]> 2010-06-17 Alan Ruttenburg Alexander D. Diehl Barry Smith Bjoern Peters Chris Mungall Lindsay Cowell Melanie Courtot Richard H. Scheuermann Ryan R. Brinkman Thomas Todd en An ontology for the annotation of the vaccine domain. Draft version OWL-DL The Vaccine Ontology (VO) is a biomedical ontology in the domain of vaccine. VO aims to standardize vaccine annotation, integrate various vaccine data, and support computer-assisted reasoning. VO supports basic vaccine R&D and clincal vaccine usage. VO is primarily developed by Dr. Yongqun "Oliver" He at the University of Michigan Medical School. VO is being developed as a community-based ontology with support and collaborations from the vaccine and bio-ontology communities. Vaccine Ontology Vision Release; 1.0.419 Yongqun "Oliver" He (YH) Zuoshuang "Allen" Xiang has_dose_specification YH, XZ has_dose_specification is a relation that specifies the dose of a vaccine used for a specific vaccination process. has_vaccine_contraindication has_vaccine_contraindication is a relation that specifies contraindication of a vaccine. YH This relation may be replaced by has_vaccine_allergen. We need to determine if any vaccine contraindicator is not a vaccine allergen. has_adverse_event_disposition YH, XZ has_adverse_event_disposition is a relation that specifies some adverse event disposition that a vaccine may have. infection_of The relation 'infection_of' is introduced to represent an infection caused by an infectious pathogen. A pathogen infection is a disorder. Since the number of pathogens is large, there are numerous infections. To make the description of a specific infection simple, the shortcut term 'infection_of' is defined: infection_of X = infection and has_part some (organism X and has_disposition some infectious disposition) YH, XZ, MC, BP, AR infection_of is a relation between a disorder and an infectious pathogen. administered_to_ameliorate administered_to_ameliorate is a relationship between a material entity (eg., vaccine) instance and an instance of a disorder which the material is developed with the function to ameliorate in a host organism (e.g., human). YH, XZ disease_caused_by YH administered_to_prevent administered_to_prevent is a relationship between a material entity (eg., vaccine) instance and an instance of a disorder against which the material is developed with the function to induce protection (prevention) in a host organism (e.g., human). "Vaccine A administered_to_prevent some 'HIV infection'": means that Vaccine A is administered to prevent HIV infection. YH vaccinates "A vaccinates B" means that the vaccine A is used for vaccinating the host B (e.g., human). A relationship between a vaccine instance and an organism type such that if the vaccine instance is given to an instance of the organism by the process vaccination, then it changes the organism's disposition to have an immune response against a disease. YH, AR, ZX, MC has_route_specification YH has_vaccination_route is a relation that specifies the route of a vaccine. has_vaccine_allergen has_vaccine_allegen is a relation that specifies an allegen to a vaccine. YH has_gene_mutation_of YH is_distributed_by YH, ZX is_distributed_by is a relation that specifies a company that distributes a product (e.g., vaccine). The company is very likely not the manufacturer of the product. participates_in independent variable specification dependent variable specification part of organism in vaccine YH 'part of organism in vaccine' is a pathogen component in vaccine that contains only a part of the pathogen organism instead of the whole organism. vaccine Many vaccines are developed to protect against infectious pathogens. Many vaccines are also being developed against some diseases such as cancer and autoimmune diseases. Vaccine is developed against a disease. Allergy. YH, BP, BS, MC, LC, XZ, RS A vaccine is a processed material with the function that when administered, it prevents or ameliorates a disorder in a target organism by inducing or modifying adaptive immune responses specific to the antigens in the vaccine. MeSH: D014612 vaccination YH, BP vaccine administration Vaccination is: an 'administering substance in vivo' that involves in adding vaccine into a host (e.g., human, mouse) in vivo with the intend to invoke a protective immune response. ACAM2000 YH ActHIB YH PMID: 1517908 PMID: 1735812 PMID: Adacel YH Afluria YH Attenuvax YH vaccine-induced lymphocyte activation YH vaccine-induced B cell antigen processing and presentation YH vaccine-induced B cell cytokine production YH B cell epitope in vaccine YH vaccine-induced B cell mediated immunity YH Bacillus anthracis vaccine anthrax vaccine A vaccine that protects against Bacillus anthrax that causes anthrax. MeSH: D022122 YH Biothrax YH Boostrix YH AE: fever YH, SS AE: pyrexia Fever is a frequent medical sign that describes an increase in internal body temperature to levels above normal. Fever is characterized as a temporary elevation in the body's thermoregulatory set-point, usually by about 1-2 掳C (1.8-3.6 掳F). febrile response AE: body temperature increased AE: rash AE:rash is a vaccine induced skin adverse event. A rash is a change of the skin which affects its color, appearance, or texture. A rash may be localized in one part of the body, or affect all the skin. Rashes may cause the skin to change color, itch, become warm, bumpy, dry, cracked or blistered, swell and may be painful. This term is a COSTART term but not a MP term (3/17/2009). YH Brucella abortus DNA vaccine pcDNA-SOD PMID: 15039330 YH A Brucella abortus vaccine that expresses Cu/Zn SOD with DNA plasmid pcDNA. PMID: 15039330. AE: infection This term is a COSTART term but not a MP term (3/17/2009). YH Brucella abortus strain RB51 as vaccine vector YH Brucella abortus RB51 Brucella abortus vaccine RB51 is a Brucella abortus vaccine that is licensed in the USA since 1992. Brucella abortus vaccine RB51 is a live attenuated cattle vaccine against brucellosis that is currently used in the USA and many other coutries. PMID: 11504226 PMID: 12438380 PMID: 12704101 Brucella RB-51 PMID: 10534009 YH PMID: 11768128 PMID: 17894637 WEB: http://rb51.com PMID: 11504238 PMID: 8740701 PMID: 7622248 PMID: 1439207 PMID: 11500423 PMID: 8039890 PMID: 11553603 PMID: 1908158 B. abortus RB51 Brucella RB51 PMID: 8890203 PMID: 12119140 PMID: 7806364 SRB51 PMID: 19362381 PMID: 16713034 PMID: 17653832 PMID: 11193615 PMID: 18836016 PMID: 19439382 PMID: 7927779 Brucella abortus strain 19 Brucella strain-19 Brucella S19 YH PMID: 8039890 PMID: 11058778 A live attenuated Brucella abortus vaccine that is licensed and used in many countries. AE: syndrome YH This term is a COSTART term but not a MP term (3/17/2009). syndrome is the association of several clinically recognizable features, signs (observed by a physician), symptoms (reported by the patient), phenomena or characteristics that often occur together, so that the presence of one feature alerts the physician to the presence of the others. AE: agitation YH emotional state of excitement or restlessness This term is a COSTART term but not a MP term (3/17/2009). Brucella vaccine A vaccine that protects against Brucella spp. that causes brucellosis in animals and humans. YH MeSH: D002004 brucellosis vaccine injection-site AE This term is a COSTART term but not a MP term (3/17/2009). injection-site reaction YH AE: injection-site hypersensitivity This term is a COSTART term but not a MP term (3/17/2009). YH Comvax PMID: YH DAPTACEL YH DECAVAC YH DNA of pathogen organism as vaccine component YH DNA from protective protein that is used as vaccine component. This is usually used for preparation of DNA vaccine. DNA vaccine synonym: naked DNA vaccine genetic vaccine nucleic acid vaccine DNA vaccine is a vaccine that is composed of a plasmid vaccine vector (a circular double stranded DNA molecule) containing genes encoding one or more proteins of a pathogen. YH naked DNA vaccine Diphtheria and Tetanus Toxoids Adsorbed by Sanofi Pasteur Inc YH Diphtheria and Tetanus Toxoids Adsorbed by Sanofi Pasteur Ltd YH Dryvax YH ETEC vaccine ACAM2010 YH PMID: 17566016 ACAM2007 is a vaccine candidate expressing CFA/II. Engerix-B YH vaccine persistence assay YH An assay that measures the persistent survival of live vaccine in a host in vivo. AE: injection-site edema YH AE: injection-site oedema This term is a COSTART term but not a MP term (3/17/2009). AE: injection-site pain YH This term is a COSTART term but not a MP term (3/17/2009). Escherichia coli vaccine A bacterial vaccine that prevents against Escherichia coli infection. E. coli vaccine YH MeSH: D022361 AE: injection-site inflammation YH This term is a COSTART term but not a MP term (3/17/2009). FluLaval YH FluMist YH Fluarix YH Fluvirin YH Fluzone YH intramuscular injection YH Gardasil YH HIV based lentivirus vaccine vector YH Balb/c mouse YH Havrix YH Neisseria meningitidis vaccine MeSH: D022401 YH A bacterial vaccine that prevents Neisseria meningitidis infection. Meningococcal vaccine IPOL YH PMID: IgA YH IgE YH IgG YH IgG1 YH IgG2a YH IgG2b YH IgG3 YH IgM YH Imovax Rabies YH Infanrix YH Influenza Virus Vaccine H5N1 by Sanofi Pasteur Inc WEB: http://atomicnewsreview.org/2009/10/22/approval-for-the-arepanrix%E2%84%A2-gsk-vaccine-in-canada/ YH JE-Vax YH KINRIX YH Listeria monocytogenes as vaccine vector YH M-M-R II YH M-M-Vax YH Menactra YH Menomune A C Y W135 YH Meruvax II YH Mumpsvax YH AE: injection-site hemorrhage This term is a COSTART term but not a MP term (3/17/2009). YH AE: injection-site mass This term is a COSTART term but not a MP term (3/17/2009). Not sure where to put "mass", which requires more discussion. AE: injection-site mass is a mass at physical injection site YH, SS Mycobacterium tuberculosis vaccine YH MeSH: D032581 tuberculosis vaccine A vaccine that protects against Mycobacterium tuberculosis. Mycobax Mycobax is a BCG vaccine that is made by Sanofi Pasteur, Ltd. Ref: http://www.biopharma.com/cgi/full6.lasso?Key=412.65916 YH O antigen of pathogen organism as vaccine compent YH AE: pruritus AE: pruritus generalised itch Itch (Latin: pruritus) is an unpleasant sensation that evokes the desire or reflex to scratch. itching This term is a COSTART term but not a MP term (3/17/2009). YH, SS WEB: http://www.ncbi.nlm.nih.gov/sites/entrez?db=mesh&cmd=DetailsSearch&term=pruritus+generalised&log$=activity Influenza A (H1N1) 2009 Monovalent