Study: NCT01049035

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 104 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 104 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 104 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 104 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 104 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 104 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 29 affected / 104 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 59 affected / 104 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 11 affected / 104 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 82 affected / 104 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 46 affected / 104 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 86 affected / 104 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 38 affected / 104 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 104 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 104 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 104 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 104 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 104 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 104 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 78 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 104 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 104 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 104 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 104 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 104 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 104 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 102 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 102 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 102 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 102 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 102 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 35 affected / 102 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 57 affected / 102 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 5 affected / 102 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 83 affected / 102 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 45 affected / 102 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 92 affected / 102 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 46 affected / 102 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 102 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 102 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 102 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 65 affected / 102 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 74 affected / 102 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 102 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 102 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 102 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 102 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 102 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 100 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 28 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 48 affected / 100 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 6 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 79 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 32 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 88 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 46 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 100 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 100 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 77 affected / 100 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 75 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 74 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 11 affected / 74 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 44 affected / 74 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 8 affected / 74 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 57 affected / 74 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 39 affected / 74 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 63 affected / 74 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 31 affected / 74 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 74 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 74 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 74 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 74 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 74 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 45 affected / 74 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 74 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 74 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 74 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 8 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 70 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 40 affected / 70 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 17 affected / 70 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 48 affected / 70 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 14 affected / 70 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 70 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 70 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 30 affected / 70 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 70 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 52 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 14 affected / 52 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 52 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 52 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 52 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 44 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 21 affected / 52 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 52 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 52 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 52 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 38 affected / 52 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 16 affected / 49 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 27 affected / 49 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 39 affected / 49 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 49 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 42 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 22 affected / 49 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 49 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 49 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 49 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 49 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Crying/Crying abnormal events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 35 affected / 49 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 49 at risk