Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: patient received expired monovalent vaccine after 30 day beyond use date; No Adverse event; patient received expired monovalent vaccine after 30 day beyond use date; Dose 1 was received on 12-Jul-2022 and dose 2 received on 27-Sep-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (patient received expired monovalent vaccine after 30 day beyond use date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 12-Jul-2022 and dose 2 received on 27-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AS1416B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: HepB-Peds (Dose 1 of 3, Lot number T004378, route of administration: Intramuscular, location of injection: LT) on 25-Jan-2021, Pentacel (Dose 1 of 4, Lot number UJ382AAA route of administration: Intramuscular, location of injection: LT) on 25-Feb-2021, Pentacel (Dose 1 of 5, Lot number UJ382AA, route of administration: Intramuscular, location of injection: LT) on 25-Feb-2021, PREVNAR 13 (dose1 of 4, Lot number DL2971 route of administration: Intramuscular, location of injection: RT) on 26-Feb-2021, ROTATEQ (Dose 1 of 3, Lot number 1694408 route of administration: oral) on 26-Feb-2021, Pentacel (Dose 1 of 4, Lot number UJ382AAA, route of administration: Intramuscular, location of injection: LT) on 26-Feb-2021, HepB-Peds (Dose 2 of 3, Lot number T004378, route of administration: Intramuscular, location of injection: RT) on 28-Feb-2021, Pentacel (Dose 2 of 4, Lot number UJ420AAAroute of administration: Intramuscular, location of injection: LT) on 30-Apr-2021, Pentacel (Dose 2 of 5, Lot number UJ420AAA, route of administration: Intramuscular, location of injection: LT) on 30-Apr-2021, ROTATEQ (Dose 2 of 3, Lot number 1688837 route of administration: oral) on 30-Apr-2021, Pentacel (Dose 2 of 4, Lot number UJ420AAA, route of administration: Intramuscular, location of injection: LT) on 30-Apr-2021, PREVNAR 13 (dose 2 of 4, Lot number DR1778 route of administration: Intramuscular, location of injection: RT) on 30-Apr-2021, Pentacel (Dose 3 of 4, Lot number UJ434AAA route of administration: Intramuscular, location of injection: LT) on 30-Apr-2021, ROTATEQ (Dose 3 of 3, Lot number T028130 route of administration: oral) on 02-Jul-2021, Pentacel (Dose 2 of 4, Lot number UJ434AAA, route of administration: Intramuscular, location of injection: LT) on 02-Jul-2021, Pentacel (Dose 3 of 5, Lot number UJ434AAA, route of administration: Intramuscular, location of injection: LT) on 02-Jul-2021, HepB-Peds (Dose 3 of 3, Lot number T032918, route of administration: Intramuscular, location of injection: LT) on 05-Oct-2021, FLUARIX QUADRIVALENT (Dose 1 of 2, Lot number 3SE27 route of administration: Intramuscular, location of injection: LT) on 07-Dec-2021, VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)] (Dose 1 of 2, Lot number U015684, route of administration: subcutaneous, location of injection: LT) on 05-Jan-2022, FLUARIX QUADRIVALENT (Dose 2 of 2, Lot number UJ776AA route of administration: Intramuscular, location of injection: RT) on 05-Jan-2022, MMR II (dose1 of 2, Lot number TO18669 route of administration: subcutaneous, location of injection: RT) on 06-Jan-2022, HepA-Ped (Dose 1 of 2, Lot number U004366, route of administration: Intramuscular, location of injection: LT) on 06-Jan-2022, HAEMOPHILUS B CONJUGATE VACCINE (Dose 4 of 4, Lot number UJ689AAB route of administration: Intramuscular, location of injection: LT) on 06-Apr-2022, DAPTACEL (Dose 4 of 5, Lot number C5816AA, route of administration: Intramuscular, location of injection: LT) on 06-Apr-2022, PREVNAR 13 (dose 4 of 4, Lot number EM2369 route of administration: Intramuscular, location of injection: RT) on 06-Apr-2022, PREVNAR 13 (dose 3 of 4, Lot number DW3411 route of administration: Intramuscular, location of injection: RT) on 02-Jul-2022, HepA-Ped (Dose 2 of 2, Lot number W007375, route of administration: Intramuscular, location of injection: LT) on 08-Aug-2022, FLUARIX QUADRIVALENT (Booster dose, Lot number UT7663JA route of administration: Intramuscular and location of injection: LT) on 19-Oct-2022. Past adverse reactions to the above products included No adverse event with DAPTACEL, FLUARIX QUADRIVALENT, FLUARIX QUADRIVALENT, FLUARIX QUADRIVALENT, HAEMOPHILUS B CONJUGATE VACCINE, HepA-Ped, HepA-Ped, HepB-Peds, HepB-Peds, HepB-Peds, MMR II, PREVNAR 13, PREVNAR 13, PREVNAR 13, PREVNAR 13, Pentacel, Pentacel, Pentacel, Pentacel, Pentacel, Pentacel, Pentacel, Pentacel, Pentacel, ROTATEQ, ROTATEQ, ROTATEQ and VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)].   On 12-Jul-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 (patient received expired monovalent vaccine after 30 day beyond use date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 12-Jul-2022 and dose 2 received on 27-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received expired monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (patient received expired monovalent vaccine after 30 day beyond use date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 12-Jul-2022 and dose 2 received 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 (patient received expired monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (patient received expired monovalent vaccine after 30 day beyond use date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 12-Jul-2022 and dose 2 received on 27-Sep-2022).    No concomitant medications were reported.   Vial size reported was 2.5 milliliter. The vial was initially stored in refrigerator on 22-Aug-2022. The vial did not undergo temperature excursion. Expiry beyond date reported was 22-Sep-2022. The patient did not experience any adverse events.   No treatment details were reported.