Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Expired product administered, No adverse event, Product storage error
Clinical narrative: Covid-19; Vial was initially stored in the refrigerator on 05-JUN-2023 and administered to patient 19-JUL-2023 after 30-day Use by Date or after Manufacturer Date of Expiry; No adverse event; 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 COVID-19 (Covid-19), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 05-JUN-2023 and administered to patient 19-JUL-2023 after 30-day Use by Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in a 74-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 19-Jul-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) .5 milliliter. On 19-Jul-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 administered after 30-day Use by Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced COVID-19 (Covid-19), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 05-JUN-2023 and administered to patient 19-JUL-2023 after 30-day Use by Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 (Covid-19), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 05-JUN-2023 and administered to patient 19-JUL-2023 after 30-day Use by Date or after Manufacturer Date of Expiry) 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 COVID-19 (Covid-19), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 05-JUN-2023 and administered to patient 19-JUL-2023 after 30-day Use by Date or after Manufacturer Date of Expiry).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Information about previous COVID-19 vaccination Doses were Dose 1 and Dose 2 was unknown and Dose 3 gave on 28Oct2021 with LOT 026D21A and Dose 4 on 12 Jul 2022 with LOT 064B22A  No concomitant medication was reported.  Vial size was 2.5 mL. Dosage text for suspect product was reported as unknown. Date the vial was initially stored in the refrigerator on 05-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 1 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-734837 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734837:Patient 1