Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Skin burning sensation; Flu like symptoms; intermittent sharp pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-APR-2025, the patient received the 1st dose of Shingrix. On 04-APR-2025, 5 hrs after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). On 05-APR-2025, the patient experienced burning sensation skin (Verbatim: Skin burning sensation). In APR-2025, the patient experienced pain (Verbatim: intermittent sharp pain). The outcome of the influenza-like symptoms was unknown and the outcome of the burning sensation skin and pain were not resolved. It was unknown if the reporter considered the influenza-like symptoms, burning sensation skin and pain to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, burning sensation skin and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 28-APR-2025 The reporter reported that patient received a Shingrix vaccine over 3 weeks ago. He experienced flu like symptoms starting about 5 hours after the injection. By the 2nd day, noticed feeling a skin burn like sunburn under his forearms, biceps, armpits and back. There were no visible signs of change in the appearance of the skin. The skin burn had persisted since that time. It was annoying but not a substantial pain. However, in the last 24 hours patient had experienced a higher level of skin burn, and in one spot a localized, intermittent sharp pain.