Age: 24.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
Clinical narrative: A serious spontaneous report of guillain-barre syndrome manifested by leg weakness, tingling in the extremities, Facial paralysis, Loss of deep tendon reflexes, Bladder dysfunction, Cardiac arrythmias, Muscle pain, Respiratory difficulty and non-serious report of flu-like symptoms, fell on some ice and sinus infection has been received from a health professional concerning a 25-year-old male, subsequent to H1N1 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1 2009 Monovalent Vaccine Live, Intranasal on 10-Dec-2009 for an unknown indication. At the end of January the subject had been complaining of flu-like symptoms. The patient's had a sinus infection in Jan-2010 approximately one week prior to admission for which he was receiving antibiotics and the patient fell on 31-Jan-2010 and landed on his back. The patient did not lose consciousness or hit his head. A magnetic resonance image (MRI) and X-rays were negative. On 03-Feb-2010 the patient was seen in the emergency room (ER) for complaints of back and leg pain. A computerized axial tomography (CT) scan and magnetic resonance imaging (MRI) were performed and the results were normal. The patient was discharged home with ibuprofen. The patient returned to the ER on 04-Feb-2010 with increasing back pain and bilateral extremity weakness and numbness. The patient as to be sent home again but was unable to walk and was subsequently admitted. A nerve conduction study was performed on 07-Feb-2010 that showed polyneuropathy with demyelination. MRI of head and lumbar puncture were normal. His status worsened to the point of quadriplegia and he was intubated on 08-Feb-2010. Blood cultures on 08-Feb-2010 showed no growth. The patient started plasmapheresis on 08-Feb-2010 and ended this therapy on 20-Feb-2010 after receiving a total of seven treatments. The patient also received intravenous immunoglobulin on 15-Feb-2010 and 17-Feb-2010 but this was discontinued after the patient developed a reaction. On 19-Feb-2010 the patient developed enterobacterial pneumonia and pseudomonas urinary tract infection on 20-Feb-2010. A tracheostomy was performed on 22-Feb-2010 and percutaneous endoscopic gastrostomy tube was inserted on 26-Feb-2010. The patient was transferred to a ventilator weaning unit on the 26-Feb-2010 and later was off the ventilator 14 hours per day. He was able to shrug his shoulders, bend his right elbow, could move both hands and had a weak grip on his right hand. Patient was on Ophthalmic Suspension 0.5% prednisolone acetate/neomycin sulfate, B-complex (Thiamine nitrate, Riboflavine, Pyridoxine hydrochloride, Nicotinamide), Celecoxib, Clonazepam, Duloxetine hydrochloride, Enoxaparin sodium, Famotidine, Hydromorphone hydrochloride, Lorazepam, Metoprolol tartrate, Polyethylene Glycol, Pregabalin, MVI (Retinol, Ergocalciferol, alpha-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin phosphate sodium, thamine, pyridoxine hydrochloride, dexpanthenol, biotin, folic acid and cyanocobalamin). On 05-Apr-2010, patient came off the ventilator. Percutaneous endoscopic gastrostomy tube was removed on an unknown date. On 12-Apr-2010 patient was transferred to rehabilitation. Tracheostomy was decannulated on 13-Apr-2010. The patient was discharged on 19-May-2010. According to his chart he was able to ambulate household distances- 100 feet twice a day while holding someones hand. On discharge, medications were Calcium carbonate, Escitalopram oxalate, Esomeprazole sodium, Ultran (probably Ultram - Tramadol hydrochloride), Benzodiazepine, Zolpidem tartrate. The outcome of the event guillain-barre syndrome was not resolved and of flu-like symptoms, fell on some ice and sinus infection was unknown. The reporter stated that per a neurology consultant note, the neurologist was unsure if the events were associated wit the H1N1 monovalent vaccine live, intranasal the patient received. The sponsor's assessment given the temporal sequence and rare but present association between guillain-barre syndrome and vaccinations, is that the reported events are probably related to the administration of H1N1 monovalent intranasal vaccine. Additional information was received on 26-May-2010 and incorporated into the narrative: sinus infection and fell on some ice events coded and removed from the patient history, as they occurred after receiving the H1N1 vaccine, treatment medications when patient was hospitalized, medications on discharge, procedures done on patient and outcome of the events.