Sex: M
Vaccine: COVID19
Symptoms: Neonatal respiratory distress syndrome
Clinical narrative: Surfactant Deficiency at birth; This spontaneous case was reported by a consumer and describes the occurrence of NEONATAL RESPIRATORY DISTRESS SYNDROME (Surfactant Deficiency at birth) in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy (Outcome recovered and resolved) on 25-Feb-2021.    No Medical History information was reported.   On 25-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 25-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEONATAL RESPIRATORY DISTRESS SYNDROME (Surfactant Deficiency at birth) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 25-Aug-2021 due to NEONATAL RESPIRATORY DISTRESS SYNDROME. At the time of the report, NEONATAL RESPIRATORY DISTRESS SYNDROME (Surfactant Deficiency at birth) outcome was unknown. Not Provided          Medical history of mother included 6 Pregnancies (including current pregnancy), 1 live birth (August 2019), 3 Miscarriages (2 D&C's May 2017, Dec 2020), 1 misoprostol induced Dec 2016), 1 L&D termination at 21 weeks for Trisomy 13 (April 2018).   Company comment: This is a spontaneous case concerning an infant male patient with fetal exposure during pregnancy, who experienced unexpected event of neonatal distress syndrome. The fetal exposure during pregnancy occurred approximately at first trimester of gestation, date of positive pregnancy test was 18-dec-2020, on 25-Feb-2021 mother received the first dose of mRNA-1273 vaccine, on 25-Mar-2021 mother received second dose. Maternal use of substances included 1-3 Drinks a day/3-4 times a week (during pregnancy, no alcohol in the first 20 weeks, 0.5 glass per day 2-3x week from 20-39weeks). Pregnancy related complications included Cardiac Arrhythmia, symptoms began in April 2021, mother was diagnosed with PVC and isolated PACs. Arrhythmia resolved within 6 weeks of delivery. Diagnostic test included Fetal Growth & Anatomy US performed on 20-May-2021 at 25 week gestation and 12-Jul-2021 at 33 week gestation, both studies were informed as normal fetal growth. Delivery type was caesarean section and occurred on 20-Aug-2021, at 39 weeks of gestation (live, full-term birth). Infant was diagnosed with Surfactant Deficiency at birth, he required respiratory support and NICU admittance. Breathing tube with surfactant were administered at birth. Treatment included ventilator for 6-12 hours, bubble CPAP 1 day, nasal canula high flow oxygen 1-day and IV antibiotics for 4-5 days. Infant was discharged on 25 Aug 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-026788 (Parent-Child Link).   See case MOD-2021-026788 for details regarding the child case.; Sender's Comments: This is a spontaneous case concerning an infant male patient with fetal exposure during pregnancy, who experienced unexpected event of neonatal distress syndrome. The fetal exposure during pregnancy occurred approximately at first trimester of gestation, date of positive pregnancy test was 18-dec-2020, on 25-Feb-2021 mother received the first dose of mRNA-1273 vaccine, on 25-Mar-2021 mother received second dose. Maternal use of substances included 1-3 Drinks a day/3-4 times a week (during pregnancy, no alcohol in the first 20 weeks, 0.5 glass per day 2-3x week from 20-39weeks). Pregnancy related complications included Cardiac Arrhythmia, symptoms began in April 2021, mother was diagnosed with PVC and isolated PACs. Arrhythmia resolved within 6 weeks of delivery. Diagnostic test included Fetal Growth & Anatomy US performed on 20-May-2021 at 25 week gestation and 12-Jul-2021 at 33 week gestation, both studies were informed as normal fetal growth. Delivery type was caesarean section and occurred on 20-Aug-2021, at 39 weeks of gestation (live, full-term birth). Infant was diagnosed with Surfactant Deficiency at birth, he required respiratory support and NICU admittance. Breathing tube with surfactant were administered at birth. Treatment included ventilator for 6-12 hours, bubble CPAP 1 day, nasal canula high flow oxygen 1-day and IV antibiotics for 4-5 days. Infant was discharged on 25 Aug 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.