Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 27-Sep-2022; No Adverse event; Received expired  Monovalent vaccine after 30 day beyond use date; 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 (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 27-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9237B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Polio (Dose 1, Lot UJ644ABA, Route IM, Body site RVL) on 17-Dec-2021, Peumoconjugate (Dose 1, Lot EM2364, Route IM, Body site LVL) on 17-Dec-2021, Hib (Dose 1, Lot UJ544ABA, Route IM, Body site RVL) on 17-Dec-2021, HepB (Dose 1 Lot 26N39, Route IM, Body site RVL) on 17-Dec-2021, DTP/aP (Dose 1, Lot UJ844ABA, Route IM, Body site RVL) on 17-Dec-2021, Rotavirus (Dose 1, Lot TJS7O, Route PO) on 17-Dec-2021, Rotavirus (Dose 2, Lot K33EZ, Route PO) on 12-Apr-2022, Hib (Dose 2, Lot UJ693AAA, Route IM, Body site RVL) on 12-Apr-2022, Peumoconjugate (Dose 2, Lot EX1981, Route IM, Body site LVL) on 12-Apr-2022, Polio (Dose 2, Lot UJ693AAA, Route IM, Body site RVL) on 12-Apr-2022, DTP/aP (Dose 2, Lot UJ893AAA, Route IM, Body site RVL) on 12-Apr-2022, DTP/aP (Dose 3, Lot UJ634AAA, Route IM, Body site LD) on 17-May-2022, Hib (Dose 3, Lot UJ63A4AAA, Route IM, Body site LD) on 17-May-2022, HepB (Dose 2, Lot DD7K7,Route IM, Body site RVL) on 17-May-2022, Peumoconjugate (Dose 3, Lot EX1981, Route IM, Body site LVL) on 17-Jun-2022, Polio (Dose 3, Lot UJ693AAA, Route IM, Body site LD) on 17-Jun-2022, HepB (Dose 3, Lot U033619, Route IM, Body site LT) on 29-Aug-2022, Influenza (Dose 1, Lot UT7882MA, Route IM and Body site LT) on 29-Aug-2022. Past adverse reactions to the above products included No adverse event with DTP/aP, DTP/aP, DTP/aP, HepB, HepB, HepB, Hib, Hib, Hib, Influenza, Peumoconjugate, Peumoconjugate, Peumoconjugate, Polio, Polio, Polio, Rotavirus and Rotavirus.   On 23-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in 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 (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vials were initially stored in 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 (Received expired  Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and administered on 27-Sep-2022).    No concomitant medication was reported.  It was reported that vaccine coordinator was called to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  Reportedly, there were unbroken cartons. Vial size for 6 months to 5 year patient was 2.5 milliliter and for adults 5.5 milliliter. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient given vaccine after BUD date.  The vial did not undergo any temperature excursions and no adverse events were reported.   No treatment medication was reported.