Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z003882 | — |
Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion. Products were supported. See TE Case# 02834802 filed. Permission to contact HCP was granted. Caller stated they will contact M; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z005233, expiration date: 27-Feb-2027). On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003882, expiration date: 03-Feb-2027). On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of prophylaxis. The patient started therapy with sterile diluent (MERCK STERILE DILUENT), for the treatment of prophylaxis. On an unknown date, the patient experienced No additional AE. On an unknown date, the patient experienced Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion. Products were supported. See TE Case# 02834802 filed. Permission to contact HCP was granted. Caller stated they will contact M. At the reporting time, the outcome of No additional AE and Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion. Products were supported. See TE Case# 02834802 filed. Permission to contact HCP was granted. Caller stated they will contact M was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent was reported as not applicable. Follow-up information was received from a medical assistant and refers to a patient of unknown age and gender. The patient's initials were updated hence the case is no longer considered to be invalid. Concomitant therapies additionally included measles, mums and rubella vaccine (MMR II). It was specified that the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003882, expiration date: 03-Feb-2027) after experiencing a temperature excursion os -13.3 C in time frame of 144 hours 0 minutes and 0 seconds (product storage error). The vaccine was reconscituted with sterile diluent solution for injection (MERCK STERILE DILUENT) (lot # and expiration date was not provided). No previous temperature excursion was noted.
MMR II; Sterile diluent