Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event, Wrong product administered
Clinical narrative: No adverse event; 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; Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg); 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), ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-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) and ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)). 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), ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)) 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 ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)).    Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Upon internal review on 19-Sep-2023, significant corrections performed to add additional event of accidental underdose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case Patient 1