Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Caesarean section, Exposure during pregnancy, Failed induction of labour, Glucose tolerance test
Clinical narrative: early partial placenta previa; mild hyperemesis; fail induction of labour; caesarian section; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLACENTA PRAEVIA (early partial placenta previa), HYPEREMESIS GRAVIDARUM (mild hyperemesis) and CAESAREAN SECTION (caesarian section) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Subfertility and In vitro fertilization. Concurrent medical conditions included Anxiety since January 2015. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, FAMOTIDINE (PEPCID AC) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Heartburn, PYRIDOXINE HYDROCHLORIDE (VIT B6), DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]), DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS), DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, TRAZODONE for Sleep disorder NOS.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Mar-2021. On 01-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 16-Mar-2021, the patient experienced CAESAREAN SECTION (caesarian section) (seriousness criterion medically significant). On an unknown date, the patient experienced PLACENTA PRAEVIA (early partial placenta previa) (seriousness criterion medically significant), HYPEREMESIS GRAVIDARUM (mild hyperemesis) (seriousness criterion medically significant) and FAILED INDUCTION OF LABOUR (fail induction of labour). The cesarean delivery occurred on 16-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 3260 grams (7lbs 3oz). The outcome was reported as Term Birth w Complications. Tried to induce (at 40 weeks 5 days), baby's heart rate dropped multiple times, leading to a non-emergency Caesarean.  Doctor suspects the baby was putting pressure on the velamentous cord and cutting off blood supply. On 01-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 16-Mar-2021, CAESAREAN SECTION (caesarian section) and FAILED INDUCTION OF LABOUR (fail induction of labour) had resolved. At the time of the report, PLACENTA PRAEVIA (early partial placenta previa) and HYPEREMESIS GRAVIDARUM (mild hyperemesis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amniocentesis: no genetic abnormalites (normal) No genetic abnormalities detected in implanted embryo. On an unknown date, Glucose tolerance test: border high (Borderline) Border high at 1-hour test and normal (normal) Normal at extended test. On an unknown date, Ultrasound scan: no issue with fetal development detected. (normal) Multiple throughout pregnancy, no issue with fetal development detected..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Upgraded case to Serious pregnancy outcome: reporter address, HCP name/phone#, test names, family history, concomitant products, Delivery outcome, On 31-May-2021: Action taken was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.