Study: NCT01436396

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 394 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 394 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 394 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 394 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 394 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 394 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 394 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 394 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 394 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 394 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 394 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 394 at risk

Adverse event: Drowsiness; Post-Any Injection
Serious: no
Organ System: Nervous system disorders
Frequency: 140 affected / 386 at risk

Adverse event: Injection site Tenderness for Stamaril® vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 98 affected / 386 at risk

Adverse event: Injection site Tenderness for CYD dengue vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 141 affected / 386 at risk

Adverse event: Injection site Erythema for Stamaril® vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 32 affected / 386 at risk

Adverse event: Injection site Erythema for CYD dengue vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 49 affected / 386 at risk

Adverse event: Injection site Swelling for CYD dengue vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 29 affected / 386 at risk

Adverse event: Fever; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 185 affected / 385 at risk

Adverse event: Crying abnormal; Post-Any injection
Serious: no
Organ System: Psychiatric disorders
Frequency: 182 affected / 394 at risk

Adverse event: Irritability; Post-Any injection
Serious: no
Organ System: Psychiatric disorders
Frequency: 179 affected / 394 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 394 at risk

Adverse event: Vomiting; Post-Any injection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 386 at risk

Adverse event: Appetite lost; Post-Any injection
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 211 affected / 394 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 394 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 118 affected / 394 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 394 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Tongue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 393 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 393 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 393 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 393 at risk

Adverse event: Drowsiness; Post-Any Injection
Serious: no
Organ System: Nervous system disorders
Frequency: 131 affected / 386 at risk

Adverse event: Injection site Tenderness for Stamaril® vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 68 affected / 386 at risk

Adverse event: Injection site Tenderness for CYD dengue vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 105 affected / 363 at risk

Adverse event: Injection site Tenderness for placebo; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 76 affected / 386 at risk

Adverse event: Injection site Erythema for Stamaril® vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 38 affected / 386 at risk

Adverse event: Injection site Erythema for CYD dengue vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 32 affected / 363 at risk

Adverse event: Injection site Erythema for placebo; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 42 affected / 393 at risk

Adverse event: Injection site Swelling for CYD dengue vaccine; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 22 affected / 363 at risk

Adverse event: Fever; Post-Any Injection
Serious: no
Organ System: General disorders
Frequency: 155 affected / 385 at risk

Adverse event: Crying abnormal; Post-Any injection
Serious: no
Organ System: Psychiatric disorders
Frequency: 170 affected / 393 at risk

Adverse event: Irritability; Post-Any injection
Serious: no
Organ System: Psychiatric disorders
Frequency: 179 affected / 393 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 393 at risk

Adverse event: Vomiting; Post-Any injection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 105 affected / 386 at risk

Adverse event: Appetite lost; Post-Any injection
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 193 affected / 393 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 393 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 120 affected / 393 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 393 at risk