Study: NCT00923702

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Notes: Hospitalized for illnesses
Frequency: 14 affected / 4348 at risk

Adverse event: Abortion/Gynecological conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Spontaneous/ elective abortions; Gynecological Conditions
Frequency: 94 affected / 4348 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Premature delivery/Congenital Anomaly
Frequency: 12 affected / 4348 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Neonatal Death
Frequency: 5 affected / 4348 at risk

Adverse event: Mild: Abdominal cramps
Serious: no
Organ System: General disorders
Frequency: 5 affected / 4348 at risk

Adverse event: Mild: Diarrhea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 4348 at risk

Adverse event: Mild: Discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4348 at risk

Adverse event: Mild: Dizziness
Serious: no
Organ System: General disorders
Frequency: 18 affected / 4348 at risk

Adverse event: Mild: Fainting (vaso vagal reaction) within 15 to 20 minutes of vaccine receipt
Serious: no
Organ System: General disorders
Frequency: 4 affected / 4348 at risk

Adverse event: Mild: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4348 at risk

Adverse event: Mild: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 344 affected / 4348 at risk

Adverse event: Mild: Low-grade fever (< 39°C sublingual) measurement)
Serious: no
Organ System: General disorders
Frequency: 88 affected / 4348 at risk

Adverse event: Mild: headaches
Serious: no
Organ System: General disorders
Frequency: 27 affected / 4348 at risk

Adverse event: Mild: injection site swelling
Serious: no
Organ System: General disorders
Frequency: 41 affected / 4348 at risk

Adverse event: Mild: Nausea
Serious: no
Organ System: General disorders
Frequency: 15 affected / 4348 at risk

Adverse event: Mild: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4348 at risk

Adverse event: Mild: Redness, mild tenderness or bruising around the injection site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4348 at risk

Adverse event: Mild: Sensation of heaviness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4348 at risk

Adverse event: Mild: Shoulder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4348 at risk

Adverse event: Mild: Skin irritation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4348 at risk

Adverse event: Mild: Other specify
Serious: no
Organ System: General disorders
Frequency: 52 affected / 4348 at risk

Adverse event: Moderate: Allergic reaction [Characterized by one or more of the following: (1) skin manifestations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4348 at risk

Adverse event: Moderate: Allergic skin reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4348 at risk

Adverse event: Moderate: High fevers sometimes associated with seizures (> 39° C)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4348 at risk

Adverse event: Moderate: Other specify
Serious: no
Organ System: General disorders
Frequency: 21 affected / 4348 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Notes: Hospitalized for illnesses
Frequency: 26 affected / 4979 at risk

Adverse event: Abortion/Gynecological conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Spontaneous/ elective abortions; Gynecological Conditions
Frequency: 92 affected / 4979 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Premature delivery/Congenital Anomaly
Frequency: 11 affected / 4979 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Neonatal Death
Frequency: 6 affected / 4979 at risk

Adverse event: Mild: Abdominal cramps
Serious: no
Organ System: General disorders
Frequency: 5 affected / 4979 at risk

Adverse event: Mild: Diarrhea
Serious: no
Organ System: General disorders
Frequency: 9 affected / 4979 at risk

Adverse event: Mild: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Mild: Dizziness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 4979 at risk

Adverse event: Mild: Fainting (vaso vagal reaction) within 15 to 20 minutes of vaccine receipt
Serious: no
Organ System: General disorders
Frequency: 6 affected / 4979 at risk

Adverse event: Mild: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Mild: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 341 affected / 4979 at risk

Adverse event: Mild: Joint stiffness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Mild: Low-grade fever (< 39°C sublingual) measurement)
Serious: no
Organ System: General disorders
Frequency: 80 affected / 4979 at risk

Adverse event: Mild: headaches
Serious: no
Organ System: General disorders
Frequency: 18 affected / 4979 at risk

Adverse event: Mild: injection site swelling
Serious: no
Organ System: General disorders
Frequency: 26 affected / 4979 at risk

Adverse event: Mild: muscle pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Mild: Nausea
Serious: no
Organ System: General disorders
Frequency: 9 affected / 4979 at risk

Adverse event: Mild: Neck pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4979 at risk

Adverse event: Mild: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 4979 at risk

Adverse event: Mild: Rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4979 at risk

Adverse event: Mild: Redness, mild tenderness or bruising around the injection site
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4979 at risk

Adverse event: Mild: Sensation of heaviness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Mild: Shoulder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Mild: Skin irritation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 4979 at risk

