Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, TD, YF
Symptoms: Pain, Paraesthesia, Quadriparesis, Sinusitis, Tremor
Clinical narrative: Initial report received from the CDC (Centers for Disease Control and Prevention) on 26 November 2008 under VAERS reference number 323896. A 19-year-old male patient had received IPV (trade name, manufacturer and lot number not reported), "TD" (trade name, manufacturer and lot number not reported), a second dose of TWINRIX (manufacturer GlaxoSmithKline, lot number not reported) and a YF-Vax (lot number not reported) on 22 August 2008 and four days later he experienced extremity numbness, tingling and weakness. The patient had previously received MMR (manufacturer Merck, lot number not reported), MENACTRA (lot number U2614AA) and a first dose of TWINRIX (lot number not reported) on 24 July 2008. The final diagnosis was Guillain Barre Syndrome. Additional details were not provided. Follow-up information was received from the CDC on 02 January 2009, and included a summary from the VAERS follow-up nurse and a copy of the VAERS report (reference number 323896) which was retrieved from the VAERS database on 05 January 2009. According to new information received, lot numbers included: YF Vax lot number UF316AA, IPV lot number A0836-2 (manufacturer by Sanofi Pasteur), TD lot number AC52B02EA and HepB dose 1, lot number AHABB123AA (previously reported as TWINRIX dose 2). The routes and sites of administration were unknown for all vaccines administered on 22 August 2008. The patient was reported to have had a two day history of extremity numbness, tingling and weakness with an onset date of 26 August 2008. The still had muscle control at that time however symptoms progressed, and the patient began having difficulty controlling their hands and legs, and had mild difficulty breathing. They had previously been well; no fever, no chills, and no night sweats. The patient was transferred to the emergency department experiencing quadriparesis evidenced by upper limb weakness which descended to the legs with difficulty lifting and climbing stairs, and poor bilateral upper extremity coordination. Emergency room records for the date of service 28 August 2008 noted a transfer diagnosis of ascending paralysis. Pansinusitis. The patient presented to the ER with complaints of dizziness, and weakness of all four extremities; arms and legs which began one day prior (previously reported as two days prior). Additional symptoms included numbness in arms and from knees down, tingling in both arms, shortness of breath, malaise, loss of strength, and intermittent sharp pain. On physical exam, the patient demonstrated unsteady gait and was unable to lift legs without strain. The patient was transferred to a higher level of care with a differential diagnosis of demyelinating encephalitis, GBS, myasthenia gravis, MS. According to a clinical summary report, the patient was admitted from 28 August 2008 to 05 September 2008 with a diagnosis of Guillain-Barre Syndrome-acute demyelinating polyneuropathy. During hospitalization, the patient became progressively weak and lost tendon reflexes. Respirations and swallowing were intact. The patient received corrective treatment with intravenous immune globulins and was transferred to rehabilitation. The patient was reported to have had past medical history of an upper respiratory infection and "other medications" included TYLENOL, MOTRIN, CLARITIN0D, MUCINEX and NASONEX. By late October 2008, the patient had not returned to a normal state of health. Laboratory and diagnostic test results included CSF: normal, low Hematocrit 34.5 on admission, slightly elevated blood glucose (141). EMG/NCS confirm GBS. At the time of the report, agency had not yet forwarded their conclusion to the CDC. Follow-up information clarified that the patient had been hospitalized for this event; therefore the statement "SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT" was removed. Documents held by sender: None Follow-up information was received from the Centers for Disease Control on 25 March 2009, which included verification of the patient's immunization record and a copy of the VAERS follow-up report (reference number 323896). MENACTRA (lot number U2614AA) was administered on 23 August 2008 (previously reported as 24 July 2008) which changed the latency of the event to three days post MENACTRA vaccination. The VAERS follow-up report (323896) included additional symptoms of paralysis and muscular weakness which have been added as co-manifestations of the event. This case was confirmed to be GBS with a diagnostic certainty of level 2 using the case definition.