Serveur d'exploration sur la grippe en Espagne

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Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database.

Identifieur interne : 000144 ( Main/Exploration ); précédent : 000143; suivant : 000145

Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database.

Auteurs : Enrique Alcalde-Cabero [Espagne] ; Javier Almazán-Isla [Espagne] ; Fernando J. García L Pez [Espagne] ; José Ram N Ara-Callizo [Espagne] ; Fuencisla Avellanal [Espagne] ; Carlos Casasnovas [Espagne] ; Carlos Cemillán [Espagne] ; José Ignacio Cuadrado [Espagne] ; Jacinto Duarte [Espagne] ; María Dolores Fernández-Pérez [Espagne] ; Scar Fernández [Espagne] ; Juan Antonio García Merino [Espagne] ; Rosa García Montero [Espagne] ; Dolores Montero [Espagne] ; Julio Pardo [Espagne] ; Francisco Javier Rodríguez-Rivera [Espagne] ; María Ruiz-Tovar [Espagne] ; Jesús De Pedro-Cuesta [Espagne]

Source :

RBID : pubmed:27206524

Descripteurs français

English descriptors

Abstract

BACKGROUND

Studies have shown a slight excess risk in Guillain-Barré syndrome (GBS) incidence associated with A(H1N1)pdm09 vaccination campaign and seasonal trivalent influenza vaccine immunisations in 2009-2010. We aimed to assess the incidence of GBS as a potential adverse effect of A(H1N1)pdm09 vaccination.

METHODS

A neurologist-led network, active at the neurology departments of ten general hospitals serving an adult population of 4.68 million, conducted GBS surveillance in Spain in 2009-2011. The network, established in 1996, carried out a retrospective and a prospective study to estimate monthly alarm thresholds in GBS incidence and tested them in 1998-1999 in a pilot study. Such incidence thresholds additionally to observation of GBS cases with immunisation antecedent in the 42 days prior to clinical onset were taken as alarm signals for 2009-2011, since November 2009 onwards. For purpose of surveillance, in 2009 we updated both the available centres and the populations served by the network. We also did a retrospective countrywide review of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis from January 2009 to December 2011.

RESULTS

Among 141 confirmed of 148 notified cases of GBS or Miller-Fisher syndrome, Brighton 1-2 criteria in 96 %, not a single patient was identified with clinical onset during the 42-day time interval following A(H1N1)pdm09 vaccination. In contrast, seven cases were seen during a similar period after seasonal campaigns. Monthly incidence figures did not, however, exceed the upper 95 % CI limit of expected incidence. A retrospective countrywide review of the registry of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis did not suggest higher admission rates in critical months across the period December 2009-February 2010.

CONCLUSIONS

Despite limited power and underlying reporting bias in 2010-2011, an increase in GBS incidence over background GBS, associated with A(H1N1)pdm09 monovalent or trivalent influenza immunisations, appears unlikely.


DOI: 10.1186/s12883-016-0598-z
PubMed: 27206524
PubMed Central: PMC4875759


Affiliations:


