Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS
Identifieur interne : 001C54 ( PascalFrancis/Curation ); précédent : 001C53; suivant : 001C55Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS
Auteurs : Neal A. Halsey [États-Unis] ; Mari Griffioen [États-Unis] ; Stephen C. Dreskin [États-Unis] ; Cornelia L. Dekker [États-Unis] ; Robert Wood [États-Unis] ; Devindra Sharma [États-Unis] ; James F. Jones [États-Unis] ; Philip S. Larussa [États-Unis] ; Jenny Garner [États-Unis] ; Melvin Berger [États-Unis] ; Tina Proveaux [États-Unis] ; Claudia Vellozzi [États-Unis] ; Karen Broder [États-Unis] ; Rosanna Setse [États-Unis] ; Barbara Pahud [États-Unis] ; David Hrncir [États-Unis] ; Howard Choi [États-Unis] ; Robert Sparks [États-Unis] ; Sarah Elizabeth Williams [États-Unis] ; Renata J. Engler [États-Unis] ; Jane Gidudu [États-Unis] ; Roger Baxter [États-Unis] ; Nicola Klein [États-Unis] ; Kathryn Edwards [États-Unis] ; Maria Cano [États-Unis] ; John M. Kelso [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2013.
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English descriptors
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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 698 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.
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS</title>
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<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
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<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Immunization Safety Office, Centers for Disease Control and Prevention</s1>
<s2>Atlanta, GA</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>12 aut.</sZ>
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<author><name sortKey="Broder, Karen" sort="Broder, Karen" uniqKey="Broder K" first="Karen" last="Broder">Karen Broder</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Immunization Safety Office, Centers for Disease Control and Prevention</s1>
<s2>Atlanta, GA</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>25 aut.</sZ>
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</affiliation>
</author>
<author><name sortKey="Setse, Rosanna" sort="Setse, Rosanna" uniqKey="Setse R" first="Rosanna" last="Setse">Rosanna Setse</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>9 aut.</sZ>
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</affiliation>
</author>
<author><name sortKey="Pahud, Barbara" sort="Pahud, Barbara" uniqKey="Pahud B" first="Barbara" last="Pahud">Barbara Pahud</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Children's Mercy Hospital and Clinics, University of Missouri</s1>
<s2>Kansas City, MO</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
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<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Hrncir, David" sort="Hrncir, David" uniqKey="Hrncir D" first="David" last="Hrncir">David Hrncir</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Vaccine Healthcare Center Network, Military Vaccine Agency, U.S. Army Public Health Command, Walter Reed National Military Medical Center</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Choi, Howard" sort="Choi, Howard" uniqKey="Choi H" first="Howard" last="Choi">Howard Choi</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Sparks, Robert" sort="Sparks, Robert" uniqKey="Sparks R" first="Robert" last="Sparks">Robert Sparks</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Williams, Sarah Elizabeth" sort="Williams, Sarah Elizabeth" uniqKey="Williams S" first="Sarah Elizabeth" last="Williams">Sarah Elizabeth Williams</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Engler, Renata J" sort="Engler, Renata J" uniqKey="Engler R" first="Renata J." last="Engler">Renata J. Engler</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Vaccine Healthcare Center Network, Military Vaccine Agency, U.S. Army Public Health Command, Walter Reed National Military Medical Center</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Gidudu, Jane" sort="Gidudu, Jane" uniqKey="Gidudu J" first="Jane" last="Gidudu">Jane Gidudu</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Immunization Safety Office, Centers for Disease Control and Prevention</s1>
<s2>Atlanta, GA</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Baxter, Roger" sort="Baxter, Roger" uniqKey="Baxter R" first="Roger" last="Baxter">Roger Baxter</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Kaiser Permanente Vaccine Study Center</s1>
<s2>Oakland, CA</s2>
<s3>USA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Klein, Nicola" sort="Klein, Nicola" uniqKey="Klein N" first="Nicola" last="Klein">Nicola Klein</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Kaiser Permanente Vaccine Study Center</s1>
<s2>Oakland, CA</s2>
<s3>USA</s3>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Edwards, Kathryn" sort="Edwards, Kathryn" uniqKey="Edwards K" first="Kathryn" last="Edwards">Kathryn Edwards</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Vanderbilt University School of Medicine</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Cano, Maria" sort="Cano, Maria" uniqKey="Cano M" first="Maria" last="Cano">Maria Cano</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Immunization Safety Office, Centers for Disease Control and Prevention</s1>
<s2>Atlanta, GA</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Kelso, John M" sort="Kelso, John M" uniqKey="Kelso J" first="John M." last="Kelso">John M. Kelso</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Division of Allergy, Asthma, and Immunology, Scripps Clinic</s1>
<s2>San Diego, CA</s2>
<s3>USA</s3>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
