Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
HCP called to state that she ran titers for a patient and she is showing no immunity for VARIVAX; This spontaneous report was received from a Nurse Practitioner on 07-Apr-2025 and refers to a 61-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (reported as DILUENT MRK) used to reconstitute the vaccine. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka-Merck) (VARIVAX) (0.5mL/ series; formulation, route, lot # and expiration date were not reported) for Prophylaxis. The patient's vaccine history was unknown, so this case was serving as a precautionary adverse event (AE). On an unknown date, the reporter ran titers for the patient, who showed no immunity for the varicella virus vaccine live (Oka-Merck) (VARIVAX) (Immunodeficiency). The action taken with varicella virus vaccine live (Oka-Merck) (VARIVAX) was reported as Dose not changed. At the reporting time, the outcome of Immunodeficiency was unknown. The causal relationship between the event of Immunodeficiency and varicella virus vaccine live (Oka-Merck) (VARIVAX) was not provided. Upon internal review, the event of Immunodeficiency was determined to be medically significant.
DILUENT MRK
Test Name: Antibody titre test; Result Unstructured Data: no immunity for VARIVAX