Age: 1.25
Sex: M
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 other adverse reactions are reported.; Pediatric 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 (Pediatric 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 other adverse reactions are reported.) in a 15-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric 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 other adverse reactions are reported.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric 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 other adverse reactions are reported.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No other adverse reactions are reported.) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric 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).    No concomitant product use was reported.   No adverse reactions were known of after first dose.  Number of doses/vials was 5 doses from 1 vial.  The vial was not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-642052, US-MODERNATX, INC.-MOD-2022-642059, US-MODERNATX, INC.-MOD-2022-642060, US-MODERNATX, INC.-MOD-2022-642869 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Live follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642052:Same reporter US-MODERNATX, INC.-MOD-2022-642059:Same reporter US-MODERNATX, INC.-MOD-2022-642060:Same reporter US-MODERNATX, INC.-MOD-2022-642869:Same reporter