Study: NCT04605159

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Abnormal labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Amniorrhoea
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 3557 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 3557 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 3557 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Blood pressure fluctuation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Bradycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 3557 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 20 affected / 3557 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 3557 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 23 affected / 3557 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Cervix dystocia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 3557 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Cholestasis of pregnancy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3557 at risk

Adverse event: Face presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Failed forceps delivery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 27 affected / 3557 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal damage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 3557 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 125 affected / 3557 at risk

Adverse event: Foetal dystocia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 3557 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 3557 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 3557 at risk

Adverse event: Foetal heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 3557 at risk

Adverse event: Foetal macrosomia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 3557 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Foetal monitoring abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3557 at risk

Adverse event: Genital herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 3557 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 46 affected / 3557 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3557 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 3557 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: High foetal head
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Labour complication
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Large for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3557 at risk

Adverse event: Macrostomia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3557 at risk

Adverse event: Mastitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 3557 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Medically induced preterm birth
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 37 affected / 3557 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Morning sickness
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 3557 at risk

Adverse event: Obstructed labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 3557 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 3557 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pancreatitis relapsing
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pelvic haematoma obstetric
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Perineal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3557 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Placental polyp
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3557 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 46 affected / 3557 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 105 affected / 3557 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 56 affected / 3557 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 3557 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 3557 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 37 affected / 3557 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 66 affected / 3557 at risk

Adverse event: Prolonged pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 3557 at risk

Adverse event: Prolonged rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 3557 at risk

Adverse event: Puerperal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Puerperal pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3557 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Renal disorder in pregnancy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 3557 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Shortened cervix
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Shoulder dystocia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 3557 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Tachycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 3557 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Transverse presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Umbilical cord compression
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 3557 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 3557 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Uterine cervical laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine contractions during pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Uterine hypertonus
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine hypotonus
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3557 at risk

Adverse event: Vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vulvovaginal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3557 at risk

Adverse event: Wound haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 62 affected / 3557 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 3557 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypochromic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Normochromic normocytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Normocytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 3557 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 3557 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 3557 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Congenital hydronephrosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Congenital renal cyst
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Thyroid dysfunction in pregnancy
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Orbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 508 affected / 3557 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 3557 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 3557 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3557 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 357 affected / 3557 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 3557 at risk

Adverse event: Enlarged uvula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3557 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 3557 at risk

Adverse event: Haemorrhoids thrombosed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hyperchlorhydria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 606 affected / 3557 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pelvic floor dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 287 affected / 3557 at risk

Adverse event: Administration site erythema
Serious: no
Organ System: General disorders
Frequency: 133 affected / 3557 at risk

Adverse event: Administration site pain
Serious: no
Organ System: General disorders
Frequency: 1294 affected / 3557 at risk

Adverse event: Administration site swelling
Serious: no
Organ System: General disorders
Frequency: 96 affected / 3557 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 3557 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1094 affected / 3557 at risk

Adverse event: Illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 3557 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 43 affected / 3557 at risk

Adverse event: Scar inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Biliary colic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Cholecystitis chronic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Cholestasis of pregnancy
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 3557 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 3557 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 3557 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Bartholin's abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3557 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 117 affected / 3557 at risk

Adverse event: COVID-19 pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Dermatophytosis of nail
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Endometritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3557 at risk

Adverse event: Eyelid infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 3557 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3557 at risk

Adverse event: Genital herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Genital infection female
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Gonococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Groin abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Hepatitis B
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 3557 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3557 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 3557 at risk

Adverse event: Mastitis postpartum
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3557 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 3557 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3557 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Otosalpingitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Perineal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3557 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 3557 at risk

Adverse event: Puerperal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Puerperal pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3557 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 3557 at risk

Adverse event: Scarlet fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 3557 at risk

Adverse event: Suspected COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 3557 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 3557 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 104 affected / 3557 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 3557 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Vulval abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 3557 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3557 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Wound cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3557 at risk

