Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
lump in perineum; she developed side pain; lumbar back pain; This serious case was reported by a consumer via call center representative and described the occurrence of perineal cyst in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-SEP-2025, the patient received the 1st dose of Shingrix. On 01-OCT-2025, 2 days after receiving Shingrix, the patient experienced perineal cyst (Verbatim: lump in perineum) (serious criteria GSK medically significant), pain (Verbatim: she developed side pain) and lumbar pain (Verbatim: lumbar back pain). The outcome of the perineal cyst and lumbar pain were not resolved and the outcome of the pain was resolving. It was unknown if the reporter considered the perineal cyst, pain and lumbar pain to be related to Shingrix. The company considered the perineal cyst to be unrelated to Shingrix. It was unknown if the company considered the pain and lumbar pain to be related to Shingrix. Additional Information: GSK Receipt Date: 03-OCT-2025 The patient reported that 2 days after vaccination in the afternoon, she developed side pain which was improved and lumbar back pain which was persisting. The patient also noticed a lump in her perineum. Nothing else was reported. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Perineal cyst, 2 days after receiving Shingrix, in a 67-year-old female patient. 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.