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Found 3,104 cases where Vaccine targets HPV (HPV2 or HPV4 or HPV9 or HPVX) and Disabled and Vaccination Date on/before '2019-05-31'

Case Details

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VAERS ID: 283648 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-06-21
Onset:2007-06-21
   Days after vaccination:0
Submitted: 2007-07-02
   Days after onset:11
Entered: 2007-07-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood human chorionic gonadotropin negative, Dyspnoea, Mobility decreased, Paraesthesia oral, Sensation of heaviness
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: beta-human chorionic 06/21?/07 - negative
CDC Split Type: WAES0706USA04917

Write-up: Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history who on 16-APR-2007 was vaccinated with 0.5 ml of the first dose of the Gardasil. On 21-JUN-2007 at 8:45 am, the patient was vaccinated intramuscularly with 0.5 ml of the second dose of Gardasil (Lot # 658100/0525U). There was no concomitant medication. A laboratory pregnancy test was performed and the result was negative. On 21-JUN-2007, at noon, the patient experienced shortness of breath, intermittent tingling of the lips and the feeling of her arm being heavy and difficult to lift. The motion of the patient''s arm had gotten worse since 21-JUN-2007 and she found it difficult to do her hair because of the arm. Patient was scheduled to be evaluated at her physician''s office on 26-JUN-2007. At the time of the report, the patient''s shortness of breath, intermittent tingling of the lips, and feeling of her arm being heavy and difficult to lift persisted. The medical assistant considered the shortness of breath, intermittent tingling of the lips and feeling of her arm being heavy and difficult to lift to be a disabling event. Additional information has been requested.


VAERS ID: 284287 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-06-21
Onset:2007-07-05
   Days after vaccination:14
Submitted: 2007-07-11
   Days after onset:6
Entered: 2007-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0523U / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2155CA / UNK UN / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0594U / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Aphasia, Areflexia, Asthenia, CSF protein increased, Computerised tomogram normal, Epstein-Barr virus test positive, Facial palsy, Facial paresis, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Muscular weakness, Occupational therapy, Physiotherapy, Protein total abnormal, Speech rehabilitation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: ENVIRONMENTAL ALLERGIES, MILD; Epstein-Barr virus antibody; Extraocular muscle disorder; Surgery; Constipation
Allergies:
Diagnostic Lab Data: POSITIVE EPSTEIN-BARR VIRUS TITER BY HISTORY spinal tap, 07/??/07, positive high protein; head computed axial, 07/05/07, within normal limits; blood pressure 07/??/07, 100/7 mmHg; diagnostic laboraatory 07/??/07, -60, negative inspiratory force; cerebrospinal fluid, 07/??/07, negative; body temp 07/??/07, 36.7; total heartbeat count 07/??/07, 20; respiratory rate 07/??/07,20
CDC Split Type:

