Study: NCT01181323

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 124 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as 'feverishness' on the memory aid
Frequency: 7 affected / 124 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited at 'fatigue/malaise' on the memory aid
Frequency: 45 affected / 124 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as 'generalized body aches/myalgia' on the memory aid
Frequency: 14 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 56 affected / 124 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'runny nose' on the memory aid
Frequency: 51 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 124 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'sore throat' on the memory aid
Frequency: 39 affected / 124 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 124 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited specifically for at the injection site on the memory aid.
Frequency: 17 affected / 124 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 124 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 124 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited as 'feverishness' on the memory aid
Frequency: 6 affected / 124 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited at 'fatigue/malaise' on the memory aid
Frequency: 38 affected / 124 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited as 'generalized body aches/myalgia' on the memory aid
Frequency: 23 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 124 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 124 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'runny nose' on the memory aid
Frequency: 38 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 124 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'sore throat' on the memory aid
Frequency: 32 affected / 124 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 124 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited specifically for at the injection site on the memory aid.
Frequency: 100 affected / 124 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 124 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 124 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 124 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'runny nose' on the memory aid
Frequency: 18 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 124 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 124 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 124 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited as 'drowsiness' on the memory aid.
Frequency: 42 affected / 124 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited as 'irritability/fussiness' on the memory aid
Frequency: 74 affected / 124 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited as 'loss of appetite' on the memory aid
Frequency: 20 affected / 124 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'difficulty breathing' on the memory aid
Frequency: 12 affected / 124 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 125 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'runny nose' on the memory aid
Frequency: 30 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 125 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 125 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 125 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 125 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited as 'drowsiness' on the memory aid.
Frequency: 33 affected / 125 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited as 'irritability/fussiness' on the memory aid
Frequency: 56 affected / 125 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited as 'loss of appetite' on the memory aid
Frequency: 14 affected / 125 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Solicited as 'difficulty breathing' on the memory aid
Frequency: 7 affected / 125 at risk