Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | — | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 2 | — | OT / LA |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
the patient broke out in "red bumps" on her left arm (the arm that the vaccine was given in)/the "red bumps" are continuing to spread to her right arm and back.; This spontaneous report was received from a Physician and refers to a 18-year-old female patient. The patient's medical history, drug history, concurrent conditions and concomitant therapies were not reported. On 26-Aug-2025, she was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (dose, route of administration, anatomical site, lot # and expiration date were not reported), the vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported), as prophylaxis. She did not have any reaction. Afterwards, on 29-Sep-2025, she was vaccinated with the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), in her left arm (dose, route of administration, lot # and expiration date were not reported, the vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported) as prophylaxis. On this same date (29-Sep-2025), within 1 hour, the patient broke out in "red bumps" on her left arm (the arm that the vaccine was given in). She was seen and started on a steroid methylprednisolone (MEDROL) dose pack and the "red bumps" were continuing to spread to her right arm and back (rash papular). At the reporting time, the patient had not recovered from this event. The causal relationship between the event of rash popular and suspect vaccine (Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX)), reconstituted suspect sterile diluent (Hollister-Stier STERILE DILUENT) was not provided. Batch/Lot number is being requested and will be submitted if received.