Received Mar 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
divot in their arm at the site of injection; Residual oedema; 4mm nodule; Painful arm; This serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (received first dose of Shingrix vaccine on 20-OCT-2025). On 30-DEC-2025, the patient received the 2nd dose of Shingrix (left deltoid). On 30-DEC-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Painful arm) (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced injection site indentation (Verbatim: divot in their arm at the site of injection), edema (Verbatim: Residual oedema) and nodule (Verbatim: 4mm nodule). The outcome of the pain in arm was not resolved and the outcome of the injection site indentation, edema and nodule were not reported. The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the injection site indentation, edema and nodule to be related to Shingrix. The company considered the pain in arm to be unrelated to Shingrix. It was unknown if the company considered the injection site indentation, edema and nodule to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2026 An ultrasound and computed tomography scan were performed and the computed tomography scan reportedly showed residual edema and 4 mm nodule. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Pain in extremity, less than a day after receiving 2nd dose of Shingrix in a 50-year-old female patient. Case lacks further information on medical history, concurrent conditions and clinical details. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought
Test Name: CT scan; Result Unstructured Data: (Test Result:residual edema and 4mm nodule,Unit:unknown,Normal Low:,Normal High:)