Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: The vial was initially stored in refrigerator on 11-Mar-2023 and administered to patient after BUD of 10-Apr-2023; No adverse event; Administered the Moderna COVID-19 monovalent vaccine to pediatric patient after the 30 day use by date; HCP confirms that the Moderna monovalent vaccine was administered to the patient and not bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID-19 monovalent vaccine to pediatric patient after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to the patient and not bivalent), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11-Mar-2023 and administered to patient after BUD of 10-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID-19 monovalent vaccine to pediatric patient after the 30 day use by date) and WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to the patient and not bivalent). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11-Mar-2023 and administered to patient after BUD of 10-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID-19 monovalent vaccine to pediatric patient after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to the patient and not bivalent), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11-Mar-2023 and administered to patient after BUD of 10-Apr-2023) 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 (Administered the Moderna COVID-19 monovalent vaccine to pediatric patient after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to the patient and not bivalent) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11-Mar-2023 and administered to patient after BUD of 10-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the monovalent intact carton vial of size 2.5 ml was not exposed to temperature excursion. The Moderna COVID-19 monovalent vaccine was administered to 7 pediatric patients as 3 patients on 18-Apr-2023, 2 patients on 20-Apr-2023 and 2 patients on 25-Apr-2023. These doses were all first or second doses. No adverse reactions were reported by patient.  It was also reported that Moderna monovalent vaccine was administered to the patient and not bivalent and was not aware that the Moderna monovalent was no longer authorized for use.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721478:(Patient no-1)(Master case)