Age: 3.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product label confusion, Wrong product administered
Clinical narrative: The HCP explained that there is confusion with the vial labeling of the Moderna COVID-19 Vaccine, Bivalent dark blue cap vial.; vaccinated her patient with the dark pink cap vial instead, this resulted in a lower than authorized dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL CONFUSION (The HCP explained that there is confusion with the vial labeling of the Moderna COVID-19 Vaccine, Bivalent dark blue cap vial.), WRONG PRODUCT ADMINISTERED (vaccinated her patient with the dark pink cap vial instead, this resulted in a lower than authorized dose.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (The HCP explained that there is confusion with the vial labeling of the Moderna COVID-19 Vaccine, Bivalent dark blue cap vial.), WRONG PRODUCT ADMINISTERED (vaccinated her patient with the dark pink cap vial instead, this resulted in a lower than authorized dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (The HCP explained that there is confusion with the vial labeling of the Moderna COVID-19 Vaccine, Bivalent dark blue cap vial.), WRONG PRODUCT ADMINISTERED (vaccinated her patient with the dark pink cap vial instead, this resulted in a lower than authorized dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 PRODUCT LABEL CONFUSION (The HCP explained that there is confusion with the vial labeling of the Moderna COVID-19 Vaccine, Bivalent dark blue cap vial.) and WRONG PRODUCT ADMINISTERED (vaccinated her patient with the dark pink cap vial instead, this resulted in a lower than authorized dose.).    Concomitant medication information was not reported.  The healthcare provider explained that there was confusion with the vial labeling of the Moderna COVID-19 Vaccine Bivalent dark blue cap vial. The healthcare provider was going to administer a dose to a 3-year-old patient from this vial but due to the labeling, she saw that it was intended for use in an older age group and vaccinated her patient with the dark pink cap vial instead. This resulted in administration of a lower than authorized dose.  Treatment information was not reported.   QUALITY-SAFETY EVALUATION OF PTC: Labeling was reviewed for the Bivalent vials and it was found that the content on the label was the approved version of the label. Parent Change Control QE-019765 was implemented to launch the new product labeling. The ambiguity was created due to the label mentioning both the 0.50mL and 0.25mL dose but the Bivalent Dear HCP letter only addresses the 0.50mL dose for the age group 18+. Upon further investigation, it was found that the 0.25mL dose mentioned on the Bivalent Label was added in anticipation of approval of the EUA booster dose for other ages. To better help answer the questions around the label for the end user, the commercial team updated the Call Center FAQs to better define the dose requirements for communication.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2023: Closed PQC investigation report received included QC investigation result added