Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z003308 | — |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | — |
No additional AE; TE with administered PROQUAD; This spontaneous report was received from a physician 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 11-Aug-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) administered as prophylaxis (Lot No. Z003308 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 21-Jul-2026) (strength, dose number, exact dose quantity volume, route, anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date, route and indication was not reported) (product storage error), after a temperature excursion of -14.55 degree Celsius (C) during a time frame of 35 minutes. No previous temperature excursion was reported. No additional information or adverse events or PQC were provided (no adverse event).