Write-up: RECEIVED GARDASIL, VARICELLA VACCINE AND MENACTRA 6-21-07. DEVELOPED LOWER EXTREMITY NUMBNESS 7-2-07 AND DIAGNOSED WITH GUILLAN-BARRE SYNDROME 7-5-07. This is in follow-up to reportial previously submitted on 08/14/2007; 10/8/2007, 1/17/2008. Initial and follow up information has been received from a physician and identitied from a line listing obtained on request by the Company form the FDA under the Freedom of Information Act, an 18 year old female with mild eviornmental allergies and positive Epstein-Marr Virus titer by history, with no pre-existing illness, and no illness at the time of vaccination whose reported weight was 158 pounds and whose reported height was 56.5 inches, who on 21-Jun-2007 was vaccinated at 10:30 a.m., intramuscularly into the right deltoied with a firset dose of HPV lot #657868/0523U and concomitantly vaccinated, intramuscularly into the right arm with the second dose of secondary suspect therapy VARIVAX Merck, (lot #657412/0594U) and vaccinated IM with the first dose of MENACTRA, (lot # U2155CA), (Sanofi Aventis-Pasteur). The physician reported that the patient developed "Guillan Barre Syndrome" after receiving a dose of HPV over at the hospital and had to be hospitalized. In follow up the physician reported that on 02-Jul-2007 the patient''s parents contacted him and stated that the patient had foot and lip numbness (hypoaesthisis). The patient went to the ER on 05-Jul-2007. She was admitted to the hospital on 05-Jul-2007 where she was seen by a neurolgist and the neurologist diagnosed the patient with Gullian-Barre Syndrome. While hospitalized the patient received the following treatment, oxygen no intubation IV therapy hyperailmentotion for nutrition and IV immunoglobin. She also received physical therapy, speech and recreational therapy. She was discharged from the hospital on 27-Jul-2007. She required physical therapy after hospital discharge. In the hospital unspecifed labs and spinal tap were performed. The "spinal tap results was positive high protein and the culture was negative". The outcome was partial recovery. This listing indicated that one or more of the events required hospitalization. No further informatio is available.The reporter indicated that the patient''s adverse events were disabling, life-threatening and an other important medical event. Information was received via Medical Recored concerning an 18 year old, female, student with mild enviornmental allergies and positive Epstein-Barr Virus titier by history, with no pre-existing illness, no allergies and no illness at the time of vaccination whose reported weight was 158 pounds and whose reported height was 56.5 inches, with a past medical history of constipation, right extraocular muscle weakness with right extraocular muscle repair, who lives with her parents and two sisters, who on 21-Jun-2007 wa vaccinated at 10:30 a.m., intramuscularly into the right deltoid with a first dose of HPB lot #657868/0523U and concomitantly vaccinated, intramuscularly into the right arm with the second dose of secondary suspect therapy MENACTRA (lot # U2155CA). "Sanofi Aventis-Pasteur". It was reported that the patient went to the hospital on 05-Jul-2007 wtih numbness and weakness of bilateral lower extremities and right hand and facial paralysis. The patient initially had an acute onset of weakness starting on 30-Jun-2007. She was vacationing at the time. The patient continued to have increased weakness after returning from her vacation. The patien was evaluated at the emergency room. She had a CAT scan of the head, within normal limits. InitiallyLP was declined. The patient was evaluated in the clinic on 05-Jul-2007, and found absent deep tendom reflexes, and she was admitted ot pediatric intensive care unit. The patient''s symptoms advanced status post five courses of IVIG. The patient continued with bilateral facial paralysis. The patient had mild imporvement in the right upper extremity weakness, and bilateral lower extremity weakness. The patient was on a thin, pureed diet with a speech therapist working with the patient. The patient had been followed by a respiratory therapist. Negative inspiratory force had been around -60. The patient was transferred to acute inpatient rehabilation. On review of the patient''s history and physical the patient had some numbness, on the platar aspect of bilateral feet. The patient had no pain and had facial weakness with bilateral facial paralysis. She was able to move slightly her right perioral muscles. She was able to smile slightly on the right side. She was alert and oriented times. Her speech and language were fluend and intact. Her temperature was 16.7: pulse 98, and blood pressure 100/70 mmHg. The patient''s upper extremity strenght was 4/5. The patient DTK were absent throughout. The patient''s sensation was grossly intact to light touch, though she complained of some numbness and tingling in the bottome of her feet bilaterally. The patient had gait abnomality, dysphasia. Gullian-Barre syndrome. The plan was to admit the patient to an acute inpatient rehabilitaiotn facility with physical therapy working on pregressive transfers and mobility to imporve balance. Occupational therapy woud be used for strengthening of her right upper extremity, and work with the patient regarding activities of daily living eating grooming, toileting, toilet transfers. The patient was scheduled for speech therapy regarding the patient''s bilaterial facial paralysis. When was on a pureed diet with liquids, with plans to unprage her diet per recommendation form speech therapy. Respiratory was scheduled to monitor the patient''s negative inspiratory force. The patient was scheduled for neurolgic evaluation for increasing weakness. The estimated time for inpatient treatment was 2 weeks time with the goal of the patient being discharged to home. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addtion, an expanded lot check investigatoin was performed. The testing performed on the batch prior to release me all release specification. The lot met the requirements of the Centerfor Biologics Evaluation and Research and was released. Additional information has been requested. Follow up information has been received from a local television news station that reported "the patient was a high school athlete and the picture of health until she suddenly ended up in the hospital. She ended up staying there for 23 days. Her family suspected an adverse reaction to the GARDASIL. Her neurologist says it is a possibility". "When the patient went to get a physical before heading off to college, she received three vaccines that day: one for HPV, one for meningitis and one for chicken pox. Within a week, the former soccer player could barely move". "At first my outer fingers, my pinkies, were going numb". She said "and my outer toes were going numb. When I went into the hospital, I couldn''t walk at all. I had to have a wheelchair". Additional information is not expected. This is a consolidation of two reports concerning the same patient.


