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Appendix B Glossary Acellular vaccine: a vaccine containing partial cellular material as opposed to complete cells.1 Adjuvant: a substance (e.g., aluminum salt) that is added during production to increase the body’s immune response to a vaccine.1 Adverse event: undesirable experiences occurring after immunization that may or may not be related to the vaccine.1 Allergic rhinitis: rhinitis (inflammation of the mucous membrane of the nose marked especially by rhinorrhea, nasal congestion and itching, and sneezing) caused by exposure to an allergen.2 Allergy: a condition in which the body has an exaggerated response to a substance (e.g., food or drug). Also known as hypersensitivity.1 Anaphylaxis: an immediate and severe allergic reaction to a substance. Symptoms of anaphylaxis include breathing difficulties, loss of conscious- ness, and a drop in blood pressure. This condition can be fatal and requires immediate medical attention.1 Antibody: a protein found in the blood that is produced in response to foreign substances (e.g., bacteria or viruses) invading the body. Antibodies protect the body from disease by binding to these organisms and destroy- ing them.1 145

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146 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY Antigens: foreign substances (e.g., bacteria or viruses) in the body that are capable of causing disease. The presence of antigens in the body triggers an immune response, usually the production of antibodies.1 Arthritis: inflammation of joints due to infectious, metabolic, or constitu- tional causes.2 Asperger syndrome: a developmental disorder resembling autism that is characterized by impaired social interaction, by repetitive patterns of behav- ior and restricted interests, by normal language and cognitive development, and often by above-average performance in a narrow field against a general background of deficient functioning—also called Asperger’s disorder.2 Asthma: a disorder that causes the airways of the lungs to swell and narrow, leading to wheezing, shortness of breath, chest tightness, and coughing.3 Atopy: a genetic disposition to develop an allergic reaction (as allergic rhinitis, asthma, or atopic dermatitis) and produce elevated levels of IgE upon exposure to an environmental antigen and especially one inhaled or ingested.2 Attention deficit disorder (ADD): a syndrome of disordered learning and disruptive behavior that is not caused by any serious underlying physical or mental disorder and that has several subtypes characterized primarily by symptoms of inattentiveness or primarily by symptoms of hyperactivity and impulsive behavior (as in speaking out of turn) or by the significant expression of all three.2 Attenuated vaccine: a vaccine in which live virus is weakened through chemical or physical processes in order to produce an immune response without causing the severe effects of the disease. Attenuated vaccines cur- rently licensed in the United States include measles, mumps, rubella, polio, yellow fever, and varicella. Also known as a live vaccine.1 Autism: a developmental disorder that appears in the first 3 years of life, and affects the brain’s normal development of social and communication skills.3 Autoimmune Diseases Disorder: a condition that occurs when the immune system mistakenly attacks and destroys healthy body tissue. There are more than 80 different types of autoimmune disorders.3

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APPENDIX B 147 Bacille Calmette-Guérin (BCG): an attenuated strain of tubercle bacillus developed by repeated culture on a medium containing bile and used in preparation of tuberculosis vaccines.2 Bias: systematic deviation of results or inferences from truth; processes leading to such deviation. An error in the conception and design of a study—or in the collection, analysis, interpretation, reporting, publication, or review of data—leading to results or conclusions that are systematically (as opposed to randomly) different from the truth.4 Case-control study: the observational epidemiological study of persons with the disease (or another outcome variable) of interest and a suitable control group of persons without the disease (comparison group, reference group). The potential relationship of a suspected risk factor or an attribute to the disease is examined by comparing the diseased and nondiseased sub- jects with regard to how frequently the factor or attribute is present (or, if quantitative, the levels of the attribute) in each of the groups (diseased and nondiseased).4 Cohort study: the analytic epidemiological study in which subsets of a de- fined population can be identified who are, have been, or in the future may be exposed or not exposed, or exposed in different degrees, to a factor or factors hypothesized to influence the occurrence of a given disease or other outcome. The main feature of cohort study is observation of large numbers over a long period (commonly years), with comparison of incidence rates in groups that differ in exposure levels. The alternative terms for a cohort study (i.e., follow-up, longitudinal, and prospective study) describe an es- sential feature of the method, which is observation of the population for a sufficient number of person-years to generate reliable incidence or mortal- ity rates in the population subsets. This generally implies study of a large population, study for a prolonged period (years), or both. The denomina- tors used for analysis may be persons or person-time.4 Community immunity: a situation in which a sufficient proportion of a population is immune to an infectious disease (through vaccination and/or prior illness) to make its spread from person to person unlikely. Even indi- viduals not vaccinated (such as newborns and those with chronic illnesses) are offered some protection because the disease has little opportunity to spread within the community. Also known as herd immunity.1 Confounding: loosely, the distortion of a measure of the effect of an expo- sure on an outcome caused by the association of the exposure with other factors that influence the occurrence of the outcome. Confounding occurs

