Study: NCT00109343

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 498 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 498 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 498 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 498 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 498 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 498 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 498 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 498 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 27 affected / 498 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 112 affected / 498 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 498 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 498 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 498 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 498 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 498 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 498 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 498 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Immune system disorders
Frequency: 59 affected / 498 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 498 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 498 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 498 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 498 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 498 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 498 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 498 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 498 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 498 at risk

Adverse event: Rash morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 498 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 498 at risk

Adverse event: Injection Site Bruising (Prevnar Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 498 at risk

Adverse event: Injection Site Erythema (Prevnar Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 106 affected / 498 at risk

Adverse event: Injection Site Pain (Prevnar Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 157 affected / 498 at risk

Adverse event: Injection Site Rash (Prevnar Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 498 at risk

Adverse event: Injection Site Swelling (Prevnar Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 92 affected / 498 at risk

Adverse event: Injection Site Bruising (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 498 at risk

Adverse event: Injection Site Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 69 affected / 498 at risk

Adverse event: Injection Site Pain (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 125 affected / 498 at risk

Adverse event: Injection Site Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 498 at risk

Adverse event: Injection Site Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 498 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 495 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 495 at risk

Adverse event: Neuroblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 495 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 495 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 495 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 495 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 16 affected / 495 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 109 affected / 495 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 495 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 495 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 495 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 495 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 495 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 495 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 495 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Immune system disorders
Frequency: 46 affected / 495 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 495 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 495 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 495 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 495 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 495 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 495 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 495 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 495 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 495 at risk

Adverse event: Rash morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 495 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 495 at risk

Adverse event: Injection Site Bruising (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 495 at risk

Adverse event: Injection Site Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 495 at risk

Adverse event: Injection Site Pain (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 127 affected / 495 at risk

Adverse event: Injection Site Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 495 at risk

Adverse event: Injection Site Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 495 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 910 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 910 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 910 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 13 affected / 910 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 138 affected / 910 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 910 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 910 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 910 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 910 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 910 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 910 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 910 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Immune system disorders
Frequency: 94 affected / 910 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 910 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 910 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 910 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 910 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 910 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 910 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 910 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 910 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 910 at risk

Adverse event: Rash morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 910 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 910 at risk

Adverse event: Injection Site Bruising (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 910 at risk

Adverse event: Injection Site Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 153 affected / 910 at risk

Adverse event: Injection Site Pain (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 163 affected / 910 at risk

Adverse event: Injection Site Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 910 at risk

Adverse event: Injection Site Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 118 affected / 910 at risk