Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date; 0.5 ml of booster dose was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date), ACCIDENTAL OVERDOSE (0.5 ml of booster dose was administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient not had known allergies. It was unknown if the patient was diagnosed or tested for COVID-19. The patient unknown if had acute illness at the time of vaccination and up to one month before and unknown if had chronic or long-lasting health conditions.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:40 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (0.5 ml of booster dose was administered). On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date), ACCIDENTAL OVERDOSE (0.5 ml of booster dose was administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessments were provided for ACCIDENTAL OVERDOSE (0.5 ml of booster dose was administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM).    No concomitant medications was reported.  The patient received after dose 30-day use by date or after manufacturer date of expiry on 03-May-2022. On same date, the vial was pulled from freezer at 10AM and was again put in refrigerator until approximately till 1:45 PM. The vial did not undergo any temperature excursions.  No treatment medications was reported.