Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
Burning sensation in back; Back pain (with radiation); This serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On 23-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular). On 23-AUG-2024, less than a day after receiving Shingrix, the patient experienced burning sensation (Verbatim: Burning sensation in back) (serious criteria hospitalization) and back pain (with radiation) (Verbatim: Back pain (with radiation)) (serious criteria hospitalization). The outcome of the burning sensation and back pain (with radiation) were not resolved. It was unknown if the reporter considered the burning sensation and back pain (with radiation) to be related to Shingrix. The company considered the burning sensation and back pain (with radiation) to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 01-MAY-2025 The reporter was the patient who received her 2nd dose of Shingrix 23 AUG 2024 and had issues of back pain and burning sensation in her back mostly on the left side per the dosage. These symptoms were ongoing, and the reporter had been seen in the hospital a few times and had no positive test drawn at this time.; Sender's Comments: Burning sensation and Back pain are unlisted events which are considered unrelated to GSK vaccine Shingrix.