Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y017511 | OT / LL |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | — |
No additional AE; Temperature excursion; This spontaneous report was received from a physician assistant and refers to a 13-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with sterile diluent (BAXTER STERILE DILUENT), lot #Y017511, expiration date: 15-Apr-2026, administered by subcutaneous route in the left thigh for prophylaxis. The vaccine administered experienced a temperature excursion of -9.8 degree celsius (°C) for a time frame of 2 hours and 3 minutes. No other information provided. No additional adverse event (no adverse event) and no previous temperature excursion reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Hepatitis A