Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z002989 | — |
No additional AE; PROQUAD was administered after being involved in a temperature excursion; This spontaneous report was received from a Certified Medical Assistant (CMA) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 07-Oct-2025, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant Human albumin]) (PROQUAD) solution for injection, 1 dosage form, administered as prophylaxis (Lot No. Z002989 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 14-Jul-2026) (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent, solution for injection (Lot No., expiration date and indication were not provided) (product storage error); after a temperature excursion of 21.9-degree Fahrenheit (F) during a time frame of 14-degree Fahrenheit (F) to 46-degree Fahrenheit (F) for 12 hours, 30 minutes; 6-degree Fahrenheit (F) to 14-degree Fahrenheit (F) for 37 hours, 30 minutes. No previous temperature excursion was reported. No additional adverse event or PQC were provided (No adverse event). This is one of several reports received from the same reporter.
Sterile diluent