Adverse Events Module

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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: 2025-12-24 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT00205803
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00205803
Study Brief: Study Evaluating Pneumococcal 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
13vPnC Infant Series Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). None None 9 120 104 120 View
13vPnC Toddler Dose Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). None None 1 86 33 86 View
7vPnC Toddler Dose Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). None None 0 103 51 103 View
13vPnC 6-Month Follow-up Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). None None 4 86 20 86 View
7vPnC 6-Month Follow-up Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). None None 1 103 33 103 View
7vPnC Infant Series Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). None None 9 126 110 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis RSV NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chairi I malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Complex febrile seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Febrile illness (fever) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever of unknown origin NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumococcal meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia right middle lobe NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RSV positive bronchiolitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right upper and left lower lobe pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rotaviral diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory integration disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Staphylococcal infection (hand) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Status asthmaticus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tethered cord syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral URI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Plagiocephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Ankyloglossia congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Macrocephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Strabismus NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glossodynia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infantile spitting up NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth cyst NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Granuloma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Xerosis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergy to chemicals NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candida nappy rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acarodermatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Body tinea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Roseola NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dacryocystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eczema infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erythema infectiosum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nail infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia primary atypical NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea versicolour NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic brain injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac murmur functional NON_SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Food intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypervitaminosis a NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lactose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vesicoureteric reflux NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Penile blister NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tracheomalacia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Macleod's syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heat rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Corrective lens user NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Exposure to communicable disease NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Middle ear effusion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Otorrhoea NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Scleral hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea capitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Burns second degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Exposure to toxic agent NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight gain poor NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Speech disorder developmental NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Penile adhesion NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acne infantile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Keratosis pilaris NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thalassaemia alpha NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cellulitis orbital NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Conjunctivitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight bearing difficulty NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders None 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°C but≤39°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but≤39°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but≤39°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but≤40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but≤40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but≤40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°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
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
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
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View