Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Umbilical granuloma
Clinical narrative: My 23wk old daughter had sleep regression this week and was waking up 5+ times a night after she had been sleeping through the night.; Umbilical granuloma; This spontaneous case was reported by a consumer and describes the occurrence of UMBILICAL GRANULOMA (Umbilical granuloma) and INSOMNIA (My 23wk old daughter had sleep regression this week and was waking up 5+ times a night after she had been sleeping through the night.) in a 6-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): She has medical history of obsessive compulsive disorder, venous malformation, iron deficiency.  The mother's past medical history included Maternal exposure during pregnancy. Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 03-May-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was on 09-Sep-2020 and the estimated date of delivery was 07-Jun-2021. In June 2021, the infant was diagnosed with UMBILICAL GRANULOMA (Umbilical granuloma). In November 2021, the infant was diagnosed with INSOMNIA (My 23wk old daughter had sleep regression this week and was waking up 5+ times a night after she had been sleeping through the night.). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The vaginal delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 9 and 10 at (1, 5 minutes). The outcome was reported as Delivered NOS. Baby was delivered on 39 weeks and 2 days. Infant length 48.26cm. Course of pregnancy and delivery was smooth, no complications. At the time of the report, UMBILICAL GRANULOMA (Umbilical granuloma) and INSOMNIA (My 23wk old daughter had sleep regression this week and was waking up 5+ times a night after she had been sleeping through the night.) outcome was unknown. Not Provided          No concomitant and treatment medication were provided  Company comment: This case concerns a 6-month-old, female infant with fetal exposure during pregnancy and vaccine exposure via breast milk, who experienced the unexpected, non-serious, events of Umbilical granuloma and Insomnia. The fetal exposure during pregnancy occurred at 33 weeks of gestation, when the mother received the second dose of mRNA-1273 vaccine. Course of pregnancy and delivery was smooth, no complications. The vaginal delivery occurred, which was reported as Full-term.  In June 2021, the infant was diagnosed with Umbilical granuloma that was cauterized. Vaccine exposure via breast milk occurred when the infant was approximately 5-months-old,  when the mother received the booster dose of mRNA-1273 vaccine on 09-Vov-2021. It was reported that in November 2021 the infant experienced sleep regression. Treatment details for event sleep regression were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-384858 (Parent-Child Link).   See case MOD-2021-384858 for details regarding the Parent case.; Sender's Comments: This case concerns a 6-month-old, female infant with fetal exposure during pregnancy and vaccine exposure via breast milk, who experienced the unexpected, non-serious, events of Umbilical granuloma and Insomnia. The fetal exposure during pregnancy occurred at 33 weeks of gestation, when the mother received the second dose of mRNA-1273 vaccine. Course of pregnancy and delivery was smooth, no complications. The vaginal delivery occurred, which was reported as Full-term.  In June 2021, the infant was diagnosed with Umbilical granuloma that was cauterized. Vaccine exposure via breast milk occurred when the infant was approximately 5-months-old,  when the mother received the booster dose of mRNA-1273 vaccine on 09-Vov-2021. It was reported that in November 2021 the infant experienced sleep regression. Treatment details for event sleep regression were not provided.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.