Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.
Identifieur interne : 000127 ( Main/Exploration ); précédent : 000126; suivant : 000128Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.
Auteurs : A M Alguacil-Ramos [Espagne] ; J. Muelas-Tirado [Espagne] ; T M Garrigues-Pelufo [Espagne] ; A. Portero-Alonso [Espagne] ; J. Diez-Domingo [Espagne] ; E. Pastor-Villalba [Espagne] ; J A Lluch-Rodrigo [Espagne]Source :
- Public health [ 1476-5616 ] ; 2016.
Descripteurs français
- KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Bases de données factuelles (MeSH), Enfant (MeSH), Enfant d'âge préscolaire (MeSH), Espagne (MeSH), Femelle (MeSH), Humains (MeSH), Jeune adulte (MeSH), Mâle (MeSH), Nourrisson (MeSH), Sujet âgé (MeSH), Surveillance post-commercialisation des produits de santé (méthodes), Systèmes de signalement des effets indésirables des médicaments (MeSH), Sécurité (MeSH), Vaccins (effets indésirables), Études rétrospectives (MeSH).
- MESH :
- effets indésirables : Vaccins.
- méthodes : Surveillance post-commercialisation des produits de santé.
- Adolescent, Adulte, Adulte d'âge moyen, Bases de données factuelles, Enfant, Enfant d'âge préscolaire, Espagne, Femelle, Humains, Jeune adulte, Mâle, Nourrisson, Sujet âgé, Systèmes de signalement des effets indésirables des médicaments, Sécurité, Études rétrospectives.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Adverse Drug Reaction Reporting Systems (MeSH), Aged (MeSH), Child (MeSH), Child, Preschool (MeSH), Databases, Factual (MeSH), Female (MeSH), Humans (MeSH), Infant (MeSH), Male (MeSH), Middle Aged (MeSH), Product Surveillance, Postmarketing (methods), Retrospective Studies (MeSH), Safety (MeSH), Spain (MeSH), Vaccines (adverse effects), Young Adult (MeSH).
- MESH :
- chemical , adverse effects : Vaccines.
- methods : Product Surveillance, Postmarketing.
- Adolescent, Adult, Adverse Drug Reaction Reporting Systems, Aged, Child, Child, Preschool, Databases, Factual, Female, Humans, Infant, Male, Middle Aged, Retrospective Studies, Safety, Spain, Young Adult.
Abstract
OBJECTIVES
The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting.
STUDY DESIGN
A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out.
METHODS
Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out.
RESULTS
More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events.
CONCLUSIONS
SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.
DOI: 10.1016/j.puhe.2015.11.010
PubMed: 26976484
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Portero-Alonso</name><affiliation wicri:level="1"><nlm:affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Diez Domingo, J" sort="Diez Domingo, J" uniqKey="Diez Domingo J" first="J" last="Diez-Domingo">J. Diez-Domingo</name><affiliation wicri:level="1"><nlm:affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Universidad Católica de Valencia 'San Vicente Mártir', Valencia, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Universidad Católica de Valencia 'San Vicente Mártir', Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Pastor Villalba, E" sort="Pastor Villalba, E" uniqKey="Pastor Villalba E" first="E" last="Pastor-Villalba">E. Pastor-Villalba</name><affiliation wicri:level="1"><nlm:affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Lluch Rodrigo, J A" sort="Lluch Rodrigo, J A" uniqKey="Lluch Rodrigo J" first="J A" last="Lluch-Rodrigo">J A Lluch-Rodrigo</name><affiliation wicri:level="1"><nlm:affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author></analytic><series><title level="j">Public health</title><idno type="eISSN">1476-5616</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Adverse Drug Reaction Reporting Systems (MeSH)</term><term>Aged (MeSH)</term><term>Child (MeSH)</term><term>Child, Preschool (MeSH)</term><term>Databases, Factual (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Infant (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Product Surveillance, Postmarketing (methods)</term><term>Retrospective Studies (MeSH)</term><term>Safety (MeSH)</term><term>Spain (MeSH)</term><term>Vaccines (adverse effects)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent (MeSH)</term><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Bases de données factuelles (MeSH)</term><term>Enfant (MeSH)</term><term>Enfant d'âge préscolaire (MeSH)</term><term>Espagne (MeSH)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Jeune adulte (MeSH)</term><term>Mâle (MeSH)</term><term>Nourrisson (MeSH)</term><term>Sujet âgé (MeSH)</term><term>Surveillance post-commercialisation des produits de santé (méthodes)</term><term>Systèmes de signalement des effets indésirables des médicaments (MeSH)</term><term>Sécurité (MeSH)</term><term>Vaccins (effets indésirables)</term><term>Études rétrospectives (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Vaccines</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Product Surveillance, Postmarketing</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Surveillance post-commercialisation des produits de santé</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Adverse Drug Reaction Reporting Systems</term><term>Aged</term><term>Child</term><term>Child, Preschool</term><term>Databases, Factual</term><term>Female</term><term>Humans</term><term>Infant</term><term>Male</term><term>Middle Aged</term><term>Retrospective Studies</term><term>Safety</term><term>Spain</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Bases de données factuelles</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Espagne</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Nourrisson</term><term>Sujet âgé</term><term>Systèmes de signalement des effets indésirables des médicaments</term><term>Sécurité</term><term>Études rétrospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting.