Appendix C

Literature Search Strategy

This appendix contains a detailed explanation of how the literature searches were performed for each vaccine and adverse event reviewed by the committee. The searches were performed by William Mcleod, Senior Research Librarian at the National Academies.

DESCRIPTION OF THE DATABASES USED
IN THE LITERATURE SEARCH

All searches were run against MEDLINE (1950–present), EMBASE (1980–present), BIOSIS (1969–2005), and Web of Science consisting of Science Citation Index (1900–present) and Social Science Citation Index (1956–present). There were no restrictions placed on year of publication, language, or publication type. All result sets were deduplicated to eliminate occurrence of the same reference two or more times among the databases employed, and all results were exported to an EndNote Library.

MEDLINE and EMBASE (in OVID SP)

OVID command-line syntax is provided below. Terms immediately followed by a forward slash (/) are Medical Subject Headings (MeSH headings from MEDLINE) or EMTREE terms (from the EMBASE controlled vocabulary). The asterisk after some terms (*) is the OVID unlimited truncation symbol (for example, rat*, will retrieve rat, rats, ratify, rational, etc.). The postqualification .ti,ab. means that a term was searched only in the titles and abstracts. Exp means that a term was “exploded” in the MeSH



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Appendix C Literature Search Strategy This appendix contains a detailed explanation of how the literature searches were performed for each vaccine and adverse event reviewed by the committee. The searches were performed by William Mcleod, Senior Research Librarian at the National Academies. DESCRIPTION OF THE DATABASES USED IN THE LITERATURE SEARCH All searches were run against MEDLINE (1950–present), EMBASE (1980–present), BIOSIS (1969–2005), and Web of Science consisting of Science Citation Index (1900–present) and Social Science Citation Index (1956–present). There were no restrictions placed on year of publication, language, or publication type. All result sets were deduplicated to eliminate occurrence of the same reference two or more times among the databases employed, and all results were exported to an EndNote Library. MEDLINE and EMBASE (in OVID SP) OVID command-line syntax is provided below. Terms immediately fol- lowed by a forward slash (/) are Medical Subject Headings (MeSH headings from MEDLINE) or EMTREE terms (from the EMBASE controlled vo- cabulary). The asterisk after some terms (*) is the OVID unlimited trunca- tion symbol (for example, rat*, will retrieve rat, rats, ratify, rational, etc.). The postqualification .ti,ab. means that a term was searched only in the titles and abstracts. Exp means that a term was “exploded” in the MeSH 655

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656 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY or EMTREE vocabulary to also capture all narrower terms associated with the broader concept. BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) All BIOSIS search terms were submitted to the database using key- word or keyword-phrase searches and were not qualified or limited to a specific field. In OVID SP BIOSIS, when a search term is not qualified, it is automatically searched in the following fields: abstract; biosystematic code; book title; chemicals and biochemicals; concept codes; diseases; gene name; major concepts; miscellaneous descriptors; methods and equipment; organisms; parts, structure; sequence data; super taxa; titles; taxa notes; text words; heading words; subject headings; and meeting information. All Web of Science searches were submitted to the databases as topic searches that automatically search titles, abstracts, and author-supplied keywords. MEASLES, MUMPS, AND RUBELLA VACCINE Measles, Mumps, and Rubella Vaccine Searches in MEDLINE and EMBASE (in OVID SP) Measles, mumps, and rubella vaccine searches in MEDLINE and EMBASE started with four “base sets” with which all specific adverse events identified for consideration were combined: 1. Measles mumps rubella vaccine/ 2. (Measles vaccine/ or (vaccination/ and measles/)) 3. (Mumps vaccine/ or (vaccination/ and mumps/)) 4. (Rubella vaccine/ or (vaccination/ and rubella/)) Each set above was combined with each of the sets below. Each pair re- sulting from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Exp arthralgia/ or exp arthritis/ or arthropathy, neurogenic/ or exp arthropathy/ • Autistic disorder/ or autism/ or infantile autism/ • (Asperger syndrome/ or Rett syndrome/ or schizophrenia, child- hood/ or child development disorders, pervasive/ or childhood

