Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
after the administration of Shingrix she tested positive for syphilis.; This serious case was reported by a pharmacist via call center representative and described the occurrence of syphilis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-SEP-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced syphilis (Verbatim: after the administration of Shingrix she tested positive for syphilis.) (serious criteria GSK medically significant). The outcome of the syphilis was not resolved. It was unknown if the reporter considered the syphilis to be related to Shingrix. The company considered the syphilis to be unrelated to Shingrix. Additional Information: GSK receipt date: 20-NOV-2025 The Pharmacist reported that she had not been sexually active for over a year. No further information was provided/obtained. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Syphilis, an unknown time after receiving 1st dose of Shingrix, in a 50-year-old female patient. Causal association is indeterminate. 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: Syphilis test positive; Result Unstructured Data: (Test Result:Positive,Unit:unknown,Normal Low:,Normal High:) she tested positive for syphilis