Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Fatigue, Feeling abnormal, Foetal heart rate abnormal
Clinical narrative: pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, 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, MISOPROSTOL (CYTOTEC) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, 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 an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided mentioned ultrasound and cytotec.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a "genetic issue.   This case was linked to MOD-2021-060699 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.