal illness, or concurrent antibiotic therapy. Repeated infectious illnesses are common in early childhood and will not interfere with the efficacy of vaccines. Generally, if a person is well enough to present for immunization in the outpatient setting, he/she is well enough to be immunized.

Opportunities for immunization should not be lost because of unfounded concerns. Information and reassurance can generally allay reservations about receiving vaccines in these circumstances. The following identifies some of the common concerns and implications for immunization.

Acute illness (with or without fever)

In general, people with minor or moderate acute illness may receive vaccines. There is no increase in risk of adverse events following immunization and no interference with response to vaccine. There are three exceptions -

  • If significant nasal congestion is present that might impede delivery of LAIV to the nasopharyngeal mucosa, TIV can be administered or LAIV could be deferred until resolution of the illness.
  • In infants with moderate-to-severe gastroenteritis, rotavirus vaccine should be deferred until the condition improves unless deferral will result in scheduling of the first dose beyond the recommended age limit.
  • Administration of oral cholera and travellers' diarrhea vaccine should be postponed in persons with acute gastrointestinal illness.

The risks and benefits of vaccinating a severely ill person need to be carefully assessed. The benefits of protection in a high risk exposure situation or when the window of opportunity is short (i.e., when travel or immunocompromise are imminent) need to be assessed against the risks that a vaccine-related adverse event (particularly fever) could complicate the management of the person. 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 strongly recommended in this situation.

Adverse event following previous immunization

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

Extensive limb swelling following immunization

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 systemic adverse events. A large injection site reaction may occur in a child after the fourth or fifth dose of a diphtheria toxoid-tetanus toxoid-acellular pertussis-containing vaccine. The presence of a large injection site reaction to a previous dose is not a contraindication to continuing the recommended schedule.
Severe injection site reactions occasionally occur in adults following receipt of diphtheria toxoid-tetanus toxoid-containing vaccine (Td). Further routine doses of Td vaccine should not be given for at least 10 years.

Hypotonic-hyporesponsive episode (HHE) following immunization

HHE may occur following immunization with pertussis-containing vaccine but occurs less frequently following receipt of current acellular pertussis-containing vaccines. There is evidence that there are no adverse consequences to these events.

Febrile seizure or syncope following immunization

Parents may hesitate to have their child have a vaccine if he/she had a history of a post-immunization febrile seizure. Likewise, people may hesitate to have a vaccine if they had an episode of syncope following a previous vaccine (such as may occur with HPV vaccine in a young girl).

Vaccines are safe to given when there is a history of a febrile seizure. For MMR vaccine for example, the risk of febrile seizures within 2 weeks following MMR vaccination was 1.56 per 1000 children overall, 3.97 per 1000 for siblings of children with a history of febrile seizures, and 19.47 per 1000 for children with a personal history of febrile seizures. This means when a child has a history of a febrile seizure 98% will not have a febrile seizure following an MMR vaccine. Children with a history of febrile seizures have no increased risk of developing a seizure disorder, such as epilepsy. Oral analgesics/antipyretics (such as acetaminophen or ibuprofen) can be used for treatment of minor adverse reactions such as fever or injection site discomfort that might occur following vaccination. There is no evidence that antipyretics prevent febrile seizures.

Vaccines are safe to give when there is a history of fainting after a vaccine. 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. Refer to Vaccine Administration Practices in Part 1 for additional information.

Inconsolable crying following immunization

Persistent or inconsolable crying and an unusual, high-pitched cry (most typically after pertussis vaccination) are not associated with any sequelae and are likely to be pain responses at the site of injection in young infants. Refer to Vaccine Administration Practices in Part 1 for comfort measures that can be taken.

Ocular-respiratory syndrome (ORS)

Oculo-respiratory syndrome is a usually transient condition characterized by bilateral conjunctivitis, facial edema, and upper respiratory symptoms that has been known to occur primarily after receiving influenza immunization. Symptoms typically appear 2 to 24 hours after vaccination and resolve within 48 hours of onset. If ORS occurred with lower respiratory symptoms, subsequent influenza vaccine is contraindicated. Refer to Influenza vaccine in Part 4 for additional information.

