Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: pregnancy lost; baby did not have a heartbeat on ultrasound; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (pregnancy lost) and FOETAL HEART RATE ABNORMAL (baby did not have a heartbeat on ultrasound) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 26-Mar-2021, the patient experienced ABORTION SPONTANEOUS (pregnancy lost) (seriousness criterion medically significant) and FOETAL HEART RATE ABNORMAL (baby did not have a heartbeat on ultrasound) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (pregnancy lost) and FOETAL HEART RATE ABNORMAL (baby did not have a heartbeat on ultrasound) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Ultrasound foetal: abnormal (abnormal) baby did not have a heartbeat and the measurement was approximately to that of the baby who is 8 weeks 3 days (coinciding with the time she had the vaccine). On an unknown date, Ultrasound foetal: normal (normal) ultrasound at 7.5 weeks and the baby was seen to have a heartbeat and the measurement s were on the right track.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was states that studies were done on the baby and no genetic or any abnormalities were found that could have caused its demise.  No concomitant and treatment medications were reported COMPANY COMMENT: This is a Spontaneous case concerning a 20-old female patient with no clinical history who experienced the unexpected events of MATERNAL EXPOSURE DURING PREGNANCY, ABORTION SPONTANEOUS and FOETAL HEART RATE ABNORMAL  The events occurred 4 days after 1st dose of mRNA-1273. The rechallenge was not applicable since only information about 1st dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-437863 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning a 20-old female patient with no clinical history who experienced the unexpected events of MATERNAL EXPOSURE DURING PREGNANCY, ABORTION SPONTANEOUS and FOETAL HEART RATE ABNORMAL  The events occurred 4 days after 1st dose of mRNA-1273. The rechallenge was not applicable since only information about 1st dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.