Study: NCT00468858

Adverse event: Cellulitis (face)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 211 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 211 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Acute viral gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 25 affected / 211 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 15 affected / 211 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 8 affected / 211 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 30 affected / 211 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 16 affected / 211 at risk

Adverse event: Swelling
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dose 2
Frequency: 10 affected / 211 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 18 affected / 211 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 17 affected / 211 at risk

Adverse event: Fever (axillary)
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 52 affected / 211 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 1
Frequency: 41 affected / 211 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 20 affected / 211 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 13 affected / 211 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 13 affected / 211 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 10 affected / 211 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 11 affected / 211 at risk

Adverse event: Fever (axillary)
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 51 affected / 211 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 2
Frequency: 34 affected / 211 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 5 affected / 211 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 5 affected / 211 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 11 affected / 211 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 8 affected / 211 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Infection parasitic
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 13 affected / 211 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 3 affected / 211 at risk

Adverse event: Parasitic gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 12 affected / 211 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 3 affected / 211 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Bruns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 4 affected / 211 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 3 affected / 211 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 211 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 211 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Conuunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 2 affected / 211 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 211 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Exercise tolerance decreased
Serious: no
Organ System: General disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Gingival abscess
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 3 affected / 211 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 7 affected / 211 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 2 affected / 211 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 4 affected / 211 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 211 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 4 affected / 211 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 4 affected / 211 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 5 affected / 211 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 211 at risk

Adverse event: Dermititis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 211 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 211 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 212 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 212 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 34 affected / 212 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 15 affected / 212 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 7 affected / 212 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 26 affected / 212 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 7 affected / 212 at risk

Adverse event: Swelling
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dose 2
Frequency: 7 affected / 212 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 26 affected / 212 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 26 affected / 212 at risk

Adverse event: Fever (axillary)
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 54 affected / 212 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 1
Frequency: 49 affected / 212 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 19 affected / 212 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 16 affected / 212 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 15 affected / 212 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 13 affected / 212 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 7 affected / 212 at risk

Adverse event: Fever (axillary)
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 46 affected / 212 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 2
Frequency: 24 affected / 212 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 8 affected / 212 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 4 affected / 212 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 11 affected / 212 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 4 affected / 212 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Abdominal pain (upper)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 6 affected / 212 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Ages 1 to 4
Frequency: 4 affected / 212 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 4 affected / 212 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 6 affected / 212 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 3 affected / 212 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 4 affected / 212 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 21 affected / 212 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Tooth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 3 affected / 212 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 8 affected / 212 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 3 affected / 212 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 212 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 212 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Anal pruritus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Gastroesophageal reflux desease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Tooth development disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Enterobiasis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 3 affected / 212 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 8 affected / 212 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 3 affected / 212 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 3 affected / 212 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 4 affected / 212 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 212 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 212 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Presumptive viral syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 213 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 213 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 31 affected / 213 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 12 affected / 213 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 6 affected / 213 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 17 affected / 213 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 8 affected / 213 at risk

Adverse event: Swelling
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dose 2
Frequency: 4 affected / 213 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 17 affected / 213 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 18 affected / 213 at risk

Adverse event: Fever (axillary)
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 47 affected / 213 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 1
Frequency: 45 affected / 213 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 13 affected / 213 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 9 affected / 213 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 14 affected / 213 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 11 affected / 213 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 14 affected / 213 at risk

Adverse event: Fever (axillary)
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 36 affected / 213 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 2
Frequency: 27 affected / 213 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 6 affected / 213 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 1 affected / 213 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 7 affected / 213 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 5 affected / 213 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 1 to 4
Frequency: 3 affected / 213 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 3 affected / 213 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 16 affected / 213 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 4 affected / 213 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 21 affected / 213 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 4 affected / 213 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 5 affected / 213 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 4 affected / 213 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 2 affected / 213 at risk

Adverse event: Rash generalized
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 1 to 4
Frequency: 1 affected / 213 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Influenza like symptoms
Serious: no
Organ System: General disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 3 affected / 213 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 5 affected / 213 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 3 affected / 213 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 7 affected / 213 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 4 affected / 213 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 3 affected / 213 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Bladder pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Ovarian disorder
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Penis disorder
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 2 affected / 213 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ages 5 - 50
Frequency: 3 affected / 213 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ages 5 - 50
Frequency: 1 affected / 213 at risk