Study: NCT00975507

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 129 affected / 321 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 321 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 321 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 321 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 321 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 321 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 321 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 321 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 321 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 321 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 321 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 321 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 321 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 321 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 321 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 321 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 321 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 321 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 321 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 321 at risk

Adverse event: Dermatomycosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 321 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 321 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 321 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 321 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 321 at risk

Adverse event: Rash, Varicella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 321 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 321 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 321 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 321 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 321 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 19 affected / 321 at risk

Adverse event: Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 321 at risk

Adverse event: Pain/Tenderness/Soreness (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 321 at risk

Adverse event: Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 321 at risk

Adverse event: Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 321 at risk

Adverse event: Infection, viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 308 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 72 affected / 308 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 308 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 308 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 308 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 308 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 308 at risk

Adverse event: Gastroenteritis, Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 308 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 308 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 308 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 308 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 308 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 308 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 308 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 308 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 308 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 308 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 308 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 308 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 308 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 308 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 308 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 308 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 308 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 308 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 308 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 308 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 308 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 308 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 308 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 308 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 308 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 308 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 308 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 308 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 308 at risk

Adverse event: Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 308 at risk

Adverse event: Pain/Tenderness/Soreness (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 308 at risk

Adverse event: Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 308 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Infection, rotovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 156 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 156 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 156 at risk

Adverse event: Hemorrhage, Venipuncture Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 156 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 156 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Gastroenteritis, Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 156 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 156 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 156 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 156 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 156 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 156 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 156 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 156 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 156 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 156 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 156 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 156 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Dermatomycosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 156 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 156 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 156 at risk

Adverse event: Rash, Varicella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 156 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 156 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 156 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 156 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 156 at risk

Adverse event: Ecchymosis (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 156 at risk

Adverse event: Erythema (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 156 at risk

Adverse event: Pain/Tenderness/Soreness (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 156 at risk

Adverse event: Swelling (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Pain/Tenderness/Soreness (M-M-R II Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 156 at risk