Vaccine by Novartis Pediarix YH PedvaxHIB YH PMID: PMID: 2791073 Pentacel YH Plague Vaccine by Greer Laboratories Inc YH AE: pain This term is a COSTART term but not a MP term (3/17/2009). YH Plasmodium falciparum vaccine a malaria vaccine that protects against malaria caused by Plasmodium falciparum. YH Pneumovax 23 YH Poliovax YH Prevnar YH ProQuad YH RNA of pathogen organism as vaccine component YH RNA from protective protein that is used as vaccine component. This is usually used for preparation of RNA vaccine. ROTARIX YH RabAvert YH Rabies Vaccine Adsorbed by BioPort Corp YH Recombivax HB YH RotaTeq YH SIV based lentivirus vaccine vector YH AE: myalgia This term is a COSTART term but not a MP term (3/17/2009). YH Myalgia means "muscle pain" and is a symptom of many diseases and disorders. muscle pain vaccine-induced T-helper 1 type immune response YH vaccine-induced T-helper 2 type immune response YH TENIVAC YH TICE BCG Intravesical TICE庐 BCG has been used as a therapy for, and to prevent recurrence of, tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage Ta T1 papillary tumors of the bladder at high risk of recurrence. Refernce URL: http://www.ticebcg.com/Consumer/aboutTice/index.asp YH TYPHIM Vi YH T cell epitope in vaccine YH vaccine-induced T cell mediated immunity YH T cell vaccine antigen processing and presentation YH Brucella abortus vaccine YH Tetanus Toxoid Adsorbed by Sanofi Pasteur Inc YH E. coli O157:H7 intimin vaccine PMID: 11500434 YH E. coli Int280a has been found to be a protective antigen. This subunit vaccine uses E. coli Int280a combined with adjuvant. This antigen can be used for development of type-specific EPEC or EHEC vaccine. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use by Massachusetts Public Health Biologic Lab YH Tripedia YH Twinrix YH AE: urticaria This term is a COSTART term but not a MP term (3/17/2009). Urticaria is a kind of skin rash notable for dark red, raised, itchy bumps. YH hives vaccine-induced T cell activation AE: headache This term is a COSTART term but not a MP term (3/17/2009). YH respiratory system AE YH I created this term and make it to be an umbrella term for different disorder terms related to respiratory system. --Oliver He VAQTA YH Varivax YH Vivotif YH YF-Vax YH Yellow fever 17D as vaccine vector YH Yellow fever virus vaccine A viral vaccine that protects against infection with Yellow fever virus. YH MeSH: D022341 Zostavax YH licensed turkey vaccine YH live attenuated pathogen as vaccine component YH aluminum hydroxide vaccine adjuvant alum YH aluminium phosphate vaccine adjuvant YH vaccination frequency YH Vaccination frequency is a qualitative term that represents how many times vaccination has occurred. AE: increased leukocyte cell number SS, YH MP: MP_0000218 According to the Vaccine Adverse Event Reporting System (VAERS), 'leukocytosis' is an adverse event that was mentioned in 1,021 VAERS reports (0.8%) during1991-2001 (Reference: PMID: 12825543). AE: white blood cell count increased greater than normal number of nucleated cells of the myeloid or lymphoid lineages, found in blood or other tissue calcium phosphate vaccine adjuvant YH AE: decreased leukocyte cell number According to the Vaccine Adverse Event Reporting System (VAERS), 'leukopenia' is an adverse event that was mentioned in 417 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). MP: MP_0000221 reduction in the number of nucleated cells of the myeloid or lymphoid lineages, found in blood or other tissue Freund's emulsified oil adjuvant YH a vaccine adjuvant that consists of a water-in-oil emulsion of aqueous antigen in paraffin (mineral) oil of low specific gravity and low viscosity. It is named after Jules T. Freund (1890-1960), Hungarian-born American immunologist. It is a water in oil emulsion. vaccine-induced T cell proliferation vaccine-induced adaptive immune response YH adenovirus vaccine vector YH adjuvant role YH live virulent pathogen as vaccine component YH complete Freund's adjuvant is a Freund's emulsfied oil adjuvant that contains inactivated and dried mycobacteria, usually Mycobacterium tuberculosis (the pathogenic agent of tuberculosis). YH agglutinating antibody YH virulence factor YH incomplete Freund's adjuvant a Freud's adjuvant that does not contain the mycobacterial components. YH cholera toxin YH alphavirus vaccine vector YH vaccine vector role YH Corynebacterium-derived P40 vaccine adjuvant YH vaccine adjuvant role YH antibody YH antibody isotype YH antibody titer Antibody titer is a titer of antibody that shows how much antibody an organism has produced that recognizes a particular epitope, expressed as the greatest dilution ratio (or its reciprocal) that still gives a positive result. ELISA is a common means of determining antibody titers. YH WEB: http://en.wikipedia.org/wiki/Antibody_titer antigen role YH Francisella tularensis vaccine YH preparation of toxoid vaccine YH A vaccine preparation that results in the generation of a toxoid vaccine Brucella abortus sodC YH bacterial gene YH viral gene YH HIV gene YH AE: abnormal blood pressure MP: MP_0000230 altered tension of the blood within the systemic arteries preparation of live attenuated vaccine by serial passages in vitro Brucella abortus cattle vaccine RB51 was developed by serial passages of virulent B. abortus strain 2308 in vitro in rifampin agar plates (Reference: PMID: 1908158). A live attenuated vaccine prepraration process that is performed by serial passages in vitro for pathogen attenuation. YH Influenza A (H1N1) 2009 Monovalent Vaccine by Sanofi Pasteur E. coli gene YH avirulent YH M. tuberculosis gene YH bacterial vaccine YH A vaccine that protects against some bacterial disease. MeSH: D001428 bacterial vaccine vector YH AE: asthenia YH This term is a COSTART term but not a MP term (3/17/2009). Asthenia is a medical term denoting symptoms of physical weakness and loss of strength. Asthenia is a side effect of vaccines such as the HPV vaccine Gardasil. Salmonella gene YH Shigella gene YH protozoan gene YH Plasmodium gene YH Plasmodium falciparum gene YH attenuated YH Leishmania gene YH AE: muscle ache muscle pain YH vaccine-induced T cell differentiation cancer vaccine neoplasm vaccine tumor vaccine A vaccine that prevents or treats cancer. It is produced using the patient's own whole tumor cells as the source of antigens, or using tumor-specific antigens, often recombinantly produced. MeSH: D019496 YH inactivated vaccine preparation A vaccine preparation that results in the generation of a inactivated vaccine YH part of vaccine YH cardinal part of vaccine vaccine component A 'part of vaccine' is a material entity that is a part or component of a vaccine. vaccine-induced cell activation YH lipopolysaccharide vaccine adjuvant YH vaccine-induced antibacterial agglutination antibody response YH Japanese encephalitis virus gene YH Ebola virus gene YH Influenza virus gene YH RNA vaccine Using RNA may eliminate the problem of having to tailor a vaccine for each individual patient with their specific immunity. The advantage of RNA is that it can be used for all immunity types and can be taken from a single cell. DNA vaccines need to produce RNA which then prompts the manufacture of proteins. However, RNA vaccine eliminates the step from DNA to RNA. A vaccine that uses RNA(s) derived from a pathogen organism. YH muramyl dipeptide YH MDP Dengue virus gene YH colony forming unit CFU WEB: http://en.wikipedia.org/wiki/Colony-forming_unit YH Colony-forming unit (CFU) is a titer measurement of viable bacterial or fungal numbers. Unlike in direct microscopic counts where all cells, dead and living, are counted, CFU measures viable cells. By convenience the results are given as CFU/mL (colony-forming units per milliliter) for water, and CFU/g (colony-forming units per gram) for soil or other porous material. squalene YH a vaccine adjuvant that contains an organic polymer with some antigenic epitopes which might be shared with other organic polymers acting as immunostimulators. arlacel A YH Montanide 103 YH Bordetella pertussis component vaccine adjuvant a vaccine adjuvant that contains components from killed Bordetella pertussis. The killed B. pertussis has a strong adjuvant effect on the diphtheria and tetanus toxoids in the DPT vaccines. YH PCV2 vaccine YH conjugate vaccine Conjugate vaccine is vaccine that conjugates/links antigens to the molecules that form the outer coat of disease-causing bacteria to promote an immune response. Conjugate vaccines are designed primarily for very young children because their immune systems can not recognize the outer coats of certain bacteria. YH preparation of recombinant vector vaccine YH A vaccine preparation that results in the generation of a recombinant vector vaccine West Nile virus gene YH chickenpox virus gene YH Rubella virus gene YH Hepatitis B virus gene YH Porcilis-PCV2 YH Characteristics: Inactivated baculovirus expressed PCV2 ORF2 protein; adjuvanted Hepatitis A virus gene YH Suvaxyn PCV2 Characteristics: Inactivated PCD1-2 chimera; adjuvanted YH Intervet YH http://www.intervet.com/ Fort Dodge YH http://www.wyeth.com/divisions/fort_dodge.asp licensed pig vaccine YH contraindication YH a contraindication is a condition or factor that increases the risks involved in using a particular drug, carrying out a medical procedure, or engaging in a particular activity. vaccine in research role YH vaccine in research role is a 'regulation-assigned roleof a vaccine that is not licensed or in clinical trial; instead, it is currently in laboratory research. AE: maculopapular rash A maculopapular rash is a rash with flat, red area on the skin that is covered with small confluent bumps. YH This term is a COSTART term but not a MP term (3/17/2009). hemagglutination-inhibition assay an immune response detection assay that detects specific antiviral antibodies in a test serum. The serum, usually a twofold dilution series, is mixed with a standard number, usually 4 to 8 HA units, of virus and incubated prior to the addition of a standard suspension of erythrocytes. The highest dilution of serum that inhibits hemagglutination is the HI titer of the serum. For example, influenza (AI) viruses agglutinate erythrocytes through the interaction of the virus surface glycoprotein, the hemagglutinin (HA), with receptors on the surface of the erythrocyte. Inhibition of the agglutination reaction