Study: NCT01641991

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 82 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as 'muscle aches' on the memory aid
Frequency: 47 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 82 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 71 affected / 82 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 52 affected / 82 at risk

Adverse event: Vaccination site warmth
Serious: no
Organ System: General disorders
Frequency: 54 affected / 82 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 81 affected / 82 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as "arm motion limitations" on the memory aid
Frequency: 44 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 53 affected / 82 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 44 affected / 82 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 82 at risk

Adverse event: Respiratory rate increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 82 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 6 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Notes: Vaccination site erythema that persisted beyond 14 days post vaccination was reported as an unsolicited adverse event.
Frequency: 4 affected / 82 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 63 affected / 82 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 82 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 82 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 82 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as 'muscle aches' on the memory aid
Frequency: 35 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 82 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 72 affected / 82 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 44 affected / 82 at risk

Adverse event: Vaccination site warmth
Serious: no
Organ System: General disorders
Frequency: 49 affected / 82 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 79 affected / 82 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as "arm motion limitations" on the memory aid
Frequency: 39 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 48 affected / 82 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 44 affected / 82 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 82 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 82 at risk

Adverse event: Respiratory rate increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 82 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 10 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Notes: Vaccination site erythema that persisted beyond 14 days post vaccination was reported as an unsolicited adverse event.
Frequency: 6 affected / 82 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 64 affected / 82 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 82 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 82 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as 'muscle aches' on the memory aid
Frequency: 38 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 82 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 72 affected / 82 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 47 affected / 82 at risk

Adverse event: Vaccination site warmth
Serious: no
Organ System: General disorders
Frequency: 50 affected / 82 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 80 affected / 82 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as "arm motion limitations" on the memory aid
Frequency: 48 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 47 affected / 82 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 40 affected / 82 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 82 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 82 at risk

Adverse event: Respiratory rate increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 82 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Notes: Vaccination site erythema that persisted beyond 14 days post vaccination was reported as an unsolicited adverse event.
Frequency: 4 affected / 82 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 66 affected / 82 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 82 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as 'muscle aches' on the memory aid
Frequency: 42 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 82 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 71 affected / 82 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 48 affected / 82 at risk

Adverse event: Vaccination site warmth
Serious: no
Organ System: General disorders
Frequency: 50 affected / 82 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 78 affected / 82 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as "arm motion limitations" on the memory aid
Frequency: 43 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 42 affected / 82 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 40 affected / 82 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 82 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 82 at risk

Adverse event: Respiratory rate increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 82 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 82 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Notes: Vaccination site erythema that persisted beyond 14 days post vaccination was reported as an unsolicited adverse event.
Frequency: 3 affected / 82 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 60 affected / 82 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 82 at risk