Study: NCT00937521

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 184 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 184 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Myoclonic epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 184 at risk

Adverse event: Ketosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 184 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 184 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Acoustic stimulation tests
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 184 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 184 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 145 affected / 184 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 122 affected / 184 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 151 affected / 184 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 141 affected / 184 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 150 affected / 184 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 136 affected / 184 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 97 affected / 184 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 105 affected / 184 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 157 affected / 184 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 84 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 184 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 184 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 184 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 184 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 184 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 184 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 184 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 184 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 184 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 184 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 184 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 184 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 184 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 184 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 184 at risk

Adverse event: Bone fissure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 184 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 184 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 184 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Aphthous ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 184 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 184 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 184 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 184 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 184 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 149 affected / 184 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 135 affected / 184 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 150 affected / 184 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 139 affected / 184 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 157 affected / 184 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 127 affected / 184 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 94 affected / 184 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 106 affected / 184 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 159 affected / 184 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 87 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 184 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 184 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 184 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 184 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 184 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 184 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 184 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 184 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 184 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 184 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 184 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 184 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 184 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 184 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 184 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 189 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 189 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 189 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 146 affected / 189 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 137 affected / 189 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 155 affected / 189 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 141 affected / 189 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 139 affected / 189 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 122 affected / 189 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 103 affected / 189 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 104 affected / 189 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 155 affected / 189 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 189 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 189 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 189 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 189 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 189 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 189 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 189 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 189 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 189 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 189 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 189 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 189 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 189 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 189 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 189 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 189 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 187 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Congenital megacolon
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 187 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 187 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: VIth nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 187 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 187 at risk

Adverse event: Bacterial pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 187 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 187 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 187 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 187 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 131 affected / 187 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 99 affected / 187 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 132 affected / 187 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 126 affected / 187 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 101 affected / 187 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 71 affected / 187 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 80 affected / 187 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 84 affected / 187 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 139 affected / 187 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 187 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 187 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 187 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 187 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 187 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 187 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 187 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 187 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 187 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 187 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 187 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 187 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 187 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 187 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 187 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 187 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 187 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 187 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 142 affected / 187 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 125 affected / 187 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 131 affected / 187 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 130 affected / 187 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 131 affected / 187 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 114 affected / 187 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 88 affected / 187 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 112 affected / 187 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 151 affected / 187 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 187 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 187 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 187 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 187 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 187 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 187 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 187 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 187 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 187 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 187 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 187 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 187 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 187 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 187 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 187 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 187 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Foreign body aspiration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 185 at risk

Adverse event: Acarodermatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 185 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 185 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 185 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 185 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 143 affected / 185 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 141 affected / 185 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 150 affected / 185 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 130 affected / 185 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 152 affected / 185 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 126 affected / 185 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 100 affected / 185 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 119 affected / 185 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 153 affected / 185 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 185 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 185 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 185 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 185 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 185 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 185 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 185 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 185 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 185 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 185 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 185 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 185 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 185 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 185 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 185 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 185 at risk

Adverse event: Fibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 184 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 184 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 184 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 184 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 184 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 113 affected / 184 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 87 affected / 184 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 119 affected / 184 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 122 affected / 184 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 105 affected / 184 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 184 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 75 affected / 184 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 63 affected / 184 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 121 affected / 184 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 184 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 184 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 184 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 184 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 184 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 184 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 184 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 184 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 184 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 184 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 184 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 184 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 184 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 184 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 184 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 183 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 183 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 183 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 134 affected / 183 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 112 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 132 affected / 183 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 126 affected / 183 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 119 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 78 affected / 183 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 77 affected / 183 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 93 affected / 183 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 137 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 183 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 183 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 183 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 183 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 183 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 183 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 183 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 183 at risk

Adverse event: Cleft palate repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 155 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 155 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 155 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 155 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Renal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 155 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 155 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 74 affected / 155 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 97 affected / 155 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 81 affected / 155 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 121 affected / 155 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 86 affected / 155 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 57 affected / 155 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 74 affected / 155 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 116 affected / 155 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 155 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 155 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 155 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 155 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 155 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 155 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 155 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 155 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 155 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 155 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 155 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 155 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 155 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 155 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 163 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 163 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 90 affected / 163 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 64 affected / 163 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 107 affected / 163 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 90 affected / 163 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 110 affected / 163 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 94 affected / 163 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 63 affected / 163 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 77 affected / 163 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 111 affected / 163 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 163 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 163 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 163 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 163 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 163 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 163 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 163 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 163 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 163 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 163 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 163 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 163 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 163 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 163 at risk

Adverse event: Injection site erythema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 169 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 169 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 90 affected / 169 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 69 affected / 169 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 120 affected / 169 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 105 affected / 169 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 126 affected / 169 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 70 affected / 169 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 76 affected / 169 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 79 affected / 169 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 112 affected / 169 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 169 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 169 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 169 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 169 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 169 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 169 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 169 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 169 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 169 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 169 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 169 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 169 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 169 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 169 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 169 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 169 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 169 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 46 affected / 169 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 83 affected / 169 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 71 affected / 169 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 92 affected / 169 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 49 affected / 169 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 46 affected / 169 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 169 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 86 affected / 169 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 169 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 169 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 169 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 169 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 169 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 169 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 169 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 169 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 169 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 169 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 169 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 169 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 169 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 169 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 168 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 168 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 168 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 168 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 168 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 168 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Bullous impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 168 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 86 affected / 168 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 71 affected / 168 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 89 affected / 168 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 76 affected / 168 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 111 affected / 168 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 168 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 53 affected / 168 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 168 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 116 affected / 168 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 168 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 168 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 168 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 168 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 168 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 168 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 168 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 168 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 168 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 168 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 168 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 168 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 168 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 168 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 165 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 165 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 165 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 165 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 165 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 165 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Viral myocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 165 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 165 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 82 affected / 165 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 96 affected / 165 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 81 affected / 165 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 116 affected / 165 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 72 affected / 165 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 57 affected / 165 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 80 affected / 165 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 115 affected / 165 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 165 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 165 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 165 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 165 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 165 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 165 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 165 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 165 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 165 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 165 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 165 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 165 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 165 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 165 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 165 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 165 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 165 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 165 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 165 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 165 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 100 affected / 165 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 85 affected / 165 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 110 affected / 165 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 97 affected / 165 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 125 affected / 165 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 92 affected / 165 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 65 affected / 165 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 72 affected / 165 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 126 affected / 165 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 165 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 165 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 165 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 165 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 165 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 165 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 165 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 165 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 165 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 165 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 165 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 165 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 165 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 165 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 161 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 161 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 161 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 161 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 161 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 161 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 161 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 161 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 161 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 50 affected / 161 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 88 affected / 161 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 70 affected / 161 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 97 affected / 161 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 59 affected / 161 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 50 affected / 161 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 161 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 96 affected / 161 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 161 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 161 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 161 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 161 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 161 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 161 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 161 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 161 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 161 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 161 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 161 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 161 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 161 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 161 at risk