What information can be provided regarding expected adverse effects for H.P.?
Adverse reactions to inactivated vaccines include pain at the injection site and
fever within 48 to 72 hours of administration.
In contrast, adverse effects from
live attenuated vaccines occur 7 to 10 days after immunization, after the virus has
replicated and the immune system has responded. Adverse reactions to live
attenuated vaccines mimic the symptoms of disease. Transient rash occurs in 5% of
patients receiving measles, mumps, rubella (MMR) immunizations, and a mild
varicella-like rash (median of five lesions) occurs in fewer than 5% of patients
receiving the varicella vaccine. Syncope, usually occurring within 30 minutes of
immunization, has been reported, with 70% of syncopal episodes occurring within 15
minutes of immunization, and occurs more commonly in female patients and
Although anaphylactic reactions to vaccines are rare, an allergic reaction may
occur as a result of specific allergy to the vaccine itself or to trace components in the
vaccine (e.g., preservatives, antibiotics).
18 Patients with egg allergy can receive
vaccines produced in chick-embryo-fibroblast tissue culture (e.g., MMR) because the
risk for serious reaction to these vaccines in egg-allergic individuals is very low.
MMR should be used cautiously in individuals with a history of a severe reaction to
gelatin, which is a stabilizer in the MMR vaccine. Trace amounts of streptomycin,
bacitracin, and neomycin are present in oral polio virus vaccine, inactivated polio
vaccine, and MMR; therefore, these vaccines should not be administered to
individuals with a history of an anaphylactic reaction to these antibiotics.
Overall, vaccinations are safe, especially when compared with the risks of the
diseases that these vaccines prevent, and the safety of immunizations are scrutinized
In response to concerns about vaccine safety, the National Vaccine
Injury Compensation Act mandated an ongoing review of evidence regarding the
possible adverse effects of vaccines and established a no-fault injury compensation
program for selected vaccines.
Misconceptions about contraindications and precautions for immunization often result
in missed opportunities to provide needed immunizations.
illness; history of anaphylaxis to the vaccine or vaccine components; and history of a
severe reaction to an immunization are clear contraindications to immunizations.
Immunizations, however, should not be delayed in a patient who has a minor illness
(e.g., upper respiratory tract infection, otitis media, diarrhea) even in the presence of
a low-grade fever. A family history of seizures, allergies, and sudden infant death
syndrome are not contraindications for immunizations. Immunization of a patient with
a history of anaphylaxis to a vaccine or vaccine component should be withheld until
he or she has undergone desensitization. Preterm infants should begin to receive
routine immunizations based on their chronological age for all vaccines, although
initiation of the hepatitis B series should begin at 1 month of age.
Allergic reaction to previous exposure to vaccine components,
immunosuppression (e.g., immunosuppressive therapy, immunodeficiencies),
encephalopathy, recent administration of blood products, and pregnancy (although the
risk in pregnancy is largely theoretical) are contraindications to live attenuated virus
or live bacterial vaccines. Pooled blood products (e.g., immunoglobulins, packed red
blood cells, platelet transfusions) can impair the immune response to a live vaccine
because these products contain antibodies, which can prevent one’s immune system
from mounting an adequate response.
1 The impairment of an immune response to an
immunization varies, depending on the type and amount of blood product
administered, and immunizations may need to be delayed for up to 12 months if
pooled blood products have been administered recently.
immune response, antibody titers can be obtained to determine if a patient needs to be
Vaccines Recommended Regimens Comment
Diphtheria, tetanus, pertussis
2, 4, 6, 15–18 months; booster at
dose can be administered at 12
Hib 2, 4, 6, 12–15 months Minimum age is 6 weeks
Hiberix should only be used for
final dose (12 months–4 years)
Hep B Birth, 1–2 months, 6–15 months Monovalent vaccine to be
Administer birth dose within 12
Final dose should not be given
Third dose 6 months after first
Two doses required for patients
aged 2–8 years at first annual
MMR 12–15 months; repeat dose 4–6
administered at 4 years as long
2 doses if <65 at time of first
intramuscular, but subcutaneous
IPV 2, 4, 6–18 months IPV minimum age 6 weeks
Final dose should be after fourth
birthday and at least 6 months
Rotavirus (live attenuated; oral) RV1
VZV 12–15 months; repeat dose at
administered at 4 years as long
as 3 months from previous dose
ZV 50 years of age (usually >60) 1 dose
HBsAG+, hepatitis-B–surface antigen positive; PRP-OMP, PedvaxHIB or Comvax (Hep B-Hib).
—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep.
