Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna bivalent booster shots were 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.; No adverse event; Patient received the Bivalent booster dose on 15Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna bivalent booster shots were 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 (Patient received the Bivalent booster dose on 15Feb2023) 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 15-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 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Bivalent booster dose on 15Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna bivalent booster shots were 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 NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna bivalent booster shots were 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 (Patient received the Bivalent booster dose on 15Feb2023) 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 PRODUCT STORAGE ERROR (Moderna bivalent booster shots were 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 (Patient received the Bivalent booster dose on 15Feb2023).    Concomitant product information was not provided by the reporter.  Suspect dosage text was reported as Initial Booster. It was reported that the vaccine was stored 35 days in the refrigerator. The vaccine was not disposed after 30 days storage period in the refrigerator. No adverse events were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712238 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712238:patient administered on 15Feb2023