Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | RA |
still in the open sore stage/oozing lesions developed at injection site; injection site started to itch (Pruritus); received first shingrix shot and had a shingles breakout at the injection site/oozing lesions developed at front and back right shoulder and righ arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erosion in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included ankylosing spondylitis. Concomitant products included certolizumab pegol (Cimzia). On 11-OCT-2024, the patient received the 1st dose of Shingrix (injection, right deltoid) .5 ml. In OCT-2024, 5 days after receiving Shingrix, the patient experienced injection site erosion (Verbatim: still in the open sore stage/oozing lesions developed at injection site), injection site itching (Verbatim: injection site started to itch (Pruritus)) and shingles (Verbatim: received first shingrix shot and had a shingles breakout at the injection site/oozing lesions developed at front and back right shoulder and righ arm). The outcome of the injection site erosion, injection site itching and shingles were not resolved. It was unknown if the reporter considered the injection site erosion, injection site itching and shingles to be related to Shingrix. It was unknown if the company considered the injection site erosion, injection site itching and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JAN-2025 The patient received Shingrix. The patient did not know the lot number of the vaccine that was administered. The patient reported that 2 days after getting the vaccine, injection site started to itch (Pruritus) (Symptomatic) The patient also reported he had a shingles breakout at the injection site that was still in the open sore stage The patient reported 5 days after getting the vaccine oozing lesions developed at injection site, front and back right shoulder, and right arm (Symptomatic). The patient reported that his symptoms had not resolved completely, stating that his skin still itches (Pruritus) and 2 lesions remain oozing at the time of reporting. The patient wanted to know if he should get the 2nd shot or continue to wait for the sores to go away.
Ankylosing spondylitis
CIMZIA