Study: NCT02980276

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bradycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 264 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cleft lip
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 264 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 264 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 264 at risk

Adverse event: Inadequate analgesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cholestasis of pregnancy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 264 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 264 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 264 at risk

Adverse event: Post lumbar puncture syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 264 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 264 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 264 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 264 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Unstable foetal lie
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Uterine contractions during pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Ketonuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 264 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 264 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Scar pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Essential hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 264 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 264 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 264 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 264 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 264 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 264 at risk

Adverse event: Congenital uterine anomaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dermoid cyst
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 264 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 264 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 264 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 264 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 264 at risk

Adverse event: Abdominal adhesions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 264 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 264 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 264 at risk

Adverse event: Abdominal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 264 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 264 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 264 at risk

Adverse event: Duodenogastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Functional gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 264 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 264 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 264 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 264 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 264 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 264 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 2 affected / 264 at risk

Adverse event: Drug intolerance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 264 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Injection site atrophy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Frequency: 2 affected / 264 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 30 affected / 264 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vessel puncture site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 264 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Bacterial disease carrier
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 264 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 264 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 264 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 264 at risk

Adverse event: Perineal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Puerperal pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 264 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 264 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 264 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 264 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 264 at risk

Adverse event: Abdominal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 264 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 264 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Post lumbar puncture syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 264 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Wound decomposition
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 264 at risk

Adverse event: Wound secretion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Amniotic fluid index decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Amniotic fluid volume decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Amniotic fluid volume increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood ketone body
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 264 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Chest X-ray abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Dural tap
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 3 affected / 264 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Ultrasound scan abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Ultrasound uterus abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 18 affected / 264 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Folate deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 264 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 264 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Impaired fasting glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 264 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 264 at risk

Adverse event: Axillary mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 264 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Diastasis recti abdominis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 264 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 264 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Symphysiolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 264 at risk

Adverse event: Haemangioma of liver
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 264 at risk

Adverse event: Intracystic breast papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 264 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 264 at risk

Adverse event: Pyogenic granuloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 264 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 264 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cluster headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 264 at risk

Adverse event: Foetal movement disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 264 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 264 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 264 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 264 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Foetal growth abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 264 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 56 affected / 264 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 264 at risk

Adverse event: Placenta praevia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Placental disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 264 at risk

Adverse event: Placental infarction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 264 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 264 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Premature separation of placenta
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Prolonged rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Retained placenta or membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 264 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Small for dates baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 264 at risk

Adverse event: Umbilical cord abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 264 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 264 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 264 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 264 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 264 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Ketonuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 264 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 264 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 48 affected / 264 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 264 at risk

Adverse event: Bartholin's cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 264 at risk

Adverse event: Breast cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Breast engorgement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 264 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Breast ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cervical cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Ectropion of cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 264 at risk

Adverse event: Lactation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 264 at risk

Adverse event: Nipple exudate bloody
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 264 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 264 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 264 at risk

Adverse event: Vaginal haematoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Vulvovaginal swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 264 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 264 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 264 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 264 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 264 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Polymorphic eruption of pregnancy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 264 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 264 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Scar pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 264 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Skin weeping
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Umbilical haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Antibiotic prophylaxis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 264 at risk

Adverse event: Retained placenta operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 264 at risk

Adverse event: Essential hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 264 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 264 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 264 at risk

Adverse event: Inferior vena cava syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 264 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 264 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 264 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 264 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 262 at risk

Adverse event: Bradycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 262 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 262 at risk

Adverse event: Congenital hydronephrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 262 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 262 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 262 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 262 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 262 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Maternal exposure during pregnancy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Post lumbar puncture syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 262 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 262 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 262 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 262 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 262 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Polyhydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 262 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 262 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Unstable foetal lie
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 262 at risk

Adverse event: Uterine contractions during pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 262 at risk

Adverse event: Uterine irritability
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Rash pruritic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 77 affected / 262 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 262 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 262 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 262 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 262 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 262 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 262 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 262 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 262 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 262 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 262 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 262 at risk

Adverse event: Abdominal adhesions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 262 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 262 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 262 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 262 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 262 at risk

