Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: bivalent vaccine 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 vaccine were stored in refrigerator beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male 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 Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 31-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 23-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 07-Jan-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 24-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 24-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 vaccine 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 vaccine 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 vaccine were stored in refrigerator beyond the 30 day BUD).    No concomitant medications was reported. The doses given were from 3 different vials with the same lot number. The vials were initially stored in the refrigerator on 21-Jan-2021.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714711, US-MODERNATX, INC.-MOD-2023-714710, US-MODERNATX, INC.-MOD-2023-714730 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2023: Live Significant follow up received: Patient details and Relevant Past Drug History added.Drug information, Case summary updated. On 08-Mar-2023: Live non significant follow up received; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714711:Patient S-S US-MODERNATX, INC.-MOD-2023-714710:Patient A-O US-MODERNATX, INC.-MOD-2023-714730:Patient S-O