Adverse event: Wound sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3557 at risk

Adverse event: Abdominal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Anaemia postoperative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3557 at risk

Adverse event: Anal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Animal scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3557 at risk

Adverse event: Bone fissure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 3557 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Incision site dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Incision site rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3557 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3557 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 71 affected / 3557 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Post procedural fever
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Postoperative wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3557 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3557 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3557 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3557 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Ulnar nerve injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Urethral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3557 at risk

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Vulvovaginal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 45 affected / 3557 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3557 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3557 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3557 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 3557 at risk

Adverse event: Drug screen positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal heart rate abnormal
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3557 at risk

Adverse event: Foetal heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal heart rate indeterminate
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3557 at risk

Adverse event: Foetal monitoring
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Foetal monitoring abnormal
Serious: no
Organ System: Investigations
Frequency: 5 affected / 3557 at risk

Adverse event: Foetal non-stress test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Inhibin A increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3557 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 3557 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Underweight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 3557 at risk

Adverse event: Coccydynia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 3557 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pubic pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Anogenital warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3557 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 962 affected / 3557 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Lumbar radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Nerve compression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Abnormal cord insertion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Abnormal labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Afterbirth pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Amniorrhexis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Amniorrhoea
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Arrested labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Breech presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 3557 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Complication of pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Face presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Failed induction of labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: False labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 3557 at risk

Adverse event: Foetal damage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 3557 at risk

Adverse event: Foetal distress syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 3557 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 3557 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 3557 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 35 affected / 3557 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 42 affected / 3557 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 3557 at risk

Adverse event: Hyperemesis gravidarum
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Intrapartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Labour complication
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Labour pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Obstructed labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 3557 at risk

Adverse event: Placenta praevia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Placental calcification
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Placental disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 3557 at risk

Adverse event: Placental polyp
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 3557 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 32 affected / 3557 at risk

Adverse event: Postpartum uterine subinvolution
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 3557 at risk

Adverse event: Precipitate labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 84 affected / 3557 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 3557 at risk

Adverse event: Premature separation of placenta
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Preterm premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 3557 at risk

Adverse event: Prolonged labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 3557 at risk

Adverse event: Prolonged pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Prolonged rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 3557 at risk

Adverse event: Retained placenta or membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 3557 at risk

Adverse event: Retained products of conception
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 3557 at risk

Adverse event: Subchorionic haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Threatened labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Umbilical cord abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Umbilical cord around neck
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 3557 at risk

Adverse event: Umbilical cord compression
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine atony
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 3557 at risk

Adverse event: Uterine hypertonus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine hypotonus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3557 at risk

Adverse event: Uterine inversion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine irritability
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 3557 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 3557 at risk

Adverse event: Brief psychotic disorder, with postpartum onset
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 3557 at risk

Adverse event: Atonic urinary bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Breast engorgement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Cystocele
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Genital haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Lactation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Lactation insufficiency
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Nipple disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Shortened cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Uterine prolapse
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 3557 at risk

Adverse event: Vaginal disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 3557 at risk

Adverse event: Vulval oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 3557 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Nasal ulcer
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 3557 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 3557 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Pemphigoid gestationis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Polymorphic eruption of pregnancy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 3557 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Scar pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3557 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 3557 at risk

Adverse event: Episiotomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3557 at risk

Adverse event: Medically induced preterm birth
Serious: no
Organ System: Surgical and medical procedures
Frequency: 17 affected / 3557 at risk

Adverse event: Essential hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 3557 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 3557 at risk

Adverse event: Inferior vena cava syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Raynaud's phenomenon
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3557 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3557 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1771 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1771 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 1771 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Bladder injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Bradycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1771 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 1771 at risk

Adverse event: Cerebral ventricle dilatation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Cervix dystocia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1771 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Cholestasis of pregnancy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 1771 at risk

Adverse event: Failed trial of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Foetal damage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1771 at risk

