Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: The vial expired on 02-May-2022, was pulled from freezer at 10 am on 03-May-2022 and was put in refrigerator until approximately 1:45 pm; administered dose past manufactures expiration date; The patient received 0.5 mL dose as first booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past manufactures expiration date), PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10 am on 03-May-2022 and was put in refrigerator until approximately 1:45 pm) and ACCIDENTAL OVERDOSE (The patient received 0.5 mL dose as first booster dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     It was unknown if the patient had any allergies to medications, food and other products. It was also unknown, if the patient was ever been diagnosed with/tested positive for COVID-19. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was also unknown if patient had any chronic or long-standing health conditions.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (The patient received 0.5 mL dose as first booster dose). On 03-May-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10 am on 03-May-2022 and was put in refrigerator until approximately 1:45 pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered dose past manufactures expiration date), PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10 am on 03-May-2022 and was put in refrigerator until approximately 1:45 pm) and ACCIDENTAL OVERDOSE (The patient received 0.5 mL dose as first booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered dose past manufactures expiration date) to be related. No further causality assessments were provided for PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10 am on 03-May-2022 and was put in refrigerator until approximately 1:45 pm) and ACCIDENTAL OVERDOSE (The patient received 0.5 mL dose as first booster dose).    Concomitant medication of the patient was not reported.   The vaccine was administrated on 03-May-2022 between 2-3 pm. As per HCP, the vial did not undergo any temperature excursions.  The event did not cause the patient to seek medical care. There were no other potential causes.  No treatment information was provided by the reporter.