Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered; No adverse event; received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered), PRODUCT STORAGE ERROR (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male 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 22-Jun-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) 1 dosage form. On 22-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 (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered), PRODUCT STORAGE ERROR (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered) 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 (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered) and PRODUCT STORAGE ERROR (received an expired 5th dose of Moderna COVID-19 vaccine /Dose administered more than 12 hours post puncture /It was in refrigerator post puncture for 22.5 hours before administered).    Concomitant medication not reported.  The vial was initially stored in the refrigerator by 13 Jun 2023.  The vial was first punctured on 21 Jun 2023 11:00 AM.  Individual Vial size was 2.5 mil.  The vial did not undergo any temperature excursions.  Treatment medication not reported.