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<series><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
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<seriesStmt><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
</seriesStmt>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Allergy</term>
<term>Anaphylaxis</term>
<term>Immediate hypersensitivity</term>
<term>Immunization</term>
<term>Influenza A</term>
<term>Influenza A virus</term>
<term>Urticaria</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Virus grippal A</term>
<term>Hypersensibilité immédiate</term>
<term>Vaccin</term>
<term>Immunisation</term>
<term>Anaphylaxie</term>
<term>Urticaire</term>
<term>Grippe A</term>
<term>Allergie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term>
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<front><div type="abstract" xml:lang="en">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 698 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.</div>
</front>
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<fA08 i1="01" i2="1" l="ENG"><s1>Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS</s1>
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<fA11 i1="01" i2="1"><s1>HALSEY (Neal A.)</s1>
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<fA11 i1="14" i2="1"><s1>SETSE (Rosanna)</s1>
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<fA11 i1="15" i2="1"><s1>PAHUD (Barbara)</s1>
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<fA11 i1="16" i2="1"><s1>HRNCIR (David)</s1>
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<fA11 i1="17" i2="1"><s1>CHOI (Howard)</s1>
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<fA11 i1="18" i2="1"><s1>SPARKS (Robert)</s1>
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<fA11 i1="25" i2="1"><s1>CANO (Maria)</s1>
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<fA11 i1="26" i2="1"><s1>KELSO (John M.)</s1>
</fA11>
<fA14 i1="01"><s1>Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>14 aut.</sZ>
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<fA14 i1="02"><s1>Department of Medicine, University of Colorado</s1>
<s2>Denver, CO</s2>
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<sZ>3 aut.</sZ>
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<fA14 i1="03"><s1>Department of Pediatrics, Stanford University School of Medicine</s1>
<s2>Stanford, CA</s2>
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<sZ>4 aut.</sZ>
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<fA14 i1="04"><s1>Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine</s1>
<s2>Baltimore, MD</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
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<fA14 i1="05"><s1>Immunization Safety Office, Centers for Disease Control and Prevention</s1>
<s2>Atlanta, GA</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>25 aut.</sZ>
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<fA14 i1="06"><s1>Chronic Viral Diseases Branch, Centers for Disease Control and Prevention</s1>
<s2>Atlanta, GA</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
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<fA14 i1="07"><s1>Department of Pediatrics, Division of Pediatric Infectious Diseases, Columbia University</s1>
<s2>New York, NY</s2>
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<sZ>8 aut.</sZ>
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<fA14 i1="08"><s1>CSL Behring</s1>
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<s3>USA</s3>
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<fA14 i1="10"><s1>Vaccine Healthcare Center Network, Military Vaccine Agency, U.S. Army Public Health Command, Walter Reed National Military Medical Center</s1>
<s2>Bethesda, MD</s2>
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<sZ>16 aut.</sZ>
<sZ>20 aut.</sZ>
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<sZ>19 aut.</sZ>
<sZ>24 aut.</sZ>
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<fA14 i1="12"><s1>Kaiser Permanente Vaccine Study Center</s1>
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<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
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<sZ>26 aut.</sZ>
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<fC01 i1="01" l="ENG"><s0>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 698 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.</s0>
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<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Influenza A</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Gripe A</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Allergie</s0>
<s5>15</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Allergy</s0>
<s5>15</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Alergia</s0>
<s5>15</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Immunopathologie</s0>
<s5>13</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Immunopathology</s0>
<s5>13</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Inmunopatología</s0>
<s5>13</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Virose</s0>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Infection</s0>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Infection</s0>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Infección</s0>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Pathologie de la peau</s0>
<s5>16</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Skin disease</s0>
<s5>16</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Piel patología</s0>
<s5>16</s5>
</fC07>
<fN21><s1>027</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>
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