Muscular weakness

INFLUENZA (FLUZONE) Side Effects Report # 336830
INFLUENZA (FLUZONE) side effect was reported on 01/08/2009. Female patient, 68.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: areflexia, asthenia, asthenia, c-reactive protein normal, fatigue"Patient experienced acute leg weakness progressing to include arm weakness and overall body weakness within a two-week period. Saw family physician on 12/8/08. Extensive lab testing was completed with normal results. Had follow-up visit with family physician who then referred patient to neurologist. Diagnosed by neurologist on 1/5/09 with Guillain-Barre. Patient still experiencing weakness and fatigue. 1/23/2009 MR received from Neurologist for DOS 1/5/2009 with DX: Acute Demyelinating Immune Polyneuropathy (Guillain-Barre syndrome). Appears to be a mild case already improving. Possibly r/t Flu shot although not certain. Pt presented for eval of weakness which developed in mid November 2008. Pt's legs felt rubbery and gait was abnormal. No muscle pain or sensory loss. Remained stable x 1 month, now improving x 2 weeks. More easily fatigued. PE (+) for slight waddling type gait, decreased strength (3/5) of the interossei upper and 4/5 lower extremities, absent tendon reflexes. No tx since pt was improving w/o tx.". None."Allergies: codeine, Medical conditions: hypertension, hypercholesterolemia. PMH: Allergy to codeine. HTN, Depression, Hyperlipidemia""Monoscreen: negative, CRP & thyroid screen: within normal limits." . During the same period patient was treated with "Lisinopril/HCTZ 10/12.5 mg, Zetia 10 mg (discontinued 12/8), Amitriptyline 75 mg, Fioricet (prn only), Darvocet N-100 (prn only)". Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 337071
INFLUENZA (FLUZONE) side effect was reported on 01/12/2009. Male patient, 14.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: muscular weakness, pain in extremity, pyrexia, vision blurred, "Four hours after vaccination, patient complained of sore arm, then started to complain of wobbly legs, blurred vision, and had high fever, and lasted 24 hours. (as reported by mother)". none . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337600
INFLUENZA (FLUZONE) side effect was reported on 01/16/2009. Female patient, 66.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: hemiparesis, muscular weakness, , , "Within 30 minutes of vaccination to the left upper arm, patient felt weakness in right side (muscular and joint) from right hip to knee; weakness lasted 45 min to an hour.". n/a . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339281
INFLUENZA (FLUZONE) side effect was reported on 02/09/2009. Female patient, 62.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: antinuclear antibody increased, areflexia, asthenia, back pain, blood product transfusion"12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. pt prescribed anti-nausea and anti-diarrheal med.12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. admitted to ICU. seen by neurologist and diagnosed with Guillian Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands. 2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days. Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit. Neuro consult done. Areflexia & loss of sensation of legs. LP done. Tx w/IVIG x 5 day w/improvement. D/C to home w/outpatient PT. 2/16/09 Received CSF results.". none"hypertension, and hypothyroidism, chronic back pain s/p mva PMH:panic attack""rpr=non-reative,lyme disease=negative, CSf studies as well as serum protein electrophoresis unremarlable other than CSF protein of 77 and WBC of 1. CSF cytology was unremarkable. MRI of head showed mild chronic ischemic micoangiopathy and p" . During the same period patient was treated with "Synthroid QD, Diovan QD". Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 340287
