Study: NCT00283283

Adverse event: Melanoma exised
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 554 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 554 at risk

Adverse event: Brusing at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 4 affected / 554 at risk

Adverse event: Aching at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Arm sore at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 554 at risk

Adverse event: Fever, chills, flu-like symptoms
Serious: no
Organ System: General disorders
Notes: Grade 4
Frequency: 1 affected / 554 at risk

Adverse event: Injection site soreness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 3 affected / 554 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 554 at risk

Adverse event: Itching, distil to injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Outbreak of HSV on face, also nasal lesions
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 554 at risk

Adverse event: Pain in right antecubital area after venipuncture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Rash on right calf
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 1 affected / 554 at risk

Adverse event: Right shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Tender at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Tingling in fingers of vaccinated arm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 554 at risk

Adverse event: Carotid endarterectomey
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 556 at risk

Adverse event: Brusing at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Body aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 1 affected / 556 at risk

Adverse event: Bruising at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 556 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Grade 4
Frequency: 1 affected / 556 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 556 at risk

Adverse event: Hurt at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 2
Frequency: 1 affected / 556 at risk

Adverse event: Idiopathic urticaria
Serious: no
Organ System: Immune system disorders
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Ichiness at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Injection site soreness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 2 affected / 556 at risk

Adverse event: Itching, distil to injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Nausea and body aches
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 556 at risk

Adverse event: Sore, achy shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 1 affected / 556 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Swollen lymph nodes in neck, sore throat, chills, body aches
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 1 affected / 556 at risk

Adverse event: Very sore at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 556 at risk