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    Postvaccinale gebeurtenissen na toediening van RIVM vaccins in het Rijksvaccinatieprogramma ; deel 1. meldingen in 1994

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    Authors
    Vermeer-de Bondt PE
    Labadie J
    Rumke HC;
    Series/Report no.
    RIVM Rapport 100012001
    Type
    Report
    Language
    nl
    
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    Title
    Postvaccinale gebeurtenissen na toediening van RIVM vaccins in het Rijksvaccinatieprogramma ; deel 1. meldingen in 1994
    Translated Title
    Adverse events following immunisation in the Dutch National vaccination programme ; part 1. reports in 1994
    Publiekssamenvatting
    Adverse events following immunisation (AEFI) in the Dutch National Vaccination Programme (RVP) have been monitored by RIVM since 1962 through an enhanced passive surveillance system. From 1984 onwards evaluation is done in collaboration with the National Health Council. Reports from health care workers are received mainly by telephone through the operating vaccine information and advisory service. Further data are obtained if necessary from parents, general practitioners, pediatricians etc. After supplementation and verification of data a (working)diagnosis is made and causality assessed. In this report on 1994 an overview of all received AEFI is presented with classification according to case definitions and causality. Reporting bias, background rates of specific events and possible pathophysiology of symptoms are discussed. On a total of approximately 2 million vaccinations 712 AEFI were submitted. Of these 2%(16) was unclassifiable because of missing information. In 85%(590) of the classifiable events a possible causal relation with vaccination was established and in 15%(106) the events were judged to be coincidental. Compared with 1993 there was a rise in the number of notifications. Thorough evaluation revealed no increase of true side effects after implementation of Hib vaccination in the Netherlands. The increase in reported AEFI appears to be due to a decrease in underreporting.
    Vermoede bijwerkingen van vaccinaties van het Rijksvaccinatieprogramma (RVP) worden in Nederlandcentraal geregistreerd door het RIVM sinds 1962. De bewaking van de veiligheid van het RVP, vanaf 1984 in nauwe samenwerking met de Gezondheidsraad, is gebaseerd op een passief systeem, dat steunt op vrijwillige spontane meldingen. Omdat behoefte bestaat aan een completer beeld van de binnengekomen meldingen is besloten alle meldingen van vermoede bijwerkingen per kalenderjaar te rapporteren. Trends in aard en aantal worden zo sneller zichtbaar en vergelijkingen tussen verschillende jaren, vaccins en eventueel vaccinatieschema's zijn daarmee mogelijk. Dit is het eerste jaaroverzicht dat is opgesteld. In 1994 zijn over een totaal van circa 2 miljoen vaccinaties 712 postvaccinale gebeurtenissen gemeld; bij 12 kinderen was het een meervoudige melding met vermoede bijwerkingen na twee verschillende vaccinaties. Wegens gebrek aan gegevens was in 2% (16) van de gevallen geen beoordeling op causaliteit mogelijk. Van de wel beoordeelbare meldingen werd in 85% (590) een mogelijk causaal verband met de vaccinaties vastgesteld; deze gelden daarmee als bijwerking. De overige 106 (15%) postvaccinale gebeurtenissen waren coincidenteel. De toename van het aantal meldingen die al in 1993 zichtbaar werd lijkt te berusten op een afname van onderrapportage en niet op een werkelijke stijging in het aantal bijwerkingen.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    URI
    http://hdl.handle.net/10029/9887
    Collections
    RIVM official reports

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