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Classification > Q - SCIENCE / PRECLINICAL SCIENCES > QW - MICROBIOLOGY AND IMMUNOLOGY > QW 805 Vaccines. Antitoxins. Toxoids
QW 805 Vaccines. Antitoxins. Toxoids |
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ISBN : 978-0-309-21435-3 : $ 72,86
Languages : English (eng)
Descriptors: Indexation
Electronic books ; Encephalitis, Varicella Zoster ; Epidemiology ; Evidence-Based Practice ; Influenza Vaccines ; Papillomavirus Vaccines ; United States ; Vaccines
Classification
QW 805 Vaccines. Antitoxins. ToxoidsAbstract:
In 1900, for every 1000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The cornerstone of the vaccine safety system in the United States is the National Childhood Vaccine Injury Act. This legislation was intended to bolster vaccine research and development through federal coordination of vaccine initiatives, and by providing relief to vaccine manufacturers facing financial burdens. A key component of the legislation required the Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse effects, especially in children.
The Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health effects associated with specific vaccines covered by the Vaccine Injury Compensation Program including varicella zoster vaccine, influenza vaccines, hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews prior studies, summarizes their findings, and evaluates the epidemiological evidence. It finds that while no vaccine is 100% safe, very few adverse events are shown to be caused by vaccines.
In addition, the evidence shows that vaccines do not cause several conditions of recent concern. For example, the MMR vaccine is not associated with autism or childhood diabetes. The DTaP vaccine is also not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. The Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.Contents note:
SUMMARY 1 -- Charge to the Committee 2 -- Assessing the Weight of Evidence 2 -- Causality Assessment 5 -- Causality Conclusions 7 -- Susceptibility 9 -- Concluding Comment 9 -- References 24 -- 1 INTRODUCTION 25 -- Charge to the Committee 27 -- Committee Process 28 -- Outline of the Report 28 -- References 33 -- 2 APPROACH 35 -- Literature Searching 35 -- Weight of Evidence 36 -- Causality Assessment 41 -- Special Considerations 45 -- References 48 -- 3 EVALUATING BIOLOGICAL MECHANISMS OF ADVERSE EVENTS 51 -- Latency Between Antigen Exposure and Peak Adaptive Immune Response 51 -- Immune-Mediated Mechanisms 52 -- Viral Activity 66 -- Injection-Related Adverse Events 67 -- Coagulation and Hypercoagulable States 69 -- Increased Susceptibility 70 -- Alterations in Brain Development 73 -- Contribution of Animal Models 76 -- References 79 -- 4 MEASLES, MUMPS, AND RUBELLA VACCINE 89 -- Introduction 89 -- Measles Inclusion Body Encephalitis 93 -- Encephalitis and Encephalopathy 95 -- Febrile Seizures 100 -- Afebrile Seizures 105 -- Meningitis 107 -- Ataxia 110 -- Autism 112 -- Acute Disseminated Encephalomyelitis 115 -- Transverse Myelitis 116 -- Optic Neuritis 117 -- Neuromyelitis Optica 119 -- Multiple Sclerosis Onset in Adults 120 -- Multiple Sclerosis Onset in Children 122 -- Guillain-Barré Syndrome 123 -- Chronic Inflammatory Disseminated Polyneuropathy 124 -- Opsoclonus Myoclonus Syndrome 125 -- Brachial Neuritis 125 -- Anaphylaxis 126 -- Transient Arthralgia in Women 130 -- Transient Arthralgia in Children 134 -- Chronic Arthralgia in Women 137 -- Chronic Arthritis in Women 140 -- Chronic Arthropathy in Children 143 -- Arthropathy in Men 144 -- Type 1 Diabetes 146 -- Hepatitis 149 -- Chronic Fatigue Syndrome 150 -- Fibromyalgia 151 -- Hearing Loss 151 -- References 196 -- 5 VARICELLA VIRUS VACCINE 211 -- Introduction 211 -- Disseminated Oka VZV Without Other Organ Involvement 213 -- Disseminated Oka VZV with Other Organ Involvement 219 -- Vaccine Strain Viral Reactivation Without Other Organ Involvement 224 -- Vaccine Strain Viral Reactivation with Other Organ Involvement 228 -- Encephalopathy 233 -- Seizures 233 -- Cerebellar Ataxia 235 -- Acute Disseminated Encephalomyelitis 236 -- Transverse Myelitis 237 -- Guillain-Barré Syndrome 238 -- Small Fiber Neuropathy 239 -- Anaphylaxis 239 -- Onset or Exacerbation of Arthropathy 242 -- Stroke 243 -- Thrombocytopenia 244 -- References 248 -- 6 INFLUENZA VACCINE 257 -- Introduction 257 -- Encephalitis and Encephalopathy 262 -- Seizures 264 -- Acute Disseminated Encephalomyelitis 267 -- Optic Neuritis 269 -- Neuromyelitis Optica 271 -- Multiple Sclerosis Onset in Adults 271 -- Multiple Sclerosis Relapse in Adults 273 -- Guillain-Barré Syndrome 275 -- Chronic Inflammatory Disseminated Polyneuropathy 281 -- Bell’s Palsy 282 -- Brachial Neuritis 284 -- Small Fiber Neuropathy 285 -- Anaphylaxis 285 -- Inactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease -- Episodes in Children and Adults 288 -- Live Attenuated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease -- Episodes in Children Younger Than 5 Years of Age 293 -- Live Attenuated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease -- Episodes in Persons 5 Years of Age or Older 298 -- Onset or Exacerbation of Systemic Lupus Erythematosus 301 -- Onset or Exacerbation of Vasculitis 304 -- Polyarteritis Nodosa 306 -- Onset or Exacerbation of Arthropathy 307 -- Stroke 308 -- Myocardial Infarction 309 -- Fibromyalgia 311 -- All-Cause Mortality 311 -- Oculorespiratory Syndrome 313 -- References 354 -- 7 HEPATITIS A VACCINE 369 -- Introduction 369 -- Acute Disseminated Encephalomyelitis 370 -- Transverse Myelitis 371 -- Multiple Sclerosis 372 -- Guillain-Barré Syndrome 373 -- Chronic Inflammatory Disseminated Polyneuropathy 374 -- Bell’s Palsy 374 -- Anaphylaxis 375 -- Autoimmune Hepatitis 376 -- References 378 -- 8 HEPATITIS B VACCINE 381 -- Introduction 381 -- Encephalitis and Encephalopathy 383 -- Seizures 383 -- Acute Disseminated Encephalomyelitis 385 -- Transverse Myelitis 386 -- Optic Neuritis 387 -- Neuromyelitis Optica 389 -- Multiple Sclerosis Onset in Adults 390 -- Multiple Sclerosis Onset in Children 392 -- Multiple Sclerosis Relapse in Adults 394 -- Multiple Sclerosis Relapse in Children 395 -- First Demyelinating Event in Adults 396 -- First Demyelinating Event in Children 399 -- Guillain-Barré Syndrome 400 -- Chronic Inflammatory Disseminated Polyneuropathy 401 -- Brachial Neuritis 402 -- Anaphylaxis 402 -- Erythema Nodosum 403 -- Onset or Exacerbation of Systemic Lupus Erythematosus 404 -- Onset or Exacerbation of Vasculitis 406 -- Onset or Exacerbation of Polyarteritis Nodosa 409 -- Onset or Exacerbation of Psoriatic Arthritis 411 -- Onset or Exacerbation of Reactive Arthritis 412 -- Onset or Exacerbation of Rheumatoid Arthritis 414 -- Onset or Exacerbation of Juvenile Idiopathic Arthritis 416 -- Type 1 Diabetes 418 -- Fibromyalgia 420 -- References 431 -- 9 HUMAN PAPILLOMAVIRUS VACCINE 441 -- Introduction 441 -- Acute Disseminated Encephalomyelitis 442 -- Transverse Myelitis 443 -- Neuromyelitis Optica 444 -- Multiple Sclerosis 444 -- Guillain-Barré Syndrome 445 -- Chronic Inflammatory Disseminated Polyneuropathy 446 -- Brachial Neuritis 447 -- Amyotrophic Lateral Sclerosis 447 -- Anaphylaxis 449 -- Transient Arthralgia 450 -- Pancreatitis 451 -- Thromboembolic Events 452 -- Hypercoagulable States 453 -- References 455 -- 10 DIPHTHERIA TOXOID-, TETANUS TOXOID-, AND ACELLULAR PERTUSSISCONTAINING -- VACCINES 457 -- Introduction 457 -- Encephalitis and Encephalopathy 461 -- Infantile Spasms 464 -- Seizures 465 -- Ataxia 468 -- Autism 468 -- Acute Disseminated Encephalomyelitis 469 -- Transverse Myelitis 470 -- Optic Neuritis 471 -- Multiple Sclerosis Onset in Adults 472 -- Multiple Sclerosis Relapse in Adults 474 -- Multiple Sclerosis Relapse in Children 476 -- Guillain-Barré Syndrome 477 -- Chronic Inflammatory Disseminated Polyneuropathy 478 -- Opsoclonus Myoclonus Syndrome 480 -- Bell’s Palsy 480 -- Anaphylaxis 482 -- Chronic Urticaria 483 -- Serum Sickness 484 -- Arthropathy 485 -- Type 1 Diabetes 487 -- Myocarditis 490 -- Fibromyalgia 491 -- Sudden Infant Death Syndrome 491 -- Immune Thrombocytopenic Purpura 492 -- References 506 -- 11 MENINGOCOCCAL VACCINE 515 -- Introduction 515 -- Encephalitis and Encephalopathy 517 -- Acute Disseminated Encephalomyelitis 518 -- Transverse Myelitis 519 -- Multiple Sclerosis 519 -- Guillain-Barré Syndrome 520 -- Chronic Inflammatory Disseminated Polyneuropathy 521 -- Anaphylaxis 522 -- Chronic Headache 523 -- References 526 -- 12 INJECTION-RELATED ADVERSE EVENTS 529 -- Complex Regional Pain Syndrome 529 -- Deltoid Bursitis 531 -- Syncope 533 -- References 538 -- 13 CONCLUDING COMMENTS 541 -- References 545Link for e-copy: http://www.nap.edu/catalog.php?record_id=13164 Format of e-copy: PDF [Open Access] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=2712 Bewaking van de vaccinveiligheid in België / Jo Robays / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
ISSN : D/2012/10.273/69 : € 0,00
Languages : English (eng) Dutch (nla)
Descriptors: Indexation
2011-22 ; Adverse Drug Reaction Reporting Systems ; Pharmacovigilance ; Product Surveillance, Postmarketing ; R188 ; Vaccination
Classification
