Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023; No adverse event; use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     Patient had no known condition.     On 24-Mar-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-Mar-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 (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) 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 (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023) and PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023).    Concomitant medications were not reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered on 24-Mar-2023 BUD. Vials were moved from freezer to refrigerator fridge since 22-Feb-2023 with a use by 23-Mar-2023. No AEs were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717199 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live Follow up included narrative updated, reporter information updated,; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717199:Master case