Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Bivalent vaccine were administered to patients after the 30 day beyond use date; The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022; 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 29SEP2022 and administered on 30-Oct-2022) 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. 027E22A) for COVID-19 prophylaxis.     Previously administered products included for Pneumococcal infection: Prevnar 13 (PCV 13, 75 years 2 months, Series Complete) on 02-Mar-2015, Prevnar 13 (PCV 13, 76 years 2 months, Series Complete) on 08-Mar-2016, ZOSTAVAX (Zoster ZVL, 76 years 3 months, Due now) on 25-Mar-2016, PNEUMOVAX 23 (PPSV23 and 78 years 3 months; Series Complete) on 15-Mar-2018; for Product used for unknown indication: DTP (Dose 1 and Tdap (adol/adult) 76 years 2 months) on 08-Mar-2016; for Influenza: INFLUENZA (Seasonal influenza; Influenza IIV4 (P-Free Inj), 76 years 9 months, Season Complete) on 28-Sep-2016, INFLUENZA (Seasonal influenza; Influenza IIV3, High dose, 77 years 9 months, Season Complete) on 03-Oct-2017, INFLUENZA (Seasonal influenza; Influenza IIV3, High dose, 78 years 9 months, Season Complete) on 01-Oct-2018, INFLUENZA (Seasonal influenza; Influenza IIV3, High dose, 79 years 9 months, Season Complete) on 07-Oct-2019, FLUZONE HIGH DOSE QUADRIVALENT (Seasonal influenza; Influenza IIV4, High dose (FluZone HD Quad), 80 years 8 months, Season Complete) on 10-Sep-2020, FLUZONE HIGH DOSE QUADRIVALENT (Seasonal influenza; Influenza IIV4, High dose (FluZone HD Quad), 82 years 9 months and Season Complete) on 14-Sep-2022; for SARS-CoV-2 infection: MODERNA COVID-19 VACCINE (Dose 1, COVID-19 (MOD 100 mcg), Age - 81 years 1 month, Due now) on 16-Jan-2021, MODERNA COVID-19 VACCINE (Dose 2, COVID-19 (MOD 100 mcg), Age - 81 years 2 months) on 13-Feb-2021, MODERNA COVID-19 VACCINE (Dose 3, COVID-19 (MOD 100 mcg) and Age - 81 years 10 months) on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with DTP, FLUZONE HIGH DOSE QUADRIVALENT, FLUZONE HIGH DOSE QUADRIVALENT, INFLUENZA, INFLUENZA, INFLUENZA, INFLUENZA, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, PNEUMOVAX 23, Prevnar 13, Prevnar 13 and ZOSTAVAX.    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) .5 milliliter. On 29-Sep-2022, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022). 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 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 29SEP2022 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 29SEP2022 and administered on 30-Oct-2022).    Concomitant product use was not provided by the reporter.  Unknown if the patient was pregnant. Patient's race was reported as UNKNOWN. Unknown if the patient has ever been diagnosed with or tested positive for COVID-19. Unknown if the patient had acute illnesses at the time of vaccination and up to one month before. Unknown if the patient had chronic or long-standing health conditions.  On 30-Oct-2022, Moderna Bivalent vaccines were administered to 10 patients. The By-use-date on the product was 29-Oct-2022. The error was discovered on 31-Oct-2022.  They had administered 10 doses of the bivalent vaccine to patients after the 30 days beyond use date. The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666556 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666556:Master Case