Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; 01-MAY-2023 they accidentally administered a 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent from the dark pink cap and a label with a yellow border. Patient received the 1st dose of the primary series on 21-MAR-2023, and on 01-MAY-2023 was accidentally administered with 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (01-MAY-2023 they accidentally administered a 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent from the dark pink cap and a label with a yellow border.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the primary series on 21-MAR-2023, and on 01-MAY-2023 was accidentally administered with 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female 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.     Patient had no known allergies and no relevant conditions.  Previously administered products included for Product used for unknown indication: Pediarix on 21-Mar-2023, Vaxneuvance on 21-Mar-2023 and flu shot on 01-May-2023. Past adverse reactions to the above products included No adverse event, Vaxneuvance and flu shot.    On 01-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 01-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (01-MAY-2023 they accidentally administered a 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent from the dark pink cap and a label with a yellow border.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the primary series on 21-MAR-2023, and on 01-MAY-2023 was accidentally administered with 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (01-MAY-2023 they accidentally administered a 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent from the dark pink cap and a label with a yellow border.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the primary series on 21-MAR-2023, and on 01-MAY-2023 was accidentally administered with 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent) 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 (01-MAY-2023 they accidentally administered a 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent from the dark pink cap and a label with a yellow border.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the primary series on 21-MAR-2023, and on 01-MAY-2023 was accidentally administered with 0.2 mL dose of Moderna COVID-19 Vaccine Bivalent).    Concomitant drugs were not reported.  It was reported that patient received 1st dose of the primary series from monovalent Moderna COVID-19 Vaccine on 21-MAR-2023, lot number: AS1903B. No other AEs were reported.  Treatment medications were not provided.