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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

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dc.contributor.authorAlcalde-Cabero, Enrique
dc.contributor.authorAlmazan-Isla, Javier
dc.contributor.authorGarcia Lopez, Fernando Jose
dc.contributor.authorAra-Callizo, José Ramón
dc.contributor.authorAvellanal, Fuencisla
dc.contributor.authorCasasnovas, Carlos
dc.contributor.authorCemillán, Carlos
dc.contributor.authorCuadrado, José Ignacio
dc.contributor.authorDuarte, Jacinto
dc.contributor.authorFernández-Pérez, María Dolores
dc.contributor.authorFernández, Óscar
dc.contributor.authorMerino, Juan Antonio García
dc.contributor.authorMontero, Rosa García
dc.contributor.authorMontero, Dolores
dc.contributor.authorPardo, Julio
dc.contributor.authorRodríguez-Rivera, Francisco Javier
dc.contributor.authorRuiz-Tovar, Maria
dc.contributor.authorPedro-Cuesta, Jesus de
dc.date.accessioned2017-09-04T16:28:42Z
dc.date.available2017-09-04T16:28:42Z
dc.date.issued2016-05-21
dc.description.abstractBACKGROUND: 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
dc.description.peerreviewedSí
dc.format.number1
dc.format.page75
dc.format.volume16
dc.identifier.citationBMC Neurol. 2016; 16:75
dc.identifier.doi10.1186/s12883-016-0598-z
dc.identifier.e-issn1471-2377
dc.identifier.journalBMC Neurology
dc.identifier.urihttp://hdl.handle.net/20.500.12105/4814
dc.language.isoeng
dc.publisherBioMed Central (BMC)
dc.relation.publisherversionhttps://bmcneurol.biomedcentral.com/articles/10.1186/s12883-016-0598-z
dc.repisalud.centroISCIII::Centro Nacional de Epidemiología
dc.repisalud.institucionISCIII
dc.rights.accessRightsopen accesses_ES
dc.rights.licenseAtribución 3.0 España*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/es/*
dc.subjectGuillain-Barré syndrome
dc.subjectInfluenza A virus H1N1 subtype
dc.subjectInfluenza vaccines
dc.subjectPublic health surveillance
dc.subjectSafety
dc.subjectICD-9-CM
dc.titleGuillain-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
dc.typejournal article
dc.type.hasVersionVoR
dspace.entity.typePublication
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