Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
right abdomen and left rib area she is having itching; right abdomen she is having stinging; left rib area she is having stinging; look like insect bites/ they are not insect bites and appear like chickenpox; swell up into big whelps at night; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose of vaccine on 14th april 2025, for tolerance to dose 1 refer case US2025107976). Concurrent medical conditions included hypothyroidism and glaucoma. On 06-AUG-2025, the patient received the 2nd dose of Shingrix (left arm). In AUG-2025, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: right abdomen and left rib area she is having itching), abdominal pain (Verbatim: right abdomen she is having stinging), rib pain (Verbatim: left rib area she is having stinging), varicella-like rash (Verbatim: look like insect bites/ they are not insect bites and appear like chickenpox) and welts (Verbatim: swell up into big whelps at night). Rechallenge with Shingrix was positive. The outcome of the pruritus, abdominal pain, rib pain, varicella-like rash and welts were not resolved. It was unknown if the reporter considered the pruritus, abdominal pain, rib pain, varicella-like rash and welts to be related to Shingrix. It was unknown if the company considered the pruritus, abdominal pain, rib pain, varicella-like rash and welts to be related to Shingrix. Linked case(s) involving the same patient: US2025107976 Additional Information: GSK Receipt Date: 21-AUG-2025 The consumer was the reporter. She stated that she had received her second dose of Shingrix on 6th August 2025 in her left arm. She reported experiencing itching and stinging on her right abdomen and left rib area. She mentioned that after both vaccinations, she developed a rash that looked like insect bites, although she believed they were not insect bites and resembled chickenpox. She noted that the rash would disappear during the day and swell into big whelps at night. She stated that the right side had resolved, but the left side remained affected. She also mentioned that she was very healthy and an active runner For tolerance to 1st dose, refer case US2025107976
Glaucoma; Hypothyroidism