Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 21Oct2021 and administered on 24Aug2022; No adverse event; 2 patients received expired Moderna Covid-19 vaccine; Extra dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), EXTRA DOSE ADMINISTERED (Extra dose administered), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Oct2021 and administered on 24Aug2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 939905, 038A21A and 025A21a) for COVID-19 vaccination.     Patient didn't had any medications, food and other products allergies.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine) and EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Oct2021 and administered on 24Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), EXTRA DOSE ADMINISTERED (Extra dose administered), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Oct2021 and administered on 24Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), EXTRA DOSE ADMINISTERED (Extra dose administered) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Oct2021 and administered on 24Aug2022).    No concomitant drug information was provided.  It was unknown if the patient ever had COVID-19 test or diagnosis. It was reported that the expired vial was placed in refrigerator on 21Oct2021 and was clearly labelled not to use as the vaccine is expired. The vaccine continued to remain in the refrigerator until it was taken out of the refrigerator and administered to patients. The vial hadn't undergone any temperature excursion issue.  It was further reported by reporter that as per Moderna, Moderna can't guarantee patients received full protection.   No treatment drug information was provided.   This case was linked to MOD-2022-635361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Follow-up received, Narrative was updated. On 25-Aug-2022: Follow-up received, Suspect drug information and I narrative was updated.