Study: NCT01026038

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Any) = present at site of vaccination
Frequency: 62 affected / 112 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Mild) = does not interfere with activity
Frequency: 55 affected / 109 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Moderate) = interferes with activity
Frequency: 17 affected / 95 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Severe) = prevents daily activity
Frequency: 1 affected / 90 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Any) = present at site of vaccination
Frequency: 40 affected / 101 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Mild) = 0.5 - 2.0 cm
Frequency: 27 affected / 96 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Moderate) = 2.5 - 7.0 cm
Frequency: 24 affected / 97 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Any) = present at site of vaccination
Frequency: 51 affected / 105 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Mild) = 0.5 - 2.0 cm
Frequency: 39 affected / 101 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Moderate) = 2.5 - 7.0 cm
Frequency: 21 affected / 95 at risk

Adverse event: Fever >= 38.0 degree C but <=39.0 degree C
Serious: no
Organ System: General disorders
Frequency: 14 affected / 93 at risk

Adverse event: Fever >39.0 to <=40.0 degree C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 92 at risk

Adverse event: Vomiting (Any)
Serious: no
Organ System: General disorders
Notes: Vomiting (Any) = present
Frequency: 3 affected / 91 at risk

Adverse event: Vomiting (Mild)
Serious: no
Organ System: General disorders
Notes: Vomiting (Mild)= 1-2 times in 24 hours
Frequency: 3 affected / 91 at risk

Adverse event: Diarrhea (Any)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Any) = present
Frequency: 8 affected / 90 at risk

Adverse event: Diarrhea (Mild)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Mild) = 2-3 loose stools in 24 hours
Frequency: 8 affected / 90 at risk

Adverse event: Diarrhea (Moderate)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Moderate) = 4-5 stools in 24 hours
Frequency: 1 affected / 90 at risk

Adverse event: Fatigue (Any)
Serious: no
Organ System: General disorders
Notes: Fatigue (Any) = present
Frequency: 42 affected / 103 at risk

Adverse event: Fatigue (Mild)
Serious: no
Organ System: General disorders
Notes: Fatigue (Mild) = does not interfere with activity
Frequency: 34 affected / 100 at risk

Adverse event: Fatigue (Moderate)
Serious: no
Organ System: General disorders
Notes: Fatigue (Moderate) = some interference with activity
Frequency: 16 affected / 96 at risk

Adverse event: Fatigue (Severe)
Serious: no
Organ System: General disorders
Notes: Fatigue (Severe) = prevents daily routine activity
Frequency: 3 affected / 92 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 130 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 130 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 130 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Any) = present at site of vaccination
Frequency: 29 affected / 52 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Mild) = does not interfere with activity
Frequency: 25 affected / 51 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Moderate) = interferes with activity
Frequency: 12 affected / 47 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Severe) = prevents daily activity
Frequency: 1 affected / 43 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Any) = present at site of vaccination
Frequency: 20 affected / 48 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Mild) = 0.5 - 2.0 cm
Frequency: 17 affected / 48 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Moderate) = 2.5 - 7.0 cm
Frequency: 9 affected / 44 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Severe) = \>7.0 cm
Frequency: 1 affected / 43 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Any) = present at site of vaccination
Frequency: 27 affected / 50 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Mild) = 0.5 - 2.0 cm
Frequency: 20 affected / 49 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Moderate) = 2.5 - 7.0 cm
Frequency: 14 affected / 45 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Severe) = \>7.0 cm
Frequency: 1 affected / 43 at risk

Adverse event: Fever >= 38.0 degree C but <=39.0 degree C
Serious: no
Organ System: General disorders
Frequency: 14 affected / 49 at risk

Adverse event: Fever >39.0 to <=40.0 degree C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vomiting (Any)
Serious: no
Organ System: General disorders
Notes: Vomiting (Any) = present
Frequency: 4 affected / 44 at risk

Adverse event: Vomiting (Mild)
Serious: no
Organ System: General disorders
Notes: Vomiting (Mild)= 1-2 times in 24 hours
Frequency: 4 affected / 44 at risk

Adverse event: Diarrhea (Any)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Any) = present
Frequency: 8 affected / 45 at risk

Adverse event: Diarrhea (Mild)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Mild) = 2-3 loose stools in 24 hours
Frequency: 8 affected / 45 at risk

Adverse event: Fatigue (Any)
Serious: no
Organ System: General disorders
Notes: Fatigue (Any) = present
Frequency: 28 affected / 54 at risk

Adverse event: Fatigue (Mild)
Serious: no
Organ System: General disorders
Notes: Fatigue (Mild) = does not interfere with activity
Frequency: 17 affected / 49 at risk

Adverse event: Fatigue (Moderate)
Serious: no
Organ System: General disorders
Notes: Fatigue (Moderate) = some interference with activity
Frequency: 15 affected / 49 at risk

Adverse event: Fatigue (Severe)
Serious: no
Organ System: General disorders
Notes: Fatigue (Severe) = prevents daily routine activity
Frequency: 1 affected / 43 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Any) = present at site of vaccination
Frequency: 34 affected / 53 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Mild) = does not interfere with activity
Frequency: 29 affected / 51 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Moderate) = interferes with activity
Frequency: 10 affected / 48 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (Severe) = prevents daily activity
Frequency: 1 affected / 45 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Any) = present at site of vaccination
Frequency: 13 affected / 47 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Mild) = 0.5 - 2.0 cm
Frequency: 11 affected / 47 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (Moderate) = 2.5 - 7.0 cm
Frequency: 5 affected / 46 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Any) = present at site of vaccination
Frequency: 23 affected / 50 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Mild) = 0.5 - 2.0 cm
Frequency: 18 affected / 48 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (Moderate) = 2.5 - 7.0 cm
Frequency: 8 affected / 47 at risk

Adverse event: Fever >= 38.0 degree C but <=39.0 degree C
Serious: no
Organ System: General disorders
Frequency: 9 affected / 46 at risk

Adverse event: Fever >39.0 to <=40.0 degree C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Fever >40.0 degree C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting (Any)
Serious: no
Organ System: General disorders
Notes: Vomiting (Any) = present
Frequency: 3 affected / 45 at risk

Adverse event: Vomiting (Mild)
Serious: no
Organ System: General disorders
Notes: Vomiting (Mild)= 1-2 times in 24 hours
Frequency: 3 affected / 45 at risk

Adverse event: Diarrhea (Any)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Any) = present
Frequency: 4 affected / 47 at risk

Adverse event: Diarrhea (Mild)
Serious: no
Organ System: General disorders
Notes: Diarrhea (Mild) = 2-3 loose stools in 24 hours
Frequency: 4 affected / 47 at risk

Adverse event: Fatigue (Any)
Serious: no
Organ System: General disorders
Notes: Fatigue (Any) = present
Frequency: 15 affected / 48 at risk

Adverse event: Fatigue (Mild)
Serious: no
Organ System: General disorders
Notes: Fatigue (Mild) = does not interfere with activity
Frequency: 10 affected / 48 at risk

Adverse event: Fatigue (Moderate)
Serious: no
Organ System: General disorders
Notes: Fatigue (Moderate) = some interference with activity
Frequency: 7 affected / 46 at risk

Adverse event: Fatigue (Severe)
Serious: no
Organ System: General disorders
Notes: Fatigue (Severe) = prevents daily routine activity
Frequency: 1 affected / 45 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk