Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days; lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the ; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days), POOR QUALITY PRODUCT ADMINISTERED (lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 001B21A, 044B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days) and POOR QUALITY PRODUCT ADMINISTERED (lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days), POOR QUALITY PRODUCT ADMINISTERED (lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the ) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 27-Apr-2022 post 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   A pharmacist, the vaccine coordinator in their health care facility, reports that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, 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 initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the university. The vial did not undergo any temperature excursions.   The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.   This case was linked to MOD-2022-566648 (E2B Linked Report).; Sender's Comments:  MOD-2022-566648:Master case - MOD22-013620