Study: NCT01654263

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Acoustic neuroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 164 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 164 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 9 affected / 164 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Fatigue/Malaise (decreased energy)"
Frequency: 30 affected / 164 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 164 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 164 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 164 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New muscle pain (exclusive of the injection site)"
Frequency: 13 affected / 164 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated muscle pain (increase in existing pain, exclusive of the injection site)"
Frequency: 4 affected / 164 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New joint pain (arthralgia)"
Frequency: 7 affected / 164 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated joint pain (increase in existing pain)"
Frequency: 6 affected / 164 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain"
Frequency: 87 affected / 164 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness"
Frequency: 120 affected / 164 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Redness/erythema measurement", reported as experienced if size \>0mm
Frequency: 23 affected / 164 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration"
Frequency: 20 affected / 164 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration measurement", reported as experienced in size \>0mm
Frequency: 21 affected / 164 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 147 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: Squamous cell carcinoma of the vulva
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 147 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 147 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 147 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 9 affected / 147 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Fatigue/Malaise (decreased energy)"
Frequency: 23 affected / 147 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 147 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 147 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 147 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New muscle pain (exclusive of the injection site)"
Frequency: 13 affected / 147 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated muscle pain (increase in existing pain, exclusive of the injection site)"
Frequency: 5 affected / 147 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New joint pain (arthralgia)"
Frequency: 4 affected / 147 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated joint pain (increase in existing pain)"
Frequency: 5 affected / 147 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain"
Frequency: 61 affected / 147 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness"
Frequency: 93 affected / 147 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Redness/erythema measurement", reported as experienced if size \>0mm
Frequency: 17 affected / 147 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration"
Frequency: 19 affected / 147 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration measurement", reported as experienced in size \>0mm
Frequency: 18 affected / 147 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 139 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 3 affected / 139 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 17 affected / 139 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Fatigue/Malaise (decreased energy)"
Frequency: 30 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 139 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 139 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 139 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New muscle pain (exclusive of the injection site)"
Frequency: 15 affected / 139 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated muscle pain (increase in existing pain, exclusive of the injection site)"
Frequency: 5 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New joint pain (arthralgia)"
Frequency: 10 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated joint pain (increase in existing pain)"
Frequency: 6 affected / 139 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain"
Frequency: 86 affected / 139 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness"
Frequency: 88 affected / 139 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Redness/erythema measurement", reported as experienced if size \>0mm
Frequency: 22 affected / 139 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration"
Frequency: 24 affected / 139 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration measurement", reported as experienced in size \>0mm
Frequency: 24 affected / 139 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 145 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 145 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 145 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 145 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 8 affected / 145 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Fatigue/Malaise (decreased energy)"
Frequency: 26 affected / 145 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 145 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 145 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 145 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New muscle pain (exclusive of the injection site)"
Frequency: 11 affected / 145 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated muscle pain (increase in existing pain, exclusive of the injection site)"
Frequency: 6 affected / 145 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New joint pain (arthralgia)"
Frequency: 5 affected / 145 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated joint pain (increase in existing pain)"
Frequency: 9 affected / 145 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain"
Frequency: 67 affected / 145 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness"
Frequency: 92 affected / 145 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Redness/erythema measurement", reported as experienced if size \>0mm
Frequency: 25 affected / 145 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration"
Frequency: 25 affected / 145 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration measurement", reported as experienced in size \>0mm
Frequency: 24 affected / 145 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 140 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 140 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 140 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 140 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 140 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 140 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 7 affected / 140 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 16 affected / 140 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Fatigue/Malaise (decreased energy)"
Frequency: 43 affected / 140 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 140 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 140 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 140 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New muscle pain (exclusive of the injection site)"
Frequency: 18 affected / 140 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated muscle pain (increase in existing pain, exclusive of the injection site)"
Frequency: 17 affected / 140 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New joint pain (arthralgia)"
Frequency: 13 affected / 140 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated joint pain (increase in existing pain)"
Frequency: 16 affected / 140 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain"
Frequency: 94 affected / 140 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness"
Frequency: 109 affected / 140 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Redness/erythema measurement", reported as experienced if size \>0mm
Frequency: 31 affected / 140 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration"
Frequency: 24 affected / 140 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration measurement", reported as experienced in size \>0mm
Frequency: 23 affected / 140 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 149 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 149 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 149 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 149 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 149 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 149 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 6 affected / 149 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 13 affected / 149 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Fatigue/Malaise (decreased energy)"
Frequency: 43 affected / 149 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 149 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 149 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 149 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New muscle pain (exclusive of the injection site)"
Frequency: 18 affected / 149 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated muscle pain (increase in existing pain, exclusive of the injection site)"
Frequency: 4 affected / 149 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "New joint pain (arthralgia)"
Frequency: 3 affected / 149 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Aggravated joint pain (increase in existing pain)"
Frequency: 5 affected / 149 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain"
Frequency: 93 affected / 149 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness"
Frequency: 105 affected / 149 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Redness/erythema measurement", reported as experienced if size \>0mm
Frequency: 22 affected / 149 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration"
Frequency: 21 affected / 149 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Swelling/induration measurement", reported as experienced in size \>0mm
Frequency: 22 affected / 149 at risk