Study: NCT04535037

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 249 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 249 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Enterovirus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 249 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 249 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 249 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 249 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Tethered oral tissue
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 249 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 249 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 249 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 249 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 249 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Anal erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 249 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 249 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 249 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 249 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 249 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 249 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 249 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 249 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 5 affected / 249 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 249 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 249 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 249 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 249 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 249 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 249 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 249 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 249 at risk

Adverse event: Irritability postvaccinal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 249 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 249 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 249 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 249 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 103 affected / 249 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 249 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 249 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 249 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 249 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 249 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 249 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 249 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 249 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 249 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 249 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Pilonidal disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 249 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 249 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 249 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 249 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 249 at risk

Adverse event: Bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 249 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 249 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 249 at risk

Adverse event: Nasal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 249 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 249 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 249 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 249 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 249 at risk

Adverse event: Hypoferritinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 249 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 249 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 249 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 249 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 249 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 249 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 249 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 249 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 249 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 249 at risk

Adverse event: Genital labial adhesions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 249 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 249 at risk

Adverse event: Pharyngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 249 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 249 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 249 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 249 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 249 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 249 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Pallor
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 249 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 251 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Pulmonary valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Developmental hip dysplasia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 251 at risk

Adverse event: Microcephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 251 at risk

Adverse event: Odontogenic cyst
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 251 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 251 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 251 at risk

Adverse event: Corneal erosion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 251 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 251 at risk

Adverse event: Eye haematoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 251 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 251 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 251 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 251 at risk

Adverse event: Dental cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 251 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 251 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 251 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 251 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 251 at risk

Adverse event: Administration site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Administration site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 7 affected / 251 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 4 affected / 251 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 251 at risk

Adverse event: Hyperpyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Injection site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 251 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 251 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 251 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Irritability postvaccinal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 251 at risk

Adverse event: Nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 251 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 132 affected / 251 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Vaccination site granuloma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Allergy to arthropod bite
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 251 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 251 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 251 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 251 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 251 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 251 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 251 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 251 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Infected fistula
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 251 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 251 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 251 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 251 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 251 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 251 at risk

Adverse event: Subglottic laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Suspected COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Tonsillitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 251 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 251 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 251 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 251 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 251 at risk

Adverse event: Electric shock
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Eye injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Hair-thread tourniquet syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Vascular procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 251 at risk

Adverse event: Body temperature decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 251 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 251 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 251 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 251 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 251 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 251 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 251 at risk

Adverse event: Head titubation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 251 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 251 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 251 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 251 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 251 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 251 at risk

Adverse event: Genital labial adhesions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 251 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 251 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 251 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 251 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 251 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 251 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 251 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 251 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 251 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 251 at risk