Study: NCT01200368

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 183 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 183 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 183 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 183 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Adenoviral conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 183 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 183 at risk

Adverse event: Gastroenteritis norovirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 183 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 183 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Pneumococcal bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 183 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Chillblains
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 183 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 183 at risk

Adverse event: Genital labial adhesions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 183 at risk

Adverse event: Fibrinous bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 183 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 183 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 183 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 183 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 183 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 183 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 183 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Palmoplantar keratoderma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 183 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 183 at risk

Adverse event: Kawasaki's disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 183 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 100 affected / 171 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 104 affected / 166 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 90 affected / 168 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 82 affected / 170 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 93 affected / 166 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 79 affected / 167 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 31 affected / 164 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 41 affected / 157 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 26 affected / 152 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 69 affected / 168 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 77 affected / 160 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 72 affected / 164 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 64 affected / 168 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 71 affected / 160 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 69 affected / 164 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 20 affected / 162 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 31 affected / 157 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 16 affected / 150 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 22 affected / 163 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 23 affected / 159 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 12 affected / 153 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 1 affected / 157 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 61 affected / 168 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 61 affected / 166 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 56 affected / 162 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 1 affected / 161 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 3 affected / 158 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 5 affected / 150 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 21 affected / 163 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 18 affected / 158 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 15 affected / 152 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 31 affected / 165 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 29 affected / 162 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 27 affected / 154 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 49 affected / 170 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 37 affected / 163 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 31 affected / 151 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 30 affected / 164 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 30 affected / 161 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 28 affected / 154 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 5 affected / 161 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 4 affected / 157 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 2 affected / 149 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 6 affected / 161 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 5 affected / 160 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 3 affected / 150 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Neuritis cranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 183 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 183 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 183 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Injection site dermatitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 183 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 183 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 183 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Adenoviral conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 183 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 183 at risk

Adverse event: Gastroenteritis norovirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 183 at risk

Adverse event: Genital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 183 at risk

Adverse event: Oral fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 183 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 183 at risk

Adverse event: Perirectal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 183 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 67 affected / 183 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 183 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 183 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 183 at risk

Adverse event: Neuritis cranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Vesicoureteric reflux
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 183 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 183 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 183 at risk

Adverse event: Adenoidal hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 183 at risk

Adverse event: Fibrinous bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 183 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 183 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 183 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 183 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 183 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 183 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 183 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 96 affected / 172 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 104 affected / 168 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 83 affected / 162 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 88 affected / 172 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 95 affected / 167 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 69 affected / 160 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 30 affected / 166 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 43 affected / 159 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 34 affected / 154 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 1 affected / 162 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 60 affected / 168 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 87 affected / 171 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 59 affected / 157 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 53 affected / 168 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 82 affected / 170 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 53 affected / 156 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 21 affected / 165 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 28 affected / 157 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 23 affected / 154 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 1 affected / 162 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 10 affected / 164 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 7 affected / 154 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 11 affected / 155 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 57 affected / 168 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 59 affected / 161 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 49 affected / 161 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 2 affected / 163 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 6 affected / 155 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 3 affected / 152 at risk

Adverse event: Fever >40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 1 affected / 152 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 15 affected / 163 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 23 affected / 159 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 15 affected / 155 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 27 affected / 164 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 29 affected / 155 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 23 affected / 156 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 44 affected / 165 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 35 affected / 158 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 32 affected / 157 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 36 affected / 169 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 19 affected / 157 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 20 affected / 156 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 2 affected / 162 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 2 affected / 154 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 4 affected / 162 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 7 affected / 155 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 5 affected / 153 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 183 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 183 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 183 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 183 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 183 at risk

Adverse event: Acetonaemic vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 183 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 183 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 183 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 183 at risk

Adverse event: Gastroenteritis norovirus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 183 at risk

Adverse event: Genital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 183 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 183 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 183 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Ear injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 183 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 183 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 183 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 183 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 183 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 183 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 183 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 183 at risk

