Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y009982 | OT |
No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD on 4/9/2025 following a TE that started on 3/17/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case #0; This spontaneous report was received from another health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 09-APR-2025, the patient was vaccinated with an improper stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 ml (lot #Y009982, which had been verified to be a valid lot number; expiration date reported and confirmed as 24-NOV-2025; route of administration and anatomical location were not provided) as prophylaxis which was diluted with a sterile diluent (lot and expiry date not provided). The suspect vaccine was administered following a temperature excursion of 13.91 degrees Celsius / 14.4 degrees Celsius up to -10.4 degrees Celsius with a time frame of 360 Hours 0 Minutes 0 Seconds (on 17-MAR-2025). No symptoms reported (no adverse event). No previous temperature excursion was reported.
Sterile diluent