Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.; No adverse event; 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.).    No concomitant medications were reported. It was reported that 3 Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-Jul-2022 which had beyond use date of 05-Aug-2022. 12 Adult patients received expired monovalent dose of Moderna COVID-19 vaccine from 19-Sep-2022 till 09-Nov-2022, out of which 9 were 3rd booster doses and 3 were second doses. No previous excursions happened.  The vial was initially stored in the refrigerator on 06-Jul-2022. The doses were administered as 6 patients on 19-Sep-2022, 2 patients on 04-Oct-2022 and 1 patient on 09-Nov-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live Follow-up : Narrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:Master case