Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5Ef45 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Z003401 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
No additional AE reported; HCP calling to state MMR II and VARIVAX were not mixed with the STERILE DILUENT instead they believe it was inadvertently mix with FLU-LAVAL; This spontaneous report was received from a Nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-SEP-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 1 dosage form (lot number Z003401 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date not provided but upon internal validation was established as 23-JAN-2027) and with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 1 dosage form (lot number Z008197 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date not reported but upon internal validation was established as, expiration date: 30-Apr-2027); both vaccines were administered as prophylaxis (exact dose, formulation, route of administration, anatomical site of injection and dose number were not provided) after inadvertently being reconstituted with Influenza vaccine inact split 3v (FLULAVAL) (lot number reported as 5Ef45; dose, expiration date, formulation, route of administration, anatomical site and indication and were not reported) instead being mixed with sterile diluent (Hollister-Stier STERILE DILUENT) (lot number and expiration date not provided) (Product preparation error). No additional adverse event was reported for the patient. No other information was provided.