Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
he had injection site pain/ The injection site muscle is still tender; bump under skin at injection site; numbness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diverticulitis (Has had for several years.). In AUG-2025, the patient received the 1st dose of Shingrix (intramuscular). In AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: he had injection site pain/ The injection site muscle is still tender), injection site swelling (Verbatim: bump under skin at injection site) and injection site numbness (Verbatim: numbness at injection site). The outcome of the injection site pain, injection site swelling and injection site numbness were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site numbness to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site swelling and injection site numbness to be related to Shingrix. Additional Information: GSK Receipt Date: 26-NOV-2025 The reporter was patient itself. The reporter mentioned that the patient had injection site pain, injection site muscle was still tender, bump under the skin at the injection site and injection site numbness. The batch number was not provided and a request for this information has been made.
Diverticulitis (Has had for several years.)