Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Wrong technique in product usage process
Clinical narrative: given vaccine in a prefilled syringe which had been at room temp more than 12hours; given vaccine in a prefilled syringe which had been at room temp more than 12hours; given vaccine in a prefilled syringe which had been at room temp more than 12hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine in a prefilled syringe which had been at room temp more than 12hours), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (given vaccine in a prefilled syringe which had been at room temp more than 12hours) and PRODUCT STORAGE ERROR (given vaccine in a prefilled syringe which had been at room temp more than 12hours) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 013F21A, 007B21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-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 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (given vaccine in a prefilled syringe which had been at room temp more than 12hours). On 18-May-2022 at 1:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine in a prefilled syringe which had been at room temp more than 12hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine in a prefilled syringe which had been at room temp more than 12hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine in a prefilled syringe which had been at room temp more than 12hours), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (given vaccine in a prefilled syringe which had been at room temp more than 12hours) and PRODUCT STORAGE ERROR (given vaccine in a prefilled syringe which had been at room temp more than 12hours) 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.  Vial was initially took out from the freezer on 17-May-2022 at 9:00am and then stored in the refrigerator. Vial was first punctured on 17-May-2022 around 1:00pm and vaccine provider drew some more up around 3:00pm. Post puncture vial was left at room temperature.  The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature (at range 8 degree Celsius to 25 degree Celsius, 46 degree F to 77 degree F) was reported as from around 3pm approximately on 17-May-2022 to 1:00pm on 18-May-2022.  Pharmacy technician reported that they inadvertently administered a dose of the Moderna Covid-19 vaccine on 18-May-2022 at around 13:20 from a prefilled syringe which had been at room temperature since 3:00pm of 17-May-2022. This was the patient's second booster dose and they wanted to know if Moderna had information regarding the potential side effect the patient might experience.   No adverse event had been reported at the time of the reporting.  No treatment medication were provided.