C C78597 APL Differentiation Syndrome Retinoic Acid Syndrome Differentiation Syndrome A syndrome observed in patients with acute promyelocytic leukemia treated with all-trans retinoic acid. It is characterized by weight gain, dyspnea, pleural and pericardial effusions, leukocytosis, and renal failure. A disorder manifesting with fever, leukocytosis, hypotension, and possible cardiac and renal failure as a result of treatment with all-trans retinoic acid or arsenic trioxide. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Retinoic acid syndrome Has Synonym LLT 10038921 MedDRA C C113669 Disseminated Bacillus Calmette-Guerin Infection Disseminated Bacillus Calmette-Guérin Infection BCGosis|Disseminated BCGitis|Disseminated Bacillus Calmette-Guerin Infection A rare systemic and life-threatening infection associated with vaccination with the live attenuated strain of Mycobacterium bovis, bacillus Calmette-Guerin. A systemic and life-threatening infection associated with vaccination with the live attenuated strain of Mycobacterium bovis, Bacillus Calmette-Guerin. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Disseminated Bacillus Calmette-Guerin infection Has Synonym LLT 10076666 MedDRA C C3423 Tuberculosis Tuberculosis Active Tuberculosis|TB|Tuberculosis Disease|Tuberculosis A chronic, recurrent infection caused by the bacterium Mycobacterium tuberculosis. Tuberculosis (TB) may affect almost any tissue or organ of the body with the lungs being the most common site of infection. The clinical stages of TB are primary or initial infection, latent or dormant infection, and recrudescent or adult-type TB. Ninety to 95% of primary TB infections may go unrecognized. Histopathologically, tissue lesions consist of granulomas which usually undergo central caseation necrosis. Local symptoms of TB vary according to the part affected; acute symptoms include hectic fever, sweats, and emaciation; serious complications include granulomatous erosion of pulmonary bronchi associated with hemoptysis. If untreated, progressive TB may be associated with a high degree of mortality. This infection is frequently observed in immunocompromised individuals with AIDS or a history of illicit IV drug use. A disease caused by Mycobacterium tuberculosis infection that is characterized by the growth of nodules in body tissues, most commonly the lungs, and may be transmitted through droplets from the throat or lungs of individuals with the active respiratory disease. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Tuberculosis Has Synonym LLT 10044755 MedDRA C C115248 Methicillin-Resistant Staphylococcus aureus Infection Methicillin-Resistant Staphylococcus aureus Infection A bacterial infection that is caused by Staphylococcus aureus and is resistant to methicillin treatment. A bacterial infection that is caused by Staphylococcus aureus and is resistant to methicillin treatment. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Methicillin-resistant Staphylococcus aureus infection Has Synonym LLT 10027508 MedDRA C C116003 Streptococcal Pharyngitis Streptococcal Pharyngitis Strep Throat Inflammation of the throat due to Streptococcus pyogenes. Inflammation of the throat due to Streptococcus pyogenes. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Streptococcal pharyngitis Has Synonym LLT 10042182 MedDRA C C118297 Bacterial Meningitis Bacterial Meningitis Inflammation of the membranes surrounding the brain and spinal cord due to a bacterial infection. Inflammation of the membranes surrounding the brain and spinal cord due to a bacterial infection. C2890 Bacterial Infection C26828 Meningitis C118464 Pediatric Adverse Events Terminology Bacterial meningitis Has Synonym LLT 10004049 MedDRA C C122523 Methicillin-Resistant Staphylococcus aureus Pneumonia Methicillin-Resistant Staphylococcus aureus Pneumonia Pneumonia that is caused by Staphylococcus aureus and is resistant to methicillin treatment. Pneumonia that is caused by Staphylococcus aureus and is resistant to methicillin treatment. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Methicillin-resistant Staphylococcus aureus pneumonia Has Synonym LLT 10058931 MedDRA C C122526 Mycoplasmal Pneumonia Mycoplasmal Pneumonia Pneumonia caused by Mycoplasma pneumoniae. Signs and symptoms include productive cough, fever, chills, shortness of breath, and chest pain. Pneumonia caused by Mycoplasma pneumoniae. Signs and symptoms include productive cough, fever, chills, shortness of breath, and chest pain. