Study: NCT04530838

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 225 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 225 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 225 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 217 affected / 225 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 84 affected / 225 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 206 affected / 225 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 136 affected / 225 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 225 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 225 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 225 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 225 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 147 affected / 225 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Frequency: 110 affected / 225 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 225 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 225 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 225 at risk

Adverse event: Congenital mitral valve incompetence
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 224 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 224 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 224 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 217 affected / 224 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 85 affected / 224 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 211 affected / 224 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 135 affected / 224 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 224 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 224 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 224 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 68 affected / 224 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 161 affected / 224 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Frequency: 119 affected / 224 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 224 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 224 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 224 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 217 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 217 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 217 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 217 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 217 at risk

Adverse event: Near drowning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 217 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Tuberculid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 217 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 217 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 130 affected / 217 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 65 affected / 217 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 119 affected / 217 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 110 affected / 217 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 217 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 217 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 217 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 217 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 154 affected / 217 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Frequency: 107 affected / 217 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 217 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 217 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 217 at risk