Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Bivalent vaccine administered after the 30 day beyond use date; The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022 and administered on 30-Oct-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered 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 62-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 Product used for unknown indication: Tdap (Dose 1, when patient was 52 yrs 1 month) on 24-Apr-2012, HEPATITIS A (Dose 1, when patient was 58 yrs 10 months) on 25-Jan-2019, Influenza IIV4 (Dose 1, P-Free-Inj, when patient was 60 yrs 5 months) on 02-Sep-2020, Sars-Cov-2 (Mod 100 mcg) on 21-Feb-2021, Sars-Cov-2 (Mod 100 mcg) on 21-Mar-2021, Sars-Cov-2 (Mod 100 mcg) on 27-Nov-2021, Sars-Cov-2 (Mod 100 mcg) on 16-Jul-2022, INFLUENZA VACCINE (Dose 2, P-Free-Inj and when patient was 62 yrs 5 months) on 04-Sep-2022. Past adverse reactions to the above products included No adverse event with HEPATITIS A, INFLUENZA VACCINE, Influenza IIV4, Sars-Cov-2, Sars-Cov-2, Sars-Cov-2, Sars-Cov-2 and Tdap.    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) .5 milliliter. In 2022, 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). On 30-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered 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 administered 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.        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 administered 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).    No concomitant product was reported. Patient had due vaccinations namely Td, MMR, Hepatitis A, Zoster RZV (Shingrix) and Hepatitis B was next due on 01-Apr-2022. Patient received Moderna vaccine first dose on 21-Feb-2021, 100 mcg; second dose on 21-Mar-2021, 100 mcg; third dose on 27-Nov-2021, 100 mcg and fourth dose on 16-Jul-2022, 100 mcg.  It was reported that patient was administered with bivalent vaccine dose after the 30 day beyond use date. Dose was administered on 30-Oct-2022 from lot number 027E22A, expiration date on vial was 18-May-2023. It was an individual vial within broken carton with vial size of 2.5 ml. The vaccine was initially moved from the freezer to the refrigerator on 29-Sep-2022.  Patient was administered with expired vaccine and the error was discovered on 31-Oct-2022. Moderna was contacted for further analysis where it was analyzed that the vaccine maintained the activity necessary to protect against the virus at the time of administration. No reported symptoms. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-666556 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666556:Same reporter