Report #2872431

Overview

Sex

Female

Age

29 yrs

State

MD

Recovered

Unknown

Vaccinated

Aug 5, 2022

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Patient received 1st dose of VARIVAX on 8/5/2022 VARIVAX (LOT U026207 unknown expiration date) and 2nd dose of VARIVAX on 9/1/2023 (Lot number X010531 unknown expiration date) but patient's "Titer is still negative"; Patient received 1st dose of VARIVAX on 8/5/2022 VARIVAX (LOT U026207 unknown expiration date) and 2nd dose of VARIVAX on 9/1/2023 (Lot number X010531 unknown expiration date) but patient's "Titer is still negative"; This spontaneous report was received from a pharmacist and refers to a 31-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 05-Aug-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka-merck) (VARIVAX), solution for injection, at a dose of 0.5 milliliters (mL), administered intramuscular as prophylaxis (Lot No. U026207 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date not reported, but upon internal validation established as 24-Aug-2023) (strength, anatomical location of administration and vaccination scheme frequency were not provided). On 01-Sep-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka-merck) (VARIVAX), solution for injection, at a dose of 0.5 milliliters (mL), administered intramuscular as prophylaxis (Lot No. X010531 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date not reported, but upon internal validation established as 11-Apr-2025) (strength, anatomical location of administration and vaccination scheme frequency); both doses were reconstituted with sterile diluent, solution for injection, administered intramuscular (Lot No., expiration date and indication were not provided). On an unknown day in 2025, it was stated that the patient titer was still negative (antibody test negative) (vaccination failure). The causal relationship between the event of antibody test negative with the suspect vaccine and the sterile diluent was not provided. The causal relationship between the event of vaccination failure with the suspect vaccine and the sterile diluent was related.

Lab data

Test Date: 2025; Test Name: Varicella Titer; Result Unstructured Data: still negative