Sex: U
Vaccine: COVID19
Symptoms: Failure to thrive, Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: Dropped too much weight after birth following IUGR dignosis; Dropped too much weight after birth following IUGR dignosis; Fetal exposure during pregnancy; This sponsored pm nis case was reported by a consumer and describes the occurrence of FAILURE TO THRIVE (Dropped too much weight after birth following IUGR dignosis) and FOETAL GROWTH RESTRICTION (Dropped too much weight after birth following IUGR dignosis) in infant of an unknown gender exposed to mRNA-1273 , while the mother received the product for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): Parent not had COVID-19 infection which was confirmed by negative test. Mother concomitant medication's includes Buspirone, Plantago seed Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Nicotinamide, Pyridoxine, Riboflavin, Thiamine, Vitamin A, Docusate, Metformin and Alprazolam.  Concurrent medical conditions included Caffeine consumption (caffeinated beverages less than 3 per day).    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (unknown route) 1 dosage form at an unspecified frequency.    On an unknown date, the infant was diagnosed with FAILURE TO THRIVE (Dropped too much weight after birth following IUGR dignosis) (seriousness criterion medically significant), FOETAL GROWTH RESTRICTION (Dropped too much weight after birth following IUGR dignosis) (seriousness criterion medically significant) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The Infant was exposed to mRNA-1273 during pregnancy. The delivery occurred  on 04-May-2022, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, FAILURE TO THRIVE (Dropped too much weight after birth following IUGR dignosis) was resolving, FOETAL GROWTH RESTRICTION (Dropped too much weight after birth following IUGR dignosis) outcome was unknown and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Transplacental) was unknown.       It was reported that patient was delivered without any congenital anomalies and achieved all the developmental milestones. At the time of reporting patient was on good curve gaining size and weight.  Treatment medications not provided.  Company Comment: This Sponsored case describes the occurrence of Fetal Exposure During Pregnancy on an infant patient of an unknown gender, born on 04-MAY-2022, with no reported medical history, who experienced the unexpected and serious (medically significant) event of Failure to Thrive and Fetal Growth Restriction, which occurred after a dose of mRNA-1273 vaccine was given to the patient's mother. Mother´s concurrent medical conditions include Caffeine consumption. Concomitant mother´s polypharmacy includes Buspirone, Plantago seed, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Nicotinamide, Pyridoxine, Riboflavin, Thiamine, Vitamin A, Docusate, Metformin and Alprazolam. It was reported that the patient was delivered without any congenital anomalies and achieved all the developmental milestones. The maternal medical condition of Caffeine consumption can be a confounder for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This Sponsored case describes the occurrence of Fetal Exposure During Pregnancy on an infant patient of an unknown gender, born on 04-MAY-2022, with no reported medical history, who experienced the unexpected and serious (medically significant) event of Failure to Thrive and Fetal Growth Restriction, which occurred after a dose of mRNA-1273 vaccine was given to the patient's mother. Mother´s concurrent medical conditions include Caffeine consumption. Concomitant mother´s polypharmacy includes Buspirone, Plantago seed, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Nicotinamide, Pyridoxine, Riboflavin, Thiamine, Vitamin A, Docusate, Metformin and Alprazolam. It was reported that the patient was delivered without any congenital anomalies and achieved all the developmental milestones. The maternal medical condition of Caffeine consumption can be a confounder for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.