Study: NCT01341639

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 610 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 610 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 610 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 610 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 610 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 610 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 610 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 610 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 610 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 610 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 610 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 610 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 610 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 610 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 610 at risk

Adverse event: Prolymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 610 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 610 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 610 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 610 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 98 affected / 610 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 610 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 205 affected / 610 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 523 affected / 610 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 459 affected / 610 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 106 affected / 610 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 469 affected / 610 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 384 affected / 610 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 537 affected / 610 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 471 affected / 610 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 610 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 610 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 610 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 610 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 401 affected / 610 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 470 affected / 610 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 610 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 610 at risk

Adverse event: Benign familial neonatal convulsions
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 605 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Swollen tongue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 605 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 605 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 605 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 605 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 605 at risk

Adverse event: Neuroendocrine cell hyperplasia of infancy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 605 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 84 affected / 605 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 605 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 194 affected / 605 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 531 affected / 605 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 430 affected / 605 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 127 affected / 605 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 456 affected / 605 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 347 affected / 605 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 518 affected / 605 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 472 affected / 605 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 605 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 605 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 86 affected / 605 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 605 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 408 affected / 605 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 485 affected / 605 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 605 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 605 at risk