267171 influenza vaccine and human papilloma virus vaccines given november 10 about 11:45 am

267171 INfluenza vaccine and Human Papilloma VIrus vaccines given November 10 about 11:45 AM. Patient woke up with numbness on right side of face on November 11. Presented to Emergency Room on November 12 with Bells Palsy of right side of face. Unable to move right side of face. Unable to close right eye. Previously healthy, no symptoms on day of vaccine administration. Received MR from pediatrician revealing a healthy 12 year old in for well-child exam. 24 hours after Flu and Gardasil vax. child developed numbness, pain, and inability to move the right side of face. Assessment: Facial Nerve Palsy-unclear etiology. Child was sent by car to Minneapolis Children's ER to be evaluated. ER report received: DX: Bell's Palsy 267197 Bell's Palsy right occurred 24 hours after injection of Gardasil. Previously healthy. MR received revealing an 18 yr. old in for well-woman exam with only c/o some discomfort in the mastoid area behind her right ear x2 days. The following day she presented with right-sided facial droop. HPI: Pt awoke morning following Gardasil vax. and had difficulty with spitting out her toothpaste. No pain or visual loss. No extremity weakness or paresthesias. Most obvious upon smiling. Able to wrinkle forehead and puff cheeks. Good sensation. Txd with Famvir, Solu-medrol and Refresh Tears. Assessment: Bell's Palsy. 267427 Information has been received from a physician concerning an 11 year old female who was the daughter of a nurse that works in his office. On 30-SEP-2006 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot #654540/0800F). At that same time, the patient received a second dose of FLUMIST. On 01-OCT-2006 the patient had a "funny feeling in her face." By 03-OCT-2006 "her face was crooked on one side and becoming paralyzed." The patient was treated with an unspecified steroid medication and was reported to be "feeling better," but the symptoms were not totally gone. The patient was seen by a neurologist and was diagnosed with Bell's Palsy. The physician reported that one year ago, the patient was given FLUMIST and had no adverse reactions. At the time of this report, the patient was recovering from the events. The physician reported that it was his opinion that "Bells Palsy was caused by FLUMIST and not GARDASIL." Additional information has been requested. 274463 Patient received first dose of HPV on 1/26/07, then around 2/24/07 experienced flu symptoms which resolved. Then 3/10/07 experienced right sided facial swelling, right eye tearing, right ear pain. Seen by MD 3/12/07 and diagnosed with Acute Otitis Media and Bell's Palsy. MRI scheduled but not completed yet. Question related Bell's Palsy to vaccination? 05/29/07-records received-3/12/07-C/O 2 day right side facial weakness, right earache for 3 days and tender lump under right ear for 5-6 days. Numb around right side of lips. PE: right ear with erythema and dull typanic membrane and tender ear canal on exam. Neck tender 1 inch lymph node under right ear. Right facial muscles paralysis related to 7th cranial nerve. Able to close eyes completely though right eyelid weak. DX:Otitis media and Bell's Palsy. 274595 Information has been received from a registered nurse concerning a 11 year old female who was vaccinated with a dose of Gardasil. Concomitant therapy administered at the same time at a different anatomical site included a dose of MENACTRA. Illness at the time of vaccination included herpes simplex on the lip. On 09-JAN-2007, the patient was seen in the office and was diagnosed with herpes zoster otitis which progressed to a diagnosis of Bell's palsy and Rasmsay-Hunt Syndrome on 15-JAN-2007. At time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 03/28/07-records received for DOS 1/16/07 DX:Bell's Palsy. Ramsay Hunt Syndrome. PH:1/9/07-Seen by PMD to treat shingles in right ear with acyclovir. TX stopped on 1/16/07 due to bells palsy. Right side facial droop difficulty eating. C/O headache thoughout with shingles. 1/16/07-stomach cramps, diarrhea. Symptoms resolved 2/8/07. 277352 Information has been received from a registered nurse, concerning a 50 year old female with hearing loss (16-AUG-2007), a facial nerve disorder, Lyme disease with arthritis, pruritus, multiple allergic reactions to antibiotics including tetracycline, CECLOR and KEFLEX, and multiple drug hypersensitivities including morphine, and propoxyphene and DARVOCET, who on 21-FEB-2007 was vaccinated with the first dose, 0.5 ml, IM in the left deltoid, of Gardasil (lot #656372/0243U). Concomitant therapy included INDERAL, MINOCIN, TRILISATE TABLETS/LIQUID), DIAMOX and MIDRIN. On 05-APR-2007 the patient was hospitalized after she developed facial palsy. The nurse reported that on 09-APR-2007, the patient called the office to report her condition. The patient remained hospitalized until 16-APR-2007, and on that day she called the office, and stated that she "had a possible diagnosis of Guillian Barre syndrome." The patient reported she believed that Gardasil caused her condition, and had requested a human papilloma virus antibody test. The reporter considered the event of facial palsy and possible Guillian Barre syndrome to be an other significant medical event. Additional information has been requested. 