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Le document en format XML

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<name sortKey="Pardo, Julio" sort="Pardo, Julio" uniqKey="Pardo J" first="Julio" last="Pardo">Julio Pardo</name>
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<name sortKey="Rodriguez Rivera, Francisco Javier" sort="Rodriguez Rivera, Francisco Javier" uniqKey="Rodriguez Rivera F" first="Francisco Javier" last="Rodríguez-Rivera">Francisco Javier Rodríguez-Rivera</name>
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<name sortKey="Ruiz Tovar, Maria" sort="Ruiz Tovar, Maria" uniqKey="Ruiz Tovar M" first="María" last="Ruiz-Tovar">María Ruiz-Tovar</name>
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<title xml:lang="en">Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database.</title>
<author>
<name sortKey="Alcalde Cabero, Enrique" sort="Alcalde Cabero, Enrique" uniqKey="Alcalde Cabero E" first="Enrique" last="Alcalde-Cabero">Enrique Alcalde-Cabero</name>
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<nlm:affiliation>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid</wicri:regionArea>
<placeName>
<settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
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<author>
<name sortKey="Almazan Isla, Javier" sort="Almazan Isla, Javier" uniqKey="Almazan Isla J" first="Javier" last="Almazán-Isla">Javier Almazán-Isla</name>
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<nlm:affiliation>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid</wicri:regionArea>
<placeName>
<settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Garcia L Pez, Fernando J" sort="Garcia L Pez, Fernando J" uniqKey="Garcia L Pez F" first="Fernando J" last="García L Pez">Fernando J. García L Pez</name>
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<nlm:affiliation>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<settlement type="city">Madrid</settlement>
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<name sortKey="Ara Callizo, Jose Ram N" sort="Ara Callizo, Jose Ram N" uniqKey="Ara Callizo J" first="José Ram N" last="Ara-Callizo">José Ram N Ara-Callizo</name>
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<nlm:affiliation>Neurology Department, Miguel Servet University Hospital, Zaragoza, Spain.</nlm:affiliation>
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<wicri:regionArea>Neurology Department, Miguel Servet University Hospital, Zaragoza</wicri:regionArea>
<wicri:noRegion>Zaragoza</wicri:noRegion>
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<name sortKey="Avellanal, Fuencisla" sort="Avellanal, Fuencisla" uniqKey="Avellanal F" first="Fuencisla" last="Avellanal">Fuencisla Avellanal</name>
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<name sortKey="Casasnovas, Carlos" sort="Casasnovas, Carlos" uniqKey="Casasnovas C" first="Carlos" last="Casasnovas">Carlos Casasnovas</name>
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<name sortKey="Cemillan, Carlos" sort="Cemillan, Carlos" uniqKey="Cemillan C" first="Carlos" last="Cemillán">Carlos Cemillán</name>
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<nlm:affiliation>Neurology Department, Severo Ochoa University Hospital, Leganés, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<name sortKey="Cuadrado, Jose Ignacio" sort="Cuadrado, Jose Ignacio" uniqKey="Cuadrado J" first="José Ignacio" last="Cuadrado">José Ignacio Cuadrado</name>
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<nlm:affiliation>Epidemiology Department, Regional Ministry of Health, Madrid Autonomous Region, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Epidemiology Department, Regional Ministry of Health, Madrid Autonomous Region</wicri:regionArea>
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<name sortKey="Duarte, Jacinto" sort="Duarte, Jacinto" uniqKey="Duarte J" first="Jacinto" last="Duarte">Jacinto Duarte</name>
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<nlm:affiliation>Neurology Department, General Hospital, Segovia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Neurology Department, General Hospital, Segovia</wicri:regionArea>
<wicri:noRegion>Segovia</wicri:noRegion>
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<name sortKey="Fernandez Perez, Maria Dolores" sort="Fernandez Perez, Maria Dolores" uniqKey="Fernandez Perez M" first="María Dolores" last="Fernández-Pérez">María Dolores Fernández-Pérez</name>
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<nlm:affiliation>Neurology Department, Virgen de las Nieves University Hospital, Granada, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Neurology Department, Virgen de las Nieves University Hospital, Granada</wicri:regionArea>
<wicri:noRegion>Granada</wicri:noRegion>
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<name sortKey="Fernandez, Scar" sort="Fernandez, Scar" uniqKey="Fernandez " first=" Scar" last="Fernández"> Scar Fernández</name>
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<nlm:affiliation>Neurology Department, Carlos Haya University Hospital, Málaga, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Neurology Department, Carlos Haya University Hospital, Málaga</wicri:regionArea>
<wicri:noRegion>Málaga</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Merino, Juan Antonio Garcia" sort="Merino, Juan Antonio Garcia" uniqKey="Merino J" first="Juan Antonio García" last="Merino">Juan Antonio García Merino</name>
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<nlm:affiliation>Neurology Department, Puerta de Hierro University Hospital, Majadahonda, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Neurology Department, Puerta de Hierro University Hospital, Majadahonda, Madrid</wicri:regionArea>
<placeName>
<settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
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<name sortKey="Montero, Rosa Garcia" sort="Montero, Rosa Garcia" uniqKey="Montero R" first="Rosa García" last="Montero">Rosa García Montero</name>
