Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator; received the Bivalent booster dose on 17Feb2023; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator), EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023) and NO ADVERSE EVENT (no adverse event) in an adult 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. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator), EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator), EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023).    No concomitant medication information was reported. Suspect dosage text was reported as Initial Booster. Pharmacist administered the Moderna bivalent booster shots to two patients that was stored beyond the storage condition. Vaccine was stored 35 days in refrigerator. Pharmacist mentioned that vaccine was not disposed after the 30 days storage period in the refrigerator. No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-711138 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711138:patient administered on 15Feb2023