Adverse event: Foetal disorder
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 69 affected / 1771 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 1771 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1771 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Foetal macrosomia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Foetal malposition
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Foetal monitoring abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 1771 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Gynaecological examination abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1771 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Malignant peritoneal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1771 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1771 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1771 at risk

Adverse event: Medically induced preterm birth
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 1771 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1771 at risk

Adverse event: Obstructed labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 1771 at risk

Adverse event: Ovarian epithelial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1771 at risk

Adverse event: Papilloma viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Pelvic haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Polyhydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Post lumbar puncture syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 1771 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 51 affected / 1771 at risk

Adverse event: Precipitate labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 1771 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1771 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 1771 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 1771 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 43 affected / 1771 at risk

Adverse event: Prolonged pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 1771 at risk

Adverse event: Prolonged rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Puerperal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Puerperal pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Shortened cervix
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1771 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Tachycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 1771 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Transverse presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Traumatic delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Traumatic haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1771 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Uterine contractions during pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Wound haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 1771 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Bandaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Normocytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Eczema eyelids
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 235 affected / 1771 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1771 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 187 affected / 1771 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 1771 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1771 at risk

Adverse event: Hyperchlorhydria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 307 affected / 1771 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 153 affected / 1771 at risk

Adverse event: Administration site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 1771 at risk

Adverse event: Administration site pain
Serious: no
Organ System: General disorders
Frequency: 231 affected / 1771 at risk

Adverse event: Administration site swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 1771 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 479 affected / 1771 at risk

Adverse event: Illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 1771 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Cholestasis of pregnancy
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1771 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 1771 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1771 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 1771 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Enterococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Escherichia infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 1771 at risk

Adverse event: Mastitis postpartum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 1771 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Puerperal pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 1771 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1771 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Suspected COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1771 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1771 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 1771 at risk

Adverse event: Uterine infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1771 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Viral rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Viral tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Vulvitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 1771 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1771 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1771 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1771 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Incision site haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1771 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1771 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Nasal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 1771 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1771 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1771 at risk

Adverse event: Urethral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1771 at risk

Adverse event: Vulvovaginal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 1771 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1771 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1771 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 1771 at risk

Adverse event: Foetal monitoring abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: HIV test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Kleihauer-Betke test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Serum ferritin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1771 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 1771 at risk

Adverse event: Ligament pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pubic pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 452 affected / 1771 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Breech presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Complication of delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Complication of pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1771 at risk

Adverse event: Failed induction of labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: False labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1771 at risk

Adverse event: Foetal damage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Foetal distress syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1771 at risk

Adverse event: Foetal dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 1771 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 1771 at risk

Adverse event: Foetal malpresentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 1771 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 20 affected / 1771 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Intrapartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Labour pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Large for dates baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Meconium abnormal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1771 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Obstructed labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 1771 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1771 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 1771 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 1771 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 43 affected / 1771 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1771 at risk

Adverse event: Premature separation of placenta
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1771 at risk

Adverse event: Preterm premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1771 at risk

Adverse event: Prolonged labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1771 at risk

Adverse event: Prolonged rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1771 at risk

Adverse event: Retained placenta or membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Small for dates baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Threatened labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1771 at risk

Adverse event: Transverse presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Umbilical cord abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Uterine atony
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1771 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 1771 at risk

Adverse event: Uterine hypotonus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1771 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Postpartum anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Adnexa uteri cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Bartholin's cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Breast engorgement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Breast inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Coital bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Endometrial hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Female genital tract fistula
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Genital blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Genital ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Lactation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Lactation insufficiency
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Threatened uterine rupture
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Uterine scar
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 1771 at risk

Adverse event: Vaginal disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Immature respiratory system
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Nasal turbinate hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1771 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1771 at risk

Adverse event: Hand dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Prurigo of pregnancy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1771 at risk

Adverse event: Scar pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Medically induced preterm birth
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1771 at risk

Adverse event: Blood pressure fluctuation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1771 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 1771 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1771 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1771 at risk

