Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal monitoring normal, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy, Ultrasound scan normal
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination.     The patient's past medical history included Alcohol abuse (Rarely.), Acne (Improved.) on 01-Jan-2002, UTI and Miscarriage (Patient had IVF 3 times in the past resulting in 3 miscarriages (Feb 2014, Nov 2014 and Jan 2020)). Concurrent medical conditions included Lupus erythematosus (No change.) since 01-Nov-2008, Asthma (Exercise induced asthma.) and Polycystic ovarian syndrome (no changes) since 01-Jan-2011. Concomitant products included CEFALEXIN (KEFLEX [CEFALEXIN]) from 01-Jun-2020 to 21-Mar-2021 for Acne, ACETYLSALICYLIC ACID (ASPIRIN 81) for Lupus erythematosus, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from 01-Nov-2008 to an unknown date for Lupus syndrome, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2020 to an unknown date and MECLOZINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE (PNV) from 01-Jan-2020 to an unknown date for Pregnancy, NITROFURANTOIN (MACROBID [NITROFURANTOIN]) from 01-Dec-2020 to 14-Dec-2020 for UTI, VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Apr-2020 and the estimated date of delivery was 27-Jan-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The cesarean delivery occurred on 27-Jan-2021, which was reported as Full-term. For neonate 1, the birth weight was 1465 grams (3lbs 4oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Baby was delivered at 39.5 weeks of pregnancy. On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2020, Ultrasound scan normal: normal (normal) Normal. On 23-Jan-2020, Glucose tolerance test: normal (normal) Normal. On 20-Feb-2020, Foetal monitoring normal: normal (normal) Normal. On 29-May-2020, Pregnancy: yes (Positive) pregnancy - positive. On 05-Jun-2020, Ultrasound scan normal: normal (normal) Normal. On 12-Jun-2020, Ultrasound scan normal: normal (normal) Normal. On 24-Sep-2020, Ultrasound scan normal: normal (normal) Normal. On 29-Oct-2020, Ultrasound scan normal: normal (normal) Normal. On 12-Nov-2020, Glucose tolerance test: abnormal (abnormal) Borderline-abnormal.. On 19-Nov-2020, Ultrasound scan normal: normal (normal) Normal. On 23-Nov-2020, Glucose tolerance test: normal (normal) Normal. On 04-Dec-2020, Ultrasound scan normal: normal (normal) Normal. On 10-Dec-2020, Ultrasound scan normal: normal (normal) Normal. On 13-Dec-2020, Foetal monitoring normal: normal. On 17-Dec-2020, Ultrasound scan normal: normal (normal) Normal. On 23-Dec-2020, Ultrasound scan normal: normal (normal) Normal. On 27-Dec-2020, Foetal monitoring normal: normal. On 30-Dec-2020, Ultrasound scan normal: normal (normal) Normal. On 04-Jan-2021, Foetal monitoring normal: normal (normal) Normal and normal (normal) Normal. On 07-Jan-2021, Ultrasound scan normal: normal (normal) Normal. On 14-Jan-2021, Ultrasound scan normal: normal (normal) Normal. On 17-Jan-2021, Foetal monitoring normal: normal (normal) Normal. On 21-Jan-2021, Ultrasound scan normal: normal (normal) Normal. On 24-Jan-2021, Foetal monitoring normal: normal (normal) Normal.         Treatment information not provided. Pregnancy related complications included UTI (urinary tract infection) twice and GBS (Group B streptococcus bacterial infection).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2021: Internal review on 20 Jul 2021 resulted in the update of pregnancy details (birth type, fetal outcome). On 20-Apr-2021: Updated LMP, due date of delivery, delivery date, no. of fetus, no. of pregnancies, no. of live births, medical history, pregnancy related complications, prior miscarriages and start date and stop date of concomitant medications.