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148 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY when all or part of the apparent association between the exposure and outcome is in fact accounted for by other variables that affect the outcome and are not themselves affected by exposure.4 Contraindication: a condition in a recipient which is likely to result in a life-threatening problem if a vaccine were given.1 Convulsion: see Seizure. Cross-sectional study: a study that examines the relationship between dis- eases (or other health-related characteristics) and other variables of interest as they exist in a defined population at one particular time. The presence or absence of disease and the presence or absence of the other variables (or, if they are quantitative, their level) are determined in each member of the study population or in a representative sample at one particular time. The relationship between a variable and the disease can be examined (1) in terms of the prevalence of disease in different population subgroups defined according to the presence or absence (or level) of the variables and (2) in terms of the presence or absence (or level) of the variables in the diseased versus the nondiseased. Note that disease prevalence rather than incidence is normally recorded in a cross-sectional study. The temporal sequence of cause and effect cannot necessarily be determined in a cross-sectional study.4 Diabetes: a chronic health condition where the body is unable to produce insulin and properly breakdown sugar (glucose) in the blood. Symptoms include hunger, thirst, excessive urination, dehydration, and weight loss. The treatment of diabetes requires daily insulin injections, proper nutri- tion, and regular exercise. Complications can include heart disease, stroke, neuropathy, poor circulation leading to loss of limbs, hearing impairment, vision problems, and death.1 Diphtheria: a specific infectious disease due to the bacterium Corynebac- terium diphtheriae and its highly potent toxin; marked by severe inflam- mation that can form a membranous coating, with formation of a thick fibrinous exudate, of the mucous membrane of the pharynx, the nose, and sometimes the tracheobronchial tree; the toxin produces degeneration in peripheral nerves, heart muscle, and other tissues, diphtheria had a high fatality rate, especially in children, but is now rare because of an effective vaccine.5 Ecological study: a study in which the units of analysis are populations or groups of people rather than individuals. Conclusions of ecological studies

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APPENDIX B 149 may not apply to individuals; thus caution is needed to avoid the ecologi- cal fallacy. Ecological studies can reach valid causal inferences on causal relationships at the ecological level—i.e., on causal processes that occur at the group level of among groups. Ecological studies are necessary for deci- sions that affect entire groups.4 Eczema: an inflammatory condition of the skin characterized by red- ness, itching, and oozing vesicular lesions which become scaly, crusted, or hardened.2 Encephalopathy: a general term describing brain dysfunction. Examples include encephalitis, meningitis, seizures, and head trauma.1 Epilepsy: any of various disorders marked by abnormal electrical discharges in the brain and typically manifested by sudden brief episodes of altered or diminished consciousness, involuntary movements, or convulsions.2 Febrile seizures: a febrile seizure is a convulsion in a child triggered by a fever. Febrile seizures occur most often in otherwise healthy children be- tween ages 9 months and 5 years. Toddlers are most commonly affected. Febrile seizures often run in families. Most febrile seizures occur in the first 24 hours of an illness and may not occur when the fever is highest. Ear infections or any cold or viral illness may trigger a febrile seizure.3 Guillain-Barré syndrome (GBS): an acute, immune-mediated disorder of peripheral nerves, spinal roots, and cranial nerves, commonly presenting as a rapidly progressive, areflexive, relatively symmetric ascending weakness of the limb, truncal, respiratory, pharyngeal, and facial musculature, with variable sensory and autonomic dysfunction; typically reaches its nadir within 2-3 weeks, followed initially by a plateau period of similar duration, and then subsequently by gradual but complete recovery in most cases.5 Haemophilus influenzae type b (Hib): a bacterial infection that may result in severe respiratory infections, including pneumonia, and other diseases such as meningitis.1 Hepatitis: inflammation of the liver, due usually to viral infection but some- times to toxic agents.5 Hepatitis A: a viral disease with a short incubation period (usually 15-50 days), caused by hepatitis A virus, a member of the family Picornaviridae, often transmitted by fecal-oral route; may be inapparent, mild, severe, or occasionally fatal and occurs sporadically or in epidemics, commonly in

