Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023; No adverse event; Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 02-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Depression, Hypothyroidism and Gastrointestinal disorder (some stomach acidity).    On 09-Mar-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 09-Mar-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 reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023) 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 reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  It was reported that the only other vaccination record they have is that the patient had Pfizer on, not indicated which dose this was. No treatment information was provided by the reporter.