Study: NCT00362336

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 243 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 243 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 243 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 243 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 243 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 243 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 106 affected / 236 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 6 affected / 237 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 202 affected / 237 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 160 affected / 236 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 130 affected / 236 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 157 affected / 236 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 105 affected / 236 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 237 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 110 affected / 236 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 143 affected / 236 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 180 affected / 236 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 237 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 242 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 238 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 9 affected / 238 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 210 affected / 238 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 173 affected / 238 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 150 affected / 238 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 165 affected / 238 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 79 affected / 238 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 238 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 133 affected / 238 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 143 affected / 238 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 186 affected / 238 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 238 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 137 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 137 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 135 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 9 affected / 136 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 119 affected / 136 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 91 affected / 135 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 65 affected / 136 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 94 affected / 135 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 136 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 135 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 112 affected / 135 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 136 at risk