%0 Journal Article
%A Alcalde-Cabero, Enrique
%A Almazán-Isla, Javier
%A García López, Fernando J
%A Ara-Callizo, José Ramón
%A Avellanal, Fuencisla
%A Casasnovas, Carlos
%A Cemillán, Carlos
%A Cuadrado, José Ignacio
%A Duarte, Jacinto
%A Fernández-Pérez, María Dolores
%A Fernández, Óscar
%A García Merino, Juan Antonio
%A García Montero, Rosa
%A Montero, Dolores
%A Pardo, Julio
%A Rodríguez-Rivera, Francisco Javier
%A Ruiz-Tovar, María
%A de Pedro-Cuesta, Jesús
%T 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.
%D 2016
%U http://hdl.handle.net/10668/2292
%X BACKGROUNDStudies 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.METHODSA 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.RESULTSAmong 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.CONCLUSIONSDespite 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.
%K Guillain-Barré syndrome
%K Influenza A virus H1N1 subtype
%K Influenza vaccines
%K Public health surveillance
%K Safety
%K ICD-9-CM
%K Síndrome de Guillain-Barré
%K Hospitales generales
%K Inmunización
%K Incidencia
%K Subtipo H1N1 del virus de la influenza A
%K Vacunas contra la influenza
%K Gripe Humana
%K Clasificación internacional de enfermedades
%K Síndrome de Miller Fisher
%K Neuritis
%K Proyectos piloto
%K Estudios prospectivos
%K Sistema de registros
%K Estudios retrospectivos
%K Riesgo
%K Estaciones del año
%K España
%K Vacunación
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