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657 APPENDIX C disintegrative disorder/ or pervasive development disorder not otherwise specified/ • Exp ataxia/ • Brachial plexus neuritis/ • Chronic fatigue syndrome/ or fatigue syndrome, chronic/ • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis • Exp complex regional pain syndromes/ or exp complex regional pain syndrome/ • Seizures/ or seizures, febrile/ or convulsion/ or exp epilepsies, myo- clonic/ or spasms, infantile/ or myoclonus epilepsy/ or myoclonus seizure/ or myoclonus/ or convulsion?.ti,ab. • Exp encephalitis/ or exp encephalitis, viral/ • Exp brain disease/ or encephal*.ti,ab. • Fibromyalgia/ • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Exp hearing loss/ • Hepatitis/ • Diabetes mellitus, type 1/ or insulin­dependent diabetes mellitus/ • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Opsoclonus­myoclonus syndrome/ • Exp syncope/ Measles, Mumps, and Rubella Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) Measles, mumps, and rubella vaccine searches in BIOSIS and Web of Science started with four “base sets” with which all specific adverse events identified for consideration were combined: 1. (((“Measles mumps rubella” or MMR) adj vaccin*) or “Triviraten Berna” or Priorix or Trimovax or Virivac or Pluserix) 2. (Measles vaccin* or ((vaccin* or immuniz*) and measles)) 3. (Mumps vaccin* or ((vaccin* or immuniz*) and mumps)) 4. (Rubella vaccin* or ((vaccin* or immuniz*) and rubella)) Each set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library:

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658 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY • Anaphylaxis or anaphylactic shock or anaphylactic reaction • Arthropath* or arthrit* or arthralgia • (Autism or autistic or “Kanner? syndrome”) • (“Autism spectrum” or “Rett? syndrome” or “Asperger? syn- drome” or “child* schizophrenia” or “pervasive child* devel- opment* disorder?” or “pervasive development disorder?” or “disintegrative disorder?”) • (Ataxia? or “coordination impairment?” or dyssynergia or rubral tremor?) • (“Brachial plexus neuritis” or “brachial neuritis” or “brachial neuralgia?” or “amyotroph* neuralgi*” or “cervicobrachial neu- ralgia?” or “cervico-brachial neuralgia?” or “Parsonage-Turner syndrome” or “Parsonage-Aldren-Turner syndrome” or “brachial neuritides” or “shoulder-girdle neuropath*” or “brachial plexus neuritides”) • (“Fatigue syndrome?” or “chronic fatigue” or “myalgic encephalo- myelitis” or “fatigue disorder” or “royal free disease” or “postviral fatigue syndrome?”) • (“Chronic remitting demyelinating disease?” or “disseminated neuropathy”) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis) • (Complex regional pain or causalgia or reflex sympathetic dystrophy) • (Epileps* or myoclon* or spasm* or convulsion? or seizure?) • (Encephalitis or brain inflammation or encephalomyelitis) • Brain disease? or encephal* • (Fibromyalgia? or fibrositis or fibrositides or “myofascial pain syndrome”) • (Frozen shoulder or bursitis or synovitis or synovitides or bur- sitides or adhesive capsulitis or adhesive capsulitides or periar- thritis or periarthritides or shoulder impingement or subacromial impingement) • (“Hearing loss” or deafness or hypoacusis or hypoacuses or “hear- ing impairment”) • Hepatitis • (“Insulin­dependent diabetes” or “type­1 diabetes” or “juvenile­ onset diabetes” or “sudden-onset diabetes” or IDDM or “brittle diabetes” or “autoimmune diabetes” or “ketosis-prone diabetes”) • (Meningitis or meningo* or meningeal or arachnoiditis or menin- gitides or pachymeningitis or pachymeningitides) • Demyelinating or encephalomyelitis or “Guillain Barre” or myelitis • (“Opsoclonus myoclonus syndrome” or “dancing eyes dancing feet

