Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | D2343 | IM |
she was in a hypertensive emergency/hypertension /headache/ blurred vision; Her Troponin level is elevated; This serious case was reported by a physician via call center representative and described the occurrence of hypertensive emergency in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number D2343, expiry date 31-JAN-2026) for prophylaxis. On 28-JUL-2025 15:00, the patient received Menveo (intramuscular). On 29-JUL-2025 03:00, 1 days after receiving Menveo, the patient experienced hypertensive emergency (Verbatim: she was in a hypertensive emergency/hypertension /headache/ blurred vision) (serious criteria hospitalization and GSK medically significant) and troponin increased (Verbatim: Her Troponin level is elevated) (serious criteria hospitalization). The outcome of the hypertensive emergency and troponin increased were not resolved. The reporter considered the hypertensive emergency and troponin increased to be related to Menveo. The company considered the hypertensive emergency and troponin increased to be related to Menveo. Additional Information: GSK Receipt Date: 05-AUG-2025 and 06-AUG-2025 The Medical Doctor reported that her patient had blurring vision and headaches shortly after receiving the dose of Menveo vaccine. The reporter stated 12 hours after the vaccination she was in a hypertensive emergency at the Emergency Room with hypertension and hospitalized for a week. Her blood pressure had risen from 112/80 to over 200/110 and her Troponin level was elevated but the echogram is normal. The doctor requested as soon as possible any report of hypertension extremely refractory with no response to medication, and blurry vision in adolescent or young adults after Menveo shots. The need to find an urgent cause to this situation; Sender's Comments: A case of Hypertensive emergency and troponin increased, 1 days after receiving Menveo. in a 18-year-old female patient Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Test Date: 20250728; Test Name: blood pressure; Result Unstructured Data: (Test Result:112/80,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250729; Test Name: blood pressure; Result Unstructured Data: (Test Result:200/110,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250729; Test Name: Troponin level; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:)