Sex: F
Vaccine: COVID19
Symptoms: Atrial septal defect, Exposure via breast milk, Hereditary haemolytic anaemia, Hyperbilirubinaemia neonatal
Clinical narrative: Hyperbilirubinemia newborn; Atrial septal defect; Congenital hemolytic anemia; Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of HYPERBILIRUBINAEMIA NEONATAL (Hyperbilirubinemia newborn), ATRIAL SEPTAL DEFECT (Atrial septal defect) and HEREDITARY HAEMOLYTIC ANAEMIA (Congenital hemolytic anemia) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): ultrasounds found normal at 13 and 20-week.  The mother's past medical history included Marijuana use. Previously administered products included for Preterm labor: progesterone (Route: vaginal suppository Indication for use: prevent early labor). Past adverse reactions to the above products included No adverse event with progesterone. Concurrent medical conditions included Alcohol use (1-2 drinks/ month while pregnant, 2-3 drinks/week when not pregnant), Depression (Product name: Zoloft Strength/ Frequency:50-100mg Route: Oral) and Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with HYPERBILIRUBINAEMIA NEONATAL (Hyperbilirubinemia newborn) (seriousness criterion hospitalization prolonged), ATRIAL SEPTAL DEFECT (Atrial septal defect) (seriousness criterion congenital anomaly), HEREDITARY HAEMOLYTIC ANAEMIA (Congenital hemolytic anemia) (seriousness criterion medically significant) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The mother had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 1338 grams (2lbs 15oz). The outcome was reported as Term Birth w Complications. Patient gave birth to female infant with weight 2.95 kg and currently breast feeding. At the time of the report, HYPERBILIRUBINAEMIA NEONATAL (Hyperbilirubinemia newborn), ATRIAL SEPTAL DEFECT (Atrial septal defect) and HEREDITARY HAEMOLYTIC ANAEMIA (Congenital hemolytic anemia) outcome was unknown and EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Maternal Zoloft was increased from 50 to 100 mg during 2nd trimester due to worsenign depression. Depression improved and has remained improved  Company Comment: This case concerns Exposure via breastmilk in a female patient of unknown age  with no reported medical history, who experienced the unexpected serious event s of Hyperbilirubinaemia, Atrial septal defect, and Hereditary haemolytic anaemia. The events occurred an unknown number of days after maternal COVID-19 vaccination since the timing of maternal vaccination is not specified. Maternal vaginal progesterone and Zoloft use were reported during pregnancy.  Breastfeeding and concurrent event of Hereditary haemolytic anaemia may have contributed to the Hyperbilirubinaemia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns Exposure via breastmilk in a female patient of unknown age  with no reported medical history, who experienced the unexpected serious event s of Hyperbilirubinaemia, Atrial septal defect, and Hereditary haemolytic anaemia. The events occurred an unknown number of days after maternal COVID-19 vaccination since the timing of maternal vaccination is not specified. Maternal vaginal progesterone and Zoloft use were reported during pregnancy.  Breastfeeding and concurrent event of Hereditary haemolytic anaemia may have contributed to the Hyperbilirubinaemia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.