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 lead 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 United States 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. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 lead 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 lead me to believe that the vaccine was bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 lead me to believe that the vaccine was bivalent).    This case is for patient 1 out of 4. Patient had a vaccine 6m-5y.  It was reported back in April it was said they are no longer able to use monovalent vaccines.  Patient scanned the code on the box (carton) which directed  towards the Site for Moderna COVID-19 Vaccine Bivalent.  This lead  to believe that the vaccine was bivalent and 4 doses were administered. The NDC number from the carton. (not bivalent per fact sheet).  Vaccines were given as follows from monovalent vaccine vials.  These should had been bivalent vaccines with authorization changes. On 02 May 2023 2 doses given, lot number AS1417B from 1 vial, on 23 May 2023 2 doses given, lot number AS1903B from 1 vial. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726365, US-MODERNATX, INC.-MOD-2023-726364, US-MODERNATX, INC.-MOD-2023-726362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2023: Live Follow Up  received include patient age group added, suspect product coding updated, iNarrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726364:Patient 3 US-MODERNATX, INC.-MOD-2023-726362:Patient 2 US-MODERNATX, INC.-MOD-2023-726365:Patient 4