Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
swelling; getting red/red rash; Limping; This spontaneous report was received from a Consumer or other non health professional via Sanofi and refers to a 4-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Dupixent (Dupilumab). Concomitant therapies were not reported. On 16-Apr-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dose, lot # and expiration date were not reported) reconstituted with sterile diluent (DSM STERILE DILUENT), (lot # and expiration date were not reported). On 16-Apr-2025, the patient started therapy with Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (lot # and expiration date were not reported). On 16-Apr-2025, the patient experienced Limping and continued limping on 17-Apr-2025. On 18-Apr-2025, the patient experienced swelling. On 18-Apr-2025, patient's leg started swelling and getting red. Caregiver said there was swelling and a red rash near patient's inner thigh and knee area on her left leg. Caregiver said one of the immunizations was administered into patient's upper outer thigh on the left leg, but she could not confirm if it was the DTaP or MMR administered into that leg. At the reporting time, the patient had not recovered from Limping, swelling and getting red/red rash. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. The action taken with Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid). The causal relationship between the event of Limping and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was unknown/not reported/not provided. The causal relationship between the event of getting red/red rash and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was unknown/not reported/not provided. The causal relationship between the event of swelling and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was unknown/not reported/not provided. The causal relationship between the event of Limping and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of swelling and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of getting red/red rash and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of Limping and Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) was unknown/not reported/not provided. The causal relationship between the event of getting red/red rash and Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) was unknown/not reported/not provided. The causal relationship between the event of swelling and Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) was unknown/not reported/not provided.
Sterile diluent