Study: NCT00444457

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 486 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 486 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 486 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 9 affected / 486 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 486 at risk

Adverse event: Macrocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 486 at risk

Adverse event: Pectus excavatum
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 486 at risk

Adverse event: Tethered oral tissue
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 486 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hemihypertrophy
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 486 at risk

Adverse event: Naevus flammeus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 486 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 486 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 486 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 486 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 486 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 486 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 486 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 486 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 486 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 486 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 486 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 486 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 486 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 486 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 486 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 486 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Abdominal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 43 affected / 486 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 15 affected / 486 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 486 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 486 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 486 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 486 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 486 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 194 affected / 486 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 142 affected / 486 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 486 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 486 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 486 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 486 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 486 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 486 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 486 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 486 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 486 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 486 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 486 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 486 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 486 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 486 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 486 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 486 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 486 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 486 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 486 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 486 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 486 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 486 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 486 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Gastroenteritis rotavirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Dermatophytosis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Cellulitis staphylococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Perirectal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 486 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 486 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 486 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 486 at risk

Adverse event: Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 486 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 486 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 486 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 486 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 486 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 486 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 486 at risk

Adverse event: Selective eating disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hypophagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 486 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 486 at risk

Adverse event: Head deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Muscle twiching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 486 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 486 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hyporeflexia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Umbilical granuloma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 486 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 486 at risk

Adverse event: Screaming
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 486 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 486 at risk

Adverse event: Penile adhesion
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 486 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 486 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 486 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 486 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 486 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 486 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 486 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 486 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Lower respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Rhonchi
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 486 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 486 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 486 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 486 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 486 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 486 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 486 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 486 at risk

Adverse event: Dandruff
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 486 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 262 affected / 420 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)=present at site of vaccination.
Frequency: 235 affected / 354 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)=present at site of vaccination.
Frequency: 198 affected / 317 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 32 affected / 348 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement.
Frequency: 26 affected / 269 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement.
Frequency: 22 affected / 248 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 59 affected / 356 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (any)=present at site of vaccination.
Frequency: 71 affected / 291 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (any)=present at site of vaccination.
Frequency: 71 affected / 263 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 52 affected / 353 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 65 affected / 288 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 64 affected / 260 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 12 affected / 338 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 11 affected / 270 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 10 affected / 242 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 69 affected / 355 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)=present at site of vaccination.
Frequency: 88 affected / 292 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)=present at site of vaccination.
Frequency: 110 affected / 278 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 64 affected / 354 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 82 affected / 289 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 102 affected / 275 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 7 affected / 334 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (moderate)=2.5 cm to 7.0 cm
Frequency: 9 affected / 268 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 13 affected / 243 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 87 affected / 353 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 97 affected / 290 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Frequency: 70 affected / 266 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 2 affected / 328 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 9 affected / 263 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 6 affected / 237 at risk

Adverse event: Fever > 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \> 40 degrees C.
Frequency: 1 affected / 259 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite.
Frequency: 199 affected / 393 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite.
Frequency: 156 affected / 322 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite.
Frequency: 131 affected / 286 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability.
Frequency: 373 affected / 435 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability.
Frequency: 326 affected / 377 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability.
Frequency: 280 affected / 352 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep.
Frequency: 304 affected / 425 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep.
Frequency: 215 affected / 332 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep.
Frequency: 160 affected / 289 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep.
Frequency: 167 affected / 379 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep.
Frequency: 159 affected / 324 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep.
Frequency: 120 affected / 282 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Hives (Urticaria).
Frequency: 2 affected / 333 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Hives (Urticaria).
Frequency: 1 affected / 263 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Hives (Urticaria).
Frequency: 4 affected / 239 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 483 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 483 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 483 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 483 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 483 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Macrocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Brachycephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Laryngomalacia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Pulmonary valve stenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Ventricular septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 483 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 483 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 483 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 37 affected / 483 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 483 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 483 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 483 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Dark circles under eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Pupillary reflex impaired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 483 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 483 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 483 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 483 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 483 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 483 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 483 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Dyschezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Gingval cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Mouth cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Oral disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Tongue discolouration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 49 affected / 483 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 12 affected / 483 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 483 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 483 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 483 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 187 affected / 483 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 125 affected / 483 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 483 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 483 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 483 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 483 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 483 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 483 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 483 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 483 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 483 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 483 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 483 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 483 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 483 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 483 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 483 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 483 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 483 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 483 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 483 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 483 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 483 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 483 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 483 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 483 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Dacryocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Gastroenteritis rotavirus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Gastritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Abscess oral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Cellulitis of male external genital organ
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Eczema infected
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Parotitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Pyelonephritis acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Scarlet fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 483 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 483 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 483 at risk