INFLUENZA (FLUZONE) side effect was reported on 02/16/2009. Male patient, 61.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: blood product transfusion, csf culture negative, csf glucose normal, csf protein increased, csf white blood cell count"Tingling both legs and arms with weakness. Muscle weakness (not working right in func). Speech impairment. 4/20/09 Received hospital & rehab medical records (referred to but not included 12/31/2008-1/14/2009), 1/14-1/22/09, 1/22-2/3/09 & 2/3-2/14/2009. FINAL DX: Guillain-Barre syndrome Records reveal patient experienced LE weakness/numbness/tingling & inability to lift legs which had been preceded by possible viral illness. Tx w/IVIG. Improved slightly & admitted to inpatient rehab 1/14-1/22/2009. While in rehab, noted to have worsening facial weakness & dysphagia & was readmitted to hospital 1/22-2/3/2009 for plasma exchange x 5. Minimally improved & d/c to inpatient rehab 2/3-2/14/2009 where he improved considerably although unable to fully close both eyelids. D/C home using walker & referred to outpatient PT & ST .". No"PMH: PSVT, HTN, hypertensive cardiovascular disease.""MRTs and CTs; multiple lab test; Spinal tap LABS: MRI brain 12/31/08 abnormal. MRI c-spine abnormal w/multilevel spondylosis. EMG/NCS abnormal. CSF: wbc 4, rbc 5, protein 118(H), glucose 67(N), c/s neg. CXR abnormal w/interstitial sc" . Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341150
INFLUENZA (FLUZONE) side effect was reported on 03/02/2009. Male patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: fall, muscular weakness, neurological examination normal, pyrexia, urticariaSee attached. Neurologist's assessment 2/20/09 - normal with coincidental viral infection with fever to 102 on day of visit 2/20/09.. NoneNoneSee attached . Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 343308
INFLUENZA (FLUZONE) side effect was reported . Male patient, 84.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: blood culture negative, brain natriuretic peptide normal, chest x-ray normal, chills, computerised tomogram abnormal"Complete loss of control - 9-13-08. Hospitalized five days. Diagnosed virus syndrome. Home doctor said had Guillain Barre syndrome. 4/8/09 Received hospital medical records of 10/5-10/8/2008. FINAL DX: probable viral syndrome; dental abscess. Records reveal patient experienced generalized weakness, muscle pain, chills, productive cough, fever 101, toothache x 2 days. Tx w/antibiotics. ID consult done. Fever thought to be from dental abscess. D/C on continued oral antibiotics & referred to dentist & PCP. 4/20/09 Received vaccine & PCP medical records of 10/27-10/30/09. FINAL DX:viral syndrome, improved. Records reveal patient received flu vaccine on 10/2/08. RTC 10/27 seen s/p hospitalization w/no new c/o. RTC 10/30 w/persistent fatigue & body aches. Supportive tx given. No further med records available.". None"None PMH: HTN, CKD, pneumonia, chronic SDH s/p head trauma, BPH, cardiac disease. Ex-smoker. Allergy: lidocaine.""Community Hospital - virus syndrome LABS: Neutros 83.5%, lymphs 9.1%. H/H 13.0/28.1(L). BMP, BNP, troponin, UA, CXR WNL. Blood & urine c/s neg. MRI & CT head WNL & c/w old chronic SDH s/p left craniotomy. Carotid US WNL." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 346462
INFLUENZA (FLUZONE) side effect was reported on 05/07/2009. Male patient, child 0.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: areflexia, blood product transfusion, csf test normal, choking, computerised tomogram normal"Influenza vaccines rec'd 10/18/07 and 11/20/07. 3 mos later developed Guillain-Barre syndrome/was hospitalizsed for acute lower extr. weakness. 5/19/09 hospital records received DOS 2/13/08 to 2/18/08. FINAL DIAGNOSIS: Acute lower limb weakness, possible Guillain-Barre Syndrome. Post vaccination: Choking episode, weakness and inability to bear weight on lower limbs. Fails to sit up or crawl. Otitis media. Decreased tone and power lower limbs. Biceps/triceps reflexes weak. Absent patellar reflexes. Weak ankle reflexes. Tachypnea, limp 3 doses of intravenous immunoglobulin. 7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Assessment: Acute infective polyneuritis, Guillain-Barre syndrome. Patient presented with absent knee, achilles reflexes and absent superficial reflexes of feet. No rolling, no tactile sensation back. No weight bearing on legs, falls forward when sitting. Keeps legs extended, scissoring. Gradual improvement of neurological findings. Left side of gluteal fold 2 inch erythematous ring surounding pustule.". PARONYCHIA & CERUMEN IMPDevelopmental D/O-Hearing; ?'s 2 mos-screen passed; No crawl/pincer @ 9 mos 7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Abscess finger. I&D."MRI Brain/Spine, EEG NL 5/19/09 hospital records received DOS 2/13/08 to 2/18/08. LABS and DIAGNOSTICS: CT head, cervical, thoracic, lumbar spine normal. CSF - WNL. EEG normal." . During the same period patient was treated with 5/19/09 hospital records received DOS 2/13/08 to 2/18/08. Amoxicillin. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 349822