Adverse event: Scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Kawasaki's disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 183 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 17 affected / 165 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 59 affected / 161 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 36 affected / 156 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 17 affected / 165 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 56 affected / 161 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 34 affected / 156 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 13 affected / 156 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 3 affected / 153 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 8 affected / 164 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 39 affected / 162 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 34 affected / 159 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 8 affected / 164 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 37 affected / 162 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 32 affected / 159 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 9 affected / 155 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 4 affected / 153 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 2 affected / 162 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2
Frequency: 3 affected / 155 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 4 affected / 153 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3
Frequency: 1 affected / 152 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 36 affected / 165 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 34 affected / 155 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 38 affected / 157 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 1 affected / 162 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 1 affected / 154 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 5 affected / 153 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 12 affected / 165 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 11 affected / 155 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 9 affected / 154 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 20 affected / 164 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 17 affected / 156 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 18 affected / 154 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 36 affected / 165 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 37 affected / 163 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 23 affected / 154 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 23 affected / 167 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 19 affected / 157 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 15 affected / 153 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 3 affected / 154 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 2 affected / 152 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 1 affected / 162 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2
Frequency: 2 affected / 154 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3
Frequency: 7 affected / 154 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 183 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 183 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 183 at risk

Adverse event: Pulmonary artery stenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 183 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 183 at risk

Adverse event: Deafness bilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Mycoplasma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 183 at risk

Adverse event: Anal fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 183 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 183 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Kawasaki's disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 183 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 183 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 183 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 183 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 183 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 183 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 183 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 183 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 183 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 183 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 183 at risk

Adverse event: Gastroenteritis rotavirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gianotti-Crosti syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 183 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 183 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 183 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 183 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Chillblains
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Eye injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 183 at risk

Adverse event: Frostbite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 183 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Body height below normal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 183 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Fibrinous bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Childhood asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 183 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 183 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 183 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 162 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 162 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 162 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 162 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 162 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 162 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 162 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 162 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 162 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 162 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 162 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 162 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Childhood asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 162 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 162 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 162 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 162 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 162 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 162 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 162 at risk

Adverse event: Kawasaki's disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 162 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 92 affected / 148 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 74 affected / 148 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 39 affected / 141 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 73 affected / 149 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 63 affected / 147 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 24 affected / 143 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 20 affected / 142 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 1 affected / 140 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 71 affected / 145 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 6 affected / 141 at risk

Adverse event: Fever >40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 2 affected / 139 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 28 affected / 143 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 26 affected / 143 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 27 affected / 145 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 18 affected / 142 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 5 affected / 140 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 10 affected / 141 at risk

Adverse event: Gastroenteritis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 162 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 162 at risk

Adverse event: Ear haemorrhage
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 162 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 162 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 162 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 162 at risk

Adverse event: Adenoviral conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 162 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Echo virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 162 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 162 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 162 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 162 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 162 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 162 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 162 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 162 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 162 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 162 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 162 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 162 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 162 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 162 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 162 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 87 affected / 152 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 72 affected / 151 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 38 affected / 139 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 66 affected / 144 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 60 affected / 143 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 26 affected / 138 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 14 affected / 140 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 72 affected / 146 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 12 affected / 136 at risk

Adverse event: Fever >40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 3 affected / 137 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 28 affected / 141 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 30 affected / 141 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 25 affected / 142 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 13 affected / 137 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 3 affected / 136 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 13 affected / 138 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 169 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 169 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 169 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 169 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 169 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Adenoviral conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 169 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 169 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 169 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 169 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 169 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 169 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 169 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 169 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 169 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 169 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 169 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 169 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 169 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 169 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 169 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 169 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 52 affected / 149 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 42 affected / 148 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 19 affected / 145 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 39 affected / 148 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 33 affected / 146 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 19 affected / 146 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 8 affected / 142 at risk

Adverse event: Fever >=37.5, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 46 affected / 146 at risk

Adverse event: Fever >=39, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 5 affected / 141 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 14 affected / 143 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 24 affected / 144 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 23 affected / 143 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 16 affected / 141 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 3 affected / 141 at risk

Adverse event: Use of antipyretic medication to treat symptoms
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose
Frequency: 6 affected / 142 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 169 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 169 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 169 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 169 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 169 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 169 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 169 at risk

Adverse event: Omphalitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 169 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 169 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 169 at risk

Adverse event: Chillblains
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 169 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 169 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 169 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 169 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 169 at risk