anatomical entity An anatomical entity is a material entity that is part of a multicellular organism, and which is large enough so that it forms an identifiable structure in the organism. Specifically, it excludes granular parts of the organism, such as atoms, molecules, cells, which can be removed from the organism without affecting it. It is defined as the union of 'multi-tissue structure', 'body substance' and 'portion of tissue' anatomical entity respiratory system Functional system which consists of structures involved in respiration. nervous system MC, 20100112: I am using the UBERON term as this one is non human specific, compared to FMA. UBERON:0001016 UBERON:FBbt_00005093-FMA_7157-MA_0000016-MIAA_0000026-WBbt_0005735-XAO_0000177-ZFA_0000396 a network of specialized cells that communicate information about an organism's surroundings and itself[Wikipedia]. cardiovascular system Anatomical system that has as its parts the heart and blood vessels. gastrointestinal system Anatomical system that has as its parts the heart and blood vessels. dermatological-mucosal system Anatomical system that consists of the integumental system plus all mucosae and submucosae. abdominal pain Sensation of discomfort or pain in the abdominal region. Vaccine 28 (2010) 4487-4498 capillary refill time Capillary refill time is the time required for the normal skin colour to reappear after a blanching pressure is applied. It is usually performed by pressing on the nail bed to cause blanching and then counting the time it takes for the blood to return to the tissue, indicated by a pink colour returning to the nail. Normally it is <3 seconds. chest tightness Inability or perception of not being able to move air in or out of the lungs. cyanosis A dark bluish or purplish discolouration of the skin and mucous membrane due to lack of oxygen in the blood. Vaccine 28 (2010) 4487-4498 level of consciousness Level of alertness or awareness of the outside world. diarrhoea Loose and/or watery stool which may occur more frequently than usual. Vaccine 28 (2010) 4487-4498 diarrhea persistent dry cough Rapid expulsion of air from the lungs to clear the lung airways and not accompanied by expectoration (a non-productive cough). Vaccine 28 (2010) 4487-4498 generalized urticaria or generalized erythema grunting Grunting A sudden and short noise with each breath when breathing out. Vaccine 28 (2010) 4487-4498 hoarse voice An unnaturally harsh cry of infant or vocalization in a child or adult. Vaccine 28 (2010) 4487-4498 increased use of accessory respiratory muscles RespMuscAccIncr sternocleidomastoid, intercostals, etc indrawing Inward movement of the muscles between the ribs (inter-costal), in the lower part of the neck (supra-clavicular or tracheal tug) or below the chest (sub-costal). The movements are usually a sign of difficulty with breathing. Vaccine 28 (2010) 4487-4498 retractions local reaction at or near vaccination site Any description of morphological or physiological change at or near the vaccination site. BCCD: Vaccine 26 (2008) 6800-6813 localized injection site urticaria palpable fluctuance Wavelike motion on palpation due to presence of liquid content. reaction crosses joint 201201105, MC: this is intended to be part of the reaction at or near vaccintation site rather than an independent term PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf Reaction extending past at least one joint adjacent to the site of vaccine administration. lymphangitic streaking Red streaks below the skin’s surface that follows the path of lymph draining from the site of infection via lymphatic vessels to regional lymph nodes. low blood pressure An abnormally low blood pressure and documented by appropriate measurement. Infants and children: age specific systolic BP of <3-5%percentile or greater than a 30% decrease from that person’s baseline; Adults: systolic BP of <90mm Hg or greater than 30% decrease from that person’s baseline. Vaccine 28 (2010) 4487-4498 nausea An unpleasant sensation vaguely referred to the upper abdominal region and the abdomen, with a tendency to vomit. Vaccine 28 (2010) 4487-4498 pain sensation of throat closure An unpleasant sensation occurring in varying degrees of severity that could be described as discomfort, distress or agony. Feeling or perception of throat closing with a sensation of difficulty breathing. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf Vaccine 28 (2010) 4487-4498 sore throat Discomfort or pain in the throat spontaneous drainage Draining of fluid from a site without intervention. stridor A harsh or vibrating noise when breathing caused by obstruction of the windpipe or larynx. A harsh and continuous sound made on breathing in. Stridor Vaccine 28 (2010) 4487-4498 surgical drainage BCCD: Vaccine 25 (2007) 5821-5838 Withdrawal of fluids from the site through needle aspiration or incision which could be complete or partial. tachycardia A heart rate that is abnormally high for age and circumstance (In beats per minute: <1year old: >160; 1 – 2 yrs: >150; 2-5 yrs: >140; 5-12 yrs: >120; >12 yrs: >100) Citation for norms is Don & Roberton; Physical examination; in Practical Pediatrics 2007; 6th ed TachyCard Vaccine 28 (2010) 4487-4498 tachypnoea Citation for norms is Don & Roberton; Physical examination; in Practical Pediatrics 2007; 6th ed Rapid breathing which is abnormally high for age and circumstance rapid breathing whichis abnormally high for age and circumstance (<1yr: >60; 1-2 yrs: >40; 2-5 yrs: >35; 5-12 yrs: >30: >12 yrs: >16) TachyPnea Vaccine 28 (2010) 4487-4498 tachypnea vomiting The reflex act of ejecting the contents of the stomach through the mouth. Vaccine 28 (2010) 4487-4498 warmth A sensation/perception of an increase in temperature. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf wheezing A whistling, squeaking, musical, or puffing sound made by breathing out. Vaccine 28 (2010) 4487-4498 generalized urticaria hives generalized erythema angioedema localized or generalized Areas of deeper swelling of the skin and/or mucosal tissues in either single or multiple sites which may not be well circumscribed and is usually not itchy. Reported symptoms of ‘swelling of the lip’ or ‘swelling of the tongue or throat’ should not be documented as angioedema unless there is visible skin or mucosal swelling. Vaccine 28 (2010) 4487-4498 generalized pruritus Pruritus involving more than one body site—that is each limb is counted separately as is the abdomen, back, head and neck. Urticaria at the injection site can be included as a separate site. skin rash bilateral wheeze bronchospasm WheezeBilat upper airway swelling lip, tongue, throat, uvula or larynx SwellUpAirways bilateral http://www.thefreedictionary.com/bilateral Affecting or undertaken by two sides equally; binding on both parties infected abscess BCCD: Vaccine 25 (2007) 5821-5838 A localized collection of pus in a cavity formed by the disintegration of tissue, usually caused by microorganisms that invade the tissues. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf sterile abscess An abscess whose contents are not caused by pyogenic bacteria. BCCD: Vaccine 25 (2007) 5821-5838 PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf cellulitis BCCD: Vaccine 25 (2007) 5803-5820 A diffuse inflammatory process within solid tissues, characterized by edema, redness, pain, and interference with function, usually caused by infection with streptococci, staphylococci, or similar organisms. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf nodule BCCD: Vaccine 22(2004) 575-585 A firm, small mass of tissue at the injection site with discrete or well demarcated borders in the absence of abscess formation, erythema and warmth. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf lymphadenitis Inflammation of one or more lymph nodes, usually caused by a primary focus of infection elsewhere in the body. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf erythema Vaccine 28 (2010) 4487-4498 Abnormal redness of the skin without any raised skin lesions induration BCCD: Vaccine 25 (2007) 5839-5857 PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf Palpable thickening, firmness or hardening of soft tissue (subcutaneous tissue, fat, fascia or muscle) that is assessed by a health care provider generalized pruritus with skin rash generalized pruritus without skin rash generalized prickle sensation A prickle sensation involving more than one body site—that is each limb is counted separately as is the abdomen, back, head and neck. Urticaria at the injection site can be included as a separate site. red and itchy eyes Redness of the whites of the eyes (sclera) with sensation that provokes the desire to rub and/or scratch to obtain relief. difficulty breathing Sensation of difficult/uncomfortable breathing or a feeling of not getting enough air. difficulty breathing without wheeze or stridor sneezing An involuntary (reflex), sudden, violent, and audible expulsion of air through the mouth and nose. Vaccine 28 (2010) 4487-4498 swelling BCCD: Vaccine 25 (2007) 5858-5874 PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf Visible enlargement of the vaccinated limb that is assessed by any person, with or without objective measurement. tenderness Abnormal sensitivity to touch or release of pressure. PHAC user guide, http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf regional lymphadenopathy Abnormal enlargement of the lymph nodes closest to the vaccination site (e.g., inguinal adenopathy when associated with an IM vaccination in the thigh, axillary adenopathy associated with an IM vaccination in the deltoid, etc.). oculo-respiratory syndrome ORS The presence of “bilateral red eyes” plus ≥1 respiratory symptom (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) that starts within 24 hrs of vaccination, with or without facial oedema. urticaria Adapted from P.A. Miescher, H.J. Müller-Eberhard (Eds.), Textbook of immunopathology (2nd ed.), Grune and Stratton, New York (1976) Localized redness of superficial layers of skin that is itchy, raised, sharply demarcated and transient (that is skin changes at any location are usually present for less than 12 h) pruritus An unpleasant skin sensation that provokes a desire to rub and/or scratch to obtain relief. prickle sensation Tingling or smarting (stinging) sensation. rash Vaccine, 25 (2007) 5697-5706 A morphologically described change in the appearance of the skin or mucosa that occurs in the context of and in conjunction with an emerging allergic event that consists of one or more clearly identified primary lesion(s) (macule, papule, vesicle, nodule, bulla, cyst, plaque, pustule) and/or secondary skin change(s) (scaling, atrophy, ulcer, fissure, excoriation). red eyes Redness of the white(s) of the eye (s) (sclera) Vaccine 28 (2010) 4487-4498 itchy eyes Vaccine 28 (2010) 4487-4498 A sensation that provokes the desire to rub and/or scratch to obtain relief. difficulty swallowing Sensation or feeling of difficulty in the passage of solids and liquids down to the stomach. anaphylaxis seizure rhinorrhea Discharge of thin nasal mucus. recession localized urticaria Localized redness of superficial layers of skin that is itchy, raised, sharply demarcated and transient (that is skin changes at any location are usually present for less than 12 hours). Vaccine 28 (2010) 4487-4498 inflammatory response The immediate defensive reaction (by vertebrate tissue) to infection or injury caused by chemical or physical agents. The process is characterized by local vasodilation, extravasation of plasma into intercellular spaces and accumulation of white blood cells and macrophages. inflammatory response