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659 APPENDIX C syndrome” or “opsoclonus myoclonus ataxia” or “Kinsbourne syndrome”) • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) VARICELLA VACCINE Varicella Vaccine Searches in MEDLINE and EMBASE (in OVID SP) Varicella vaccine searches in MEDLINE and EMBASE started with one “base set” with which all specific adverse events identified for consideration were combined: 1. Exp chickenpox vaccine/ or ((vaccines/ or vaccination/) and chickenpox/) The set above was combined with each of the sets below. Each pair result- ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Exp arthralgia/ or exp arthritis/ or arthropathy, neurogenic/ or exp arthropathy/ • Exp cerebellar ataxia/ or spinocerebellar ataxias/ or ataxia telangi- ectasia/ or Machado-Joseph disease/ • Exp myocardial infarction/ or exp stroke/ or exp death, sudden/ • Seizures/ or seizures, febrile/ or convulsion/ or exp epilepsies, myo- clonic/ or spasms, infantile/ or myoclonus epilepsy/ or myoclonus seizure/ or myoclonus/ or convulsion?.ti,ab. • “Oka VZV”.ti,ab,sh. or “Oka varicella”.ti,ab. • (“Varicella zoster virus”.mp. or “herpesvirus 3, human”/) and (im- munocompromis* or immunosuppress*) • (Disseminat* adj2 Oka) • Exp brain disease/ or encephal*.ti,ab. • Exp encephalitis/ or exp encephalitis, viral/ • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • (Hepatitis adj3 varicella).ti,ab. [Looks for hepatitis within 3 words, minus stop words (articles, prepositions) of varicella in any order.] • Exp meningitis/ • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Exp pneumonia/

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660 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY • Exp stroke/ or exp myocardial infarction/ or exp death, sudden/ • Exp syncope/ • Exp lupus erythematosus, systemic/ • Exp thrombocytopenia/ or hemolytic­uremic syndrome/ or Jacob- sen distal 11q deletion syndrome/ or purpura, thrombocytopenic/ or thrombocytopenia, neonatal alloimmune/ Varicella Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) Varicella vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consid- eration were combined: 1. (Chickenpox vaccin* or varicella vaccin*) or ((vaccin* or immu- niz*) and (chicken pox or varicella)) The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Anaphylaxis or anaphylactic shock or anaphylactic reaction • Arthropathy or arthritis or arthralgia • Cerebellar ataxia? or cerebellar incoordination? or cerebellar dys- metria? or hypermetria? or adiadochokinesis or adiadochokineses or cerebellar hemiataxia? or spinocerebellar ataxia* or spinocer- ebellar atrophy or ataxia telangiectasia or Machado-Joseph disease or Louis-Bar syndrome or Azorean disease • (“Myocardial infarction?” or “heart attack” or stroke or “sudden death”) • Convulsion? or spasm? or myoclon* or seizure? • Oka vzv or Oka varicella • (Disseminat* adj2 Oka) • Brain disease? or encephal* or brain disorder? • (Frozen shoulder or bursitis or synovitis or synovitides or bur- sitides or adhesive capsulitis or adhesive capsulitides or periar- thritis or periarthritides or shoulder impingement or subacromial impingement) • Varicella adj3 hepatitis [varicella within 3 words, minus stop­ words, of hepatitis] • Meningitis or meningitides or pachymeningitis or pachymeningiti- des or meningoencephalitis or arachnoiditis • Demyelinating or encephalomyelitis or “Guillain Barre” or myelitis

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661 APPENDIX C • (Varicella zoster virus or “herpesvirus 3” or “VZ virus*” or “HHV-3” or “ocular herpes zoster virus” or “chickenpox vi- rus*” or “herpesvirus varicellae”) and (immunocompromis* or immunosuppres*) • Pneumonia or “lung inflammation” or “pulmonary inflammation” • (Stroke or “myocardial infarction?” or “heart attack” or “sudden death”) • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) • “Systemic lupus erythematosus” or “Libman­Sacks” or “systemic lupus” • Thrombocytopenia? or thrombopenia? or hemolytic­uremic syndrome INFLUENZA VACCINE Influenza Vaccine Searches in MEDLINE and EMBASE (in OVID SP) Influenza vaccine searches in MEDLINE and EMBASE started with one “base set” with which all specific adverse events identified for consideration were combined: 1. Influenza vaccines/ or (vaccination/ and influenza, human/) The set above was combined with each of the sets below. Each pair result- ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Exp arthralgia/ or exp arthritis/ or arthropathy, neurogenic/ or exp arthropathy/ • Asthma/ or status asthmaticus/ • Bell palsy/ • Brachial plexus neuritis/ • Exp myocardial infarction/ or exp stroke/ or exp death, sudden/ • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis/ or neuromyelitis optica/ • Exp complex regional pain syndromes/ or exp complex regional pain syndrome/ • Seizures/ or seizures, febrile/ or convulsion/ or exp epilepsies, myo- clonic/ or spasms, infantile/ or myoclonus epilepsy/ or myoclonus seizure/ or myoclonus/ or convulsion?.ti,ab.