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150 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY school-age children and young adults; necrosis of periportal liver cells with lymphocytic and plasma cell infiltration is characteristic, and jaundice is a common symptom.5 Hepatitis B: a viral disease with a long incubation period (usually 50- 160 days), caused by a hepatitis B virus, a DNA virus and member of the family Hepadnaviridae, usually transmitted by injection of infected blood or blood derivatives or by use of contaminated needles, lancets, or other instruments or by sexual transmission; clinically and pathologically similar to viral hepatitis type A, but there is no cross-protective immunity; HBsAg is found in the serum and the hepatitis delta virus occurs in some patients. May lead to acute or chronic liver disease.5 Human papillomavirus (HPV): an icosahedral DNA virus, 55 nm in diam- eter, of the genus Papillomavirus, family Papovaviridae; certain types cause cutaneous and genital warts; other types are associated with severe cervical intraepithelial neoplasia and anogenital and laryngeal carcinomas.5 Immune thrombocytopenic purpura (ITP): a systemic illness characterized by extensive ecchymoses and hemorrhages from mucous membranes and very low platelet counts; resulting from platelet destruction by macrophages due to an antiplatelet factor; childhood cases are usually brief and rarely present with intracranial hemorrhages, but adult cases are often recurrent and have a higher incidence of grave bleeding, especially intracranial. Also known as idiopathic thrombocytopenic purpura.5 Immunoglobulins: see Antibody. Inactivated vaccine: a vaccine made from viruses and bacteria that have been killed through physical or chemical processes. These killed organisms cannot cause disease.1 Influenza: an acute infectious respiratory disease, caused by influenza vi- ruses, which are in the family Orthomyxoviridae, in which the inhaled virus attacks the respiratory epithelial cells of those susceptible and produces a catarrhal inflammation; characterized by sudden onset, chills, fever of short duration (3-4 days), severe prostration, headache, muscle aches, and a cough that usually is dry and may be followed by secondary bacterial infections that can last up to 10 days.5 Live vaccine: a vaccine in which live virus is weakened (attenuated) through chemical or physical processes in order to produce an immune response without causing the severe effects of the disease. Attenuated vaccines

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APPENDIX B 151 currently licensed in the United States include measles, mumps, rubella, shingles (herpes zoster), varicella, and yellow fever. Also known as an at- tenuated vaccine.1 Measles: an acute exanthematous disease, caused by measles virus (genus Morbillivirus), a member of the family Paramyxoviridae, and marked by fever and other constitutional disturbances, a catarrhal inflammation of the respiratory mucous membranes, and a generalized dusky red maculopapu- lar eruption; the eruption occurs early on the buccal mucous membrane in the form of Koplik spots, a manifestation useful in early diagnosis; average incubation period is from 10-12 days.5 Meningitis: inflammation of the membranes of the brain or spinal cord.5 Mumps: an acute infectious and contagious disease caused by a mumps vi- rus of the genus Rubulavirus and characterized by fever, inflammation, and swelling of the parotid gland, and sometimes of other salivary glands, and occasionally by inflammation of the testis, ovary, pancreas, or meninges.5 Myoclonus: irregular involuntary contraction of a muscle usually resulting from functional disorder of controlling motor neurons.2 Nested case-control study: an important type of case-control study in which cases and controls are drawn from the population in a fully enumerated cohort. Typically, some data on some variables are already available about both cases and controls; thus concerns about differential (biased) misclassi- fication of these variables can be reduced (e.g., environmental or nutritional exposures may be analyzed in blood from cases and controls collected and stored years before disease onset). A set of controls is selected from subjects (i.e., noncases) at risk of developing the outcome of interest at the time of occurrence of each case that arises in the cohort.4 Observational study: a study that does not involve any intervention (experi- mental or otherwise) on the part of the investigator. A study with random allocation is inherently experimental or nonobservational. Observations are not just a haphazard collection of facts; in their own way, observational studies must apply the same rigor as experiments. Many important epidemi- ological, clinical, and microbiological studies are completely observational or have large observational components.4 Otitis Media: a viral or bacterial infection that leads to inflammation of the middle ear. This condition usually occurs along with an upper respiratory infection. Symptoms include earache, high fever, nausea, vomiting, and