Allergies

A history of allergies is one of the most common concerns that people have about 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. An immediate hypersensitivity reaction usually occurs within moments or up to one hour after vaccine. It is IgE mediated (Type 3) and can be either mild (e.g. hives) or severe, such as anaphylaxis. Refer to Early Vaccine Reactions Including Anaphylaxis in Part 2 for additional information.

Delayed hypersensitivity reactions may appear several hours to days after immunization. These reactions include an Arthus or Type 3 reaction (a local vasculitis due to deposition of IgG-based immune complexes in dermal blood vessels) or more typically, a cell-mediated, delayed hypersensitivity or Type 4 reaction (typically a contact dermatitis). These are typically local reactions to a component of the vaccine.

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 experiencing severe injection site reactions should not receive further routine doses of Td vaccine for at least 10 years.

On close questioning, it may become evident that people think they have an allergy to a vaccine or vaccine component but it is not an allergy. Most adverse skin events associated with vaccines, for example, are simply a normal inflammatory response to a foreign substance. As these inflammatory reactions are not related to allergy, patients can receive subsequent vaccinations safely. People can be reassured if they have a mild hypersensitivity reaction, such as a contact dermatitis from either the vaccine or one of its components. People with a suspected moderate to severe hypersensitivity reaction, should be referred to an allergist for further testing. Suspected hypersensitivity should not be an ongoing reason to not administer vaccine. It should be investigated by an allergist to clarify whether the person may proceed with vaccination or not.

Egg allergy

Anaphylactic egg allergy is rare. People with egg allergy may be immunized with influenza, MMR or MMRV vaccines in the routine manner. The amount of egg protein in these vaccines have been found to be insufficient to cause an allergic reaction in egg-allergic individuals; individuals may be vaccinated without skin testing and with the full dose, irrespective of a past severe reaction to egg. Referral to a specialist with expertise in allergies may be necessary in occasional circumstances where there is strong concern about proceeding with the recommendation above.

Other allergies

People may report an allergy to a number of vaccine components, such as gelatin, latex, neomycin or thimerosol. Anaphylactic reactions to these components are extremely rare. When mild hypersensitivity reactions occur, vaccines that are administered subcutaneously or intramuscularly are generally safe. A thimerosol allergy is extremely rare. If there is a documented history of a delayed hypersensitivity reaction to thimerosal (such as a large local reaction or an eczematous rash), immunization with thimerosal-containing vaccines can proceed. In the rare instance of individuals with proven delayed hypersensitivity to thimerosol, 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. Refer to Table 2 and Contents of Immunizing Agents Available for Use in Canada in Part 1 for additional information.

Bleeding disorder

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 use of a small gauge needle and apply pressure for 5-10 minutes after the immunization. Refer to Immunization of Persons with Chronic Diseases in Part 3.

Breastfeeding

Following routine immunization of either a mother or her infant during breastfeeding there is no reduction in maternal or infant response to vaccines and no increase in the risk of adverse events for either mother or infant. There is some evidence that breastfeeding may have a beneficial effect in infants after vaccination and is associated with less fever and pain. BCG, smallpox and yellow fever vaccines are generally contraindicated in breastfeeding women but may be considered in high-risk situations.

Concerns about immunization

Concern about exposure to too many antigens

Parents often have a concern about exposing their young child to too many antigens when multiple vaccines are recommended at one time. It is useful to identify that the human immune system has an enormous capacity to respond to antigens; infants can respond to about 10,000 different antigens at any one time - and may do so when crawling on the floor. Immunization does not significantly add to the vaccinee's daily exposure to antigens. The vaccines given to young infants in Canada engage less than 0.01% of an infant's immune response capacity. Generally, vaccinees have similar immune responses whether vaccines are given at the same time or at different visits. Concomitant administration of most routine vaccines at the same visit does not result in increased rates of adverse reaction.

Concern about multiple injections

Routine administration of all age-appropriate doses of vaccines simultaneously is recommended for children without contraindications. There are no contraindications to giving multiple injections at the same visit and all opportunities to immunize should be utilized. Live viral vaccines given by injection may be either given concomitantly or a minimum interval of 4 weeks apart to address the hypothetical risk of interference from the vaccine given first on the vaccine given later. Generally if two live parenteral vaccines are indicated, it is preferable to them concomitantly to avoid the need for a follow up visit. Concomitant administration of vaccines may be critical when preparing for international travel. Refer to recently administered live viral vaccines.

