Sex: M
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Personality change, Pollakiuria, Substance use, Visual impairment
Clinical narrative: wild spasticity; thought he again had a stroke; had weird moment in June of 2017 where he thought he had stroke but looking back he realized it was not, has done research on the package inserts of shots he has taken, thought he had encephalopathy; was in a coma for 2 weeks; lot of arching in his back; constantly urinate; lot of muscle spasm /lot of muscle spasm on his face and on his arms/had a lot of back spasm /thumb goes into weird spasms/completely uncontrollable muscle spasms; 2 to 3 to 4 months of personality changes; tingling; weird positions for hours so for several hours his face would look like he had cerebral palsy, he would drool; jaundice; vision was changing; fist would clench, and arms would contract upwards; lot of upper lip contracting; Initial information received on 19-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 14 years old male patient who experienced thought he again had a stroke, had weird moment in june of 2017 where he thought he had stroke but looking back he realized it was not, has done research on the package inserts of shots he has taken, thought he had encephalopathy, was in a coma for 2 weeks, lot of arching in his back, constantly urinate, lot of muscle spasm /lot of muscle spasm on his face and on his arms/had a lot of back spasm /thumb goes into weird spasms/completely uncontrollable muscle spasms, 2 to 3 to 4 months of personality changes, tingling, weird positions for hours so for several hours his face would look like he had cerebral palsy, he would drool, jaundice, wild spasticity, vision was changing, fist would clench, and arms would contract upwards and lot of upper lip contracting after receiving vaccines meningococcal vaccine, influenza vaccine and diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown day and month in 2016, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site and received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site and received a dose of suspect meningococcal vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, patient also received a dose of suspect HPV vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site  (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) for Immunisation.Information on the batch number was requested.  On Jun-2017 the patient developed thought he again had a stroke (cerebrovascular accident), had weird moment in june of 2017 where he thought he had stroke but looking back he realized it was not, has done research on the package inserts of shots he has taken, thought he had encephalopathy (encephalopathy), was in a coma for 2 weeks (coma), lot of arching in his back (opisthotonus),  (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine, influenza vaccine, HPV vaccine  and meningococcal vaccine. These events were assessed as medically significant.  On an unknown date and month in 2017 the patient developed a non-serious constantly urinate (pollakiuria), lot of muscle spasm /lot of muscle spasm on his face and on his arms/had a lot of back spasm /thumb goes into weird spasms/completely uncontrollable muscle spasms (muscle spasms), 2 to 3 to 4 months of personality changes (personality change), tingling (paraesthesia), weird positions for hours so for several hours his face would look like he had cerebral palsy, he would drool (drooling), jaundice,  wild spasticity (muscle spasticity), vision was changing (visual impairment), fist would clench, and arms would contract upwards (extremity contracture), lot of upper lip contracting (muscle twitching), (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine, influenza vaccine, HPV vaccine and meningococcal vaccine.  Action taken- not applicable.  Patient was using CBD (cannabidiol and cannabis) on his own for muscle spasms and It was not reported if the patient received a corrective treatment for other events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event constantly urinate, was Not Recovered / Not Resolved for the event thought he again had a stroke, was Not Recovered / Not Resolved for the event had weird moment in june of 2017 where he thought he had stroke but looking back he realized it was not, has done research on the package inserts of shots he has taken, thought he had encephalopathy, was Not Recovered / Not Resolved for the event lot of muscle spasm /lot of muscle spasm on his face and on his arms/had a lot of back spasm /thumb goes into weird spasms/completely uncontrollable muscle spasms, was Not Recovered / Not Resolved for the event 2 to 3 to 4 months of personality changes, was Not Recovered / Not Resolved for the event tingling, was Not Recovered / Not Resolved for the event weird positions for hours so for several hours his face would look like he had cerebral palsy, he would drool, was Not Recovered / Not Resolved for the event jaundice, was Not Recovered / Not Resolved for the event wild spasticity, was Recovered / Resolved on an unknown date for the event was in a coma for 2 weeks, was Not Recovered / Not Resolved for the event vision was changing, was Not Recovered / Not Resolved for the event lot of arching in his back, was Not Recovered / Not Resolved for the event fist would clench, and arms would contract upwards and was Not Recovered / Not Resolved for the event lot of upper lip contracting.; Sender's Comments: Sanofi Company Comment dated 25-Oct-2023: This case involves a 14 years old male patient who experienced thought he again had a stroke, had weird moment in june of 2017 where he thought he had stroke but looking back he realized it was not, has done research on the package inserts of shots he has taken, thought he had encephalopathy, was in a coma for 2 weeks, lot of arching in his back, constantly urinate, lot of muscle spasm /lot of muscle spasm on his face and on his arms/had a lot of back spasm /thumb goes into weird spasms/completely uncontrollable muscle spasms, 2 to 3 to 4 months of personality changes, tingling, weird positions for hours so for several hours his face would look like he had cerebral palsy, he would drool, jaundice, wild spasticity, vision was changing, fist would clench, and arms would contract upwards and lot of upper lip contracting after receiving vaccines meningococcal vaccine, influenza vaccine, HPV vaccine and diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, 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.