Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.; No adverse event; Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.), PRODUCT STORAGE ERROR (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.) 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 (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.), PRODUCT STORAGE ERROR (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.) 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 (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.) and PRODUCT STORAGE ERROR (Patient received the vaccine as frozen from the state and placed it in the freezer with expiration date of 02-Jan- 2022. The vials were thawed and administered on 23-Oct-2022.).    Concomitant medications were not reported.  It was reported that 100 doses Monovalent vaccine was already discarded but the state said 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 no. 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 from the state and placed it in the freezer. There was no temperature excursion. Also reported that reporter did not know what the state means by saying that we could have used the vaccine after beyond use date.  No treatment information was provided.  This case contains information for the 5th patient out of 8 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694237 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694237:master case