Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 14-Jan-2023 and administered on 16-Feb-2023.; No Adverse Event; Pharmacist inadvertently gave vaccine past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently gave vaccine past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jan-2023 and administered on 16-Feb-2023.) and NO ADVERSE EVENT (No Adverse Event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Janssen Covid-19 vaccine (Dose 1 at Walmart) on 19-Nov-2021. Past adverse reactions to the above products included No adverse reaction with Janssen Covid-19 vaccine. Concurrent medical conditions included Drug allergy. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    On 16-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently gave vaccine past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jan-2023 and administered on 16-Feb-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently gave vaccine past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023.) had not resolved and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jan-2023 and administered on 16-Feb-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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently gave vaccine past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023.) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jan-2023 and administered on 16-Feb-2023.).    It was unknown if patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. Pharmacist reported that they inadvertently gave some vaccines past the 30-day BUD date of 13-Feb-2023 and were administered on 16-Feb-2023. The vial size was reported as 2.5 ml. It was reported that vial was initially stored in refrigerator on 14-Jan-2023 and administered on 16-Feb-2023. It was reported that the vial did not undergo temperature excursions. No treatment information was reported.