Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: bivalent vaccines were stored in refrigerator beyond the 30 day BUD; No adverse event; administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (bivalent vaccines were stored in refrigerator beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 16-Nov-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 10-Dec-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 26-May-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 26-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (bivalent vaccines were stored in refrigerator beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (bivalent vaccines were stored in refrigerator beyond the 30 day BUD) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD) and PRODUCT STORAGE ERROR (bivalent vaccines were stored in refrigerator beyond the 30 day BUD).    Concomitant medication was not reported. There was no associated co-morbidity reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient administered Moderna bivalent booster. Pharmacist states that the doses given were from 3 different vials with the same lot number. Lot number was 059F22A, published expiration date on 15May2023. Initial date when the vials were stored in the refrigerator on 21Jan2021.   Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714607.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2023: Live follow-up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714607:Master case