Adverse event: Duodenogastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 262 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Faecaloma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 262 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 262 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 262 at risk

Adverse event: Application site vesicles
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 262 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 262 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 40 affected / 262 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 262 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 262 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 262 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 262 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Endometritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Enterobiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 262 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 262 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Mumps
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 262 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Pelvic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Perineal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 262 at risk

Adverse event: Puerperal pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 262 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 262 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 262 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 262 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 262 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 262 at risk

Adverse event: Abdominal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Dental restoration failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 262 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Repetitive strain injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Vascular access site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 262 at risk

Adverse event: Wound secretion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Amniotic fluid index increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Amniotic fluid volume increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 262 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 262 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 3 affected / 262 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 19 affected / 262 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Folate deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Impaired fasting glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 262 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 262 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 262 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 262 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 262 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 262 at risk

Adverse event: Symphysiolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 262 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 262 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 262 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 262 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 262 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 262 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 262 at risk

Adverse event: Psychogenic seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 262 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 262 at risk

Adverse event: Chronic villitis of unknown etiology
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Foetal growth abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 262 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 65 affected / 262 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 262 at risk

Adverse event: Placenta accreta
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Placenta praevia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Placental disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 262 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 262 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Retained products of conception
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Small for dates baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 262 at risk

Adverse event: Umbilical cord prolapse
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Umbilical cord vascular disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Uterine hyperstimulation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Uterine irritability
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 262 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 262 at risk

Adverse event: Bence Jones proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 262 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 262 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ketonuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 262 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 262 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Urethral perforation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 262 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Breast cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Cervical cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Cystocele
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ectropion of cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 262 at risk

Adverse event: Genital blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Nipple exudate bloody
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Nipple pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 262 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Rectocele
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Uterine malposition
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Uterine tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Vaginal cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 262 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 262 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 262 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 262 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Erythema ab igne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ingrown hair
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 262 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 262 at risk

Adverse event: Scar pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 262 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Antibiotic prophylaxis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Retained placenta operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Tooth restoration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 262 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 262 at risk

Adverse event: Inferior vena cava syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 262 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 262 at risk

Adverse event: Thymus enlargement
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 21 affected / 264 at risk

Adverse event: Aorta hypoplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 264 at risk

Adverse event: Birth mark
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 264 at risk

Adverse event: Chordee
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cleft uvula
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Congenital acrochordon
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Congenital melanocytic naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 264 at risk

Adverse event: Congenital pneumonia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 264 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 264 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 264 at risk

Adverse event: Newborn persistent pulmonary hypertension
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pectus carinatum
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 264 at risk

Adverse event: Syndactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 264 at risk

Adverse event: Trisomy 13
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 264 at risk

Adverse event: Eyelid ptosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 264 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Infantile colic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Infantile vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 264 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 264 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Omphalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Reaction to previous exposure to any vaccine
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 264 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 264 at risk

Adverse event: Poor feeding infant
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 264 at risk

Adverse event: Infantile haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 264 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 264 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 264 at risk

Adverse event: Neonatal disorder
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 264 at risk

Adverse event: Weight decrease neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Irritability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cyanosis neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 264 at risk

Adverse event: Neonatal tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 264 at risk

Adverse event: Antibiotic prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 264 at risk

Adverse event: Hepatitis B immunisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 264 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 264 at risk

Adverse event: Bradycardia neonatal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 264 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 264 at risk

Adverse event: Congenital skin dimples
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 264 at risk

Adverse event: Developmental hip dysplasia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 264 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Laryngomalacia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Phimosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pyloric stenosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Talipes
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 264 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 264 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 264 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 264 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 264 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Anal skin tags
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 264 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Duodenogastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 264 at risk

Adverse event: Faecaloma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 264 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 264 at risk

Adverse event: Infantile vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 264 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 264 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 264 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 264 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 264 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 264 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 264 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 264 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Urosepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 264 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 264 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Skin pressure mark
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 264 at risk

Adverse event: Vaccination complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Blood lactic acid increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 264 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 5 affected / 264 at risk

Adverse event: Klebsiella test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 264 at risk

Adverse event: Dairy intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 264 at risk

