Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 070H21A, 043B21A and 027C21A) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy, Allergy to nuts (tree nut) and Food allergy (Wheat). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022) 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) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022). No concomitant drug information was provided. Patient never been diagnosed with or tested positive for COVID-19. Patient did not have any acute illnesses at the time of vaccination. It was reported that the expired vial was placed in refrigerator on 21-Oct-2021 and was clearly labelled not to use as the vaccine  which was 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.  As per Moderna CMC Lot analysis, regarding dose(s) administered on 24-Aug-2022: Moderna cannot guarantee patients received full protection against the COVID-19 Virus No treatment drug information was provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Live Follow-up has been received in which Reporter information and Narrative  were  updated. On 25-Aug-2022: Live Follow-up has been received, Suspect drug information and I narrative was updated.