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Guillain-Barre syndrome from PNEUMO (PNEUMOVAX) 2008

Vaccine Manufacturer:MERCK & CO. INC.
Vaccine Code:PPV
Vaccine Type:PNEUMOCOCCAL VACCINE, POLYVALENT
Vaccine Name:PNEUMO (PNEUMOVAX)
Year Reported:2008
Symptom Reported:Guillain-Barre syndrome

PNEUMO (PNEUMOVAX) Side Effects Report #301599
PNEUMO (PNEUMOVAX) vaccine side effect was reported on 01/03/2008. Male patient, 74.0 years of age, was vaccinated with PNEUMO (PNEUMOVAX). Patient symptoms: Guillain-Barre syndrome, "double vision and decreased balance. The patient had been traveling to China. Upon return he developed some headaches and stomach upset. His wife actually came to the emergency room for a similar situation. Prior to admission he started noticing some imbalance. The next morning he was unable to ambulate on his own. He does have some base line decrease in his balance, but previously he had not been needing to use an assistive device. He was admitted to Methodist for further evaluation. Neurology was consulted. Neurology monitored him, consideration was for treatment for Guillain-Barre, however, due to significant improvement this was not required. He was started in therapy services. 1/18/08 Reviewed hospital medical records which reveals patient experienced URI w/cough, HA & upset stomach while on foreign travel. On return, developed difficulty walking & imbalance w/slurred speech, diplopia. Also has chronic numbness over arms/legs which was unchanged. Admitted10/19-10/25/2007. Neuro consult done. Patient had spontaneous recovery w/o treatment. Transferred to inpatient rehab 10-25-11/1/2007. D/C to home w/continued outpatient PT/OT & f/u w/pcp. FINAL DX: Guillain-Barre syndrome, Miller-Fisher variant w/diplopia & ataxia; HTN. 1/25/08 Reviewed EMG/NCS report of 10/22/07 which concludes generalized sensory/motor polyneuropathy w/axonal & demyelinating feathres." "thrombocytopenia, single episode of atrial fibrillation, peripheral neuropathy, hypertension, lymphoma, monoclonal gammopathy. Prior history of Guillain-Barre, ankle fracture, history of alcohol dependance in the past. PMH: GBS 20 yrs prior. Lyme disease w/peripheral neuropathy. Mantle cell lymphoma tx/research protocol drug. Chronic thrombocytopenia. Single episode of atrial""MRI was negative for a stroke. Findings of acute sinusitis was incidental. MRA was also performed and shows some dilatation of the inferior ophthalmic vein on the right that was unchanged. He also underwent spinal tap, revealed normal RB" . During the same period patient was treated with "metoprolol, lisinopril, hydrochlorothiazide, research drug which sounds like monoclonal antibody directed against lymphoma cells. Takes multivitamin, B-complex.". Patient was hospitalized Patient recovered.

PNEUMO (PNEUMOVAX) Side Effects Report #304128
PNEUMO (PNEUMOVAX) vaccine side effect was reported on 01/31/2008. Male patient, 80.0 years of age, was vaccinated with PNEUMO (PNEUMOVAX). Patient symptoms: Guillain-Barre syndrome, "Information has been received from a nurse concerning an 80 year old male patient who on an unspecified date was vaccinated with a dose of Pneumovax 23, (lot # not reported) (manufacturer unknown). The nurse reported that the patient received the Pneumovax 23 and developed a ~Guillain-Barre syndrome~ which made him develop pneumonia and the patient died as a result. She reported that the patient was not treated or vaccinated at that practice and was not sure if it was Pneumovax 23, she said it was a pneumonia shot (manufacturer unknown). No further information was reported. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

