Adverse Events in the Netherlands Vaccination Programme

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Adverse Events in the Netherlands Vaccination Programme Adverse Events in the Netherlands Vaccination Programme Adverse Events in the Netherlands Vaccination Adverse Adverse Events in the Netherlands Vaccination Programme Events in the Reports in 2010 and Review 1994-2010 Netherlands Adverse Events in the Netherlands Vaccination Programme Reports in 2010 and Review 1994-2010 RIVM Report 205051004/2011 RIVM Report 205051004 Colophon © RIVM 2011 Parts of this publication may be reproduced, provided acknowledgement is given to the 'National Institute for Public Health and the Environment', along with the title and year of publication. P.E. Vermeer-de Bondt, Centre for Infectious Disease Control Netherlands N. Moorer-Lanser, Centre for Infectious Disease Control Netherlands T.A.J. Phaff, Centre for Infectious Disease Control Netherlands B. Oostvogels, Centre for Infectious Disease Control Netherlands C. Wesselo, Centre for Infectious Disease Control Netherlands N.A.T. van der Maas, Centre for Infectious Disease Control Netherlands Contact: P.E.Vermeer-de Bondt Preparedness and Response Unit-LCI [email protected] This investigation has been performed by order and for the account of the Ministry of Health, Welfare and Sport and the Health Care Inspectorate, within the framework of Safety Surveillance of the Netherlands Vaccination programme V/205021/01/VR Page 2 of 143 RIVM Report 205051004 Abstract Adverse Events in the Netherlands Vaccination Programme Reports in 2010 and Review 1994-2010 In 2010, 800,000 children received one or more vaccines on 1.3 million dates, with more than 7 million vaccine components. There is always some chance of adverse reactions but these are usually not severe, though sometimes frightening. This year, RIVM received 1380 reports of adverse events following immunisation (AEFI). This is 16% less than in 2009 when 2 vaccination campaigns raised considerable adverse publicity with subsequent increase in reports. Data show that the benefit of the vaccination programme outweighs the risk of adverse reactions by far. Safety surveillance: necessary part of the vaccination programme Enhanced safety surveillance has been an integral part of the vaccination programme since 1962. Annual reports have been published since 1983, following independent re- evaluation. The surveillance system of the Netherlands enjoys very high reporting rates and is highly sensitive for signals. It allows individual follow-up because of name-based reporting. In this last year of safety surveillance in this setting, we present an overview of results since 1994. This brings some new insights. Careful reporting and validation system All reports were validated and complemented, preferably also with eyewitness accounts (92%). Final assessment followed according to case definitions and causality criteria. The embedding of the safety surveillance in the telephone consultation service has contributed to the quality of the reports. Reported adverse events In 2010, 78% of reports (1082) had possible causal relation with the vaccination. These concerned major adverse reactions in 48% (523), including very high fever (>40.5 °C), persistent screaming, collapse, discoloured legs, febrile convulsions or atypical attacks with chills, myoclonics or hyper/hypo-tonicity. Altogether 22% (296) of reports were chance occurrences. Reported severe infections and epilepsy had no causal relation with the vaccinations. In addition, none of the 5 reports on death was related to vaccination. An independent expert committee has reassessed these severe adverse events. Keywords: adverse event following immunisation, AEFI, vaccination programme, safety surveillance, childhood vaccines, immunisation Page 3 of 143 RIVM Report 205051004 Page 4 of 143 RIVM Report 205051004 Rapport in het kort Bijwerkingen van het Rijksvaccinatieprogramma Meldingen in 2010 en overzicht 1994-2010 In 2010 kregen 800.000 kinderen in Nederland vaccinaties binnen het Rijksvaccinatieprogramma (RVP). In het totaal is ruim 1,3 miljoen keer gevaccineerd, met meer dan 7 miljoen vaccins – de meeste prikken bevatten meerdere vaccins. Dit jaar zijn 1380 vermoede bijwerkingen gemeld. Dat is 16 procent minder dan in 2009, een jaar waarin de twee grootschalige vaccinatiecampagnes tegen baarmoederhalskanker en pandemische griep aanzienlijke onrust veroorzaakten, waardoor het aantal meldingen van bijwerkingen toenam. De grote gezondheidswinst van het RVP weegt op tegen de bijwerkingen, ook al zijn deze soms heftig en schrikaanjagend. Veiligheidsbewaking: noodzakelijk onderdeel RVP Intensieve veiligheidsbewaking is sinds 1962 een vast en noodzakelijk onderdeel van het vaccinatieprogramma. Vanaf 1983 is jaarlijks hierover gerapporteerd, waarbij een onafhankelijke partij meldingen herbeoordeeld. Het gestimuleerde bewakingssysteem heeft een uitermate hoge meldgraad en is door de jaren heen steeds gevoelig gebleken voor signalen. Het laat bovendien toe dat meldingen op langere termijn worden gevolgd, omdat bijwerkingen op naam worden gemeld. In dit laatste