Study: NCT00943631

Adverse event: Lipoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 202 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 202 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 202 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 202 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Thoracotomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 202 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 202 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 21 affected / 202 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 54 affected / 202 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 202 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 202 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 202 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 86 affected / 202 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 57 affected / 202 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 31 affected / 202 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 36 affected / 202 at risk

Adverse event: Umbilical hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 204 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 204 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 204 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 204 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 204 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 14 affected / 204 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 48 affected / 204 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 204 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 204 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 48 affected / 204 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 94 affected / 204 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 42 affected / 204 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 29 affected / 204 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 35 affected / 204 at risk