Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine with lot number 011B22A expired and was in freezer and administered on 26-Oct-2022; No adverse event; The box of vaccines with more than 12 red vials were expired and was possibly administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The box of vaccines with more than 12 red vials were expired and was possibly administered to a patient), PRODUCT STORAGE ERROR (The vaccine with lot number 011B22A expired and was in freezer and administered on 26-Oct-2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The box of vaccines with more than 12 red vials were expired and was possibly administered to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine with lot number 011B22A expired and was in freezer and administered on 26-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The box of vaccines with more than 12 red vials were expired and was possibly administered to a patient), PRODUCT STORAGE ERROR (The vaccine with lot number 011B22A expired and was in freezer and administered on 26-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The box of vaccines with more than 12 red vials were expired and was possibly administered to a patient) and PRODUCT STORAGE ERROR (The vaccine with lot number 011B22A expired and was in freezer and administered on 26-Oct-2022).    No concomitant medications were reported. It was reported that the site which had Moderna vaccine in a freezer unit had good readings on the digital data logger until August. In Aug-2022, the battery died and they had no logs from 01-Aug-2022 until 01-Jan-2023. Reporter was asking Moderna about the viability of the vaccines. 1 Box of vaccine with Lot 011B22A with more than 12 red vials were expired. Vaccines were still in the freezer. HCP confirmed that there had been some doses given between 01-Aug-2022 to 01-Jan-2023.  HCP checked notes left and indicated 100 doses were received and 30 doses were currently left discarded due to expiration. HCP noted that 49 doses of open multi dose vials in Nov-2022 were expired and discarded. Possibly 2 patients were given that vaccine, one Male patient on 26-Oct-2022 with year of Birth 1997. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712557:Adult patient