Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, SARS-CoV-2 test, Stillbirth, Ultrasound scan
Clinical narrative: baby was stillborn; Miscarriage; baby boy was formally pronounced dead; baby last kick was 3Dec2021; body aches; cramps; Chills; pregnant and got two shots; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of FOETAL DEATH (baby boy was formally pronounced dead), STILLBIRTH (baby was stillborn), ABORTION SPONTANEOUS (Miscarriage) and FOETAL HYPOKINESIA (baby last kick was 3Dec2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism (PMH: Hypothyroidism).   On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-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 an unknown date and the estimated date of delivery was 03-May-2022. On 25-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got two shots). On 23-Nov-2021, the patient experienced MYALGIA (body aches), MUSCLE SPASMS (cramps) and CHILLS (Chills). On 03-Dec-2021, the patient experienced FOETAL HYPOKINESIA (baby last kick was 3Dec2021) (seriousness criterion medically significant). On 06-Dec-2021, the patient experienced FOETAL DEATH (baby boy was formally pronounced dead) (seriousness criterion medically significant). The patient experienced STILLBIRTH (baby was stillborn) (seriousness criterion medically significant) and ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. Stillbirth. On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got two shots) had resolved. At the time of the report, FOETAL DEATH (baby boy was formally pronounced dead), STILLBIRTH (baby was stillborn), ABORTION SPONTANEOUS (Miscarriage), FOETAL HYPOKINESIA (baby last kick was 3Dec2021), MYALGIA (body aches), MUSCLE SPASMS (cramps) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On 06-Dec-2021, Ultrasound scan: abnormal (abnormal) that's when the baby boy was formally pronounced dead.         Patient was using Medication for the thyroid prior to pregnancy Treatment medication was not provided. Patient stated, she received a flu shot on October 1 month prior to receiving Moderna first dose. Patient had no allergies to medications or foods  Company comment: This Spontaneous case of Maternal exposure during pregnancy concerns a 26-year-old, female patient with medical history of hypothyroidism, who experienced the unexpected, serious (Medically significant) events of abortion spontaneous, foetal hypokinesia, foetal death and still birth, among other non-serious events. The patient stopped feeling her son kick 10 days after receiving the second dose mRNA-1273 vaccine. An ultrasound was performed 3 days later and the baby boy was formally pronounced dead. 14 days after vaccination a still birth occurred. As gestation period was not reported, event abortion spontaneous was kept. The medical history of hypothyroidism remains as confounder for the event abortion spontaneous. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Live follow-up document received on 17-Feb-2022, Contains no new information On 18-Feb-2022: Follow up received on 18-FEB-2022, contains significant information includes laboratory data and new event were added.; Sender's Comments: This Spontaneous case of Maternal exposure during pregnancy concerns a 26-year-old, female patient with medical history of hypothyroidism, who experienced the unexpected, serious (Medically significant) events of abortion spontaneous, foetal hypokinesia, foetal death and still birth, among other non-serious events. The patient stopped feeling her son kick 10 days after receiving the second dose mRNA-1273 vaccine. An ultrasound was performed 3 days later and the baby boy was formally pronounced dead. 14 days after vaccination a still birth occurred. As gestation period was not reported, event abortion spontaneous was kept. The medical history of hypothyroidism remains as confounder for the event abortion spontaneous. The benefit-risk relationship of the mRNA-1273 is not affected by this report.