Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023; No adverse event; Patient received Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date/Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date/Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023   ) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date/Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023   ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date/Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023   ) 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 (Patient received Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date/Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 12Jun2023/Date(s) of administration of vaccine: 13Jul2023   ).    Concomitant product use was not provided by the reporter.  Individual vial was 2.5 ml. Vial did not undergo any temperature excursions. Dose administered after 30-day use by date or after manufacturer date of expiry.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-733883 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2023: Live significant Follow up received, patient initials, gender, age were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733883:Patient 1