PNEUMO (PNEUMOVAX) Side Effects Report #304686
PNEUMO (PNEUMOVAX) vaccine side effect was reported on 01/21/2008. Female patient, 66.0 years of age, was vaccinated with PNEUMO (PNEUMOVAX). Patient symptoms: Guillain-Barre syndrome, "Patient received immunizations for Influenza and Pneumonia at the same time at different sites on 10/14/2007. Shortly after receiving them, ~patient~ described that she had a headache and then noticed increased numbness/tingling in her hands and feet with difficulty swallowing for a week prior to admission.~Patient~ was admitted to Medical Center, on 10/21/2007 with headache, gait disorder, weakness, balance problems, facial weakness and ataxia and was diagnosed with Guillain-Barre Syndrome Miller Fisher variant secondary to immunizations. She was transferred to a rehab center on 12/10/2007 but still is experiencing numbness in her hands and feet. 3/27/08-records received for DOS 10/21-10/30-07-DC DX:Miller Fisher Guillain Barre syndrome. Dysphagia. Admitted with C/O fascial numbness, difficulty swallowing, slurred speech, weakness and ataxia. RX with IVIG, transferred to rehab facility, at time of DC continued to have significant issues with dysphagia." "Her past medical history is positive for peripheral neuropathy and dysphagia but is negative for GBS. Patient didn't recall the last time getting the Influenza vaccine or if she ever had. Only allergy patient listed was a silk tape allergy. 3/27/08-records received-PMH:Bell's palsy, endometriosis. Facial surgery after automobile accident.""3/27/08-records received- EEg normal. MRI/MRA mild to moderate ischemia. MRI spine, signal abnormality lumbar spine. Lumbar puncture no acute abnormality. Culture no growth." . Patient was hospitalized Patient recovered.

PNEUMO (PNEUMOVAX) Side Effects Report #313036
PNEUMO (PNEUMOVAX) vaccine side effect was reported on 05/22/2008. Male patient, 66.0 years of age, was vaccinated with PNEUMO (PNEUMOVAX). Patient symptoms: Guillain-Barre syndrome, "I was in hospital for hernia repair. An un-named nurse ~PUSHED~ pneumoccal vaccines on me and my roommate when I was recovering from my surgery. She was very pushy. Seven days later, I fell victim to the sudden onslaught of Guillian Barre' Syndrome. 6/02/2008 MR received for DOS 7/27-8/21/2007 with D/C DX: Guillain-Barre Syndrome. Respiratory Failure 2' to GBS. Pneumonia. Hypertension, Hyperglycemia, Chronic Pain. Pt presented with worsening progressive ascending weakness. Sx began with leg weakness and hip pain and progressed to arm weakness, numbness of the lower extremities with walking difficulty and subsequent fall. PE (+) for weakness and decreased muscle strength of the legs and stocking-glove sensory loss. Absent reflexes in lower extremities and depressed in upper. L toe upgoing. Pt progressed to respiratory failure and was intubated, complicated by Serratia and Pseudomonas pneumonia. Tx with IVIG with minimal improvement. PEG tube placed for nutrition on 8/14/08. Tracheostomy done. By transfer date pt was breathing on own and taking po, but still weak. D/C to rehab." Hernia repair operation"Arrhythmia,Hemochromotosis, Chronic edema in right leg; High blood pressure; Excessive sleepiness; Arthritis in knees and ankles; Allergies in spring and fall; Heart murmur. I had suffered a ~daisy chain~ of unrelated non-life threatening health problems (involving hospitalization and surgery) from Dec. 2006 until the vaccination. These involved: Plastic surgery to remove meloanoma""Labs and Diagnsotics: EMG/ NCS abnormal and c/w demyelinating neuropathy. LP with CSF Protein 79 and glucose 89. MRI Cspine with C3-C4 herniation with cord impingement, cervical spondylosis. CXR (+) for infiltrate by 8/3/08. LLL consolid" . During the same period patient was treated with "Allegra, 60 mg tab/2Xday for allergies; Amiodarone HCL, 100 mg/day for Arrhythmia; Flonase, 1X @ bedtime and 1X later in nighttime if needed for allergies; Hydrocodone-APAP 5-500,2 tabs every 4 hrs as needed for pain; Lasix, 40mg tab/2X day". Patient was hospitalized Patient recovered.

