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Guillain-Barre syndrome from INFLUENZA (SEASONAL) (FLUARIX) 2009

Vaccine Manufacturer:GLAXOSMITHKLINE
Vaccine Code:FLU
Vaccine Type:INFLUENZA VIRUS VACCINE
Vaccine Name:INFLUENZA (SEASONAL) (FLUARIX)
Year Reported:2009
Symptom Reported:Guillain-Barre syndrome

INFLUENZA (SEASONAL) (FLUARIX) Side Effects Report #337321
INFLUENZA (SEASONAL) (FLUARIX) vaccine side effect was reported on 01/14/2009. Male patient, 78.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUARIX). Patient symptoms: Guillain-Barre syndrome, "Patient began with cough and upper respiratory infection after vaccine administered. Patient began taking over the counter meds and got worse. Patient began to have difficulty walking and unsteady gait came to the ER and was admitted to Charlton Memorial Hosp on 12/29/08. Patient was treated with supportive therapy and IGG, and condition is improving. Patient is still in the hospital. 1/15/09- received-presented to ED with C/O cough, unsteady walking, balanace. Cough times week. ED DX: URI, bronchospasm, polypharmacy abuse. Unsteady gait. Tingling of extremities. Generalized body aches, fevers. 1/21/09-DC summary received for DOS 12/29/08-1/15/09 DC DX: Guillain-Barre syndrome, recovered almost completely. Ileus, recovered. Urinary retention. Chronic obstructive pulmonary disease (COPD). Hypertension. and DC DX summary for DOS 1/15-1/21/09 DX: Status post neuropathy likely a variant of Guillaine-Barre. Status post treatment with IVIG and high dose steroids. Painful paresthesias, tremulousness, weakness and ataxia and inability to mobilize. Treated with IVIG." none 1/15/09-records received- Cough times week. Patient was diagnosed with pneumonia and started on Zithromax. Pneumonia on anone 1/21/09 records received-PMH: Kidney stone. Diverticulitis. history of DJD. Chronic sinusitis."U/A, CXR, CBC, CMP, Head CT-done in the ER 12/29. 1/15/09-records received- MRI negative. CT normal. Urine tox negative.WBC 14.3. 1/21/09-records received- EMG demonstrated acute inflammatory demyelinating polyneuropathy thought to be a" . During the same period patient was treated with "Dayquil, Nyquil, Benadryl, Tylenol". Patient was hospitalized Patient recovered.

INFLUENZA (SEASONAL) (FLUARIX) Side Effects Report #344131
INFLUENZA (SEASONAL) (FLUARIX) vaccine side effect was reported on 04/14/2009. Female patient, 67.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUARIX). Patient symptoms: Guillain-Barre syndrome, "Patient developed Guillan Bare syndrome, 4 days after the vaccination. 4/22/09 MR received for DOS 10/29-11/17/2008 with D/C DX: Guillain-Barre Syndrome. Non-Hodgkin's Lymphoma controlled with chemotherapy and radiation. Pancytopenia r/t tx for Hodgkin's Lymphoma. Pt initially presented to PCP on 10/13/08 with c/o L arm weakness x 8 days. Pt had recently been treated with radiation to the L axilla. Initially thought to be a radiation plexitis. Some improvement in pain level with steroids, none in weakness. Returned 10/28/08 with c/o profound lower and upper extremity weakness. By 10/29/08 unable to stand or walk. Admitted after (+) EMG/NCS in office. PE (+) for weakness in upper and lower extremities, areflexia, and brisk knee jerks. Tx with plasmapheresis w/o improvement. Developed bladder retention with Foley cath insertion. Unable to use IVIG due to low IgA level. Some improvement by d/c to rehab on 11/17/08. 4/28/09 Received Neuro consult of 10/13/08-2/19/09. FINAL DX: acute demyelinating inflammatory polyneuropathy, slowly resolving Records reveal patient experienced abrupt onset profound weakness of left arm x 1 wk prior to initial eval & beginning approx 2 days s/p radiation tx. Tx w/steroids & referred for MRI. Developed weakness of all 4 extremities within about 2 wks. Subsequently hospitalized as above for GBS & inpatient rehab. Returned to Neuro 2/19/09. Remained areflexic & profoundly weak LUE & LLE." left arm was weak"Allergic to PCN PMH: non-Hodgkin lymphoma left axilla 2003, tx w/chemo & radiation tx completed 2007. Left supraclavicular mass 8/08 tx w/radiation tx completed 10/3/08.""Paatient with lymphoma, had radioation on 10/3, last dose of a 26 rqadiation course. diagnostic work up 10/28, including spinal tap. MD admitted to hospital on 10/29 with diagnosis of Guillan Bare. Labs and Diagnostics: EMG/NCS (+) for" . During the same period patient was treated with Fluxoetine 20mg; dexameethsone 4mg. Patient was hospitalized Patient recovered.

