Study: NCT00205803

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Bronchiolitis RSV
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Chairi I malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 120 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Irritability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Sensory integration disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Staphylococcal infection (hand)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Tethered cord syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 120 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 120 at risk

Adverse event: Tethered oral tissue
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 120 at risk

Adverse event: Macrocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 120 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 120 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 120 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 120 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 120 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 120 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 120 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 120 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 120 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 120 at risk

Adverse event: Granuloma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 120 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 120 at risk

Adverse event: Allergy to chemicals
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 120 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 120 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 120 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 120 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 120 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 120 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 120 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 120 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 120 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 120 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 120 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 120 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 120 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Dacryocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Eczema infected
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Atypical pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 120 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 120 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 120 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 120 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 120 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 120 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 120 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 120 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Tracheomalacia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 120 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 120 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 120 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Exposure to communicable disease
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 120 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 120 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: 41 affected / 119 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)
Frequency: 31 affected / 110 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)
Frequency: 26 affected / 107 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: 10 affected / 119 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)
Frequency: 2 affected / 110 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)
Frequency: 5 affected / 107 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: 26 affected / 119 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (any)
Frequency: 18 affected / 110 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (any)
Frequency: 18 affected / 107 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: 24 affected / 119 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)
Frequency: 18 affected / 110 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)
Frequency: 18 affected / 107 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: 4 affected / 119 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)
Frequency: 4 affected / 110 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: 25 affected / 119 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)
Frequency: 18 affected / 111 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)
Frequency: 19 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: 24 affected / 119 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)
Frequency: 15 affected / 110 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (mild)
Frequency: 17 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: 3 affected / 119 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 / 108 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (moderate)
Frequency: 1 affected / 106 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: 19 affected / 114 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: 22 affected / 102 at risk

Adverse event: Fever ≥38°C but≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 20 affected / 100 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 / 113 at risk

Adverse event: Fever >39°C but≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \>39 degrees C but ≤40 degrees C
Frequency: 4 affected / 102 at risk

Adverse event: Fever >39°C but≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \>39 degrees C but ≤40 degrees C
Frequency: 2 affected / 101 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 / 118 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 25 affected / 110 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite
Frequency: 29 affected / 107 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 22 affected / 118 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 27 affected / 110 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 23 affected / 107 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 67 affected / 119 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 47 affected / 111 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep
Frequency: 37 affected / 107 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 79 affected / 118 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 69 affected / 110 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 55 affected / 107 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 126 at risk

Adverse event: Febrile illness (fever)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Meningitis pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Pneumonia right middle lobe
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: RSV positive bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Right upper and left lower lobe pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rotaviral diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 126 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 126 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 126 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 126 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 126 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 126 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 126 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 126 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 126 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Mouth cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 126 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 6 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 126 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 126 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 126 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 126 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 126 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 126 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 126 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 126 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 126 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 126 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 126 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 126 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 126 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 126 at risk

Adverse event: Cardiac murmur functional
Serious: no
Organ System: Investigations
Frequency: 2 affected / 126 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 126 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 126 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 126 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypervitaminosis A
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 126 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 126 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 126 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 126 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 126 at risk

Adverse event: Vesicoureteric reflux
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Penile blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 126 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 126 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 126 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 126 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Tracheomalacia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: MacLeod's syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 126 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 126 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 126 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 126 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 126 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Corrective lens user
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 126 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: 54 affected / 124 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)
Frequency: 43 affected / 118 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)
Frequency: 30 affected / 117 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: 7 affected / 124 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)
Frequency: 10 affected / 118 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)
Frequency: 7 affected / 117 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: 24 affected / 124 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (any)
Frequency: 23 affected / 118 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (any)
Frequency: 22 affected / 117 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: 22 affected / 123 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)
Frequency: 20 affected / 117 at risk

Adverse event: Induration (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)
Frequency: 20 affected / 116 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 / 123 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)
Frequency: 4 affected / 117 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (moderate)
Frequency: 5 affected / 116 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: 24 affected / 124 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)
Frequency: 21 affected / 118 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)
Frequency: 23 affected / 117 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: 24 affected / 124 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)
Frequency: 20 affected / 117 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (mild)
Frequency: 21 affected / 116 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (moderate)
Frequency: 3 affected / 116 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: 20 affected / 121 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: 28 affected / 114 at risk

Adverse event: Fever ≥38°C but≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C
Frequency: 23 affected / 113 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 / 121 at risk

Adverse event: Fever >39°C but≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \>39 degrees C but ≤40 degrees C
Frequency: 4 affected / 113 at risk

Adverse event: Fever >39°C but≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \>39 degrees C but ≤40 degrees C
Frequency: 1 affected / 113 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 39 affected / 124 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 27 affected / 118 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite
Frequency: 36 affected / 117 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 22 affected / 124 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 23 affected / 118 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 22 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: 67 affected / 124 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 55 affected / 118 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep
Frequency: 48 affected / 117 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 88 affected / 124 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 67 affected / 118 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 63 affected / 117 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Conjunctivitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Viral respiratory infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 86 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 86 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 86 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 86 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 86 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 86 at risk

Adverse event: Penile adhesion
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 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 / 85 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 / 85 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: 16 affected / 85 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: 16 affected / 85 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: 2 affected / 85 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: 21 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: 21 affected / 85 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: 3 affected / 85 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: 11 affected / 78 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: 2 affected / 77 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 19 affected / 85 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 11 affected / 84 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 24 affected / 86 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 33 affected / 85 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 103 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 103 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 103 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 103 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 103 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 103 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 103 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 103 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 103 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 103 at risk

Adverse event: Scleral hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Burns second degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Exposure to toxic agent
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Speech disorder developmental
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Penile adhesion
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Keratosis pilaris
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 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: 30 affected / 101 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: 4 affected / 101 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: 17 affected / 100 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: 17 affected / 100 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 / 100 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: 19 affected / 100 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: 16 affected / 99 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: 5 affected / 99 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: 12 affected / 94 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 / 101 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 15 affected / 101 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 44 affected / 101 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 48 affected / 101 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Complex febrile seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: RSV positive bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Viral URI
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 86 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 86 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 86 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 86 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 103 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 103 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 103 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 103 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 103 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 103 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Thalassaemia alpha
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cellulitis orbital
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Weight bearing difficulty
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk