Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022; No adverse event; Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (Lot number 557B3 on right arm  intramuscular.) and FluBlok (Lot number QFAA2238 on right arm  intramuscular.). Past adverse reactions to the above products included No adverse reaction with FluBlok and Shingrix.   On 07-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022).    No concomitant medications were reported. Patient received 0.5 mL of Moderna COVID-19 vaccine as dose 1 on 24-Apr-2021 on right arm with Lot/Batch number 008C21A. Patient received 0.5 mL of Moderna COVID-19 vaccine as dose 2 on 22-May-2021 on right arm with Lot/Batch number 026C21A. Patient received Moderna COVID-19 vaccine as dose 3 on 03-Jan-2022 on right arm with Lot/Batch number 060H21A. The pharmacist stated that she had a Moderna vaccine that had been punctured and used. The vial size was 2.5 mL. It was in their fridge for 32 days. Patient was administered a Moderna vaccine from a vial with a fridge BUD of 05-Nov-2022 (removed from freezer and put in fridge on 06-Oct2022) on 07-Nov-2022. Patient had reported no issues and was just waiting to hear back about re-vaccinating.  The patient did not experience a similar event in the past. The vial did not undergo any temperature excursions. No treatment drugs were reported.