Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator 05-Aug-2022 and date of administration of vaccine 06-Sep-2022 from 9:15 to 9:45; No adverse event; Patient received Moderna Covid-19 vaccine 30 days past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 05-Aug-2022 and date of administration of vaccine 06-Sep-2022 from 9:15 to 9:45) and NO ADVERSE EVENT (No adverse event) in a 23-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR92347B and AR9237B) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 05-Aug-2022 and date of administration of vaccine 06-Sep-2022 from 9:15 to 9:45) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 05-Aug-2022 and date of administration of vaccine 06-Sep-2022 from 9:15 to 9:45) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 05-Aug-2022 and date of administration of vaccine 06-Sep-2022 from 9:15 to 9:45).    Concomitant product use was not provided by the reporter.  The patient had no adverse reactions after first dose.  During the second dose, the patient received Moderna COVID-19 vaccine 30 days past its use by date. The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642059, US-MODERNATX, INC.-MOD-2022-642869, US-MODERNATX, INC.-MOD-2022-642060 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Live follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642057:Same reporter US-MODERNATX, INC.-MOD-2022-642059:Same reporter US-MODERNATX, INC.-MOD-2022-642869:Same reporter US-MODERNATX, INC.-MOD-2022-642060:Same reporter