Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022; No adverse event; bivalent vaccine were administered to patients after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccine were administered to patients after the 30 day beyond use date), PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     It was unknown whether patient had diagnosed with or tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: DTap on 07-Apr-1998, HEPATITIS A on 07-Apr-1998, Influenza (IIV3, High dose, 72 years 7 months) on 24-Oct-2019, prevnar 13 (72 years 9 months) on 27-Dec-2019, Fluad quad (IIV4, Pre filled injection, 73 years 8 months) on 17-Nov-2020, Fluad quad (IIV4, Pre filled injection and 74 years 8 months) on 14-Dec-2021. Past adverse reactions to the above products included No adverse event with DTap, Fluad quad, Fluad quad, HEPATITIS A, Influenza and prevnar 13. Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for an unknown indication.    On 30-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccine were administered to patients after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccine were administered to patients after the 30 day beyond use date), PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (bivalent vaccine were administered to patients after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022).    The size of the vial was 2.5ml.  The vial was initially stored in refrigerator on 29-Sep-2022.  The vial did not undergo any temperature excursions.  Patient got administered with Moderna as Dose 1 on 10-Feb-2021 (73 years 10 months), Dose 2 on 10-Mar-2021 (73 years 11 months) and Dose 3 on 28-Oct-2021 (74 years 7 months).  On 30-Oct-2022, 10 (ten) Moderna Bivalent vaccines were administered to 10 patients. The by-use-date on the product was 29Oct2022. LOT 027E22A. The error was discovered on 31Oct2022.  It was reported that patients had no reported symptoms, no additional doses, medications, or treatments.