Adverse event: Dairy intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypoglycaemia neonatal
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 264 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 264 at risk

Adverse event: Poor feeding infant
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 264 at risk

Adverse event: Bone swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Delayed fontanelle closure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypertonia neonatal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hypotonia neonatal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neck mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Poor sucking reflex
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 264 at risk

Adverse event: Birth trauma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 264 at risk

Adverse event: Cephalhaematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 264 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Hypothermia neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 42 affected / 264 at risk

Adverse event: Neonatal disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Poor weight gain neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Umbilical cord abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Weight decrease neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 264 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 264 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Penile swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Scrotal erythema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Scrotal oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Testicular retraction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 264 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 264 at risk

Adverse event: Cyanosis neonatal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Grunting
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 264 at risk

Adverse event: Neonatal respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 264 at risk

Adverse event: Neonatal tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 264 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 264 at risk

Adverse event: Erythema toxicum neonatorum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 264 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Rash neonatal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 264 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Transient neonatal pustular melanosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Extravasation blood
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 264 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 262 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 35 affected / 262 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 262 at risk

Adverse event: Birth mark
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 262 at risk

Adverse event: Cleft lip
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Congenital acrochordon
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Congenital melanocytic naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 12 affected / 262 at risk

Adverse event: Congenital torticollis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 262 at risk

Adverse event: Epispadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 262 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 262 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 262 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 262 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Eye movement disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 262 at risk

Adverse event: Optic atrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 262 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Duodenogastric reflux
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hepatitis neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Allergy to vaccine
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 262 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Foetal exposure during delivery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 262 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 262 at risk

Adverse event: Poor feeding infant
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Infantile haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 262 at risk

Adverse event: Melanocytic naevus
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 262 at risk

Adverse event: Cephalhaematoma
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 262 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 262 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 262 at risk

Adverse event: Weight decrease neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 262 at risk

Adverse event: Urethral meatus stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Neonatal pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 262 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 262 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Antibiotic prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 262 at risk

Adverse event: Subgaleal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk

Adverse event: Polycythaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Bradycardia neonatal
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 262 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Neonatal tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 262 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 262 at risk

Adverse event: Congenital acrochordon
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 262 at risk

Adverse event: Congenital skin dimples
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 10 affected / 262 at risk

Adverse event: Developmental hip dysplasia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 262 at risk

Adverse event: Talipes
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 8 affected / 262 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 262 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 262 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 262 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 262 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 262 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 262 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Duodenogastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 262 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 262 at risk

Adverse event: Infantile vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 262 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 262 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 262 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 262 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 262 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 262 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 262 at risk

Adverse event: Omphalitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 262 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 262 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 262 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 262 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Skin pressure mark
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 262 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Vaccination complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 262 at risk

Adverse event: Antimicrobial susceptibility test
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Blood gases abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 262 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Urine uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 262 at risk

Adverse event: Dairy intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypoglycaemia neonatal
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 262 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypoproteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Poor feeding infant
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 262 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 262 at risk

Adverse event: Delayed fontanelle closure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Diastasis recti abdominis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hip deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hypertonia neonatal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Infantile haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: Nasal neoplasm benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: Fontanelle bulging
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 262 at risk

Adverse event: Hypokinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Cephalhaematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 262 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 262 at risk

Adverse event: Hypothermia neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 37 affected / 262 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Shoulder dystocia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 262 at risk

Adverse event: Umbilical cord abnormality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 262 at risk

Adverse event: Weight decrease neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 262 at risk

Adverse event: Crystalluria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ureteral disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Genital blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Scrotal oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: Testicular retraction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 262 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 262 at risk

Adverse event: Cyanosis neonatal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 262 at risk

Adverse event: Nasal septum haematoma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Neonatal hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 262 at risk

Adverse event: Neonatal respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Neonatal respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 262 at risk

Adverse event: Neonatal tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 262 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 262 at risk

Adverse event: Erythema toxicum neonatorum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 262 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Rash neonatal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 262 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Extravasation blood
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 262 at risk

Adverse event: Pallor
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk

Adverse event: Subgaleal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk