Study: NCT04032093

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 115 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Oophoritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 115 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 115 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 115 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 115 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Diarrhoea (DIARRHOEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 115 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 115 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 115 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Frequency: 55 affected / 115 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 115 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Frequency: 33 affected / 115 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 115 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 115 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 115 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 115 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 5 affected / 115 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 115 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 115 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 115 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 115 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 115 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 115 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 115 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 115 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 115 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 115 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 115 at risk

Adverse event: Anaemia of pregnancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 117 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Influenza virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Osteitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 117 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 117 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Prolonged rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 117 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 117 at risk

Adverse event: Diarrhoea (DIARRHOEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 117 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 117 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 117 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Frequency: 55 affected / 117 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 117 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Frequency: 81 affected / 117 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 117 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 117 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 117 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 117 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 117 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 117 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 5 affected / 117 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 117 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 117 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 117 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 117 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 117 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 117 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 117 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 116 at risk

Adverse event: Puerperal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Foetal heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Foetal heart rate indeterminate
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 116 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 116 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 116 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 116 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 116 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 116 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 116 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 116 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 116 at risk

Adverse event: Diarrhoea (DIARRHOEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 116 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 116 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 116 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 116 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Frequency: 53 affected / 116 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 116 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Frequency: 40 affected / 116 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 116 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 116 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Vulvovaginal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 116 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 116 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 116 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 116 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 116 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 116 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 116 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 116 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 116 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 116 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 116 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Baseline foetal heart rate variability disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Tachycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 114 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Anorectal cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 114 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 114 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 114 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 114 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 114 at risk

Adverse event: Diarrhoea (DIARRHOEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 114 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 114 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 114 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Frequency: 58 affected / 114 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 114 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Frequency: 69 affected / 114 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 114 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 114 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 114 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 114 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 114 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 114 at risk

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 114 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 5 affected / 114 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 114 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 114 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 114 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 114 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 114 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 114 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 114 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 114 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 114 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 114 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 114 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 114 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 114 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Uterine rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 117 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Umbilical cord abnormality
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Uterine tachysystole
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 117 at risk

Adverse event: Diarrhoea (DIARRHOEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 117 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 117 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 117 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Frequency: 55 affected / 117 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 117 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 117 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 117 at risk

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 117 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 4 affected / 117 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 117 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 117 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 117 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 117 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 117 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 117 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 114 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 114 at risk

Adverse event: Birth mark
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Chordee
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Chromosomal deletion
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cleft lip
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 8 affected / 114 at risk

Adverse event: Congenital umbilical hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 114 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 114 at risk

Adverse event: Cystic fibrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Double ureter
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Gastrointestinal disorder congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 114 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 114 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 114 at risk

Adverse event: Supernumerary nipple
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 114 at risk

Adverse event: Tongue cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 114 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Postoperative adhesion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 114 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 114 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 114 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 114 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 114 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 114 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 114 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 114 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 114 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 114 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 114 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 114 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 114 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 114 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 114 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 114 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 114 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 114 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 114 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 114 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Alpers disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 117 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 8 affected / 117 at risk

Adverse event: Congenital umbilical hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 117 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Spina bifida cystica
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 117 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 117 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Infusion site extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 117 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 117 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Acoustic stimulation tests abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Cardiac murmur functional
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Right ventricular systolic pressure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 117 at risk

Adverse event: Haemangioma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 117 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Cafe au lait spots
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Neonatal hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 117 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 117 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 117 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 117 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 117 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 117 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 117 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 117 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 117 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 117 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 117 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 117 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 117 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 117 at risk

Adverse event: Acquired plagiocephaly
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 117 at risk

Adverse event: Umbilical granuloma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 117 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 117 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 117 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 117 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 117 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 117 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 117 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 113 at risk

Adverse event: Chordee
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 113 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 113 at risk

Adverse event: Congenital skin dimples
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 113 at risk

Adverse event: Congenital umbilical hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 113 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 113 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 113 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 113 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 113 at risk

Adverse event: Penoscrotal fusion
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 113 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 113 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 113 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 113 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 113 at risk

Adverse event: Peripheral nerve palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 113 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 113 at risk

Adverse event: Macule
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 113 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 113 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 113 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 113 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 113 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 113 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 113 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 113 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 113 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 113 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 113 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 113 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 113 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 113 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 113 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 113 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 113 at risk

Adverse event: Low birth weight baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 113 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 113 at risk

Adverse event: Umbilical granuloma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 113 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 113 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 113 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 113 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 113 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 113 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 113 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 113 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 113 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 113 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 113 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 113 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 113 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 112 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 9 affected / 112 at risk

Adverse event: Congenital umbilical hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 112 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 112 at risk

Adverse event: Haemoglobin D trait
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 112 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 112 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 112 at risk

Adverse event: Penile torsion
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 112 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 112 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 112 at risk

Adverse event: Vascular malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 112 at risk

Adverse event: Gingival cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 112 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Acrochordon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 112 at risk

Adverse event: Melanocytic naevus
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 112 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 112 at risk

Adverse event: Testicular retraction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 112 at risk

Adverse event: Neonatal respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 112 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 112 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 112 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 112 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 112 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 112 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 112 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 112 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 112 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 112 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Acquired plagiocephaly
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 112 at risk

Adverse event: Low birth weight baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 112 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 112 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 112 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 112 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 112 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 116 at risk

Adverse event: Aplasia cutis congenita
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Birth mark
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Congenital coronary artery malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 116 at risk

Adverse event: Congenital skin dimples
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Congenital tracheomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Congenital umbilical hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 116 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Cystic fibrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 116 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Penoscrotal fusion
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 116 at risk

Adverse event: XYY syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 116 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 116 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory syncytial virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Acrochordon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 116 at risk

Adverse event: Haemangioma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 116 at risk

Adverse event: Brain hypoxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Clonic convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Encephalopathy neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 116 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Subgaleal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 116 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Neonatal pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Neonatal respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 116 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 116 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 116 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 116 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 116 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 116 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 116 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 116 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 116 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 116 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 116 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 116 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 116 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 116 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 116 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 116 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 116 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 116 at risk

Adverse event: Acquired plagiocephaly
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 116 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 116 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 116 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 116 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 116 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 116 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 116 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 116 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk