Adverse events associated with pandemic influenza vaccines: comparison of the results of a follow-up study with those coming from spontaneous reporting.
Identifieur interne : 000418 ( Main/Exploration ); précédent : 000417; suivant : 000419Adverse events associated with pandemic influenza vaccines: comparison of the results of a follow-up study with those coming from spontaneous reporting.
Auteurs : A. Carvajal [Espagne] ; P García Ortega ; M. Sáinz ; V. Velasco ; I. Salado ; L H Martín Arias ; J M Eiros ; A Pérez Rubio ; J. CastrodezaSource :
- Vaccine [ 1873-2518 ] ; 2011.
Descripteurs français
- KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Collecte de données (méthodes), Espagne (MeSH), Femelle (MeSH), Grippe humaine (prévention et contrôle), Humains (MeSH), Jeune adulte (MeSH), Mâle (MeSH), Sous-type H1N1 du virus de la grippe A (immunologie), Sujet âgé (MeSH), Sujet âgé de 80 ans ou plus (MeSH), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables).
- MESH :
- administration et posologie : Vaccins antigrippaux.
- effets indésirables : Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A.
- méthodes : Collecte de données.
- prévention et contrôle : Grippe humaine.
- Adolescent, Adulte, Adulte d'âge moyen, Espagne, Femelle, Humains, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus.
- Wicri :
- geographic : Espagne.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Data Collection (methods), Female (MeSH), Humans (MeSH), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (prevention & control), Male (MeSH), Middle Aged (MeSH), Spain (MeSH), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- geographic : Spain.
- immunology : Influenza A Virus, H1N1 Subtype.
- methods : Data Collection.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Young Adult.
Abstract
Prior to marketing of pandemic influenza vaccines, the only safety data were those from clinical trials. The objective of this study was to compare information coming from spontaneous reporting with that systematically collected in a formal observation study; this also permits to further evaluate safety of pandemic influenza vaccines in the targeted patients' population. Out of a sample of 507 vaccinated subjects, 103 (20.3%) developed some complication. In the same period 83 reports corresponding to all vaccinated people of Castilla y León (n=131,462) were collected. Severe cases were 1 (1%) and 7 (8.4%), respectively, with the two procedures. The spontaneous reporting rate was 322-fold lower than that identified through the follow-up study; when considered the severe cases, it was 37-fold lower. Under certain circumstances reporting might be performing better than usual due to strengthening of the surveillance system. Adverse events observed for the pandemic H1N1 vaccines lie within the expected safety profile for common events with influenza vaccines. An overall benefit-risk assessment of these vaccines should be done.
DOI: 10.1016/j.vaccine.2010.10.067
PubMed: 21112311
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Carvajal</name><affiliation wicri:level="2"><nlm:affiliation>Instituto de Farmacoepidemiología, Universidad de Valladolid, Ramón y Cajal, 7, 47005 Valladolid, Spain. carvajal@ife.uva.es</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Instituto de Farmacoepidemiología, Universidad de Valladolid, Ramón y Cajal, 7, 47005 Valladolid</wicri:regionArea><placeName><region nuts="2" type="communauté">Castille-et-León</region></placeName></affiliation></author><author><name sortKey="Ortega, P Garcia" sort="Ortega, P Garcia" uniqKey="Ortega P" first="P García" last="Ortega">P García Ortega</name></author><author><name sortKey="Sainz, M" sort="Sainz, M" uniqKey="Sainz M" first="M" last="Sáinz">M. Sáinz</name></author><author><name sortKey="Velasco, V" sort="Velasco, V" uniqKey="Velasco V" first="V" last="Velasco">V. Velasco</name></author><author><name sortKey="Salado, I" sort="Salado, I" uniqKey="Salado I" first="I" last="Salado">I. 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The objective of this study was to compare information coming from spontaneous reporting with that systematically collected in a formal observation study; this also permits to further evaluate safety of pandemic influenza vaccines in the targeted patients' population. Out of a sample of 507 vaccinated subjects, 103 (20.3%) developed some complication. In the same period 83 reports corresponding to all vaccinated people of Castilla y León (n=131,462) were collected. Severe cases were 1 (1%) and 7 (8.4%), respectively, with the two procedures. The spontaneous reporting rate was 322-fold lower than that identified through the follow-up study; when considered the severe cases, it was 37-fold lower. Under certain circumstances reporting might be performing better than usual due to strengthening of the surveillance system. Adverse events observed for the pandemic H1N1 vaccines lie within the expected safety profile for common events with influenza vaccines. An overall benefit-risk assessment of these vaccines should be done.