Study: NCT00404651

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 337 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Food intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 337 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 323 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 220 affected / 323 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 95 affected / 302 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 74 affected / 310 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 188 affected / 323 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 75 affected / 310 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 323 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 93 affected / 323 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 160 affected / 323 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 345 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 336 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 237 affected / 336 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 101 affected / 319 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 86 affected / 336 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 198 affected / 336 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 317 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 336 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 110 affected / 336 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 156 affected / 336 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 340 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 340 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 340 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 340 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 329 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 225 affected / 329 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 101 affected / 306 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 80 affected / 329 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 193 affected / 329 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 315 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 70 affected / 329 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 329 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 148 affected / 329 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 156 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 95 affected / 155 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 43 affected / 149 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 156 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 83 affected / 156 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 153 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 149 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 156 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 62 affected / 156 at risk