Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine had expired on 13-May-2022, but was it was refrigerated on 17-May-2022 and later administered on  08-June-2022.; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vaccine had expired on 13-May-2022, but was it was refrigerated on 17-May-2022 and later administered on  08-June-2022.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 034F21A, 040B21A and 037A21B) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medications, food and other products. Also it was unknown if patient diagnosed or tested positive with COVID-19.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 9:15 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 9:15 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 (Vaccine had expired on 13-May-2022, but was it was refrigerated on 17-May-2022 and later administered on  08-June-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vaccine had expired on 13-May-2022, but was it was refrigerated on 17-May-2022 and later administered on  08-June-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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 (Vaccine had expired on 13-May-2022, but was it was refrigerated on 17-May-2022 and later administered on  08-June-2022.).    Concomitant medication information was not provided by the reporter.  Vaccine had expired on 13-May-2022, but was it was refrigerated on 17-May-2022 and later administered on 08-June-2022.  It was unknown whether 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. It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown whether the patient had chronic or long-standing health conditions. The event did not cause the patient to seek medical care. There were no other potential causes. It was unknown whether the patient experienced a similar event in the past.  Treatment information was not provided by the reporter.   This case was linked to PR-MODERNATX, INC.-MOD-2022-586794 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-586794: