Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase increased
Clinical narrative: Rhabdomyolysis; episodic pain; profound weakness/generalized weakness; abdominal pain; bilateral leg pain; shortness of breath; syncopal episode; tachypnea; pallorous; moderate pitting edema extending to both her thighs; collapsing upon completion of a 2-mile run; renal failure following rhabdomyolysis; liver failure following rhabdomyolysis; tibial nerve palsy following rhabdomyolysis; tingling type neuropathy from her midarch distally; lower extremity parasthesias; xerosis of the right foot; Tinel's sign; hammering of the lesser toes; hyperesthesias of the feet and posterior lower leg bilaterally; The authors present an unusual case that has been seldom reported in the literature. The clinical rhabdomyolysis syndrome, resulting from muscle disintegration, can be the result of numerous etiologic events and have serious sequelae. The pedal manifestations result from muscular and neurologic insult. The patient in this reported case survived rhabdomyolysis despite renal and hepatic failure requiring diuresis and hemodialysis. The only permanent long-term sequelae the patient suffered was flexible hammertoe deformities and parasthesias of all lesser digits of both feet. The follow-up is over 8 years.  Initial information received on 30-Dec-2024 via other healthcare professional regarding an unsolicited valid serious case issued from a literature article:   This case involves a 30-year-old female patient who experienced rhabdomyolysis (Latency: 1 week), renal failure, tibial nerve palsy and liver failure following rhabdomyolysis (Hepatic failure) (Renal failure) while receiving influenza vaccine (Latency: unknown).  The patient's past medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site 1 week earlier.  The patient recalled a previous reaction to the influenza vaccine 1 year earlier that consisted of high fever, rigor, and myalgia exactly 1 week postimmunization.   Patient presented to Medical Center after collapsing upon completion of a 2-mile run (Circulatory collapse). The patient related profound weakness (asthenia), abdominal pain, bilateral leg pain (pain in extremity), lower extremity parasthesias (Paraesthesia), and shortness of breath (dyspnoea) followed by a syncopal episode (syncope). Prior to admission, she denied any illness, medication use, allergies, diet changes, or drug use.   Initial objective findings were a pulse of 150, oral temperature of 103F, tachypnea (tachypnoea), and a blood pressure of 53/83. Overall, she was pallorous (pallor) and had generalized weakness (asthenia). The lower extremity exam showed palpable pulses, moderate pitting edema extending to both her thighs (oedema), and hyperesthesias of the feet and posterior lower leg bilaterally (Hyperaesthesia). Her lab studies were remarkable for elevated creatinine phosphokinase of greater then 150,000 units, BUN (blood urea nitrogen) of 74, serum creatinine of 12.1, and elevated LFT' s (liver function tests) (SGOT (Serum Glutamic-Oxaloacetic Transaminase)= 7373, SGPT (Serum Glutamic Pyruvic Transaminase)= 3707) and the presence of heme proteins on the urinalysis.  The patient was admitted to the hospital with a diagnosis of rhabdomyolysis with concurrent hepatic and renal failure, and tibial nerve palsy (Peripheral nerve palsy). Diagnosis was made based on the history, clinical symptomatology, and laboratory diagnostic testing. The patient was treated with aggressive diuresis and hemodialysis for 11/2months, and was discharged from the hospital with improved musculoskeletal, hepatic, and renal function. Approximately 18 months following the episode of rhabdomyolysis, the patient fully recovered from renal and liver failure. The only residual symptoms noted were confined to her lower extremities, in association with her nerve palsy. Her chief complaint consisted of episodic pain (pain) with minimal pressure (sub metatarsals on weightbearing) and a the sensation of "a rolled up sock in her right shoe." She also noted the development of hammering of the lesser toes (foot deformity). Upon physical examination, there was xerosis of the right foot (xerosis). There was also decreased sensation in both feet from plantar mid arch and lesser metatarsophalangeal joints distally and the posterior distal one third of the leg, bilaterally. A positive Tinel's sign and valleix phenomenon were noted over the posterior tibial nerves . Flexible hammertoes (2-5) were noted bilateral with the right foot being worse. EMG (electromyogram)/nerve conduction studies were performed and revealed a decreased amplitude and conduction velocity of both posterior tibial nerves. The right side demonstrated more severe pathologic changes. The findings were consistent with right tibial nerve palsy and left partial tibial nerve palsy. After over 8 years of follow-up, the patient still has bilateral lesser digit hammertoes and experiences tingling type neuropathy from her mid arch distally (Neuropathy peripheral). She feels her symptoms now are permanent.  Seriousness criteria: medically significant and hospitalization for all events Action taken: not applicable Corrective treatment: diuresis and hemodialysis for renal failure; not reported for other events Outcome: recovering for renal failure, hepatic failure, rhabdomyolysis and not recovered for tibial nerve palsy Reporter causality: related; Sender's Comments: Sanofi company comment dated 06-JAN-2025: This case involves a 30-year-old female patient who experienced rhabdomyolysis (Latency: 1 week), renal failure, tibial nerve palsy and liver failure following rhabdomyolysis while receiving influenza vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. 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 vaccine cannot be assessed completely.