Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM; No adverse event; Patient administered dose of the bivalent booster which were beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023 at 2:22 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Feb-2023 at 2:22 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM) 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 (Patient administered dose of the bivalent booster which were beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM).    No concomitant medications were reported.  Pharmacist reports that they inadvertently administered 4 doses of the bivalent booster which were beyond the 30-day BUD. 2 doses were administered on 06Feb2023 and 2 doses on 07Feb2023.  It was reported the patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  It was reported the patient had any acute illness at the time of vaccination and up to 1 month before and chronic long -Standing health conditions were unknown.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709192, US-MODERNATX, INC.-MOD-2023-710235, US-MODERNATX, INC.-MOD-2023-710239 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710235:Patient   US-MODERNATX, INC.-MOD-2023-709192:Patient - Female US-MODERNATX, INC.-MOD-2023-710239:Patient