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<nlm:affiliation>Neurology Department, Virgen de la Salud Hospital, Toledo, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Neurology Department, Virgen de la Salud Hospital, Toledo</wicri:regionArea>
<wicri:noRegion>Toledo</wicri:noRegion>
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<name sortKey="Montero, Dolores" sort="Montero, Dolores" uniqKey="Montero D" first="Dolores" last="Montero">Dolores Montero</name>
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<nlm:affiliation>Spanish Medicines & Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Spanish Medicines & Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), Madrid</wicri:regionArea>
<placeName>
<settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
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<name sortKey="Pardo, Julio" sort="Pardo, Julio" uniqKey="Pardo J" first="Julio" last="Pardo">Julio Pardo</name>
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<nlm:affiliation>Neurology Department, University Teaching Hospital Clínico, Santiago de Compostela (Corunna), Spain.</nlm:affiliation>
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<author>
<name sortKey="Rodriguez Rivera, Francisco Javier" sort="Rodriguez Rivera, Francisco Javier" uniqKey="Rodriguez Rivera F" first="Francisco Javier" last="Rodríguez-Rivera">Francisco Javier Rodríguez-Rivera</name>
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<nlm:affiliation>Neurology Department, La Paz University Hospital, Madrid, Spain.</nlm:affiliation>
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<author>
<name sortKey="Ruiz Tovar, Maria" sort="Ruiz Tovar, Maria" uniqKey="Ruiz Tovar M" first="María" last="Ruiz-Tovar">María Ruiz-Tovar</name>
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<nlm:affiliation>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid, Spain.</nlm:affiliation>
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<author>
<name sortKey="De Pedro Cuesta, Jesus" sort="De Pedro Cuesta, Jesus" uniqKey="De Pedro Cuesta J" first="Jesús" last="De Pedro-Cuesta">Jesús De Pedro-Cuesta</name>
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<nlm:affiliation>National Centre for Epidemiology, CIBERNED, Carlos III Health Institute, Madrid, Spain. jpedro@isciii.es.</nlm:affiliation>
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<title level="j">BMC neurology</title>
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<term>Adult (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Databases, Factual (MeSH)</term>
<term>Epidemiological Monitoring (MeSH)</term>
<term>Female (MeSH)</term>
<term>Guillain-Barre Syndrome (epidemiology)</term>
<term>Humans (MeSH)</term>
<term>Incidence (MeSH)</term>
<term>Influenza A Virus, H1N1 Subtype (immunology)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Neurologists (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Prospective Studies (MeSH)</term>
<term>Public Health Surveillance (MeSH)</term>
<term>Retrospective Studies (MeSH)</term>
<term>Spain (epidemiology)</term>
<term>Time Factors (MeSH)</term>
</keywords>
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<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Bases de données factuelles (MeSH)</term>
<term>Espagne (épidémiologie)</term>
<term>Facteurs temps (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Incidence (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Neurologues (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Sous-type H1N1 du virus de la grippe A (immunologie)</term>
<term>Sujet âgé (MeSH)</term>
<term>Surveillance de la santé publique (MeSH)</term>
<term>Surveillance épidémiologique (MeSH)</term>
<term>Syndrome de Guillain-Barré (épidémiologie)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
<term>Études prospectives (MeSH)</term>
<term>Études rétrospectives (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en">
<term>Influenza Vaccines</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en">
<term>Guillain-Barre Syndrome</term>
<term>Spain</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr">
<term>Sous-type H1N1 du virus de la grippe A</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en">
<term>Influenza A Virus, H1N1 Subtype</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr">
<term>Espagne</term>
<term>Syndrome de Guillain-Barré</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Databases, Factual</term>
<term>Epidemiological Monitoring</term>
<term>Female</term>
<term>Humans</term>
<term>Incidence</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neurologists</term>
<term>Pandemics</term>
<term>Prospective Studies</term>
<term>Public Health Surveillance</term>
<term>Retrospective Studies</term>
<term>Time Factors</term>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Bases de données factuelles</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Incidence</term>
<term>Mâle</term>
<term>Neurologues</term>
<term>Pandémies</term>
<term>Sujet âgé</term>
<term>Surveillance de la santé publique</term>
<term>Surveillance épidémiologique</term>
<term>Études prospectives</term>
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<p>
<b>BACKGROUND</b>
</p>
<p>Studies have shown a slight excess risk in Guillain-Barré syndrome (GBS) incidence associated with A(H1N1)pdm09 vaccination campaign and seasonal trivalent influenza vaccine immunisations in 2009-2010. We aimed to assess the incidence of GBS as a potential adverse effect of A(H1N1)pdm09 vaccination.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>A neurologist-led network, active at the neurology departments of ten general hospitals serving an adult population of 4.68 million, conducted GBS surveillance in Spain in 2009-2011. The network, established in 1996, carried out a retrospective and a prospective study to estimate monthly alarm thresholds in GBS incidence and tested them in 1998-1999 in a pilot study. Such incidence thresholds additionally to observation of GBS cases with immunisation antecedent in the 42 days prior to clinical onset were taken as alarm signals for 2009-2011, since November 2009 onwards. For purpose of surveillance, in 2009 we updated both the available centres and the populations served by the network. We also did a retrospective countrywide review of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis from January 2009 to December 2011.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>Among 141 confirmed of 148 notified cases of GBS or Miller-Fisher syndrome, Brighton 1-2 criteria in 96 %, not a single patient was identified with clinical onset during the 42-day time interval following A(H1N1)pdm09 vaccination. In contrast, seven cases were seen during a similar period after seasonal campaigns. Monthly incidence figures did not, however, exceed the upper 95 % CI limit of expected incidence. A retrospective countrywide review of the registry of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis did not suggest higher admission rates in critical months across the period December 2009-February 2010.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>Despite limited power and underlying reporting bias in 2010-2011, an increase in GBS incidence over background GBS, associated with A(H1N1)pdm09 monovalent or trivalent influenza immunisations, appears unlikely.</p>
</div>
</front>
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<Year>2016</Year>
<Month>12</Month>
<Day>19</Day>
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<Year>2018</Year>
<Month>12</Month>
<Day>02</Day>
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<ISSN IssnType="Electronic">1471-2377</ISSN>
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<Volume>16</Volume>
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<Year>2016</Year>
<Month>May</Month>
<Day>21</Day>
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<Title>BMC neurology</Title>
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<ArticleTitle>Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database.</ArticleTitle>
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<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Studies have shown a slight excess risk in Guillain-Barré syndrome (GBS) incidence associated with A(H1N1)pdm09 vaccination campaign and seasonal trivalent influenza vaccine immunisations in 2009-2010. We aimed to assess the incidence of GBS as a potential adverse effect of A(H1N1)pdm09 vaccination.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">A neurologist-led network, active at the neurology departments of ten general hospitals serving an adult population of 4.68 million, conducted GBS surveillance in Spain in 2009-2011. The network, established in 1996, carried out a retrospective and a prospective study to estimate monthly alarm thresholds in GBS incidence and tested them in 1998-1999 in a pilot study. Such incidence thresholds additionally to observation of GBS cases with immunisation antecedent in the 42 days prior to clinical onset were taken as alarm signals for 2009-2011, since November 2009 onwards. For purpose of surveillance, in 2009 we updated both the available centres and the populations served by the network. We also did a retrospective countrywide review of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis from January 2009 to December 2011.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Among 141 confirmed of 148 notified cases of GBS or Miller-Fisher syndrome, Brighton 1-2 criteria in 96 %, not a single patient was identified with clinical onset during the 42-day time interval following A(H1N1)pdm09 vaccination. In contrast, seven cases were seen during a similar period after seasonal campaigns. Monthly incidence figures did not, however, exceed the upper 95 % CI limit of expected incidence. A retrospective countrywide review of the registry of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis did not suggest higher admission rates in critical months across the period December 2009-February 2010.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Despite limited power and underlying reporting bias in 2010-2011, an increase in GBS incidence over background GBS, associated with A(H1N1)pdm09 monovalent or trivalent influenza immunisations, appears unlikely.</AbstractText>
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<ForeName>Enrique</ForeName>
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<ForeName>Javier</ForeName>
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<country>
<li>Espagne</li>
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<li>Communauté de Madrid</li>
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<name sortKey="Alcalde Cabero, Enrique" sort="Alcalde Cabero, Enrique" uniqKey="Alcalde Cabero E" first="Enrique" last="Alcalde-Cabero">Enrique Alcalde-Cabero</name>
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<name sortKey="Fernandez Perez, Maria Dolores" sort="Fernandez Perez, Maria Dolores" uniqKey="Fernandez Perez M" first="María Dolores" last="Fernández-Pérez">María Dolores Fernández-Pérez</name>
<name sortKey="Fernandez, Scar" sort="Fernandez, Scar" uniqKey="Fernandez " first=" Scar" last="Fernández"> Scar Fernández</name>
<name sortKey="Garcia L Pez, Fernando J" sort="Garcia L Pez, Fernando J" uniqKey="Garcia L Pez F" first="Fernando J" last="García L Pez">Fernando J. García L Pez</name>
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<name sortKey="Pardo, Julio" sort="Pardo, Julio" uniqKey="Pardo J" first="Julio" last="Pardo">Julio Pardo</name>
<name sortKey="Rodriguez Rivera, Francisco Javier" sort="Rodriguez Rivera, Francisco Javier" uniqKey="Rodriguez Rivera F" first="Francisco Javier" last="Rodríguez-Rivera">Francisco Javier Rodríguez-Rivera</name>
<name sortKey="Ruiz Tovar, Maria" sort="Ruiz Tovar, Maria" uniqKey="Ruiz Tovar M" first="María" last="Ruiz-Tovar">María Ruiz-Tovar</name>
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