Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; no adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     It was reported that patient had never diagnosed or tested positive for COVID-19. It was unknown if the patient had Acute illnesses at the time of vaccination and up to one month before vaccination. Also it was unknown if patient had an chronic or long standing health condition. It was unknown if patient Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event:.  Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE (Lot no : ER8730, Route: Intramuscular, Body site: Left arm, Dose: 0.3) on 06-Apr-2021, Covid-19 vaccine (Lot no : ER8733, Route: Intramuscular, Body site: Left arm and Dose: 0.3) on 27-Apr-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and Covid-19 vaccine.    On 26-May-2022 at 11:05 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-May-2022 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    No concomitant information was reported.  The event does not cause the patient to seek medical care. It was unknown whether there are any other potential causes for the event to occur and patient experienced any similar event in the past.   The used vial was stored in refrigerator on 26-May-2022. The vial did not undergo any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-586783 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-586783: