Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 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 patient 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 patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (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 66-year-old female 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.     Previously administered products included for Product used for unknown indication: tdap on 13-Nov-2017, COVID-19 (PFR 30 mcg) (PFR 30 mcg, 64 years 10 months) on 05-Mar-2021, COVID-19 (PFR 30 mcg) (PFR 30 mcg, 64 years 11 months) on 31-Mar-2021, influenza iiv4 (IIV 4 high dose, (Inject), 65 years 6 months) on 29-Oct-2021, COVID-19 (PFR 30 mcg) (PFR 30 mcg, 65 years 6 months) on 29-Oct-2021, COVID-19 (PFR 30 mcg) (PFR-BNT 30 mcg/0.3 ml) on 20-Apr-2022, Fluad Quad (IIV 4, (P- Free Inject) and 66 years 6 months) on 29-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 (PFR 30 mcg), COVID-19 (PFR 30 mcg), COVID-19 (PFR 30 mcg), COVID-19 (PFR 30 mcg), Fluad Quad, influenza iiv4 and tdap. Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for an unknown indication.    On 30-Oct-2022, the patient received fifth 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 patient after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (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 patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (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 patient after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022).    Patient age was 66 year 7 months.  Individual vials within broken carton and vial size were 2.5mL. Date the vial was initially stored in the refrigerator was 29-Sep-2022. Vial did not undergo any temperature excursions.  10 patients had administered 10 doses of the bivalent vaccine after the 30 days beyond use. The by use date of the product was 29-Oct-2022. The error was discovered on 31-Oct-2022. No reported symptoms. Since the vaccine was evaluated as valid, no adverse event occurred.   Treatment drug was not reported.