Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Dose 1 received on 26-May-2023 and dose 2 on 15-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- wrong vaccine; This spontaneous case was reported by an other health care professional 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- wrong vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 26-May-2023 and dose 2 on 15-Jul-2023) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7647B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-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 15-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 26-May-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- wrong vaccine). On 15-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 received on 26-May-2023 and dose 2 on 15-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- wrong vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 26-May-2023 and dose 2 on 15-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- wrong vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 26-May-2023 and dose 2 on 15-Jul-2023).    Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna bivalent was reported as BI.  No adverse event was reported. Appropriate vaccine scheduled or given as indicated by the CDC.  Treatment information was not provided.   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