Received May 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | Y015120 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y015995 | OT / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UK113AB | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y015995 | OT |
severe measleslike symptoms following vaccination; This spontaneous report was received from a non-health care professional and refers to a Child patient of unknown gender (exact age unknown). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reported lot #4015995 was confirmed as invalid lot # for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; expiration date: 24-Sep-2026 (formulation, site of administration not provided), 0.5ML administered intramuscularly (IM) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis. On 21-Apr-2025, the patient experienced severe measles like symptoms following vaccination, high fever for 4 days, cough, conjunctivitis, runny nose, and koplik spots (Measles). On 24-APR-2025, another symptom rash (reported as rash for 6 days) started. On 26-Apr-2025, a polymerase chain reaction (PCR) test and Measles virus assay (MeVA) test (MeVA testing determines if a case was caused by measles vaccine strain or wild-type measles virus) were both positive. On an unknown day in April 2025, respiratory viral test (RVP) was negative. At the reporting time, the outcome of severe measles was unknown. The reporter considered the events of severe measles and measles virus test positive to be related to the suspect vaccine and sterile diluent (reported as MMR vaccine reactions). This is one of the 3 reports received from the same reporter. Follow up information from FDA (agency #US-009507513-2283670) on 19-May-2025. Patient information was updated, it was confirmed that concerned to a 1-year-old patient. The lot # Y015995 was reported and has been verified to be valid for this product, expiration date confirmed as 24-Sep-2026.
DILUENT MRK
Test Date: 20250426; Test Name: PCR+; Test Result: Positive ; Test Date: 20250426; Test Name: MeVA+; Result Unstructured Data: positive for measles vaccine strain or wild-type measles virus; Test Date: 202504; Test Name: RVP; Test Result: Negative