Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Stored in refrigerator on 02-JUN-2022, Administered on 05-JUL-2022 and expired on 15-OCT-2022; Dose administered after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date) and PRODUCT STORAGE ERROR (Stored in refrigerator on 02-JUN-2022, Administered on 05-JUL-2022 and expired on 15-OCT-2022) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 011F21A, 026A21A and 031M20A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed or tested positive for COVID-19.Also there was no acute illness at the time of vaccination or one month before. Patient had no known allergies.  Previously administered products included for Drug use for unknown indication: Influenza (Afluria) (Lot no.P100367231, Route- Intramuscular, body site-right deltoid.) on 02-Nov-2021, PNEUMOCOCCAL VACCINE (Lot no.FJ2605, Route- Intramuscular and body site-left deltoid.) on 05-Jul-2022. Past adverse reactions to the above products included No adverse event with Influenza (Afluria) and PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Hypertension since 26-Apr-2016 and Hypokalemia since 26-Apr-2016. Concomitant products included ENALAPRIL from 06-Apr-2016 to an unknown date, HYDROCHLOROTHIAZIDE from 06-Apr-2016 to an unknown date and METOPROLOL TARTRATE from 06-Apr-2016 to an unknown date for Hypertension, POTASSIUM CHLORIDE from 06-Apr-2016 to an unknown date for Hypokalemia.   On 10-Feb-2021 at 10:28 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Mar-2021 at 3:31 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Nov-2021 at 9:14 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 12:56 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored in refrigerator on 02-JUN-2022, Administered on 05-JUL-2022 and expired on 15-OCT-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date) and PRODUCT STORAGE ERROR (Stored in refrigerator on 02-JUN-2022, Administered on 05-JUL-2022 and expired on 15-OCT-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients received expired booster MODERNA COVID-19 vaccine on 05-JUL-2022 through 07-JUL-2022.Total number doses15 doses/ 3 red cap vials. The vial was initially stored in refrigerator on 02-JUN-2022 and the vial did not undergo any temperature excursions.  No adverse events were noted in patients.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-604302 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-604302:Master case