Received Apr 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | LA |
Injection site feverish welts; feverish at injection site; knot in their left arm; Painful arm; Nauseous; much pain at the injection site; Can't lift left arm above their head; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes (Diabetes). On 08-APR-2026, the patient received Shingrix (left arm). On 08-APR-2026, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: much pain at the injection site), pain in arm (Verbatim: Painful arm) and nausea (Verbatim: Nauseous). On 09-APR-2026, the patient experienced injection site wheal (Verbatim: Injection site feverish welts), injection site warmth (Verbatim: feverish at injection site) and swelling (Verbatim: knot in their left arm). In APR-2026, the patient experienced mobility decreased (Verbatim: Can't lift left arm above their head). On 08-APR-2026, the outcome of the nausea was resolved. The outcome of the injection site wheal and pain in arm were not resolved and the outcome of the injection site pain, injection site warmth, swelling and mobility decreased were not reported. The reporter considered the injection site wheal, pain in arm and nausea to be unrelated to Shingrix. It was unknown if the reporter considered the injection site pain, injection site warmth, swelling and mobility decreased to be related to Shingrix. The company considered the injection site wheal, pain in arm and nausea to be unrelated to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, swelling and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 09-APR-2026 The patient reported much pain at the injection site that day. By the following day, there is a knot in their left arm and a feverish welt at injection site. The patient could not lift left arm above their head, was a sleep and rolled over on it and jumped up from bed because of pain. The batch number was not provided and a request for this information has been made.
Diabetes (Diabetes)