VAERS ID: 285692 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-05-15
Onset:2007-06-01
   Days after vaccination:17
Submitted: 2007-07-23
   Days after onset:52
Entered: 2007-07-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Full blood count, Joint range of motion decreased, Joint swelling, Mobility decreased, Red blood cell sedimentation rate, Rheumatoid factor
SMQs:, Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: complete blood cell; erythrocyte; serum rheumatoid factor
CDC Split Type: WAES0707USA03092

Write-up: Information has been received from a physician, concerning a 21 year old female patient, who on 15-MAY-2007 was vaccinated IM, with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication. On 01-JUN-2007, the patient began to experience prolonged swelling and tenderness of all her joints, as well as, a decreased mobility of her joints. Diagnostic labs included a complete blood count (CBC) with differential, sedimentation rate, rheumatoid factor C3 and C4, and an autoimmune workup (results were not provided). Treatment included meloxicam (MOBIC), and the patient was referred to a rheumatologist for further evaluation. At the time of this report, the patient had not recovered from the events. The reporting physician considered one or more of the events to be serious, as disabling/incapacitating. Additional information has been requested.


VAERS ID: 286275 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-07-30
Entered: 2007-07-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Muscle spasms, Pain, X-ray normal
SMQs:, Dystonia (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Sulfonamide allergy; Rash
Allergies:
Diagnostic Lab Data: X-ray - nothing conclusive
CDC Split Type: WAES0707USA03793

Write-up: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergies rash only, who, on an unspecified date, was vaccinated in the right arm with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Both parents of the patient reported that she was vaccinated very high up in the deltoid area, almost right at the joint at the top of the arm, almost posterior. The father who is an anesthetist nurse is concerned that this may have been an intraarticular injection. Subsequently, three weeks after the vaccination the patient has experienced increased pain at the injection site, throbbing pain down the arm, and her fingers of the right hand cramp. She is being treated with Motrin over the counter 600mg three times daily. The patient was seen at the doctor''s office who states that it may be tissue necrosis, but is unsure. The patient was also seen by the orthopedic office and an A-P Plane X Ray was performed, nothing conclusive. The patient is scheduled for an MRI. The reporter indicated, the patient experienced significant disability or incapacity. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 286561 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Delaware  
Vaccinated:2006-09-14
Onset:2006-09-15
   Days after vaccination:1
Submitted: 2007-08-02
   Days after onset:321
Entered: 2007-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNKNOWN / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test, Lymphadenopathy, Pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: allergic to ceclor, some adhesives, some sun-tan lotions...no medical conditions
Allergies:
Diagnostic Lab Data: blood tests for various imbalances
CDC Split Type:

Write-up: Lymphnode in Left side of neck swelled up. Sought care at Health Services, but none could be provided. Painful for a time. Went away after about three months. Came back with third dose of HPV vaccine. Has not yet gone back to normal completely. It has been three months. 8/15/07-records received from clinic. Diagnoses for DOS 10/10/06-2/8/07- include pelvic pain with C/O menstrual type cramps. Abdominal pain with C/O abdominal cramping. Enlarged lymph node left neck. Painful. HX of mono. Neck hurts less but has some nasal congestion. Bilateral rib pain. Lymphadenopathy. Lump in neck first appeared around 10/28/06-Lymphadenitis. Cold few days prior to first vaccine


