Reporte zur Charge 026L20A/027L20A

Symptomtext

Multiple doses were administered out of vials that had been punctured for more than 6 hours; A spontaneous report was received from a physician concerning approximately 50 patients who received Moderna's COVID-19 vaccine (mRNA-1273) administered from vials that had been punctured more than 6 hours. The patients' medical history was not provided. Concomitant product use was not provided by the reporter. Between 24 Dec 2020 and 08 Feb 2021, patients received their first of two planned doses of mRNA-1273 (Batch number 026L20A and 027L20A) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, vaccine administered from vials that had been punctured more than 6 hours, was considered resolved on 08 Feb 2021. Treatment, action taken with RNA-1273 in response to the event and the outcome of the event were unknown; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, batch number 027L20A. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.