Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Pyrexia
Clinical narrative: 102.4 fever during delivery; Received Moderna's COVID-19 vaccination while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna's COVID-19 vaccination while pregnant) and PYREXIA (102.4 fever during delivery) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Hormonal imbalance and Alcohol use (1 drink/month) from 25-Feb-2009 to 04-Aug-2020. Concurrent medical conditions included Polycystic ovarian syndrome (No recent changes) since 2005, Nickel sensitivity (Skin rash from nickel) and Hay fever (Seasonal hay fever). Concomitant products included FOLIC ACID from 04-Aug-2020 to an unknown date, ASCORBIC ACID (VIT C), LINUM USITATISSIMUM SEED OIL (FLAX OIL), PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 7:15 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 07-Aug-2020 and the estimated date of delivery was 28-May-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna's COVID-19 vaccination while pregnant). In May 2021, the patient experienced PYREXIA (102.4 fever during delivery). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. The vaginal delivery occurred on 26-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 2950 grams (6lbs 8oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. A male infant was born at 39 weeks gestation, exact date not provided. Length: 48 cm Head circumference: 32 cm  He had no perinatal complications. No fetal abnormalities on delivery or at 1 month post-partum were identified. The baby was breast feeding. On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna's COVID-19 vaccination while pregnant) had resolved. At the time of the report, PYREXIA (102.4 fever during delivery) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2020, Pregnancy test: positive (Positive) Positive. On 17-Nov-2020, Ultrasound foetal: normal (normal) Normal,  1st Trimester. On 08-Jan-2021, Glucose tolerance test: normal (normal) Normal. On 12-Jan-2021, Ultrasound foetal: normal (normal) Normal, 2nd Trimester. On 04-Mar-2021, Glucose tolerance test: normal (normal) Normal. In May 2021, Body temperature: 102.4 (High) 102.4. In May 2021, Ultrasound scan: normal (normal) Normal.         Concomitant medication included Prenatal Gummy on 14-SEP-2020 for prenatal.    No treatment information was reported.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   This case was linked to MOD-2021-272343 (Parent-Child Link).   See case MOD-2021-272343 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 17-APR-2021 included: Added patient's demographics, Estimated due date changed (from 29-MAY-2021 to 28-MAY-2021), Number of fetus, Number of previous pregnancies, Alcohol use (amount, start date and stop date), Laboratory tests (Ultrasound 1st Trimester and 2nd Trimester, Glucose tolerance), Date of positive pregnancy test, Vaccine information (2nd dose start date, lot number, route, body site), Concomitant medications (start date, frequency, route, indication), New concomitant medication (Prenatal Gummy) added. On 30-Jul-2021: Follow-up received and added details of pregnancy/delivery information and laboratory data.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy