Study: NCT00985153

Adverse event: Seizure, febrile
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 969 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 969 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 969 at risk

Adverse event: Infection, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 969 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 379 affected / 969 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 969 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 969 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 969 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 969 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 969 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 969 at risk

Adverse event: Gastroenteritis, Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 969 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 969 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 105 affected / 969 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 969 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 969 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 969 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 969 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 969 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 280 affected / 969 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 969 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 969 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 969 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 969 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 969 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 969 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 969 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 969 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 969 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 969 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 969 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 969 at risk

Adverse event: Rash, Diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 72 affected / 969 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 969 at risk

Adverse event: Rash, Varicella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 969 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 969 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 969 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 969 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 30 affected / 969 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 133 affected / 969 at risk

Adverse event: Ecchymosis (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 969 at risk

Adverse event: Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 149 affected / 969 at risk

Adverse event: Pain/Tenderness/Soreness (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 221 affected / 969 at risk

Adverse event: Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 969 at risk

Adverse event: Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 89 affected / 969 at risk

Adverse event: Seizure, febrile
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 950 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 950 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 950 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 950 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 950 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 950 at risk

Adverse event: Fracture, humerus, right
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 950 at risk

Adverse event: Fracture, radius, right
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 950 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 950 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 950 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 950 at risk

Adverse event: Infection, RSV
Serious: yes
Organ System: Infections and infestations
Notes: Infection, respiratory syncytial virus (RSV)
Frequency: 1 affected / 950 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 950 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 362 affected / 950 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 950 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 950 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 950 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 950 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 950 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 950 at risk

Adverse event: Gastroenteritis, Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 950 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 950 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 101 affected / 950 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 950 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 950 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 950 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 950 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 950 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 248 affected / 950 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 950 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 950 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 950 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 950 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 950 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 950 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 950 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 950 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 950 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 950 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 950 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 950 at risk

Adverse event: Rash, Diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 78 affected / 950 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 950 at risk

Adverse event: Rash, Varicella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 950 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 950 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 950 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 950 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 27 affected / 950 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 109 affected / 950 at risk

Adverse event: Ecchymosis (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 950 at risk

Adverse event: Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 163 affected / 950 at risk

Adverse event: Pain/Tenderness/Soreness (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 246 affected / 950 at risk

Adverse event: Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 950 at risk

Adverse event: Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 950 at risk

Adverse event: Seizure, febrile
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 941 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 941 at risk

Adverse event: Infection, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 941 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 941 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 941 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 941 at risk

Adverse event: Infection, RSV
Serious: yes
Organ System: Infections and infestations
Notes: Infection, respiratory syncytial virus (RSV)
Frequency: 1 affected / 941 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 941 at risk

Adverse event: Gastroenteritis, Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 941 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 941 at risk

Adverse event: Infection, viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 941 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 941 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 941 at risk

Adverse event: Bite, animal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 941 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 941 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 941 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 378 affected / 941 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 941 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 941 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 941 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 941 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 941 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 941 at risk

Adverse event: Gastroenteritis, Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 941 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 941 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 119 affected / 941 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 941 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 941 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 941 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 941 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 61 affected / 941 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 249 affected / 941 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 941 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 941 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 941 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 941 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 941 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 941 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 941 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 941 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 941 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 941 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 941 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 941 at risk

Adverse event: Rash, Diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 80 affected / 941 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 941 at risk

Adverse event: Rash, Varicella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 941 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 941 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 941 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 941 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 941 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 133 affected / 941 at risk

Adverse event: Ecchymosis (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 941 at risk

Adverse event: Erythema (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 163 affected / 941 at risk

Adverse event: Pain/Tenderness/Soreness (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 230 affected / 941 at risk

Adverse event: Rash (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 941 at risk

Adverse event: Swelling (ProQuad Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 941 at risk

Adverse event: Seizure, febrile
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 993 at risk

Adverse event: Seizure disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 993 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 993 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 993 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 993 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 993 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 993 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 993 at risk

Adverse event: Gastroenteritis, Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 993 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Drug abuse refers to cocaine metabolites found in subject's urine.
Frequency: 1 affected / 993 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 993 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 993 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 993 at risk

Adverse event: Breathing Pattern Abnormal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 993 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 327 affected / 993 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 993 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 993 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 993 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 993 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 993 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 993 at risk

Adverse event: Gastroenteritis, Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 993 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 993 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 86 affected / 993 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 993 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 993 at risk

Adverse event: Congestion, Nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 993 at risk

Adverse event: Congestion, Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 993 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 61 affected / 993 at risk

Adverse event: Infection, Respiratory, Upper
Serious: no
Organ System: Infections and infestations
Frequency: 245 affected / 993 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 993 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 993 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 993 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 993 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 993 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 993 at risk

Adverse event: Bite/Sting, Non-Venomous
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 993 at risk

Adverse event: Dermatitis, Contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 993 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 993 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 993 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 993 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 993 at risk

Adverse event: Rash, Diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 993 at risk

Adverse event: Rash, Measles/Rubella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 993 at risk

Adverse event: Rash, Varicella-Like
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 993 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 993 at risk

Adverse event: Viral Exanthema
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 993 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 993 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 993 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 117 affected / 993 at risk

Adverse event: Ecchymosis (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 993 at risk

Adverse event: Erythema (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 136 affected / 993 at risk

Adverse event: Pain/Tenderness/Soreness (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 262 affected / 993 at risk

Adverse event: Rash (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 993 at risk

Adverse event: Swelling (Varivax Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 91 affected / 993 at risk

Adverse event: Ecchymosis (M-M-R II Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 993 at risk

Adverse event: Erythema (M-M-R II Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 134 affected / 993 at risk

Adverse event: Pain/Tenderness/Soreness (M-M-R II Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 266 affected / 993 at risk

Adverse event: Swelling (M-M-R II Injection-site)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 80 affected / 993 at risk