Study: NCT00689351

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 88 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 88 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 88 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Intussusception
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 88 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Atopy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 88 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 88 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 88 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 88 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 88 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Hypophagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 88 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 88 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Grunting
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 88 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 88 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 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: 23 affected / 72 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; tenderness (any)=present at site of vaccination
Frequency: 23 affected / 60 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; tenderness (any)=present at site of vaccination
Frequency: 15 affected / 64 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: 6 affected / 68 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination
Frequency: 14 affected / 71 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Swelling (any)=present at site of vaccination
Frequency: 22 affected / 62 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Swelling (any)=present at site of vaccination
Frequency: 18 affected / 65 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 cm
Frequency: 8 affected / 69 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Swelling (mild)=0.5 to 2.0 cm
Frequency: 18 affected / 61 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Swelling (mild)=0.5 to 2.0 cm
Frequency: 13 affected / 62 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 7 affected / 69 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 56 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 7 affected / 62 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination.
Frequency: 27 affected / 72 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Redness (any)=present at site of vaccination
Frequency: 20 affected / 61 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Redness (any)=present at site of vaccination
Frequency: 19 affected / 63 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm
Frequency: 23 affected / 70 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Redness (mild)=0.5 to 2.0 cm
Frequency: 18 affected / 61 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Redness (mild)=0.5 to 2.0 cm
Frequency: 12 affected / 60 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 69 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Redness (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 56 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Redness (moderate)=2.5 to 7.0 cm
Frequency: 7 affected / 61 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever 38 degrees C but 39 degrees C
Frequency: 11 affected / 69 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever 38 degrees C but 39 degrees C
Frequency: 6 affected / 55 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever 38 degrees C but 39 degrees C
Frequency: 8 affected / 59 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 23 affected / 71 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 16 affected / 59 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite
Frequency: 14 affected / 61 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 38 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 25 affected / 62 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 13 affected / 62 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 37 affected / 75 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 17 affected / 59 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep
Frequency: 18 affected / 61 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 28 affected / 74 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 18 affected / 60 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep
Frequency: 10 affected / 61 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 89 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 89 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 89 at risk

Adverse event: Entropion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 89 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 89 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 89 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 89 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 89 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 89 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 89 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 89 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 89 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 89 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 89 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 89 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 89 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 89 at risk

Adverse event: Perineal fistula
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 89 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 89 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 89 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 89 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 89 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 89 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 89 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 89 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 89 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 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: 26 affected / 76 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; tenderness (any)=present at site of vaccination
Frequency: 24 affected / 64 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; tenderness (any)=present at site of vaccination
Frequency: 16 affected / 59 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 / 72 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement
Frequency: 3 affected / 60 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement
Frequency: 1 affected / 54 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination
Frequency: 18 affected / 73 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Swelling (any)=present at site of vaccination
Frequency: 18 affected / 63 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Swelling (any)=present at site of vaccination
Frequency: 14 affected / 60 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 cm
Frequency: 18 affected / 73 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Swelling (mild)=0.5 to 2.0 cm
Frequency: 15 affected / 61 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Swelling (mild)=0.5 to 2.0 cm
Frequency: 13 affected / 59 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 70 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 61 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 57 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination.
Frequency: 22 affected / 75 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Redness (any)=present at site of vaccination
Frequency: 25 affected / 65 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Redness (any)=present at site of vaccination
Frequency: 16 affected / 61 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm
Frequency: 19 affected / 75 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Redness (mild)=0.5 to 2.0 cm
Frequency: 24 affected / 65 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Redness (mild)=0.5 to 2.0 cm
Frequency: 15 affected / 60 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm
Frequency: 3 affected / 70 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Redness (moderate)=2.5 to 7.0 cm
Frequency: 3 affected / 59 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Redness (moderate)=2.5 to 7.0 cm
Frequency: 3 affected / 54 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever 38 degrees C but 39 degrees C
Frequency: 9 affected / 72 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever 38 degrees C but 39 degrees C
Frequency: 8 affected / 61 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever 38 degrees C but 39 degrees C
Frequency: 5 affected / 54 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 39 degrees C but 40 degrees C
Frequency: 1 affected / 51 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 22 affected / 76 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 28 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite
Frequency: 16 affected / 57 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 56 affected / 79 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 36 affected / 67 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 25 affected / 60 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 30 affected / 77 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 16 affected / 61 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep
Frequency: 12 affected / 57 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 38 affected / 76 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 27 affected / 66 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep
Frequency: 17 affected / 58 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 88 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 89 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 89 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 89 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 89 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 89 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 84 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 84 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Periorbital cellulit
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 84 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Upper airway obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 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: 19 affected / 56 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 / 51 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination
Frequency: 11 affected / 49 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 cm
Frequency: 4 affected / 49 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 9 affected / 49 at risk

Adverse event: Swelling (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (severe) \>7.0 cm
Frequency: 1 affected / 49 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination.
Frequency: 15 affected / 52 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm
Frequency: 9 affected / 51 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm
Frequency: 8 affected / 50 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees 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 / 51 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees 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 / 50 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 13 affected / 57 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 18 affected / 59 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 11 affected / 52 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 11 affected / 54 at risk

Adverse event: Soft tissue inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 88 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 88 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 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: 14 affected / 54 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: 1 affected / 50 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination
Frequency: 10 affected / 53 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 cm
Frequency: 7 affected / 52 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm
Frequency: 4 affected / 51 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination.
Frequency: 12 affected / 54 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm
Frequency: 10 affected / 54 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm
Frequency: 3 affected / 50 at risk

Adverse event: Fever ≥ 38 degrees C but ≤ 39 degrees 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 / 51 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 15 affected / 54 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 21 affected / 56 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 8 affected / 52 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 20 affected / 58 at risk