Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 21-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 date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 21-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 066H22A and 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Apr-2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 21-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 date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 21-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 date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 21-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 date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 21-Apr-2023).    No concomitant medications were reported.  No adverse event was reported and a dose of the Moderna vaccine was given to the patient beyond the use by date of 13-Apr-2023.  The dose details of the fourth and third doses of Moderna vaccine was reported as 0.5.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722267 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:master case