Age: 26.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Loss of consciousness, Mydriasis, Seizure, Syncope, Vision blurred
Clinical narrative: Two episodes of syncopal; feeling hot; dilated pupils; Once regained consciousness endorsed blurry vision; difficulty swallowing; numb ears - kept slowly grabbing for ears; Two episodes of seizure/convulsions; Two episodes of LOC (Loss of consciousness)/confusion; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Two episodes of seizure/convulsions), LOSS OF CONSCIOUSNESS (Two episodes of LOC (Loss of consciousness)/confusion) and SYNCOPE (Two episodes of syncopal) in a 26-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Influenza vaccine rHA 4v (baculovirus) (Flublok quadrivalent) for Flu vaccination.    Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included Syncope with Influenza vaccine.   On 25-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 25-Oct-2024 at 4:00 PM, the patient received dose of Influenza vaccine rHA 4v (baculovirus) (Flublok quadrivalent) (Intramuscular use) .5 milliliter. On 25-Oct-2024, the patient experienced SEIZURE (Two episodes of seizure/convulsions) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Two episodes of LOC (Loss of consciousness)/confusion) (seriousness criterion medically significant), MYDRIASIS (dilated pupils), VISION BLURRED (Once regained consciousness endorsed blurry vision), DYSPHAGIA (difficulty swallowing) and HYPOAESTHESIA (numb ears - kept slowly grabbing for ears). On 25-Oct-2024 at 4:04 PM, the patient experienced SYNCOPE (Two episodes of syncopal) (seriousness criterion medically significant) and FEELING HOT (feeling hot). On 25-Oct-2024, SEIZURE (Two episodes of seizure/convulsions), LOSS OF CONSCIOUSNESS (Two episodes of LOC (Loss of consciousness)/confusion), SYNCOPE (Two episodes of syncopal), FEELING HOT (feeling hot), MYDRIASIS (dilated pupils), VISION BLURRED (Once regained consciousness endorsed blurry vision), DYSPHAGIA (difficulty swallowing) and HYPOAESTHESIA (numb ears - kept slowly grabbing for ears) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2024, Blood pressure measurement: within normal limits. On 25-Oct-2024, Heart rate: within normal limits.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 25-Oct-2024, once the needle for moderna vaccine was withdrawn, patient felt hot and syncopal around 16:04 P.M. Patient's head was slumped to side and came to within 30 or so seconds, mild confusion when came out of it but continued conversation, that had been occurring prior to the event.  While conversing about vaccinations, patient was asked if he could talk about something else, meanwhile a second time syncopal occurred around 16:10 P.M. Again, convulsions were noted, head slumped to side, LOC lasted a little longer than initial episode, slowly grabbing for ears (slow, uncoordinated movements) to see if they felt normal yet. Patient had difficulty swallowing and stated it never happened with syncopal episodes before.  It was reported that the patient had syncopal episodes multiple times for vaccines over the last four years, however never in the childhood. So, icepacks, fan and alcohol swabs were readily available for sensory distraction. Bedside doctor assessed the patient, and exams were within normal limits. Vitals (BP and HR) though BP were extremely difficult to obtain due to running, quietness could not be heard on manual BP.   Patient was monitored for 10 minutes and assisted to feel. Patient denied dizziness, vision impairment while standing left clinic independently. Patient had never received Moderna vaccine before and had endorsed syncopal episodes to flu shot in the past. Patient had syncope in setting of vaccinations new as four years ago, and had no issues prior to that historically. Water was provided to the patient, icepacks applied 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) or not.; Reporter's Comments: Company comment: Patient's medical history of prior syncopal episodes after vaccination (in 4 years prior to events described) is a confounder along with concurrent administration of Influenza vaccine. The benefit-risk relationship of product is not affected by this report.