QW 805 Vaccines. Antitoxins. ToxoidsContents note: SYNTHESE 11 -- 1 INLEIDING 11 -- 1.1 VERSCHILLENDE BENADERINGEN VAN SIGNAALDETECTIE 12 -- 1.2 DOEL VAN DE STUDIE 12 -- 2 DATABASES DIE GEGEVENS OVER DE ACHTERGRONDINCIDENTIE IN BELGIË KUNNEN -- VERSTREKKEN 13 -- 2.1 GEGEVENSBRONNEN VAN DE OVERHEID 13 -- 2.1.1 Minimale Klinische Gegevens 13 -- 2.1.2 CARENET 13 -- 2.1.3 Overlijdensregister 14 -- 2.2 SENTINELNETWERKEN 14 -- 2.2.1 Netwerken voor huisartsen 14 -- 2.2.2 Pedisurv 15 -- 3 BEREKENING VAN DE ACHTERGRONDINCIDENTIE: EEN PILOTSTUDIE 15 -- 3.1 WIEGENDOOD 15 -- 3.2 SYNDROOM VAN GUILLAIN-BARRÉ 16 -- 3.3 STUIPEN 17 -- 3.4 HAALBAARHEID EN BETROUWBAARHEID VAN DE BEREKENING VAN DE -- ACHTERGRONDINCIDENTIE IN BELGIË 17 -- 4 UITDAGINGEN EN OPPORTUNITEITEN IN VERBAND MET DE BEWAKING VAN -- VACCINVEILIGHEID 18 -- 4.1 BEWAKING VAN DE VACCINVEILIGHEID IN BELGIË 18 -- 4.1.1 Gegevensvergaring 18 -- 4.1.2 Gegevensanalyse 20 -- 4.2 TEKORTKOMINGEN EN MOGELIJKE OPLOSSINGEN 20 -- 5 VOORUITGANG? 23 -- SCIENTIFIC REPORT 24 -- 1 BACKGROUND OF THE STUDY 24 -- 2 BACKGROUND RATES IN SAFETY SURVEILLANCE: OVERVIEW OF ISSUES 26 -- 2.1 USING BACKGROUND RATES FOR SIGNAL DETECTION. 26 -- 2.1.1 Computation 26 -- 2.1.2 Signal management: prioritization and evaluation 27 -- 2.2 CHALLENGES AND OPTIONS IN PHARMACOVIGILANCE BASED ON BACKGROUND RATES 28 -- 2.2.1 Counting events 28 -- 2.2.2 Counting exposed ones 31 -- 2.2.3 Confounding 32 -- 2.2.4 Analytical issues 33 -- 2.3 CHALLENGES AND OPPORTUNITIES FOR VACCINE SAFETY SURVEILLANCE BASED ON A -- BACKGROUND APPROACH 34 -- 3 BELGIAN DATABASES FOR COMPUTING BACKGROUND RATES 37 -- 3.1 INTRODUCTION & METHODS 37 -- 3.2 DESCRIPTION OF THE DATABASES 37 -- 3.2.1 Minimal Clinical Data 37 -- 3.2.2 Carenet 38 -- 3.2.3 GP sentinel practice networks 38 -- 3.2.4 Special Solidarity Fund 39 -- 3.2.5 Increased child allowance for disabled or ill children 39 -- 3.2.6 Pedisurv 39 -- 3.2.7 Cause-specific deaths 40 -- 3.2.8 The European Mortality Monitoring Project 40 -- 3.2.9 Vaccinnet 41 -- 3.2.10 Disease reporting at regional level 41 -- 3.3 CONCLUSION 42 -- BACKGROUND RATES IN EUROPE 42 -- 4.1 GENERAL INTRODUCTION 42 -- 4.2 METHODS 42 -- 4.3 POPULATION 43 -- 4.4 OUTCOMES 43 -- 5 ESTIMATION OF BACKGROUND RATES FOR SELECTED CONDITIONS IN BELGIUM 45 -- 5.1 SUDDEN INFANT DEATH 45 -- 5.1.1 Definitions 45 -- 5.1.2 Literature review 46 -- 5.1.3 Rates of SID in Belgium 50 -- 5.1.4 Conclusions on sudden infant deaths 53 -- 5.2 SUDDEN DEATH WITH UNKNOWN CAUSE IN ≥1 YEAR OF AGE 53 -- 5.2.1 Rationale 53 -- 5.2.2 Definitions 53 -- 5.2.3 Literature review 55 -- 5.2.4 Rates of sudden deaths in Belgium 56 -- 5.2.5 Conclusions on sudden deaths 60 -- 5.3 GUILLAIN-BARRÉ SYNDROME 60 -- 5.3.1 Rationale 60 -- 5.3.2 Definitions 60 -- 5.3.3 Literature review 60 -- 5.3.4 Background rates of Guillain-Barré Syndrome in the literature 61 -- 5.3.5 Seasonal or temporal patterns 63 -- 5.3.6 Prediction models 63 -- 5.3.7 Belgian data on GBS from Minimal Clinical Data 63 -- 5.3.8 Conclusions on Guillain-Barré syndrome (GBS) 65 -- 5.4 SEIZURES 66 -- 5.4.1 Case definition 66 -- 5.4.2 Literature review 66 -- 5.4.3 Results 67 -- 5.4.4 Belgian data 69 -- 5.4.5 Discussion 69 -- 6 POTENTIAL DETECTION OF CASES OF SD/SID, GBS, THROMBOCYTOPENIA AND -- CONVULSIONS FROM IMMUNOGLOBULIN’S PRESCRIPTIONS 69 -- 6.1 IMMUNOGLOBULINS FOR EXTRAVASCULAR ADMINISTRATION (J06BA01) 70 -- 6.2 IMMUNOGLOBULINS FOR INTRAVASCULAR ADMINISTRATION (J06BA02) 71 -- 7 MINIMAL CLINICAL DATA 72 -- 7.1 GUILLAIN-BARRÉ SYNDROME 72 -- 7.2 SEIZURES. 74 -- 7.3 DEMYELINATING DISEASE 75 -- 7.4 OPTIC NEURITIS 76 -- 7.5 BELL’S PALSY 77 -- 7.6 THROMBOCYTOPENIA 78 -- 7.7 GENERAL DISCUSSION ON MCD DATA 78 -- 8 PHARMACOVIGILANCE IN BELGIUM 79 -- 8.1 DATA COLLECTION 79 -- 8.2 DATA ANALYSIS 81 -- 9 GENERAL DISCUSSION AND RECOMMENDATIONS 82 -- APPENDICES. 83 -- REFERENCES 108 Link for e-copy: https://doi.org/10.57598/R188A Format of e-copy: PDF (1,11 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3089 Copies
