Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Developed Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included sclerosing cholangitis (n autoimmune disorder of the bile ducts.), cholesterol and hypertension. Concomitant products included amlodipine and rosuvastatin. On 19-AUG-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25-AUG-2025, 6 days after receiving Shingrix, the patient experienced shingles (Verbatim: Developed Shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 29-AUG-2025 Patient noticed a rash on my face, in front of right ear. It felt like poison ivy but did not itch. Earlier on the same day, patient underwent an abdominal MRI/MRCP with Gadavist (gadobutrol) contrast to monitor Primary Sclerolsing Cholangitis (PSC) an autoimmune disorder of the bile ducts. The rash was first noted a few hours after the procedure was completed. By the next day the rash had spread to right cheek, right jawline, back and front of neck on right, upper and lower right shoulder and back of right upper arm near axilla. There is some intermittent burning, and also occasional pain on the right side of my head, more involving the scalp rather than a headache. On 27Aug2025, patient was prescribed valacyclovir 1 gram 3 times/day for 7 days after in-person evaluation by the physician. Started med the same day. My physician told me that the shingles started in cervical nerve 3 and spread to C2 and C4. He explained why the Shingrix vaccine does not cause a rash (not a live virus).
Cholesterol; Hypertension; Sclerosing cholangitis (n autoimmune disorder of the bile ducts.)
AMLODIPINE; ROSUVASTATIN
Comments: On 25-Aug-2025 patient underwent abdominal MRI/MRCP with Gadavist (gadobutrol)