Study: NCT01173211

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 48 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 48 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 48 at risk

Adverse event: Congenital cardiovascular anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Congenital cerebral cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Pelvic kidney
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Aqueductal stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 48 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 2 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 48 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as Feverishness
Frequency: 1 affected / 48 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 10 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 48 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited as a reaction at the vaccination site
Frequency: 29 affected / 48 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 48 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited based on impact on daily activities
Frequency: 5 affected / 48 at risk

Adverse event: Injection site swelling (measured reaction)
Serious: no
Organ System: General disorders
Notes: Solicited as a measured value in millimeters
Frequency: 5 affected / 48 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 45 at risk

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 45 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 45 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 45 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 45 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 45 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 45 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: Reported for infant delivered by pregnant participant
Frequency: 2 affected / 45 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 45 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 2 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 45 at risk

Adverse event: Vaccination site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as Feverishness
Frequency: 1 affected / 45 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 10 affected / 45 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 45 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited as a reaction at the vaccination site
Frequency: 37 affected / 45 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited based on impact on daily activities
Frequency: 1 affected / 45 at risk

Adverse event: Injection site swelling (measured reaction)
Serious: no
Organ System: General disorders
Notes: Solicited as a measured value in millimeters
Frequency: 2 affected / 45 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 46 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 46 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 2 affected / 46 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Body temperature fluctuation
Serious: yes
Organ System: Investigations
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Pyelocaliectasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 2 affected / 46 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Reported for infant delivered by pregnant participant
Frequency: 1 affected / 46 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 46 at risk

Adverse event: Vaccination site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as Feverishness
Frequency: 3 affected / 46 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 46 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 46 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited as a reaction at the vaccination site
Frequency: 33 affected / 46 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 15 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as Feverishness
Frequency: 1 affected / 15 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited as a reaction at the vaccination site
Frequency: 8 affected / 15 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited based on impact on daily activities
Frequency: 1 affected / 15 at risk

Adverse event: Injection site swelling (measured reaction)
Serious: no
Organ System: General disorders
Notes: Solicited as a measured value in millimeters
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Vaccination site discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Vaccination site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vaccination site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as Feverishness
Frequency: 1 affected / 16 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 16 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited as a reaction at the vaccination site
Frequency: 11 affected / 16 at risk

Adverse event: Injection site swelling (measured reaction)
Serious: no
Organ System: General disorders
Notes: Solicited as a measured value in millimeters
Frequency: 1 affected / 16 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 13 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited as a reaction at the vaccination site
Frequency: 8 affected / 13 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited based on impact on daily activities
Frequency: 1 affected / 13 at risk

Adverse event: Injection site swelling (measured reaction)
Serious: no
Organ System: General disorders
Notes: Solicited as a measured value in millimeters
Frequency: 1 affected / 13 at risk