Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days; Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No medical history reported.     On 30-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023) 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 (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Health care professional explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge.  6 doses administered after 30-day Use By Date Product Monovalent, Bivalent BA.1, Bivalent BA.4-5: bivalent Lot number 066H22A. Individual vials or intact cartons: inside a carton Vial size were 0.4 mL, 0.5 mL, 2.5 mL, or 5.5 mL 2.5 mL Date the vial was initially stored in the refrigerator was 02 MAR 2023. Date(s) of administration of vaccine 27 APR 2023, 10 MAY 2023, 30 MAY2023. The vial did not undergo any temperature excursions. No AEs were reported. It was the 6th dose for this patient. Concomitant medication not reported.  Treatment medication not reported.