Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: Date when the vials were stored in the refrigerator: 21Jan2023 and Dates of administration of vaccine: 03Mar2023; No adverse event; Pharmacist reports that they administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD; dose 4: 10/17/22- Pfizer bivalent booster / Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):drug_dosage_text : Additional Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 4: 10/17/22- Pfizer bivalent booster / Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):drug_dosage_text : Additional Booster), EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (Date when the vials were stored in the refrigerator: 21Jan2023 and Dates of administration of vaccine: 03Mar2023) and NO ADVERSE EVENT (No adverse event) in a 64-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 COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 07-Apr-2021, Moderna COVID-19 Vaccine (Dose 2) on 05-May-2021 and MODERNA COVID-19 VACCINE (Dose 3) on 02-Dec-2021; for Drug use for unknown indication: COMIRNATY (Dose 4 and Pfizer bivalent booster) on 17-Oct-2022. Past adverse reactions to the above products included No adverse event with COMIRNATY, MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 03-Mar-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 4: 10/17/22- Pfizer bivalent booster / Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):drug_dosage_text : Additional Booster). On 03-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date when the vials were stored in the refrigerator: 21Jan2023 and Dates of administration of vaccine: 03Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 4: 10/17/22- Pfizer bivalent booster / Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):drug_dosage_text : Additional Booster), EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (Date when the vials were stored in the refrigerator: 21Jan2023 and Dates of administration of vaccine: 03Mar2023) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 4: 10/17/22- Pfizer bivalent booster / Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):drug_dosage_text : Additional Booster), EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Date when the vials were stored in the refrigerator: 21Jan2023 and Dates of administration of vaccine: 03Mar2023).    No concomitant information was reported. Date when the vials were stored in the refrigerator: 21Jan2023.  Date of administration of vaccine: 03Mar2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714607 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2023: Live non-significant follow-up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714607:Master case