Age: 8.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; They provided two infant vaccines past the expired time/A couple of kids (2) received the blue cap vials and the vials are expired because it was past the allowed time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They provided two infant vaccines past the expired time/A couple of kids (2) received the blue cap vials and the vials are expired because it was past the allowed time) and NO ADVERSE EVENT (No adverse event) in an 8-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023 at 10:28 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Jun-2023 at 10:28 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (They provided two infant vaccines past the expired time/A couple of kids (2) received the blue cap vials and the vials are expired because it was past the allowed time). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They provided two infant vaccines past the expired time/A couple of kids (2) received the blue cap vials and the vials are expired because it was past the allowed time) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (They provided two infant vaccines past the expired time/A couple of kids (2) received the blue cap vials and the vials are expired because it was past the allowed time).    The case was for Patient 1 out of 2 patients.  No concomitant medications were reported.   It was reported that the patient received Moderna monovalent primary series. The HCP states that the vaccines were reconstituted and then left out. She confirms it's the Moderna bivalent with blue cap. She states it was reconstituted with the sterile diluent and everything was fine up until they were administered. The MA had grabbed an old vial that was left on the counter. Then the nurse confirmed that the product was Moderna bivalent vaccine. She clarified that it was not reconstituted. It was punctured yesterday 20-Jun-2023 and administered today 21-Jun-2023. It was reported that the vial was initially stored in the refrigerator on 15-Jun-2023. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was unsure. The vial was not exposed to room temperature for more than 24 hours.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730164.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2023: Live Significant follow-up appended: Reporter added and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730164:Patient 2