tetano
Editor, Senior Moderator
Vaccine
Available online 8 October 2013
In Press, Uncorrected Proof ? Note to users
Cover image
Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS
Neal A. Halseya, Corresponding author contact information, E-mail the corresponding author,
Mari Griffioena,
Stephen C. Dreskinb,
Cornelia L. Dekkerc,
Robert Woodd,
Devindra Sharmae,
James F. Jonesf,
Philip S. LaRussag,
Jenny Garnera,
Melvin Bergerh,
Tina Proveauxa, E-mail the corresponding author,
Claudia Vellozzie,
The Hypersensitivity Working Group of the Clinical Immunization Safety Assessment Network
a Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
b Department of Medicine, University of Colorado, Denver, CO, USA
c Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA
d Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
e Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA
f Chronic Viral Diseases Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA
g Department of Pediatrics, Division of Pediatric Infectious Diseases, Columbia University, New York, NY, USA
h CSL Behring, King of Prussia, PA, USA
Highlights
?
The rate of reported hypersensitivity reactions following 2009 H1N1 vaccine was 10.8 per million.
?
The rates of hypersensitivity reactions were equal for 3 manufacturers of vaccine, but higher following live vaccine.
?
Females of childbearing age had higher rates of allergic reactions than males, but equal rates in other ages.
?
Epinephrine was underutilized for treatment of anaphylaxis following influenza vaccination.
Abstract
Background
Hypersensitivity disorders following vaccinations are a cause for concern.
Objective
To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines.
Design
A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines.
Setting/patients
US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010.
Measurements
Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event.
Results
Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 701 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine.
Limitations
Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males.
Conclusions
Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions.
http://www.sciencedirect.com/science/article/pii/S0264410X1301342X
Available online 8 October 2013
In Press, Uncorrected Proof ? Note to users
Cover image
Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS
Neal A. Halseya, Corresponding author contact information, E-mail the corresponding author,
Mari Griffioena,
Stephen C. Dreskinb,
Cornelia L. Dekkerc,
Robert Woodd,
Devindra Sharmae,
James F. Jonesf,
Philip S. LaRussag,
Jenny Garnera,
Melvin Bergerh,
Tina Proveauxa, E-mail the corresponding author,
Claudia Vellozzie,
The Hypersensitivity Working Group of the Clinical Immunization Safety Assessment Network
a Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
b Department of Medicine, University of Colorado, Denver, CO, USA
c Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA
d Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
e Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA
f Chronic Viral Diseases Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA
g Department of Pediatrics, Division of Pediatric Infectious Diseases, Columbia University, New York, NY, USA
h CSL Behring, King of Prussia, PA, USA
Highlights
?
The rate of reported hypersensitivity reactions following 2009 H1N1 vaccine was 10.8 per million.
?
The rates of hypersensitivity reactions were equal for 3 manufacturers of vaccine, but higher following live vaccine.
?
Females of childbearing age had higher rates of allergic reactions than males, but equal rates in other ages.
?
Epinephrine was underutilized for treatment of anaphylaxis following influenza vaccination.
Abstract
Background
Hypersensitivity disorders following vaccinations are a cause for concern.
Objective
To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines.
Design
A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines.
Setting/patients
US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010.
Measurements
Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event.
Results
Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 701 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine.
Limitations
Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males.
Conclusions
Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions.
http://www.sciencedirect.com/science/article/pii/S0264410X1301342X