Received Jun 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | X011424 | OT |
immunocompromised patient developed VZV after being vaccinated with VARIVAX/type of AE: rash papulovesiculat/Herpes zoster; immunocompromised patient developed VZV after being vaccinated with VARIVAX.; This spontaneous report was received from a microbiologist and refers to a patient of unknown age and gender. The patient's concurrent conditions included immunocompromised. The patient's medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (dose, route of administration, lot # and expiration date were not reported) as prophylaxis (contraindicated product administered) which was reconstituted with sterile diluent (lot # and expiration date were not reported). On an unknown date, patient developed varicella-zoster virus (VZV) (Varicella zoster virus infection) after being vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). The causal relationship between the event and the suspect vaccine/therapy was not provided. Follow-up information was received from Varicella Zoster Virus Identification Program (VZVIP) on 09-Jun-2025 and on 11-Jun-2025 from the physician. Patent's demographics were reported and referred to a 13-month-old male patient. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. Specimen collection date o Source of specimen: blood o Was the patient on an oral antiviral (e.g., acyclovir, famciclovir or valacylovir) prior to specimen collections? No. o Final PCR Results: NEGATIVE (adequate sample, no VZV identified) The patient had no recent VZV exposure to chickenpox or shingles and had never had chickenpox and did not have a prior history of herpes zoster or herpes zoster ophthalmic. He had recurrent liver failure (moreover it was reported the following information difficult to read "new diagnosis ILF2 syndrome"). He did not have any allergies or concurrent medications. On 06-Feb-2024, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X011424, expiration date not provided but upon internal validation established as: 19-Apr-2025), (dose and route of administration were not reported) reconstituted with sterile diluent (expiration date, and lot # were not reported) (contraindicated product administered, as previously reported). Rash did not occur at the site of injection following the vaccination. On 21-May-2025, the patient experienced a rash papulovesicular (description reported as "crusting by presentation", number of lesions were reported as "innumerable" [information difficult to read]), distribution of lesions: T1 (right side) and developed herpes zoster (dermatome T1)). On May-2025, body temperature showed maximum temperature: less than or equal to 100.4 F. On 26-May-2025, VZV Strain Identification PCR in blood was negative (adequate sample, no VZV identified) (as previously reported). The patient recovered from the event of herpes zoster on an unspecified day in 2025. The causal relationship between the event and suspect vaccine/therapy was not provided.
Immunocompromised; Liver failure ("new diagnosis ILF2 syndrome")
Diluent Mrk
Test Date: 20250526; Test Name: VZV Strain Identification PCR; Result Unstructured Data: NEGATIVE (adequate sample, no VZV identified); Comments: Source of specimen: blood; Test Date: 202505; Test Name: Body temperature; Result Unstructured Data: Maximum temperature: less than or equal to 100.4 F