Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y018702 | — |
No other information provided. No additional AEs reported; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; This spontaneous report was received from a Pharmacist and refers to a(n) 48-year-old female patient. The patient's medical history, concurrent condition, concomitant therapies were not reported. On 22-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y018702, expiration date reported 11-NOV-2026, but upon internal validation established as 26-Apr-2026), with sterile diluent (MERCK STERILE DILUENT) (lot #2031274, expiration date: 10-Dec-2026) for prophylaxis. During administration, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) leaked out onto the patient's arm. The reporter states he thinks he did not secure the needle tightly to the PFS (not fully secured by the administered Registered Pharmacist) (Incorrect dose administered; Product preparation error; Exposure via skin contact; Device leakage). No adverse event. The patient was told to return 28 days after event to re-vaccinate.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02793444-02793443 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZANKIYA5|02052025230031|5173 , Central date : 2025-05-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2279609 , MNSC case number : 02793444 , MNSC interaction number : 02793443 , Integration log UniqueID : 500UW00000ZANKIYA5|02052025230031|5173 , Service cloud CaseID : 500UW00000ZANKIYA5
Sterile diluent