Study: NCT01339923

Adverse event: Congenital central nervous system anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 252 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 252 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 252 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 252 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 252 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 252 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 252 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 252 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 252 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 252 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 252 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 252 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 96 affected / 252 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 252 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 198 affected / 252 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 58 affected / 252 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 169 affected / 252 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 162 affected / 252 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 202 affected / 252 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 120 affected / 252 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 201 affected / 252 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 26 affected / 252 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 252 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 252 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 252 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 252 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 252 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 252 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 252 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 252 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 252 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 252 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 252 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 252 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 252 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 252 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 252 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 186 affected / 252 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 141 affected / 252 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 181 affected / 252 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 252 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 252 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 252 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 252 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 252 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 249 at risk

Adverse event: Allergic colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 249 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 249 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Dairy intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 249 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 249 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 249 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 249 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 186 affected / 249 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 23 affected / 249 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 160 affected / 249 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 118 affected / 249 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 175 affected / 249 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 76 affected / 249 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 192 affected / 249 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 249 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 249 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 249 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 249 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 249 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 249 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 249 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 249 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 249 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 249 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 249 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 249 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 249 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 249 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 249 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 249 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 152 affected / 249 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 112 affected / 249 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 156 affected / 249 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 249 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 249 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 249 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 249 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 249 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 250 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 250 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 250 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 250 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 250 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 250 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 157 affected / 250 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 27 affected / 250 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 157 affected / 250 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 122 affected / 250 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 168 affected / 250 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 84 affected / 250 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 189 affected / 250 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 19 affected / 250 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 250 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 250 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 250 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 250 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 250 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 250 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 250 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 250 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 250 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 250 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 250 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 250 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 250 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 250 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 144 affected / 250 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 121 affected / 250 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 153 affected / 250 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 250 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 250 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 250 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 104 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 104 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 104 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 59 affected / 104 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 41 affected / 104 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 99 affected / 104 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 50 affected / 104 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 104 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 104 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 104 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 104 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 104 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 104 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 104 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 104 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 104 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 104 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 49 affected / 104 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 104 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 104 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 104 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Idiopathic intracranial hypertension
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 300 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 300 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 300 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 47 affected / 300 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 300 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 180 affected / 300 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 124 affected / 300 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 287 affected / 300 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 146 affected / 300 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 117 affected / 300 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 47 affected / 300 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 300 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 300 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 300 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 300 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 300 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 127 affected / 300 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 90 affected / 300 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 300 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 300 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 300 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 300 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 126 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 126 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 105 affected / 126 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 62 affected / 126 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 42 affected / 126 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 114 affected / 126 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 34 affected / 126 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 99 affected / 126 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 126 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 126 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 126 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 126 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 126 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 126 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 126 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 126 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 126 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 93 affected / 126 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 67 affected / 126 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 95 affected / 126 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 126 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 126 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 126 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 123 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 123 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 123 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 123 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 93 affected / 123 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 41 affected / 123 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 41 affected / 123 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 102 affected / 123 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 123 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 77 affected / 123 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 123 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 123 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 123 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 123 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 123 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 123 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 123 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 123 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 123 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 123 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 123 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 123 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 123 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 123 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 123 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 123 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 79 affected / 123 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 123 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 123 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1404 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Congenital central nervous system anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Allergic colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1404 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1404 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1404 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1404 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1404 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1404 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1404 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1404 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1404 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1404 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1404 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1404 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1404 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1404 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1404 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1404 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1404 at risk

Adverse event: Dairy intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1404 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Idiopathic intracranial hypertension
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1404 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1404 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1404 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 353 affected / 1404 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 1404 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 248 affected / 1404 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 47 affected / 1404 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 739 affected / 1404 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 123 affected / 1404 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 828 affected / 1404 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 650 affected / 1404 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1147 affected / 1404 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 545 affected / 1404 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 117 affected / 1404 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 827 affected / 1404 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 61 affected / 1404 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 68 affected / 1404 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 122 affected / 1404 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 1404 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 1404 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 1404 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 95 affected / 1404 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 1404 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 1404 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 151 affected / 1404 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 1404 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 1404 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 1404 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 1404 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1404 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 287 affected / 1404 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 85 affected / 1404 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 1404 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 127 affected / 1404 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 1404 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 698 affected / 1404 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 540 affected / 1404 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 714 affected / 1404 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 1404 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 1404 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 1404 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 1404 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 143 affected / 1404 at risk