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662 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY • Exp encephalitis/ or exp encephalitis, viral/ • Exp brain disease/ or encephalopath*.ti,ab. • Fibromyalgia/ • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • “Oculorespiratory syndrome?”.ti,ab. • Polyarteritis nodosa/ • “Small fiber neuropath*”.ti,ab. • Exp lupus erythematosus, systemic/ • Exp syncope/ • Exp Vasculitis/ Influenza Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) Influenza vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consid- eration were combined: 1. (Flu vaccine or influenza vaccine? or ((vaccin* or immuniz*) and (influenza or flu))) The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Anaphylaxis or anaphylactic shock or anaphylactic reaction • Arthropath* or arthrit* or arthralgia • Asthma* • (“Bell? palsy” or “facial paralys*” or “facial neuropath*”) • (Brachial neuritis or brachial plexus neuritis or neuralgia or bra- chial plexus neuropath*) • (“Myocardial infarction?” or “heart attack” or stroke or “sudden death”) • (“Chronic remitting demyelinating disease?” or “disseminated neu- ropathy” or “multiple sclerosis” or “neuromyelitis optica”) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis or neuromyelitis optica) • (Complex regional pain or causalgia or reflex sympathetic dystrophy) • (Epileps* or myoclon* or spasm* or convulsion? or seizure?)

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663 APPENDIX C • (Encephalitis or brain inflammation or encephalomyelitis) • Brain disease? or encephal* • (Fibromyalgia? or fibrositis or fibrositides or “myofascial pain syndrome”) • (Frozen shoulder or bursitis or synovitis or synovitides or bur- sitides or adhesive capsulitis or adhesive capsulitides or periar- thritis or periarthritides or shoulder impingement or subacromial impingement) • Demyelinating or encephalomyelitis or “Guillain Barre” or myelitis • “Oculorespiratory syndrome?” • (“Polyarteritis nodosa” or “periarteritis nodosa” or “essential polyarteritis” or “necrotizing arteritis”) • “Small fiber neuropath*” • “Systemic lupus” or “Libman­Sacks” • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) • (Vasculitis or vasculitides or angiitis or angiitides or aortitis or arteritis or phlebitis or “Behcet syndrome” or “Wegener granulo- matosis” or thrombophlebitis or papulosis) HEPATITIS A VACCINE Hepatitis A Vaccine Searches in MEDLINE and EMBASE (in OVID SP) Hepatitis A vaccine searches in MEDLINE and EMBASE started with one “base set” with which all specific adverse events identified for consid- eration were combined: 1. (Hepatitis a vaccines/ or ((vaccination/ or vaccines/) and (hepatitis a/ or hepatitis a virus, human/))) The set above was combined with each of the sets below. Each pair result- ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Bell palsy/ • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Hepatitis, autoimmune/ or autoimmune hepatitis/

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664 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY • Exp Guillain­Barre syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Exp syncope/ Hepatitis A Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) Hepatitis A vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consid- eration were combined: 1. (“Hepatitis a vaccin*” or ((vaccin* or immuniz*) and hepatitis a)) The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Anaphylaxis or anaphylactic shock or anaphylactic reaction • (“Bell? palsy” or “facial paralys*” or “facial neuropath*”) • (“Chronic remitting demyelinating disease?” or “disseminated neuropathy”) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis) • (Frozen shoulder or bursitis or synovitis or synovitides or bursitides or adhesive capsulitis or adhesive capsulitides or periarthritis or peri- arthritides or shoulder impingement or subacromial impingement) • Autoimmune hepatitis • Demyelinating or encephalomyelitis or “Guillain Barre” or myelitis • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) HEPATITIS B VACCINE Hepatitis B Vaccine Searches in MEDLINE and EMBASE (in OVID SP) Hepatitis B vaccine searches in MEDLINE and EMBASE started with one “base set” with which all specific adverse events identified for consid- eration were combined: 1. Hepatitis b vaccines/ or (vaccination/ and (hepatitis b virus/ or hepatitis b/)) /) The set above was combined with each of the sets below. Each pair result-

