Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Received the vaccine as frozen and placed it in the freezer with expiration date of 02Jan2022. The vials were thawed and administered on 23Oct2022.; No adverse event; HCP is calling to report that 8 patients received Moderna COVID-19 primary doses from Lot# 037C21A & MFG Expiration Date: 02 Jan 2022. The vials were thawed and administered on 23OCT2022.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that 8 patients received Moderna COVID-19 primary doses from Lot# 037C21A & MFG Expiration Date: 02 Jan 2022. The vials were thawed and administered on 23OCT2022.), PRODUCT STORAGE ERROR (Received the vaccine as frozen and placed it in the freezer with expiration date of 02Jan2022. The vials were thawed and administered on 23Oct2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that 8 patients received Moderna COVID-19 primary doses from Lot# 037C21A & MFG Expiration Date: 02 Jan 2022. The vials were thawed and administered on 23OCT2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received the vaccine as frozen and placed it in the freezer with expiration date of 02Jan2022. The vials were thawed and administered on 23Oct2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that 8 patients received Moderna COVID-19 primary doses from Lot# 037C21A & MFG Expiration Date: 02 Jan 2022. The vials were thawed and administered on 23OCT2022.), PRODUCT STORAGE ERROR (Received the vaccine as frozen and placed it in the freezer with expiration date of 02Jan2022. The vials were thawed and administered on 23Oct2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that 8 patients received Moderna COVID-19 primary doses from Lot# 037C21A &amp; MFG Expiration Date: 02 Jan 2022. The vials were thawed and administered on 23OCT2022.) and PRODUCT STORAGE ERROR (Received the vaccine as frozen and placed it in the freezer with expiration date of 02Jan2022. The vials were thawed and administered on 23Oct2022.).    It was reported that 100 doses Monovalent vaccine was already discarded but they say they could have used it, after beyond use date. HCP was calling to report that 8 patients received Moderna COVID-19 primary doses from Lot 037C21A and manufacture expiration date was 02-Jan-2022. The vials were thawed and administered on 23-Oct-2022. The remainder of vials were discarded already. Stated that they received the vaccine as frozen and placed it in the freezer. There was no temperature excursion. Also reported that reporter do not know what they mean by saying that we could have used the vaccine after beyond use date.  No treatment information was provided.  This case contains information for the 8 patient out of 8 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694237 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694237:master case