Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 15-MAR-2023 and administered to patient on 21-APR-2023.; No adverse event; Pharmacist seeking guidance when the Moderna Bivalent vaccine is given at 37 days past use by date./Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist seeking guidance when the Moderna Bivalent vaccine is given at 37 days past use by date./Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 15-MAR-2023 and administered to patient on 21-APR-2023.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Apr-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 (Pharmacist seeking guidance when the Moderna Bivalent vaccine is given at 37 days past use by date./Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 15-MAR-2023 and administered to patient on 21-APR-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist seeking guidance when the Moderna Bivalent vaccine is given at 37 days past use by date./Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 15-MAR-2023 and administered to patient on 21-APR-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 (Pharmacist seeking guidance when the Moderna Bivalent vaccine is given at 37 days past use by date./Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 15-MAR-2023 and administered to patient on 21-APR-2023.).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Vial size was reported as 2.5 ml. Vial was initially stored in refrigerator on 15-MAR-2023. Vial did not undergo any temperature excursion. Individual vial was reported in source document. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721025:Same Reporter