Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
fainted; After a few minutes of getting the vaccine had some reaction; Initial information received on 19-Nov-2025 regarding an unsolicited valid serious case received from a consumer/non-health care professional. This case involves an unknown age female patient who had fainted and had some reaction after a few minutes of receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Jun-2025, the patient received 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 30-Jun-2025 the patient had fainted (syncope) and a few minutes of getting the vaccine had some reaction (immunisation reaction) (latency: same day). Reportedly,At the hospital patient went through several checks (triage) and tests like x-ray, blood work etc. She was asked to drink a lot of water. We were told that fortunately she is doing fine and has nothing to worry about her health. She was finally released after a few hours .Patient fortunately didn't have any noticeable issues since then. All the events happened so fast because of the reaction of the vaccine. We followed as guided and before we could realize what was going on, an ambulance was called and she was sent to the Hospital Emergency Room [ER]. We as a family went through an emotional rollercoaster on that day. When she was in the Hospital going through tests, we couldn't' t see her or get any updates about her for hours. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date in June 2025 for both the events. Seriousness criteria: Medically significant for the event Syncope.; Sender's Comments: Sanofi company comment dated 21-Nov-2025: This case involves an unknown age female patient who had fainted and had some reaction after a few minutes of receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].The time to onset was compatible with the role of vaccine.Furthermore, lack of information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.