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Mycoplasmal pneumonia Has Synonym LLT 10028478 MedDRA C C122576 Staphylococcus aureus Infection Staphylococcus aureus Infection An infectious process in which the bacteria Staphylococcus aureus is present. An infectious process in which the bacteria Staphylococcus aureus is present. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Staphylococcus aureus infection Has Synonym LLT 10075981 MedDRA C C26715 Cellulitis Cellulitis Inflammation of the dermis and subcutaneous tissues caused by a bacterial infection. Symptoms include erythema, edema, and pain to the affected area. An infection of the skin and subcutaneous tissues with induration and erythema. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Cellulitis Has Synonym LLT 10007882 MedDRA C C3364 Septicemia Sepsis Sepsis Syndrome|Septicemia The presence of pathogenic microorganisms in the blood stream causing a rapidly progressing systemic reaction that may lead to shock. Symptoms include fever, chills, tachycardia, and increased respiratory rate. It is a medical emergency that requires urgent medical attention. A systemic inflammatory response to an infection. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Sepsis Has Synonym LLT 10040047 MedDRA C C34965 Pyelonephritis Pyelonephritis An inflammatory process affecting the kidney. The cause is most often bacterial, but may also be fungal in nature. Signs and symptoms may include fever, chills, flank pain, painful and frequent urination, cloudy or bloody urine, and confusion. An infection of the kidney. C2890 Bacterial Infection C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Pyelonephritis Has Synonym LLT 10037596 MedDRA C C34572 Empyema Empyema An accumulation of pus in a body cavity, usually the pleural space. An accumulation of pus in a body cavity, usually the pleural space. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Empyema Has Synonym LLT 10014568 MedDRA C C78302 Flu-Like Symptoms Flu-Like Symptoms Influenza-Like Illness Complaints describing a pattern similar to influenza, which may include one or more of the following symptoms: fever, chills, muscle or body aches, cough, sore throat, rhinitis, or fatigue. Complaints describing a pattern similar to influenza, which may include one or more of the following symptoms: fever, chills, muscle or body aches, cough, sore throat, rhinitis, or fatigue. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Flu-like symptoms Has Synonym LLT 10016797 MedDRA C C2851 Acquired Immunodeficiency Syndrome Acquired Immunodeficiency Disease AIDS|Acquired Immunodeficiency Syndrome A syndrome resulting from the acquired deficiency of cellular immunity caused by the human immunodeficiency virus (HIV). It is characterized by the reduction of the Helper T-lymphocytes in the peripheral blood and the lymph nodes. Symptoms include generalized lymphadenopathy, fever, weight loss, and chronic diarrhea. Patients with AIDS are especially susceptible to opportunistic infections (usually pneumocystis carinii pneumonia, cytomegalovirus (CMV) infections, tuberculosis, candida infections, and cryptococcosis), and the development of malignant neoplasms (usually non-Hodgkin lymphoma and Kaposi sarcoma). The human immunodeficiency virus is transmitted through sexual contact, sharing of contaminated needles, or transfusion of contaminated blood. A chronic, potentially life threatening condition that is caused by human immunodeficiency virus (HIV) infection, and is characterized by increased susceptibility to opportunistic infections, certain cancers and neurologic disorders. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Acquired immune deficiency syndrome Has Synonym LLT 10000563 MedDRA C C34578 Acute Disseminated Encephalomyelitis Acute Disseminated Encephalomyelitis ADEM An inflammatory process affecting the central nervous system. It is characterized by perivascular demyelination. Symptoms usually follow an acute viral infection or immunization and include fever, confusion, somnolence and involuntary movements. It may lead to coma and death. Transitory inflammation of the brain and spinal cord that is associated with demyelination with or without neuronal damage. C34580 Encephalomyelitis C118464 Pediatric Adverse Events Terminology Acute disseminated encephalomyelitis Has Synonym LLT 10000709 MedDRA C C35286 Clostridium difficile Colitis Clostridium difficile Infection C. diff Colitis|C. diff Infection|Clostridium