Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error, Underdose
Clinical narrative: No adverse event; received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses; the patients received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses), PRODUCT ADMINISTRATION ERROR (the patients received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. In 2023, the patient experienced UNDERDOSE (received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses) and PRODUCT ADMINISTRATION ERROR (the patients received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses), PRODUCT ADMINISTRATION ERROR (the patients received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses) and PRODUCT ADMINISTRATION ERROR (the patients received a lower than authorized dose from the pink cap vial, rather than the correct dosage from the blue cap vial for the primary doses).    Patient was pediatric patient between the age of 6 months to 5 years old. The dosage text was reported as unknown. It was unknown whether the patient had any previous COVID-19 vaccination doses. Concomitant product use was not provided by the reporter. It was received that the patient received the vaccine between 27-Apr-2023 to 31-Jul-2023. Patient received the 10-mcg dose of the Moderna COVID-19 vaccine as either their first or second dose, or both doses. 13 doses were administered from Moderna COVID-19 bivalent lot number 216K22A and 5 doses were administered from Moderna COVID-19 bivalent lot number 201L22A. Out of the 14 patients, there were 4 patients who received the 10-microgram dose for both their 1st and 2nd dose.  Patient did not had any adverse reaction at the time of reporting.  Treatment information was not provided.  This case contains information about patient 2nd out of 14 pediatric patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736788 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736788:Master case, (Patient 1)