Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
rash the size of a dime on her left arm; her first dose of SHINGRIX she was sleepy and her left arm was sore.; her first dose of SHINGRIX she was sleepy and her left arm was sore.; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-MAR-2025 16:56, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 07-MAR-2025, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: her first dose of SHINGRIX she was sleepy and her left arm was sore.) and pain in arm (Verbatim: her first dose of SHINGRIX she was sleepy and her left arm was sore.). On 08-MAR-2025, the patient experienced rash (Verbatim: rash the size of a dime on her left arm). The outcome of the rash was not resolved and the outcome of the sleepiness and pain in arm were unknown. It was unknown if the reporter considered the rash, sleepiness and pain in arm to be related to Shingrix. It was unknown if the company considered the rash, sleepiness and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The consumer was the reporter. The patient had her first dose of Shingrix vaccine administered on 07th March 2025 at 4:56 pm in her left arm. The reporter stated the evening of 08th March 2025 she noticed a rash the size of a dime on her left arm. The reporter stated the rash was not located at the site of injection. Consumer states on the evening of 09th March 2025 the rash was the size of a lemon. The consumer stated on 10th March 2025, the rash remains the same size. The reporter stated the rash was not itchy, bothersome, or painful. The consumer stated after receiving her first dose of Shingrix she was sleepy and her left arm was sore. No other information was provided/obtained. This case has been linked to the US2025AMR029990 case reported by the same reporter.