Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, 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 Side Effects or reactions occurred; Vaccines were given as follows from monovalent vaccine vials. These should have been bivalent vaccines with authorization changes.; This spontaneous case was reported by an other 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 lead me to believe that the vaccine was bivalent) and NO ADVERSE EVENT (No Side Effects or reactions occurred) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     It was unknown that the patient had ever been diagnosed with or tested positive for Covid-19.     On 02-May-2023 at 4:44 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-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 Side Effects or reactions occurred). 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 Side Effects or reactions occurred) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Side Effects or reactions occurred) 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).    Concomitant medication details not reported by the reporter.  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 was 80777-279-99. (Not bivalent per fact sheet).  Vaccines were given as follows from monovalent vaccine vials. These should had been bivalent vaccines with authorization changes.   Treatment details was not reported by the reporter.  This case contains information about third patient out of four.   This case was linked to US-MODERNATX, INC.-MOD-2023-726308, US-MODERNATX, INC.-MOD-2023-726365 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2023: Upon internal review on 31-Aug-2023, significant correction performed: The event Inappropriate schedule of vaccine administered and the suspect product dose 2 details were deleted; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726308:Patient 1 US-MODERNATX, INC.-MOD-2023-726365:Patient 4