5/29/07 Received hospital medical records which reveal patient experienced sudden inability to speak, close eyelids or move face, and unable to swallow. Admitted 4/4-4/16/07. Neuro & Psych consults done. Treated w/IV antibiotics in hospital & continued on IV antibiotics at home FINAL DX: cerebral Lyme disease. 279082 Patient presented 5/10/07 with a ten history of tingling in the right hand. On 5/14/07, she presented with right foot pain and numbness as well. She was referred to the Neurologist where she had an appointment 5/15/07. Patient was admitted, after ER evaluation, on 5/16/07. Patient was treated with IVIG in the hospital and multiple tests were ordered. Patient's working diagnosis is Landry-Guillain-Barre Miller-Fisher variant. 06/05/07-records received from facility for DOS 05/16-05/21/07-DC DX: Guillain Barre variant. Left Bell's Palsy. Paresthesias. C/O numbness in dorsum of right hand progressing up her forearm also left foot numbness progressing up her leg and a left facial droop. Numbness started in right hand approximately 1 month after received HPV, Hep A and Menactra vaccine. HX of living in woods and a family pet with ticks. PE: Crainal nerves II through XII intact with exception of mild left facial droop. Paresthesias of bilateral lower extremity and hands and arms in glove and stocking formation. Strength and motor intact. Treated with IVIG. Symptoms without progression and slight improvement daily. Lost reflex in lower extremities but at time of discharge 2+ of right but have not returned on left 281051 2 months following vaccine administration patient developed Bell's Palsy. Treated with Valtrex and prednisone. 7/26/07 Received call from pcp w/additional patient information. States Lyme test initially reported as neg has now been determined to be positive. Feels Bells palsy secondary to Lymes disease & not related to vaccine. 8/31/07 Reviewed pcp medical records which included vax records & corrected vax info. VAERS database updated w/same. Office note of 4/4/07 reveals patient healthy on day of vax, only concern was acne. Returned on 6/7/07 w/left side facial weakness x 4 days. Unable to lift left eyebrow or close left eye. Unable to smile on left side. Tx w/antiviral & prednisone, eye drops & eye patch at night. Returned 6/26/07. Lyme titers had returned (+). Facial numbness & weakness had improved. Smile remained slightly asymmetrical but able to lift eyebrow & squeeze eyes shut. Tx w/antibiotics & received 2nd dose Gardisil. Returned 7/24/07. Had completed meds & symptoms had improved & smile now symmetrical. FINAL DX: Bell's Palsy secondary to Lyme's disease. 284776 (R) facial nerve palsy Treatment-Doxycycline 100 mg po bid Prednisone 50 mg po dd x 5 dy 7/19/07-records received-7/6/07 seen in ED. 7/12/07 follow-up visit. Right facial nerve pasy. No headaches, no fever no ear pain. Improved mobility, noticing that she is able to open and close her eye a little bit more, able to close eye 90% of way. . Speech better. No associated weakness. No joint swelling 285909 Diagnosed with Bells Palsy (paralysis on left side of face) Acyclovir 400 mg-1 tab 5 times a day Prednisone 20mg-2 tabs for 3 days 1.5 3 days, 1.0 3 days, 0.5 3 day. 8/14/07 Received vax record & VAERS database updated w/same. 9/11/07 Received medical records from clinic for visit on 7/6/07 which reveals patient experienced left eye swelling, left tongue numbness & left lower lip numbness. Had URI for approx 10 days, sinus congestion, rhinitisfatigued & easy bruising. Exam revealed left side eyelid drooping, inability to completely close left eye, flattening of nasal labial fold & left side lip drooping. Tx w/antiviral, prednisone. Referred to hematology. FINAL DX: Bell's palsy, thrombocytopenia. 288261 left sided facial nerve paralysis (Bell's palsy) 9/7/07 Reviewed pcp medical records which reveal patient well & healthy on day of vax. Only concern was for hair loss. Returned to pcp on 8/15 s/p developed left eye watery & twitchy x 3 days. Awakened 8/14 & could not smile or squint. Exam revealed left ptosis w/sluggish light reflex & left side facial paralysis. Tx w/steroid taper. PCP discussed case w/neurologist & started on antiviral 8/16. Noted to have tingling/burning s/s of herpetic outbreak 8/13 but no actual vesicles. F/U visit on 8/29 revealed smile almost normal but still residual eye involvement. Exam revealed improved smile but still mildly weak on left. Eye exam WNL. Immunization records do not include lot #s. Does indicate patient received initial meningococcal 8/22/06. FINAL DX: Bell's Palsy 289186 Left facial weakness started 1 week after receiving Gardasil and Menactra. Started with sense of fullness on left side of face with left retroauricular pain and abnormal taste - seen with doctor ER. Treatment Acyclovir 200mg qd x 10 days and Prednisone 40mg qd x 2 weeks tape left eye shut q bedtime. 9/10/07 Received ER medical records of 7/25/07 from hospital which reveals patient experienced left sided headache, weakness, numbness, tingling & left facial droop upon awakening on 7/25/07. Had left tongue numbness w/altered taste x 4 days prior. Exam revealed prominent tearing of left eye, left facial weakness, weak left side smile & inability to completely close left eye or to wrinkle left forehead. Tx w/eye patch, steroids & anti virals. D/C to home from ER to f/u w/neurologist. FINAL DX: Left sided Bell's palsy. 9/18/07 Received vax record which confirms as reported & neuro note of 8/6/07. S/S had markedly improved but w/ mod left facial weakness. Neuro DX: Post vaccinal idiopathic left sided Bell's palsy. 289753 Patient developed Bell's Palsy 12 days after the vaccine was administered. 9/7/07 Received vax record which provided dose & Lot #. VAERS database updated w/same. 9/28/07 Reviewed hospital medical records which reveal patient experienced left eye twitching & abnormal taste x 2 days. Noted crooked smile & difficulty closing left eye. Seen in ER on 8/31/07. Had returned from summer camp 1 week prior. Peds neuro consult done. Tx w/prednisone & antivirals. FINAL DX: Bell's Palsy. 291405 see ER note of 8/25/07 and office note of 9/18/07. 9/27/07 Case closed as complete w/medical records which accompanied report. ER note of 8/25/07 reveals patient experienced headache, fever, vomiting & generally feeling unwell since received 2nd HPV vax on 8/21. Developed left side ear ache & facial weakness 8/24 w/difficulty smiling & closing left eye. Tx w/prednisone & antiviral meds. D/C to home. PCP office visit 9/19/07 reveals patient had continued mild left facial droop otherwise improved. Warts had improved on antiviral & that med was continued. FINAL DX: Bell's palsy; viral syndrome. 294611 Bell's Palsy dx 10/23/07 Tx aphtheus stomatitis 10/14/07. 10/29/2007 ER record received for DOS 10/23/07 for DX: L Seventh Nerve Palsy. Bells Palsy suspected. Lyme Disease manifestation not excluded. Pt presented with L sided facial droop, numbness and inability to close L eye. Recently seen for infection/apthous stomatitis. 294858 Patient developed Bell's Palsey on August 17th, 2007. She was taken to an immediate care clinic in Wisconsin. Patient was on vacation at time. 12/06/2007 MR received for OV 8/18/2007 with DX: Bell's Palsy. Pt presented with L sided facial swelling. Smile is asymmetric as pt cannot bring L side of mouth into smile.Orbicularic oculi muscles (+) for weakness on L. Txd with Amoxicillin pending Lyme's test. Lot # updated in VAERS database (0954F). 295242 Numbness starting in feet, now hands and mouth. No muscle weakness 12/11/07-records received for DOS 10/30/07 C/O numbness to hands and feet began last week 10/17/07. Numbness in hands and lower arms as well as lips and face. 11/12/07-seen by neurologist, DX Postinfection cerebelitis, improving. Right Bell's palsy, improving. Current clinical events are not related to vaccination with Gardasil. 295507 Pt presented to the clinic on 8/13/07 with 1 week history of diplopia, ataxia, and weakness of extremities R>L. Pt was admitted to hospital on 8/14 and dx with acute disseminated encephalomyelitis and azotemia. Pt was treated with a 5 day course of Solumedrol and Prednisone taper started with improvement in all sx's except diplopia. 12/26/2007 MR received for DOS 8/14-24/2007. No formal D/C DX noted but following diagnostic studies DX o. f ADEM is proposed. Child presented to ER with 6 day hx of double vision, 4 day hx of unsteady gait, extremity weakness (R>L) and abnormal eye movements noted by dad. Pt began running into things and falling while walking. Weakness, pain and unsteady gait have worsened. PE (+) for decreased strength upper & lower extremities, 1 beat clonus bilat, CN III palsy, R exotropia. Neurologic sequelae: Pt became more encephalopathic during admission (ataxia and III CN palsy) so transfered to PICU. Pt developed deteriorating renal function/azotemia which worsened after CT contrast. Txd with IV and po steroids. Discharged on day 10 in stable condition with aspiration precautions. 12/28/2007 Spoke with reporter who states only sequelae at this time is some occasional double vision when pt gets tired. Other sx such as ataxia, dysphagia and renal function are now resolved. 299046 facial assymetry, Drooping of unilateral eye/corner of mouth. Only able to close one eye, other has to be taped shut at night. 12/12/07-records received-11/9/07-Bell's Palsy-presented with C/O pain left side of mouth and twitching of face. Facial drooping on left began 4 days after vaccination. Unable to close her left eye. In office no facial twitching noted. 299103 Stiff neck Wed 11/28 gradually progressed - required visit to Emergency Room. Dx Bells Palsy by doctor at hospital - visited 12/1/01. 1/18/08 Reviewed ER medical records which reveal patient experienced left lateral neck pain, left side of lips numb, left facial droop x 1 day. Left eye tearing & unable to close left eye tightly or lift left eyebrow as high as right. No treatment provided. Referred to neurologist & opthalmologist for f/u upon d/c from ER w/o any prescriptions. FINAL DX: Left Bell's palsy.

Source: http://silgard.files.wordpress.com/2008/11/cazuri-de-fete-paralizate-engleza.pdf