Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 13-Apr-2022; Patient received an expired vaccine on 13-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 13-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 13-Apr-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 032L20A) 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-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 13-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 13-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist stated that they inadvertently administered expired dose of the Moderna Covid-19 vaccine to 18 patients - 9 doses administered on 09-May-2022 and 9 doses administered on 11-May-2022.   On 17-May-2022, the pharmacist reported after doing further research, she stated the actual total number of patients that received expired doses after the 30 day use by date was 82 patients total and not 18 patients.  The pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022 which meant that all doses administered more than 30 days after 11-Jan-2022 which was not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from the same lot more than 30 days after it was in the fridge). The vaccine was administered between 16-feb-2022 and 11-May-2022.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions.  No patients had reported any adverse reactions  No treatment medication were provided.