2011;60:1; Strikas RA; Advisory Committee on Immunization Practices (ACIP); ACIP Child/Adolescent
pediatric patients? When should these immunizations be given to K.C.?
The goal of immunization is to prevent specific infectious diseases and their
sequelae. For maximal effectiveness, a vaccine must be administered to the
susceptible population before anyone has been exposed to the pathogen. The age at
which immunizations are administered to specific individuals depends on several
factors (e.g., age-specific risks of the disease, risks of complications, presence of
maternal antibodies transferred through the placenta, maturity of the immune system).
Usually, immunizations are administered at the youngest age that the child is able to
develop an adequate antibody response.
The recommended childhood and adolescent immunization schedules are reviewed
annually by the Advisory Committee on Immunization Practice (ACIP) and American
Academy of Pediatrics (AAP), and supported by the American Academy of Family
Physicians (AAFP), the American College of Obstetricians and Gynecologists
(ACOG), and published within the Morbidity and Mortality Weekly Report
are available online (http://www.cdc.gov/schedules). A partial summary of
vaccination schedules is included in Table 64-1, but the reader is referred to the
online publication of immunization schedules for a more complete listing of the most
current recommendations. The minimal immunization requirements for entry into
public schools and day-care centers vary with each state and the departments of
health of individual states need to be consulted for these guidelines. The ACIP
reviews the adult immunization schedule annually as supported by the American
College of Physicians (ACP), American Academy of Family Physicians (AAFP), and
the American College of Nurse-Midwives (ACNM) and published within the Annals
of Internal Medicine and Morbidity and Mortality Weekly Report
online at http://www.cdc.gov/schedules). The respective schedules for children and
adults should be reviewed annually, and policies and procedures revised to ensure
A review of the childhood immunization schedule reveals that the recommended
vaccines to be administered at 2 months of age include diphtheria, tetanus, and
acellular pertussis (DTaP), inactivated polio (IPV), Haemophilus influenzae type b
(Hib), conjugated pneumococcal vaccine (PCV13), and rotavirus vaccine. A second
dose of the Hepatitis B (Hep B) vaccine should also be administered if the first dose
was given at birth. If Hep B vaccine was not given to K.C. at birth, the first dose
should be given today, then repeated at 1 to 2 months and again at 6 months (see Case
QUESTION 1: K.C.’s mother also mentions that she personally received two doses of an HPV vaccine
need to restart the vaccination series for HPV?
Immunization schedules can be adjusted to meet individual needs and may begin at
any time of the year. Vaccines should not be administered at time intervals shorter
than those recommended to allow for maximal immune responses before the
administration of subsequent doses.
1 A “catch-up” schedule for immunizations of
children and adolescents who begin their immunizations late or who are more than 1
month behind schedule in their immunizations and recommendations for minimal
intervals between doses for the administration of various vaccine can be
It is not necessary for adults who delay administration of a
subsequent dose of an immunization series to restart the vaccination series. An
interruption or delay in the recommended schedule does not interfere with the final
Alternative immunization recommendations are available for patients with altered
immunocompetence to ensure protection from vaccine associated disease, yet prevent
adverse effects or acquiring disease from the vaccine itself in the case of live
31 K.C.’s mother should receive a third dose of HPV
vaccine as soon as possible, but she does not need to restart the whole series.
(HBsAg) status is unknown. How should A.G. be managed?
Hepatitis B virus (HBV) can be transmitted via exposure to contaminated blood
(e.g., blood products or medical instruments, non-sterilized needles used in
intravenous drug abuse, or tattooing), exposure to body fluids (e.g., sexual
intercourse), and transplacentally from an HBsAg-positive mother. The prevention of
HBV maternal transmission to an infant is essential because acute disease can
progress to a chronic carrier state, which can lead to chronic liver disease and
primary hepatocellular carcinoma. Children acquiring HBV infection before 5 years
of age are at an especially high risk of developing chronic infection.
women should be tested for HBsAg, and infants born to HBsAg-positive mothers
should receive their first vaccine dose in addition to hepatitis B immune globulin
(HBIG) within 12 hours of birth to prevent vertical transmission.
HBIG plus HBV vaccine are 99% effective in preventing acute and chronic infection
in infants born to HBsAg-positive mothers.
