Age: 70.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.), PRODUCT STORAGE ERROR (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.) and NO ADVERSE EVENT (no adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.), PRODUCT STORAGE ERROR (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.) 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 gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.) and PRODUCT STORAGE ERROR (Inadvertently gave a dose of the bivalent booster from a vial that had been in the refrigerator for 34 days (4 days past when it should have been salvaged)/ Inadvertently gave a Moderna bivalent vaccine 4 days after 30-day window.).    No concomitant medications were reported.  No treatment medications were reported.  Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2023: Live Follow-up  Significant information accepted-Patient details updated, Vaccine administration date updated.