Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
surgical wound infected; Wound dehiscence Right knee surgical wound opened; Knee replacement surgery right knee; diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck; Pain; back twisted; hurt a muscle; This serious case was reported by a consumer via call center representative and described the occurrence of knee replacement in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included retinal detachment. Concurrent medical conditions included hypertension, indigestion and prostate cancer. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), gabapentin, aciclovir (Acyclovir), prednisolone, lisinopril, cyanocobalamin (B 12), famotidine, latanoprost and tamsulosin. On 23-DEC-2024, the patient received the 2nd dose of Shingrix (left arm) .5 ml. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced sprained back (Verbatim: back twisted) and muscle injury (Verbatim: hurt a muscle). On 02-JAN-2025, the patient experienced knee replacement (Verbatim: Knee replacement surgery right knee) (serious criteria clinically significant/intervention required). In JAN-2025, the patient experienced shingles (Verbatim: diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck) and pain (Verbatim: Pain). On an unknown date, the patient experienced surgical wound infection (Verbatim: surgical wound infected) and wound dehiscence (Verbatim: Wound dehiscence Right knee surgical wound opened). The patient was treated with clobetasol propionate. The outcome of the knee replacement, surgical wound infection, wound dehiscence, sprained back and muscle injury were not reported and the outcome of the shingles and pain were not resolved. It was unknown if the reporter considered the knee replacement, shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix. The company considered the knee replacement to be unrelated to Shingrix. It was unknown if the company considered the shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix. Additional Information: GSK Receipt Date: 28-MAY-2025 The reporter is the patient who reports that he received both Shingrix doses as recommended in the prescribing information in 2024. The reporter read on social media that he should report any adverse event concerning Shingrix. The reporter stated that he twisted his back in December of 2024 and hurt a muscle in his left back. He stated in the second week of January 2025 he was diagnosed with shingles at the same location he hurt his back in December of 2024. The shingles spread to his left neck and left groin. The shingles were still ongoing.; Sender's Comments: Knee arthroplasty is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Hypertension; Indigestion; Prostate cancer
Medical History/Concurrent Conditions: Retinal detachment
SHINGRIX; GABAPENTIN; ACYCLOVIR; PREDNISOLONE; LISINOPRIL; B 12; FAMOTIDINE; LATANOPROST; TAMSULOSIN
Test Date: 20250521; Test Name: Biopsy; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Comments: Biopsy completed and results are pending