Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | X026404 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y014182 | OT |
No symptomatic events were reported.; administered to a patient after suffering Temperature excursion; This spontaneous report was received from registered nurse (RN) concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On unspecified date, doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) underwent a temperature excursion at a temperature of 70 (units not provided) during a time frame of 72 hours, 0 minutes, and 0 seconds. Previous temperature excursions were reported as not applicable (N/A.) On 21-FEB-2025, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #X026404, expiration date: 08-NOV-2025) 0.5 mL (0.5mL/series) (dosage regimen, anatomical location and route of administration were not provided), and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y014182, expiration date: 20-AUG-2026, 0.5 mL (0.5mL/series) (dosage regimen, anatomical location and route of administration were not provided), both administered a prophylaxis (product storage error) which were reconstituted with an unknown sterile diluent (manufacturer unknown) injection (dose, indication, expiration date, and lot # were not reported.) No symptomatic events were reported (no adverse event). No additional information was provided. Lot # is being requested and will be submitted if received. Follow-up information has been received from RN on 31-MAR-2025 concerning 4-years-old male patient. The patient's medical historu included "NKA" and allantonic cyst. His concurrent conditions included gross motor development delay and cow's milk intolerance. Concomitant vaccine included dtap polio vaccine (QUADRACEL). All suspect vaccines were administered by subcutaneous route. Lot # #X026404 and lot #Y014182 has been established as valid.
Cow's milk intolerance; Motor developmental delay
Medical History/Concurrent Conditions: Cyst
Quadracel; Sterile diluent