Sex: U
Vaccine: COVID19
Symptoms: Developmental hip dysplasia, Ultrasound scan, Umbilical hernia
Clinical narrative: Congenital Hip Dysplasia; umbilical hernia; The mother of infant of an unknown gender   The mother of infant of an unknown gender received mRNA-1273 for COVID-19 prophylaxis.   The report describes a case of DEVELOPMENTAL HIP DYSPLASIA (Congenital Hip Dysplasia). The occurrence of additional non-serious events is detailed below.     The subject's past medical history included Maternal exposure during pregnancy.    On an unknown date, the mother received dose of mRNA-1273 (unknown route) 1 dosage form at an unspecified frequency.    On 06-Apr-2022, the infant was diagnosed with DEVELOPMENTAL HIP DYSPLASIA (Congenital Hip Dysplasia) (seriousness criteria medically significant and congenital anomaly) and UMBILICAL HERNIA (umbilical hernia). The delivery occurred on an unknown date, which was reported as Abnormal Pregnancy Outcome. For neonate 1, The outcome was reported as Term Birth w Cong Anomaly. At the time of the report, DEVELOPMENTAL HIP DYSPLASIA (Congenital Hip Dysplasia) and UMBILICAL HERNIA (umbilical hernia) had resolved with sequelae. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: Bilateral infant hip ultrasound was performed and Congenital Hip Dysplasia was ruled out.    The action taken with mRNA-1273 (Transplacental) was unknown.   Company comment: This non-interventional study case concerns am infant subject which mother was exposed on mRNA-1273 during pregnancy, who experienced the unexpected, serious (medically significant/ congenital anomaly) event of developmental hip dysplasia and non-serious event of umbilical hernia. The events occurred unknown days after mother`s exposure to a dose of mRNA-1273 vaccine. Patient had ultrasound scan which rule out congenital hip dysplasia. Patient will be followed up by orthopedics at 2 years old. No treatment drug information was provided. The causality of the events umbilical hernia and developmental hip dysplasia was assessed as related, however limited information regarding risk factors, etiology and exact date of vaccination and events is provided in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter's Comments: This non-interventional study case concerns am infant subject which mother was exposed on mRNA-1273 during pregnancy, who experienced the unexpected, serious (medically significant/ congenital anomaly) event of developmental hip dysplasia and non-serious event of umbilical hernia. The events occurred unknown days after mother`s exposure to a dose of mRNA-1273 vaccine. Patient had ultrasound scan which rule out congenital hip dysplasia. Patient will be followed up by orthopedics at 2 years old. No treatment drug information was provided. The causality of the events umbilical hernia and developmental hip dysplasia was assessed as related, however limited information regarding risk factors, etiology and exact date of vaccination and events is provided in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.