People may need to be reassured that concomitant administration of most routine vaccines at the same visit does not result in decreased antibody responses or increased rates of adverse reaction. Giving multiple vaccines at one visit helps to ensure that people are up to date with the vaccines required for their age and risk factors.

Concern about thimerosol

It is not unusual for people to voice concerns about thimerosol and the effect it can have on brain tissue. Thimerosol is used as a preservative in some vaccines, but not in a dose that would cause safety concerns. If no allergic history is present, there is no legitimate safety reason to avoid the use of thimerosol-containing products, for children or adults, including pregnant women

Concurrent medication, including biologics

Antibiotic therapy

Antibiotic therapy, does not interfere with response to inactivated vaccines or most live vaccines with the following exceptions: Live, oral typhoid vaccine should be delayed until 48 to 72 hours after receipt of the last dose of antibiotics active against Salmonella typhi. 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 safely immunized through either the intramuscular or subcutaneous route (as recommended for the vaccine product)without discontinuation of anticoagulation therapy. Give intramuscular administration with a small gauge needle (23 gauge or smaller) and apply firm pressure to the injection site for 5 to 10 minutes. There is a paucity of evidence on whether there is an increased risk of bleeding complications following immunization with the newer types of anticoagulants, such as antiplatelet agents, but there is no reason to believe that they need to be treated any differently from those receiving other anticoagulants.

Antiviral therapy

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

  • Varicella vaccine and herpes zoster vaccine 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 or herpes zoster 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 and zanamivir) 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 immune globulin or receipt of most blood products can interfere with the immune response to certain live vaccines. Measles-containing or varicella vaccines should be given at least 14 days prior to administration of an immune globulin preparation or blood product, or delayed until the antibodies in the immune globulin preparation or blood product have degraded. A risk-benefit assessment is needed for post-partum women who have received Rh immune globulin (RhIg) and require MMR or varicella vaccine (refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional information). Herpes zoster vaccine should be delayed until 3 months after a dose of intravenous immune globulin.

Salicylates

It is generally safe to be immunized when taking salicylates (acetylsalicylic acid, aspirin, or ASA) although some exceptions apply. 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. TIV is a good alternative. ASA-containing products should be delayed for 4 weeks after receipt of LAIV in children less than 18 years of age.

Another exception is varicella immunization. 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 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.

Neurologic disorder

There is no evidence of increased risk of adverse events following immunization in persons with neurologic disorders. Such persons may be at increased risk of complications from vaccine preventable diseases such as influenza and should be immunized appropriately with the exception of people who experience an episode of GBS with onset within 6 weeks after immunization.

Premature birth

Premature infants respond adequately to vaccines used in infancy and are not at significantly increased risk of adverse events. In general, immunize premature infants per the routine immunization schedule, according to child's chronological age with the exception of hepatitis B vaccination of preterm infants with a birth weight of less than 2,000 grams. The response to hepatitis B vaccine may be diminished in such infants; refer to Hepatitis B Vaccine in Part 4 for additional information. Hospitalized premature infants should have continuous cardiac and respiratory monitoring for 48 hours after their first immunization.

Skin Disorders

Vaccines are generally safe for people with skin disorders. For comfort, administer vaccine into non-affected area. There are two exceptions to this. Smallpox vaccine is contraindicated in those with eczema (atopic dermatitis) in non-outbreak situation; refer to Smallpox Vaccine in Part 4. BCG vaccine is contraindicated when there is extensive skin disease or burns; refer to Bacille Calmette-Guerin Vaccine in Part 4.

Table 2 provides a reader-friendly summary of common conditions and vaccine concerns that could be used as an educational tool when obtaining informed consent for immunization.

Table 2: Common conditions and vaccine concerns and implications for immunization
Condition or concern Implications for immunization -
Acute illness, minor (including upper respiratory infection, diarrhea)

SafeTable 2 - Footnote 1 with the following exceptions:

  • LAIV: If significant nasal congestion is present that might impede delivery of LAIV to the nasopharyngeal mucosa, TIV can be administered or LAIV could be deferred until resolution of the illness.
  • Rotavirus vaccine: If moderate-to-severe gastroenteritis, defer until condition improves unless deferral will result in scheduling of the first dose beyond the recommended age limit.Oral cholera vaccine: defer until acute gastrointestinal illness resolved.
  • Oral cholera and travellers' diarrhea vaccine should be postponed in persons with acute gastrointestinal illness
Acute illness, severe

Need to consider risk-benefit. Refer to Acute Illness in text.

