Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
patient experienced injection site pain; fever; felt like crap; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date (refer case US2025AMR059456)). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient experienced injection site pain), fever (Verbatim: fever) and feeling abnormal (Verbatim: felt like crap). Rechallenge with Shingrix was positive. The outcome of the injection site pain, fever and feeling abnormal were resolved (duration 36 hrs). It was unknown if the reporter considered the injection site pain, fever and feeling abnormal to be related to Shingrix. It was unknown if the company considered the injection site pain, fever and feeling abnormal to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR059456 Additional Information: GSK Receipt Date: 08-MAY-2025 Patient was approximately 60 years old. Patient had been vaccinated with Shingrix and a few hours after the injections the patient experienced injection site pain, within a few hours experienced fever and felt like crap. The symptoms lasted about 36 hours and patient is fully recovered.