Adverse event: Mild: Other specify
Serious: no
Organ System: General disorders
Frequency: 53 affected / 4979 at risk

Adverse event: Moderate: High fevers sometimes associated with seizures (> 39° C)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 4979 at risk

Adverse event: Moderate: Larger reactions (> 2 cm) around the injection site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4979 at risk

Adverse event: Moderate: Other specify
Serious: no
Organ System: General disorders
Frequency: 17 affected / 4979 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Notes: Hospitalized for illnesses
Frequency: 20 affected / 3452 at risk

Adverse event: Abortion/Gynecological conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Spontaneous/ elective abortions; Gynecological Conditions
Frequency: 214 affected / 3452 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Premature delivery/Congenital Anomaly
Frequency: 28 affected / 3452 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Neonatal Death
Frequency: 30 affected / 3452 at risk

Adverse event: Mild: Abdominal cramps
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3452 at risk

Adverse event: Mild: Diarrhea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3452 at risk

Adverse event: Mild: Discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3452 at risk

Adverse event: Mild: Dizziness
Serious: no
Organ System: General disorders
Frequency: 22 affected / 3452 at risk

Adverse event: Mild: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 352 affected / 3452 at risk

Adverse event: Mild: Joint stiffness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Mild: Low-grade fever (< 39°C sublingual) measurement)
Serious: no
Organ System: General disorders
Frequency: 96 affected / 3452 at risk

Adverse event: Mild: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Mild: headaches
Serious: no
Organ System: General disorders
Frequency: 18 affected / 3452 at risk

Adverse event: Mild: injection site swelling
Serious: no
Organ System: General disorders
Frequency: 58 affected / 3452 at risk

Adverse event: Mild: irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3452 at risk

Adverse event: Mild: muscle pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Mild: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 3452 at risk

Adverse event: Mild: Rash
Serious: no
Organ System: General disorders
Frequency: 8 affected / 3452 at risk

Adverse event: Mild: Skin irritation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3452 at risk

Adverse event: Mild: Other specify
Serious: no
Organ System: General disorders
Frequency: 19 affected / 3452 at risk

Adverse event: Moderate: Allergic skin reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Moderate: Facial edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Moderate: High fevers sometimes associated with seizures (> 39° C)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 3452 at risk

Adverse event: Moderate: Larger reactions (> 2 cm) around the injection site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Moderate: Temporary joint pain or swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3452 at risk

Adverse event: Moderate: Other specify
Serious: no
Organ System: General disorders
Frequency: 7 affected / 3452 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Notes: Hospitalized for illnesses
Frequency: 26 affected / 4950 at risk

Adverse event: Abortion/Gynecological conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Spontaneous/ elective abortions; Gynecological Conditions
Frequency: 239 affected / 4950 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Premature delivery/Congenital Anomaly
Frequency: 40 affected / 4950 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Neonatal Death
Frequency: 51 affected / 4950 at risk

Adverse event: Mild: Abdominal cramps
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4950 at risk

Adverse event: Mild: Diarrhea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4950 at risk

Adverse event: Mild: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4950 at risk

Adverse event: Mild: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 4950 at risk

Adverse event: Mild: Fainting (vaso vagal reaction) within 15 to 20 minutes of vaccine receipt
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4950 at risk

Adverse event: Mild: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 137 affected / 4950 at risk

Adverse event: Mild: Joint stiffness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4950 at risk

Adverse event: Mild: Low-grade fever (< 39°C sublingual) measurement)
Serious: no
Organ System: General disorders
Frequency: 76 affected / 4950 at risk

Adverse event: Mild: headaches
Serious: no
Organ System: General disorders
Frequency: 8 affected / 4950 at risk

Adverse event: Mild: injection site swelling
Serious: no
Organ System: General disorders
Frequency: 22 affected / 4950 at risk

Adverse event: Mild: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4950 at risk

Adverse event: Mild: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4950 at risk

Adverse event: Mild: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 4950 at risk

Adverse event: Mild: Rash
Serious: no
Organ System: General disorders
Frequency: 4 affected / 4950 at risk

Adverse event: Mild: Other specify
Serious: no
Organ System: General disorders
Frequency: 10 affected / 4950 at risk

Adverse event: Moderate: High fevers sometimes associated with seizures (> 39° C)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4950 at risk

Adverse event: Moderate: Other specify
Serious: no
Organ System: General disorders
Frequency: 7 affected / 4950 at risk