Age: 3.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/: Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/: Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2023, 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 22-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/: Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/: Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/: Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23.).    No concomitant medication were reported.  HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 days use by date.  Reporter does not have patient information at this time as the error occurred at a different facility. She states that the patients could have possibly been 2 infants and 1 adult impacted by this invalid dose.   It was reported that Moderna vaccine lot 044C22A BUD 22Jan2023 used on 23Jan2023 and Lot 215K22A BUD 20Jan2023 and given on 23Jan2023.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Non significant live follow up On 31-Jan-2023: Follow up received contains no new information. On 31-Jan-2023: Non-significant follow-up appended On 15-Feb-2023: Follow up received included significant information reporter details, patient's demographics and LOT number was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706705:Master Case