Study: NCT03547271

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 696 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 696 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 696 at risk

Adverse event: Aphthous ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 696 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Food protein-induced enterocolitis syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Gastrointestinal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 696 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 696 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 696 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 696 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 696 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 696 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 696 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 696 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 696 at risk

Adverse event: Burns third degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 696 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 696 at risk

Adverse event: Exposure to toxic agent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 696 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 696 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 696 at risk

Adverse event: Musculoskeletal stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 696 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 696 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 696 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 696 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 696 at risk

Adverse event: Balanoposthitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 696 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Respiration abnormal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 696 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 696 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 696 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 99 affected / 696 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 696 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 196 affected / 696 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 579 affected / 696 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 110 affected / 696 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 537 affected / 696 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 55 affected / 696 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 68 affected / 696 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 64 affected / 696 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 562 affected / 696 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 422 affected / 696 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 375 affected / 696 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 696 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 696 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 696 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 696 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 696 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 696 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 696 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 389 affected / 696 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 529 affected / 696 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 600 affected / 696 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 696 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 696 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 696 at risk

Adverse event: Congenital hydronephrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 706 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 706 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 706 at risk

Adverse event: Blepharitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 706 at risk

Adverse event: Anal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Gastrointestinal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Regurgitation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 706 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 706 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 706 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 706 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Gastrointestinal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 706 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 706 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 706 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 706 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 706 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 706 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 706 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 706 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 706 at risk

Adverse event: Testicular yolk sac tumour stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 706 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 706 at risk

Adverse event: Petit mal epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 706 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 706 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 706 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 706 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 706 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 706 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 706 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 706 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 706 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 706 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 197 affected / 706 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 579 affected / 706 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 124 affected / 706 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 520 affected / 706 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 56 affected / 706 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 52 affected / 706 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 60 affected / 706 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 566 affected / 706 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 417 affected / 706 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 345 affected / 706 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 706 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 706 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 706 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 706 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 706 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 706 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 706 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 372 affected / 706 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 545 affected / 706 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 608 affected / 706 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 706 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 706 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 706 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Clinically isolated syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 112 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 112 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 112 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 74 affected / 112 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 3 affected / 112 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 61 affected / 112 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 7 affected / 112 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 112 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 3 affected / 112 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 88 affected / 112 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 41 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 112 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 112 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 112 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 112 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 112 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 112 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 112 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 91 affected / 112 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 112 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Lymphatic malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 108 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 108 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 108 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 75 affected / 108 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 58 affected / 108 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 16 affected / 108 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 108 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 47 affected / 108 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 42 affected / 108 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 108 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 108 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 108 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 108 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 108 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 108 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 108 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 75 affected / 108 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 86 affected / 108 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 108 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 108 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 108 at risk