Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023; No adverse event; Dose was administered after more than 12 hours post first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture), PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 60-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.     No Medical History information was reported.    On 24-Feb-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 24-Feb-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 (Dose was administered after more than 12 hours post first vial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture), PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-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 (Dose was administered after more than 12 hours post first vial puncture) and PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023).    The concomitant medication was not reported.  The date of last administration was 24-Feb-2023.  The treatment medication was not reported. The dose was administered more than 12 hours post puncture. It was confirmed that the vial had not undergone any temperature excursion issue. The information about individual vial used was unknown. The vial was initially stored in the refrigerator on 20-Feb-2023, first punctured on 21-Feb-2023 at 06:00 am.  Administered on 24-Feb-2023 at 07:45 am and 8.45 am  respectively. None of the patients had reported any adverse events after the vaccination.   Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712701 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Non-significant follow up received, updated reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712701:60 years old patient