Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 19-May-2022 and then administered on 21-Jun-2022; Expired vaccine dose administered after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-May-2022 and then administered on 21-Jun-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 027H21B, 026A21A and 031M20A) for COVID-19 prophylaxis.     Patient does not have any known allergies. Patient does not have any acute illness at the time of vaccination and up to one month before.  Previously administered products included for Product used for unknown indication: Influenza (Lot number - P100360866, Route - Intramuscular, Body site - Right Deltoid, Dose number 1.) on 07-Oct-2021, VARICELLA ZOSTER VACCINE (Lot number - C4NC5, Route - Intramuscular, Body site - Right Deltoid, Dose number 1.) on 03-Dec-2021, Zoster (Lot number - D4CZ3, Route - Intramuscular, Body site - Left Deltoid and Dose number 2.) on 08-Feb-2022. Past adverse reactions to the above products included No adverse event with Influenza, VARICELLA ZOSTER VACCINE and Zoster. Concurrent medical conditions included Atrial fibrillation since 16-Nov-2017, Peripheral vascular disease since 04-Aug-2020, Hypertension since 14-May-2019, Type 2 diabetes mellitus since 16-Nov-2015 and Coronary artery disease since 28-Oct-2004. Concomitant products included RIVAROXABAN from 09-Mar-2021 to an unknown date for AFib, CLOPIDOGREL from 10-Dec-2020 to an unknown date, ATORVASTATIN from 16-Feb-2021 to an unknown date and LISINOPRIL from 13-Jan-2021 to an unknown date for Coronary artery disease, METFORMIN from 05-Dec-2020 to an unknown date for Type 2 diabetes mellitus.   On 13-Feb-2021 at 1:51 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Dec-2021 at 1:27 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022 at 2:04 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-May-2022 and then administered on 21-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-May-2022 and then administered on 21-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received a booster dose of Moderna COVID vaccine on 21-Jun-2022, vaccine had reached working expiration on 18-Jun-2022 but Manufacturer expiration date was 13-Aug-2022. The vial was initially stored in the refrigerator on 19-May-2022 and the vial did not undergo any temperature excursions. No adverse events had occurred. No treatment medication was reported.