Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 30-JAN-2023, vaccine was administered on 02-MAR-2023; No adverse event; Patient had received a dose of the Moderna COVID-19 bivalent vaccine after a beyond use date of 01-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had received a dose of the Moderna COVID-19 bivalent vaccine after a beyond use date of 01-MAR-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, vaccine was administered on 02-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, 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 02-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 (Patient had received a dose of the Moderna COVID-19 bivalent vaccine after a beyond use date of 01-MAR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, vaccine was administered on 02-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had received a dose of the Moderna COVID-19 bivalent vaccine after a beyond use date of 01-MAR-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, vaccine was administered on 02-MAR-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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had received a dose of the Moderna COVID-19 bivalent vaccine after a beyond use date of 01-MAR-2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, vaccine was administered on 02-MAR-2023).    No concomitant medications were reported. Patient did not report any adverse reactions Vial was initially stored in the refrigerator on 30-JAN-2023 and BUD was 01-MAR-2023. Vial did not undergo any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714608, US-MODERNATX, INC.-MOD-2023-714729, US-MODERNATX, INC.-MOD-2023-714789, US-MODERNATX, INC.-MOD-2023-714792 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714608:Same reporter US-MODERNATX, INC.-MOD-2023-714729:Same reporter US-MODERNATX, INC.-MOD-2023-714789:Same reporter US-MODERNATX, INC.-MOD-2023-714792:Same reporter