Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 043L20A, 014M20A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022 at 1:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 12-May-2022. Date(s) and time(S) vial was first punctured was 17-May-2022 at 2:16PM. The vial was stored post puncture in R/T FRIDGE.. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was probably 5 MINS, It was reported that just drawing up. It was never really left out at room temperature. No treatment medications were reported.   This case was linked to MOD-2022-570995.