Adverse event: Cardiac murmur functional
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Head circumference abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 483 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 483 at risk

Adverse event: Head deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 483 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 483 at risk

Adverse event: Benign neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 483 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 483 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Head titubation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Subdural effusion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Neonatal disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 483 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 483 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 483 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 483 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 483 at risk

Adverse event: Urine odour abnormal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 483 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 483 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 483 at risk

Adverse event: Genital discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 483 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 483 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 483 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 483 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 483 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 483 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Tracheomalacia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 483 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 483 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 483 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 483 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 483 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 483 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 483 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 483 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 483 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 483 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 483 at risk

Adverse event: Dandruff
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 483 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 483 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Mechanical urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Rash neonatal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 262 affected / 409 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)=present at site of vaccination.
Frequency: 222 affected / 330 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)=present at site of vaccination.
Frequency: 185 affected / 304 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 35 affected / 337 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement.
Frequency: 17 affected / 231 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement.
Frequency: 17 affected / 226 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 68 affected / 347 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (any)=present at site of vaccination.
Frequency: 56 affected / 248 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (any)=present at site of vaccination.
Frequency: 59 affected / 250 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 58 affected / 344 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 54 affected / 246 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 56 affected / 249 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 19 affected / 328 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 3 affected / 224 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 9 affected / 221 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 88 affected / 352 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)=present at site of vaccination.
Frequency: 95 affected / 265 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)=present at site of vaccination.
Frequency: 94 affected / 262 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 87 affected / 352 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 91 affected / 263 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 88 affected / 260 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 2 affected / 326 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (moderate)=2.5 cm to 7.0 cm
Frequency: 4 affected / 223 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 9 affected / 219 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 79 affected / 337 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 91 affected / 250 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Frequency: 68 affected / 246 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 1 affected / 319 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 7 affected / 216 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 8 affected / 219 at risk

Adverse event: Fever > 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 40 degrees C.
Frequency: 1 affected / 216 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite.
Frequency: 177 affected / 385 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite.
Frequency: 144 affected / 293 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite.
Frequency: 131 affected / 273 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability.
Frequency: 364 affected / 432 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability.
Frequency: 320 affected / 370 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability.
Frequency: 273 affected / 339 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep.
Frequency: 303 affected / 417 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep.
Frequency: 217 affected / 318 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep.
Frequency: 170 affected / 289 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep.
Frequency: 177 affected / 377 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep.
Frequency: 142 affected / 291 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep.
Frequency: 137 affected / 272 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Hives (Urticaria).
Frequency: 3 affected / 328 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Hives (Urticaria).
Frequency: 5 affected / 225 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Hives (Urticaria).
Frequency: 2 affected / 218 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 483 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Allergy to vaccine
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 483 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 483 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 483 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Productive cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 483 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 483 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 483 at risk

Adverse event: Developmental hip dysplasia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hypospadias
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Phimosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Congenital musculoskeletal disorder of skull
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 483 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 483 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 483 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 483 at risk

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 483 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 44 affected / 483 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 483 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 483 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Anisocoria
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 483 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 483 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 483 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 483 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 483 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 483 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 483 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 483 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Allergic colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Gingval ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Tongue geographic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Vomiting projectile
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 483 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 483 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 483 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 483 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Allergy to vaccine
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 204 affected / 483 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 135 affected / 483 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 483 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 483 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 483 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 483 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 483 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 483 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 483 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 483 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 483 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 483 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 483 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 483 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 483 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 483 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 483 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 483 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 483 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 483 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 483 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 483 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 483 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 483 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Dacryocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Pneumonia viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Gastritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Periorbital cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 483 at risk

Adverse event: Gastroenteritis salmonella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 483 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 483 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Chemical burns of eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 483 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 483 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 483 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 483 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 483 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Selective eating disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Dairy intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Overweight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 483 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 483 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 483 at risk

Adverse event: Poor quality sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Cephalhaematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 483 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 483 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 483 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 483 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 483 at risk

Adverse event: Penile adhesion
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 483 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 483 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 483 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 483 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 483 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 483 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 483 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 483 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 483 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 483 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 483 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 483 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 483 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 483 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 483 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 483 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 483 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 483 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 483 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 483 at risk