PNEUMO (PNEUMOVAX) Side Effects Report #327104
PNEUMO (PNEUMOVAX) vaccine side effect was reported on 10/03/2008. Male patient, 55.0 years of age, was vaccinated with PNEUMO (PNEUMOVAX). Patient symptoms: Guillain-Barre syndrome, "Information has been received regarding a case in litigation from a 55 year old male with no pertinent medical history and no allergies/drug reactions, who on 13-DEC-2006 was vaccinated with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included medication for blood pressure [therapy unspecified] and medication for inflammatory bowel disease (IBS) [therapy unspecified]. The patient reported that twelve days after receiving PNEUMOVAX 23, Christmas Day 25-DEC-2006 he experienced numbness in his hands. Day by day the numbness kept getting worse and it spread to around his mouth and eyes. He was diagnosed with Guillain-Barre syndrome and was hospitalized for three months. Unspecified ~routine labs~ were performed (results not reported). The patient reported that since his diagnosis he has yet to heal, and his doctor feels as if they were wrong about him having Guillain-Barre syndrome. They believe it may actually be chronic inflammatory demyelinating polyneuropathy (CIDP). The patient reported that he goes to therapy 3 times a week and is being treated with intravenous immunoglobulin (IVIG). Unspecified medical attention was sought. At the time of reporting, the patient had not recovered. No further information was provided. Additional information has been requested." Blood pressure; Inflammatory bowel disease"Diagnostic laboratory, not reported" . During the same period patient was treated with [Therapy unspecified]; [Therapy unspecified]. Patient was hospitalized Patient recovered.

PNEUMO (PNEUMOVAX) Side Effects Report #335053
PNEUMO (PNEUMOVAX) vaccine side effect was reported on 12/11/2008. Female patient, 60.0 years of age, was vaccinated with PNEUMO (PNEUMOVAX). Patient symptoms: Guillain-Barre syndrome, "Progressive weakness, numbness/tingling in arms & legs with back pain beginning 11/10/08. ED visit followed by hospital admission (Dx - Guillain Barre syndrome following influenza and pneumococcal vaccinations) on 11/20 after pt fell at home. Pt currently in ICU on ventilator since 11/21 being treated with IVIG 42g IV daily. 2/2/09 MR received for DOS 11/21/08-1/9/09 with D/C DX: Guillain-Barre Syndrome requiring ventilator support, sh is currently weaning off the ventilator. Pt presented with 4-5 day hx of fever, tingling of hands and feet with subsequent weakness, nausea and vomiting, and difficulty with ambulation. Recent sinus sx tx with abx. PE (+) for areflexia, decreased muscle strength. Neuro consult Impression GBS, probably post vaccinial. Developed progressive weakness and respiratory failure requiring intubation. Tx with IVIG with no significant improvement. Trach and PEG tubes placed. Had possible seizure with (-) EEG. UTI tx with abx. Autonomic instability with HTN and bradycardia. Developed a sacral decubitus ulcer. Brief episode of atrial fib on 1/5/09. In January able to begin weaning from vent. Transferred for further rehab. 02/01/2010 Follow-up: Neurology consult 7/22/09-Residuall numbness and tingling in both legs, right>left. Numbness and tingling in her hands and weakness. Right foot drop and facial tenderness with difficulty chewing and masticating. Altered taste and decreased appetite. Residual numbness around her mouth as well." sinusitis - amox/clav txPAST MEDICAL HISTORY 1. Type 2 diabetes mellitus. 2. Obesity - BMI > 30. 3. Hypertension. 4. Hypercholesterolemia. 5. Osteoarthritis in the left knee. 6. Gastroesophageal reflux disease. 7. History of depression. 8. Coronary artery disease - S/P MI in 04/96. Angioplasty to an obtuse marginal. Angioplasty mid LAD 1997 and angioplasty proximal LAD 1989 and 1"MRI, LP. Labs and Diagnostics: MRI LS, thoracic spine (+) degenerative changes. CT head (-). CK 357-558. CKMB (-). Troponin I 0.03-0.09. WBC increased. CSF cell count WNL. CSF protein 155. CSF glucose 104. CSF cx (-). CXR (+) infiltr" . During the same period patient was treated with Reg Insulin - sliding scale Lisinopril 40 mg po daily Lorazepam 0.5 mg po tid Metoprolol 100 mg po bid Omeprazole 20 mg po bid. Patient was hospitalized Patient recovered.


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