Study: NCT00644059

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1177 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1177 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1177 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Febrile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1177 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Hand-foot and mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1177 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Lymphangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1177 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Pneumococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1177 at risk

Adverse event: Subglottic laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1177 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1177 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1177 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1177 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1177 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1177 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1177 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1177 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1177 at risk

Adverse event: Spinal cord injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1177 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1177 at risk

Adverse event: Paracentesis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1177 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Fistula
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1177 at risk

Adverse event: Petit mal epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1177 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Adenoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1177 at risk

Adverse event: Brain tumour operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1177 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1177 at risk

Adverse event: Colonoscopy
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1177 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1177 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 164 affected / 1177 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 309 affected / 1177 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 188 affected / 1177 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 77 affected / 1177 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 423 affected / 1177 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 146 affected / 1177 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 214 affected / 1177 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 334 affected / 1177 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 123 affected / 1177 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 482 affected / 1177 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 169 affected / 1177 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 131 affected / 1177 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 178 affected / 1177 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 153 affected / 1177 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 250 affected / 1177 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 1177 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 260 affected / 1177 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 1177 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 362 affected / 1177 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 373 affected / 1177 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 1177 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 381 affected / 1177 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 327 affected / 1177 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 246 affected / 1177 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 76 affected / 1177 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1177 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 63 affected / 1177 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 1177 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 835 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 835 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 835 at risk

Adverse event: Arthropod infestation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 835 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 835 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 835 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 835 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 835 at risk

Adverse event: Perineal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 835 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 835 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 835 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 835 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 835 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 835 at risk

Adverse event: Adenoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 835 at risk

Adverse event: Toe amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 835 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 835 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 835 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 835 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 835 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 835 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 83 affected / 835 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 835 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 835 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 131 affected / 835 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 338 affected / 835 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 321 affected / 835 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 131 affected / 835 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 169 affected / 835 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 478 affected / 835 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 156 affected / 835 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 196 affected / 835 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 299 affected / 835 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 68 affected / 835 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 835 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 835 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 835 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 109 affected / 835 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 835 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 122 affected / 835 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 835 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 170 affected / 835 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 183 affected / 835 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 5 affected / 835 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 201 affected / 835 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 835 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 835 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 176 affected / 835 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 835 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 69 affected / 835 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 835 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 835 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 835 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Aphthous ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1069 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1069 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1069 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 1069 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1069 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 39 affected / 1069 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1069 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Pneumococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1069 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Subglottic laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1069 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1069 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1069 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Electric shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Vaccination failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Acetonaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1069 at risk

Adverse event: Dysphemia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Scrotal oedema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Child abuse
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 1069 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1069 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 156 affected / 1069 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 260 affected / 1069 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 166 affected / 1069 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 69 affected / 1069 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 325 affected / 1069 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 107 affected / 1069 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 131 affected / 1069 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 250 affected / 1069 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 90 affected / 1069 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 412 affected / 1069 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 153 affected / 1069 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 132 affected / 1069 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 152 affected / 1069 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 161 affected / 1069 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 226 affected / 1069 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 1069 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 219 affected / 1069 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 1069 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 306 affected / 1069 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 325 affected / 1069 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 1069 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 315 affected / 1069 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 263 affected / 1069 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 210 affected / 1069 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 1069 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 1069 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 1069 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Autoimmune thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 777 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 777 at risk

Adverse event: Allergy to arthropod bite
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 777 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 777 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 777 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 777 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 777 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 777 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 777 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 777 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 777 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 777 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 777 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 777 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 777 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 777 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 777 at risk

Adverse event: Attention deficit / Hyperactivity disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 777 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 777 at risk

Adverse event: Tonsillar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Patent ductus arteriosus repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 777 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Acquired epileptic aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 777 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 777 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 777 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 51 affected / 777 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 224 affected / 777 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 268 affected / 777 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 93 affected / 777 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 152 affected / 777 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 360 affected / 777 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 128 affected / 777 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 120 affected / 777 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 183 affected / 777 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 777 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 777 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 85 affected / 777 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 777 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 110 affected / 777 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 777 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 777 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 777 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 156 affected / 777 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 102 affected / 777 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 3 affected / 777 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 120 affected / 777 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 777 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 166 affected / 777 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 777 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 777 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 777 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 777 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 777 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 607 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 607 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 607 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 607 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 607 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 33 affected / 607 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 607 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 607 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Electric shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 607 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 607 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 607 at risk

Adverse event: Abnormal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 607 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Accidental poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Exposure via ingestion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 91 affected / 607 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 147 affected / 607 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 102 affected / 607 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 50 affected / 607 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 607 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 240 affected / 607 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 69 affected / 607 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 154 affected / 607 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 173 affected / 607 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 83 affected / 607 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 221 affected / 607 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 95 affected / 607 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 607 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 94 affected / 607 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 89 affected / 607 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 130 affected / 607 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 607 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 123 affected / 607 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 607 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 174 affected / 607 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 607 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 163 affected / 607 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 607 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 186 affected / 607 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 161 affected / 607 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 119 affected / 607 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 607 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 607 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 607 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 607 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 607 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 422 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 422 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 422 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 422 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 422 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 422 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 422 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: Lice infestation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 422 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 422 at risk

Adverse event: Malabsorption
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 422 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 422 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 422 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 422 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 37 affected / 422 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 122 affected / 422 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 128 affected / 422 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 49 affected / 422 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 79 affected / 422 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 179 affected / 422 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 54 affected / 422 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 64 affected / 422 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 125 affected / 422 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 422 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 422 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 422 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 422 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 422 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 422 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 422 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 422 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 85 affected / 422 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 422 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 66 affected / 422 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 422 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 97 affected / 422 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 422 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 422 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 422 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 422 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 422 at risk