INFLUENZA (FLUZONE) side effect was reported on 06/02/2009. Male patient, 63.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: anaemia, areflexia, asthenia, axonal neuropathy, bedridden"112408 - Pt c/o pain in feet; 112508 pain cont, now can't pick up objects with hands; 112608 requires assist to walk into ER; 112708 is now bedbound. Test, plasmapheresis - anemia - RBC given - rehab 7/7/09 MR received for DOS 12/20/2008-01/08/2009 with D/C DX: Guillain_Barre Syndrome, axonal type. HTN. DM. Mild tachycardia. Pt presented with progressive weakness in LEs, then hands. PE (+) for decreased strength and sensation. Absent reflexes. Pt c/o severe pain and muscle spasm of lower extremities, 1-2+ LE edema. DVTs noted in LEs tx with anticoagulants. Plasmapheresis with little improvement. One dose of IVIG with some improvement. Transferred for rehab on 1/8/09. ICD9: V5783. 3570. 4019. /". None"NIDDM; HTN PMH: HTN. DM. Tachycardia.Sinus surgery. appy. Herniated disc w/ surgery. Nausea, diarrhea and vomiting 11/2008.""Dx: Guillain-Barre Synd; Electromyography; CXR, MRI Spine; Lumbar puncture Labs and diagnostics: LP traumatic but WNL. MRI sppine (+) for degenerative changes and stenosis. EMG/NCS abnormal. BS 67-175. PT 20.1-29.1. Venous dopplers (+)" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 350162
INFLUENZA (FLUZONE) side effect was reported on 06/18/2009. Male patient, child 0.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: anaemia, aspartate aminotransferase increased, asthenia, blood glucose increased, csf white blood cell count increased"progressive decreased motor skills LE >> VE Dxd - " transverse myelitis". 7/2/09 Hospital records received DOS 5/29/09 to 6/2/09. Assessment: Transverse myelitis, constipation, mild anemia, left empty scrotum or cryptorchism. Patient presented with bilateral lower extremity weakness. More fussy than usual, waking up during the night, not rolling over, fell over from sitting position, will not bear weight and 'crumble' to the ground. No movement lower extremities. PO intake decreased. 4-5 wet diapers. 1 small hard bowel movement last 24 hours. Patellar and Achilles reflexes 3+/5 bilaterally. Ankle clonus. Limited hand extension and weaker pincer on right. Truncal weakness. 7/22/09-ICD-9 code 341.20". Mild URI 1-2 week prior illnessUnilateral Cryptorchidism - CF carrier.5/29 MRI head & spine. LABS and DIAGNOSTICS: 7/2/09 Hospital records received DOS 5/29/09 to 6/2/09. MRI Spine - abnormal intrinsic cord signal. MRI Brain - WNL. CHEM - AST 47 U/L (H) Glucose 117 mg/dL (H). CK 220 U/L (H). CBC - RBC 3.85 mi . Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 352739
INFLUENZA (FLUZONE) side effect was reported on 07/19/2009. Male patient, 67.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: aphasia, csf glucose increased, csf protein increased, chest x-ray abnormal, computerised tomogram normal"May 26, 2007 couldn't walk right - took him to ER they admitted him to hospital at that time. his condition kept getting worse - May 28, 07 he went Code Blue - twice - had ventilator put in and on oxygen - totally paralyzed from that time on. Approx 1 1/2-2 wks later had a spinal tap, found he had GUILLAIN BARRE Syndrome. He couldn't move talk nothing. 8/5/09 MR received for DOS 5/26-6/13/07 with D/C DX: Guillaine Barre Syndrome. Pt presented with arm and leg numbness/weakness. PE (+) for facial droop, dysarthria, sensation loss, upper and lower extremity weakness and difficulty with ambulation. Progressed to full respiratory arrest and pt intubated and later trached. PEG tube placed. Still very weak and unable to lift arms/legs. Transferred for intensive rehab.". high BP"Blind in left eye; loss of hearing left ear; High BP. PMH: COPD, high cholesterol. HTN. back surgery."Labs and Diagnostics: Head CT (-). EEG abnormal. EMG c/w post-infectious neuropathy/GBS. CSF glucose 120. CSF protein 64. CSF cx (-). Sputum (+) for staph aureus. MRI brain (-). CXR (+) infiltrates. . Patient was hospitalized Patient recovered.