by HA subtype-specific antisera is the basis of the hemagglutination-inhibition (HI) assay. YH HI assay inactivated YH AE: arthralgia This term is a COSTART term but not a MP term (3/17/2009). Arthralgia means joint pain. It is a symptom of injury, infection, illnesses (in particular arthritis) or an allergic reaction to medication. According to MeSH, the term "arthralgia" should only be used when the condition is non-inflammatory, and the term "arthritis" should be used when the condition is inflammatory. YH hypersensitivity to chicken product YH AE: vesiculobullous rash This term is a COSTART term but not a MP term (3/17/2009). vesiculobullous rash is a blistering rash characterized by serous-fluid-filled vesicles (blisters) YH AE: screaming syndrome YH This term is a COSTART term but not a MP term (3/17/2009). AE: dizziness YH, SS This term is a COSTART term but not a MP term (3/17/2009). Dizziness describes a number of subjective symptoms, which the patient may describe as feelings of lightheadedness, floating, wooziness, giddiness, confusion, disorientation or loss of balance. Medical terms include vertigo, disequilibrium, pre-syncope or syncoptic episode. Causes may stem from a variety of failures of equilibrioception, hypotension, cerebral hypoxia or a reaction to environmental chemicals or drugs. AE: peripheral edema AE: oedema peripheral AE: peripheral edema is an edema thatresults in swelling of tissues, usually in the lower limbs, due to the accumulation of fluids This term is a COSTART term but not a MP term (3/17/2009). WEB: http://en.wikipedia.org/wiki/Peripheral_edema AE: edema peripheral YH, SS hypersensitivity to chicken egg YH vaccine solvent solution A vaccine solvent solution is a vaccine additive that helps to dissolve all vaccine components in liquid. YH malaise This term is a COSTART term but not a MP term (3/17/2009). YH Malaise is a feeling of general discomfort or uneasiness, an "out of sorts" feeling. Malaise is often the first indication of an infection or other disease. Vaccination may induce malaise. AE: somnolence This term is a COSTART term but not a MP term (3/17/2009). drowsiness YH, SS Somnolence (or "drowsiness") is a state of near-sleep, a strong desire for sleep, or sleeping for unusually long periods (c.f. hypersomnia). AE: paresthesia Paresthesia is a sensation of tingling, pricking, or numbness of a person's skin with no apparent long-term physical effect. It is more generally known as the feeling of "pins and needles" or of a limb being "asleep" (although this is not directly related to the phenomenon of sleep). The manifestation of paresthesia may be transient or chronic. YH This term is a COSTART term but not a MP term (3/17/2009). AE: paraesthesia AE: crying abnormal This term is a COSTART term but not a MP term (3/17/2009). YH hypersensitivity to antibiotic YH hypersensitivity to neomycin YH hypersensitivity to polymyxin YH reaction to previous vaccination YH parasite vaccine YH, ZX bacterial vaccine preparation A vaccine preparation that results in the generation of a bacterial vaccine YH, ZX chills YH Chills refers to feeling cold after an exposure to a cold environment. The word can also refer to an episode of shivering, accompanied by paleness and feeling cold. This term is a COSTART term but not a MP term (3/17/2009). AE: stupor This term is a COSTART term but not a MP term (3/17/2009). Stupor is the lack of critical cognitive function and level of consciousness wherein a sufferer is almost entirely unresponsive and only responds to base stimuli such as pain. The word derives from the Latin stupure, meaning insensible. Being characterised by impairments of reactions to external stimuli, in this case, vaccine immunization. YH AE: anorexia AE: decreased appetite Anorexia is the decreased sensation of appetite. This term is a COSTART term but not a MP term (3/17/2009). anorexia nervosa YH life-threatening reaction to previous vaccination YH AE: face edema AE: face oedema WEB:http://www.nlm.nih.gov/medlineplus/ency/article/003105.htm This term is a COSTART term but not a MP term (3/17/2009). AE: face edema is an edema that results in facial swelling, the build-up of fluid in the tissues of the face. Swelling may also affect the neck and upper arms YH, SS life-threatening reaction to previous influenza vaccination YH AE: cough increased WEB: http://www.nlm.nih.gov/medlineplus/cough.html This term is a COSTART term but not a MP term (3/17/2009). AE: cough increased is an abnormal respiration that results in a reflex that keeps your throat and airways clear YH, SS cough hypersensitivity to gentamicin YH dominant epitope in vaccine YH vaccine-induced down-regulated gene expression YH hypersensitity to gelatin YH preparation of vaccine using heat inactivation YH A vaccine prepraration process that is performed by heat inactivation of virulent pathogen. CFU reduction assay CFU reduction assay is an assay that measures the reduction of the colony forming units of infected pathogens in vaccine-vaccinated animals compared to nonvaccinated animals. YH assay of CFU reduction in spleen YH assay of CFU reduction in spleen is a CFU reduction assay that is measured using the extracted spleen as the tissue for isolation of infected pathogens. hypersensitity to arginine Arginine is a conditionally essential amino acid, meaning most of the time it can be manufactured by the human body, and does not need to be obtained directly through the diet. The biosynthetic pathway however does not produce sufficient arginine, and some must still be consumed through diet. Individuals who have poor nutrition or certain physical conditions may be advised to increase their intake of foods containing arginine. Infants are unable to meet their requirements and thus arginine is nutritionally essential for infants. YH edibility Melanie has submitted this term and its two subclasses to PATO: http://sourceforge.net/tracker/?func=detail&aid=2873643&group_id=76834&atid=595654 YH, MC A physical quality inhering in a bearer by virtue of the bearer being fit to be eaten. edible This term may be submitted to PATO. A quality of edibility that inheres in a bearer by virtue of the bearer being suitable for oral ingestion as food, drug, or vaccine. YH vaccine efficacy Vaccine efficacy is an efficacy of a vaccine in induction of protective immune response in vivo or protection against infection of a virulent pathogen. Specifically, vaccine efficacy (VE) is the percentage reduction in disease incidence attributable to vaccination, calculated by means of the following equation: VE(%) = (U - V)/U x 100 where U = the incidence in unvaccinated people and V = the incidence in vaccinated people. Ref: Hadler TC, et al. Immunization in developing countries. In: Vaccines. Editors: Plotkin S, et al. 2008. p1542-71. YH history of asthma YH vaccine-induced antiviral neutralizing antibody response YH AE: flu syndrome This term is a COSTART term but not a MP term (3/17/2009). YH peptide of pathogen organism as vaccine component YH peptide of pathogen that is used as vaccine component. This peptide may function as epitope to stimulate protective immunity. AE: syncope This term is a COSTART term but not a MP term (3/17/2009). Syncope is the medical term for fainting, a sudden, usually temporary, loss of consciousness. YH, SS AE: syncope is a sensory capability AE that results in loss of consciousness, fainting fainting WEB: http://en.wikipedia.org/wiki/Syncope_%28medicine%29 AE: sweating According to the Vaccine Adverse Event Reporting System (VAERS), 'sweating' is an adverse event that was mentioned in 2,301 VAERS reports (1.8%) during1991-2001 (Reference: PMID: 12825543). YH vaccination with a licensed cattle vaccine YH usage of bronchodilator YH AE: abdominal pain According to the Vaccine Adverse Event Reporting System (VAERS), 'abdominal pain' is an adverse event that was mentioned in 2,254 VAERS reports (1.8%) during1991-2001 (Reference: PMID: 12825543). YH, SS AE: abdominal pain is a pain in abdominal cavity, stomach ache WEB: http://en.wikipedia.org/wiki/Abdominal_pain This term is a COSTART term but not a MP term (3/17/2009). AE: hypertension According to the Vaccine Adverse Event Reporting System (VAERS), 'hypertension' is an adverse event that was mentioned in 1,038 VAERS reports (0.8%) during1991-2001 (Reference: PMID: 12825543). blood pressure increased YH, SS MP: MP_0000231 hypertension sustained high blood pressure at a level that is likely to result in cardiovascular disease and/or other pathological states AE: lab test abnormal YH According to the Vaccine Adverse Event Reporting System (VAERS), 'sweating' is an adverse event that was mentioned in 2,056 VAERS reports (1.6%) during1991-2001 (Reference: PMID: 12825543). Intially, 'adverse event' and (is_specified_output_of some 'laboratory test') However, it cannot be inferred right. The reason appears that the is_specified_output_of cannot be another process (here, the AE is defined as a process.) We will think it over. This term is a COSTART term but not a MP term (3/17/2009). AE: myasthenia myasthenia gravis Myasthenia represenats myasthenia gravis, a neuromuscular disease leading to fluctuating muscle weakness and fatiguability. This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'myasthenia' is an adverse event that was mentioned in 1,812 VAERS reports (1.4%) during1991-2001 (Reference: PMID: 12825543). vaccine-induced follicular dendritic cell activation YH usage of steroid YH AE: chest pain This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'chest pain' is an adverse event that was mentioned in 1,752 VAERS reports (1.4%) during1991-2001 (Reference: PMID: 12825543). sodB(Ft) PMID: 16923916 sodBFt is a live vaccine strain mutant of Francisella tularensis with reduced Fe-superoxide dismutase gene expression. Ref: PMID: 18692537. YH PMID: 18692537 licensed human vaccine role Oliver He: The previous OWL definition includes: contained_in some 'homo sapiens' However, the contained_in relation is not right. On the other hand, we have not found an appropriate way to define it by including the species name like 'homo sapiens'. We will look into it later. YH, ZX licensed human vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for human use. licensed cattle vaccine role YH licensed cattle vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for cattle use. fungal disease YH fungal