Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Rash; Muscle soreness; red rash on arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart rate irregular (Irregular heart beat). Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included blood pressure high (Blood pressure high), blood cholesterol increased (High cholesterol), diabetes (Diabetes), crohn's disease (Crohn's disease) and hidradenitis (Hidradenitis). Concomitant products included amlodipine, apixaban, clindamycin, dulaglutide (Trulicity), esomeprazole sodium (Nexium), furosemide (Lasix), gabapentin, hydrochlorothiazide, losartan, metformin, simvastatin, ustekinumab (Stelara) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin). In MAY-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), muscle soreness (Verbatim: Muscle soreness) and red rash (Verbatim: red rash on arm). The outcome of the rash, muscle soreness and red rash were not resolved. It was unknown if the reporter considered the rash, muscle soreness and red rash to be related to Shingrix. It was unknown if the company considered the rash, muscle soreness and red rash to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JUN-2025 The case was self reported by patient. The patient received Shingrix vaccine 3.5 weeks ago after that he experienced muscle soreness in his right arm which has not gone away. This now extends down to his right wrist and to the back of his arm. He had a red rash on this arm as well as on his waist.
Blood cholesterol increased (High cholesterol); Blood pressure high (Blood pressure high); Crohn's disease (Crohn's disease); Diabetes (Diabetes); Hidradenitis (Hidradenitis)
Medical History/Concurrent Conditions: Heart rate irregular (Irregular heart beat)
Amlodipine; Apixaban; Clindamycin; Trulicity; Nexium; Lasix; Gabapentin; Hydrochlorothiazide; Losartan; Metformin; Simvastatin; Stelara; Multivitamin