Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Haemophilus influenza; trouble breathing; felt dizziness; nausea; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 16 year old female patient who had haemophilus influenza, patient is still experiencing felt dizziness, nausea and trouble breathing after receiving vaccine 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 20-Jun-2025, at 11:00 hours the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection standard strength frequency-once (lot number and expiry date-unknown) 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 22-Jun-2025 the patient developed haemophilus influenza (haemophilus infection) (latency-2 days) On 20-Jun-2025 at 02:00 hours the patient developed felt dizziness (dizziness), nausea, trouble breathing (dyspnoea) (latency- 11 hours). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events of (dizziness), nausea, trouble breathing (dyspnoea) and haemophilus infection). At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness Criteria-The patient was hospitalized for the event of haemophilus infection.; Sender's Comments: Sanofi company comment dated 26-JUN-2024: This case involves a 16 year old female patient who had haemophilus influenza, patient is still experiencing felt dizziness, nausea and trouble breathing after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.