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152 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY diarrhea. In addition, hearing loss, facial paralysis, and meningitis may result.1 Pertussis: an acute infectious inflammation of the larynx, trachea, and bron- chi caused by Bordetella pertussis; characterized by recurrent bouts of spas- modic coughing that continues until the breath is exhausted, then ending in a noisy inspiratory stridor (the “whoop”) caused by laryngeal spasm.5 Pneumonia: inflammation of the lung parenchyma characterized by consoli- dation of the affected part, the alveolar air spaces being filled with exudate, inflammatory cells, and fibrin.5 Poliomyelitis: an acute infectious virus disease caused by the poliovirus, characterized by fever, motor paralysis, and atrophy of skeletal muscles of- ten with permanent disability and deformity, and marked by inflammation of nerve cells in the ventral horns of the spinal cord—called also infantile paralysis, polio.2 Randomized controlled trial (RCT): an epidemiological experiment in which subjects in a population are randomly allocated into groups, usually called study and control groups, to receive or not receive an experimental preventive or therapeutic procedure, maneuver, or intervention. The results are assessed by rigorous comparison of rates of disease, death, recovery, or other appropriate outcome in the study and control groups. RCTs are generally regarded as the most scientifically rigorous method of hypothesis testing available in epidemiology and medicine. Nonetheless, they may suffer serious lack of generalizability, due, for example, to the nonrepre- sentativeness of patients who are ethically and practically eligible, chosen, or consent to participate.4 Retrospective study: a research design used to test etiological hypotheses in which inferences about exposure to the putative causal factor(s) are derived from data relating to characteristics of the persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or other outcome condition of interest, and their characteristics and past experiences are compared with those of other, unaffected persons. Persons who differ in the severity of the disease may also be compared. It is no longer considered a synonym for case-control study.4 Rotavirus: a group of viruses that cause diarrhea in children.1

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APPENDIX B 153 Rubella: an acute but mild exanthematous disease caused by rubella virus (Rubivirus family Togaviridae), with enlargement of lymph nodes, but usually with little fever or constitutional reaction; a high incidence of birth defects in children results from maternal infection during the first trimester of fetal life (congenital rubella syndrome).5 Seizure: a violent spasm or series of jerkings of the face, trunk, or extremi- ties. Also known as convulsions.5 Self-controlled case series study: the method, like the case-crossover method, uses cases as their own controls. However, the similarity stops there, as the case series method derives from cohort rather than case-control logic. In particular, ages at vaccination are regarded as fixed, and the random vari- able of interest is the age at adverse event, conditionally on its occurrence within a pre-determined observation period.6 Socioeconomic status (SES): descriptive term for a person’s position in so- ciety, which may be expressed on an ordinal scale using such criteria as in- come, level of education attained, occupation, value of dwelling place, etc.4 Stroke: any acute clinical event, related to impairment of cerebral circula- tion, that lasts longer than 24 hours.5 Sudden death: unexpected death that is instantaneous or occurs within minutes or hours from any cause other than violence.2 Surveillance: systematic and continuous collection, analysis, and interpreta- tion of data, closely integrated with the timely and coherent dissemination of the results and assessment to those who have the right to know so action can be taken. It is an essential feature of epidemiologic and public health practice. The final phase in the surveillance chain is the application of in- formation to health promotion and to disease prevention and control. A surveillance system includes functional capacity for data collection, analy- sis, and dissemination linked to public health programs.4 Tetanus: a disease marked by painful tonic muscular contractions, caused by the neurotropic toxin (tetanospasmin) of Clostridium tetani acting upon the central nervous system.5 Thimerosal: thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930s. There is no convincing evi- dence of harm caused by the low concentrations of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.

