Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product Storage error; 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 an other health care professional 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 (Product Storage error) 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 patient had acute illnesses at the time of vaccination and up to one month before.  It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.  It was unknown if patient had chronic or long-standing health conditions.    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 30-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 (Product Storage error) 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 (Product Storage error) 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 (Product Storage error).    No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions. It was unknown the patient experienced any similar event in the past. It was unknown the cause of patient to seek medical care (office visit, Urgent care, ER, hospitalized). Reporter provided some information on the recipients of booster doses of expired Moderna COVID-19 vaccine. It was unknown patient had other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No adverse event were reported.  It was reported that Moderna booster had given to patient on 08-Jun-2022, 19 days after expiration date.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow up received on 01-Sep-2022. Suspect product dose details, expiration date and relevant information were added. On 02-Sep-2022: Follow up received contains No New Information