Study: NCT01480258

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 653 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 653 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 653 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 653 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 653 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 653 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 653 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 653 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 653 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 653 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 653 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 220 affected / 653 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 583 affected / 653 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 13 affected / 653 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 485 affected / 653 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 17 affected / 653 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 119 affected / 653 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 496 affected / 653 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 406 affected / 653 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 598 affected / 653 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 490 affected / 653 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 653 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 653 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 653 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 653 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 431 affected / 653 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 562 affected / 653 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 653 at risk

Adverse event: Vitello-intestinal duct remnant
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 659 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 659 at risk

Adverse event: Injection site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 659 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 659 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 659 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 659 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 659 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 659 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 659 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 211 affected / 659 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 574 affected / 659 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 23 affected / 659 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 450 affected / 659 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 17 affected / 659 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 107 affected / 659 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 493 affected / 659 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 373 affected / 659 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 589 affected / 659 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 452 affected / 659 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 659 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 659 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 659 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 659 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 411 affected / 659 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 529 affected / 659 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 659 at risk