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ISSN : D/2012/10273/72 : € 0,00
Languages : Dutch (nla)
Descriptors: Indexation
2011-22 ; Adverse Drug Reaction Reporting Systems ; Pharmacovigilance ; Product Surveillance, Postmarketing ; R188 ; Vaccination
Classification
QW 805 Vaccines. Antitoxins. ToxoidsLink for e-copy: https://doi.org/10.57598/R188AS Format of e-copy: PDF (336 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3090 Copies
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ISBN : 978-0-387-40313-7 : € 79,95
Languages : English (eng)
Descriptors: Indexation
Epidemiologic Study Characteristics as Topic ; Epidemiology ; Statistical methods ; statistics and numerical data [Subheading] ; Vaccines
Classification
QW 805 Vaccines. Antitoxins. ToxoidsContents note: Introduction and examples -- Overview of vaccine effects and study designs -- Immunology and early phase trials -- binomial and stochastic transmission models -- R0 and deterministic models -- Evaluating protective effects of vaccination -- Modes of action and time-varying VES -- Further Evaluation of Protective Effects -- Vaccine effects on post-infection outcomes -- House-hold based studies -- Analysis of households in communities -- Analysis of independent households -- Assessing Indirect, total and overall effects -- Randomization and baseline transmission -- Surrogates of protection. Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=2214 Hold
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Barcode Call number Media type Location Section Status 10273-02093 QW 805 / HAL Book KCE Library (10.124) Due for return by 03/31/2015 Readers who borrowed this document also borrowed:
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ISSN : D/2012/10.273/70 : € 0,00
Languages : English (eng) French (fre)
Descriptors: Indexation
2011-22 ; Adverse Drug Reaction Reporting Systems ; Pharmacovigilance ; Product Surveillance, Postmarketing ; R188 ; Vaccination
Classification
QW 805 Vaccines. Antitoxins. ToxoidsContents note: 1 INTRODUCTION 11 -- 1.1 DIFFÉRENTES APPROCHES DE DÉTECTION DES SIGNAUX 12 -- 1.2 OBJECTIF DE L'ÉTUDE. 12 -- 2 BASE DE DONNÉE PERMETTANT DE FOURNIR LE TAUX DE BASE EN BELGIQUE. 13 -- 2.1 SOURCES DE DONNÉES ADMINISTRATIVES 13 -- 2.1.1 Le résumé clinique minimum (RCM) 13 -- 2.1.2 CARENET 13 -- 2.1.3 Registre des décès 14 -- 2.2 RÉSEAUX SENTINELLES 14 -- 2.2.1 Réseaux de MG 14 -- 2.2.2 Pedisurv 15 -- 3 ESTIMATION DES TAUX DE BASE : UNE ÉTUDE PILOTE 15 -- 3.1 MORT SUBITE DU NOURRISSON 15 -- 3.2 SYNDROME DE GUILLAIN-BARRÉ 16 -- 3.3 EPILEPSIE 17 -- 3.4 FAISABILITÉ ET FIABILITÉ DU CALCUL DES TAUX DE BASE EN BELGIQUE 17 -- 4 DÉFIS ET OPPORTUNITÉS DE LA SURVEILLANCE DE LA SÉCURITÉ VACCINALE 18 -- 4.1 SURVEILLANCE DE LA SÉCURITÉ VACCINALE EN BELGIQUE 18 -- 4.1.1 Collecte des données 18 -- 4.1.2 Analyse des données 20 -- 4.2 LIMITATIONS ET PISTES DE SOLUTION 20 -- 5 UN PAS EN AVANT?. 