Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25 Apr 22, after 30-day Use By Date or after manufacturer date of expiry.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 077C12B, 003B21A and 010A21A) for COVID-19 vaccination. Patient had not diagnosed or tested positive for COVID-19. Concurrent medical conditions included Penicillin allergy. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 10:50 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 10:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25 Apr 22, after 30-day Use By Date or after manufacturer date of expiry.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25 Apr 22, after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25 Apr 22, after 30-day Use By Date or after manufacturer date of expiry) to be related. No concomitant information was reported. The patient not had any acute illness at the time of vaccination and up to 1 month before and did not received any vaccine one month prior to Moderna Covid-19 vaccine. It was unknown if the patient had experienced similar adverse event in the past and there were no any other potential causes for the event. The event does not caused the patient to seek medical care. The patient received dose after manufacturer date of expiry. Date the vial was initially stored in the refrigerator was 25 Apr 22 and the vaccine was administered on the same date. The vial did not undergo any temperature excursions. Reporter stated that a few months ago the Vial Expiration Look up Tool displayed 26 Apr 2022 as the expiration date of Lot number 022J21A, so they administered Moderna booster dose to the patient on 25 Apr 2022, and that they checked the expiration date again in the tool, the new expiration date was 24 Apr 2022. Reporter stated that the expiration date changed. No treatment information was reported.