Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
| MNP | MENINGOCOCCAL CONJUGATE (PENMENVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
nausea; rash; dizziness; shortness of breath; This serious case was reported by a nurse via call center representative and described the occurrence of nausea in a 16-year-old patient who received Men ABCWY NVS (Penmenvy) suspension for injection in pre-filled syringe for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) solution for injection for prophylaxis. On 30-MAY-2026, the patient received the 1st dose of Penmenvy and the 2nd dose of HPV vaccine. On 31-MAY-2026, 1 days after receiving Penmenvy and HPV vaccine, the patient experienced nausea (Verbatim: nausea) (serious criteria hospitalization), rash (Verbatim: rash), dizziness (Verbatim: dizziness) and shortness of breath (Verbatim: shortness of breath). On 01-JUN-2026, the outcome of the nausea was resolved (duration 1 day). The outcome of the rash, dizziness and shortness of breath were not reported. It was unknown if the reporter considered the nausea, rash, dizziness and shortness of breath to be related to Penmenvy, Penmenvy Pre-Filled Syringe Device and HPV vaccine. The company considered the nausea to be unrelated to Penmenvy, Penmenvy Pre-Filled Syringe Device and HPV vaccine. 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: 02-JUN-2026 The nurse manager had reached out on 02-JUN-2026. The patient had not had any side effects on 30-MAY-2026 but on the afternoon of 31-MAY-2026 and had started to get a rash, dizziness, shortness of breath, nausea and had gone to the emergency room. The patient had also received a second dose of HPV (human papillomavirus) during the visit. This had not been related to an existing case. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Nausea, 1 days after receiving the 1st dose of Penmenvy, Penmenvy PRE-FILLED SYRINGE DEVICE and 2nd dose of HPV vaccine in a 16-year-old patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.