Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 24M7E | IM / RA |
Rash has flared back up on his arms in the last; itchy rash on the top of his left arm/on the top of his right arm from his wrist to elbow; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 06-APR-2026) for prophylaxis. The patient's past medical history included cardiac arrest. Concurrent medical conditions included mitral valve incompetence (10 years ago) and heart disorder. Concomitant products included propranolol, losartan, furosemide and warfarin. On 21-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). In SEP-2024, 2 weeks after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on the top of his left arm/on the top of his right arm from his wrist to elbow). In FEB-2025, the patient experienced condition aggravated (Verbatim: Rash has flared back up on his arms in the last). The outcome of the itchy rash and condition aggravated were not resolved. It was unknown if the reporter considered the itchy rash and condition aggravated to be related to Shingrix. It was unknown if the company considered the itchy rash and condition aggravated to be related to Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 and 03-MAR-2025 The patient self-reported this case. The patient received the first dose of Shingrix for shingles prevention and a couple of weeks after receiving the first dose he had an itchy rash on the top of his right arm from his wrist to his elbow and that around the end of November 2024 to early December 2024 (no specific date provided) he also had this itchy rash on the top of his left arm from his wrist to his elbow and on the top of his chest from below his neck to about the end of of his chest cage. By the top of his arms, the patient meant the top side of his forearms. The patient still had all of these same itchy rash areas today (on the reporting day) The patient reported that the rash seemed to start to dissipate, but had flared back up on his arms in the last week or so (no specific dates provided) and the presentation on his left arm at first was not as bad as the presentation on his right arm at first. The patient had seen 3 healthcare providers about this itchy rash. One provided him a topical (Unknown Product Information) that he used for a month and it helped a little bit. The patient has tried over the counter salves and lotions (Unknown Products Information) and right now was using topical Aloe (Unknown Product Information). The patient reported that he blew his mitral valve 10 years ago and flat lined 24 hours later (Pre Existing Shingrix). The patient did not had any paper work to provide, but said he received the vaccine from his Pharmacist. The patient had been on all of his concurrent medications for 10 years, all pre-existing receiving Shingrix, but took them all the day the vaccine was received.
Heart disorder; Mitral valve incompetence (10 years ago)
Medical History/Concurrent Conditions: Cardiac arrest
PROPRANOLOL; LOSARTAN; FUROSEMIDE; WARFARIN