Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:57 AM
Ignite Modification Date: 2025-12-26 @ 1:38 AM
NCT ID: NCT00475033
Description: Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Frequency Threshold: 0
Time Frame: Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.
Study: NCT00475033
Study Brief: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
7vPnC After the Infant Series Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series). None None 7 301 16 301 View
13vPnC Infant Series Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273. None None 5 300 273 300 View
7vPnC Infant Series Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279. None None 5 303 279 303 View
13vPnC After the Infant Series Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series). None None 11 299 20 299 View
13vPnC Toddler Dose Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199. None None 2 286 199 286 View
7vPnC Toddler Dose Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193. None None 2 280 193 280 View
13vPnC Toddler Dose 6-Month Follow-up Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age. None None 7 299 6 299 View
7vPnC Toddler Dose 6-Month Follow-up Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age. None None 3 301 4 301 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Periorbital cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Developmental delay NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mastoiditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis meningococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Eye swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Physical testicle examination abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Complex partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faecal volume increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faeces discoloured NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Frequent bowel movements NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingival cyst NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingival pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Infantile spitting up NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Regurgitation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peripheral coldness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Tenderness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Allergy to metals NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Milk allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Acarodermatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candida nappy rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Roseola NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulval disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal erythema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal ulceration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cold sweat NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dandruff NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Drug eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cryptorchism NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Plagiocephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Ventricular septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hypermetropia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting neonatal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting projectile NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site mass NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Incision site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Accidental needle stick NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Physical examination abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haemangioma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Head titubation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Poor quality sleep NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Psychomotor hyperactivity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Perineal laceration NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Crying NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Listless NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Tearfulness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Chromaturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Genital labial adhesions NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Genital rash NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Heat rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pustular psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discoloration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin nodule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin plaque NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin warm NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Xeroderma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Coxsackie viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis norovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hand-foot-and-mouth disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injection site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Measles NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Measles post vaccine NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ankyloglossia congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Molluscum contagiosum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media chronic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Positional plagiocephaly NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyskinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Movement disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Livedo reticularis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Tenderness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Fever ≥38 degrees Celsius (C) but ≤39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38 degrees Celsius C but ≤39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38 degrees C but ≤39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39 degrees C but ≤40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39 degrees C but ≤40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39 degrees C but ≤40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View