Age: 26.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dysphagia, Feeling hot, Hypoaesthesia, Loss of consciousness, Mydriasis
Clinical narrative: felt hot; syncopal; LOC; Convulsions; dilated pupils; Once regained consciousness endorsed blurry vision; numb ears - kept slowly grabbing for ears; difficulty swallowing; Initial information received on 28-Oct-2024 regarding an unsolicited valid  serious case received from a nurse.  This case involves a 26 years old male patient who experienced convulsions, syncopal, loc, felt hot, dilated pupils, once regained consciousness endorsed blurry vision, numb ears - kept slowly grabbing for ears and difficulty swallowing after receiving vaccines Moderna Covid-19 Vaccine And Influenza Quadrivalent Recombinant Vaccine [Flublok].  The patient's past vaccination(s) included Influenza Vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On 25-Oct-2024 at 16:00, the patient received a single 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine injection (lot TFAA2439, with unknown strength and expiry) via intramuscular route in unknown administration site as annual flu shot. On 25-Oct-2024 at 16:03, the patient received a dose of suspect Moderna Covid-19 Vaccine not produced by Sanofi Pasteur (lot number, strength, dose, form and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination.  On 25-OCT-2024, once needle for Moderna withdrawn, patient felt hot (feeling hot) and was syncopal (syncope) around 16:04 PM (Latency: 4 min). Convulsions (seizure), LOC (loss of consciousness), dilated pupils (mydriasis) noted. Head slumped to side. Came to within 30 or so seconds, mild confusion when came out of it but continued conversation that had been ocurring prior to event While conversing about vaccinations, patient asked if we could talk about something else and then was syncopal for a second time around maybe 16:10 PM. Again convulsions were noted, head slumped to side, LOC lasted a little longer than initial episode. Once regained consciousness endorsed blurry vision (vision blurred), numb ears - kept slowly grabbing for ears (hypoaesthesia) (slow, uncoordinated movements) to see if they felt normal yet. Stated difficulty swallowing (dysphagia) (Latency: same day) and that that had never happened with syncopal episodes before.   Reportedly, Patient has been syncopal multiple times for vaccines over the last four years however never before then/in childhood so ice packs, fan, and alcohol swabs were readily available for sensory distraction. MD (Doctor of Medicine) to bedside to assess, exam WNL (within normal limits). Vitals WNL (BP and HR (heart rate)) though BP (blood pressure) extremely difficult to obtain due to running 'quiet' (could not be heard on manual BP). Patient monitored x 10 minutes and assisted to feet. Denied dizziness, vision impairment while standing. Left clinic independently. Of note, patient had never received Moderna before. Has endorsed syncopal episodes to 'flu shot' in past but unsure of brand. Syncope in setting of vaccinations new as of four years ago, no issues prior to that historically.   Action taken: not applicable.  Water provided, ice packs to head and neck as corrective treatment for the events (syncopal, Convulsions, dilated pupils, LOC, felt hot). It was not reported if the patient received a corrective treatment for the events (numb ears - kept slowly grabbing for ears, difficulty swallowing, Once regained consciousness endorsed blurry vision).  At time of reporting, the outcome was Recovered / Resolved on 25-Oct-2024 for the events.  Seriousness: Medically significant for convulsions, syncopal and loss of consciousness.; Sender's Comments: Sanofi company comment for information received on 04-NOV-2024: This case involves a 26 years old male patient who experienced convulsions, syncopal, loc, felt hot, dilated pupils, once regained consciousness endorsed blurry vision, numb ears - kept slowly grabbing for ears and difficulty swallowing after receiving vaccines Moderna Covid-19 Vaccine And Influenza Quadrivalent Recombinant Vaccine [Flublok]. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history, 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 individual suspect vaccine cannot be assessed.