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 11MAR2023 and administered on 18APR2023, 20APR2023 and 25APR2023; No adverse event; HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent; They administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent), EXPIRED PRODUCT ADMINISTERED (They administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11MAR2023 and administered on 18APR2023, 20APR2023 and 25APR2023) 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 WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent) and EXPIRED PRODUCT ADMINISTERED (They administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11MAR2023 and administered on 18APR2023, 20APR2023 and 25APR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent), EXPIRED PRODUCT ADMINISTERED (They administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11MAR2023 and administered on 18APR2023, 20APR2023 and 25APR2023) 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 WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent), EXPIRED PRODUCT ADMINISTERED (They administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 11MAR2023 and administered on 18APR2023, 20APR2023 and 25APR2023).    No concomitant medication details was reported.  It was reported that doses were administered to 3 patients on 18-APR-2023, 2 patients on 20-APR-2023, and 2 patients on 25-APR-2023. No adverse reactions have been reported by the patient. Intact carton was used and vial size was 2.5 ml. The vial was initially stored in the refrigerator on 11-MAR-2023 (BUD:10-APR-2023). The vial did not undergo any temperature excursions.  No treatment medication details was reported.  This case contains information for the 5th patient out of 7 infant patients described by the reporter.   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)