Age: 39.0
Sex: F
Vaccine: 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 (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 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044C22A) 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,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (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 (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.        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 (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 case contains information for the 1st infant patient out of 3 patients (2 infants and 1 adult) described by the reporter.  No concomitant information was reported. Reporter wants to know if there was any stability information for this invalid dose and reporter states that the patients could had possibly been 2 infants and 1 adult impacted by this invalid dose. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706707, US-MODERNATX, INC.-MOD-2023-706711 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Follow-up received contains no new information On 31-Jan-2023: Live significant Follow-up contains Product information and narrative updated. On 31-Jan-2023: Follow-up received contains no new information On 15-Feb-2023: Significant follow-up: Patient details, Reporter details and lot number updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706707:Master Case US-MODERNATX, INC.-MOD-2023-706711:Master Case