Adverse event following previous immunization Extensive limb swelling following immunization

Safe, even when it crosses a joint.

Febrile seizure or syncope after previous immunization

Safe; refer to Vaccine Administration Practices in Part 1 for general precautions.

Hypotonic-hyporesponsive episode (HHE)

Safe; no long term consequences from an HHE episode.

Inconsolable crying

Safe; refer to Vaccine Administration Practices in Part 1 for general comfort measures.

Oculo-respiratory syndrome (ORS)

Safe except:

  • Influenza vaccine: contraindicated if ORS is present with lower respiratory involvement. Refer to Influenza Vaccine in Part 4.
Allergies Allergies, known

Safe for most non-anaphylactic allergies with the following considerations:

  • Vaccine components: If suspected hypersensitivity or non-anaphylactic allergy to vaccine components, investigation is indicated which may involve immunization in a controlled setting. Consultation with an allergist is advised.

Diphtheria toxoid or tetanus toxoid-containing vaccines: If there is a history of a severe Arthus-type reactions following diphtheria toxoid or tetanus toxoid-containing vaccines, recipients should not receive further routine doses of Td vaccine for at least 10 years. Refer to Table 1.

Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for lists of immunizing agents available for use in Canada and their contents.

Egg allergy

Anaphylactic egg allergy is rare. When present it is a contraindication to vaccines containing egg with the exception of influenza, MMR and MMRV vaccines.

Gelatin allergy

Generally safe. Most gelatin allergies are non-anaphylactic and gelatin-containing vaccines may be given.

Anaphylactic allergy to gelatin is extremely rare. For an anaphylactic allergy see Contraindications Table 1.

Latex allergy

Generally safe. 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.

Anaphylactic allergy to latex is very rare. For an anaphylactic allergy see Contraindications Table 1.

Neomycin allergy

Generally safe. 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.

For an anaphylactic allergy see Contraindications Table 1.

Thimerosal allergy

Generally safe. A local or delayed-type hypersensitivity reaction to thimerosal is not a contraindication to receipt of a vaccine that contains thimerosal.

Thimerosol allergy is extremely rare. In the rare instance of individuals with proven delayed hypersensitivity to thimerosol, they should be advised that long-lasting local or systemic cutaneous reactions can occur with repeat injection. They should report any reaction of concern following immunization so that it can be managed appropriately

For an anaphylactic allergy see Contraindications Table 1.

Bleeding disorder

Safe with the following measures:

  • Optimize control of bleeding disorder before immunization.
  • Give intramuscular administration with a small gauge needle (23 gauge or smaller) and apply firm pressure to the injection site for 5 to 10 minutes.

Refer to Immunization of Persons with Chronic Diseases in Part 3

Breastfeeding

Generally safe with the following considerations:

  • BCG vaccine: Exercise caution because it is not known whether BCG is excreted in human milk.
  • Japanese encephalitis vaccine: should only be given if the risk of disease outweighs the unknown risk of vaccination to the woman and her breastfeeding infant.
  • Yellow fever vaccine: Generally, breastfeeding mothers should not receive yellow fever vaccine.
  • Smallpox vaccine is contraindicated for breastfeeding mothers in non-outbreak situations; special precautions required if needed for post-exposure prophylaxis. Refer to Smallpox Vaccine in Part 4.

Refer to Immunization in Pregnancy and Breastfeeding in Part 3.

Concerns about immunization Exposure to too many antigens

Combination vaccines are safe. Most children are exposed to thousands of antigens a day.

Multiple injections

Multiple injections of vaccines are safe.

  • For live viral parenteral vaccines, it is preferable to give concomitantly (otherwise need to give at least 4 weeks apart).
  • Oral and intranasal live vaccines can be given at the same time as, or any time before or after, other live vaccines

Refer to Vaccine Administration Practices in Part 1 for measures to address potential anxiety and discomfort.

