Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022; No Adverse event; Patient was given vaccine beyound 30 day use by date; 1st dose on 11-07-2022 and  2nd dose on 26-09-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 dosage form. On 26-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022) 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 was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022).    No concomitant medication was reported.  Route and body site of first vaccination was mentioned as LO. It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date (22-Sep-2022). There were unbroken cartons. Vial size for 6 months to 5 years. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date. Vial sizes were reported as 2.5 mL or 5.5 mL For six months to five-year-old patient vial size was reported as 2.5 ml For adult patient Vial size was reported as 5.5 ml. The vial did not undergo any temperature excursions.  No treatment medication was reported.