Study: NCT00829010

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Hepatitis neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: HIV-associated neurocognitive disorder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 83 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 83 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 83 at risk

Adverse event: Measles
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Meningitis meningococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 83 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 83 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Near drowning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Kwashiorkor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 83 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 13 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 76 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 18 affected / 83 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 1 affected / 76 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 8 affected / 83 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 49 affected / 83 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 17 affected / 74 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 38 affected / 83 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 9 affected / 74 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 63 affected / 83 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 25 affected / 74 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 36 affected / 83 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 17 affected / 74 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 73 affected / 83 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 40 affected / 74 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 62 affected / 83 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 25 affected / 74 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 67 affected / 83 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 28 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 17 affected / 83 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 83 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 2 affected / 76 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 4 affected / 76 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 35 affected / 83 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 17 affected / 76 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 29 affected / 83 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 7 affected / 76 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 1 affected / 76 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 83 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 26 affected / 83 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 4 affected / 76 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 5 affected / 83 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 1 affected / 83 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 5 affected / 83 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 83 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 83 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 83 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 12 affected / 83 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 83 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 83 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cerebral palsy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 101 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 101 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 101 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Measles
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Electric shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Herbal toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Kwashiorkor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 16 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 10 affected / 96 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 16 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 8 affected / 96 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 5 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 62 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 28 affected / 95 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 36 affected / 101 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 11 affected / 95 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 84 affected / 101 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 35 affected / 95 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 53 affected / 101 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 23 affected / 95 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 93 affected / 101 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 58 affected / 95 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 80 affected / 101 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 31 affected / 95 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 83 affected / 101 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 39 affected / 95 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 19 affected / 101 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 13 affected / 101 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 96 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 6 affected / 96 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 73 affected / 101 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 23 affected / 96 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 40 affected / 101 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 4 affected / 96 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 96 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 12 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 25 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 4 affected / 96 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 8 affected / 101 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 101 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 101 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 101 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 101 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 101 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 8 affected / 101 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 101 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 1 affected / 101 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 101 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

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

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 100 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

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

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

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

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

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

Adverse event: Rectal abscess
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: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 18 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 10 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 11 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 7 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 12 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 70 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 34 affected / 96 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 41 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 7 affected / 96 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 89 affected / 98 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 31 affected / 96 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 56 affected / 98 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 29 affected / 96 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 92 affected / 98 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 62 affected / 96 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 83 affected / 98 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 39 affected / 96 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 84 affected / 98 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 38 affected / 96 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 15 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 13 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 6 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 4 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 67 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 24 affected / 98 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 50 affected / 100 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 6 affected / 98 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 7 affected / 98 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 11 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 16 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 3 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 5 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 1 affected / 100 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 10 affected / 100 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 11 affected / 100 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 11 affected / 100 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 100 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

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

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

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

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

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

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

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

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: Kwashiorkor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
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: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 13 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 15 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 10 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 70 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 28 affected / 98 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 89 affected / 98 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 57 affected / 98 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 95 affected / 98 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 83 affected / 98 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 91 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 18 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 11 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 58 affected / 100 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 49 affected / 100 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 12 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 28 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 8 affected / 100 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 100 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 100 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 8 affected / 100 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 100 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 5 affected / 100 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 100 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

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

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

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

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

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

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

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

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

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

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

Adverse event: Near drowning
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: 2 affected / 100 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 11 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 8 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 12 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 5 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 68 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 33 affected / 96 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 28 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 11 affected / 96 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 91 affected / 98 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 43 affected / 96 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 62 affected / 98 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 37 affected / 96 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 97 affected / 98 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 60 affected / 96 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 84 affected / 98 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 45 affected / 96 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 84 affected / 98 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Frequency: 53 affected / 96 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: During the 4-day (Days 0-3) post-primary vaccination period
Frequency: 23 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 12 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 4 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 66 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 13 affected / 98 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 51 affected / 100 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 6 affected / 98 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 98 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 14 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 21 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Frequency: 5 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 2 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 2 affected / 100 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 10 affected / 100 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 100 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 4 affected / 100 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 3 affected / 100 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 9 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31-day (Days 0-30) post-primary vaccination period
Frequency: 6 affected / 100 at risk