Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1-2 drinks or 1-2 times/month) from 2007 to 15-Dec-2020. Concurrent medical conditions included Asthma (since childhood, not worse.) and Allergy to nuts (Tree nut allergy). Concomitant products included LORATADINE for Allergy, ACYCLOVIR [ACICLOVIR] for Cold sores, TRIAMCINOLONE for Eczema, FISH OIL for Mineral supplementation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 21-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Jun-2020 and the estimated date of delivery was 09-Apr-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The vaginal delivery occurred on 16-Mar-2021, which was reported as Premature. For neonate 1, the birth weight was 2730 grams (6lbs 0oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Pre-Term Birth NOS. Weight of the baby was 2.73 Kg, length was 46cm, and head circumference was 32cm. On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2020, Pregnancy test: postive Positive. On 26-Aug-2020, Ultrasound scan: normal (normal) Normal. On 23-Nov-2020, Ultrasound scan: normal (normal) Normal. On 16-Jan-2021, Glucose tolerance test: normal mg/dl (normal) 3 hour. On 06-Mar-2021, Glucose tolerance test: 145 mg/dl (Inconclusive) 1 hour.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The estimated date of conception was reported as 15-Jul-2020. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.   This case was linked to MOD-2021-105810, MOD-2021-105810 (Parent-Child Link).   See case MOD-2021-105810,MOD-2021-105810 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Follow up received and contains patient's medical history, current conditions, allergies, concomitant medications, lab tests, second dose details and pregnancy outcome with baby's details updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.