RT Journal Article T1 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. A1 Alcalde-Cabero, Enrique A1 Almazán-Isla, Javier A1 García López, Fernando J A1 Ara-Callizo, José Ramón A1 Avellanal, Fuencisla A1 Casasnovas, Carlos A1 Cemillán, Carlos A1 Cuadrado, José Ignacio A1 Duarte, Jacinto A1 Fernández-Pérez, María Dolores A1 Fernández, Óscar A1 García Merino, Juan Antonio A1 García Montero, Rosa A1 Montero, Dolores A1 Pardo, Julio A1 Rodríguez-Rivera, Francisco Javier A1 Ruiz-Tovar, María A1 de Pedro-Cuesta, Jesús K1 Guillain-Barré syndrome K1 Influenza A virus H1N1 subtype K1 Influenza vaccines K1 Public health surveillance K1 Safety K1 ICD-9-CM K1 Síndrome de Guillain-Barré K1 Hospitales generales K1 Inmunización K1 Incidencia K1 Subtipo H1N1 del virus de la influenza A K1 Vacunas contra la influenza K1 Gripe Humana K1 Clasificación internacional de enfermedades K1 Síndrome de Miller Fisher K1 Neuritis K1 Proyectos piloto K1 Estudios prospectivos K1 Sistema de registros K1 Estudios retrospectivos K1 Riesgo K1 Estaciones del año K1 España K1 Vacunación AB 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. PB BioMed Central YR 2016 FD 2016-05-21 LK http://hdl.handle.net/10668/2292 UL http://hdl.handle.net/10668/2292 LA en NO Alcalde-Cabero E, Almazán-Isla J, García López FJ, Ara-Callizo JR, Avellanal F, Casasnovas C, et al. 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. BMC Neurol. 2016; 16(1):75 NO Journal Article; DS RISalud RD Apr 7, 2025