INFLUENZA (SEASONAL) (FLUARIX) Side Effects Report #360752
INFLUENZA (SEASONAL) (FLUARIX) vaccine side effect was reported on 10/06/2009. Female patient, 48.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUARIX). Patient symptoms: Guillain-Barre syndrome, "Guillain-Barre Syndrome - 1st seen here 2/4/09 - Hospitalization and long rehab stay - Still symptomatic 10/5/09. 12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09 - 02/20/09 Final DX: Guillain Barre syndrome, hyponatremia Pt presented with abdominal and back pain, parasthesias, bilateral weakness, diplopia, hyponatremia, unstable gait, and frontal headache. On neurological examination: ophthalmoparesis, absent reflexes, UE ataxia, sensory loss. Pt diagnosed with GBS. Tx: normal saline, IVIG. Pt with SIADH. Pt's sensation and strength improved. Pt discharged home. 12/07/09 MR received for DOS 02/21/09 - 02/25/09. DX: Acute inflammatory demyelinating polyneuropathy, s/p IVIG. Pt in rehab hospital. Neurological exam: cranial nerve deficits on L side; muscle strength 3/5 proximally in BLE and 4/5 distall; DTRs absent; dysesthetic in trunk and extremities. Pt has atypical GBS. Pt discharged home." No"Hypertension; Multicystic Kidney disease 12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09 - 02/20/09 PMH: arthritis, gastritis, GERD, polycystic kidney disease, mild pancreatitis. Allergies: NKDA""Would need medical record 12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09 - 02/20/09 Lab and DX studies: BP 160-170/80, HR 50, Na 115; CSF: 22 WBC, 0 RBC, glucose 58, protein 299; EMG/nerve conduction studies: demyelina" . Patient was hospitalized Patient recovered.

INFLUENZA (SEASONAL) (FLUARIX) Side Effects Report #363424
INFLUENZA (SEASONAL) (FLUARIX) vaccine side effect was reported on 10/28/2009. Male patient, 70.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUARIX). Patient symptoms: Guillain-Barre syndrome, "for 3 days had burning at site of injection, parathesias, numbness of hands and feet, blotchy red rash, head and neck. Serum sickness considered, treated with Prednisone. 11/23/2009 DC summary hospital records, neurology consult received. Service dates 10/2709 to 10/30/09. Assessment: Sensory polyneuropathy likely due to diabetes. Guillain Barre syndrome ruled out. Patient c/o burning, numbness. Numbness bilateral, pain in legs, weak in legs, off balance, staggering, red in face, sweats, and flutters in chest. Sore throat, indigestion, nausea, stomach problem." Sinusitis- Amoxicillin from 10/7/09 through 10/17/09"Allergic: Hydrocodone, Lipitor GERD, HBP, DM, Hyperlipidemia. 11/23/2009 DC summary hospital records, neurology consult received. Service dates 10/2709 to 10/30/09. Sinusitis, bronchitis 5 days prior to flu vaccine. Diabetes, hypertension, hypercholesterolemia, prostate cancer, gallbladder problem, difficulty controlling urination, back pain, pneumonia. Allergies to ampicillin, m""Patient referred to neurology and IVIG treatments started for probable Guillian Barre syndrome. LP results are pending. 11/23/2009 DC summary hospital records, neurology consult received. Service dates 10/27/09 to 10/30/09. CBC - MCHC 33." . Patient recovered.


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