vaccine MeSH: D005657 A vaccine that protects against infection with some fungus. YH licensed dog vaccine role licensed dog vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for dog use. YH, XZ licensed pig vaccine role licensed pig vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for pig use. YH, XZ F. tularensis vaccine LVS PMID: 16912944 PMID: 8757866 YH A live attenuated Francisella tularensis vaccine. It is available in American Type Culture Collection with ATCC ID: 29684. AE: exacerbation of underlying condition According to the Vaccine Adverse Event Reporting System (VAERS), 'exacerbation of underlying condition' is an adverse event that was mentioned in 1,606 VAERS reports (1.2%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH AE: insomnia Insomnia is a symptom of a sleeping disorder characterized by persistent difficulty falling asleep or staying asleep despite the opportunity. Insomnia is a symptom, not a stand-alone diagnosis or a disease. YH According to the Vaccine Adverse Event Reporting System (VAERS), 'insomnia' is an adverse event that was mentioned in 1,526 VAERS reports (1.2%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). AE: twitching Involuntary sudden movement of part of the body. According to the Vaccine Adverse Event Reporting System (VAERS), 'twitching' is an adverse event that was mentioned in 1,511 VAERS reports (1.2%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). AE: febrile seizure This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'febrile seizure' is an adverse event that was mentioned in 1,490 VAERS reports (1.2%) during1991-2001 (Reference: PMID: 12825543). YH AE: asthma According to the Vaccine Adverse Event Reporting System (VAERS), 'asthma' is an adverse event that was mentioned in 1,373 VAERS reports (1.1%) during1991-2001 (Reference: PMID: 12825543). Asthma is a common chronic lung disease. It has been defined by the National Heart, Lung and Blood Institute as a common chronic disorder of the airways that is complex and characterized by variable and recurring symptoms, airflow obstruction, bronchial hyperresponsiveness (bronchospasm), and an underlying inflammation. This term is a COSTART term but not a MP term (3/17/2009). YH vaccine function YH, MC, XZ, and AR PERSPN: Oliver He: There has been hot discussion about whether we use 'vaccine function' or 'vaccine role'. Vaccine role may not be the good term to use. Vaccine is designed to be 'vaccine', so it should be vaccine function. One special case is cowpox virus. The cowpox virus can be mixed with some liquid like water and used as a smallpox vaccine. In this case, people often say: the cowpox virus has a 'vaccine role'. However, the cowpox virus vaccine is a processed material of a mix of the virus with water. The virus is a virus, it is not a vaccine per se. Therefore, vaccine role may not be an accurate term. vaccine function is a function that enheres in a vaccine that induces protective immune response against a disease. It is realized in the vaccination process in the host. AE: neck pain This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'neck pain' is an adverse event that was mentioned in 1,323 VAERS reports (1.0%) during1991-2001 (Reference: PMID: 12825543). AE: positive rechallenge In contrast, positive dechallenge occurs when the adverse reaction disappears once the drug is stopped. Positive rechallenge occurs when the adverse reaction re-emerges once a drug (e.g., vaccine) is restrarted. This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'positive rechallenge' is an adverse event that was mentioned in 1,292 VAERS reports (1.0%) during1991-2001 (Reference: PMID: 12825543). YH heat killed pathogen in vaccine YH AE: back pain YH According to the Vaccine Adverse Event Reporting System (VAERS), 'back pain' is an adverse event that was mentioned in 1,277 VAERS reports (1.0%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). herpesvirus vaccine vector YH AE: alopecia MP: MP_0000414 VAE According to the Vaccine Adverse Event Reporting System (VAERS), 'alopecia'; is an adverse event that was mentioned in 260 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). absence of hair or loss of hair; not usually in reference to primary genetic hairlessness but may be due to dietary, stress, secondary to immune condition alopecia AE: gastrointestinal hemorrhage According to the Vaccine Adverse Event Reporting System (VAERS), 'gastrointestinal hemorrhage'; is an adverse event that was mentioned in 183 VAERS reports (0.1%) during1991-2001 (Reference: PMID: 12825543). MP: MP_0000465 bleeding in the stomach and/or the intestines vaccine-induced host gene response YH vaccine-induced host immune response YH vaccine-induced host response a processual entity that specifies host response to a vaccine. YH host response to vaccine adjuvant YH a process that specifies host response to a vaccine adjuvant. host response to vaccine component a processual entity that specifies host response to a vaccine component. YH host response to vaccine antigen a process that specifies host response to a vaccine antigen. YH host response to vaccine vaccine vector a process that specifies host response to a vaccine vector. YH AE: eyes gaze upward According to the Vaccine Adverse Event Reporting System (VAERS), 'eyes gaze upward' is an adverse event that was mentioned in 1,249 VAERS reports (1.0%) during1991-2001 (Reference: PMID: 12825543). YH AE: neuropathy This term is a COSTART term but not a MP term (3/17/2009). peripheral neuropathy Neuropathy is a medical term describing disorders of the nerves of the peripheral nervous system (specifically excluding encephalopathy and myelopathy, which refer to the central nervous system.) It is usually considered equivalent to peripheral neuropathy. YH According to the Vaccine Adverse Event Reporting System (VAERS), 'neuropathy' is an adverse event that was mentioned in 1,154 VAERS reports (0.9%) during1991-2001 (Reference: PMID: 12825543). human immunodeficiency virus vaccine AIDS vaccine YH MeSH: D016915 HIV vaccine A viral vaccine that protects against infection with human immunodeficiency virus that causes AIDS. licensed horse vaccine role licensed horse vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for horse use. YH, XZ AE: skin nodule According to the Vaccine Adverse Event Reporting System (VAERS), 'skin nodule' is an adverse event that was mentioned in 1,134 VAERS reports (0.9%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). AE: arthrosis According to the Vaccine Adverse Event Reporting System (VAERS), 'arthrosis' is an adverse event that was mentioned in 1,129 VAERS reports (0.9%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). A degenerative disease of a joint. Arthrosis is an articular illness that produces fibrosis or degeneration of the cartilage. YH company YH Brucella melitensis strain VTRM1 YH AE: hypokinesia YH Hypokinesia refers to slow or diminished movement of body musculature. AE: muscle twitching muscle contraction muscle fasciculation YH Brucella suis strain VTRS1 YH PMID: 17428946 B. suis VTRS1 AE: skin discoloration AE: skin discoloration is a skin adverse event that results in change in color of skin or mucus membranes According to the Vaccine Adverse Event Reporting System (VAERS), 'skin discoloration' is an adverse event that was mentioned in 909 VAERS reports (0.7%) during1991-2001 (Reference: PMID: 12825543). YH, SS AE: skin discolouration AE: herpes zoster This term is a COSTART term but not a MP term (3/17/2009). zoster shingles Herpes zoster is a viral disease characterized by a painful skin rash with blisters in a limited area on one side of the body, often in a stripe. The initial infection with varicella zoster virus (VZV) causes the acute (short-lived) illness chickenpox, and generally occurs in children and young people. Once an episode of chickenpox has resolved, the virus is not eliminated from the body but can go on to cause shingles (an illness with very different symptoms) often many years after the initial infection. According to the Vaccine Adverse Event Reporting System (VAERS), 'herpes zoster' is an adverse event that was mentioned in 892 VAERS reports (0.7%) during1991-2001 (Reference: PMID: 12825543). YH AE: laryngismus This term is a COSTART term but not a MP term (3/17/2009). YH sudden laryngeal spasm with crowing inhalation and cyanosis. It is an uncontrolled/involuntary muscular contraction (spasm) of the laryngeal cords. laryngospasm According to the Vaccine Adverse Event Reporting System (VAERS), 'laryngismus' is an adverse event that was mentioned in 881 VAERS reports (0.7%) during1991-2001 (Reference: PMID: 12825543). KKF24 YH PMID: 16552035 KKF24 is a recombinant strain of Francisella novicida U112 with iglC mutation (F. novicida delta-iglC::ermC). PMID: 14680699. F. tularensis vaccine LVS LPS YH F. tularensis vaccine LVS lipopolysaccharide PMID: 10722593 vaccine-induced antibody mediated immune response immunoglobulin mediated immune response to vaccine YH immunologic adjuvant YH B. melitensis lipopolysaccharide vaccine YH B. melitensis LPS-GBOMP noncovalent complex vaccine PMID: 8723881 B. melitensis LPS-GBOMP subunit vaccine YH AE: speech disorder According to the Vaccine Adverse Event Reporting System (VAERS), 'speech disorder' is an adverse event that was mentioned in 848 VAERS reports (0.7%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH AE: hemorrhage MP: MP_0001914 According to the Vaccine Adverse Event Reporting System (VAERS), 'hemorrhage' is an adverse event that was mentioned in 338 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). hemorrhage loss of blood from the vascular compartment to the exterior or into nonvascular body space as a result of rupture or severance of the blood vessels inactivated vaccine killed vaccine YH A vaccine that is made from whole viruses or bacteria that have been inactivated with chemicals or heat. inactivated organism vaccine AE: neck rigidity YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'Neck rigidity' is an adverse event that was mentioned in 829 VAERS reports (0.6%) during1991-2001 (Reference: PMID: 12825543). AE: Guillain-Barr茅 syndrome AE: GBS YH, SS This term is a COSTART term but not a MP term (3/17/2009). Guillain-Barr茅 syndrome is a disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until the muscles cannot be used at all and the