Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours then administerd; vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours; patient received a Moderna booster that was drawn up27 hours prior to giving(so beyond use)/administer a vaccine to a patient that was drawn up on the 31May2022 and was giving more than 24 hours later; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster that was drawn up27 hours prior to giving(so beyond use)/administer a vaccine to a patient that was drawn up on the 31May2022 and was giving more than 24 hours later), PRODUCT STORAGE ERROR (vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours then administerd) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 004F21A, 007C21A and 020B21A) for COVID-19 vaccination.     Patient had no known allergies. Patient was never tested positive or diagnosed with COVID-19. Patient  does not have any acute or chronic illness during the time of vaccination. Patient does not received any other vaccine one month prior to the Moderna COVID-19 vaccine.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022 at 10:41 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022 at 10:41 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster that was drawn up27 hours prior to giving(so beyond use)/administer a vaccine to a patient that was drawn up on the 31May2022 and was giving more than 24 hours later). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours then administerd) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster that was drawn up27 hours prior to giving(so beyond use)/administer a vaccine to a patient that was drawn up on the 31May2022 and was giving more than 24 hours later), PRODUCT STORAGE ERROR (vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours then administerd) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines were store in syringes that were at room temperature for up three hours and then kept in the refrigerator for 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that one dose out of a vial administered to a patient that was drawn up on the 31-May-2022 and was giving more than 24 hours late. The vaccine was initially stored in refrigerator on 21-May-2022. The vail was first punctured on 31-May-2022 7:30 AM. Post puncture vaccine was stored in fridge in an individual syringe. The vial was exposed to room temperature (8 to 25 degree centigrade) for almost 3 hours.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow-up- reporter contact information, patient details, dosage information, batch details, event, narrative updated.