Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y013347 | — |
No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered. Permission was given to contact HCP. No additional AE /PQC reported. ? Names of vaccines involved (including lot/exp): VARIVAX Y013347 8/08/20; This spontaneous report was received from an other health professional and refers to a(n) 55-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-MAR-2025, the patient was vaccinated with improperly stored dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Injection, lot #Y013347, expiration date 02-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The excursion lasted for 36 minutes in temperature -7.8 Celsius degrees. There was previous excursion that lasted 13 minutes in temperature -14.0 Celsius degrees (-14.4°C up to -10.4°C) (improper storage of product in use). No additional adverse events were reported.
Sterile diluent