Risk of anaphylaxis after vaccination in children and adults
Michael M. McNeil, MD, MPH, a Eric S. Weintraub, MPH, a Jonathan Duffy, MD, MPH, a Lakshmi Sukumaran, MD, MPH, a
Steven J. Jacobsen, MD, PhD, b Nicola P. Klein, MD, PhD,c Simon J. Hambidge, MD, PhD,d Grace M. Lee, MD, MPH, e
Lisa A. Jackson, MD, MPH, f Stephanie A. Irving, MHS,g Jennifer P. King, MPH, h Elyse O. Kharbanda, MD, MPH, i
Robert A. Bednarczyk, PhD, j and Frank DeStefano, MD, MPHa Atlanta, Ga, Pasadena and Oakland, Calif, Denver, Colo,
Boston, Mass, Seattle, Wash, Portland, Ore, Marshfield, Wis, and Minneapolis, Minn
Background: Anaphylaxis is a potentially life-threatening
allergic reaction. The risk of anaphylaxis after vaccination has
not been well described in adults or with newer vaccines in
children.
Objective: We sought to estimate the incidence of anaphylaxis
after vaccines and describe the demographic and clinical
characteristics of confirmed cases of anaphylaxis.
Methods: Using health care data from the Vaccine Safety
Datalink, we determined rates of anaphylaxis after vaccination
in children and adults. We first identified all patients with a
vaccination record from January 2009 through December 2011
and used diagnostic and procedure codes to identify potential
anaphylaxis cases. Medical records of potential cases were
reviewed. Confirmed cases met the Brighton Collaboration
definition for anaphylaxis and had to be determined to be
vaccine triggered. We calculated the incidence of anaphylaxis
after all vaccines combined and for selected individual vaccines.
Results: We identified 33 confirmed vaccine-triggered
anaphylaxis cases that occurred after 25,173,965 vaccine doses.
The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million
vaccine doses. The incidence did not vary significantly by age,
and there was a nonsignificant female predominance. Vaccine-
specific rates included 1.35 (95% CI, 0.65-2.47) per million doses
for inactivated trivalent influenza vaccine (10 cases, 7,434,628
doses given alone) and 1.83 (95% CI, 0.22-6.63) per million
doses for inactivated monovalent influenza vaccine (2 cases,
1,090,279 doses given alone). The onset of symptoms among
cases was within 30 minutes (8 cases), 30 to less than
120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to
8 hours (2 cases), the next day (1 case), and not documented
(4 cases).
Conclusion: Anaphylaxis after vaccination is rare in all age
groups. Despite its rarity, anaphylaxis is a potentially
life-threatening medical emergency that vaccine providers
need to be prepared to treat. (J Allergy Clin Immunol
2015;nnn:nnn-nnn.)
Key words: Anaphylaxis, vaccine safety, immunization
Anaphylaxis is an acute, systemic, and potentially lethal
hypersensitivity reaction with multiple organ system
involvement.1-4 Anaphylaxis can occur after exposure to
allergens from a variety of sources, including food, venom, drugs,
and immunizations. Virtually all vaccines have the potential to
trigger anaphylaxis.5,6 Recently, a committee of the Institute of
Medicine (IOM) concluded that epidemiologic and mechanistic
evidence convincingly supports a causal relationship between
anaphylaxis and several childhood and adolescent vaccines
(measles, mumps, rubella [MMR] vaccine; varicella vaccine;
influenza vaccine; hepatitis B vaccine; diphtheria toxoid-, tetanus
toxoid-, and acellular pertussis antigen-containing vaccines; and
meningococcal vaccine), favors acceptance of a causal
relationship for the human papillomavirus vaccine (HPV;
mechanistic evidence only), and is inadequate for hepatitis
A vaccine (HAV).7 Vaccine components that might be
allergenic include the vaccine antigen, residual animal protein,
antimicrobial agents, preservatives, stabilizers, or other vaccine
components. 8 Individual vaccine components that have been
implicated in acute vaccine reactions include egg protein, gelatin,
milk proteins, and potentially other additives. Natural rubber
latex, which can be contained in the syringe plunger, the tips on
prefilled syringes, and vial stoppers, is another potential cause
of anaphylaxis.9
The life-threatening nature of anaphylaxis and the acceptance
of a causal relationship with certain vaccines make estimation of
the magnitude of risk after vaccination an important priority for
research into vaccine safety. Current data are limited for
quantifying the risk of anaphylaxis associated with vaccination
in general or with specific vaccines. Given the infrequency with
which anaphylaxis occurs, large populations are necessary to
From a
the Immunization Safety Office, Division of Healthcare Quality Promotion, Na-
tional Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease
Control and Prevention, Atlanta; b
Southern California Kaiser Permanente, Pasadena;
c
Kaiser Permanente Vaccine Study Center, Oakland; d
the Institute for Health
Research, Kaiser Permanente, Denver; e the Department of Population Medicine, Har-
vard Medical School and the Harvard Pilgrim Health Care Institute, Boston; f
Group
Health Research Institute, Seattle; g
the Center for Health Research, Kaiser Permanente
Northwest, Portland; h
the Marshfield Clinic Research Foundation, Marshfield; i the
HealthPartners Institute for Education and Research, Minneapolis; and j Kaiser
Permanente Center for Health Research, and the Rollins School of Public Health,
Emory University, Atlanta.
The findings and conclusions of this report are those of the authors and do not necessarily
represent the official policy or position of the Centers for Disease Control and
Prevention (CDC). Use of trade names and commercial sources is for identification
only and does not imply endorsement by the CDC. The Vaccine Safety Datalink
Project is funded by the CDC. This study was supported by the CDC, and no external
funding was secured.
Disclosure of potential conflict of interest: L. Sukumaran has received research support
from the National Institutes of Health (NIH). N. P. Klein has received research and
travel support, as well as payment for writing/reviewing the manuscript, from the
Centers for Disease Control and Prevention (CDC) and has received research support
from Sanofi Pasteur, GlaxoSmithKline, Novartis, MedImmune, Protein Science,
Merck, Pfizer, and Nuron Biotech. S. J. Hambidge has received research support from
the CDC Vaccine Safety Datalink. G. M. Lee and L. A. Jackson have received research
support from the CDC. S. A. Irving has received research and travel support from the
CDC. J. P. King has received research support from the CDC. The rest of the authors
declare that they have no relevant conflicts of interest.
Received for publication March 18, 2015; revised July 31, 2015; accepted for publication
July 31, 2015.
Corresponding author: Michael M. McNeil, MD, MPH, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS D-26, Atlanta, GA 30333. E-mail: mmm2@
cdc.gov.
0091-6749
http://dx.doi.org/10.1016/j.jaci.2015.07.048
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Risk of anaphylaxis after vaccination

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