Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM |
Itching on his back, near the lumbar area; bumps are very small red spots the size of a pin head and are not blistered or open, they are just barely raised; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included atrial fibrillation, blood pressure high and hyperlipidemia. Concomitant products included flecainide, diltiazem (Cardizem), atorvastatin, acetylsalicylic acid (Aspirin) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin). In APR-2025, the patient received Shingrix (intramuscular use, unknown deltoid) .5 ml. On 15-MAY-2025, less than 2 months after receiving Shingrix, the patient experienced pruritus (Verbatim: Itching on his back, near the lumbar area) and red papule (Verbatim: bumps are very small red spots the size of a pin head and are not blistered or open, they are just barely raised). The outcome of the pruritus and red papule were not resolved. It was unknown if the reporter considered the pruritus and red papule to be related to Shingrix. It was unknown if the company considered the pruritus and red papule to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine in mid-April this year and about 3 or 4 weeks later he noticed itching on his back, near the lumbar area. He reported that it remained confined to that area until one week ago, when it spread around his waist just below the belt line, onto his hip, and up his chest almost to his nipples and the bumps were very small red spots the size of a pin head and were not blistered or open, they were just barely raised. They crossed the midline in both the back and the front of his body, and it seemed to be progressing, getting more widespread and itchy. He started using a new soap about 6 months ago. The information on the medications listed is all that is available. He did not wish to locate his bottles to tell me the dosage. He stated that he has been taking these medicines for a very long time and did not believe they could be impacting his experiences with the bumps or itching.
Atrial fibrillation; Blood pressure high; Hyperlipidemia
FLECAINIDE; CARDIZEM; ATORVASTATIN; ASPIRIN; Multivitamin