Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event, Wrong product administered
Clinical narrative: She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023; Dose may have been administered after 30-day Use By Date; Dose may have been administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date), EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Jun-2023, the patient received first 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 WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date), EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date), EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date) 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 WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date).    Concomitant product use was not provided by the reporter.  The patient received first dose Moderna Bivalent COVID-19 vaccine.  Dose may have been administered after 30-day Use By Date.  NDC: 80777-0282-02  Intact Carton, Vial size 0.4ml, Dark Pink Cap.  Date the vial was initially stored in the refrigerator was unknown.   The vial did not undergo any temperature excursions.  Treatment information was not provided.