Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022; No adverse event; Patients were provided vaccine after the published expiration date/ received Moderna COVID-19 vaccine that was expired and past the Manufacturers expiration date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were provided vaccine after the published expiration date/ received Moderna COVID-19 vaccine that was expired and past the Manufacturers expiration date), PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     It was unknown if the patient had any allergies.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were provided vaccine after the published expiration date/ received Moderna COVID-19 vaccine that was expired and past the Manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were provided vaccine after the published expiration date/ received Moderna COVID-19 vaccine that was expired and past the Manufacturers expiration date), PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-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 (Patients were provided vaccine after the published expiration date/ received Moderna COVID-19 vaccine that was expired and past the Manufacturers expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022).    No concomitant product reported by reporter. Vaccine was initially stored in refrigerator on 07-Jun-2022. Vial did not undergone any temperature excursion issue. the lot number was entered incorrectly or patients were provided vaccine. It was reported that 27 patients received expired vaccine after 19 days of expiry date. It was unknown if the patient got tested positive for COVID-19. It was unknown that other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No adverse events reported by the reporter. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Significant live follow-up received. Vaccine dose information added. Expiry date updated. On 02-Sep-2022: Follow-up information included non-significant information.