Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | Y015995 | IM / LL |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK113AB | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y015995 | OT / LL |
2 patients developed prolonged symptoms of measles like rashes and fever after receiving MMR II vaccines with the same lot/diaper rash; 2 patients developed prolonged symptoms of measles like rashes and fever after receiving MMR II vaccines with the same lot; This spontaneous report was received from a Nurse and refers to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapies, psat drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered as prophylaxis (lot number Y015995 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date 24-SEP-2026; formulation, dose, vaccination scheme frequency, route of administration and anatomical site of injection were not reported), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not provided). On an unknown date, the 2 patients developed prolonged symptoms of measles like rashes (Rash morbilliform) and fever (pyrexia) after receiving Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccines with the same lot. The nurse mentioned that the patients went to a health department to get tested for measles (results not provided). At the reporting time, the outcome of both events were not reported. The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and sterile diluent (BAXTER STERILE DILUENTE) regarding the events of Rash morbilliform and pyrexia was not provided. No further information provided. This report was considered as non-valid due to the lack of patient´s identifiers and as it concerned 2 patients. This is an amendment report. AE QIR required field was updated from ¨Yes¨ to ¨No¨ for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Follow up information was received from a Nurse on 14-May-2025. Patient details were provided: 15-month-old male patient. Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), was administered subcutaneously in the left thigh. On 23-Apr-2025, the patient was also vaccinated with HIB vaccine, administered intramuscularly in the left vastus lateralis (lot number: UK113AB, expiration date: 30-SEP-2025; formulation, dose and vaccination scheme frequency were not reported). On 02-May-2025, the patient returned to the office with complains of fever (pyrexia) for 3 days. On 04-May-2025, the patient experienced diaper rash (Rash morbilliform). Comfort measures were given, and no medication was prescribed. On 05-May-2025, the patient returned to consultation with complains of worsening of rash and return of fever. That same date, a PCR was positive for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). At the reporting time, the outcome of the events was recovering. The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and sterile diluent (BAXTER STERILE DILUENTE) regarding the events was reported as related. The causal relationship between the events and HIB vaccine, was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02801836-02801834 , CLIC number : , ESTAR number : , IRMS number : 500UW00000aLA7kYAG|14052025230025|6409 , Central date : 2025-05-15 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2284529 , MNSC case number : 02801836 , MNSC interaction number : 02801834 , Integration log UniqueID : 500UW00000aLA7kYAG|14052025230025|6409 , Service cloud CaseID : 500UW00000aLA7kYAG
Sterile diluent
Test Date: 20250505; Test Name: Meales PCR swab was positive; Test Result: Positive