Age: 17.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Increased upper airway secretion, Intensive care, Leukocytosis, Lumbar puncture abnormal, Mental status changes
Clinical narrative: Initial report was received on 07 September 2011 from another manufacturer; MFR Control number WAES 108USA03747. The following is verbatim per the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old male patient with tuberculosis (on INH therapy), polysubstance abuse, alcohol abuse, and a history of jaw surgery for a fracture and Hematuria who on 26-JUN-2011 was vaccinated IM into the left arm with the third dose of GARDASIL (lot number 668260/1570Z), and the first dose of ADACEL (lot number C3837BA) given IM into the left arm. Other concomitant therapy included isoniazid (INR) and pyridoxine. On 01-JUL-2011, the patient experienced weakness, ataxia, dysphasia, dysphagia, coarse tremor. Diagnosis (Dx): Guillain-Barre, Miller-Fisher variant. The following information was obtained through follow-up and/or provided by the government. 14-JUL-2011 ER record, internal medicine consult and labs received for DOS 04-JUL-2011. The patient presented to ER due to complaint of sore throat, difficulty swallowing, headache, weakness, slurred speech and ataxia. The patient was reported to have received vaccinations a week prior to presentation. The patient reported difficulty swallowing x 3 days then he became progressively weaker with upper extremity weakness and now he noted difficulty walking. Examination noted bilateral upper extremity weakness (L>R) and bilateral lower extremity weakness (not as weak as upper extremity). Internal medicine consultation assessment noted: Altered mental status, slurred speech, weakness and dysphagia/unclear etiology. The patient was admitted with plan to transfer to higher level facility for further neurology consultation. 27-JUL-2011 Discharge summary for DOS 04-JUL-2011 and 15-JUL-2011, rehab. Summary 15-JUL-2011 and 22-JUL-2011, Inpatient hospital records (H&P), neurology consult, ID consult). Discharge DX: Miller Fisher variant of Guillain-Barre with dysphagia. The patient was received via transfer from another facility ER. The patient had slurred speech, weakness and was noted to have frequent coughing but was not in distress. The patient was initially admitted to floor, however the patient experienced airway issues due to increased secretions and was transferred to neuro. intensive care and intubated. On 05-JUL-2011, ID consultation impression: acute ataxia, dysphagia, dysarthria, odynophagia, bilateral upper and lower extremity weakness. Plan: start empiric vancomycin and cefepime in view of fever and leukocytosis. The patient underwent a lumbar puncture and EMG nerve conduction studies, which confirmed the demyelinating process. The patient was started on IVIG therapy with improvement in symptoms. The patient experienced autonomic dysfunction. On 15-JUL-2011 the patient was transferred to rehab, and received PT, OT and speech therapy. By discharge the patient was ambulatory without assistive device and was on a regular diet. The patient was discharged home and to have outpatient therapies. Discharge DX: Guillain-Barre syndrome, facial weakness and gait disorder. The patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # is 427426". Documents held by sender: None.