Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Foetal growth restriction, Loss of consciousness, Pregnancy test, Pregnancy test urine
Clinical narrative: Passed out from blood loss; Foetal Growth Arrest; Spotting; Cramping; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of FOETAL GROWTH RESTRICTION (Foetal Growth Arrest), LOSS OF CONSCIOUSNESS (Passed out from blood loss), VAGINAL HAEMORRHAGE (Spotting) and ABDOMINAL PAIN (Cramping) in a 32-year-old female patient (gravida 6, para 5) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 04-Feb-2021. Concurrent medical conditions included Body mass index high.    On 02-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Mar-2022, the patient experienced VAGINAL HAEMORRHAGE (Spotting) (seriousness criterion hospitalization) and ABDOMINAL PAIN (Cramping) (seriousness criterion hospitalization). On 28-Mar-2022, the patient experienced FOETAL GROWTH RESTRICTION (Foetal Growth Arrest) (seriousness criteria hospitalization and medically significant). On 01-Apr-2022, the patient experienced LOSS OF CONSCIOUSNESS (Passed out from blood loss) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Apr-2022 due to ABDOMINAL PAIN, FOETAL GROWTH RESTRICTION, LOSS OF CONSCIOUSNESS and VAGINAL HAEMORRHAGE. The vaginal delivery occurred on 28-Mar-2022, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 02-Apr-2022, FOETAL GROWTH RESTRICTION (Foetal Growth Arrest), VAGINAL HAEMORRHAGE (Spotting) and ABDOMINAL PAIN (Cramping) had resolved. In April 2022, LOSS OF CONSCIOUSNESS (Passed out from blood loss) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2022, Pregnancy test: Positive. On 04-Mar-2022, Pregnancy test urine: Positive. On 15-Mar-2022, Ultrasound scan: 7 weeks 6 days pregnant The embryo was measuring 6 weeks 0 days, with no cardiac activity seen. On 28-Mar-2022, Ultrasound scan: still no fetal activity, and there was no change in the size of the embryo.. On an unknown date, Smear cervix: No abnormal PAP Smears.         The patient did not have any additional medical history, concomitant disease or risk factor.  The patient never had any issues with her reproductive system in past. No abnormal PAP Smears, no issues with conceiving or having healthy pregnancies. She had given birth to 5 healthy children, all were conceived within the first 2 months of trying to conceive.   On 20-Feb-2022, well over a year of trying to conceive (with no previous issues with conceiving prior to being vaccinated for Covid-19). The patient was tested positive at-home pregnancy test. The patient visited her OB/GYN on 04-Mar-2022 for pregnancy confirmation, and a urine test at the office confirmed that she was pregnant. On 14-Mar-2022, she began noticing some cramping and spotting. On 15-Mar-2022, the ultrasound was performed and she was 7 weeks 6 days pregnant. The embryo was measuring 6 weeks 0 days, with no cardiac activity seen. The physician suggested repeating the ultrasound in one week since she was still early in her pregnancy. On 28-Mar-2022, ultrasound was performed during follow-up and there was still no fetal activity, and there was no change in the size of the embryo. She was given management options after being told that her pregnancy was not viable. She received medication to help start a miscarriage. The patient had cramping, bleeding and passed tissue from 28-Mar-2022 to 31-Mar-2022.  On 01-Apr-2022, she had severe pain and started hemorrhaging. She was sent to the Emergency Room via ambulance, where she saw in the waiting room for 4 hours. As soon as they brought her back for treatment, she passed out from blood loss. On 02-Apr-2022, within 45 minutes the patient was moved into operating room performing and Emergency Dilation and curettage (D&C). It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Oral medication, followed by an emergency D&C.  Company comment: This spontaneous case reported by a consumer, concerns a 32-year-old female patient, with no relevant history, who experienced the unexpected, serious (Hospitalization and medically significant) events of foetal growth restriction and loss of consciousness and unexpected, serious (Hospitalization) events of abdominal pain (reported as cramping) and vaginal haemorrhage, which occurred approximately 2.5 months after a dose of mRNA-1273 vaccine. Patient had given birth to 5 healthy children. The patient was tested positive at-home pregnancy test. At gestation age of 7 weeks 6 days, she began noticing some cramping and spotting. Ultrasound confirmed the pregnancy with embryo, measuring 6 weeks 0 days, with no cardiac activity seen. 2 weeks late, ultrasound was performed again and there was still no fetal activity, and there was no change in the size of the embryo. She received medication to help start a miscarriage since her pregnancy was not viable. The patient had cramping, bleeding and passed tissue, 3 days later, she had severe pain and started hemorrhaging. She passed out from blood loss and Emergency Dilation and curettage (D&C) was performed. Treatment details are not provided. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 32-year-old female patient, with no relevant history, who experienced the unexpected, serious (Hospitalization and medically significant) events of foetal growth restriction and loss of consciousness and unexpected, serious (Hospitalization) events of abdominal pain (reported as cramping) and vaginal haemorrhage, which occurred approximately 2.5 months after a dose of mRNA-1273 vaccine. Patient had given birth to 5 healthy children. The patient was tested positive at-home pregnancy test. At gestation age of 7 weeks 6 days, she began noticing some cramping and spotting. Ultrasound confirmed the pregnancy with embryo, measuring 6 weeks 0 days, with no cardiac activity seen. 2 weeks late, ultrasound was performed again and there was still no fetal activity, and there was no change in the size of the embryo. She received medication to help start a miscarriage since her pregnancy was not viable. The patient had cramping, bleeding and passed tissue, 3 days later, she had severe pain and started hemorrhaging. She passed out from blood loss and Emergency Dilation and curettage (D&C) was performed. Treatment details are not provided. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.