Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | — | OT |
she developed shingles (blisters broke out on Thursday 8/14/2025) and symptoms of a headache; Earache in left ear; Diagnosed with stage 3 breast cancer; This spontaneous report was received from a Physician and refers to a 59-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Anastrozole (reported as anastrovole), Irbesartan (reported as irvesarton), Calcium, Vitamin D and Vitamin K. On 06-May-2014, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (lot #, expiration date, strength, route of administration, anatomical location not provided) as shingles vaccination. On an unspecified date in November 2021, the patient was diagnosed with stage 3 breast cancer for which had unspecified chemotherapy and radiation (reported as medical history). On an unspecified date, the patient recovered from this event (reported as "no evidence of disease"). On 11-Aug-2025, the patient experienced Earache in left ear. On 14-Aug-2025 (also reported as Thursday), the patient developed shingles (blisters broke out with rash on forehead on left side and some above the hairline) with symptoms of headache. Therefore, the patient went to "teledoc" and was prescribed valacyclovir (VALTREX). At the reporting time, the outcome of Earache and shingles was unknown. The causal relationship between all the events and Zoster Vaccine Live (ZOSTAVAX) was not reported. Upon internal review, the event of stage 3 breast cancer was determined to be medically significant.
Anastrovole; Irvesarton; Calcium; Vit D; Vit K; Sterile diluent