Age: 0.83
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 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 (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 10-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Apr-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 03-Jun-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 10 microgram. On 03-Jun-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 (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023). In 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 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 (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023).    The route of administration of suspect Moderna bivalent was reported as BI. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case