jaar van de veiligheidsbewaking bij het RIVM wordt naast de meldingen van 2010 een overzicht gegeven van bevindingen vanaf 1994. Dit toont diverse nieuwe inzichten. Zorgvuldig meldings- en validatiesysteem Alle meldingen worden gevalideerd en aangevuld met gegevens die nodig zijn om een juist beeld van de situatie te krijgen. Dit gebeurt bij voorkeur ook met een ooggetuigenverslag (92 procent). Daarna worden de meldingen getoetst aan definities voor diagnoses en wordt beoordeeld of er een oorzakelijk verband is met de vaccinaties. De telefonische adviesdienst is een belangrijk instrument van de bijwerkingenbewaking en heeft aanzienlijk bijgedragen aan de kwaliteit van de meldingen. Gemelde bijwerkingen In 2010 werd 78 procent (1082) van de meldingen daadwerkelijk als bijwerking beschouwd. Daarvan betrof het in 48 procent (523) zogenoemde major ziektebeelden, zoals zeer hoge koorts (vanaf 40,5 °C), langdurig huilen, collapsreacties, verkleurde benen, koortsstuipen of atypische aanvallen met rillingen, schrikschokken, gespannenheid of slapte. Bij 296 meldingen (22 procent) was er een toevallige samenloop van omstandigheden en geen oorzakelijk verband met de vaccinatie. Ook de gemelde ernstige infecties en epilepsie stonden los van de vaccinaties. Bij de vijf kinderen die na een vaccinatie zijn overleden, zijn de vaccinaties daarvan evenmin de oorzaak geweest. Dergelijke ernstige beelden zijn herbeoordeeld door een groep van externe deskundigen. Trefwoorden: bijwerking, rijksvaccinatieprogramma, vaccinaties, veiligheidsbewaking, RVP Page 5 of 143 RIVM Report 205051004 Page 6 of 143 RIVM Report 205051004 Contents Summary—9 Samenvatting—11 1 Introduction—13 2 The Netherlands Vaccination Programme—15 2.1 Vaccines, Schedule and Registration—15 2.2 Child Health Care System—16 2.3 Safety Surveillance—16 3 Materials and methods—19 3.1 Post Vaccination Events—19 3.2 Reporting Criteria—19 3.3 Notification and Single, Compound or Multiple Reports—20 3.4 Reporters and Information Sources—21 3.5 Additional Information—21 3.6 Working Diagnosis and Event Categories—21 3.7 Causality Assessment—23 3.8 Recording, Filing, Feedback and Follow-up—24 3.9 Annual Reports and Aggregated Analysis—24 3.10 Expert Panel—25 3.11 Quality Assurance—25 3.12 Medical Control Agency and Pharmacovigilance—25 4 Results—27 4.1 Number and Type of Reports—27 4.2 Reporters, Reporting Route, and Information Sources—30 4.2.1 Reporters—30 4.2.2 Reporting Route—30 4.2.3 Regional Distribution and Reporting Rates—32 4.2.4 Source of Additional Information—34 4.3 Vaccines, Schedule, Age and Sex Distribution—35 4.3.1 Vaccines and Reports per Dose—35 4.3.2 Age at Vaccination—39 4.3.3 Sex Distribution—40 4.4 Diagnoses, Severity, Information Sources and Medical Intervention—41 4.4.1 Diagnosis and Severity—41 4.4.2 Information Source—43 4.4.3 Medical Intervention—44 4.5 Causal Relation—46 4.6 Follow-up, Subsequent Vaccinations and Expert Panel Assessment—49 4.6.1 Feedback and Follow-up—49 4.6.2 Reassessment by Expert Panel—50 4.7 Specific Vaccines—50 4.7.1 DTP-IPV Booster at 4 Years—50 4.7.2 HPV vaccine—52 4.7.3 MMR vaccine—53 4.8 Categories of Adverse Events—54 4.8.1 Local Reactions—56 4.8.2 Minor General Illness—59 Page 7 of 143 RIVM Report 205051004 4.8.3 Major General Illness—62 4.8.4 Persistent Screaming—65 4.8.5 General Skin Symptoms—66 4.8.6 Discoloured Legs—69 4.8.7 Faints—70 4.8.8 Fits—73 4.8.9 Encephalopathy or Encephalitis—76 4.8.10 Anaphylactic Shock—76 4.8.11 Death—76 5 Discussion—79 5.1 Safety Surveillance of the Netherlands Vaccination Programme—80 5.1.1 Reports in 2010—80 5.1.2 Enhanced Passive Surveillance System of the RVP—81 5.1.3 Numbers and Reporters—81 5.1.4 Route of Reports and Quality of Information—82 5.1.5 Validation, Complementation and Systematic Evaluation—83 5.1.6 Causality Assessment—84 5.1.7 Aggregated Analysis—85 5.1.8 Absolute Numbers, Reporting Rates, Signals and Trends—85 5.1.9 Results for 1994-2010—85 5.2 Specific Events—86 5.2.1 Local Reactions—87 5.2.2 Collapse (HHE) and Fainting—89 5.2.3 Discoloured Legs—91 5.2.4 Convulsions and Epilepsy—92 5.2.5 Persistent Screaming—95 5.2.6 Allergic Reactions, Anaphylaxis—95 5.2.7 Rashes and Eczema—96 5.2.8 Encephalopathy or Encephalitis—97 5.2.9 Death, including sudden infant death syndrome—98 5.2.10 ITP—99 5.2.11 Autoimmune Disorders—100 5.2.12 Retardation, Autism and Behavioural Problems—101 5.2.13 Susceptibility for Infection and Immune Overload—102 5.2.14 Coincidental Events—102 5.3 Summarisation of Adverse Events for Specific Vaccines—102 5.3.1 Neonatal Hepatitis-B Vaccination—103 5.3.2 Infant Vaccines, DTP-IPV, Hib, HepB, Pneu—103 5.3.3 MMR with or without MenC—107 5.3.4 4-year Booster DT-IPV, DTP-IPV—109 5.3.5 9-year Booster DT-IPV and MMR—109 5.3.6 HPV—109 6 Conclusion—111 Acknowledgement—113 References—115 List of abbreviations—125 Appendices 1-4—127 Page 8 of 143 RIVM Report 205051004 Summary The National Institute for Public Health and Environment (RIVM) has monitored adverse events following immunisation (AEFI) under the Netherlands Vaccination Programme (RVP) of the Netherlands since 1962.
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