Study: NCT02640664

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Parainfluenzae viral bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 61 at risk

Adverse event: Hyperphosphatasaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 61 at risk

Adverse event: Cerebellar haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 61 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Urticarial vasculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 61 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 61 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 61 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 61 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 61 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 61 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 61 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Autism spectrum disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 61 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 61 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Cerebral palsy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 65 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 65 at risk

Adverse event: Eye disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 65 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 65 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 65 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Acetonaemic vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Pharyngitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 65 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Viral pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Viral tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Endotracheal intubation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 65 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Motor dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Periventricular leukomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Quadriparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Psychomotor retardation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Increased bronchial secretion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nasal discharge discolouration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pulmonary vein stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Rash papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 65 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 65 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 65 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 65 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 65 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 65 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 65 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 65 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 65 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 65 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 65 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 65 at risk

Adverse event: Autism spectrum disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 65 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 65 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 65 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 54 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 54 at risk

Adverse event: Conjunctival haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Bacterial food poisoning
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 54 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Epstein-Barr virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 54 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Leptospirosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 54 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 54 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Foreign body in respiratory tract
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 54 at risk

Adverse event: Periorbital haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 54 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 54 at risk

Adverse event: Osteopenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Perinatal brain damage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 54 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 54 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 54 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 54 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 54 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 54 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 54 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 54 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 54 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 54 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 54 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 54 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 54 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 54 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 54 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 54 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 54 at risk

Adverse event: Rickets
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 54 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Autism spectrum disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 54 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 54 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 180 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cerebral palsy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 180 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 180 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 180 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 180 at risk

Adverse event: Conjunctival haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 180 at risk

Adverse event: Eye disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 180 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 180 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 180 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 180 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Acetonaemic vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 180 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 180 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 180 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 180 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 180 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Bacterial food poisoning
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 180 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 180 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 180 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Epstein-Barr virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 180 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 180 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Leptospirosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 180 at risk

Adverse event: Parainfluenzae viral bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 180 at risk

Adverse event: Pharyngitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 180 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 180 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 180 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 180 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 180 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 180 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Viral pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Viral tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Endotracheal intubation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Foreign body in respiratory tract
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Periorbital haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 180 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 180 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 180 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 180 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 180 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 180 at risk

Adverse event: Hyperphosphatasaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 180 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 180 at risk

Adverse event: Osteopenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 180 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 180 at risk

Adverse event: Cerebellar haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 180 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 180 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Motor dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Periventricular leukomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Quadriparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Perinatal brain damage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 180 at risk

Adverse event: Psychomotor retardation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 180 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 180 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 180 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 180 at risk

Adverse event: Increased bronchial secretion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 180 at risk

Adverse event: Nasal discharge discolouration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Pulmonary vein stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 180 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 180 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 180 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 180 at risk

Adverse event: Rash papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 180 at risk

Adverse event: Urticarial vasculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 180 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 180 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 180 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 34 affected / 180 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 180 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 180 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 180 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 180 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 9 affected / 180 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 180 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 180 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 180 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 180 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 180 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 180 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 180 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 180 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 180 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 180 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 180 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 180 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 180 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 180 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 180 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 180 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 180 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 180 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 180 at risk

Adverse event: Rickets
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 180 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 180 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 180 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 180 at risk

Adverse event: Autism spectrum disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 180 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 180 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 180 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 180 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 180 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 180 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 180 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 180 at risk