Contraindications and Precautions

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Updates

Major changes to the best practice guidance in this section include 1) enhancement of the definition of a “precaution” to include any condition that might confuse diagnostic accuracy and 2) recommendation to vaccinate during a hospitalization if a patient is not acutely moderately or severely ill.

 

General Principles

Contraindications (conditions in a recipient that increases the risk for a serious adverse reaction) and precautions to vaccination are conditions under which vaccines should not be administered. Because the majority of contraindications and precautions are temporary, vaccinations often can be administered later when the condition leading to a contraindication or precaution no longer exists. A vaccine should not be administered when a contraindication is present; for example, MMR vaccine should not be administered to severely immunocompromised persons (1). However, certain conditions are commonly misperceived as contraindications (i.e., are not valid reasons to defer vaccination).

National standards for pediatric vaccination practices have been established and include descriptions of valid contraindications and precautions to vaccination (2). Persons who administer vaccines should screen patients for contraindications and precautions to the vaccine before each dose of vaccine is administered (Table 4-1). Screening is facilitated by consistent use of screening questionnaires, which are available from certain state vaccination programs and other sources (e.g., the Immunization Action Coalition).

Severely immunocompromised persons generally should not receive live vaccines (3). Because of the theoretical risk to the fetus, women known to be pregnant generally should not receive live, attenuated virus vaccines (4). Persons who experienced encephalopathy within 7 days after administration of a previous dose of pertussis-containing vaccine not attributable to another identifiable cause should not receive additional doses of a vaccine that contains pertussis (4, 5). Severe Combined Immunodeficiency (SCID) disease and a history of intussusception are both contraindications to the receipt of rotavirus vaccines (6).

A precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the ability of the vaccine to produce immunity (e.g., administering measles vaccine to a person with passive immunity to measles from a blood transfusion administered up to 7 months prior) (7). A person might experience a more severe reaction to the vaccine than would have otherwise been expected; however, the risk for this happening is less than the risk expected with a contraindication. In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction.

The presence of a moderate or severe acute illness with or without a fever is a precaution to administration of all vaccines (Table 4-1). The decision to administer or delay vaccination because of a current or recent acute illness depends on the severity of symptoms and etiology of the condition. The safety and efficacy of vaccinating persons who have mild illnesses have been documented (8-11). Vaccination should be deferred for persons with a moderate or severe acute illness. This precaution avoids causing diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination or superimposing adverse effects of the vaccine on the underlying illness. After they are screened for contraindications, persons with moderate or severe acute illness should be vaccinated as soon as the acute illness has improved. Studies indicate that failure to vaccinate children with minor illnesses can impede vaccination efforts (12–14). Among persons whose compliance with medical care cannot be ensured, use of every opportunity to administer appropriate vaccines is critical.

Hospitalization should be used as an opportunity to provide recommended vaccinations. Health-care facilities are held to standards of offering influenza vaccine for hospitalized patients, so providers are incentivized to vaccinate these patients at some point during hospitalization (15). Likewise, patients admitted for elective procedures will not be acutely ill during all times during their hospitalization. Most studies that have explored the effect of surgery or anesthesia on the immune system were observational, included only infants and children, and were small and indirect, in that they did not look at the immune effect on the response to vaccination specifically (16-35). They do not provide convincing evidence that recent anesthesia or surgery significantly affect response to vaccines. Current, recent, or upcoming anesthesia/surgery/hospitalization is not a contraindication to vaccination (16-35). Efforts should be made to ensure vaccine administration during the hospitalization or at discharge. For patients who are deemed moderately or severely ill throughout the hospitalization, vaccination should occur at the earliest opportunity (i.e., during immediate post-hospitalization follow-up care, including home or office visits) when patients’ clinical symptoms have improved.

A personal or family history of seizures is a precaution for MMRV vaccination; this is because a recent study found an increased risk for febrile seizures in children 12-23 months who receive MMRV compared with MMR and varicella vaccine (36).

Clinicians or other health-care providers might misperceive certain conditions or circumstances as valid contraindications or precautions to vaccination when they actually do not preclude vaccination (2) (Table 4-2). These misperceptions result in missed opportunities to administer recommended vaccines (37).

Routine physical examinations and procedures (e.g., measuring temperatures) are not prerequisites for vaccinating persons who appear to be healthy. The provider should ask the parent or guardian if the child is ill. If the child has a moderate or severe illness, the vaccination should be postponed.

