Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: I had a miscarriage after the 2nd dose of the vaccine; COVID-19; After the vaccine, I was already pregnant; This spontaneous retrospective pregnancy case was reported by a non-health professional and describes the occurrence of ABORTION SPONTANEOUS (I had a miscarriage after the 2nd dose of the vaccine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939004 and 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, 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 19-Oct-2021 and the estimated date of delivery was 26-Jun-2022. In November 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (After the vaccine, I was already pregnant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (I had a miscarriage after the 2nd dose of the vaccine) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. In November 2021, MATERNAL EXPOSURE DURING PREGNANCY (After the vaccine, I was already pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (I had a miscarriage after the 2nd dose of the vaccine) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Ultrasound scan: baby died at 8 weeks, he didn't have arms or legs (abnormal) ultrasound to make sure everything was out,baby died at 8 weeks, he didn't have arms or legs.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Last Menstrual Period is given as Oct 19 2021 and due date was 26-Jun-2022  Concomitant medication includes birth control pill once a day.  No treatment information was reported.  Company Comment: This spontaneous case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected serious (hospitalization) event of Abortion spontaneous and non-serious AESI event of COVID-19. Maternal exposure during pregnancy was reported as an additional event. The patient received mRNA-1273 vaccine as a second dose of COVID-19 vaccine at approximately 3-4 weeks of gestation. Abortion spontaneous occurred approximately 1 month after the second dose of mRNA-1273 vaccination. Concomitant use of birth control pill is a confounder for the event. The current pandemic situation of COVID 19 may remain as confounder for the event of COVID-19. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender's Comments: This spontaneous case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected serious (hospitalization) event of Abortion spontaneous and non-serious AESI event of COVID-19. Maternal exposure during pregnancy was reported as an additional event. The patient received mRNA-1273 vaccine as a second dose of COVID-19 vaccine at approximately 3-4 weeks of gestation. Abortion spontaneous occurred approximately 1 month after the second dose of mRNA-1273 vaccination. Concomitant use of birth control pill is a confounder for the event. The current pandemic situation of COVID 19 may remain as confounder for the event of COVID-19. The benefit-risk relationship of mRNA-1273 in not affected by this report.