Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 26-Oct-2022 at 11:45, stored in fridge post puncture and administered to patient after more than 12 hours; No adverse event; Patient received the dose of the Moderna COVID-19 vaccine after more than 12 hours from the initial vial puncture; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the dose of the Moderna COVID-19 vaccine after more than 12 hours from the initial vial puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 26-Oct-2022 at 11:45, stored in fridge post puncture and administered to patient after more than 12 hours) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the dose of the Moderna COVID-19 vaccine after more than 12 hours from the initial vial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 26-Oct-2022 at 11:45, stored in fridge post puncture and administered to patient after more than 12 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the dose of the Moderna COVID-19 vaccine after more than 12 hours from the initial vial puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 26-Oct-2022 at 11:45, stored in fridge post puncture and administered to patient after more than 12 hours) 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)) (Intramuscular), 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 the dose of the Moderna COVID-19 vaccine after more than 12 hours from the initial vial puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 26-Oct-2022 at 11:45, stored in fridge post puncture and administered to patient after more than 12 hours).    This case contains information for the first patient out of the 3 adult patients as described by the reporter.  No concomitant medication information was reported.  The size of the vial was 5.5ml.  The vial was initially stored in refrigerator on 17-Oct-2022.  The vial was first punctured on 26-Oct-2022 at 11:45 and time of administration of the vaccine was either 10:00 A.M or 11:00 A.M of 27-Oct-2022.  The vial was stored in refrigerator post puncture.  The vial did not undergo any temperature excursions.  The total amount of time during which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was less than 30 minutes.  It was reported that the patient had not reported any symptoms or side effects. No additional doses, medications,or treatments had been administered up to that point.   This case was linked to US-MODERNATX, INC.-MOD-2022-665352, US-MODERNATX, INC.-MOD-2022-665353 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665352:MOD-2022-665352 (patient 2) US-MODERNATX, INC.-MOD-2022-665353:MOD-2022-665353 (patient 3)