Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product expiration date issue, Product storage error, Product temperature excursion issue
Clinical narrative: vial was initially stored in the refrigerator on 09Jan2023 and administered on 10Feb2023; A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date; A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date), PRODUCT TEMPERATURE EXCURSION ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 09Jan2023 and administered on 10Feb2023), PRODUCT EXPIRATION DATE ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:No known Allergies.  Concomitant products included HEPATITIS B VACCINE for an unknown indication.    On 10-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date) and PRODUCT TEMPERATURE EXCURSION ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 09Jan2023 and administered on 10Feb2023), PRODUCT EXPIRATION DATE ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date), PRODUCT TEMPERATURE EXCURSION ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 09Jan2023 and administered on 10Feb2023), PRODUCT EXPIRATION DATE ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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-day Use By Date or after manufacturer date), PRODUCT TEMPERATURE EXCURSION ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 09Jan2023 and administered on 10Feb2023) and PRODUCT EXPIRATION DATE ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration.).    A vial was transported for same day use, was left out at room temp for 6 to 7 hours, was labelled with the wrong expiration. Patient received expired doses on 10 Feb 2023. Patient also received Hepatitis B vaccine on the same day. The vial was initially stored in the refrigerator on 09 Jan 2023 and administered on 10 Feb 2023 7. The vial undergo temperature excursions as stored at room temperature for 6 or 7 hours. No treatment information was provided.