Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
she began itching in several places on her body; she scratched and noted raised bumps coming up in the places where she scratches; Urticaria; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included levothyroxine sodium (Levothyroxine). On 21-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular). On 21-JUL-2025, less than a day after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: she began itching in several places on her body), papular rash (Verbatim: she scratched and noted raised bumps coming up in the places where she scratches), urticaria (Verbatim: Urticaria) and rash (Verbatim: Rash). The patient was treated with levocabastine hydrochloride (Zyrtec). The action taken with Shingrix was unknown. The outcome of the generalized pruritus and papular rash were not reported and the outcome of the urticaria and rash were not resolved. It was unknown if the reporter considered the generalized pruritus, papular rash, urticaria and rash to be related to Shingrix. It was unknown if the company considered the generalized pruritus, papular rash, urticaria and rash to be related to Shingrix. Linked case(s) involving the same patient: US2025107407 Additional Information: GSK receipt date: 20-AUG-2025 Beginning about an hour after the injection, patient began itching in several places on her body. Thinking it was a bug bite, she scratched and noted raised bumps coming up in the places where she scratches. This was continued to happen all over her body. The bumps did not raise until the area was rubbed or scratched in response to the intense itching. She stated that the bumps went away after about an hour. The itching was worst in the evenings. She reported having treated the itching with Zyrtec for about two weeks, but it did not help. Patient was on Levothyroxine since 2000. For tolerance of 1st dose, please refer US2025107407.; Sender's Comments: US-GSK-US2025107407:Same patient
LEVOTHYROXINE