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21112311</PMID><DateCompleted><Year>2011</Year><Month>04</Month><Day>04</Day></DateCompleted><DateRevised><Year>2010</Year><Month>12</Month><Day>28</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>3</Issue><PubDate><Year>2011</Year><Month>Jan</Month><Day>10</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Adverse events associated with pandemic influenza vaccines: comparison of the results of a follow-up study with those coming from spontaneous reporting.</ArticleTitle><Pagination><MedlinePgn>519-22</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2010.10.067</ELocationID><Abstract><AbstractText>Prior to marketing of pandemic influenza vaccines, the only safety data were those from clinical trials. The objective of this study was to compare information coming from spontaneous reporting with that systematically collected in a formal observation study; this also permits to further evaluate safety of pandemic influenza vaccines in the targeted patients' population. Out of a sample of 507 vaccinated subjects, 103 (20.3%) developed some complication. In the same period 83 reports corresponding to all vaccinated people of Castilla y León (n=131,462) were collected. Severe cases were 1 (1%) and 7 (8.4%), respectively, with the two procedures. The spontaneous reporting rate was 322-fold lower than that identified through the follow-up study; when considered the severe cases, it was 37-fold lower. Under certain circumstances reporting might be performing better than usual due to strengthening of the surveillance system. Adverse events observed for the pandemic H1N1 vaccines lie within the expected safety profile for common events with influenza vaccines. An overall benefit-risk assessment of these vaccines should be done.</AbstractText><CopyrightInformation>Copyright © 2010 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Carvajal</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Instituto de Farmacoepidemiología, Universidad de Valladolid, Ramón y Cajal, 7, 47005 Valladolid, Spain. carvajal@ife.uva.es</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ortega</LastName><ForeName>P García</ForeName><Initials>PG</Initials></Author><Author ValidYN="Y"><LastName>Sáinz</LastName><ForeName>M</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Velasco</LastName><ForeName>V</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Salado</LastName><ForeName>I</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Arias</LastName><ForeName>L H Martín</ForeName><Initials>LH</Initials></Author><Author ValidYN="Y"><LastName>Eiros</LastName><ForeName>J M</ForeName><Initials>JM</Initials></Author><Author ValidYN="Y"><LastName>Rubio</LastName><ForeName>A Pérez</ForeName><Initials>AP</Initials></Author><Author ValidYN="Y"><LastName>Castrodeza</LastName><ForeName>J</ForeName><Initials>J</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2010</Year><Month>11</Month><Day>26</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003625" MajorTopicYN="N">Data Collection</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013030" MajorTopicYN="N" Type="Geographic">Spain</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2010</Year><Month>09</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2010</Year><Month>10</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2010</Year><Month>10</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2010</Year><Month>11</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2010</Year><Month>11</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2011</Year><Month>4</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">21112311</ArticleId><ArticleId IdType="pii">S0264-410X(10)01568-9</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2010.10.067</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Espagne</li></country><region><li>Castille-et-León</li></region></list><tree><noCountry><name sortKey="Arias, L H Martin" sort="Arias, L H Martin" uniqKey="Arias L" first="L H Martín" last="Arias">L H Martín Arias</name><name sortKey="Castrodeza, J" sort="Castrodeza, J" uniqKey="Castrodeza J" first="J" last="Castrodeza">J. Castrodeza</name><name sortKey="Eiros, J M" sort="Eiros, J M" uniqKey="Eiros J" first="J M" last="Eiros">J M Eiros</name><name sortKey="Ortega, P Garcia" sort="Ortega, P Garcia" uniqKey="Ortega P" first="P García" last="Ortega">P García Ortega</name><name sortKey="Rubio, A Perez" sort="Rubio, A Perez" uniqKey="Rubio A" first="A Pérez" last="Rubio">A Pérez Rubio</name><name sortKey="Sainz, M" sort="Sainz, M" uniqKey="Sainz M" first="M" last="Sáinz">M. Sáinz</name><name sortKey="Salado, I" sort="Salado, I" uniqKey="Salado I" first="I" last="Salado">I. Salado</name><name sortKey="Velasco, V" sort="Velasco, V" uniqKey="Velasco V" first="V" last="Velasco">V. Velasco</name></noCountry><country name="Espagne"><region name="Castille-et-León"><name sortKey="Carvajal, A" sort="Carvajal, A" uniqKey="Carvajal A" first="A" last="Carvajal">A. Carvajal</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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