Age: 78.0
Sex: M
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 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 (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 NO ADVERSE EVENT (no adverse event) in a 78-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 prophylaxis. 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 (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 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 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 (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 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 (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). No relevant concomitant medications were reported. Date the vial was initially stored in the refrigerator (initial thaw date) was 28-Oct-2022.Date and time vial was first punctured was 11-Nov-2022 at 12:30pm. Date and time of administration of vaccine was 12-Nov-2022 at 11 am. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 22 hours. No treatment information was provided. This case was linked to MOD-2022-672548 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2022: Live-significant follow up received contains reporter added, narrative updated. On 14-Nov-2022: Live significant follow-up received contains narrative updated.