Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure before pregnancy, Pregnancy test, Ultrasound abdomen
Clinical narrative: First Dose 21 Jan 2021 and 2nd Dose 05 March 2021; The patient was 2 weeks pregnant at the time; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (The patient was 2 weeks pregnant at the time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 21 Jan 2021 and 2nd Dose 05 March 2021) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2 drinks most days.) on 30-Mar-2021, Ectopic pregnancy on 23-Dec-2020 and Spontaneous abortion on 23-Dec-2020. Concurrent medical conditions included Attention deficit hyperactivity disorder. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD.   On 21-Jan-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 1:45 AM, 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 22-Feb-2021 and the estimated date of delivery was 29-Nov-2021. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (The patient was 2 weeks pregnant at the time). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 21 Jan 2021 and 2nd Dose 05 March 2021). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Ectopic pregnancy. On 05-Mar-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (The patient was 2 weeks pregnant at the time) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 21 Jan 2021 and 2nd Dose 05 March 2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Pregnancy test: positive (Positive) Positive for pregnancy test.. On 12-Jul-2021, Ultrasound abdomen: abnormal (abnormal) The baby had Cleft lip. On 26-Jul-2021, Ultrasound abdomen: abnormal (abnormal) The baby had Cleft  palate..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  The lab test includes amniocentesis on 26-Jul-2021.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  This is a case of product exposure before  pregnancy with  associated AEs for the fetus, in this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. A new case for Adverse events in the fetus has been created.   This case was linked to MOD-2021-278592 (Parent-Child Link).   See case MOD-2021-278592 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up document received on 19-Aug-2021 included current pregnancy details, previous pregnancy history, maternal medical history, reporter details, dose and patient details were updated. Second reporter and new event ectopic pregnancy were added.; Sender's Comments: This is a case of product exposure before  pregnancy with  associated AEs for the fetus, in this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. A new case for Adverse events in the fetus has been created.