Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Extra dose administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023; No adverse event; Dose administered after 30-day Use By Date; Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023), EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    In November 2022, 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 13-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 13-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023), EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-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 (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023) and EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023).    No concomitant medications were provided. The vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 11-Apr-2023 . The vial did not undergo any temperature excursions. No reports of side effects were reported by patient after receiving the vaccine. No treatment medication was provided.