Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y017511 | OT / RL |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | OT |
No additional AEs; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a physician and refers to a 13-month-old female 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), Diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+)Pertussis vaccine acellular 5-component (+)Polio vaccine inact 3v (MRC 5) (+) Tetanus vaccine toxoid (PENTACEL), Hepatitis b vaccine and Pneumococcal vaccine conj 20v (CRM197) (PREVENAR 20) . On 31-Mar-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA [recombinant Human albumin]) administered subcutaneous on the right thigh as prophylaxis (Lot No. Y017511 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and but upon internal validation established as 15-Apr-2026; that was reconstituted with sterile diluent, administered subcutaneous (indication, Lot No., and expiration date was not provided) (product storage error). No additional adverse event was reported (no adverse event). This is one of several reports received from the same reporter.; 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 Merck; Pentacel; Hepatitis B; PCV 20