Reporte zur Charge 039K20A, 011L20

Symptomtext

three 16 year old patients received their first dose of the Moderna vaccine; A spontaneous report was received from a pharmacist concerning three 16 year old patients who were administered a COVID vaccine at an inappropriate age. The patient's medical histories were not provided. Concomitant medication details were not provided On an unreported date, the patients received their first of two planned doses of mRNA-1273 (Batch numbers: 039K20A, 011L20A, 013L20A) some time between 11/Jan/2021 and 21/Jan/2021 intramuscularly for prophylaxis of COVID-19 infection. On an unreported date, three 16 year old patients were administered a COVID vaccine at an inappropriate age. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case series of three (3) individual 16-year-old patients who each experienced the nonserious unexpected event of 'PT Product administered to patient of inappropriate age' for the first dose of mRNA-1273 (mRNA-1273 lots # 039K20A, 011L20A, 013L20A), with no associated adverse events in any patient. Very limited information regarding this event has been provided at this time. Further information has been requested.