patient is almost totally paralyzed. In these cases, the disorder is life-threatening and is considered a medical emergency. Usually Guillain-Barr茅 occurs a few days or weeks after the patient has had symptoms of a respiratory or gastrointestinal viral infection. Occasionally, surgery or vaccinations will trigger the syndrome. Reference: http://www.ninds.nih.gov/disorders/gbs/gbs.htm. According to the Vaccine Adverse Event Reporting System (VAERS), 'Guillain-Barr茅 syndrome' is an adverse event that was mentioned in 820 VAERS reports (0.6%) during1991-2001 (Reference: PMID: 12825543). AE: nausea and vomiting This term will most likely removed since it is just a combination of nausea and vomiting. YH According to the Vaccine Adverse Event Reporting System (VAERS), 'nausea and vomiting' is an adverse event that was mentioned in 812 VAERS reports (0.6%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). AE: sudden infant death This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'sudden infant death' is an adverse event that was mentioned in 808 VAERS reports (0.6%) during1991-2001 (Reference: PMID: 12825543). AE: fever with chills This term is a COSTART term but not a MP term (3/17/2009). AE: chills and fever successive stages of chills and fever. This is a symptom of malaria. YH According to the Vaccine Adverse Event Reporting System (VAERS), 'chills and fever' is an adverse event that was mentioned in 722 VAERS reports (0.6%) during1991-2001 (Reference: PMID: 12825543). Brucella abortus DNA vaccine encoding BCSP31, SOD and L7/L12 YH B. abortus DNA vaccine expressing BCSP31, SOD and L7/L12 PMID: 17570767 AE: personality disorder YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'personality disorder' is an adverse event that was mentioned in 678 VAERS reports (0.5%) during1991-2001 (Reference: PMID: 12825543). Brucella abortus subunit vaccine using L7/L12 YH PMID: 8873388 recombinant B. abortus L7/L12 vaccine AE: lung disorder YH According to the Vaccine Adverse Event Reporting System (VAERS), 'lung disorder' is an adverse event that was mentioned in 614 VAERS reports (0.5%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). B. melitensis DNA vaccine encoding Omp31 PMID: 17428946 YH muscle adverse event YH AE: liver/biliary system disorder YH AE: enlarged liver MP: MP_0000599 According to the Vaccine Adverse Event Reporting System (VAERS), 'hepatomegaly'; is an adverse event that was mentioned in 106 VAERS reports (<0.1%) during1991-2001 (Reference: PMID: 12825543). enlarged liver larger than average size of the liver licensed goat and sheep vaccine role licensed goat and sheep vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for goat and sheep use. YH inedible YH, MC A quality of edibility that inheres in a bearer by virtue of the bearer being not suitable for oral ingestion. AE: meningitis Meningitis is a medical condition caused by inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The inflammation is caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs or diseases. According to the Vaccine Adverse Event Reporting System (VAERS), 'meningitis' is an adverse event that was mentioned in 592 VAERS reports (0.5%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH tertiary vaccination YH, Thom Todd tertiary vaccination is a vaccination that is performed at the third time in a row. licensed cat vaccine role YH, XZ licensed cat vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for cat use. digestive system AE YH vaccine injection site YH AE: facial paralysis YH According to the Vaccine Adverse Event Reporting System (VAERS), 'facial paralysis' is an adverse event that was mentioned in 580 VAERS reports (0.5%) during1991-2001 (Reference: PMID: 12825543). AE: confusion According to the Vaccine Adverse Event Reporting System (VAERS), 'confusion' is an adverse event that was mentioned in 579 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH Brucella melitensis bp26 deletion vaccine Brucella CGV26 PMID: 16519974 CGV26 YH A B. melitensis vaccine that is recombinant B. melitensis Rev. 1 vaccine with the bp26 deletion. It has similar vaccien efficacy to Rev. 1. Its advantage compared to Rev. 1 is that this feature of bp26 deletion promotes diagnosis. PMID: 17070627. F. tularensis vaccine FSC043 A spontaneous mutant of the SCHU S4 strain that protects against virulent F. tularensis infection. PMID: 16299332. PMID: 16299332 YH intramuscular route YH intranasal route YH intranasal route by drop YH intranasal route by spray YH intraperitoneal route YH Brucella melitensis WR201 YH AE: joint disorder According to the Vaccine Adverse Event Reporting System (VAERS), 'joint disorder' is an adverse event that was mentioned in 562 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). Brucella abortus bacA mutant YH PMID: 17196866 B. abortus bacA mutant Influenza A (H1N1) 2009 Monovalent Vaccine by CSL Limited Influenza A (H1N1) 2009 Monovalent Vaccine from MedImmune LLC Arepanrix MC, YH vaccine host a vaccine host is a role that inheres in an organism that is the target of a vaccine administration (vaccination process). Megan Egg WEB: http://www.fda.gov/ohrms/dockets/dockets/00n0504/00N-0504_emc-001650-02.pdf Megan Egg is a Salmonella vaccine that that consists of a double gene-deleted S. enterica serovar Typhimurium strain and is formulated fro immunization of pullets. Megan Egg contains the same Megan Vac1 organism but Megan Vac1 is used for younger birds (broilers). YH AE: eye disorder YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'eye disorder' is an adverse event that was mentioned in 543 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). B. ovis microparticle subunit vaccine PMID: 16481077 YH AE: autism This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'autism' is an adverse event that was mentioned in 530 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). Autism is a brain development disorder characterized by impaired social interaction and communication, and by restricted and repetitive behavior. AE: sedimentation rate increased erythrocyte sedimentation rate ESR Sedimentation rate is a diagnostic test for inflammation. The test measures the rate at which red blood cells fall to the bottom of a tube over time. An increased sedimentation rate corresponds to increased non-specific inflammation in the body. It is often called "sedrate" for short. This term should be inferred to lab test abnormal. YH sedrate According to the Vaccine Adverse Event Reporting System (VAERS), 'sedimentation rate increased' is an adverse event that was mentioned in 530 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). AE: red blood cell sedimentation rate increased AE: red blood cell sedimentation rate increased is an AE: sedimentation rate increased that has an increase in rate at which red blood cells precipitate in a period of 1 hour. This term is a COSTART term but not a MP term (3/17/2009). AE: accidental injury According to the Vaccine Adverse Event Reporting System (VAERS), 'accidental injury' is an adverse event that was mentioned in 530 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH an injury that occurs accidentally. Brucella recombinant SurA protein vaccine YH PMID: 17686554 lentivirus vaccine vector YH AE: amblyopia According to the Vaccine Adverse Event Reporting System (VAERS), 'amblyopia' is an adverse event that was mentioned in 507 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). YH vaccine-induced leukocyte activation YH licensed human vaccine in USA YH a human vaccine with license that is commercially used in the USA. licensed vaccine A vaccine that is licensed for commercial use. YH AE: mental retardation YH According to the Vaccine Adverse Event Reporting System (VAERS), 'mental retardation' is an adverse event that was mentioned in 498 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). lipopolysaccharide of pathogen organism as vaccine component YH liposome-based vaccine adjuvant YH a vaccine adjuvant that contains particles made up of concentric lipid membranes containing phospholipids and other lipids in a bilayer configuration separated by aqueous compartments. It is a relatively stable but non-covalently-bound complex of saponin adjuvant Quil-A, cholesterol and amphipathic antigen in a molar ratio of approximately 1:1:1. The spectrum of viral capsid antigens and non-viral amphipathic antigens of relevance for human vaccination, incorporated into ISCOMs, comprises influenza, measles, rabies, gp340 from EB-virus, gp120 from HIV, Plasmodium falciparum and Trypanosoma cruzi. Ref: http://www.vaccination.inoz.com/adjuvants.html. live attenuated vaccine A live vaccine that is made from microbes that have been attenuated (weakened) in the laboratory so that they can't cause disease. attenuated vaccine YH live pathogen organism as vaccine component YH live vaccine YH A vaccine that is made of live whole organism. live virulent vaccine YH quaternary vaccination quaternary vaccination is a vaccination that is performed at the fourth time in a row. YH, Thom Todd AE: erythema multiforme YH brain inflammation local accumulation of fluid, plasma proteins, and leukocytes in the brain According to the Vaccine Adverse Event Reporting System (VAERS), 'erythema multiforme' is an adverse event that was mentioned in 483 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). Brucella recombinant DnaK protein vaccine YH PMID: 17686554 divalent DNA B. abortus vaccine using L7/L12 and Omp16 PMID: 16622210 YH AE: SGOT increased According to the Vaccine Adverse Event Reporting System (VAERS), 'SGOT increased' is an adverse event that was mentioned in 477 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). Increased level of SGOT. SGOT respresents serum glutamic oxaloacetic transaminase, an enzyme that is normally present in liver and heart cells. SGOT is released into blood when the liver or heart is damaged. The blood SGOT levels are thus elevated with liver damage (for example, from viral hepatitis) or with an insult to the heart (for example, from a heart attack). Some medications can also raise SGOT levels. SGOT is also called aspartate aminotransferase (AST). AE: SGPT increased According to the Vaccine Adverse Event Reporting System (VAERS), 'SGPT increased' is an adverse event that was mentioned in 459 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH Increased level of