Received Jun 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8661AA | IM / LA |
nearly fainting after vaccine administration; shaking; dilated pupils; paleness; nausea; Initial information received on 21-May-2026 regarding an unsolicited valid serious case received from a healthcare professional (HCP) other. This case involves a 15-year-old male patient who experienced nearly fainting after vaccine administration, shaking, dilated pupils, paleness, and nausea after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] . The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 20-May-2026, the patient received a 0.5 mL (dose 1) of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], solution for injection (batch: U8661AA, expiry: 28-Feb-2029) (strength: unknown) via intramuscular route in Left deltoid for immunization [Immunisation]. A pharmacy intern sought guidance following the adverse reactions experienced by two patients after receiving Menquadfi on 20-May-2026. The pharmacy intern noted that after approximately two minutes of receiving Menquadfi, the patients became pale and nauseous. The patients were also reported to be shaking and nearly fainting after vaccine administration, with pupils dilated. One of the patients reported that their throat was also hurting. The pharmacy intern stated that the pharmacist was with the patients until they left and that there was an ambulance called, but the intern was unsure whether the patients had been sent to the emergency room (ER).The pharmacy intern expressed their intent to call the patients later to check how they were doing. The patient experienced paleness (Pallor, onset date: 20-May-2026 and latency: same day). The patient experienced nausea (Nausea, onset date: 20-May-2026 and latency: same day). The patient experienced shaking (Tremor, onset date: 20-May-2026 and latency: same day). The patient experienced dilated pupils (Mydriasis, onset date: 20-May-2026 and latency: same day). The patient experienced nearly fainting after vaccine administration (Syncope, onset date: 20-May-2026 and latency: same day). Action taken: not applicable. Corrective treatment: not reported. Event outcome: unknown for nearly fainting after vaccine administration (Syncope), shaking (Tremor), dilated pupils (Mydriasis), paleness (Pallor), and nausea (Nausea). Seriousness criteria: medically significant for nearly fainting after vaccine administration (Syncope).; Sender's Comments: Sanofi company comment dated 31-May-2026: This case involves a 15-year-old male patient who experienced nearly fainting after vaccine administration, shaking, dilated pupils, paleness, and nausea after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi]. Further information regarding allergic history, laboratory investigations, medical history, concomitant medication and tolerance, 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.
Comments: NONE