Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: On 22AUG2022, vial was initially stored in the refrigerator and on 27SEP2022 vaccine administrated.; No Adverse event; Received expired Monovalent vaccine after 30 day beyond use date; First dose received on 16AUG2022, and second dose received on 27SEP2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (On 22AUG2022, vial was initially stored in the refrigerator and on 27SEP2022 vaccine administrated.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 16AUG2022, and second dose received on 27SEP2022) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AS1416B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: HEPATITIS B [HEPATITIS B VACCINE] (Full Dose 1 of 3) on 22-Oct-2019, ROTATEQ (Full Dose 1 of 3) on 18-Dec-2019, DTaPIPV/Hib Pentacel (Full Dose 1 of 4) on 18-Dec-2019, PENTACEL (Full Dose 1 of 4) on 18-Dec-2019, HEPATITIS B [HEPATITIS B VACCINE] (Full Dose 2 of 3) on 18-Dec-2019, PREVNAR 13 (Full Dose 1 of 4) on 18-Dec-2019, PENTACEL (Full Dose 1 of 5) on 19-Dec-2019, DTaPIPV/Hib Pentacel (Full Dose 2 of 4) on 25-Feb-2020, ROTATEQ (Full Dose 2 of 3) on 25-Feb-2020, PENTACEL (Full Dose 2 of 5) on 25-Feb-2020, PREVNAR 13 (Full Dose 2 of 4) on 25-Feb-2020, PENTACEL (Full Dose 2 of 4) on 26-Feb-2020, PREVNAR 13 (Full Dose 3 of 4) on 27-May-2020, PENTACEL (Full Dose 3 of 4) on 27-May-2020, PENTACEL (Full Dose 3 of 5) on 27-May-2020, ROTATEQ (Full Dose 3 of 3) on 27-May-2020, HEPATITIS B [HEPATITIS B VACCINE] (Full Dose 3 of 3) on 27-Jun-2020, DTaPIPV/Hib Pentacel (Full Dose 3 of 4) on 27-Jun-2020, HEPATITIS A (Full Dose 1 of 2) on 27-Oct-2020, MMR II (Full Dose 1 of 2) on 27-Oct-2020, VARICELLA VACC. (Full Dose 1 of 2) on 27-Oct-2020, FLU [INFLUENZA VACCINE] (Full Dose 1 of 2) on 12-Oct-2021, DTAP (Full Dose 4 of 5) on 17-Nov-2021, FLU [INFLUENZA VACCINE] (Full Dose 2 of 2) on 17-Nov-2021, PENTACEL (Full Dose 4 of 4) on 17-Nov-2021, PREVNAR 13 (Full Dose 4 of 4) on 17-Nov-2021 and HEPATITIS A (Full Dose 2 of 2) on 17-Nov-2021. Past adverse reactions to the above products included No adverse event with DTAP, DTaPIPV/Hib Pentacel, DTaPIPV/Hib Pentacel, DTaPIPV/Hib Pentacel, FLU [INFLUENZA VACCINE], FLU [INFLUENZA VACCINE], HEPATITIS A, HEPATITIS A, HEPATITIS B [HEPATITIS B VACCINE], HEPATITIS B [HEPATITIS B VACCINE], HEPATITIS B [HEPATITIS B VACCINE], MMR II, PENTACEL, PENTACEL, PENTACEL, PENTACEL, PENTACEL, PENTACEL, PENTACEL, PREVNAR 13, PREVNAR 13, PREVNAR 13, PREVNAR 13, ROTATEQ, ROTATEQ, ROTATEQ and VARICELLA VACC.   On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 16AUG2022, and second dose received on 27SEP2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 22AUG2022, vial was initially stored in the refrigerator and on 27SEP2022 vaccine administrated.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (On 22AUG2022, vial was initially stored in the refrigerator and on 27SEP2022 vaccine administrated.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 16AUG2022, and second dose received on 27SEP2022) 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 (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (On 22AUG2022, vial was initially stored in the refrigerator and on 27SEP2022 vaccine administrated.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 16AUG2022, and second dose received on 27SEP2022).    Concomitant medications were not reported.  The patient's age was reported as 3 Years 27 days. On 27SEP2022, they administered 9 doses to patients. The vial size was 2.5 mL 5. The vial did not undergo any temperature excursions. No adverse events were reported.  Treatment medications were not reported.