Study: NCT00134719

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Respiratory tract malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 6 affected / 661 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 3 affected / 661 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 2 affected / 661 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 9 affected / 661 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 5 affected / 661 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 2 affected / 661 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 2 affected / 661 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 2 affected / 661 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 4 affected / 661 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Post-primary vaccination phase
Frequency: 3 affected / 661 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Hypotonic-hyporesponsive episode
Serious: yes
Organ System: Nervous system disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Vesicoureteric reflux
Serious: yes
Organ System: Renal and urinary disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: Post-fourth dose vaccination phase
Frequency: 2 affected / 625 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 4 affected / 625 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 3 affected / 625 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 661 at risk

Adverse event: Middle ear effusion
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 2 affected / 625 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 11 affected / 625 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 3 affected / 625 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 8 affected / 625 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 2 affected / 625 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Viral tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Mouth injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 625 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 432 affected / 658 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 556 affected / 658 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 492 affected / 658 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 217 affected / 622 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 379 affected / 622 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 225 affected / 622 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 530 affected / 659 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 196 affected / 659 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 616 affected / 659 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 410 affected / 659 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 196 affected / 622 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 60 affected / 622 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 361 affected / 622 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 224 affected / 622 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 154 affected / 661 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 98 affected / 661 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 99 affected / 661 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 52 affected / 661 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 49 affected / 661 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 49 affected / 661 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 48 affected / 661 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 44 affected / 661 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 37 affected / 661 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 40 affected / 661 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 24 affected / 661 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 157 affected / 625 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 109 affected / 625 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Post-fourth dose vaccination phase
Frequency: 78 affected / 625 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 55 affected / 625 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 51 affected / 625 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 44 affected / 625 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 48 affected / 625 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Post-fourth dose vaccination phase
Frequency: 41 affected / 625 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 24 affected / 625 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 3 affected / 221 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 3 affected / 221 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 2 affected / 221 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 3 affected / 221 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Pharyngeal abscess
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 3 affected / 206 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Tooth fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 206 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 171 affected / 220 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 189 affected / 220 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 163 affected / 220 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 60 affected / 202 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 102 affected / 202 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 63 affected / 202 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 193 affected / 220 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 83 affected / 220 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 211 affected / 220 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 153 affected / 220 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 63 affected / 202 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 14 affected / 202 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 120 affected / 202 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 76 affected / 202 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 53 affected / 221 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 44 affected / 221 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 33 affected / 221 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 16 affected / 221 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 16 affected / 221 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 20 affected / 221 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 12 affected / 221 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 14 affected / 221 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 9 affected / 221 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 10 affected / 221 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 4 affected / 221 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 40 affected / 206 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 41 affected / 206 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Post-fourth dose vaccination phase
Frequency: 35 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 17 affected / 206 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 14 affected / 206 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 20 affected / 206 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 16 affected / 206 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Post-fourth dose vaccination phase
Frequency: 14 affected / 206 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 9 affected / 206 at risk

Adverse event: Hypertrophic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 5 affected / 221 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 2 affected / 221 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Investigation
Serious: yes
Organ System: Investigations
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 1 affected / 221 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Otorrhoea
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 2 affected / 204 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 1 affected / 204 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 152 affected / 220 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 189 affected / 220 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 167 affected / 220 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 100 affected / 201 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 157 affected / 201 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited local symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 123 affected / 201 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 176 affected / 220 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 80 affected / 220 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 212 affected / 220 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This post-primary vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 135 affected / 220 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 71 affected / 201 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 31 affected / 201 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 117 affected / 201 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This post-fourth dose vaccination phase solicited general symptom was assessed in subjects who had symptom sheet filled in.
Frequency: 62 affected / 201 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Post-primary vaccination phase
Frequency: 54 affected / 221 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 27 affected / 221 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 26 affected / 221 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 15 affected / 221 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 17 affected / 221 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-primary vaccination phase
Frequency: 10 affected / 221 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 14 affected / 221 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 10 affected / 221 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Post-primary vaccination phase
Frequency: 18 affected / 221 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-primary vaccination phase
Frequency: 8 affected / 221 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-primary vaccination phase
Frequency: 17 affected / 221 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 49 affected / 204 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 38 affected / 204 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Post-fourth dose vaccination phase
Frequency: 23 affected / 204 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 16 affected / 204 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Post-fourth dose vaccination phase
Frequency: 14 affected / 204 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 17 affected / 204 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 16 affected / 204 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Post-fourth dose vaccination phase
Frequency: 17 affected / 204 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-fourth dose vaccination phase
Frequency: 13 affected / 204 at risk