23 -- SCIENTIFIC REPORT 24 -- 1 BACKGROUND OF THE STUDY 24 -- 2 BACKGROUND RATES IN SAFETY SURVEILLANCE: OVERVIEW OF ISSUES 26 -- 2.1 USING BACKGROUND RATES FOR SIGNAL DETECTION. 26 -- 2.1.1 Computation 26 -- 2.1.2 Signal management: prioritization and evaluation 27 -- 2.2 CHALLENGES AND OPTIONS IN PHARMACOVIGILANCE BASED ON BACKGROUND RATES 28 -- 2.2.1 Counting events 28 -- 2.2.2 Counting exposed ones 31 -- 2.2.3 Confounding 32 -- 2.2.4 Analytical issues 33 -- 2.3 CHALLENGES AND OPPORTUNITIES FOR VACCINE SAFETY SURVEILLANCE BASED ON A -- BACKGROUND APPROACH 34 -- 3 BELGIAN DATABASES FOR COMPUTING BACKGROUND RATES 37 -- 3.1 INTRODUCTION & METHODS 37 -- 3.2 DESCRIPTION OF THE DATABASES 37 -- 3.2.1 Minimal Clinical Data 37 -- 3.2.2 Carenet 38 -- 3.2.3 GP sentinel practice networks 38 -- 3.2.4 Special Solidarity Fund 39 -- 3.2.5 Increased child allowance for disabled or ill children 39 -- 3.2.6 Pedisurv 39 -- 3.2.7 Cause-specific deaths 40 -- 3.2.8 The European Mortality Monitoring Project 40 -- 3.2.9 Vaccinnet 41 -- 3.2.10 Disease reporting at regional level 41 -- 3.3 CONCLUSION 42 -- 4 BACKGROUND RATES IN EUROPE 42 -- 4.1 GENERAL INTRODUCTION 42 -- 4.2 METHODS 42 -- 4.3 POPULATION 43 -- 4.4 OUTCOMES 43 -- 5 ESTIMATION OF BACKGROUND RATES FOR SELECTED CONDITIONS IN BELGIUM 45 -- 5.1 SUDDEN INFANT DEATH 45 -- 5.1.1 Definitions 45 -- 5.1.2 Literature review 46 -- 5.1.3 Rates of SID in Belgium 50 -- 5.1.4 Conclusions on sudden infant deaths 53 -- 5.2 SUDDEN DEATH WITH UNKNOWN CAUSE IN ≥1 YEAR OF AGE 53 -- 5.2.1 Rationale 53 -- 5.2.2 Definitions 53 -- 5.2.3 Literature review 55 -- 5.2.4 Rates of sudden deaths in Belgium 56 -- 5.2.5 Conclusions on sudden deaths 60 -- 5.3 GUILLAIN-BARRÉ SYNDROME 60 -- 5.3.1 Rationale 60 -- 5.3.2 Definitions 60 -- 5.3.3 Literature review 60 -- 5.3.4 Background rates of Guillain-Barré Syndrome in the literature 61 -- 5.3.5 Seasonal or temporal patterns 63 -- 5.3.6 Prediction models 63 -- 5.3.7 Belgian data on GBS from Minimal Clinical Data 63 -- 5.3.8 Conclusions on Guillain-Barré syndrome (GBS) 65 -- 5.4 SEIZURES 66 -- 5.4.1 Case definition 66 -- 5.4.2 Literature review 66 -- 5.4.3 Results 67 -- 5.4.4 Belgian data 69 -- 5.4.5 Discussion 69 -- 6 POTENTIAL DETECTION OF CASES OF SD/SID, GBS, THROMBOCYTOPENIA AND -- CONVULSIONS FROM IMMUNOGLOBULIN’S PRESCRIPTIONS 69 -- 6.1 IMMUNOGLOBULINS FOR EXTRAVASCULAR ADMINISTRATION (J06BA01) 70 -- 6.2 IMMUNOGLOBULINS FOR INTRAVASCULAR ADMINISTRATION (J06BA02) 71 -- 7 MINIMAL CLINICAL DATA 72 -- 7.1 GUILLAIN-BARRÉ SYNDROME 72 -- 7.2 SEIZURES. 74 -- 7.3 DEMYELINATING DISEASE 75 -- 7.4 OPTIC NEURITIS 76 -- 7.5 BELL’S PALSY 77 -- 7.6 THROMBOCYTOPENIA 78 -- 7.7 GENERAL DISCUSSION ON MCD DATA 78 -- 8 PHARMACOVIGILANCE IN BELGIUM 79 -- 8.1 DATA COLLECTION 79 -- 8.2 DATA ANALYSIS 81 -- 9 GENERAL DISCUSSION AND RECOMMENDATIONS 82 -- APPENDICES. 83 -- REFERENCES 108 Link for e-copy: https://doi.org/10.57598/R188B Format of e-copy: PDF (1,17 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3087 Copies
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