Study: NCT00510874

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 25 affected / 78 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 78 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 15 affected / 78 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 78 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 78 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 5 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 6 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 3 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 3 affected / 78 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 5 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 3 affected / 78 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 152 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 133 affected / 152 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 152 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 152 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 64 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 71 affected / 152 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 49 affected / 152 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 74 affected / 152 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 152 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 23 affected / 152 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 152 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 10 affected / 152 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 5 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 152 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 152 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 152 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 11 affected / 152 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 5 affected / 152 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 5 affected / 152 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 130 affected / 151 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 50 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 61 affected / 151 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 151 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 64 affected / 151 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 151 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 12 affected / 151 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 6 affected / 151 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 4 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 151 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 2 affected / 151 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 14 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 3 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 6 affected / 151 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 151 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 2 affected / 151 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 139 affected / 151 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 151 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 67 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 66 affected / 151 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 151 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 86 affected / 151 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 27 affected / 151 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 24 affected / 151 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 7 affected / 151 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 10 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 13 affected / 151 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 5 affected / 151 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 9 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 13 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 7 affected / 151 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 10 affected / 151 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 7 affected / 151 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 148 at risk

Adverse event: Gastroenteritis clostridial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 148 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 148 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Rectal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 124 affected / 148 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 148 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 148 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 69 affected / 148 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 61 affected / 148 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 39 affected / 148 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 63 affected / 148 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 17 affected / 148 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 21 affected / 148 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 148 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 5 affected / 148 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 7 affected / 148 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 12 affected / 148 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 7 affected / 148 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 148 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 12 affected / 148 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 5 affected / 148 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 7 affected / 148 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 8 affected / 148 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 48 affected / 50 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 19 affected / 50 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 2 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 2 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 1 affected / 50 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 2 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 2 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 3 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 1 affected / 50 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 3 affected / 50 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 42 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 21 affected / 50 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 3 affected / 50 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-20 following vaccination.
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 2 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 4 affected / 50 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed within Days 0-84 following vaccination.
Frequency: 1 affected / 50 at risk