Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 22-Aug-2022 and administered on 27-Sep-2022; No adverse event; Dose administered after 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Aug-2022 and administered on 27-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: DTAP (Dose 2 was given via Intramuscular route in Right thigh with Batch no.: UJ256AAA.) on 21-Feb-2000, HEPATITIS B VACCINE (Dose 1 was given via Intramuscular route in Right thigh with Batch no.: YL2L3.) on 20-Oct-2019, HEPATITIS B VACCINE (Dose 2 was given via Intramuscular route in Left thigh with Batch no.: 955N2.) on 26-Dec-2019, DTP/aP (Dose 1 was given via Intramuscular route in Right thigh with Batch no.: UJ198ABA.) on 26-Dec-2019, PNEUMOCOCCAL CONJUGATE VACCINE (Dose 1 was given via Intramuscular route in Left thigh with Batch no.: CH3694.) on 26-Dec-2019, POLIO (Dose 1 was given via Intramuscular route in Right thigh with Batch no.: UJ198ABA.) on 26-Dec-2019, Rotavirus (Dose 1 was given via Oral route with Batch no.: S010682.) on 26-Dec-2019, HIB (Dose 1 was given via Intramuscular route in Right thigh with Batch no.: UJ188ABA.) on 28-Dec-2019, PNEUMOCOCCAL CONJUGATE VACCINE (Dose 2 was given via Intramuscular route in Left thigh with Batch no.: CM0988.) on 21-Feb-2020, POLIO (Dose 2 was given via Intramuscular route in Right thigh with Batch no.: UJ258AAA.) on 21-Feb-2020, HIB (Dose 2 was given via Intramuscular route in Right thigh with Batch no.: UJ258AAA.) on 21-Feb-2020, Rotavirus (Dose 2 was given via Oral route with Batch no.: S018278.) on 21-Feb-2020, PNEUMOCOCCAL CONJUGATE VACCINE (Dose 3 was given via Intramuscular route in Right thigh with Batch no.: CM1133.) on 20-Apr-2020, POLIO (Dose 3 was given via Intramuscular route in Left thigh with Batch no.: UJ190AAA.) on 20-Apr-2020, HIB (Dose 3 was given via Intramuscular route in Left thigh with Batch no.: UJ190AAA.) on 20-Apr-2020, Rotavirus (Dose 3 was given via Oral route with Batch no.: S018278.) on 20-Apr-2020, DTAP (Dose 3 was given via Intramuscular route in Left thigh with Batch no.: UJ190AAA.) on 20-Apr-2020, HEPATITIS B VACCINE (Dose 3 was given via Intramuscular route in Left thigh with Batch no.: R02B383.) on 20-Jul-2020, Varicella (Dose 1 was given via Subcutaneous route in Left thigh with Batch no.: T0D2846.) on 19-Oct-2020, MMR (Dose 1 was given via Subcutaneous route in Right thigh with Batch no.: S036668.) on 19-Oct-2020, HepA (Dose 1 was given via Intramuscular route in Left thigh with Batch no.: T022999.) on 19-Oct-2020, Influenza (Dose 1 was given via Intramuscular route in Left thigh with Batch no.: UT7108KA.) on 14-Nov-2020, Influenza (Dose 2 was given via Intramuscular route in Left thigh with Batch no.: UT7058LA.) on 16-Dec-2020, PNEUMOCOCCAL CONJUGATE VACCINE (Dose 4 was given via Intramuscular route in Right thigh with Batch no.: CM1779.) on 18-Jan-2021, HIB (Dose 4 was given via Intramuscular route in Left thigh with Batch no.: UJ324AAA.) on 18-Jan-2021, DTAP (Dose 4 was given via Intramuscular route in Left thigh with Batch no.: O5706AA.) on 18-Jan-2021, HepA (Dose 2 was given via Intramuscular route in Left thigh with Batch no.: T022338.) on 19-Apr-2021 and Influenza (Booster dose was given via Intramuscular route in Right thigh with Batch no.: UT7330LA.) on 22-Oct-2021. Past adverse reactions to the above products included No adverse event with DTAP, DTAP, DTAP, DTP/aP, HEPATITIS B VACCINE, HEPATITIS B VACCINE, HEPATITIS B VACCINE, HIB, HIB, HIB, HIB, HepA, HepA, Influenza, Influenza, Influenza, MMR, PNEUMOCOCCAL CONJUGATE VACCINE, PNEUMOCOCCAL CONJUGATE VACCINE, PNEUMOCOCCAL CONJUGATE VACCINE, PNEUMOCOCCAL CONJUGATE VACCINE, POLIO, POLIO, POLIO, Rotavirus, Rotavirus, Rotavirus and Varicella.    On 27-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Aug-2022 and administered on 27-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Aug-2022 and administered on 27-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Aug-2022 and administered on 27-Sep-2022).    Patient was 3 years 30 days old.  No concomitant medication was reported.  On 01-Nov-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter at Left Vastus Lateralis with Batch no. AR9236B and expiry date 11-Feb-2023.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date.  The vial did not undergo any temperature excursions.  No treatment medication was reported.