Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 24-Oct-2022 and administred on 13 Dec 2022; No adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 24-Oct-2022 and administred on 13 Dec 2022) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     It was unknown the patient ever been diagnosed with or tested positive for COVID-19. It was unknown that the patient had acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.     On 13-Dec-2022 at 12:28 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-Dec-2022 at 12:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 24-Oct-2022 and administred on 13 Dec 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 24-Oct-2022 and administred on 13 Dec 2022) 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 and EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 24-Oct-2022 and administred on 13 Dec 2022).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were unknown.  Reportedly, Patient had received first dose of moderna vaccine on 8-Mar-2021 11:33am, lot/batch number 010M20A, dose, volume 0.5mL, route and body site intramuscular, left arm. Patient had received second dose of moderna vaccine on 12-Apr-2021 8:54, lot/batch number 038A21A, dose, volume 0.5mL, route and body site intramuscular and right arm. Patient had received third dose of moderna vaccine on 22-Nov-2021 9:11, lot/batch number 076C21A, dose, volume 0.25mL, route and body site intramuscular and right arm.   Patient received COVID vaccine after expiration date. 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 08-Dec-2022 to 10-Jan-2023.  Date the vial was initially stored in the refrigerator was 24-Oct-2022.  Vial did not undergo any temperature excursions.  It as reported that the event did not cause the patient to seek medical care. It was unknown that any other potential causes related to the event and it was unknown if the patient experienced a similar event in the past.  No treatment medication was provided.  This case contains information of 14th adult patient as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live Significant Follow up received included patient demographics On 24-Jan-2023: Live follow-up contains no new information. On 22-Feb-2023: Follow up received contains significant information. Reporter information was updated. Patient demographic details, suspect product information (start time, dose number, anatomical site) was updated. Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case - 1st adult