Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015557 | — |
HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX were administered. Permission was given to contact HCP. No additional AE/PQC reported. ? Names of vaccines involved (including lot/exp): VARIVAX Y015557 09/1; no adverse event; This spontaneous report was received from a nurse and regarding a 10-year-old patient of unknown gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection, as prophylaxis (lot #Y015557, expiration date: 16-Sep-2026) (dose, anatomical location, and route of administration were not reported), reconstituted with sterile diluent (MERCK STERILE DILUENT), solution for injection (dose, indication, route of administration, expiration date, and lot # were not reported). It was stated that this vaccine, underwent a temperature excursion (TE) at -7.8 °C, during 36 minutes. A previous temperature excursion had occurred at -14.4°C (up to -10.4°C) and 14.0 °C during 13 minutes.
Sterile diluent