Study: NCT01994629

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Tongue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 99 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 99 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 99 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 25 affected / 99 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 29 affected / 99 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 99 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 26 affected / 99 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 99 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 99 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 99 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 99 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 99 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Exhantema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 99 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 101 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 101 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 26 affected / 101 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 101 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 101 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 27 affected / 101 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 101 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 101 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 101 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Exhantema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 101 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 101 at risk