Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV2 | HPV (CERVARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
patient is freaking out; abnormal pap smear; but that she received her first dose in 2011 and her last dose in 2013.; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of feeling anxious in a female patient who received HPV 16-18 (Cervarix) for prophylaxis. Previously administered products included Cervarix (patient received first dose in 2011). On an unknown date, the patient received the 2nd dose of Cervarix. On an unknown date, an unknown time after receiving Cervarix, the patient experienced feeling anxious (Verbatim: patient is freaking out), pap smear abnormal (Verbatim: abnormal pap smear) and drug administration duration too long (Verbatim: but that she received her first dose in 2011 and her last dose in 2013.). The outcome of the feeling anxious and pap smear abnormal were not reported and the outcome of the drug administration duration too long was not applicable. It was unknown if the reporter considered the feeling anxious and pap smear abnormal to be related to Cervarix and Cervarix Pre-Filled Syringe Device. It was unknown if the company considered the feeling anxious and pap smear abnormal to be related to Cervarix and Cervarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-DEC-2025 and 18-DEC-2025 A nurse practitioner called and reported that patient had received the full series of Cervarix, but that she received her first dose in 2011 and her last dose in 2013. The caller said that was prior to the patient's 15 birthday and the patient now had an abnormal pap smear and was scheduled to have a LEEP procedure. The caller said the patient was freaking out. The batch number was not provided, and we are unable to contact the reporter.