Study: NCT01411241

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 309 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 309 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 309 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 309 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 309 at risk

Adverse event: Amoebic dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Ascariasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Drowsiness; Post-injection 1
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 308 at risk

Adverse event: Injection site Tenderness; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 92 affected / 309 at risk

Adverse event: Injection site Erythema; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 43 affected / 308 at risk

Adverse event: Injection site Swelling; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 15 affected / 308 at risk

Adverse event: Fever; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 77 affected / 307 at risk

Adverse event: Crying abnormal; Post-injection 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 112 affected / 308 at risk

Adverse event: Irritability; Post-injection 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 145 affected / 308 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 309 at risk

Adverse event: Vomiting; Post-injection 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 308 at risk

Adverse event: Appetite lost; Post-injection 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 100 affected / 308 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 309 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 109 affected / 309 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 309 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 309 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 309 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 315 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 315 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 315 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 315 at risk

Adverse event: Acute myelomonocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 315 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 315 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 315 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 315 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 315 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 315 at risk

Adverse event: Drowsiness; Post-injection 1
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 312 at risk

Adverse event: Injection site Tenderness; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 104 affected / 312 at risk

Adverse event: Injection site Erythema; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 49 affected / 312 at risk

Adverse event: Injection site Swelling; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 34 affected / 312 at risk

Adverse event: Fever; Post-injection 1
Serious: no
Organ System: General disorders
Frequency: 88 affected / 313 at risk

Adverse event: Crying abnormal; Post-injection 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 120 affected / 312 at risk

Adverse event: Irritability; Post-injection 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 142 affected / 312 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 315 at risk

Adverse event: Vomiting; Post-injection 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 312 at risk

Adverse event: Appetite lost; Post-injection 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 108 affected / 311 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 315 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 104 affected / 315 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 315 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 315 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 315 at risk