Study: NCT00258895

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 487 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 487 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 487 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 487 at risk

Adverse event: Staring
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 487 at risk

Adverse event: Asthma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 487 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 36 affected / 487 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 487 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 62 affected / 487 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 487 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 487 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 487 at risk

Adverse event: Lethargy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 487 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 487 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 487 at risk

Adverse event: Thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 162 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 162 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 162 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 162 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 55 affected / 162 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 162 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 162 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 162 at risk

Adverse event: Lethargy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 162 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 162 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 162 at risk