Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vials were stored in the fridge was 14-Mar2023 and dose were administered on 14-Apr-2023,20-Apr-2023,21-Apr-2023, 23-Apr-2023 and 24-Apr-2023; no adverse event; inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The vials were stored in the fridge was 14-Mar2023 and dose were administered on 14-Apr-2023,20-Apr-2023,21-Apr-2023, 23-Apr-2023 and 24-Apr-2023) and NO ADVERSE EVENT (no adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2023, 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 24-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials were stored in the fridge was 14-Mar2023 and dose were administered on 14-Apr-2023,20-Apr-2023,21-Apr-2023, 23-Apr-2023 and 24-Apr-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The vials were stored in the fridge was 14-Mar2023 and dose were administered on 14-Apr-2023,20-Apr-2023,21-Apr-2023, 23-Apr-2023 and 24-Apr-2023) 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 (inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD) and PRODUCT STORAGE ERROR (The vials were stored in the fridge was 14-Mar2023 and dose were administered on 14-Apr-2023,20-Apr-2023,21-Apr-2023, 23-Apr-2023 and 24-Apr-2023).    No concomitant medications were reported.  It was reported that inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD. The vials were stored in the fridge on14-Mar-2023 and the dates of administration were 14Apr2023 (2 doses), 20Apr2023 (1 dose), 21Apr2023 (2 doses), 23Apr2023 (1 dose) and 24Apr2023 (2 doses). On 13-Sep-2021, 0.5 of dose 1 was administered to the patient with the batch no 014F21A at intramuscular body site. On 04-May-2022, 0.5 of dose 2 was administered to the patient with the batch no 004M21A at intramuscular body site. On 07-Oct-2022, 0.5 of dose 3 was administered to the patient with the batch no 057F22A at intramuscular body site.  5.5 of dose 4 was administered to the patient. There were no adverse events reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-722079, US-MODERNATX, INC.-MOD-2023-722085, US-MODERNATX, INC.-MOD-2023-722128, US-MODERNATX, INC.-MOD-2023-722151, US-MODERNATX, INC.-MOD-2023-722198, US-MODERNATX, INC.-MOD-2023-722207, US-MODERNATX, INC.-MOD-2023-722262, US-MODERNATX, INC.-MOD-2023-722084 (E2B Linked Report). This case was linked to MOD-2023-722960 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2023: Follow up received contains updated patient demographics, dose information and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722084:master case US-MODERNATX, INC.-MOD-2023-722085:Master Case US-MODERNATX, INC.-MOD-2023-722079:Master case (cluster case) US-MODERNATX, INC.-MOD-2023-722128:Case for 32 Year Female US-MODERNATX, INC.-MOD-2023-722207:Case for 65 Year Male US-MODERNATX, INC.-MOD-2023-722151:Case for 48 year Female US-MODERNATX, INC.-MOD-2023-722262:case for 81 year female US-MODERNATX, INC.-MOD-2023-722198:Case for 81 Year Male