Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine administered after punctured vial was left at room temperature for 22 hours; Bivalent Vaccine that was stored in room temperature for more that 12 hours was given to 2 patients/vaccine administered after punctured vial was left at room temperature for 22 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Bivalent Vaccine that was stored in room temperature for more that 12 hours was given to 2 patients/vaccine administered after punctured vial was left at room temperature for 22 hours), EXPIRED PRODUCT ADMINISTERED (vaccine administered after punctured vial was left at room temperature for 22 hours) and NO ADVERSE EVENT (no adverse event) in an 88-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2022 at 11:00 AM, 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 12-Nov-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after punctured vial was left at room temperature for 22 hours). In November 2022, the patient experienced PRODUCT STORAGE ERROR (Bivalent Vaccine that was stored in room temperature for more that 12 hours was given to 2 patients/vaccine administered after punctured vial was left at room temperature for 22 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Bivalent Vaccine that was stored in room temperature for more that 12 hours was given to 2 patients/vaccine administered after punctured vial was left at room temperature for 22 hours), EXPIRED PRODUCT ADMINISTERED (vaccine administered after punctured vial was left at room temperature for 22 hours) 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 PRODUCT STORAGE ERROR (Bivalent Vaccine that was stored in room temperature for more that 12 hours was given to 2 patients/vaccine administered after punctured vial was left at room temperature for 22 hours) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after punctured vial was left at room temperature for 22 hours).    No concomitant medications were reported.  The vial was initially stored in the refrigerator (initial thaw date) on 28-Oct-2022. Vial was first punctured on 11-Nov-2022 12:30 pm. Post puncture, vial was stored in room temperature for 22 hours. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-672547 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2022: Reporter added and Narrative updated. On 14-Nov-2022: Information added in i-narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672547:same reporter