Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7647B and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-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) 10 microgram. On 10-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 01-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On 10-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023).    Concomitant medication was not reported.  The route of administration of suspect Moderna bivalent dose 1 and 2 was reported. No adverse effects were noted.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case