TABLE 4-1. Contraindications and precautions^(a) to commonly used vaccines

Vaccine	Citation	Contraindications	Precautions
DT, Td	(4)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	GBS <6 weeks after previous dose of tetanus-toxoid–containing vaccine History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid—containing or tetanus-toxoid–containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid-containing vaccine Moderate or severe acute illness with or without fever
DTaP	(38)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Encephalopathy (e.g., coma, decreased level of consciousness,  prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP or DTaP	Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy; defer DTaP until neurologic status clarified and stabilized Temperature of ≥105°F (≥40.5°C) within 48 hours after vaccination with a previous dose of DTP or DTaP Collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours after receiving a previous dose of DTP/DTaP Seizure ≤3 days after receiving a previous dose of DTP/DTaP Persistent, inconsolable crying lasting ≥3 hours within 48 hours after receiving a previous dose of DTP/DTaP GBS <6 weeks after previous dose of tetanus-toxoid–containing vaccine History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid–containing or tetanus-toxoid–containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid–containing vaccine Moderate or severe acute illness with or without fever
Hepatitis A	(39)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Moderate or severe acute illness with or without fever
Hepatitis B	(40)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Hypersensitivity to yeast	Moderate or severe acute illness with or without fever
Hib	(41)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Age <6 weeks	Moderate or severe acute illness with or without fever
HPV	(42)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Pregnancy Moderate or severe acute illness with or without fever
IIV	(43)	Severe allergic reaction (e.g., anaphylaxis) after previous dose of influenza vaccine or to vaccine component.	GBS <6 weeks after a previous dose of influenza vaccine Moderate or severe acute illness with or without fever Egg allergy other than hives, e.g., angioedema, respiratory distress, lightheadedness, recurrent emesis; or required epinephrine or another emergency medical intervention (IIV may be administered in an inpatient or outpatient medical setting and under the supervision of a health care provider who is able to recognize and manage severe allergic conditions).
IPV	(44)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Pregnancy Moderate or severe acute illness with or without fever
LAIV(b)	(43)	Severe allergic reaction (e.g., anaphylaxis) after a vaccine component, including egg protein Concomitant use of aspiring or aspirin-containing medication in children and adolescents LAIV4 should not be administered to persons who have taken influenza antiviral medications within the previous 48 hours	GBS <6 weeks after a previous dose of influenza vaccine Asthma in persons aged 5 years old or older Medical conditions which might predispose to higher risk of complications attributable to influenza(c) Moderate of severe acute illness with or without fever
MenACWY	(45)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Moderate or severe acute illness with or without fever
MenB	(46, 47)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Moderate or severe acute illness with or without fever
MMR(d),(e)	(1)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Pregnancy Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy(f) or patients with HIV infection who are severely immunocompromised) Family history of altered immunocompetence	Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product) History of thrombocytopenia or thrombocytopenic purpura Need for tuberculin skin testing or interferon-gamma release assay (IGRA) testing(g) Moderate or severe acute illness with or without fever
MPSV4	(48)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Moderate or severe acute illness with or without fever
PCV13	(49)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose of PCV13 or any diphtheria-toxoid–containing vaccine or to a component of a vaccine (PCV13 or any diphtheria-toxoid–containing vaccine)	Moderate or severe acute illness with or without fever
PPSV23	(50)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component	Moderate or severe acute illness with or without fever
RIV	(43)	Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine	GBS <6 weeks after a previous dose of influenza vaccine Moderate or severe acute illness with or without fever
Rotavirus	(6)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component SCID History of intussusception	Altered immunocompetence other than SCID Chronic gastrointestinal disease(h) Spina bifida or bladder exstrophy(h) Moderate or severe acute illness with or without fever
Tdap	(51)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Encephalopathy (e.g., coma, decreased level of consciousness,  prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP, DTaP, or Tdap	GBS <6 weeks after a previous dose of tetanus-toxoid–containing vaccine Progressive or unstable neurological disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid—containing or tetanus-toxoid–containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid–containing vaccine Moderate or severe acute illness with or without fever
Varicella(d),(e)	(52)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency,  long-term immunosuppressive therapy(f) or patients with HIV infection who are severely immunocompromised)(e) Pregnancy Family history of altered immunocompetence	Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product) Moderate or severe acute illness with or without fever Receipt of specific antiviral drugs (acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination (avoid use of these antiviral drugs for 14 days after vaccination)
Zoster	(53)	Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency,  long-term immunosuppressive therapy(f) or patients with HIV infection who are severely immunocompromised)(e) Pregnancy	Moderate or severe acute illness with or without fever Receipt of specific antiviral drugs (acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination (avoid use of these antiviral drugs for 14 days after vaccination)