</p></div><div type="abstract" xml:lang="en"><p><b>STUDY DESIGN</b></p><p>A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">26976484</PMID><DateCompleted><Year>2017</Year><Month>04</Month><Day>07</Day></DateCompleted><DateRevised><Year>2018</Year><Month>12</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1476-5616</ISSN><JournalIssue CitedMedium="Internet"><Volume>135</Volume><PubDate><Year>2016</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Public health</Title><ISOAbbreviation>Public Health</ISOAbbreviation></Journal><ArticleTitle>Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.</ArticleTitle><Pagination><MedlinePgn>66-74</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.puhe.2015.11.010</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0033-3506(15)00461-8</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting.</AbstractText><AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.</AbstractText><CopyrightInformation>Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Alguacil-Ramos</LastName><ForeName>A M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain; Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Universidad Católica de Valencia 'San Vicente Mártir', Valencia, Spain. Electronic address: alguacil_ana@gva.es.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Muelas-Tirado</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Dirección General de Farmacia y Productos Sanitarios, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garrigues-Pelufo</LastName><ForeName>T M</ForeName><Initials>TM</Initials><AffiliationInfo><Affiliation>Facultad de Farmacia, Universitat de Valencia, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Portero-Alonso</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Diez-Domingo</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Universidad Católica de Valencia 'San Vicente Mártir', Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pastor-Villalba</LastName><ForeName>E</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lluch-Rodrigo</LastName><ForeName>J A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>03</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Public Health</MedlineTA><NlmUniqueID>0376507</NlmUniqueID><ISSNLinking>0033-3506</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014612">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="D016907" MajorTopicYN="Y">Adverse Drug Reaction Reporting Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016208" MajorTopicYN="N">Databases, Factual</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011358" MajorTopicYN="N">Product Surveillance, Postmarketing</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012449" MajorTopicYN="N">Safety</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013030" MajorTopicYN="N">Spain</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014612" MajorTopicYN="N">Vaccines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">AEFI (adverse event following immunization)</Keyword><Keyword MajorTopicYN="N">Immunization registry</Keyword><Keyword MajorTopicYN="N">Passive surveillance</Keyword><Keyword MajorTopicYN="N">Vaccine safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>05</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>11</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>11</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>3</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>3</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>4</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26976484</ArticleId><ArticleId IdType="pii">S0033-3506(15)00461-8</ArticleId><ArticleId IdType="doi">10.1016/j.puhe.2015.11.010</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Espagne</li></country></list><tree><country name="Espagne"><noRegion><name sortKey="Alguacil Ramos, A M" sort="Alguacil Ramos, A M" uniqKey="Alguacil Ramos A" first="A M" last="Alguacil-Ramos">A M Alguacil-Ramos</name></noRegion><name sortKey="Diez Domingo, J" sort="Diez Domingo, J" uniqKey="Diez Domingo J" first="J" last="Diez-Domingo">J. Diez-Domingo</name><name sortKey="Garrigues Pelufo, T M" sort="Garrigues Pelufo, T M" uniqKey="Garrigues Pelufo T" first="T M" last="Garrigues-Pelufo">T M Garrigues-Pelufo</name><name sortKey="Lluch Rodrigo, J A" sort="Lluch Rodrigo, J A" uniqKey="Lluch Rodrigo J" first="J A" last="Lluch-Rodrigo">J A Lluch-Rodrigo</name><name sortKey="Muelas Tirado, J" sort="Muelas Tirado, J" uniqKey="Muelas Tirado J" first="J" last="Muelas-Tirado">J. Muelas-Tirado</name><name sortKey="Pastor Villalba, E" sort="Pastor Villalba, E" uniqKey="Pastor Villalba E" first="E" last="Pastor-Villalba">E. Pastor-Villalba</name><name sortKey="Portero Alonso, A" sort="Portero Alonso, A" uniqKey="Portero Alonso A" first="A" last="Portero-Alonso">A. Portero-Alonso</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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