If the mother’s HBsAg status is
unknown, the infant should be also immunized within 12 hours of birth regardless of
birth weight. For infants weighing less than 2,000 g, HBIG should also be
administered within 12 hours of birth. The mother’s HBsAg status should be
determined as soon as possible and if the mother is HBsAg-positive, HBIG should be
administered to infants weighing >2,000 g as soon as possible, but no later than day 7
Infants weighing >2,000 g born to HBsAg-negative mothers should begin
all situations, subsequent vaccine doses should be administered at age 1 to 2 months
and again at age 6 months. All unimmunized children should receive HBV vaccine as
AG should receive Hep B vaccine within 12 hours of birth and the mother’s status
should be determined. If her mother is found to be HBsAg-positive, HBIG should
also be administered within 7 days of birth. A.G. can receive her subsequent doses of
HBV vaccine according to the childhood immunization schedule. Two Hep B
vaccines are currently available for use in the United States. Recombivax-HB and
Engerix-B are yeast-derived recombinant vaccines administered as a three-dose
can be used because the immune response from an immunization series using
different vaccines is comparable to that of a full series using a single vaccine.
CASE 64-4, QUESTION 2: A.G.’s mother has not been immunized herself against hepatitis B. Should she
begin receiving the Hep B series as well?
Despite a decline in hepatitis B infections in the United States after universal
childhood immunization, more than a million adults are living with chronic hepatitis
B infection. The highest incidence of acute hepatitis B in the United States occurs in
adults 25 to 45 years of age, the majority of which occur in individuals with high-risk
behaviors including multiple sexual partners, anal intercourse, and injectable drug
Individuals who have close contact with patients infected with hepatitis B,
including health care workers, are also at risk of infection.
adolescents not vaccinated during infancy should be given a three-dose series of
intramuscular injections. Similarly, adults aged 19 to 59 years old with type 2
diabetes are recommended to receive the three-dose series.
groups who should receive the hepatitis B vaccination include sexually active
persons not in a long-term monogamous relationship, persons seeking treatment for a
household contacts and sexual partners of hepatitis B surface antigen positive
persons, staff of institutions for persons with developmental disabilities,
international travelers to areas with high prevalence of hepatitis B, and adults in
settings of STD treatment facilities, HIV testing and treatment facilities, or facilities
providing care for patients at risk of having hepatitis B.
after immunization is only recommended in high-risk groups in whom future clinical
management may depend on knowledge of immune status (e.g., health care workers).
Recommendations for serologic testing and revaccination and postexposure
prophylaxis for such situations are available.
34 Patients on dialysis and other
immunocompromised patients may require a fourth dose if the anti-HBs level is less
than 10 MIU/mL 2 months after the third dose.
A.G.’s mother should begin a three-dose series of Hep B vaccine. Monovalent
vaccines are preferred for the initial vaccination; however, combination vaccines
(see Table 64-2). Combination vaccines should not be used for
infants younger than 6 weeks of age; therefore, only single antigen doses should be
QUESTION 1: A mother presents with her 2-year-old to her pediatrician for a well-child visit. Her
hepatitis B and hepatitis A infections, and what are the immunization recommendations?
Hepatitis A infection can present as either an acute or chronic illness, but it is
often asymptomatic in infants and young children. However, infections in older
children and adults typically present with fever, malaise, anorexia, nausea,
abdominal discomfort, and jaundice.
37 Clinical illness usually lasts 1 to 2 months, but
it may be relapsing and can last up to 6 months. Approximately one-third of hepatitis
A cases occur in children younger than 15 years of age.
the most common source of infection is household or sexual contact, followed by
day-care attendance or employment, international travel, and food or waterborne
outbreaks. Asymptomatic children serve as a source of infection, especially for
household or other close contacts.
Vaccination programs targeting toddlers and young children are important because
children are often asymptomatic and unwittingly transmit the virus to adolescents and
adults. In addition, data suggest a “herd effect” when vaccination of children is
widespread (i.e., large population immunization programs indirectly protect those
who are not immunized because the risk of being exposed to an infected individual is
39 A program aimed exclusively at toddlers in an endemic area reduced the
prevalence of hepatitis A by more than 90%, not only in the 2- to 4-year-old vaccine
recipients but in all age groups.
Kinrix DTaP-IPV 4–6 years Only for fourth dose IPV and fifth dose
Quadracel DTap-IPV 4-6 years For fourth or fifth dose IPV series and fifth
c DTaP-Hep B-IPV 6 weeks–6 years 2, 4, 6 months
Pentacel DTaP-IPV-Hib 6 weeks–4 years 2, 4, 6, 15–18 months
An extra monovalent IPV recommended
for IPV at 4–6 years (total, five doses)
d MMR-V 12 months–12 years 12–15 months, 4–6 years
Twinrix HepA-Hep B 18 years+ 0, 1, 6 months
different manufacturers is unknown.
particularly for inactivated vaccines which are reactogenic (e.g., DTaP vaccine).
cHepatitis B: Combination vaccines not recommended for hepatitis B birth doses (<6 weeks).
The use of MMR is preferred during this time.
—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep.
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