Study: NCT00578175

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 705 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 705 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Accidental exposure to product by child
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 705 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 705 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 705 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 705 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 705 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 705 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 705 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 136 affected / 673 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 111 affected / 673 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 50 affected / 673 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 312 affected / 676 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 221 affected / 676 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 705 at risk

Adverse event: Uper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 705 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 705 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 705 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 25 affected / 705 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 705 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 689 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 689 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 689 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 689 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 689 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Autism spectrum disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 689 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 689 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 689 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 689 at risk

Adverse event: Hpoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 689 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 689 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 689 at risk

Adverse event: Primitive neuroectodermal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 689 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 689 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 689 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 689 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 689 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 689 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 114 affected / 666 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 120 affected / 666 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 49 affected / 666 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 302 affected / 668 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 219 affected / 668 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 689 at risk

Adverse event: Uper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 689 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 689 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 689 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 35 affected / 689 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 689 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 389 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 389 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 378 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 54 affected / 378 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 378 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 163 affected / 379 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 128 affected / 379 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 389 at risk

Adverse event: Uper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 389 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 389 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 389 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 20 affected / 389 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 389 at risk