Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Allergies to medication, food and other products were unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.     On 18-Nov-2022 at 8:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Nov-2022 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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 not related and EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date 17-Nov-2022) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022).    On 11-Dec-2021, patient received third dose of Moderna COVID-19 vaccine (intramuscular). On 01-May-2021, patient received second dose of Moderna COVID-19 vaccine (intramuscular). On 03-Apr-2021, patient received first dose of Moderna COVID-19 vaccine (intramuscular). Prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event was unknown. It was reported that 14 doses of the bivalent Moderna COVID-19 vaccine were given after the beyond use date BUD. Individual vials of vial size 2.5ml. The vial was initially stored in the refrigerator on 18-Oct-2022. The vial had not undergone any temperature excursions. The event had not caused patient to seek medical care. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675238, US-MODERNATX, INC.-MOD-2022-675258, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675261, US-MODERNATX, INC.-MOD-2022-675262, US-MODERNATX, INC.-MOD-2022-675263, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675265, US-MODERNATX, INC.-MOD-2022-675266, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270, US-MODERNATX, INC.-MOD-2022-675271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675238:same reporter US-MODERNATX, INC.-MOD-2022-675258:same reporter US-MODERNATX, INC.-MOD-2022-675259:same reporter US-MODERNATX, INC.-MOD-2022-675260:same reporter US-MODERNATX, INC.-MOD-2022-675261:same reporter US-MODERNATX, INC.-MOD-2022-675262:same reporter US-MODERNATX, INC.-MOD-2022-675263:same reporter US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675265:same reporter US-MODERNATX, INC.-MOD-2022-675266:same reporter US-MODERNATX, INC.-MOD-2022-675268:same reporter US-MODERNATX, INC.-MOD-2022-675269:same reporter US-MODERNATX, INC.-MOD-2022-675270:same reporter US-MODERNATX, INC.-MOD-2022-675271:same reporter