Study: NCT01827371

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 116 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 116 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 116 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the subject memory aid as "Joint pain"
Frequency: 18 affected / 116 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the subject memory aid as 'Change in appetite'
Frequency: 19 affected / 116 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 116 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feeling tired"
Frequency: 56 affected / 116 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Muscle aches"
Frequency: 42 affected / 116 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 116 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Edema/swelling measurement", reported as experienced if size \>0mm
Frequency: 74 affected / 116 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema/redness measurement", reported as experienced if size \>0mm
Frequency: 82 affected / 116 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at injection site"
Frequency: 67 affected / 116 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited by memory aid as "Pain at injection site"
Frequency: 108 affected / 116 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm pain"
Frequency: 17 affected / 116 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm swelling"
Frequency: 11 affected / 116 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 96 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 96 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 96 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the subject memory aid as "Joint pain"
Frequency: 20 affected / 96 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the subject memory aid as 'Change in appetite'
Frequency: 16 affected / 96 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 16 affected / 96 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feeling tired"
Frequency: 59 affected / 96 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Muscle aches"
Frequency: 49 affected / 96 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 96 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Edema/swelling measurement", reported as experienced if size \>0mm
Frequency: 67 affected / 96 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema/redness measurement", reported as experienced if size \>0mm
Frequency: 66 affected / 96 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at injection site"
Frequency: 44 affected / 96 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited by memory aid as "Pain at injection site"
Frequency: 84 affected / 96 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm pain"
Frequency: 21 affected / 96 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm swelling"
Frequency: 14 affected / 96 at risk

Adverse event: Type I hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 103 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the subject memory aid as "Joint pain"
Frequency: 17 affected / 103 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the subject memory aid as 'Change in appetite'
Frequency: 14 affected / 103 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 103 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feeling tired"
Frequency: 49 affected / 103 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Muscle aches"
Frequency: 46 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 103 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Edema/swelling measurement", reported as experienced if size \>0mm
Frequency: 74 affected / 103 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema/redness measurement", reported as experienced if size \>0mm
Frequency: 81 affected / 103 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at injection site"
Frequency: 52 affected / 103 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited by memory aid as "Pain at injection site"
Frequency: 96 affected / 103 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm pain"
Frequency: 18 affected / 103 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm swelling"
Frequency: 16 affected / 103 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 120 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 120 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 9 affected / 120 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the subject memory aid as "Joint pain"
Frequency: 21 affected / 120 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the subject memory aid as 'Change in appetite'
Frequency: 19 affected / 120 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 120 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feeling tired"
Frequency: 61 affected / 120 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Muscle aches"
Frequency: 49 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 120 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Edema/swelling measurement", reported as experienced if size \>0mm
Frequency: 112 affected / 120 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema/redness measurement", reported as experienced if size \>0mm
Frequency: 114 affected / 120 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at injection site"
Frequency: 86 affected / 120 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited by memory aid as "Pain at injection site"
Frequency: 115 affected / 120 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm pain"
Frequency: 28 affected / 120 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Underarm swelling"
Frequency: 19 affected / 120 at risk