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665 APPENDIX C ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Exp arthralgia/ or exp arthritis/ or arthropathy, neurogenic/ or exp arthropathy/ • Brachial plexus neuritis/ • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis/ or neuromyelitis optica/ • Exp complex regional pain syndrome/ or exp complex regional pain syndromes/ • Seizures/ or seizures, febrile/ or convulsion/ or exp epilepsies, myo- clonic/ or spasms, infantile/ or myoclonus epilepsy/ or myoclonus seizure/ or myoclonus/ or convulsion?.ti,ab. • Exp encephalitis/ or exp encephalitis, viral/ • Exp brain disease/ or encephalopath*.ti,ab. • Erythema nodosum/ • Fibromyalgia/ • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Polyarteritis nodosa/ • Exp lupus erythematosus, systemic/ • Exp syncope/ • Exp vasculitis/ Hepatitis B Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) Hepatitis B vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consid- eration were combined: 1. (“Hepatitis b vaccin*” or ((vaccin* or immuniz*) and hepatitis b)) The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Anaphylaxis or anaphylactic shock • (Arthrit* or arthropath* or arthralgia)

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666 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY • (Brachial neuritis or brachial plexus neuritis or neuralgia or bra- chial plexus neuropath*) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis or neuromyelitis optica) • (Complex regional pain or causalgia or reflex sympathetic dystrophy) • (Epileps* or myoclon* or spasm* or convulsion? or seizure?) • (Encephalitis or brain inflammation or encephalomyelitis) • (Encephal* or brain disease?) • (Erythema nodosum or erythematous) • (Fibromyalgia? or fibrositis or fibrositides or “myofascial pain syndrome”) • (Frozen shoulder or bursitis or synovitis or synovitides or bur- sitides or adhesive capsulitis or adhesive capsulitides or periar- thritis or periarthritides or shoulder impingement or subacromial impingement) • (Guillain­Barré or myelitis or encephalomyelitis) • (Polyarteritis or periarteritis or necrotizing arteritis) • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) • (Systemic lupus or Libman­Sacks disease) • (Vasculitis or angiitis or angiitides or aortitis or arteritis or Behcet syndrome or phlebitis or thrombophlebitis or endarteritis) HUMAN PAPILLOMAVIRUS VACCINE Human Papillomavirus (HPV) Vaccine Searches in MEDLINE and EMBASE (in OVID SP) HPV vaccine searches in MEDLINE and EMBASE started with one “base set” with which all specific adverse events identified for consideration were combined: 1. Papillomavirus vaccines/ or (vaccination/ and (papillomaviridae/ or papillomavirus infections/)) The set above was combined with each of the sets below. Each pair result- ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Amyotrophic lateral sclerosis/ • Anaphylactic shock/ or anaphylaxis/

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667 APPENDIX C • Exp arthralgia/ or exp arthritis/ or arthropathy, neurogenic/ or exp arthropathy/ • Brachial plexus neuritis/ • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis/ or neuromyelitis optica/ • Seizures/ or seizures, febrile/ or convulsion/ or exp epilepsies, myo- clonic/ or spasms, infantile/ or myoclonus epilepsy/ or myoclonus seizure/ or myoclonus/ or convulsion?.ti,ab. • Exp encephalitis/ or exp encephalitis, viral/ • Exp brain disease/ or encephal*.ti,ab. • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Hypercoagulab* • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Exp pancreatitis/ • Exp lupus erythematosus, systemic/ • Exp syncope/ • Thromboembolism/ or thromboembol* HPV Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) HPV vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consideration were combined: 1. (Papillomavirus vaccin* or ((vaccin* or immuniz*) and (papillo- maviridae or papillomavirus))) The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Amyotrophic lateral sclerosis • Anaphylaxis or anaphylactic shock or anaphylactic reaction • (Arthrit* or arthropath* or arthralgia) • (Brachial neuritis or brachial plexus neuritis or neuralgia or bra- chial plexus neuropath*) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis or neuromyelitis optica) • (Epileps* or myoclon* or spasm* or convulsion? or seizure?)