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154 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure. Today, all routinely recommended childhood vaccines manufactured for the U.S. market contain either no thimerosal or only trace amounts with the exception of some flu vaccines. There are thimerosal-free influenza vaccines available.1 Thrombocytopenia: a condition in which an abnormally small number of platelets is present in the circulating blood.5 Toxoid vaccines: toxoid vaccines contain a toxin or chemical made by the bacteria or virus. They make you immune to the harmful effects of the infection, instead of to the infection itself. Examples are the diphtheria and tetanus vaccines.3 Type 1 diabetes: diabetes of a form that usually develops during child- hood or adolescence and is characterized by a severe deficiency of insulin secretion resulting from atrophy of the islets of Langerhans and causing hyperglycemia and a marked tendency toward ketoacidosis—called also insulin-dependent diabetes, insulin-dependent diabetes mellitus, juvenile diabetes, juvenile-onset diabetes, type 1 diabetes mellitus.2 Vaccination: injection of a killed or weakened infectious organism in order to prevent the disease.1 Vaccine: immunobiological substance used for active immunization by introducing into the body a live modified, attenuated, or killed inactivated infectious organism or its toxin. The vaccine is capable of stimulating an immune response by the host, who is thus rendered resistant to infection. The word vaccine was originally applied to the serum from a cow infected with vaccinia virus (cowpox; from Latin vacca, “cow”); it is now used of all immunizing agents.4 Vaccine Adverse Event Reporting System (VAERS): a database managed by the Centers for Disease Control and Prevention and the Food and Drug Ad- ministration. VAERS provides a mechanism for the collection and analysis of adverse events associated with vaccines currently licensed in the United States. Reports to VAERS can be made by the vaccine manufacturer, recipi- ent, their parent/guardian, or health care provider. For more information on VAERS call (800) 822-7967.1

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APPENDIX B 155 Vaccine Safety Datalink (VSD) Project: to increase knowledge about vaccine adverse events, the Centers for Disease Control and Prevention have formed partnerships with nine large health management organizations (HMOs) to continually evaluate vaccine safety. The project contains data on more than 9 million people. Medical records are monitored for potential adverse events following immunization. The VSD project allows for planned vac- cine safety studies as well as timely investigations of hypotheses.1 Varicella: an acute contagious disease, usually occurring in children, caused by the Varicella-zoster virus genus, Varicellovirus, a member of the family Herpesviridae, and marked by a sparse eruption of papules, which become vesicles and then pustules, like that of smallpox although less severe and varying in stages, usually with mild constitutional symptoms; incubation period is about 14-17 days.5 SOURCES 1Centers for Disease Control and Prevention as defined on the following webpage: http://www. vaccines.gov/more_info/glossary/index.html. 2Merriam-Webster Medical Dictionary, a source used by the National Institutes of Health’s Medline Plus website, which is produced by the National Library of Medicine. The citation for the Merriam-Webster Medical Dictionary term is Merriam-Webster Medical Dictionary [Internet]. [Springfield (MA)]: Merriam-Webster, Incorporated; © 2003, and the specific term can be obtained on the following website: http://www.nlm.nih.gov/ medlineplus/mplusdictionary.html. 3A.D.A.M. Medical Encyclopedia, a source used by the National Center for Biotechnology Information, a division of the National Library of Medicine at the National Institutes of Health. The citation for the A.D.A.M. Medical Encyclopedia term is A.D.A.M. Medical Encyclopedia [Internet]. [Atlanta (GA)]: A.D.A.M., Inc.; © 2010, and the specific term can be obtained on the following website: http://www.ncbi.nlm.nih.gov/pubmedhealth/s/ diseases_and_conditions. 4A Dictionary of Epidemiology, fifth edition, a handbook sponsored by the International Epidemiology Association. The citation for the term is: Porta, M. 2008. A Dictionary of Epidemiology, 5th ed. New York, NY: Oxford University Press. © 2008. 5Stedman, Thomas Lathrop. 2006. Stedman’s medical dictionary. Philadelphia: Lippincott Williams & Wilkins. © 2006. 6C.P. Farrington. 2004. Control without separate controls: Evaluation of vaccine safety using case-only methods. Vaccine 22(15-16):2064-2070. Elsevier Ltd. © 2004.

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