Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Patient developed rash on one side of face area; Patient developed rash inside mouth; This serious case was reported by a physician via sales rep and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included varicella zoster (left varicella zoster). Concurrent medical conditions included gout (gout), hepatitis b (hep b), fatty liver (fatty liver), hyperlipidemia (hyperlipidemia) and gallstones (gall stones). Concomitant products included allopurinol. On 27-MAR-2025, the patient received the 1st dose of Shingrix (left deltoid). On 31-MAR-2025, 4 days after receiving Shingrix, the patient experienced rash (Verbatim: Patient developed rash on one side of face area) (serious criteria other: Serious as per reporter) and rash mouth (Verbatim: Patient developed rash inside mouth) (serious criteria other: Serious as per reporter). The patient was treated with valaciclovir, gabapentin and triamcinolone. On 04-APR-2025, the outcome of the rash and rash mouth were resolved (duration 4 days). It was unknown if the reporter considered the rash and rash mouth to be related to Shingrix. The company considered the rash and rash mouth to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-APR-2025 Patient developed rash on one side of face area and inside mouth 2-3 days after first dose of Shingrix. Patient was started on valacyclovir, gabapentin, triamcinolone, vision check and sent to consult with ophthalmologist .; Sender's Comments: Rash is a listed event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK vaccine Oral mucosal eruption Shingrix. Oral mucosal eruption is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Fatty liver (fatty liver); Gallstones (gall stones); Gout (gout); Hepatitis B (hep b); Hyperlipidemia (hyperlipidemia)
Medical History/Concurrent Conditions: Varicella zoster (left varicella zoster)
ALLOPURINOL