difficile Colitis|Clostridium difficile Infection A bacterial infection of the colon secondary to infection with Clostridium difficile bacteria. This infection generally results from the loss of normal gut flora secondary to recent antibiotic use, and manifests as copious watery stools, with associated abdominal pain and myalgia. C. difficile is the most common cause of pseudomembranous colitis, and can progress to toxic megacolon if left untreated. An infection of the large intestine by the bacterium Clostridium difficile. C26723 Colitis C118464 Pediatric Adverse Events Terminology Clostridium difficile infection Has Synonym LLT 10054236 MedDRA C C35498 Toxic Shock Syndrome Toxic Shock Syndrome TSS A rare acute life-threatening systemic bacterial noncontagious illness caused by any of several related staphylococcal exotoxins. It is characterized by high fever, hypotension, rash, multi-organ dysfunction, and cutaneous desquamation during the early convalescent period. The toxins affect the host immune system, causing an exuberant and pathological host inflammatory response. Laboratory findings include leukocytosis, elevated prothrombin time, hypoalbuminemia, hypocalcemia, and pyuria. Profoundly reduced blood flow that results in impaired tissue perfusion and possible end organ damage resulting from an exotoxin released from certain bacteria, most often Staphylococcus aureus, or Streptococcus pyogenes. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Toxic shock syndrome Has Synonym LLT 10044248 MedDRA C C50791 Urinary Tract Infection Urinary Tract Infection UTI|Urinary Tract Infectious Disease A bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. Symptoms include urinary urgency and frequency, burning sensation during urination, lower abdominal discomfort, and cloudy urine. An infection of the kidneys, ureters, bladder and/or urethra. C26726 Infectious Disorder C3430 Urinary System Disorder C118464 Pediatric Adverse Events Terminology Urinary tract infection Has Synonym LLT 10046571 MedDRA C C113671 Vaccine-Associated Paralytic Poliomyelitis Vaccine-Associated Paralytic Poliomyelitis OPV associated Paralytic Poliomyelitis|VAPP A rare, paralytic poliomyelitis associated with the orally administered live attenuated strain of the poliovirus, OPV. A paralytic poliomyelitis syndrome associated with the orally administered live attenuated strain of the poliovirus, OPV. C2959 Complication C118464 Pediatric Adverse Events Terminology Vaccine associated paralytic poliomyelitis Has Synonym LLT 10076716 MedDRA C C115164 Nosocomial Infection Nosocomial Infection HAI|Healthcare-Associated Infection|Hospital-Acquired Infection|Hospital-Onset Infection An infection acquired in a hospital or other healthcare setting. An infection acquired in a hospital or other healthcare setting. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Nosocomial infection Has Synonym LLT 10029803 MedDRA C C115165 Sialitis Sialitis Sialadenitis Inflammation of the salivary glands. Inflammation of the salivary glands. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Salivary gland inflammation Has Synonym LLT 10075244 MedDRA C C116007 Epiglottitis Epiglottitis Supraglottitis Inflammation of the epiglottis. Inflammation of the epiglottis. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Epiglottitis Has Synonym LLT 10015030 MedDRA C C26726 Infectious Disorder Infectious Disorder Clinical Infection|ID|Infectious Disease A disorder resulting from the presence and activity of a microbial, viral, fungal, or parasitic agent. It can be transmitted by direct or indirect contact. A disorder resulting from the presence and activity of a microbial, viral, fungal, or parasitic agent. It can be transmitted by direct or indirect contact. C2991 Disease or Disorder C118464 Pediatric Adverse Events Terminology Infection Has Synonym LLT 10021789 MedDRA C C26735 Croup Croup Laryngotracheitis|Laryngotracheobronchitis Acute upper respiratory airways infection that results in the swelling of the larynx. It is usually caused by parainfluenza viruses. Signs include a characteristic barking cough and stridor. Swelling and narrowing of the trachea, vocal cords, and bronchi usually due to a viral infection and which typically manifests with stridor and barking cough. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Croup Has Synonym LLT 10011415 MedDRA C C26821 Lymphadenitis Lymphadenitis Adenitis Acute or chronic inflammation of one or more lymph nodes. It is usually caused by an infectious process. Inflammation of one or more lymph nodes. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Lymphadenitis Has Synonym LLT 10025188 MedDRA C C28137 Oral Candidiasis Oral Candidiasis Thrush Infection of the mucosal lining of the mouth with the fungus Candida albicans. Infection of the mucosal lining of the mouth with the fungus Candida albicans. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Oral candidiasis Has Synonym LLT 10030963 MedDRA C C35000 Schistosomiasis Schistosomiasis Bilharzia|Snail Fever A parasitic infection caused by flukes of the genus Schistosoma. Signs and symptoms include fever, abdominal pain, eosinophilia and hepatosplenomegaly. If left untreated it may eventually cause liver damage leading to cirrhosis, bladder cancer and kidney failure. Schistosoma parasite infection that is commonly seen in tropical and subtropical regions and may be transmitted through skin contact with contaminated freshwater. C27864 Parasitic Infection C118464 Pediatric Adverse Events Terminology Schistosomiasis Has Synonym LLT 10039603 MedDRA C C35650 Upper Respiratory Tract Infection Upper Respiratory Infection Cold|URI|Upper Respiratory Tract Infection An infectious process affecting the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea). Symptoms include congestion, sneezing, coughing, fever, and sore throat. Infection of the nose, pharynx, larynx, or any combination thereof. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Upper respiratory infection Has Synonym LLT 10046300 MedDRA C C39658 Bronchiolitis Bronchiolitis Wheezy Bronchitis Inflammation of the bronchioles characterized by swelling of the bronchioles and mucus accumulation. It is usually caused by the respiratory syncytial virus and affects children. Signs and symptoms include coughing, wheezing, and shortness of breath. Inflammation of the bronchioles. C3198 Lung Disorder C118464 Pediatric Adverse Events Terminology Bronchiolitis Has Synonym LLT 10006448 MedDRA C C5028 Verrucous Lesion Wart Verruca|Verrucous Lesion A papillomavirus related epithelial overgrowth. It can be located anywhere on the body though when it involves the perineal region it is generally referred to as condyloma acuminata. A growth on the skin with a thickened, rough surface. C3262 Neoplasm C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Wart Has Synonym LLT 10047825 MedDRA C C50706 Pressure Sore Decubitus Bedsore|Decubiti|Decubitus Ulcer|Pressure Sore|Pressure Ulcer Death of tissue due to external pressure. Skin damage generally present over a bony prominence that is associated with uninterrupted external pressure. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Decubitus Has Synonym LLT 10011983 MedDRA C C50764 Lymphadenopathy Lymphadenopathy Adenopathy An enlarged lymph node. Causes include viral and bacterial infections and cancers that affect the lymph nodes. Abnormal enlargement of the lymph nodes. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Lymphadenopathy Has Synonym LLT 10025197 MedDRA C C85171 Subacute Sclerosing Panencephalitis Subacute Sclerosing Panencephalitis SSPE A rare, slowly progressive post-infectious neurological disorder affecting the central nervous system. It is characterized by seizures, ataxia, myoclonus, personality changes, spasticity, and coma. The symptoms appear several years following measles infection at an early age. An encephalitic disorder that occurs following a measles infection. The disease initially manifests as personality changes, and then progresses to muscle spasms and seizures, possibly death. C26760 Encephalitis C118464 Pediatric Adverse Events Terminology Subacute sclerosing panencephalitis Has Synonym LLT 10042297 MedDRA C C85231 Whooping Cough Whooping Cough Pertussis A contagious bacterial respiratory infection caused by Bordetella pertussis. It is characterized by severe and uncontrollable cough, resulting in a whooping sound during breathing following the cough. A bacterial respiratory infection caused by Bordetella pertussis, which is characterized by severe and uncontrollable cough, resulting in a whooping sound during breathing following the cough. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Whooping cough Has Synonym LLT 10047974 MedDRA C C112181 Tinea Infection Tinea Infection A skin infection caused by a fungus. A skin infection caused by a fungus. C26726 Infectious Disorder C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Tinea Has Synonym LLT 10043864 MedDRA