Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
Lack of efficacy 15-month old child developed a mild case of chicken pox; rash started around Friday 3/21.; Lack of efficacy; This spontaneous report was received from a consumer regarding a 15-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported). On 21-MAR-2025, the patient experienced lack of efficacy as he developed a mild case of chicken pox (Varicella, Vaccination failure). The patient was in a daycare setting and his brother was also vaccinated. The outcome of varicella was not reported. The reporter considered the event of vaccination failure to be related to Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). The causal relationship between the event varicella and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not reported.