Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product label confusion, Wrong product administered
Clinical narrative: Scanned the code on the box (carton) which directed me towards the Site for Moderna COVID-19 Vaccine Bivalent. This led me to believe that the vaccine was bivalent; No adverse event; Vaccines were given as follows from monovalent vaccine vials. These should have been bivalent vaccines with authorization changes.; This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Vaccines were given as follows from monovalent vaccine vials. These should have been bivalent vaccines with authorization changes.), PRODUCT LABEL CONFUSION (Scanned the code on the box (carton) which directed me towards the Site for Moderna COVID-19 Vaccine Bivalent. This led me to believe that the vaccine was bivalent) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis. No Medical History information was reported. On 23-May-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Vaccines were given as follows from monovalent vaccine vials. These should have been bivalent vaccines with authorization changes.). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (Scanned the code on the box (carton) which directed me towards the Site for Moderna COVID-19 Vaccine Bivalent. This led me to believe that the vaccine was bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Vaccines were given as follows from monovalent vaccine vials. These should have been bivalent vaccines with authorization changes.), PRODUCT LABEL CONFUSION (Scanned the code on the box (carton) which directed me towards the Site for Moderna COVID-19 Vaccine Bivalent. This led me to believe that the vaccine was bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Vaccines were given as follows from monovalent vaccine vials. These should have been bivalent vaccines with authorization changes.) and PRODUCT LABEL CONFUSION (Scanned the code on the box (carton) which directed me towards the Site for Moderna COVID-19 Vaccine Bivalent. This led me to believe that the vaccine was bivalent). Concomitant medications were not reported. It was reported back in April that they were no longer able to use monovalent vaccines. The reporter scanned the code on the box (carton) which directed towards the Site for Moderna COVID-19 Vaccine Bivalent which led to believe that the vaccine was bivalent hence, 4 doses were administered. The NDC number from the carton was (not bivalent per fact sheet). The 6 months to 5 years vaccines were given as 2 doses on 02-May-2023 lot number AS1417B and 2 doses on 23-May-2023 lot number AS1903B. No other symptoms were reported. No treatment information was provided by the reporter. This case was for patient 4 out of 4. This case was linked to US-MODERNATX, INC.-MOD-2023-726308 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-726308:Patient 1.