Vaccine contains thimerosal

Vaccines that contain thimerosal are safe in children, adults and during pregnancy

Concurrent medication, including biologics Antibiotic therapy

Generally safe with the following exceptions:

  • Live typhoid vaccine: Delay immunization if on antibiotics active against Salmonella typhi until 48 to 72 hours after last dose, refer to Typhoid Vaccine in Part 4.
  • BCG vaccine: Delay immunization if receiving antibiotic therapy active against mycobacteria (including quinolones), delay BCG immunization until antibiotic therapy completed. Refer to Bacille Calmette-Guerin Vaccine in Part 4.
Anticoagulation

Generally safe with the following considerations:

  • Give intramuscular administration with a small gauge needle (23 gauge or smaller) and apply firm pressure to the injection site for 5 to 10 minutes.

Less data for risk with newer anticoagulants such as antiplatelet agents.

Refer to Immunization of Persons with Chronic Diseases in Part 3

Antiviral therapy

Generally safe with the following exceptions:

  • LAIV, herpes zoster and varicella: Consider timing of administration if antiviral drug active against virus in vaccine. Recommended interval between these vaccines and antiviral drugs are vaccine and antiviral specific. Refer to vaccine specific chapters in Part 4.
Blood products containing antibodies (immunoglobulins; transfusion of reconstituted red blood cells, platelets or plasma)

Generally safe to give vaccine with the following exceptions:

  • MMR, varicella-containing vaccine or herpes zoster vaccine: Consider timing of vaccines; recommended interval between blood product and these vaccines are vaccine and blood product specific. Refer to Recent Administration of Human Immune Globulin Products in Part 1 and vaccine specific chapters in Part 4.
  • Risk benefit assessment is needed for post-partum women who have received Rh immune globulin (RhIg) and require MMR or varicella vaccine. Refer to Immunization in Pregnancy and Breastfeeding in Part 3.
Salicylates

Generally safe with the following exceptions:

  • LAIV:
    • If on salicylate therapy: LAIV is contraindicated.Table 2 - Footnote 2 Use TIV instead.
    • For intermittent salicylate use: In children and adolescents, avoid salicylates for 4 weeks after receiving LAIV.Table 2 - Footnote 2
  • Varicella-containing vaccine:
    • For chronic salicylate therapy: Varicella-containing vaccine may be considered with close monitoring
    • For intermittent salicylate use: Avoid salicylates for 6 weeks after receiving varicella-containing vaccine.Table 2 - Footnote 2

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

Inflammatory eye disease requiring steroid therapy

Generally safe with the following exception:

  • Smallpox vaccine: In a non-outbreak situation, defer svaccination until condition resolves or course of steroids completed. Refer to Smallpox Vaccine in Part 4.
Measles infection

Generally safe with the following exception:

Neurologic disorders History or family history of febrile seizure

Safe; refer to Vaccine Administration Practices in Part 1 for general precautionary measures.

History of Guillain-Barre Syndrome (GBS)

Safe unless GBS occurred within 6 weeks of receiving previous dose of same vaccine. See Contraindications Table 1.

History of syncopal episodes

Vaccinate in a safe environment which could include being vaccinated lying down, remaining seated in immunization clinic setting, and being accompanied when leaving clinic. Refer to Early Vaccine Reactions Including Anaphylaxis in Part 2 and Vaccine Administration Practices in Part 1.

Multiple Sclerosis (MS)

Safe

Premature birth

Vaccines are safe when given to infants who weighed 1500 grams or more at birth.Table 2 - Footnote 3 Refer to Immunization of Infants Born Prematurely in Part 3.

Skin disorder

Vaccines are generally safe; for comfort, administer vaccine into non-affected area. Smallpox vaccine is contraindicated in those with eczema (atopic dermatitis) in non-outbreak situation; refer to Smallpox Vaccine in Part 4.

If extensive skin disease or burns, BCG vaccine is contraindicated; refer to Bacille Calmette-Guerin Vaccine in Part 4.

Concerns about conditions in close contacts of vaccinees

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:

  • TIV is preferred over LAIV for those in close contact with severely immunocompromised persons.
  • If there are household contacts who have received live, oral polio vaccine in another country within the last 6 weeks, they should not have contact with immunocompromised persons.
  • 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
  • Smallpox vaccine should not be administered to household contacts of an immunocompromised person in a non-emergency situation.
  • Special precautions should be taken for unvaccinated pregnant household and other close contacts of persons receiving smallpox vaccine in order to eliminate viral transfer to these contacts.