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668 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY • (Encephalitis or brain inflammation or encephalomyelitis) • (Encephal* or brain disease?) • (Frozen shoulder or bursitis or synovitis or synovitides or bursitides or adhesive capsulitis or adhesive capsulitides or periarthritis or peri- arthritides or shoulder impingement or subacromial impingement) • Hypercoagulab* • (Guillain­Barré or encephalomyelitis or myelitis or demyelinating) • Pancreatitis • (Systemic lupus or Libman­Sacks disease) • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) • Thromboembol* DIPHTHERIA TOXOID–, TETANUS TOXOID–, AND ACELLULAR PERTUSSIS–CONTAINING VACCINES Diphtheria Toxoid (DT)–, Tetanus Toxoid (TT)–, and Acellular Pertussis (aP)–Containing Vaccine Searches in MEDLINE and EMBASE (in OVID SP) DT–, TT–, and aP–containing vaccine searches in MEDLINE and EM- BASE started with one “base set” with which all specific adverse events identified for consideration were combined: 1. (Diphtheria-tetanus-acellular pertussis vaccines/ or diphtheria per- tussis tetanus vaccine/ or tetanus toxoid/ or “diphtheria-tetanus vaccine”/ or (“diphtheria tetanus” or “tetanus diphtheria” or “tetanus and diphtheria” or “diphtheria and tetanus”).ti,ab. or “tetanus toxoid”.mp. or DTaP.mp. or TDaP.mp. or (vaccin* adj5 (DT or TD or TT)).mp. or “tetanus diphtheria acellular pertussis”. mp. or “tetanus diphtheria and acellular pertussis”.mp.) The set above was combined with each of the sets below. Each pair result- ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Exp ataxia/ • Exp arthralgia/ or exp arthritis/ or arthropathy, neurogenic/ or exp arthropathy/ • Autistic disorder/ or autism/ or infantile autism/ • (Asperger syndrome/ or Rett syndrome/ or schizophrenia, childhood/ or child development disorders, pervasive/ or childhood disinte-

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669 APPENDIX C grative disorder/ or pervasive development disorder not otherwise specified/ • Bell palsy/ • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis • Exp urticaria/ • Exp complex regional pain syndromes/ or exp complex regional pain syndrome/ • Seizures/ or seizures, febrile/ or convulsion/ or exp epilepsies, myo- clonic/ or spasms, infantile/ or myoclonus epilepsy/ or myoclonus seizure/ or myoclonus/ or convulsion?.ti,ab. • Exp encephalitis/ or exp encephalitis, viral/ • Exp brain disease/ or encephal*.ti,ab. • Fibromyalgia/ • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Exp purpura, thrombocytopenic, ideiopathic/ or idiopathic throm- bocytopenic purpura/ • Diabetes mellitus, type 1/ or insulin­dependent diabetes mellitus/ • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Myocarditis/ • Opsoclonus­myoclonus syndrome/ • Exp optic neuritis/ • Serum sickness/ • Sudden infant death/ • Exp syncope/ DT–, TT–, and aP–Containing Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) DT–, TT–, and aP–containing vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consideration were combined: 1. (((“Diphtheria tetanus acellular pertussis” or “tetanus diphtheria acellular pertussis” or “diphtheria tetanus” or “tetanus diphtheria” or “tetanus toxoid” or “tetanus and diphtheria” or “diphtheria and tetanus” or DTaP or TDAP or DT or TD or TT) adj5 (vaccin* or immuniz*)) or Tripedia or “Acel-Imune” or Acelimune or Infanrix)

