Study: NCT00721396

Adverse event: Lymphadentitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 625 at risk

Adverse event: Abdominal strangulated hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 625 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 625 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 625 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 625 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Gatroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 625 at risk

Adverse event: Gatroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 625 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Lymph gland infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 625 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 625 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 625 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 625 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 625 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 625 at risk

Adverse event: Exposure to toxic agent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 625 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 625 at risk

Adverse event: Blood alkaline phosphatase abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 625 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 625 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 625 at risk

Adverse event: Crying
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hypotonic-hyporesponsive episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 625 at risk

Adverse event: Aponetic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 625 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 625 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 523 affected / 625 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 489 affected / 625 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 514 affected / 625 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 535 affected / 625 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 328 affected / 625 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 526 affected / 625 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 544 affected / 625 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 543 affected / 625 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 470 affected / 625 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 302 affected / 625 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 625 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 208 affected / 625 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 100 affected / 625 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 625 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 625 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 67 affected / 625 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 625 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 625 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 625 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 625 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 625 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 625 at risk

Adverse event: Craniosynostosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 627 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 627 at risk

Adverse event: Urachal abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 627 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 627 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 627 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 627 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 627 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Gatroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 627 at risk

Adverse event: Gatroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Gatroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 627 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 627 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 627 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 627 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 627 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 627 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 627 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 627 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Petit mal epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 627 at risk

Adverse event: Vesicoureteric reflux
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 627 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 627 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 627 at risk

Adverse event: Prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 627 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 627 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 96 affected / 627 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 525 affected / 627 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 519 affected / 627 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 462 affected / 627 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 553 affected / 627 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 383 affected / 627 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 516 affected / 627 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 536 affected / 627 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 527 affected / 627 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 473 affected / 627 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 338 affected / 627 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 627 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 245 affected / 627 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 142 affected / 627 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 627 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 98 affected / 627 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 91 affected / 627 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 627 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 627 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 627 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 627 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 627 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 627 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 318 at risk

Adverse event: Retinal dystrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 318 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 318 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 318 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 318 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 318 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 318 at risk

Adverse event: Gatroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 318 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 318 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 318 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 318 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 318 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 318 at risk

Adverse event: Glioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 318 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 318 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 318 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 318 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 282 affected / 318 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 254 affected / 318 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 246 affected / 318 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 271 affected / 318 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 170 affected / 318 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 268 affected / 318 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 279 affected / 318 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 289 affected / 318 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 249 affected / 318 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 318 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 318 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 318 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 318 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 318 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 318 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 318 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 318 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 318 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 318 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 318 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 318 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 318 at risk

Adverse event: Congenital musculoskeletal disorder
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 312 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 312 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 312 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Gatroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 312 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 312 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 224 affected / 312 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 204 affected / 312 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 176 affected / 312 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 229 affected / 312 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 115 affected / 312 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 187 affected / 312 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 182 affected / 312 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 220 affected / 312 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 159 affected / 312 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 312 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 312 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 312 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 312 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 312 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 312 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 312 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 312 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 312 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 312 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 312 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 312 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 312 at risk