Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | UNK | — | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
car accident because she fainted; car accident because she fainted; Nauseated; This is a spontaneous report received from Nurses and Other HCPs. A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 10Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 17 years for immunisation; meningococcal vaccine a/c/y/w conj (CRM197) (MENVEO), on 10Sep2025 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 10Sep2025, outcome "unknown", described as "Nauseated"; SYNCOPE (medically significant), ROAD TRAFFIC ACCIDENT (non-serious) all with onset 10Sep2025, outcome "unknown" and all described as "car accident because she fainted". Clinical course: Reporter stated that they had a patient that they administered Menveo and Trumenba to a 17 years old patient and, 15 minutes later, after getting the vaccine. She left the office and was involved in a car accident because she fainted. Well, they said that because I asked them did anybody get hurt, and they said no one was hurt. She got nauseated and tried to pull over, reporter was not sure if she hit another vehicle or what the circumstances were. Reporter stated, she got the Menveo and Trumenba together. Menveo, which is the quadrivalent vaccine." The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Based on the known drug safety profile and temporal relationship, a causal association between suspect product and nausea and SYNCOPE cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.