Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 16-Mar-2023 and was administered on 20-Apr-2023; No adverse event; Patient received Moderna COVID-19 vaccine Bivalent after 30 days beyond use date on 20-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine Bivalent after 30 days beyond use date on 20-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 066H22A, 001M21A, 939905, 029K20A and 011M20A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No known allergies to medications, food, and other products reported. It was unknown if patient diagnosed with/ tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before and Chronic or long-standing health conditions were reported unknown.    On 04-Jan-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Feb-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .5 milliliter. On 03-Nov-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-Apr-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 20-Apr-2023, received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine Bivalent after 30 days beyond use date on 20-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine Bivalent after 30 days beyond use date on 20-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and was administered on 20-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine Bivalent after 30 days beyond use date on 20-Apr-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and was administered on 20-Apr-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional Booster. The BUD date was reported as 15-Apr-2023. The 2.5 ml vial did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720516 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2023: Follow-up received included vaccine dose details added, race added. On 12-May-2023: Live non significant follow up received. On 12-May-2023: Live non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720516:1st patient case (Master case)