Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: First excursion Freezer on 27APR2023; First excursion Freezer on 27 APR 2023: For 1 hour and 15 minutes: Max: 12.31 F & Min: -5.008 F and Date of administration of vaccine was 02 JUN 2023; No adverse event; 49 -year-old patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (49 -year-old patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (First excursion Freezer on 27APR2023), POOR QUALITY PRODUCT ADMINISTERED (First excursion Freezer on 27 APR 2023: For 1 hour and 15 minutes: Max: 12.31 F & Min: -5.008 F and Date of administration of vaccine was 02 JUN 2023) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient 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.     Relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     On 02-Jun-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-Jun-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 (49 -year-old patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First excursion Freezer on 27APR2023), POOR QUALITY PRODUCT ADMINISTERED (First excursion Freezer on 27 APR 2023: For 1 hour and 15 minutes: Max: 12.31 F & Min: -5.008 F and Date of administration of vaccine was 02 JUN 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (49 -year-old patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (First excursion Freezer on 27APR2023), POOR QUALITY PRODUCT ADMINISTERED (First excursion Freezer on 27 APR 2023: For 1 hour and 15 minutes: Max: 12.31 F & Min: -5.008 F and Date of administration of vaccine was 02 JUN 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 (49 -year-old patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (First excursion Freezer on 27APR2023) and POOR QUALITY PRODUCT ADMINISTERED (First excursion Freezer on 27 APR 2023: For 1 hour and 15 minutes: Max: 12.31 F & Min: -5.008 F and Date of administration of vaccine was 02 JUN 2023).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacist stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent after the expiration date. The vial expired on 01JUN2023 and they administered the vaccine on 02JUN2023.   Individual 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 24MAY2023 and Date of administration of vaccine was 02JUN2023   First excursion Freezer on 27 APR 2023: For 1 hour and 15 minutes: Max: 12.31 F and Min: -5.008 F  Concomitant medication not reported. Treatment medication not reported.