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TABLE 4-2. Conditions incorrectly perceived as contraindications to vaccination (i.e., vaccines may be given under these conditions)

Vaccine	Conditions commonly misperceived as contraindications
General for all vaccines, including DTaP, pediatric DT, adult Td, adolescent-adult Tdap, IPV, MMR, Hib, hepatitis A, hepatitis B, varicella, rotavirus, PCV13, IIV, LAIV, PPSV23, MenACWY, MPSV4, HPV, and herpes zoster	Mild acute illness with or without fever Mild to moderate local reaction (i.e., swelling, redness, soreness); low-grade or moderate fever after previous dose Lack of previous physical examination in well-appearing person Current antimicrobial therapy(a) Convalescent phase of illness Preterm birth (hepatitis B vaccine is an exception in certain circumstances)(b) Recent exposure to an infectious disease History of penicillin allergy, other nonvaccine allergies, relatives with allergies, or receiving allergen extract immunotherapy History of GBS(c)
DTaP	Fever of <105°F (<40.5°C), fussiness or mild drowsiness after a previous dose of DTP/DTaP Family history of seizures Family history of sudden infant death syndrome Family history of an adverse event after DTP or DTaP administration Stable neurologic conditions (e.g., cerebral palsy, well-controlled seizures, or developmental delay)
Hepatitis B	Pregnancy Autoimmune disease (e.g., systemic lupus erythematosus or rheumatoid arthritis)
HPV	Immunosuppression Previous equivocal or abnormal Papanicolaou test Known HPV infection Breastfeeding History of genital warts
IIV	Nonsevere (e.g., contact) allergy to latex, thimerosal, or egg Concurrent administration of Coumadin (generic: warfarin) or aminophylline
IPV	Previous receipt of ≥1 dose of oral polio vaccine
LAIV	Health-care providers that see patients with chronic diseases or altered immunocompetence (an exception is providers for severely immunocompromised patients requiring care in a protected environment) Breastfeeding Contacts of persons with chronic disease or altered immunocompetence (an exception is contacts of severely immunocompromised patients requiring care in a protected environment)
MMR(d),(e)	Positive tuberculin skin test Simultaneous tuberculin skin or interferon-gamma release assay (IGRA) testing(f) Breastfeeding Pregnancy of recipient’s mother or other close or household contact Recipient is female of child-bearing age Immunodeficient family member or household contact Asymptomatic or mildly symptomatic HIV infection Allergy to eggs
PPSV23	History of invasive pneumococcal disease or pneumonia
Rotavirus	Prematurity Immunosuppressed household contacts Pregnant household contacts
Tdap	History of fever of ≥105°F (≥40.5°C) for <48 hours after vaccination with a previous dose of DTP or DTaP History of collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours after receiving a previous dose of DTP/DTaP History of seizure <3 days after receiving a previous dose of DTP/DTaP History of persistent, inconsolable crying lasting >3 hours within 48 hours after receiving a previous dose of DTP/DTaP History of extensive limb swelling after DTP/DTaP/Td that is not an Arthus-type reaction History of stable neurologic disorder History of brachial neuritis Latex allergy that is not anaphylactic Breastfeeding Immunosuppression
Varicella	Pregnancy of recipient’s mother or other close or household contact Immunodeficient family member or household contact(g) Asymptomatic or mildly symptomatic HIV infection Humoral immunodeficiency (e.g., agammaglobulinemia)
Zoster	Therapy with low-dose methotrexate (≤0.4 mg/kg/week), azathioprine (≤3.0 mg/kg/day), or 6-mercaptopurine (≤1.5 mg/kg/day) for treatment of rheumatoid arthritis, psoriasis, polymyositis, sarcoidosis, inflammatory bowel disease, or other conditions Health-care providers of patients with chronic diseases or altered immunocompetence Contacts of patients with chronic diseases or altered immunocompetence Unknown or uncertain history of varicella in a U.S.-born person

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