Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023; No adverse event; Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Patient medical history was unknown.     On 24-Jul-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 24-Jul-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 (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023) 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 (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 22 Jun 2023, Beyond use date 22 Jul 2023 and administration date was 24 Jul 2023).    No concomitant medications were provided.  Dosage text for suspect product was reported as unknown.  Vial did not undergo any temperature excursions.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734896, US-MODERNATX, INC.-MOD-2023-734899, US-MODERNATX, INC.-MOD-2023-734932 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734896:Same reporter US-MODERNATX, INC.-MOD-2023-734899:Same reporter US-MODERNATX, INC.-MOD-2023-734932:Same Reporter