Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 053C21A and 022C21A) for COVID-19 prophylaxis.     Allergies to medications, food, and other products was reported as unknown. Acute illnesses at the time of vaccination and up to one month before was reported as unknown. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-May-2022 at 11:13 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 11:13 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022).    No concomitant medication was provided by the reporter.  It was reported that expired vaccine was administered to more than 40 patients. They thought that Moderna had an extension like Pfizer, and they though it would expired on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022.  Vials did not undergo any temperature excursion.  Vaccines expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022.  The event did not cause the patient to seek medical care. There was not any other potential causes and  it was unknown if the patient experienced a similar event in the past.  No treatment medication was provided by the reporter.   This case was linked to MOD-2022-598085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2022: Follow up received contains significant information-Patient demographics, medical history, suspect product dose details, event product storage and causality for expired vaccine were updated. On 29-Jun-2022: Follow-up received contain No new information; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-598044:Master case (same reporter) PR-MODERNATX, INC.-MOD-2022-598047:MCN Number