SGPT. SGPT represents serum glutamic pyruvic transaminase, an enzyme that is normally present in liver and heart cells. SGPT is released into blood when the liver or heart are damaged. The blood SGPT levels are thus elevated with liver damage (for example, from viral hepatitis) or with an insult to the heart (for example, from a heart attack). Some medications can also raise SGPT levels. SGPT is also called alanine aminotransferase (ALT). AE: thinking abnormality YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'thinking abnormality' is an adverse event that was mentioned in 457 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). AE: dyspepsia This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'dyspepsia' is an adverse event that was mentioned in 454 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). Dyspepsia is popularly known as indigestion, meaning hard or difficult digestion. It is a medical condition characterized by chronic or recurrent pain in the upper abdomen, upper abdominal fullness and feeling full earlier than expected when eating. AE: anaphylactoid reaction This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'anaphylactoid reaction' is an adverse event that was mentioned in 452 VAERS reports (0.4%) during1991-2001 (Reference: PMID: 12825543). is an acute systemic (multi-system) and very severe Type I Hypersensitivity allergic reaction in humans and other mammals. Minute amounts of allergens may cause a life-threatening anaphylactic reaction. AE: gastrointestinal disorder YH According to the Vaccine Adverse Event Reporting System (VAERS), 'gastrointestinal disorder' is an adverse event that was mentioned in 449 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). AE: previous reaction This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'previous reaction' is an adverse event that was mentioned in 442 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). YH AE: serum sickness Serum sickness is a reaction to proteins in antiserum derived from an animal source. It is a type of hypersensitivity, specifically immune complex hypersensitivity (type III). This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'serum sickness' is an adverse event that was mentioned in 428 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). AE: injection-site abscess YH According to the Vaccine Adverse Event Reporting System (VAERS), 'injection-site abscess' is an adverse event that was mentioned in 426 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). AE: abnormal electroencephalogram YH According to the Vaccine Adverse Event Reporting System (VAERS), 'abnormal electroencephalogram' is an adverse event that was mentioned in 420 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). Abnormal results of electroencephalography (EEG). EEG is the recording of electrical activity along the scalp produced by the firing of neurons within the brain. In clinical contexts, EEG refers to the recording of the brain's spontaneous electrical activity over a short period of time, usually 20-40 minutes, as recorded from multiple electrodes placed on the scalp. In neurology, the main diagnostic application of EEG is in the case of epilepsy, as epileptic activity can create clear abnormalities on a standard EEG study. A secondary clinical use of EEG is in the diagnosis of coma and encephalopathies. EEG used to be a first-line method for the diagnosis of tumors, stroke and other focal brain disorders, but this use has decreased with the advent of anatomical imaging techniques such as MRI and CT. Brucella abortus DNA vaccine encoding L7/L12 and P39 PMID: 16537031 B. abortus DNA vaccine encoding L7/L12 and P39 YH attenuated Brucella abortus with deletion of znuA PMID: 16790759 YH mucosal immune response to vaccine YH nanoparticle vaccine adjuvant YH licensed fish vaccine role YH, XZ licensed fish vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for fish use. licensed bird vaccine role YH, XZ licensed bird vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for bird use. licensed rabbit vaccine role licensed rabbit vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for rabbit use. YH, XZ licensed ferret vaccine role YH, XZ licensed ferret vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for ferret use. licensed turkey vaccine role licensed turkey vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for turkey use. YH, XZ licensed chicken vaccine role YH, XZ licensed chicken vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for chicken use. licensed deer vaccine role licensed deer vaccine role is a licensed vaccine role that is specifically dedicated a vaccine for deer use. YH, XZ licensed rabbit vaccine neutralizing antibody YH microencapsulated B. melitensis mutant vaccine A B. melitensis vaccine that is composed of live Brucella melitensis attenuated mutant vjbR::Tn5 (BMEII1116) delivered using alginate microspheres that is coated with a protein of the parasite Fasciola hepatica (vitelline protein B [VpB]). PMID: 18362129. YH A B. melitensis vaccine that is composed of live Brucella melitensis attenuated mutant delivered using a microsphere delivery system. PMID: 18362129 AE: vertigo Vertigo is a specific type of dizziness, a major symptom of a balance disorder. It is the sensation of spinning or swaying while the body is actually stationary with respect to the surroundings. The effects of vertigo may be slight. It can cause nausea and vomiting and, in severe cases, it may give rise to difficulties with standing and walking. This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'vertigo' is an adverse event that was mentioned in 412 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). AE: heart arrest According to the Vaccine Adverse Event Reporting System (VAERS), 'heart arrest' is an adverse event that was mentioned in 410 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). cardiac arrest cardiopulmonary arrest asystole This term is a COSTART term but not a MP term (3/17/2009). heart arrest is the abrupt cessation of normal circulation of the blood due to failure of the heart to contract effectively during systole. YH circulatory arrest AE: bronchitis Bronchitis is an inflammation of the air passages within the lungs. It occurs when the trachea (windpipe) and the large and small bronchi (airways) within the lungs become inflamed because of infection or other causes. YH According to the Vaccine Adverse Event Reporting System (VAERS), 'bronchitis' is an adverse event that was mentioned in 407 VAERS reports 0.3%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). AE: grand malconvulsion According to the Vaccine Adverse Event Reporting System (VAERS), 'grand malconvulsion' is an adverse event that was mentioned in 402 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). YH A generalized seizure disorder characterized by recurrent major motor seizures. The initial brief tonic phase is marked by trunk flexion followed by diffuse extension of the trunk and extremities. The clonic phase features rhythmic flexor contractions of the trunk and limbs, pupillary dilation, elevations of blood pressure and pulse, urinary incontinence, and tongue biting. This is followed by a profound state of depressed consciousness (post-ictal state) which gradually improves over minutes to hours. The disorder may be cryptogenic, familial, or symptomatic (caused by an identified disease process). This term is a COSTART term but not a MP term (3/17/2009). porin-S-LPS from B. abortus strain 2308 YH complex of porin and S-LPS from B. abortus strain 2308 PMID: 2844673 Brucella abortus RB51WboA PMID: 15327798 B. abortus RB51WboA YH AE: liver function tests abnormal According to the Vaccine Adverse Event Reporting System (VAERS), 'liver function tests abnormal' is an adverse event that was mentioned in 717 VAERS reports (0.6%) during1991-2001 (Reference: PMID: 12825543). MP: MP_0000609 aberrant function of this bile-secreting exocrine gland, which is important for detoxification; for fat, carbohydrate, and protein metabolism; and for glycogen storage AE: ear disorder This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'ear disorder' is an adverse event that was mentioned in 362 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). YH recombinant O. anthropi 49237SOD YH PMID: 11953393 organ or tissue specific immune response to vaccine YH licensed horse vaccine YH AE: infect viral This term is a COSTART term but not a MP term (3/17/2009). viral infection According to the Vaccine Adverse Event Reporting System (VAERS), 'infect viral' is an adverse event that was mentioned in 358 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). YH, SS WEB: http://en.wikipedia.org/wiki/Viral_infection AE: infect viral is an infection that results in detrimental colonization of a host organism by virus B. melitensis Bp26 and Tf vaccine YH B. melitensis P39 recombinant protein vaccine PMID: 11447155 YH A Brucella subunit vaccine that uses recombinant Brucella melitensis 16M P39, a putative periplasmic binding protein. PMID: 11447155. recombinant chimera BLSOmp31 YH PMID: 17442465 rBLSOmp31 Panvax Panvax is an H1N1 unadjuvanted monovalent vaccine. MC, YH WEB: http://www.infowars.com/h1n1-panvax-training-powerpoint-received-by-health-care-workers-in-australia/ parasite YH intravenous route YH, Thom Todd protozoan vaccine A vaccine that protects against some protozoan disease. parasitic vaccine MeSH: D016052 YH AE: lacrimation disorder According to the Vaccine Adverse Event Reporting System (VAERS), 'lacrimation disorder' is an adverse event that was mentioned in 334 VAERS reports (0.3%) during1991-2001 (Reference: PMID: 12825543). Disorder of lacrimation. Lacrimation is the production, secretion, and shedding of tears. YH This term is a COSTART term but not a MP term (3/17/2009). AE: jaundice MP: MP_0000611 AE: icterus WEB: http://en.wikipedia.org/wiki/Jaundice SS, YH According to the Vaccine Adverse Event Reporting System (VAERS), 'jaundice' is an adverse event that was mentioned in 317 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). clinical manifestation of hyperbilirubinemia, with deposition of bile pigments in the skin, resulting in yellowish staining of the skin and mucous membranes jaundice organism component in vaccine a part of vaccine that originates from an organism such as a pathogen or an attenuated organism. YH