Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vials looked to have been taken out of the Freezer on 25May2023 and were placed in our Fridge on5Jun2023 with a timed out date for 23Jun2023 and administered on 29Jun2023; 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 PRODUCT STORAGE ERROR (The vials looked to have been taken out of the Freezer on 25May2023 and were placed in our Fridge on5Jun2023 with a timed out date for 23Jun2023 and administered on 29Jun2023), EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD) 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 looked to have been taken out of the Freezer on 25May2023 and were placed in our Fridge on5Jun2023 with a timed out date for 23Jun2023 and administered on 29Jun2023) and NO ADVERSE EVENT (No reported symptoms). At the time of the report, PRODUCT STORAGE ERROR (The vials looked to have been taken out of the Freezer on 25May2023 and were placed in our Fridge on5Jun2023 with a timed out date for 23Jun2023 and administered on 29Jun2023), EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD) 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 PRODUCT STORAGE ERROR (The vials looked to have been taken out of the Freezer on 25May2023 and were placed in our Fridge on5Jun2023 with a timed out date for 23Jun2023 and administered on 29Jun2023) and EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD).    No concomitant drug information was provided.   Reporter reported that on the day of report it was discovered that 2 vials of Moderna Bivalent Lot# AS7185B that were injection into 6 pts on 29Jun23. The vials looked to have been taken out of the Freezer on 5/25/23 and were placed in their Fridge on 5Jun23 with a timed-out date for 23Jun23. The MA misunderstood another MA who said they looked up the expiration date by the Lot as they no longer needed to go by the bags in the fridge.  The reporter was enquiring that how would they proceed with these 6 pts now and if they need to be re-vaccinated. It was further reported that 2 patients had received their 6th doses and rest were 5th doses in this error.  No treatment medication information was provided.  The case corresponds to 3rd out of 6 elderly patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732158, US-MODERNATX, INC.-MOD-2023-732466, US-MODERNATX, INC.-MOD-2023-732470, US-MODERNATX, INC.-MOD-2023-732474, US-MODERNATX, INC.-MOD-2023-732475 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732158:Master case (Patient 1) US-MODERNATX, INC.-MOD-2023-732466:Patient 2 US-MODERNATX, INC.-MOD-2023-732470:Patient 4 US-MODERNATX, INC.-MOD-2023-732474:Patient 5 US-MODERNATX, INC.-MOD-2023-732475:Patient 6