Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | OT |
A FBE called to report an AE on behalf of an HCP for MMR II. The FBE stated she spoke with the HCP last Tuesday, 06/10/2025, then went out of town, and was just getting back to town and wanted to call and report the AE but the HCP also told the FBE t; This spontaneous report was received from a Physician and refers to a 4-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included rash. Historical drugs included COVID-19 vaccine (COVID-19 vaccine). Concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered by Unknown route (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). On an unknown date, the patient experienced hives on his shoulder and back that "blanched" within an unknown time-frame after the injection. The HCP stated she administered an antihistamine which improved the reaction of hives but when the antihistamine wore off, the hives would return until the hives resolved and got better all together on an unknown date or time-frame. The patient recovered/resolved from the event on an unspecified date. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent (reported as reaction from MMR II).; Reporter's Comments:
Rash
Sterile diluent