Age: 0.58
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product label confusion
Clinical narrative: The line "booster dose only" on the label is causing confusion.; Circumstance or information capable of leading to medication error; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL CONFUSION (The line "booster dose only" on the label is causing confusion.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No Adverse Event) in a 7-month-old patient of an unknown 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.    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 line "booster dose only" on the label is causing confusion.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT LABEL CONFUSION (The line "booster dose only" on the label is causing confusion.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) 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 line "booster dose only" on the label is causing confusion.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medication information was not reported.  Label was available on the vial/pre-filled syringe or cartoon but the line "booster dose only" on the label had caused confusion. The patient was not previously vaccinated and need to get the first dose of Moderna COVID-19 Vaccine, bivalent dose. The HCP was confused about which dose they should be administering and wanted to confirm. The HCP stated that both boxes which they had (including Dark Blue Cap and a Label with Gray Border as well as Dark Pink Cap and a Label with a Yellow Box) stated that it is for booster doses only. This labeling caused confusion. HCP did not have any lot numbers on hand.  No further investigation was recommended as no lot number was provided and consent to follow up was declined the reporter. Medical information provided the information to the provider along with the fact sheet for the vaccine.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2023: Significant follow-up received contains reporter details updated, added PQC report, narrative updated and patient details added.