Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
NCT ID:
NCT04754594
Description:
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
Frequency Threshold:
1
Time Frame:
Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Study:
NCT04754594
Study Brief:
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Maternal Participants: BNT162b2 30 mcg (Blinded Phase) | Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery. HIV positive maternal participants were excluded. | 0 | None | 21 | 161 | 143 | 161 | View |
| Maternal Participants: Placebo (Blinded Phase) | Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. HIV positive maternal participants were excluded. | 0 | None | 23 | 163 | 119 | 163 | View |
| Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase) | Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination. HIV positive maternal participants were excluded. | 0 | None | 0 | 144 | 21 | 144 | View |
| Infant Participants: BNT162b2 30 mcg | Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded. | 0 | None | 21 | 156 | 29 | 156 | View |
| Infant Participants: Placebo | Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded. | 1 | None | 24 | 159 | 33 | 159 | View |
| HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase) | Maternal participants who were HIV positive received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery. | 0 | None | 2 | 12 | 12 | 12 | View |
| HIV Positive Maternal Participants: Placebo (Blinded Phase) | Maternal participants who were HIV positive received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. | 0 | None | 4 | 10 | 10 | 10 | View |
| HIV Positive Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase) | HIV positive maternal participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination. | 0 | None | 0 | 8 | 1 | 8 | View |
| HIV Positive Infant Participants: BNT162b2 30 mcg | Infant participants who were born to HIV positive maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age. | 1 | None | 1 | 11 | 1 | 11 | View |
| HIV Positive Infant Participants: Placebo | Infant participants who were born to HIV positive maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age. | 0 | None | 2 | 9 | 3 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Traumatic intracranial hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Low birth weight baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Mucopolysaccharidosis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Hypoxic-ischemic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Bradycardia fetal | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Non reassuring fetal heart rate pattern | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Abdominal wall haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Allergic colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Meconium plug syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Pneumoperitoneum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Hyperbilirubinaemia neonatal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Endometritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Neonatal pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia respiratory syncytial viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Sepsis neonatal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Injury to brachial plexus due to birth trauma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Urinary tract procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Fetal heart rate abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Ultrasound fetal abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Arrested labor | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Breech presentation | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Cephalo-pelvic disproportion | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Failed induction of labor | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Fetal distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Fetal growth restriction | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Fetal hypokinesia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Gestational hypertension | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Hemorrhage in pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Meconium in amniotic fluid | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Meconium stain | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Omphalorrhexis | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Placental insufficiency | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Postpartum hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Pre-eclampsia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Premature separation of placenta | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Preterm premature rupture of membranes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Prolonged rupture of membranes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Retained placenta or membranes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Caput succedaneum | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Jaundice neonatal | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Premature baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Small for dates baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Weight decrease neonatal | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Uterine disorder | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Hypoperfusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Subgaleal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Ankyloglossia congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Atrial septal defect | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Congenital rubella syndrome | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Congenital skin dimples | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| DiGeorge's syndrome | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Microcephaly | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Patent ductus arteriosus | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Polydactyly | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Syndactyly | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Trisomy 21 | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Ventricular septal defect | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Hypoglycemia neonatal | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Coma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Encephalopathy neonatal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Nervous system disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Renal tubular necrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Vesicoureteric reflux | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Meconium aspiration syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Neonatal pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Neonatal respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Neonatal respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Neonatal respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Failed trial of labor | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Fetal death | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Superior sagittal sinus thrombosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chills (CHILLS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Caput succedaneum | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Myalgia (NEW OR WORSENED MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Headache (HEADACHE) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Abnormal labor | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Fetal hypokinesia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Gestational diabetes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Gestational hypertension | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Oligohydramnios | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Pre-eclampsia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Premature delivery | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Uterine contractions during pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Vaginal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.1 | View |
| Episiotomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v25.1 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Ankyloglossia congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Congenital naevus | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Hydrocele | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Hypothermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Hyperbilirubinemia neonatal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Apgar score low | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Hypoglycemia neonatal | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypotonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Jaundice neonatal | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Large for dates baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Low birth weight baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Small for dates baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Umbilical cord around neck | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Body tinea | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Leukocyturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Vaginal discharge | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.1 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Polydactyly | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Exposure to communicable disease | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Diarrhea (DIARRHEA) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Hemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Vomiting (VOMITING) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Fatigue (FATIGUE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Injection site pain (PAIN AT INJECTION SITE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia (FEVER) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Swelling (SWELLING) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Amniotic cavity infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Streptococcus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Arthralgia (NEW OR WORSENED JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |