Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured; No Adverse event; Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022), PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured) and NO ADVERSE EVENT (No Adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022 at 8:30 AM, 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 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022), PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured) 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 received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022) and PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured).    No concomitant medication information was provided.  They forgot to discard them last night. This morning someone garbed the expired prefilled syringe from the refrigerator and administered a dose. Dose administered greater than 12 hours post puncture. Received it as liquid on 18-Nov-2022, it went into liquid state on transport in a cooler (Refrigerator). On 29-Nov-2022 8:30 AM, vial was first punctured.  The cartons were unbroken cartons, and the vial size was 2.5 mL.  The vial did not undergo any temperature excursions.  Vial did not expose to room temperature for more than 24 hours.  No treatment medication was provided.