Adverse event: Dandruff
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 483 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 483 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 483 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 483 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Acanthosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 483 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Post inflammatory pigmentation change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 483 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Urticaria papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 483 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 483 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 250 affected / 400 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)=present at site of vaccination.
Frequency: 219 affected / 337 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)=present at site of vaccination.
Frequency: 165 affected / 300 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 36 affected / 345 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement.
Frequency: 32 affected / 262 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement.
Frequency: 24 affected / 237 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 68 affected / 352 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (any)=present at site of vaccination.
Frequency: 80 affected / 279 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (any)=present at site of vaccination.
Frequency: 75 affected / 262 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 54 affected / 348 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 74 affected / 276 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 71 affected / 260 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 17 affected / 340 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 12 affected / 255 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 9 affected / 229 at risk

Adverse event: Induration (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (severe) \>7.0 cm.
Frequency: 1 affected / 250 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 83 affected / 360 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)=present at site of vaccination.
Frequency: 97 affected / 281 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)=present at site of vaccination.
Frequency: 103 affected / 274 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 76 affected / 358 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 93 affected / 279 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 99 affected / 272 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 8 affected / 337 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (moderate)=2.5 cm to 7.0 cm
Frequency: 8 affected / 252 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 13 affected / 231 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 87 affected / 353 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 103 affected / 290 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Frequency: 80 affected / 252 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 3 affected / 333 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 9 affected / 248 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 13 affected / 231 at risk

Adverse event: Fever > 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 40 degrees C.
Frequency: 1 affected / 331 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite.
Frequency: 193 affected / 386 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite.
Frequency: 156 affected / 325 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite.
Frequency: 145 affected / 286 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability.
Frequency: 386 affected / 433 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability.
Frequency: 318 affected / 376 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability.
Frequency: 287 affected / 347 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep.
Frequency: 279 affected / 402 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep.
Frequency: 231 affected / 343 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep.
Frequency: 171 affected / 286 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep.
Frequency: 159 affected / 377 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep.
Frequency: 136 affected / 305 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep.
Frequency: 140 affected / 289 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Hives (Urticaria).
Frequency: 2 affected / 335 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Hives (Urticaria).
Frequency: 4 affected / 253 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Hives (Urticaria).
Frequency: 4 affected / 229 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 244 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Irritability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Meningitis enteroviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 244 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 244 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 244 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 244 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 244 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 244 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 244 at risk

Adverse event: External ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 244 at risk

Adverse event: Tympanic membrane disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 244 at risk

Adverse event: Precocious puberty
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 244 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 244 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 244 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 244 at risk

Adverse event: Heterophoria
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Scleral disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 244 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 244 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 244 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 244 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Infantile spitting up
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 244 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 244 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 244 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 244 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 244 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 244 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 244 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 85 affected / 244 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 244 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 244 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 244 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 244 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 244 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 244 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 244 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 244 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 244 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 244 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 244 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 244 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 244 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 244 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 244 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 244 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Dacryocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Pneumonia viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Breast cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Eczema herpeticum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Staphylococcal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 244 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 244 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Head deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Benign penile neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 244 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 244 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Breath holding
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 244 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 244 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 244 at risk

Adverse event: Breast cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 244 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 244 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 244 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 244 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 244 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 244 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Tracheomalacia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 244 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 244 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 244 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 244 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 244 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 244 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 244 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 244 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dandruff
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cafe au lait spots
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pityriasis alba
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Overfeeding of infant
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 244 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 142 affected / 212 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)=present at site of vaccination.
Frequency: 114 affected / 176 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)=present at site of vaccination.
Frequency: 101 affected / 156 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 22 affected / 170 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement.
Frequency: 15 affected / 132 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement.
Frequency: 14 affected / 118 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 32 affected / 176 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (any)=present at site of vaccination.
Frequency: 25 affected / 141 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (any)=present at site of vaccination.
Frequency: 39 affected / 128 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 28 affected / 173 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 25 affected / 141 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)=0.5 cm to 2.0 cm.
Frequency: 37 affected / 127 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 6 affected / 167 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 5 affected / 128 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 8 affected / 114 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 41 affected / 180 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)=present at site of vaccination.
Frequency: 46 affected / 153 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)=present at site of vaccination.
Frequency: 54 affected / 137 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 39 affected / 180 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 44 affected / 153 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 52 affected / 135 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 2 affected / 164 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (moderate)=2.5 cm to 7.0 cm
Frequency: 4 affected / 128 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 9 affected / 116 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 45 affected / 173 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 40 affected / 143 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Frequency: 43 affected / 132 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 2 affected / 161 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 7 affected / 113 at risk

Adverse event: Fever > 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 40 degrees C.
Frequency: 1 affected / 160 at risk

