Age: 32.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia, Paraplegia
Clinical narrative: paralysis at the bottom half of her body; peripheral neuropathy; she could not breath and was gasping for air; severe, painful tingling after the 3rd booster/paresthesia (mild or severe tingling) starting from her legs up to her chest; felt super weak; lower back pain after experiencing the paralysis; she has walked a hundred miles because the muscle in her legs feels tired; she can hardly walk; she could not sleep; Initial information received on 11-Sep-2024 regarding an unsolicited valid serious case received from a Patient.  This case involves a 32 years old female patient who experienced  paralysis at the bottom half of her body, peripheral neuropathy, severe, painful tingling after the 3rd booster/paresthesia (mild or severe tingling) starting from her legs up to her chest, she could not breath and was gasping for air, she can hardly walk, she could not sleep, lower back pain after experiencing the paralysis, she has walked a hundred miles because the muscle in her legs feels tired and felt super weak after receiving vaccine RABIES (HDC) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Aug-2024 she received a dose of vaccine RABIES (HDC) Vaccine Powder and solvent for suspension for injection with an unknown batch number via intramuscular route and on 22-Aug-2024 she received booster dose 1 of vaccine with an unknown batch number via intramuscular route in unknown administration site. On 26-Aug-2024 she received booster dose 2 of vaccine with an unknown batch number via intramuscular route in unknown administration site and on 02-Sep-2024, the patient received a dose 3 Booster dose of suspect lot number not reported via intramuscular route in the left arm (strength and expiration date: not provided) for Immunisation. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On 02-Sep-2024 the patient developed severe, painful tingling after the 3rd booster/paresthesia (mild or severe tingling) starting from her legs up to her chest (paraesthesia) and felt super weak (asthenia) (latency- 15 days).  On 08-Sep-2024 the patient developed peripheral neuropathy (neuropathy peripheral) and she could not breath and was gasping for air (dyspnoea) and paralysis at the bottom half of her body (paralysis) (latency- 21 days).   On an unknown date in Sep-2024 the patient developed lower back pain after experiencing the paralysis (back pain) (approximately few days latency).  On an unknown date in 2024, she can hardly walk (gait disturbance), she could not sleep(Sleep disorder due to a general medical condition) and she has walked a hundred miles because the muscle in her legs feels tired (muscle fatigue) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for Muscle fatigue, Paraesthesia, Gait disturbance, Not Recovered / Not Resolved for Back pain, Dyspnoea, Neuropathy peripheral and Paralysis, recovered on 10-Sep-2024 for Sleep disorder due to a general medical condition.  Seriousness criteria- Medically significant for Neuropathy peripheral and Paralysis.; Sender's Comments: Sanofi Company Comment dated 07-Mar-2024:  This case involves a 32 years old female patient who experienced peripheral neuropathy, severe, painful tingling after the 3rd booster/paresthesia (mild or severe tingling) starting from her legs up to her chest, she could not breath and was gasping for air, she can hardly walk, paralysis at the bottom half of her body, lower back pain after experiencing the paralysis, she has walked a hundred miles because the muscle in her legs feels tired and felt super weak after receiving vaccine RABIES (HDC) Vaccine [Imovax Rabies]. 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.