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670 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Anaphylaxis or anaphylactic shock or anaphylactic reaction • Arthropath* or arthrit* or arthralgia • (Autism or autistic or “Kanner? syndrome”) • (“Autism spectrum” or “Rett? syndrome” or “Asperger? syn- drome” or “child* schizophrenia” or “pervasive child* devel- opment* disorder?” or “pervasive development disorder?” or “disintegrative disorder?”) • (Ataxia? or “coordination impairment?” or dyssynergia or rubral tremor?) • (“Bell? palsy” or “facial paralys*” or “facial neuropath*”) • (“Chronic remitting demyelinating disease?” or “disseminated neuropathy”) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis) • (Urticaria? or hives or angioedema) • (Complex regional pain or causalgia or reflex sympathetic dystrophy) • (Epileps* or myoclon* or spasm* or convulsion? or seizure?) • (Encephalitis or brain inflammation or encephalomyelitis) • Brain disease? or encephal* • (Fibromyalgia? or fibrositis or fibrositides or “myofascial pain syndrome”) • (Frozen shoulder or bursitis or synovitis or synovitides or bur- sitides or adhesive capsulitis or adhesive capsulitides or periar- thritis or periarthritides or shoulder impingement or subacromial impingement) • (“Idiopathic thrombocytopenic purpura?” or “Werlhof? disease” or “autoimmune thrombocytopenic purpura?” or “autoimmune thrombocytopenia?”) • (“Insulin­dependent diabetes” or “type­1 diabetes” or “juvenile­ onset diabetes” or “sudden-onset diabetes” or IDDM or “brittle diabetes” or “autoimmune diabetes” or “ketosis-prone diabetes”) • Demyelinating or encephalomyelitis or “Guillain Barre” or myelitis • (Myocarditis or carditis or myocarditides) • (“Opsoclonus myoclonus syndrome” or “dancing eyes dancing feet syndrome” or “opsoclonus myoclonus ataxia” or “Kinsbourne syndrome”) • (“Optic neuritis” or “optic neuritides” or neuropapillitis or neuro- papillitides or “retrobulbar neuritis”) • (“Serum sickness?” or “serum disease” or “plasma sensitivity”)

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671 APPENDIX C • (“Sudden infant death” or SIDS or “cot death” or “unexpected infant death”) • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction))) MENINGOCOCCAL VACCINE Meningococcal Vaccine Searches in MEDLINE and EMBASE (in OVID SP) Meningococcal vaccine searches in MEDLINE and EMBASE started with one “base set” with which all specific adverse events identified for consideration were combined: 1. (Meningococcal vaccines/ or MPSV4.mp. or menomune.mp. or MCV4.mp. or menactra.mp. or ((vaccination/ or vaccines/) and exp meningitis/)) The set above was combined with each of the sets below. Each pair result- ing from this combination was deduplicated, when the online database provided this utility, and then exported to an EndNote library: • Anaphylaxis/ or anaphylactic shock/ • Exp headache disorders/ or (chronic adj2 headache?) • Chronic inflammatory demyelinating polyneuropathy/ or polyra- diculoneuropathy, chronic inflammatory demyelinating/ or exp multiple sclerosis • Exp encephalitis/ or exp encephalitis, viral/ • Exp brain disease/ or encephal*.ti,ab. • Frozen shoulder/ or exp bursitis/ or shoulder impingement syn- drome/ or exp synovitis/ • Exp Guillain­Barré syndrome/ or myelitis, transverse/ or encepha- lomyelitis, acute disseminated/ • Exp syncope/ Meningococcal Vaccine Searches in BIOSIS (in OVID SP) and Web of Science (Science Citation Index and Social Science Citation Index) Meningococcal vaccine searches in BIOSIS and Web of Science started with one “base set” with which all specific adverse events identified for consideration were combined: 1. (Mening* vaccin* or ((vaccin* or immuniz*) and meningitis))

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672 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY The set above was combined with each of the sets below. Each pair was deduplicated, when the online database provided this utility, and then ex- ported to an EndNote library: • Anaphylaxis or anaphylactic shock or anaphylactic reaction • ((Chronic adj2 headache?) or headache disorder? or headache syn- drome? or cephalgia syndrome? or intractable headache?) • (“Chronic remitting demyelinating disease?” or “disseminated neuropathy”) • (Polyneuropath* or polyradiculoneuropath* or multiple sclerosis) • (Encephalitis or brain inflammation or encephalomyelitis) • Brain disease? or encephal* • (Frozen shoulder or bursitis or synovitis or synovitides or bur- sitides or adhesive capsulitis or adhesive capsulitides or periar- thritis or periarthritides or shoulder impingement or subacromial impingement) • Demyelinating or encephalomyelitis or “Guillain Barre” or myelitis • (Syncope or syncopes or syncopal or fainting or (vasovagal adj (collapse or attack or shock or reaction)))