Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022.; No Adverse Event; given bivalent dose which was beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022.) and NO ADVERSE EVENT (No Adverse Event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products. It was unknown  whether patient had been diagnosed with or tested positive for COVID-19.    On 17-Feb-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Mar-2022, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2022, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022.) 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 (given bivalent dose which was beyond the 30 use by date) and NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022.).    No concomitant medication was provided.  Vial size was reported as 2.5ml. It was reported that vial was initially stored in the refrigerator on 22-Sep-2022 at 12:00pm. Vial did not undergo any temperature excursions.The event did not cause patient to seek medical case. There was no other potential cause. It was unknown whether patient experienced similar event in the past.  It was reported that no treatment was required.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2022: Significant follow up received contains reporter added, patient details added, suspect details added, causality of event updated, narrative updated.