Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; Dose administered past manufactures expiration date; 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) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     It was unknown if patient had allergies to medications, food and other products. It was unknown if patient had diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Cerebral palsy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:20 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown.        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 assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    No concomitant product reported by reporter.  Prescriptions, over-the-counter medications, dietary supplements, herbal remedies being taken at the time of vaccination and or at the time of adverse event was reported as unknown. It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03 May 2022 and was put in refrigerator until approximately 1:45 PM.  No treatment medication reported by reporter.