Sex: F
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 and was administered from 19-Sep-2022 until 09-Nov-2022; No adverse event; Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient 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 (Adult patient received expired Monovalent second 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 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 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 (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022).    This case contains information for the 2nd of 10th adult patients described by the reporter.  No concomitant information was reported. It was reported that monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and beyond use date was 05-AUG-2022. The unknown vial did not underwent any temperature excursions. 6 Patients received on 19-Sep-2022, 2 Patients 04-Oct-2022, 1 Patients on 06-Oct-2022, 1 Patient on 09-Nov-2022.  Live follow-up received it was reported that, Per Moderna CMC Lot analysis, regarding doses administered on or after 19SEP2022, 4OCT2022, 6OCT2022 and 9NOV2022: Moderna cannot guarantee patients received full protection against the COVID- 19 Virus Unless noted in previous AE. Age group Adult was selected as default as its required field. No treatment medications were reported.   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 ((1st Patient out of 12)