Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-2022, after manufacturer date of expiry 24-Apr-2022; Expired vaccine administered to the patient; 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-2022, after manufacturer date of expiry 24-Apr-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 010A21A, 003B21A and 019F21A) for COVID-19 vaccination.     The patient did not have any known drug allergies. The patient has no acute illness at the time of vaccination and up to one month before. It was unknown that patient ever tested positive or diagnosed with COVID-19. It was also unknown that if patient had any chronic conditions.    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 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 3:25 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 3:25 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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-2022, after manufacturer date of expiry 24-Apr-2022). 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-2022, after manufacturer date of expiry 24-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) to be not related. No further causality assessment was provided for 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-2022, after manufacturer date of expiry 24-Apr-2022).    Concomitant medication information was unknown.  It was unknown if the patient was taking any over the count, herbal remedies at the time of vaccination.  The vials were initially stored in refrigerator on 25-Apr-2022. The vials has not undergone temperature excursion. It was reported Moderna booster was given on 25-Apr-2022, thinking that expiration date was 26-Apr-2022. Later noticed that vaccine expiration date was 24-Apr-2022. It was reported that the event did not cause the patient to seek medical care. There was not any potential cause. The patient did not experience similar events in past. Dose or volume of dose number 3 and 4 was reported as 0.25.   Treatment medication information was given.