Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Y010306 | — |
patient developed redness and swelling at the injection site.; patient developed redness and swelling at the injection site.; This spontaneous report has been received from a nurse referring to a 4-year-old male patient. The patient's concurrent conditions and medical history were reported as none. Concomitant therapies were not provided. On 28-FEB-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA) (+) sterile diluent, 1 dose (route of administration not reported) with lot # y010306 which was verified to be valid and expiration date not reported but upon internal validation established as 01-DEC-2025, for vaccination. On the same date, the patient went to an emergency room (ER) because he developed redness and swelling at the injection site (Vaccination site erythema and vaccination site swelling). He was treated with Cefazolin 1000mg, Dexamethasone 4mg, Diphenhydramine 50mg and went home. Basic laboratory tests (unspecified) and X-ray were performed, however results were not provided. The patient was not admitted into the hospital. On 02-MAR-2025, the patient was fully recovered from both events. The causal relationship between vaccination site erythema and vaccination site swelling with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) sterile diluent was not reported.
Sterile diluent