Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023; No reported symptoms; patients received doses of vaccine after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD), PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023) and NO ADVERSE EVENT (No reported symptoms) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 29-Jun-2023, 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 29-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023) and NO ADVERSE EVENT (No reported symptoms). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD), PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023) and NO ADVERSE EVENT (No reported symptoms) 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 reported symptoms) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD) and PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023).    Concomitant medication details not reported by the reporter.  Reporter stated that on the day of report it was discovered that 2 vials of Moderna Bivalent Lot# AS7185B that were injection into 6 pts on 29-Jun-23.  The vials were taken out of the freezer on 25-May-2023.  The vials were placed in fridge on 05-Jun-2023 with a timed-out date of 23-Jun-2023.  It was reported that 2 patients had received their 6th doses and rest were 5th doses in this error.  Dosage text was reported as unknown.  Treatment details was not reported by the reporter.  This case contains information for the 4th patient out of 6 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732158, US-MODERNATX, INC.-MOD-2023-732468, US-MODERNATX, INC.-MOD-2023-732470 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732158:Master case US-MODERNATX, INC.-MOD-2023-732470:Patient 1 US-MODERNATX, INC.-MOD-2023-732468:Patient 1