Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
HCP reports an unknown number of patients may have received improperly stored VARIVAX or PROQUAD anytime between 03-JAN-2025 and 04-FEB-2025; No adverse event; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: . The previous case ID: 2502USA001449. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report. This spontaneous report was received from a registered medical assistant referring to an unknown number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications. On unknown dates between 03-JAN-2025 and 04-FEB-2025, the patients were vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) that were improperly stored at 6.2 Fahrenheit degrees for 38 minutes and at 33 Fahrenheit degrees for 5 hours and 19 minutes (most recent). No adverse event was reported. This case was considered to be non-valid due to unknown number of patients without patient identifiers. Follow-up information has been received from the medical assistant on 10-FEB-2025. It was confirmed that no patients have reported any side effects since receiving doses of varicella virus vaccine live (oka/merck) (VARIVAX) or measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) after the temperature excursion.
Sterile Diluent