Study: NCT00708682

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 223 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 223 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 223 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 223 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 223 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Mucous stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 223 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 223 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 223 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 223 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 223 at risk

Adverse event: Viral rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 223 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 223 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 223 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 223 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 223 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Pyoderma
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 223 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 223 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Cephalhaematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 223 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 223 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 223 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 223 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 223 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 223 at risk

Adverse event: Rash morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 223 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 223 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; tenderness (any)=present at site of vaccination
Frequency: 134 affected / 211 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; tenderness (any)=present at site of vaccination
Frequency: 136 affected / 196 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; tenderness (any)=present at site of vaccination
Frequency: 100 affected / 163 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement
Frequency: 25 affected / 202 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement
Frequency: 23 affected / 183 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement
Frequency: 22 affected / 143 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; swelling (any)=present at site of vaccination
Frequency: 64 affected / 205 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; swelling (any)=present at site of vaccination
Frequency: 56 affected / 187 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; swelling (any)=present at site of vaccination
Frequency: 45 affected / 153 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; swelling (mild)=present at site of vaccination
Frequency: 51 affected / 203 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; swelling (mild)=present at site of vaccination
Frequency: 37 affected / 185 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; swelling (mild)=present at site of vaccination
Frequency: 28 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; swelling (moderate)=present at site of vaccination
Frequency: 24 affected / 201 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; swelling (moderate)=present at site of vaccination
Frequency: 24 affected / 180 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; swelling (moderate)=present at site of vaccination
Frequency: 21 affected / 144 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; redness (any)=present at site of vaccination
Frequency: 69 affected / 204 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; redness (any)=present at site of vaccination
Frequency: 54 affected / 187 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; redness (any)=present at site of vaccination
Frequency: 49 affected / 154 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; redness (mild)=present at site of vaccination
Frequency: 57 affected / 204 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; redness (mild)=present at site of vaccination
Frequency: 36 affected / 185 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; redness (mild)=present at site of vaccination
Frequency: 31 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; redness (moderate)=present at site of vaccination
Frequency: 21 affected / 199 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; redness (moderate)=present at site of vaccination
Frequency: 22 affected / 179 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; redness (moderate)=present at site of vaccination
Frequency: 20 affected / 144 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C
Frequency: 14 affected / 199 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥38°C but ≤39°C
Frequency: 33 affected / 178 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥38°C but ≤39°C
Frequency: 26 affected / 142 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \>39°C but ≤40°C
Frequency: 1 affected / 175 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \>39°C but ≤40°C
Frequency: 3 affected / 138 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 63 affected / 203 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 55 affected / 188 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite
Frequency: 38 affected / 148 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 148 affected / 212 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 120 affected / 193 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 103 affected / 163 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 77 affected / 207 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 45 affected / 184 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep
Frequency: 35 affected / 153 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 67 affected / 204 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 66 affected / 188 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep
Frequency: 56 affected / 150 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 223 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 223 at risk

Adverse event: Allergy to arthropod bite
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 223 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Seizure anoxic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 191 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 191 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 191 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 191 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 191 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 191 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Prurigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; tenderness (any)=present at site of vaccination
Frequency: 66 affected / 151 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement
Frequency: 5 affected / 132 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; swelling (any)=present at site of vaccination
Frequency: 30 affected / 141 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; swelling (mild)=present at site of vaccination
Frequency: 11 affected / 136 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; swelling (moderate)=present at site of vaccination
Frequency: 22 affected / 139 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; redness (any)=present at site of vaccination
Frequency: 31 affected / 141 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; redness (mild)=present at site of vaccination
Frequency: 12 affected / 136 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; redness (moderate)=present at site of vaccination
Frequency: 22 affected / 140 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C
Frequency: 32 affected / 139 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite
Frequency: 51 affected / 151 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability
Frequency: 71 affected / 152 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep
Frequency: 25 affected / 140 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep
Frequency: 31 affected / 141 at risk