Study: NCT01059617

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 19 affected / 33 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 3 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 9 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 7 affected / 33 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 4 affected / 33 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 8 affected / 33 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 3 affected / 33 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 5 affected / 33 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 14 affected / 34 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 1 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 13 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 11 affected / 34 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 2 affected / 34 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 12 affected / 34 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 2 affected / 34 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 4 affected / 34 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 24 affected / 33 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 2 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 12 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 9 affected / 33 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 9 affected / 33 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 12 affected / 33 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 5 affected / 33 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 4 affected / 33 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 10 affected / 33 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 1 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 8 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 8 affected / 33 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 3 affected / 33 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Frequency: 5 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 35 affected / 67 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 18 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 19 affected / 67 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 13 affected / 67 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 20 affected / 67 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 8 affected / 67 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 9 affected / 67 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 4 affected / 67 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 5 affected / 66 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 7 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 4 affected / 66 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 2 affected / 66 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 3 affected / 66 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 1 affected / 66 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 7-day (Days 0-6) after the administration of the Flulaval or Placebo dose.
Frequency: 1 affected / 66 at risk