Study: NCT00943488

Adverse event: Cellullitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 204 at risk

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

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 204 at risk

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

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

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

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 204 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 204 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 204 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 9 affected / 204 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 204 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 27 affected / 204 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 53 affected / 204 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 204 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 204 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 49 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: 89 affected / 204 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 40 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: 30 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

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 204 at risk

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

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 204 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal 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: Cutaneous T-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 204 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 204 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 17 affected / 204 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 204 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 39 affected / 204 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 69 affected / 204 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 204 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 204 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 73 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: 119 affected / 204 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 41 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: 34 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: 41 affected / 204 at risk