Adverse event: ABO incompatibility
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Acarodermatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Amoebic dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Anaemia macrocytic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anaemia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Anomalous pulmonary venous connection
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Apgar score low
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Aplasia cutis congenita
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 22 affected / 3494 at risk

Adverse event: Atrioventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Bicuspid aortic valve
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Biliary dilatation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Biotinidase deficiency
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Blood type incompatibility
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Brachial plexus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3494 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Brain hypoxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Branchial cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 56 affected / 3494 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Buried penis syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 3494 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Caput succedaneum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3494 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Carnitine deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cataract congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Cephalhaematoma
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3494 at risk

Adverse event: Cerebral cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Chordee
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Chronic respiratory disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital cerebral cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Congenital choroid plexus cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital cystic kidney disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital ectopic bladder
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital great vessel anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital hydronephrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Congenital inguinal hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital knee dislocation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital laryngeal stridor
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital melanosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital musculoskeletal disorder of skull
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital nephrotic syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital pneumonia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Congenital pyelocaliectasis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Congenital skin dimples
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Congenital torticollis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Craniosynostosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Crying
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 16 affected / 3494 at risk

Adverse event: Cyanosis neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cystic fibrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cytogenetic abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Deafness bilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Deafness unilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 3494 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 12 affected / 3494 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Disseminated neonatal herpes simplex
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dysplasia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Ectopic kidney
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Encephalopathy neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Epispadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Erythema toxicum neonatorum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Erythroblastosis foetalis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Escherichia pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Exposure to SARS-CoV-2
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Eye infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Face injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Feeding disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Fibromatosis colli of infancy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Foetal exposure during delivery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Food intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Fracture of clavicle due to birth trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Fractured skull depressed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3494 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Genital labial adhesions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Genitalia external ambiguous
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Glucose-6-phosphate dehydrogenase deficiency
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Haemangioma congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haemorrhagic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hepatitis B surface antigen positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Hepatitis neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Heterotaxia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: High risk infant
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3494 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hydrops foetalis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3494 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 3494 at risk

Adverse event: Hypersplenism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 3494 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Hypothermia neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3494 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hypoxic ischaemic encephalopathy neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3494 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Infant irritability
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Infantile apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Infantile colic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Intestinal malrotation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Intestinal pseudo-obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Intestinal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Iris coloboma
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 89 affected / 3494 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Kernicterus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Kidney duplex
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Large for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3494 at risk

Adverse event: Laryngeal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Left ventricular hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Leishmaniasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 53 affected / 3494 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Male genital examination abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Measles
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 3494 at risk

Adverse event: Melanoderma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Metapneumovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Micrognathia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Micropenis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Monoplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Multiple congenital abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Myotonic dystrophy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neonatal dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Neonatal hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neonatal hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neonatal hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Neonatal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Neonatal respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 3494 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 3494 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neonatal tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Norovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Oesophageal atresia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Omphalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Ophthalmia neonatorum
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Osteochondrodysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Osteogenesis imperfecta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3494 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Pectus excavatum
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Pelvi-ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Penile torsion
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Penoscrotal fusion
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 46 affected / 3494 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pneumonia parainfluenzae viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3494 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Polycythaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Post procedural pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 84 affected / 3494 at risk

Adverse event: Pulmonary artery stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Pulmonary vein stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pulmonary venous hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pyelocaliectasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Renovascular hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Respiratory disorder neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 3494 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Retrognathia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Salmonella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Scaphocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Seizure like phenomena
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 46 affected / 3494 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Shone complex
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3494 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 3494 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Subependymal cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Subgaleal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Syndactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Syringomyelia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Systemic viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Thyroglossal cyst infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tongue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Torticollis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 3494 at risk

Adverse event: Trigger finger
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Umbilical cord around neck
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3494 at risk

Adverse event: Umbilical haemorrhage
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Umbilical sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Underweight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Urachal abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 3494 at risk

