Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023; No adverse event; Dose administered after 30-day Use By Date/Beyond Use Date bivalent vaccine administered, no notable effects; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/Beyond Use Date bivalent vaccine administered, no notable effects), PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19. The patient did not have any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had any chronic or long-standing health conditions.     On 08-May-2023 at 10:00 AM, 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 08-May-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/Beyond Use Date bivalent vaccine administered, no notable effects). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-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/Beyond Use Date bivalent vaccine administered, no notable effects), PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-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/Beyond Use Date bivalent vaccine administered, no notable effects) and PRODUCT STORAGE ERROR (The vial was removed from freezer to refrigerator on 02-Feb-2023 and was administered on 08-May-2023).    It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  The patient received the dose 1 of Moderna vaccine on 15-Feb-2021 and dose 2 of Moderna vaccine on 16-Mar-2021, both at a dose of 100 mcg. The patient received the dose 3 of Moderna vaccine on 27-Oct-2021 and dose 4 of Moderna vaccine on 14-Nov-2022.  It was reported that the event did not cause the patient to seek medical care.   It was reported that the patient was administered Bivalent dose outside of use date due to removal from freezer to refrigerator. The vaccine was stored in the refrigerator at a temperature of 41-degree Fahrenheit. The vial did not undergo any temperature excursions.  The patient denied any adverse event.  Treatment medication of the patient was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2023: Upon follow-up received, report type of the case was updated from invalid to spontaneous due to addition of patient details (patient initials, age, gender and race), secondary reporter added, suspect vaccine dosing details (administration date) was updated, onset date for the event expired product administered was updated and event description was updated.