Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient (gravida 6, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 12AZIA) for COVID-19 vaccination.     The patient's past medical history included Factor V Leiden carrier on 15-Aug-2020, Pre-eclampsia on 25-Sep-2013, Pregnancy (Live, full-term birth) on 18-Apr-2010, Miscarriage on 16-Sep-2012, Pregnancy (Live, full-term birth) on 25-Sep-2015, Miscarriage on 16-Apr-2020, Hysterosalpingography in September 2020 and Uterine polypectomy in September 2020. Concurrent medical conditions included Polycystic ovarian syndrome in May 2000, Hashimoto's thyroiditis on 20-May-2020, Smoker in September 2019, Alcoholic and Vitamin D deficiency on 15-May-2018. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, PHENYLEPHRINE HYDROCHLORIDE (SINEX [PHENYLEPHRINE HYDROCHLORIDE]) for Sinus infection, ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Thrombus, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, Pregnancy test: positive (Positive) Positive. In December 2020, Ultrasound scan: normal (normal) Normal. In February 2021, Ultrasound scan: normal (normal) Normal. On 02-Apr-2021, Full blood count: inconclusive (Inconclusive) Iron-deficient anemia. On 16-Apr-2021, Glucose tolerance test: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In 2020, patient had genetic testing that resulted in no chromosomal abnormalities. On 19-Feb-2021, the patient had an anatomy scan the resulted in normal findings. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up received on 26-Apr-2021, second dose taken, lab test updated,; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.