PEDIATRICS Vol. 114 No. 2 August 2004, pp. 524
RISK OF ANAPHYLAXIS AFTER VACCINATION OF CHILDREN AND ADOLESCENTS
Mark H. Moss, MD
Madison, WI
Bohlke K, Davis RL, Marcy SM, et al. Pediatrics. 2003;112:815–820
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Purpose of the Study.
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Anaphylaxis is a risk of vaccination. This study retrospectively
quantified the risk in a population of pediatric patients.
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Study Population.
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Children and adolescents enrolled in 4 West Coast health maintenance
organizations that participated in the Vaccine Safety Data Link
Project between 1991 and 1997 were studied.
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Methods.
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A total of 7 644 049 vaccine doses were administered to 2 226
907 children between the ages of 0 and 17 years at 3 sites and
between 0 and 6 years at a fourth site. Potential cases of anaphylaxis
were identified by using International Classification of Diseases,
9th revision, codes suggesting anaphylaxis. A total of 657 cases
were reviewed, of 664 cases of interest. Missing chart information
excluded 7 cases. Criteria including organ systems involved
in reactions, timing of reactions after vaccination, and treatments
were reviewed, to identify possible or probable cases of anaphylaxis.
Two analyses were performed. One included all sites, and 1 included
a single site for which more detailed data on outpatient diagnoses
were available.
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Results.
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Six possible cases of anaphylaxis were identified. After a more
detailed chart review, 2 cases were considered unlikely to be
anaphylaxis, 1 case was unlikely to be secondary to vaccination,
and 1 case of anaphylaxis predated and was not attributable
to vaccination. The final risk of anaphylaxis was calculated
as 0.26 case per 1 000 000 doses (2 cases per 7 644 049 doses).
At the single site with more complete data on outpatient diagnoses,
a risk of 1.53 cases per 1 000 000 doses was calculated. Rates
for individual vaccines ranged from 0 to 14.4 cases per 1 000
000 doses. Most reactions were seen with diphtheria- and tetanus-containing
vaccines, hepatitis B vaccine, measles-mumps-rubella vaccine,
and oral polio vaccine. These vaccines were also more commonly
administered. No reactions were seen with diphtheria-tetanus-acellular
pertussis vaccine, influenza vaccine, inactivated polio vaccine,
adult diphtheria-tetanus vaccine, hepatitis A vaccine, or varicella
vaccine. However, these vaccines were less commonly administered.
No deaths resulted from the anaphylactic episodes. No association
was made with atopic status.
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Conclusions.
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The frequency of vaccine-associated anaphylaxis is very low.
Nonetheless, providers should be prepared to provide immediate
treatment should it occur.
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Reviewer’s Comments.
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Vaccination remains one of the most effective preventative treatments
provided for children. Some advocates for better access to vaccination
lobby for administration of vaccines at locations where acute
health care is absent (eg, pharmacies). Although the risk of
anaphylaxis is extremely low, it is not negligible. Providers
of vaccines must be prepared to provide immediate treatment
if anaphylaxis should occur, and society must determine when
the need for vaccine access outweighs this risk.
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics
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Purpose of the Study.
Study Population.