VAERS ID: 286564 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-07-05
Onset:2007-07-13
   Days after vaccination:8
Submitted: 2007-08-02
   Days after onset:20
Entered: 2007-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0246U / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0802U / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0535U / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood glucose increased, Diabetes mellitus insulin-dependent
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: glucose - 977 records received 8/30/07-WBC 10.5. Segs 85. Postassium 5.6. carbon dioxide 18.9. Anion Gap of 33, Phosporus 6.6. osmolality of 322. Blood sugar greater than 900.
CDC Split Type:

Write-up: Came to office 1 week after immunizations were given with New onset Type 1 DM with sugar of 977. 8/30/07-records received-for DOS 7/13-7/15/07- DC DX: Diabetic ketoacidosis resolved. Type I diabetes new onset. Dehydration resolved. Hyperkalemia, resolved. Two week history of polyuria, polydipsia, nocturia, dry mouth and blurry vision, 12 pound weight loss for the last month or so. in ED blood sugar over 1000. C/O not feeling well, weak, decreased appetite, nausea and vomiting. 1/11/2010 Patient has type I DM.


VAERS ID: 286586 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-06-15
Onset:2007-06-26
   Days after vaccination:11
Submitted: 2007-08-02
   Days after onset:37
Entered: 2007-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UPON REQUEST / 3 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Demyelination, Hypoaesthesia, Lumbar puncture, Multiple sclerosis, Muscular weakness, Nervous system disorder, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Clonazepam (1mg 2x daily)
Current Illness: None
Preexisting Conditions: Allergy to Bactrim 10/22/07-records received-PMH significant for posttraumatic stress disorder and back pain, anxity/panic disorder.
Allergies:
Diagnostic Lab Data: MRI of brain and spine, lumbar puncture, standard neurological tests. records received 10/22/07-CSF-protein 32, glucose 57, total nucleated cells 2, ANA negative.
CDC Split Type:

Write-up: Onset of what was later diagnosed as Multiple Sclerosis or another demylinating disorder. Began with numbness and muscle weakness on lower left side of body, including left buttock, leg, and foot. Onset was 06/26/2007. Rectum, tailbone area, and toes of right foot also went numb within 10 days after initial symptoms. Patient presented in mid-July with *no rectal tone* and was unable to defecate normally for nearly 2 weeks. Following an MRI of the brain (on 07/20/2007), which showed several lesions, was formally diagnosed with Multiple Sclerosis "or another demylinating disorder." 10/22/07-records received for DOS 7/16-7/22/07-DX:Multiple Sclerosis.On 6/27/07-suddenly awoke with insidious onset of left lower extremity numbness, symptoms distributed from hip to foot, felt lower extremity was heavy. Seen in ER no motor dysfunction seen in ER on 6/29/07-with weakness, referred to PCP-seen by PCP 7/3/07-decreased sensation on left buttock area, descreased sensation left side of genitals and rectum. 7/8/07-some dysfunction with defecation, unable to complete defaction. Sitting causes pain. MRI of spine no focal disk herniation or central canal stenosis. Neurology consults 7/19/07-left lower limb numbness for 1 month. Impression: first presentation of demyelination, syndrome is most keeping with Multiple Sclerosis.


VAERS ID: 287371 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-03-28
Onset:2007-04-11
   Days after vaccination:14
Submitted: 2007-08-06
   Days after onset:117
Entered: 2007-08-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0314U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Deafness unilateral, Nuclear magnetic resonance imaging, Tinnitus, Viral infection
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: dizziness 2 yrs prior lasting 1 day follwed by intermittent imbalance, all involving left side. Previous smoker. HSV. Colposcopy w/biopsy 2002, 10/21/03 (CIN II), LEEP 11/24/03, colposcopy 3/05, excisional breast biopsy 4/05.
Allergies:
Diagnostic Lab Data: magnetic resonance - no result reported LABS: MRI brain & IACs WNL. Audiograms on 5/1, 5/8, 6/14 & 9/13 revealed left ear hearing loss.
CDC Split Type: WAES0707USA04654