Adverse event: Fever > 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \> 40 degrees C.
Frequency: 1 affected / 111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite.
Frequency: 98 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite.
Frequency: 81 affected / 164 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite.
Frequency: 72 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability.
Frequency: 198 affected / 226 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability.
Frequency: 163 affected / 201 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability.
Frequency: 157 affected / 186 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep.
Frequency: 154 affected / 212 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep.
Frequency: 112 affected / 177 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep.
Frequency: 71 affected / 138 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep.
Frequency: 90 affected / 194 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep.
Frequency: 77 affected / 159 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep.
Frequency: 83 affected / 147 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Hives (Urticaria).
Frequency: 1 affected / 127 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Hives (Urticaria).
Frequency: 2 affected / 112 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Dacryostenosis acquired
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1445 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1445 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1445 at risk

Adverse event: Eczema herpeticum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1445 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1445 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Von Willebrand's disease
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1445 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 1445 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 1445 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 1445 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1445 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1445 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1445 at risk

Adverse event: Coxsackie viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1445 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1445 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1445 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Cerebral cyst
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Vesicoureteric reflux
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1445 at risk

Adverse event: Renal tubular acidosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Genital labial adhesions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1445 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1445 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1445 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1445 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 1445 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1445 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 1445 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Keratosis pilaris
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1445 at risk

Adverse event: Vitiligo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1445 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Injection site rash
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Cellulitis pharyngeal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Viral rash
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Near drowning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1210 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Macrocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Congenital neavus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Tibial torsion
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 1210 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Precocious puberty
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 1210 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 1210 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 1210 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1210 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 1210 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 1210 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 1210 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 70 affected / 1210 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 1210 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 1210 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 1210 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1210 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 1210 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1210 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 1210 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 1210 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1210 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1210 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1210 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1210 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1210 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1210 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1210 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1210 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1210 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Coxsackie viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 1210 at risk

Adverse event: Dermatitis infected
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1210 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1210 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1210 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Burns second degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Torus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1210 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 6 affected / 1210 at risk

Adverse event: Body height below normal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1210 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1210 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Underweight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Knee deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1210 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1210 at risk

Adverse event: Fibrous histiocytoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1210 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Speech disorder developmental
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Gross motor delay
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Breath holding
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Vesicoureteric reflux
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Penile adhesion
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Penile oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 1210 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1210 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 1210 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1210 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1210 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1210 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 1210 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 1210 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 1210 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Dandruff
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1210 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Post inflammatory pigmentation change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Cafe au lait spots
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Urticaria papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 473 affected / 826 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 42 affected / 630 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 220 affected / 698 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 199 affected / 689 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 53 affected / 627 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 319 affected / 749 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 288 affected / 735 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 67 affected / 631 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 192 affected / 667 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 26 affected / 592 at risk

Adverse event: Fever > 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 40 degrees C.
Frequency: 6 affected / 586 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite.
Frequency: 410 affected / 790 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability.
Frequency: 771 affected / 943 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep.
Frequency: 372 affected / 779 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep.
Frequency: 361 affected / 770 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Hives (Urticaria).
Frequency: 13 affected / 607 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 208 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 208 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 208 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 208 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 208 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 208 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 208 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 208 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 208 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 208 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 208 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 208 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 208 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 208 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Coxsackie viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Lyme disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 208 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Vaccination complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Blood lead increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 208 at risk

Adverse event: Knee deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 208 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 208 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 208 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 208 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
Frequency: 83 affected / 131 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
Frequency: 4 affected / 97 at risk

Adverse event: Induration (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
Frequency: 48 affected / 110 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 44 affected / 107 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 18 affected / 101 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
Frequency: 64 affected / 121 at risk

Adverse event: Erythema (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
Frequency: 58 affected / 116 at risk

Adverse event: Erythema (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
Frequency: 22 affected / 104 at risk

Adverse event: Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.
Frequency: 32 affected / 107 at risk

Adverse event: Fever > 39 degrees C but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Fever \> 39 degrees C but ≤ 40 degrees C.
Frequency: 5 affected / 95 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased appetite.
Frequency: 58 affected / 115 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Irritability.
Frequency: 128 affected / 160 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Increased sleep.
Frequency: 60 affected / 126 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Decreased sleep.
Frequency: 50 affected / 117 at risk

Adverse event: Hives (Urticaria)
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1 and Toddler Dose; Hives (Urticaria).
Frequency: 5 affected / 96 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1443 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1443 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1443 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1443 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Near drowning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1443 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1443 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1443 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1443 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1443 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Precocious puberty
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Anal skin tags
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 1443 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 1443 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1443 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1443 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1443 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1443 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1443 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1443 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1443 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 244 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 244 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 244 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk