Study: NCT00384059

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 138 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 138 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 138 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 138 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 138 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 138 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 138 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 138 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 138 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 138 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 138 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 138 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 138 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 138 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 138 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 138 at risk

Adverse event: Injection site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 138 at risk

Adverse event: Eczema infected
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 138 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 138 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 138 at risk

Adverse event: Traumatic haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 138 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: High-pitched crying
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 138 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 138 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Grunting
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 138 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 138 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 138 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 138 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Umbilical erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 138 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 55 affected / 123 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)
Frequency: 48 affected / 114 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 2 affected / 116 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)
Frequency: 4 affected / 97 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 30 affected / 121 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (Any)
Frequency: 32 affected / 106 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 26 affected / 120 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (Mild)
Frequency: 30 affected / 105 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (Moderate)=2.5 cm to 7.0 cm.
Frequency: 8 affected / 118 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)
Frequency: 8 affected / 98 at risk

Adverse event: Induration (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 27 affected / 122 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)
Frequency: 42 affected / 107 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 26 affected / 122 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)
Frequency: 40 affected / 106 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 2 affected / 116 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (moderate)
Frequency: 4 affected / 98 at risk

Adverse event: Erythema (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (severe)
Frequency: 2 affected / 97 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 7 affected / 116 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 3 affected / 96 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \>39 degrees C but ≤40 degrees C
Frequency: 1 affected / 115 at risk

Adverse event: Fever >40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \>40 degrees C
Frequency: 2 affected / 96 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 47 affected / 120 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 37 affected / 104 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 98 affected / 128 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 84 affected / 117 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 90 affected / 129 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 59 affected / 114 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 39 affected / 119 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 35 affected / 98 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 139 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Gastrooesophaegeal reflux
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 139 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 139 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 139 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 139 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 139 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 139 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 139 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 139 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 139 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 139 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 139 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 139 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 139 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 139 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 139 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 139 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 139 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 139 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 139 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Injection site infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Dermatitis infected
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 139 at risk

Adverse event: Physical examination abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 139 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 139 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 139 at risk

Adverse event: High-pitched crying
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 139 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 139 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 139 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 139 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 139 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 139 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 139 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 139 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 139 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 139 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 139 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 139 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 139 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 139 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 139 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 139 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 55 affected / 127 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)
Frequency: 39 affected / 96 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 8 affected / 122 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)
Frequency: 4 affected / 89 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 37 affected / 126 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (Any)
Frequency: 32 affected / 93 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 34 affected / 125 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (Mild)
Frequency: 27 affected / 93 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (Moderate)=2.5 cm to 7.0 cm.
Frequency: 8 affected / 121 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)
Frequency: 6 affected / 88 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 50 affected / 126 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)
Frequency: 40 affected / 99 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 50 affected / 126 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)
Frequency: 37 affected / 99 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (moderate)
Frequency: 3 affected / 88 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 4 affected / 119 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 4 affected / 88 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 44 affected / 129 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 37 affected / 98 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 100 affected / 135 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 96 affected / 119 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 86 affected / 129 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 62 affected / 109 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 42 affected / 124 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 38 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 139 at risk

Adverse event: Tongue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 139 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Lymphangioma
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 138 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Rubella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Staring
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 139 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 139 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 130 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 130 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 130 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 130 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 130 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 130 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 130 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 130 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 130 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 130 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 130 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 130 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 130 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 130 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 130 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 130 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 130 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 130 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 39 affected / 87 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 3 affected / 77 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 25 affected / 83 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 23 affected / 82 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (Moderate)=2.5 cm to 7.0 cm.
Frequency: 3 affected / 77 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 33 affected / 85 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 28 affected / 83 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 10 affected / 78 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 6 affected / 78 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 36 affected / 92 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 72 affected / 97 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 34 affected / 88 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 26 affected / 81 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 122 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 122 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 122 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 122 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 122 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 122 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 122 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 122 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 122 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 122 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 122 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 122 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 122 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 122 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 122 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 122 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 122 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 122 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 122 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 36 affected / 71 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 2 affected / 58 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 27 affected / 68 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 23 affected / 66 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (Moderate)=2.5 cm to 7.0 cm.
Frequency: 7 affected / 60 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 39 affected / 73 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 35 affected / 71 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 10 affected / 61 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 10 affected / 61 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \>39 degrees C but ≤40 degrees C
Frequency: 3 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 30 affected / 68 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 61 affected / 80 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 29 affected / 71 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 30 affected / 67 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 139 at risk