Write-up: Information has been received from a nurse practitioner concerning a female nurse (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil. On 29-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # not reported) IM. On the morning of 11-APR-2007, the patient was non-symptomatic. Later that day, she woke up from a nap and she could hear nothing in her ear, except ringing. The patient sought the medical attention of primary care, ear, nose and throat (ENT) and surgical ENT services. It was determined that the patient had a "92% hearing loss". A magnetic resonance imaging was performed, result not reported. She was treated with antibiotics, steroids, and steroids injected into her ear without any improvement. The diagnosis was sudden, unilateral hearing loss due to a viral attack on the nerve. The surgical ENT had no idea of the etiology except that this was a rare experience. The patient had no idea of the etiology except that this was a rare experience. The patient had 8% word recognition in the left ear with the ability to hear one tonal frequency. It was reported that the permanent hearing loss was disabling. At the time of reporting, the unilateral hearing loss persisted. Additional information has been requested. 8/28/07 Received medical records from reporter which reveal patient received #1 HPV vax 2/1/07, lot # 1427F. #2 HPV vax 3/28/07 lot# 0314U. #3 HPV vax 7/19/07, lot# 0524U. With 3rd HPV, patient reported complete hearing loss of left ear which ENT felt permanent. 10/2/07 Reviewed ENT medical records of 5/1-9/13/2007 which reveal patient experienced sudden hearing loss of left ear on 4/11/2007. Upon awakening from nap, had tinnitus & hearing loss. Seen by pcp on 4/13 & referred to another ENT. Hearing test at that time revealed left hearing loss at all frequencies. Intratympanic steroid injection series x 3 w/o significant improvement. FINAL DX: viral labyrinthitis left ear; sudden hearing loss, left ear; tinnitus, left ear; abnormal auditory perception.


VAERS ID: 288458 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-06
Onset:2007-08-06
   Days after vaccination:0
Submitted: 2007-08-17
   Days after onset:11
Entered: 2007-08-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood thyroid stimulating hormone normal, Diarrhoea, Full blood count normal, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OVCON
Current Illness:
Preexisting Conditions: Cholecystectomy
Allergies:
Diagnostic Lab Data: complete blood cell 08/07/07 normal; serum TSH 08/07/07 normal
CDC Split Type: WAES0708USA01429

Write-up: Information has been received from a registered nurse concerning a 19 year old female patient with a history of cholecystectomy (FEBRUARY 2005) and no allergies who on 06-AUG-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot # 658282/0929U). Concomitant therapy included ethinyl estradiol/norethidrone (OVCON). About 2 hours after receiving the vaccine, the patient experienced severe abdominal pain, nausea, vomiting and diarrhea. The patient stated that the area that hurts was about 2 inches from her belly button. The patient was prescribed atropine sulfate (+) diphenoxylate hydrochloride (LOMOTRIL) and promethazine hydrochloride (PHENERGAN). It was reported that the next day the patient called the office and her stomach pain had gotten worse. On a scale of 1 to 10 the patient felt her pain was a six. Laboratory diagnostic studies given on 07-AUG-2007 included a CBC and a thyroid study. Both were reported as normal. The patient no longer has diarrhea but was still experiencing nausea and vomiting. The outcome of severe abdominal pain was unknown. No product quality complaint was involved. Severe abdominal pain, nausea, vomiting and diarrhea were considered to be disabling. Additional information has been requested.


VAERS ID: 288761 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-05-29
Onset:2007-05-29
   Days after vaccination:0
Submitted: 2007-08-22
   Days after onset:85
Entered: 2007-08-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Incorrect dose administered, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; antimicrobial (unspecified); YASMIN; phentermine hydrochloride 37.5 mL
Current Illness: Obesity; Hypersensitivity; Asthma
Preexisting Conditions: Headache
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA01863

Write-up: Information has been received from a physician concerning a 24 year old female with obesity, hypersensitivity and asthma and a history of headaches who on 29-MAY-2007 was vaccinated in the left arm with a 65 ml confirmed dose of Gardasil. Concomitant therapy included albuterol, phentermine HCL, antimicrobial (unspecified) and Yasmin. On 29-MAY-2007 the needle accidentally hit a "vursar sac" in the patient''s left arm. Subsequently, the patient developed arm pain. The patient was going to physical therapy and is seeing an orthopedic doctor. At the time of the report the patient had not recovered. The reporting physician considered arm pain to be disabling. Additional information has been requested.


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