Sex: U
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Tracheomalacia
Clinical narrative: This sponsored PM NIS case was reported by a consumer and describes the occurrence of TRACHEOMALACIA (Tracheomalacia) in infant of an unknown gender exposed to mRNA-1273, while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. MEDICAL HISTORY (Parent): Patient not had COVID-19 infection which was confirmed by negative test. Concurrent medical conditions included Smoker (6 to 10 cigarettes per day), Caffeine consumption (caffeinated beverages Less than 3 beverages per day) and Alcoholic (1 to 9 drinks per week). MEDICAL HISTORY (Patient): Concomitant product exposures included Ascorbic Acid; Cholecalciferol; Cyanocobalamin; Dl-Alpha Tocopheryl Acetate; Ferrous Fumarate; Folic Acid; Nicotinamide; Pyridoxine; Riboflavin; Sodium Ascorbate; Thiamine; Diphenhydramine for an unknown indication. 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 TRACHEOMALACIA (Tracheomalacia) (seriousness criteria hospitalization, medically significant and congenital anomaly) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The subject was hospitalized for 5 days due to TRACHEOMALACIA. The Infant was exposed to mRNA-1273 during pregnancy. The delivery occurred  on 24-Nov-2021, 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, TRACHEOMALACIA (Tracheomalacia) 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. Company Comment: This Sponsored PM NIS case describes the occurrence of foetal exposure during pregnancy in an infant patient born on 24-NOV-2021, with no medical history reported, who experienced the unexpected and serious (due to hospitalization, congenital anomaly and medically significant) event of Tracheomalacia, which occurred after a dose of mRNA-1273 vaccine. Mother´s concurrent medical conditions include smoker and alcoholic. Concomitant mother´s polypharmacy includes ascorbic acid, cholecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, nicotinamide, pyridoxine, diphenhydramine and thiamine, among others. Patient was hospitalized for 5 days due to mild tracheomalacia. Outcome of the event is unknown. No other congenital defects have been noticed. 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 PM NIS case describes the occurrence of foetal exposure during pregnancy in an infant patient born on 24-NOV-2021, with no medical history reported, who experienced the unexpected and serious (due to hospitalization, congenital anomaly and medically significant) event of Tracheomalacia, which occurred after a dose of mRNA-1273 vaccine. Mother´s concurrent medical conditions include smoker and alcoholic. Concomitant mother´s polypharmacy includes ascorbic acid, cholecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, nicotinamide, pyridoxine, diphenhydramine and thiamine, among others. Patient was hospitalized for 5 days due to mild tracheomalacia. Outcome of the event is unknown. No other congenital defects have been noticed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.