<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1130-6343</journal-id>
<journal-title><![CDATA[Farmacia Hospitalaria]]></journal-title>
<abbrev-journal-title><![CDATA[Farm Hosp.]]></abbrev-journal-title>
<issn>1130-6343</issn>
<publisher>
<publisher-name><![CDATA[Grupo Aula Médica]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1130-63432018000500191</article-id>
<article-id pub-id-type="doi">10.7399/fh.10989</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations]]></article-title>
<article-title xml:lang="es"><![CDATA[Reacciones adversas asociadas a la vacuna del meningococo B (4CMenB) en adultos en situaciones especiales]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández-Prada]]></surname>
<given-names><![CDATA[María]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez-Ortega]]></surname>
<given-names><![CDATA[Carmen]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hidalgo-Peña]]></surname>
<given-names><![CDATA[Lara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Álvarez-Vázquez]]></surname>
<given-names><![CDATA[Clara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Aguirre-del Pino]]></surname>
<given-names><![CDATA[Rodrigo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Huerta-González]]></surname>
<given-names><![CDATA[Ismael]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Hospital Universitario Central de Asturias Department of Preventive Medicine and Public Health Vaccination Unit]]></institution>
<addr-line><![CDATA[Oviedo ]]></addr-line>
<country>Spain</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital Valle del Nalón Department of Preventive Medicine and Public Health ]]></institution>
<addr-line><![CDATA[Riaño ]]></addr-line>
<country>Spain</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Universidad de Oviedo School of Medicine ]]></institution>
<addr-line><![CDATA[Oviedo ]]></addr-line>
<country>Spain</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Regional Ministry of Health of the Principality of Asturias Directorate General of Public Health Department of Epidemiological Surveillance]]></institution>
<addr-line><![CDATA[Oviedo ]]></addr-line>
<country>Spain</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>10</month>
<year>2018</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>10</month>
<year>2018</year>
</pub-date>
<volume>42</volume>
<numero>5</numero>
<fpage>191</fpage>
<lpage>196</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1130-63432018000500191&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1130-63432018000500191&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1130-63432018000500191&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations.  Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied. The adverse reactions described in the data sheet were collected. The adverse reactions evaluation was performed 24 hours after vaccination (&#8220;requested&#8221;) and during the first seven days (&#8220;not requested&#8221;).  Results: 72 patients were included (54.2% men, mean age 52.5 years, 81.9% anatomic asplenia). The frequency of fever &gt; 38 ºC in the first 24 hours of vaccination was higher than the observed in the summary of product characteristics for the group of adults (12.5% vs. not known). More than 75% of the patients reported local pain in the first hours (average of the Analog Visual Scale score 3.22 (95% CI: 2.67-3.76) in the first dose and 3.23 (95% CI: 2.69-3.78) in the second dose). There were no statistically significant differences. 97.22% registered symptoms until 7 days after vaccination.  Conclusions: 4CMenB shows a good safety profile in adults in special situations. The frequency of fever &gt; 38 ºC is higher than expected. Local pain is the most frequently recorded adverse reactions, but the intensity is low. These results suggest a review of the situation in order to suggest a possible modification of the summary of product characteristics of the vaccine.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Objetivo: Conocer el perfil de seguridad de la vacuna del meningococo B (4CMenB) en adultos en situaciones especiales.  Método: Estudio prospectivo de seguridad de fase IV. Se aplicaron criterios de inclusión y ciertas condiciones de vacunación. Se recogieron las reacciones adversas descritas en la ficha técnica. La evaluación de las reacciones adversas se realizó a las 24 horas de la vacunación (&#8220;solicitadas&#8221;) y durante los siete primeros días (&#8220;no solicitadas&#8221;).  Resultados: Se incluyeron 72 pacientes (54,2% hombres; media de edad 52,5 años; 81,9% asplenia anatómica). La frecuencia de fiebre &gt; 38 ºC en las primeras 24 horas fue mayor de la observada en la ficha técnica para el grupo de adultos (12,5% versus no conocida). Más del 75% de los pacientes refirió dolor local en las primeras horas (media de la puntuación de la Escala Visual Analógica 3,22 (IC95%: 2,67-3,76) en la primera dosis y 3,23 (IC95%: 2,69-3,78) en la segunda dosis). No hubo diferencias estadísticamente significativas. El 97,22% registró síntomas hasta los siete días postvacunación.  Conclusiones: 4CMenB muestra un buen perfil de seguridad en adultos en situaciones especiales. La frecuencia de fiebre &gt; 38 ºC es mayor que la esperada. El dolor local es la reacción adversa más frecuentemente registrada, pero la intensidad es baja. Estos resultados invitan a una revisión de la situación de cara a sugerir una posible modificación de la ficha técnica.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Postmarketing Drug Surveillance]]></kwd>
<kwd lng="en"><![CDATA[Adverse effects]]></kwd>
<kwd lng="en"><![CDATA[Vaccines]]></kwd>
<kwd lng="en"><![CDATA[4CMenB]]></kwd>
<kwd lng="en"><![CDATA[Meningitis]]></kwd>
<kwd lng="en"><![CDATA[Immunocompromised patients]]></kwd>
<kwd lng="en"><![CDATA[Meningococcus]]></kwd>
<kwd lng="es"><![CDATA[Seguimiento postautorización]]></kwd>
<kwd lng="es"><![CDATA[Efectos adversos]]></kwd>
<kwd lng="es"><![CDATA[Vacuna]]></kwd>
<kwd lng="es"><![CDATA[4CMenB]]></kwd>
<kwd lng="es"><![CDATA[Meningitis]]></kwd>
<kwd lng="es"><![CDATA[Pacientes inmunocomprometidos]]></kwd>
<kwd lng="es"><![CDATA[Meningococo]]></kwd>
</kwd-group>
</article-meta>
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