Table 3 summarizes conditions in persons who may be in close contact with vaccinees and provides information for vaccine providers and vaccine recipients about the appropriateness and safety of vaccines in these circumstances.

Table 3: Conditions in close contacts of vaccinee
Condition in close contact SafeTable 3 - Footnote 1 to be immunized with the following exceptions -
Close contact is immunocompromised
  • TIV is preferred for household contacts of severely immunocompromised persons.
  • If LAIV received, vaccinee should avoid close association with severely immunocompromised person for at least 2 weeks.
  • Following varicella vaccine, if the 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
  • Live, oral polio vaccineTable 3 - Footnote 2 contraindicated.
  • If a household contact (traveller or immigrant) has received live, oral polio vaccine within the last 6 weeks; they should avoid contact with immunocompromised persons. Refer to Poliomyelitis Vaccine in Part 4.
  • Smallpox vaccine should not be administered to household contacts of an immunocompromised person in a non-emergency situation
  • Refer to Immunization of Immunocompromised Persons in Part 3.
Close contact is a neonate/infant
  • Defer smallpox vaccine (if non-outbreak situation). If smallpox vaccine is received, vaccine should avoid close contact with the neonate until the scab at the vaccination site falls off.
  • Refer to Immunization of Immunocompromised Persons in Part 3.
Close contact is a pregnant women
  • Defer smallpox vaccine (if non-outbreak situation)
  • If smallpox vaccine needed in an outbreak situation, avoid contact with the pregnant woman until the scab at vaccination site falls off.
  • Refer to Immunization in Pregnancy and Breastfeeding in Part 3.

Selected References

  • Centers for Disease Control and Prevention. An ounce of prevention…what are the returns? 1999;2nd ed. Accessed June 2012 at: http://www.cdc.gov/epo/prevent.htm
  • Centers for Disease Control and Prevention. Chart of Contraindications and Precautions to Commonly Used Vaccines. Accessed June 2012 at: http://www.cdc.gov/vaccines/hcp/admin/contraindications-vacc.html  
  • Centers for Disease Control and Prevention. General recommendations on immunization Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2011;60(RR-2):1-61.
  • Centers for Disease Control and Prevention. The Pink Book: Epidemiology and Prevention of Vaccine Preventable Diseases. 12th ed.; May 2012.Accessed June 2012 at: http://www.cdc.gov/vaccines/pubs/pinkbook/genrec.html
  • Centers for Disease Control and Prevention. Recommendations and Guidelines: Conditions Commonly Misperceived as Contraindications to Vaccination. Accessed June 2012 at: http://www.cdc.gov/vaccines/hcp/admin/contraindications-misconceptions.html
  • Ess SM, Szucs TD. Economic evaluation of immunization strategies. Clin Infect Dis 2002;35:294-97.
  • Halperin BA, Eastwood BJ, Halperin SA. Comparison of parental and health care professional preferences for the acellular or whole cell pertussis vaccine. Pediatr Infect Dis J 1998;17(2):103-9.
  • National Advisory Committee on Immunization. ADDENDUM – LAIV Use in Egg Allergic Individuals-Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2016-2017. Accessed September 2016 at: http://www.phac-aspc.gc.ca/naci-ccni/flu-2016-grippe-addendum-eggs-oeufs-eng.php
  • Tengs TO, Adams ME, Pliskin JS. Five hundred live-saving interventions and their cost-effectiveness. Risk Analysis 1995;15(3):369-90.
  • United States Food and Drug Administration. Code of Federal Regulations. Title 21 - Food and Drugs. Chapter 1 - Food and Drug Administration. Department of Health and Human Services.Sec 600.3. Revised April 1, 2012. Accessed February 2013 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=600.3
  • Vestergaard M, Hviid A, Madsen KM, Wohlfahrt J, Thorsen P, Schendel D, Melbye M, Olsen J. MMR vaccination and febrile seizures: evaluation of susceptible subgroups and long-term prognosis. JAMA. 2004 Jul 21;292(3):351-7.
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