Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product expiration date issue, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Sep-2022 and was administered on 28-Nov-2022; Caller would like to viability information because they had the wrong expiration date for the Covid-19 vaccine; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional 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 01-Sep-2022 and was administered on 28-Nov-2022), PRODUCT EXPIRATION DATE ISSUE (Caller would like to viability information because they had the wrong expiration date for the Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Nov-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 28-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and was administered on 28-Nov-2022), PRODUCT EXPIRATION DATE ISSUE (Caller would like to viability information because they had the wrong expiration date for the Covid-19 vaccine) 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 01-Sep-2022 and was administered on 28-Nov-2022), PRODUCT EXPIRATION DATE ISSUE (Caller would like to viability information because they had the wrong expiration date for the Covid-19 vaccine) 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 01-Sep-2022 and was administered on 28-Nov-2022) and PRODUCT EXPIRATION DATE ISSUE (Caller would like to viability information because they had the wrong expiration date for the Covid-19 vaccine).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The one dose vial did not underwent any temperature excursions. The vial was 01-Oct-2022. No treatment information was provided.