Study: NCT00231413

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Post-traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 81 affected / 86 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 36 affected / 86 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 33 affected / 86 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 11 affected / 86 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 54 affected / 86 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 10 affected / 86 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 36 affected / 86 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 45 affected / 86 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 25 affected / 86 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 6 affected / 86 at risk

Adverse event: Urticaria*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 3 affected / 86 at risk

Adverse event: Diarrhea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 88 at risk

Adverse event: Nausea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 88 at risk

Adverse event: Toothache**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 88 at risk

Adverse event: Injection site pruritus**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 88 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 88 at risk

Adverse event: Cystitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 88 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 9 affected / 88 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 88 at risk

Adverse event: Dizziness**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 88 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 13 affected / 88 at risk

Adverse event: Dysmenorhoea**
Serious: no
Organ System: Reproductive system and breast disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 88 at risk

Adverse event: Pharyngolaryngeal Pain**
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 11 affected / 88 at risk

Adverse event: Rhinitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 88 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 48 affected / 49 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 28 affected / 49 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 22 affected / 49 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 13 affected / 49 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 33 affected / 49 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 4 affected / 49 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 15 affected / 49 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 24 affected / 49 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 18 affected / 49 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 4 affected / 49 at risk

Adverse event: Urticaria*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 2 affected / 49 at risk

Adverse event: Diarrhea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Nausea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Injection site pruritus**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Cystitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 50 at risk

Adverse event: Dizziness**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 8 affected / 50 at risk

Adverse event: Dysmenorhoea**
Serious: no
Organ System: Reproductive system and breast disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Pharyngolaryngeal Pain**
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 49 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 49 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 46 affected / 47 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 15 affected / 47 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 12 affected / 47 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 9 affected / 47 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 30 affected / 47 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 4 affected / 47 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 18 affected / 47 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 23 affected / 47 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 19 affected / 47 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 2 affected / 47 at risk

Adverse event: Urticaria*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 3 affected / 47 at risk

Adverse event: Diarrhea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 49 at risk

Adverse event: Nausea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 49 at risk

Adverse event: Toothache**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 49 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 49 at risk

Adverse event: Cystitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 49 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 5 affected / 49 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 9 affected / 49 at risk

Adverse event: Dizziness**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 49 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 7 affected / 49 at risk

Adverse event: Dysmenorhoea**
Serious: no
Organ System: Reproductive system and breast disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 49 at risk

Adverse event: Pharyngolaryngeal Pain**
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 49 at risk

Adverse event: Rhinitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 49 at risk

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

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

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 45 affected / 46 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 22 affected / 46 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 18 affected / 46 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 11 affected / 46 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 32 affected / 46 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 3 affected / 46 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 20 affected / 46 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 31 affected / 46 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 16 affected / 46 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 2 affected / 46 at risk

Adverse event: Diarrhea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 48 at risk

Adverse event: Nausea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 48 at risk

Adverse event: Injection site pruritus**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Influenza**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 48 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 48 at risk

Adverse event: Dizziness**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 48 at risk

Adverse event: Dysmenorhoea**
Serious: no
Organ System: Reproductive system and breast disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

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

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

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 44 affected / 46 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 24 affected / 46 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 21 affected / 46 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 11 affected / 46 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 25 affected / 46 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 9 affected / 46 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 17 affected / 46 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 22 affected / 46 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 17 affected / 46 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 4 affected / 46 at risk

Adverse event: Diarrhea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 48 at risk

Adverse event: Toothache**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Cystitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 48 at risk

Adverse event: Influenza**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 48 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 48 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 6 affected / 48 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 7 affected / 48 at risk

Adverse event: Dysmenorhoea**
Serious: no
Organ System: Reproductive system and breast disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 48 at risk

Adverse event: Pharyngolaryngeal Pain**
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 48 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 50 affected / 50 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 22 affected / 50 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 27 affected / 50 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 9 affected / 50 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 34 affected / 50 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 4 affected / 50 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 17 affected / 50 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 33 affected / 50 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 19 affected / 50 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Urticaria*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Cystitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 50 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 5 affected / 50 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 7 affected / 50 at risk

Adverse event: Dizziness**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 5 affected / 50 at risk

Adverse event: Dysmenorhoea**
Serious: no
Organ System: Reproductive system and breast disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Pharyngolaryngeal Pain**
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 50 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 47 affected / 48 at risk

Adverse event: Redness*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 25 affected / 48 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 19 affected / 48 at risk

Adverse event: Arthralgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 11 affected / 48 at risk

Adverse event: Fatigue*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 31 affected / 48 at risk

Adverse event: Fever*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 2 affected / 48 at risk

Adverse event: Gastrointestinal*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 18 affected / 48 at risk

Adverse event: Headache (solicited)*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 27 affected / 48 at risk

Adverse event: Myalgia*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 15 affected / 48 at risk

Adverse event: Rash*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 2 affected / 48 at risk

Adverse event: Urticaria*
Serious: no
Organ System: General disorders
Notes: \*Solicited symptom during the 7-day post-vaccination period (across doses)
Frequency: 3 affected / 48 at risk

Adverse event: Nausea**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 1 affected / 50 at risk

Adverse event: Toothache**
Serious: no
Organ System: Gastrointestinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 50 at risk

Adverse event: Injection site reaction**
Serious: no
Organ System: General disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 50 at risk

Adverse event: Influenza**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk

Adverse event: Nasopharyngitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 6 affected / 50 at risk

Adverse event: Upper respiratory tract infection**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 5 affected / 50 at risk

Adverse event: Dizziness**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 2 affected / 50 at risk

Adverse event: Headache (unsolicited)**
Serious: no
Organ System: Nervous system disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 6 affected / 50 at risk

Adverse event: Pharyngolaryngeal Pain**
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 4 affected / 50 at risk

Adverse event: Rhinitis**
Serious: no
Organ System: Infections and infestations
Notes: \*\*Unsolicited symptom during the 30-day post-vaccination period (across doses)
Frequency: 3 affected / 50 at risk