Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | X028353 | — |
no adverse event; some of the vaccine spilled out resulting in a lower than recommended dose; some of the vaccine spilled out; that this was a user error; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-May-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #X028353 was verified to be a valid number, expiration date: 11-Dec-2025) (dose, scheme, injection site, formulation and route of administration was not reported), reconstituted with sterile diluent (BAXTER Sterile Diluent) (dose, formulation, expiration date and lot # were not reported) for prophylaxis; while administering some of the vaccine spilled out (product leakage) resulting in a lower than recommended dose (underdose). The Medical Assistant reports that this was a user error (wrong technique in product usage process) and not related to any product quality issue with the vaccine or syringe. No additional adverse event was reported.
Sterile diluent