Study: NCT05408429

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 121 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 121 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 121 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 121 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 40 affected / 121 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 33 affected / 121 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 121 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 121 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 121 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 116 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 116 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 116 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 34 affected / 116 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 116 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 116 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 63 affected / 116 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 118 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 118 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 118 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 118 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 118 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 34 affected / 118 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 25 affected / 118 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 118 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 118 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 117 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 117 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 117 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 38 affected / 117 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 117 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 117 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 117 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 54 affected / 117 at risk