Brucella abortus pcDNA-BLS B. abortus pcDNA-BLS YH AE: abscess An abscess is a collection of pus (dead neutrophils) that has accumulated in a cavity formed by the tissue on the basis of an infectious process (usually caused by bacteria or parasites) or other foreign materials (e.g. splinters, bullet wounds, or injecting needles). It is a defensive reaction of the tissue to prevent the spread of infectious materials to other parts of the body. YH This term is a COSTART term but not a MP term (3/17/2009). abscessus According to the Vaccine Adverse Event Reporting System (VAERS), 'abscess' is an adverse event that was mentioned in 318 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). escheriosome-mediated delivery of B. abortus L7/L12 escheriosome-encapsulated B. abortus L7/L12 YH PMID: 17931756 AE: eye pain This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'eye pain' is an adverse event that was mentioned in 316 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH palpitation YH According to the Vaccine Adverse Event Reporting System (VAERS), 'palpitations' is an adverse event that was mentioned in 313 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). A palpitation is an abnormal awareness of the beating of the heart, whether it is too slow, too fast, irregular, or at its normal frequency. This term is a COSTART term but not a MP term (3/17/2009). period of persistence of vaccine induced immune response period of persistence of vaccine induced immune response is a temporal interval during which a vaccine-induced immune response continuously exists. This term is related to the process 'persistence of vaccine induced immune response'. YH, MC phase 1 vaccine trial YH A vaccine clinical trial that investigates the safety profile of a vaccine in a small group (10-50) of healthy volunteers. phase 2 vaccine trial YH A vaccine clinical trial that studies vaccine efficacy with a target population (numbering 50-100). Different dosage levels will also be explored at this stage to determine the optimum dose. phase 3 vaccine trial YH A vaccine clinical trial that takes the trial to a large-scale safety and efficacy study in a relevant patient population, usually in excess of 3,000. phase 4 vaccine trial YH The final stage of vaccine clinical evaluation. Phase IV occurs after a vaccine or therapy is licensed and is being used by large numbers of people. These studies are not always required or completed. rLm/iglC Seven F. tularensis proteins including IglC (rLm/iglC) were expressed in recombinant L. monocytogenes (rLm) vaccines. These 7 F. tularensis proteins are: AcpA, Bfr, DnaK, GroEL, IglC, Pld and KatG from SchuS4 strain. YH nontypeable H. influenzae Hap Protein Vaccine PMID: 15557618 YH A subunit nontypeable H. influenzae vaccine that uses Hap protein. AE: tongue edema AE: tongue oedema According to the Vaccine Adverse Event Reporting System (VAERS), 'tongue edema'; is an adverse event that was mentioned in 310 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). AE: ear pain According to the Vaccine Adverse Event Reporting System (VAERS), 'ear pain'; is an adverse event that was mentioned in 302 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). plasmid vaccine vector YH B. melitensis DNA vaccine encoding Omp31 boosted with Omp31 pCIBLSOmp31 YH AE: angioedema This term is a COSTART term but not a MP term (3/17/2009). YH According to the Vaccine Adverse Event Reporting System (VAERS), 'angioedema'; is an adverse event that was mentioned in 296 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). Angioedema is the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues. It is very similar to urticaria, but urticaria, commonly known as hives, occurs in the upper dermis. AE: rheumatoid arthritis According to the Vaccine Adverse Event Reporting System (VAERS), 'rheumatoid arthritis'; is an adverse event that was mentioned in 295 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). an autoimmune disease that causes chronic inflammation of the joints and may also cause inflammation of the tissue around the joints, as well as other organs in the body YH licensed cattle vaccine in USA role YH, XZ vaccine approval process WEB: http://www.examiner.com/x-7707-Infectious-Disease-Examiner~y2009m9d15-News-Release-H1N1-vaccines-get-FDA-approval-expected-to-be-available-in-4-weeks @2009/10/06. H1N1 vaccines get FDA approval. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. Obtaining FDA licensure of this vaccine for A (H1N1) pandemic response is a key milestone that will enable Sanofi Pasteur to provide a licensed vaccine to the U.S. government to support pandemic immunization efforts WEB: http://energycommerce.house.gov/images/stories/Documents/PDF/publications/109_health.pdf @2009/10/06. This is the US Health Law which includes a section about vaccine. vaccine product approval process YH, ZX, AR, and MC WEB: http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/09-15-2009/0005094621&EDATE @2009/10/06 vaccine approval process is a processual entity that involves approval of a vaccine. WEB: http://www.hhs.gov/nvpo/factsheets/fs_tableII_doc2.htm @2009/10/06 #Following the FDA's review of a license application, the sponsor and the FDA may present their findings to the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication. vaccine candidate role BP, YH vaccine candidate role is the role of a material entity in an investigation, which is tested for its capability to serve as a vaccine. This role should be a subclass of 'test substance role', which will be mireoted from OBI by OntoFox. CFU measurement assay CFU measurement assay is an assay that measures the colony forming unit (CFU) of a bacterium in a specific location (e.g., spleen of a mouse). YH, MC vaccine effectiveness rate vaccine effectiveness rate is a measurement datum that measues the vaccine effectiveness. It is assessed with respect to prevention of the disease against which the vaccine is given. One simple method to estimate vaccine effectiveness is to use routine data on notifications of disease cases in vaccinated and unvaccinatted children and to compare the porportion of cases vaccinated with the vaccine covervage among the same age group in the general population. If p is the proportion vaccinated in the population and c is the proportion of cases reported to be vaccinated, then VE = (p-c)/p(1-c) x 100%. Hadler TC, et al. Immunization in developing countries. In: Vaccines. Editors: Plotkin S, et al. 2008. p1542-71. YH, MC WEB: http://en.wikipedia.org/wiki/Influenza_vaccine vaccine licensing YH, ZX vaccine licensing is a vaccine approval process that involves in licensing a vaccine. licensed chicken vaccine YH, XZ poxvirus vaccine vector YH AE: immune system disorder YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'immune system disorder'; is an adverse event that was mentioned in 292 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). AE: antinuclear antibody present This term is a COSTART term but not a MP term (3/17/2009). anti-nuclear factor present YH The presence of anti-nuclear antibodies (ANAs) that are antibodies directed against contents of the cell nucleus. ANAs are present in higher than normal numbers in autoimmune disease. The ANA test measures the pattern and amount of autoantibody which can attack the body's tissues as if they were foreign material. Autoantibodies are present in low titers in the general population, but in about 5% of the population, their concentration is increased, and about half of this 5% have an autoimmune disease. According to the Vaccine Adverse Event Reporting System (VAERS), 'antinuclear antibody present'; is an adverse event that was mentioned in 288 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). NPAP Brucella vaccine Brucella vaccine using nonpathogenic alphaproteobacteria PMID: 17715332 YH AE: myelitis This term is a COSTART term but not a MP term (3/17/2009). Myelitis is a disease involving inflammation of the spinal cord, which disrupts central nervous system functions linking the brain and limbs. According to the Vaccine Adverse Event Reporting System (VAERS), 'myelitis'; is an adverse event that was mentioned in 280 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH preventive vaccine function preventive vaccine function is a vaccine function realized by the process of vaccination and leading to induction of an adaptive immune response to the antigens in a vaccine, which protects against a specific disorder. YH prophylactic vaccine function prime boost regimen YH APEC vaccine using GST-Iss fusion protein YH Colibacillosis, caused by avian pathogenic Escherichia coli (APEC), is a major problem for the poultry industry in the world. prophylactic vaccine a vaccine that is used for prevention against a disease. YH protection efficacy Protection efficacy is an efficiency that is associated with protection by a biological product (e.g., vaccine) against a disease. YH protective antigen role YH Protective antigen is an antigen that stimulates protective immunity when used in vivo. E. coli LB-T vaccine E. coli heat-labile enterotoxin B-subunit (LB-T) vaccine PMID: 11500434 YH E. coli O157:H7 subunit vaccine expressing Esps and Tir PMID: 14670317 YH AE: migraine A migraine is a very painful type of headache. People who get migraines often describe the pain as pulsing or throbbing in one area of the head. During migraines, people are very sensitive to light and sound. They may also become nauseated and vomit. migraine headache This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'migraine'; is an adverse event that was mentioned in 267 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH AE: thrombocytopenic purpura Thrombocytopenic purpura are purpura associated with a reduction in circulating blood platelets which can result from a variety of causes. YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'thrombocytopenic purpura'; is an adverse event that was mentioned in 267 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). AE: multiple sclerosis Multiple sclerosis is an autoimmune condition in which the immune system attacks the central nervous system, leading to demyelination. YH MS This term is a COSTART term but not a MP term (3/17/2009). encephalomyelitis disseminata disseminated sclerosis According to the Vaccine Adverse Event Reporting System (VAERS), 'multiple