Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023; No adverse event; Patient had dose administered after 30-day Use By Date or after manufacturer date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-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 02-Mar-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 had dose administered after 30-day Use By Date or after manufacturer date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-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 (Patient had dose administered after 30-day Use By Date or after manufacturer date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that bivalent vial of unknown size was administered to 5 patients after 30 days use by date. The vial never underwent any temperature excursions. No adverse reaction was reported by patient at that time.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714731, US-MODERNATX, INC.-MOD-2023-714608, US-MODERNATX, INC.-MOD-2023-714789, US-MODERNATX, INC.-MOD-2023-714792 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714731:Same reporter US-MODERNATX, INC.-MOD-2023-714608:Same reporter US-MODERNATX, INC.-MOD-2023-714789:Same reporter US-MODERNATX, INC.-MOD-2023-714792:Same reporter