Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border/1 patient received 2 Bivalent doses dark pink cap vial instead of the Blue cap; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border/1 patient received 2 Bivalent doses dark pink cap vial instead of the Blue cap) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border/1 patient received 2 Bivalent doses dark pink cap vial instead of the Blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border/1 patient received 2 Bivalent doses dark pink cap vial instead of the Blue cap) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (3 patients received 1 original monovalent and were due for their 2 dose, received the Bivalent dose from dark pink cap vial instead of the Blue cap vial with grey border/1 patient received 2 Bivalent doses dark pink cap vial instead of the Blue cap).    Patient was pediatric patient in the 6 months to 5 years age group. It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Patient received the vaccine between April-2023 and July-2023. It was reported that 3 patients who had received 1 original monovalent and were due for their 2 doses, received the Bivalent dose from dark pink cap vial instead of the blue cap vial with grey border. There was a more recent incident where 1 patient received their 2 Bivalent doses, however it was dark pink cap vial instead of the blue cap vial with grey border. Did not had any patient identifiers, date of administration, nor product information. Suspect product dosage text was unknown. Treatment information was not provided. This case contains information about patient 1 out of 4 pediatric patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733925, US-MODERNATX, INC.-MOD-2023-733928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733925:Patient 3 US-MODERNATX, INC.-MOD-2023-733928:Patient 4