sclerosis'; is an adverse event that was mentioned in 264 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). AE: amnesia Amnesia is a short term memory condition in which memory is disturbed. In simple terms it is the loss of memory. According to the Vaccine Adverse Event Reporting System (VAERS), 'amnesia'; is an adverse event that was mentioned in 262 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). YH protein of pathogen organism as vaccine component YH AE: incoordination YH a lack of normal adjustment of muscular action so that the intended movement of the limb or other part is not made smoothly and harmoniously, and does not accurately achieve its objective. If the abnormality is hypermetric, the condition is referred to as ataxia. If it is inclined to weakness, e.g. knuckling at the turn, stumbling, failure to flex limbs properly, or to misdirection as in a proprioceptive deficit, it is called incoordination. This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'incoordination'; is an adverse event that was mentioned in 261 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). soybean-expressed E. coli LTB vaccine YH PMID: 17188785 AE: voice alteration This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'voice alteration'; is an adverse event that was mentioned in 259 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH AE: abortion WEB: http://en.wikipedia.org/wiki/Abortion This term is a COSTART term but not a MP term (3/17/2009). AE: abortion is a reproductive system AE that is the termination of a pregnancyby the removal or expulsion from the uterus of a fetus or embryo, resulting in or caused by its death. According to the Vaccine Adverse Event Reporting System (VAERS), 'abortion'; is an adverse event that was mentioned in 257 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH, SS AE: shock According to the Vaccine Adverse Event Reporting System (VAERS), 'shock'; is an adverse event that was mentioned in 253 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). mental shock acute stress reaction psychological shock Mental shock (or shock) is a psychological condition arising in response to a terrifying event. It should not be confused with the unrelated circulatory condition of shock. This term is a COSTART term but not a MP term (3/17/2009). acute stress disorder YH AE: purpura YH Purpura is the appearance of red or purple discolorations on the skin that do not blanch on applying pressure. They are caused by bleeding underneath the skin. This is common with typhus and can be present with meningitis caused by meningococcal meningitis or septicaemia. Reference: http://en.wikipedia.org/wiki/Purpura. This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'purpura'; is an adverse event that was mentioned in 251 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). nontypeable H. influenzae vaccine YH nontypeable Haemophilus influenzae NTHi Nontypeable Haemophilus influenzae (NTHi) is a nonencapsulated Haemophilus influenzae (a gram-negative bacterium). It is the cause of a number of human respiratory tract diseases, such as otitis media, sinusitis, bronchitis, and pneumonia. YH non-typeable H. influenzae rLP4/rLP6 and Moraxella catarrhalis UspA2 protein vaccine YH rLP4/rLP6/UspA2 PMID: 15308371 killed nontypeable H. influenzae whole-cell vaccine PMID: 1953532 PMID: 2867396 YH PMID: 2184330 PMID: 1859055 AE: bacterial infection event AE: bacterial infection event is an infection that results in detrimental colonization of a host organism by bacteria AE: bacterial infection This term is a COSTART term but not a MP term (3/17/2009). WEB: http://en.wikipedia.org/wiki/Bacterial_infection According to the Vaccine Adverse Event Reporting System (VAERS), 'bacterial infection'; is an adverse event that was mentioned in 250 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH, SS radiated pathogen as vaccine component YH AE: skin striae striae distensae Skin striae are irregular areas of skin that look like bands, stripes, or lines. Striae are seen when a person grows or gains weight rapidly or has certain diseases or conditions. YH According to the Vaccine Adverse Event Reporting System (VAERS), 'skin striae'; is an adverse event that was mentioned in 247 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). stretch marks E. coli vaccine using intimin polypeptide YH PMID: 14688094 PMID: 17258324 nontypeable H. influenzae cell membrane vaccine (CM-Hi) PMID: 10353870 YH nontypeable H. influenzae LOS-TT conjugate vaccine YH PMID: 12706701 Nontypeable H. influenzae lipooligosaccharide-tetanus toxoid conjugate vaccine PMID: 9353024 E. coli subunit vaccine using IroN YH PMID: 17145948 preparation of recombinant protein vaccine A vaccine preparation process that uses recombinant molecular technology to prepare recombinant protein. YH protein subunit vaccine A subunit vaccine that is made using recombinant DNA technology to engineer the antigen molecules of the particular microbe. YH recombinant vector vaccine A vaccine that uses a modified virus or bacterium to deliver genes that code for microbial antigens to cells of the body. YH E. coli subunit vaccine using CO393 YH PMID: 17145948 vaccination with a licensed pig vaccine YH AE: acute brain syndrome According to the Vaccine Adverse Event Reporting System (VAERS), 'acute brain syndrome'; is an adverse event that was mentioned in 240 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). E. coli subunit vaccine using FyuA PMID: 17258324 PMID: 14688094 YH vaccination with a licensed horse vaccine YH immunization WEB: http://en.wikipedia.org/wiki/Immunization immunization is a processual entity that primes or modifies an adaptivie immune response to some antigens. YH, XZ, BP active immunization WEB: http://en.wikipedia.org/wiki/Immunization Active immunization is an immunization process that entails the introduction of a foreign molecule into the body, which causes the body itself to generate adaptive immunity against the target. YH, XZ passive immunization WEB: http://en.wikipedia.org/wiki/Immunization YH, XZ Currently, antibodies can be used for passive immunization. This method of immunization works very quickly. However, it is short lasting. The antibodies are naturally broken down. If there are no B cells to produce more antibodies, they will disappear. Passive immunization is an immunization process where pre-synthesized elements of the immune system are transferred to an organism so that the body does not need to produce these elements itself. natural active immunization YH, XZ WEB: http://en.wikipedia.org/wiki/Immunization natural active immunization is an active immunization that occur naturally when a person or animal comes in contact with antigens includeing microbes. artificial active immunization YH, XZ WEB: http://en.wikipedia.org/wiki/Immunization artificial active immunization is an active immunization that occurs when a person or animal is vaccinated with a specific vaccine. induction of adaptive immune response to antigen induction of adaptive immune response to antigen is an active immunization process that results in induction of adaptive immune response to some antigens, for example, in a vaccine. YH, XZ disorder prevention disorder prevention is a processual entity that prevents a disorder that is the physical basis of a disease. YH, XZ disorder treatment disorder treatment is a processual entity that leads to treat a disorder that is the physical basis of a disease. YH, XZ modification of adaptive immune response to antigen modification of adaptive immune response to antigen is an active immunization process that results in modification of an adaptive immune response to some antigens, for example, in a therapeutic vaccine. YH, XZ preventive infectious disease vaccine function YH, XZ infection disorder prevention YH, XZ infection disorder prevention is a process that prevents a disorder that is the physical basis of an infectious disease. E. coli vaccine using verocytotoxin toxoid PMID: 17145948 YH Inactivated ETEC expressing expressing CFA/I and CFA/II PMID: 1612730 YH coma YH Coma is a profound state of unconsciousness. A comatose person cannot be awakened, fails to respond normally to pain or light, does not have sleep-wake cycles, and does not take voluntary actions. This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'coma'; is an adverse event that was mentioned in 230 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). AE: hyperkinesia YH Hyperkinesia is an abnormal increase in muscular activity. According to the Vaccine Adverse Event Reporting System (VAERS), 'hyperkinesia'; is an adverse event that was mentioned in 227 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). This term is a COSTART term but not a MP term (3/17/2009). EHEC O157 subunit vaccine using his-tagged N-terminal intimin YH PMID: 1612730 AE: cardiovascular disorder According to the Vaccine Adverse Event Reporting System (VAERS), 'cardiovascular disorder'; is an adverse event that was mentioned in 225 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). AE: encephalopathy According to the Vaccine Adverse Event Reporting System (VAERS), 'encephalopathy'; is an adverse event that was mentioned in 224 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). Encephalopathy is disorder or disease of the brain. YH This term is a COSTART term but not a MP term (3/17/2009). AE: urine abnormality This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'urine abnormality'; is an adverse event that was mentioned in 223 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH nontypeable H. influenzae P5 peptide MVF/H3 vaccine PMID: 10603411 YH nontypeable H. influenzae rTbpB vaccine YH PMID: 10225866 ETEC vaccine ACAM2007 ACAM2007 is a vaccine candidate expressing CFA/II. YH AE: gastroenteritis YH This term is a COSTART term but not a MP term (3/17/2009). According to the Vaccine Adverse Event Reporting System (VAERS), 'gastroenteritis'; is an adverse event that was mentioned in 218 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). AE: peripheral vascular disorder According to the Vaccine Adverse Event Reporting System (VAERS), 'peripheral vascular disorder'; is an adverse event that was mentioned in 215 VAERS reports (0.2%) during1991-2001 (Reference: PMID: 12825543). YH This term is a COSTART term but not a MP term (3/17/2009). AE: urinary tract infection