Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius), dose administered on 08-APR-2022.; Patient received Moderna vaccine Booster on 08-Apr-2022, vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30 day time in refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 08-Apr-2022, vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30 day time in refrigerator.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius), dose administered on 08-APR-2022.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 014F21A and 041C21A) for COVID-19 vaccination.     Patient not had acute illnesses at the time of vaccination and up to one month before. It was unknown that patient had any chronic illness or long-standing health conditions.  Concurrent medical conditions included Sulfonamide allergy (SULFA).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 08-Apr-2022, vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30 day time in refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius), dose administered on 08-APR-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 08-Apr-2022, vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30 day time in refrigerator.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius), dose administered on 08-APR-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 08-Apr-2022, vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30 day time in refrigerator.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius), dose administered on 08-APR-2022.) to be not related.    Patient's race was reported.  It was unknown if the patient had concomitant medications taken at time of vaccination and or at the time of the adverse event.  The vial was stored in the refrigerator since 07-Mar-2022 in temperatures between 2 to 8 degrees Celsius The vial did not undergo any temperature excursion. The event did not cause patient to seek medical care. The reporter did not report any other potential causes. It was unknown if the patient experienced a similar event in the past.  No information on treatment medications was reported.  It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.   This case was linked to MOD-2022-539513 (Patient Link).