Study: NCT01897402

Adverse event: Tenderness around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 134 affected / 265 at risk

Adverse event: Pain around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 109 affected / 265 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic from Dairy Cards
Frequency: 53 affected / 265 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systemic from Dairy Cards
Frequency: 46 affected / 265 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systemic from Dairy Cards
Frequency: 43 affected / 265 at risk

Adverse event: Hardness around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 37 affected / 265 at risk

Adverse event: Swelling around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 35 affected / 265 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Systemic from Dairy Cards
Frequency: 24 affected / 265 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic from Dairy Cards
Frequency: 22 affected / 265 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic from Dairy Cards
Frequency: 21 affected / 265 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic from Dairy Cards
Frequency: 25 affected / 265 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Systemic from Dairy Cards
Frequency: 19 affected / 265 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic from Dairy Cards
Frequency: 18 affected / 265 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 16 affected / 265 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Not associated with the vaccine. All 3 Serious Adverse Events affected the same subject.
Frequency: 1 affected / 260 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: Not associated with the vaccine. All 3 Serious Adverse Events affected the same subject.
Frequency: 1 affected / 260 at risk

Adverse event: Glomerular filtration rate decreased
Serious: yes
Organ System: Investigations
Notes: Not associated with the vaccine. All 3 Serious Adverse Events affected the same subject.
Frequency: 1 affected / 260 at risk

Adverse event: Tenderness around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 100 affected / 260 at risk

Adverse event: Pain around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 86 affected / 260 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic from Dairy Cards
Frequency: 49 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systemic from Dairy Cards
Frequency: 40 affected / 260 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systemic from Dairy Cards
Frequency: 42 affected / 260 at risk

Adverse event: Hardness around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 26 affected / 260 at risk

Adverse event: Swelling around injection site
Serious: no
Organ System: General disorders
Notes: Local from Dairy Cards
Frequency: 23 affected / 260 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Systemic from Dairy Cards
Frequency: 26 affected / 260 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic from Dairy Cards
Frequency: 20 affected / 260 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic from Dairy Cards
Frequency: 21 affected / 260 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic from Dairy Cards
Frequency: 15 affected / 260 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Systemic from Dairy Cards
Frequency: 14 affected / 260 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic from Dairy Cards
Frequency: 12 affected / 260 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 12 affected / 260 at risk