Sex: M
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Foetal heart rate, Premature baby death
Clinical narrative: The baby died after birth 5 days after first vaccine; Foetal exposure during pregnancy; This spontaneous case was reported by a consumer and describes the occurrence of PREMATURE BABY DEATH (The baby died after birth 5 days after first vaccine) in a male neonate of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): On an unknown date patient had performed following tests. There was a vaginal bleeding.  Patient blood pressure 117/76, pulse 80, respiration 18, oxygen saturation 99%, temperature 98.6 degree Fahrenheit. multiple sonographic images of the fetus and uterus were obtained using transabdominal technique, single viable intrauterine pregnancy was visualized. Treatment medication included metronidazole (Flagyl) 500 mg oral tablet and nitrofurantoin (Macrodantin) 100 mg oral capsule.  The mother's past medical history included Maternal exposure during pregnancy.    No Medical History information was reported.    On 31-Jan-2022, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on an unknown date and the estimated date of delivery was 27-Jun-2022. On 31-Jan-2022, the neonate was diagnosed with FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy). The neonate was diagnosed with PREMATURE BABY DEATH (The baby died after birth 5 days after first vaccine). The Neonate was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. The placenta is fundal, and evaluation is limited due to lack of amniotic fluid.  No detectable amniotic fluid.  The cervix contains a small amount of fluid, with a length of 6.6 cm.  Fetal measurements:  Biparietal diameter: 4.3 cm cm / 19 weeks 0 days.  Abdominal circumference: 14.3 cm / 19 weeks 4 days.  Femur length: 3 cm / 19 weeks 1 day.  Composite gestational age: 19 weeks 1 day. On 31-Jan-2022, FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) had resolved. The neonate died on an unknown date. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2022, Foetal heart rate: 161 beats per minute 161beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were provided. Delivery occurred at 20 weeks gestation 5 days after first shot.  Company comment: This is a spontaneous case of fetal exposure during pregnancy at 19 weeks of gestation, for a male neonate who experienced serious unexpected event of premature baby death after mother´s vaccination with the first dose of mRNA-1273. Patient´s mother experienced diarrhea, leaking amniotic fluids and vaginal bleeding the same day after first dose of mRNA-1273. She visited the ER, an ultrasound was performed; single viable intrauterine gestation, marked oligohydramnios, trace fluid was seen within the cervical canal. The mother was diagnosed with Acute cystitis with hematuria and premature rupture of membranes.  Five days later, she had contractions, went to the emergency room  and had a premature delivery. The baby died on an unknown date with no further information available. Mother´s acute cystitis and premature rupture of membrane could be confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-486635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Significant Followup was received on 17-FEB-2022, and includes patient details and parent delivery notes information.; Sender's Comments: This is a spontaneous case of fetal exposure during pregnancy at 19 weeks of gestation, for a male neonate who experienced serious unexpected event of premature baby death after mother´s vaccination with the first dose of mRNA-1273. Patient´s mother experienced diarrhea, leaking amniotic fluids and vaginal bleeding the same day after first dose of mRNA-1273. She visited the ER, an ultrasound was performed; single viable intrauterine gestation, marked oligohydramnios, trace fluid was seen within the cervical canal. The mother was diagnosed with Acute cystitis with hematuria and premature rupture of membranes.  Five days later, she had contractions, went to the emergency room  and had a premature delivery. The baby died on an unknown date with no further information available. Mother´s acute cystitis and premature rupture of membrane could be confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.