Study: NCT01688921

Adverse event: Duodenal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The SAE was unrelated to subject's participation in the study.
Frequency: 1 affected / 624 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Notes: The SAE reported was unrelated to subject's participation in the study.
Frequency: 1 affected / 624 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Local symptoms at injection site within 6 days of vaccination with Grade of \>=1
Frequency: 397 affected / 616 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction within 6 days of vaccination and Grade of \>=1
Frequency: 551 affected / 616 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction occurring within 6 days of vaccination and a Grade of \>=1
Frequency: 146 affected / 540 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Local event occurring within 6 days of vaccination and Grade of \>=1
Frequency: 366 affected / 609 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction occurring within 6 days of vaccination with Grade level \>=1
Frequency: 392 affected / 605 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction occurring within 6 days of vaccination with Grade level of \>=1
Frequency: 104 affected / 607 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 222 affected / 610 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 151 affected / 612 at risk

Adverse event: Malaise
Serious: no
Organ System: Immune system disorders
Frequency: 191 affected / 612 at risk

Adverse event: Chills
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 610 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 610 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Notes: The SAE reported was unrelated to the subject's participation in the study.
Frequency: 1 affected / 623 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: The SAE reported was unrelated to the subject's participation in the study.
Frequency: 1 affected / 623 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: The SAE reported was unrelated to the subject's participation in the study.
Frequency: 1 affected / 623 at risk

Adverse event: Arterial injury
Serious: yes
Organ System: Cardiac disorders
Notes: The SAE reported was unrelated to the subject's participation in the study.
Frequency: 1 affected / 623 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Local symptoms at injection site within 6 days of vaccination with Grade of \>=1
Frequency: 299 affected / 606 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction within 6 days of vaccination and Grade of \>=1
Frequency: 471 affected / 606 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction occurring within 6 days of vaccination and a Grade of \>=1
Frequency: 49 affected / 527 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Local event occurring within 6 days of vaccination and Grade of \>=1
Frequency: 115 affected / 599 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction occurring within 6 days of vaccination with Grade level \>=1
Frequency: 118 affected / 599 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Notes: Local Adverse Reaction occurring within 6 days of vaccination with Grade level of \>=1
Frequency: 30 affected / 599 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 214 affected / 602 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 133 affected / 603 at risk

Adverse event: Malaise
Serious: no
Organ System: Immune system disorders
Frequency: 171 affected / 602 at risk

Adverse event: Chills
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 601 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 601 at risk