Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored on refrigerator on 22-Aug-2022 and administered on 27-SEP-2022; No Adverse event; Received expired monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was initially stored on refrigerator on 22-Aug-2022 and administered on 27-SEP-2022), EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30 day beyond use date) 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 AR9236B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: ROTATEQ (Dose no: 1 full, lot number: 1821785, route : peroral) on 02-Aug-2021, DTPA IPV HIB VACCINE (Dose no: 1 full, lot number: UJ503AAA, Route: intramuscular, Site: LT) on 02-Aug-2021, ROTATEQ (Dose no: 3 full, lot number: 1821785, route : peroral) on 02-Aug-2021, HEPATITIS B VACCINE (Dose no: 2 full, lot number: T018888, Route: intramuscular, Site: LT) on 08-Aug-2021, DTPA IPV HIB VACCINE (Dose no: 2 full, lot number: UJ503AAA, Route: intramuscular, Site: LT) on 07-Oct-2021, PREVNAR 13 (Dose no: 2 full, lot number: EE7117, Route: intramuscular, Site: LT) on 07-Oct-2021, ROTATEQ (Dose no: 2 full, lot number: 1741819, route : peroral) on 07-Oct-2021, QUADRIVALENT INFLUENZA VACCINE (Dose no: 1 full, lot number: UJ776AA, Route: intramuscular, Site: LT) on 16-Dec-2021, PREVNAR 13 (Dose no: 3 full, lot number: EJ4559, Route: intramuscular, Site: LT) on 16-Dec-2021, DTPA IPV HIB VACCINE (Dose no: 3 full, lot number: UJ503AAA, Route: intramuscular, Site: LT) on 16-Dec-2021, HEPATITIS B VACCINE (Dose no: 3 full, lot number: T018888, Route: intramuscular, Site: LT) on 21-Jan-2022, QUADRIVALENT INFLUENZA VACCINE (Dose no: 2 full, lot number: UJ776AA, Route: intramuscular, Site: RT) on 21-Jan-2022, HEPATITIS A (Dose no: 1 full, lot number: U004388, Route: intramuscular, Site: LT) on 09-Jun-2022, MMR II (Dose no: 1 full, lot number: U011883, Route: subcutaneous, Site: LT) on 09-Jun-2022, VARIVAX II (Dose no: 1 full, lot number: U028165, Route: subcutaneous, Site: RT) on 09-Jun-2022, QUADRIVALENT INFLUENZA VACCINE (Dose no: 3, booster dose full, lot number: 348360, Route: intramuscular and Site: LT) on 06-Oct-2022. Past adverse reactions to the above products included No adverse event with DTPA IPV HIB VACCINE, DTPA IPV HIB VACCINE, DTPA IPV HIB VACCINE, HEPATITIS A, HEPATITIS B VACCINE, HEPATITIS B VACCINE, MMR II, PREVNAR 13, PREVNAR 13, QUADRIVALENT INFLUENZA VACCINE, QUADRIVALENT INFLUENZA VACCINE, QUADRIVALENT INFLUENZA VACCINE, ROTATEQ, ROTATEQ, ROTATEQ and VARIVAX II.   On 27-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 01-Nov-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). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored on refrigerator on 22-Aug-2022 and administered on 27-SEP-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was initially stored on refrigerator on 22-Aug-2022 and administered on 27-SEP-2022), EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30 day beyond use date) 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 PRODUCT STORAGE ERROR (Vaccine was initially stored on refrigerator on 22-Aug-2022 and administered on 27-SEP-2022) and EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30 day beyond use date).    Concomitant medication information was not provided.  It was reported that the vaccine coordinator was calling to report that some patients (adults and pediatric ages) received expired Moderna COVID-19 vaccine after 30 days from the beyond use date of 22-Sep-2022.  The vials were unbroken cartons. The vial size was of 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022.  The vial did not undergo any temperature excursions.  There were no reported adverse events.  Treatment medication information was not provided.