Study: NCT00573651

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This pregnancy occurred months after the immunization series was completed.
Frequency: 1 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinusitis, cold, cough
Frequency: 10 affected / 43 at risk

Adverse event: Achiness
Serious: no
Organ System: Infections and infestations
Notes: fatigue/flu-like symptoms
Frequency: 3 affected / 43 at risk

Adverse event: nausea or diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomach upset
Frequency: 8 affected / 43 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: stiffness
Frequency: 4 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: dizziness
Frequency: 5 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 43 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: urticaria
Frequency: 1 affected / 43 at risk

Adverse event: Contusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: contusion
Frequency: 2 affected / 43 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: strep throat
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: syncope vaso-vagal
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 43 at risk

Adverse event: flare
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: arthritis flare, enthesitis flare
Frequency: 2 affected / 43 at risk

Adverse event: dry socket following extraction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: complications wisdom tooth extraction
Frequency: 1 affected / 43 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 43 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Shingles
Frequency: 1 affected / 43 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injection șite reaction
Frequency: 1 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: sleep disorder
Frequency: 1 affected / 43 at risk

Adverse event: musculoskeletal pain due to MVA injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: joint pain due to car accident
Frequency: 1 affected / 43 at risk

Adverse event: warts, plantar
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: oral candidiasis
Frequency: 1 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: emesis, stomach flu
Frequency: 2 affected / 43 at risk