Adverse event: Urinary tract infection neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Vascular malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 12 affected / 3494 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Viral rash
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Viral test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Wolff-Parkinson-White syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 3494 at risk

Adverse event: Anaemia neonatal
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Bandaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hypochromic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 3494 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Microcytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Polycythaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Bradycardia neonatal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Albinism
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tethered oral tissue
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 51 affected / 3494 at risk

Adverse event: Anomaly of external ear congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anorectal malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Birth mark
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Carnitine-acylcarnitine translocase deficiency
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital hypothyroidism
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital melanosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital musculoskeletal disorder of skull
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital naevus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Congenital skin dimples
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Congenital syphilis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital thymus absence
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 42 affected / 3494 at risk

Adverse event: Cryptorchism
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Cystic fibrosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Dermoid cyst
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ear malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Fibromatosis colli of infancy
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Glucose-6-phosphate dehydrogenase deficiency
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Haemangioma congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 3494 at risk

Adverse event: Heart disease congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 3494 at risk

Adverse event: Tethered oral tissue
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Laryngomalacia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Naevus flammeus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Patent ductus arteriosus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Phimosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Polydactyly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Preauricular cyst
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Sickle cell anaemia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Sickle cell disease
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Stahl's ear
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Ventricular septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Eustachian tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Excessive cerumen production
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Amblyopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Strabismus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Swelling of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Abdominal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 3494 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Allergic colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anal erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 3494 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 3494 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dyschezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3494 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 3494 at risk

Adverse event: Gastrooesophageal reflux in neonate
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Gingival cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 3494 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Meconium plug syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Oral disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rectal prolapse
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3494 at risk

Adverse event: Tooth demineralisation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tooth development disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 3494 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 3494 at risk

Adverse event: Adverse food reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Fever neonatal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: High-pitched crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Hypertrophy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Macrosomia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 129 affected / 3494 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 27 affected / 3494 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: ABO incompatibility
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Allergy to chemicals
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Allergy to vaccine
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atopy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 3494 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 3494 at risk

Adverse event: Multiple allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rhesus incompatibility
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 3494 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Amoebic dysentery
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 298 affected / 3494 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 3494 at risk

Adverse event: Bullous impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 159 affected / 3494 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 3494 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 3494 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Cellulitis orbital
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 141 affected / 3494 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 3494 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 3494 at risk

Adverse event: Dacryocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Dengue fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Dermatitis infected
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Dysentery
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 120 affected / 3494 at risk

Adverse event: Eczema impetiginous
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Eczema infected
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Enterobiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Enterovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 3494 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Eye infection staphylococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Eye infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 3494 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 104 affected / 3494 at risk

Adverse event: Gastroenteritis adenovirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 3494 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 3494 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3494 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 3494 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 3494 at risk

Adverse event: Klebsiella urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 3494 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 124 affected / 3494 at risk

Adverse event: Lower respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 3494 at risk

Adverse event: Metapneumovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Nail bed infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 590 affected / 3494 at risk

Adverse event: Neonatal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Neonatal pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Norovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Omphalitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Ophthalmia neonatorum
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3494 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 3494 at risk

Adverse event: Oral fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Oral viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 114 affected / 3494 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 98 affected / 3494 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Parainfluenzae virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Parasitic gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Pertussis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 3494 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 3494 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 3494 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia mycoplasmal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pustule
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pyoderma
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 3494 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 3494 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 140 affected / 3494 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 86 affected / 3494 at risk

Adverse event: Rhinovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 3494 at risk

Adverse event: Roseola
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 3494 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Subglottic laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Suspected COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 3494 at risk

Adverse event: Systemic viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3494 at risk

Adverse event: Thyroglossal cyst infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 3494 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 848 affected / 3494 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 3494 at risk

Adverse event: Urogenital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 3494 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 3494 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 3494 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 3494 at risk

Adverse event: Anal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3494 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Chemical burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk