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Found 6884 cases where Vaccine is HPV4 and Serious

Case Details

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VAERS ID: 279595 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-05-08
Onset:2007-05-15
   Days after vaccination:7
Submitted: 2007-05-23
   Days after onset:8
Entered: 2007-05-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0210U / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cough, Demyelination, Hyperhidrosis, Nuclear magnetic resonance imaging abnormal, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: numbness or tingling of fingers
Preexisting Conditions: Exercise induced asthma, poor vision, tingling of fingers not successful records received-7/5/07- PMH: asthma
Allergies:
Diagnostic Lab Data: MRI - demyelinating disease of white matter cerebri and spinal cord cervical records received 7/5/07-CT and MRI head were abnormal shows periventricular white matter lesions. MRI spine showed inactive C5 white matter lesion. Labs, CBC WNL, with gran % 71.9. ESR, CSF normal. IGG 1656.
CDC Split Type: CT200708

Write-up: Gardasil HPV vaccine Administered on 05/08/07 cough on 05/14/07 vomiting 5/15/07 morning at school, sweating followed by syncope few minutes no Tonic-Clonic seizure. MRI done in ER showed Demyelinated Foci in Occipital, L temporal lobes and R frontal L 7/5/07-records received from facility for DOS 05/18-05/23/07-DC DX: Multiple Sclerosis. Previously healthy femal who was admitted due to a lesion seen on brain MRI. Patient reports symtoms became in December when she started having numbness in left thumb and slowly spread down her hands and arms. Also had some funny feeling in lower back. Symptoms resolved. Since then she has intermittent numbness with more than 50 episodes per day last less than 1 minutes. On 5/14 she started having nonproductive cough and sore throat, and posttussive vomiting the day after. Felt tingling over her left hand, right fingers and toes for less than 1 minute. Lightheaded, fell and hit her head. Out for almost 10 minutes. Disoriented.


VAERS ID: 279693 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-24
Entered: 2007-05-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Chills, Computerised tomogram normal, Myalgia, Nausea, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: X-ray negative; computed axial negative; diagnostic laboratory negative
CDC Split Type: WAES0705USA04056

Write-up: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately two and half weeks after the vaccination, the patient experienced abdominal pain, nausea, chills and muscle aches. She was hospitalized for 5-6 days. Multiple unspecified CT-scans, x-rays and blood tests were performed. All the results were negative. She was treated with an unspecified antibiotic. Subsequently, the patient recovered. The physician felt that the abdominal pain, nausea, chills and muscle aches were disabling. Additional information has been requested.


VAERS ID: 279815 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2007-05-25
Onset:2007-05-25
   Days after vaccination:0
Submitted: 2007-05-25
   Days after onset:0
Entered: 2007-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2278AA / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Flushing, Food allergy, Laboratory test, Seasonal allergy, Skin test positive, Throat irritation, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
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: None; Unknown
Current Illness: None
Preexisting Conditions: None; Nasal congestion; Sneezing
Allergies:
Diagnostic Lab Data: allergen skin test, 06/18/07, positive reaction to Kiwi and grass pollen; diagnostic laboratory, 06/18/07, ImmunoCap testing to Kiwi pending
CDC Split Type: WAES070USA06515

Write-up: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning, flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC: anaphylactic reaction most likely to either Gardasil or Menactra This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician, his office manager and an allergist via medical records concerning an 18 year old (previously reported as 17 year old) female with no known drug allergies and a history of nasal congestion and sneezing after exposure to cut grass who on 25-MAY-2007 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot #657737/0522U) and concomitant suspect therapy MENACTRA (lot #U2278AA). Additionally, information has been received through the Freedom of Information Act pertaining to this case. It was reported that the patient left the physician''s office feeling fine after the vaccinations, and subsequently, returned home. The patient ate a turkey sandwich and a kiwi, and "I hour after receiving the vaccine", the patient experienced an acute onset of throat tightness, throat burning, flushed face and trouble breathing. The patient returned to the physician''s office with throat tightness, throat burning, flushed face, shortness of breath and lips were slightly swollen. The patient was diagnosed with an anaphylactic reaction and was treated with one EPI-PEN injection, prednisone, 60 mg and BENADRYL, 50 mg. The patient''s breathing returned to normal, and subsequently, the patient recovered from the anaphylactic reaction. On 18-JUN-2007, the patient was seen by an allergist who reported that percutaneous skin testing was performed on the patient and revealed positive reactions to kiwi and grass pollen. The patient was diagnosed with a kiwi allergy and grass pollen allergy with seasonal allergic rhinitis. ImmunoCap allergy testing to kiwi, other fruits, pollens and Latex was also performed on the patient (results pending). The patient was instructed on the proper technique and indications for EPI-PEN use and follow-up was pending laboratory results. The reporting physician considered the anaphylactic reaction to be a disabling immediately life-threatening and medically significant event and felt it was most likely related to either therapy with GARDASIL or MENACTRA, although, the allergist felt that the "vaccines were not likely the cause of her reaction" and recommended that an attempt to proceed with the GARDASIL series "can be done in a closely monitored and equipped setting." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.


VAERS ID: 280069 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-30
Entered: 2007-05-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA04010

Write-up: Information has been received from physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient may have experienced encephalitis and was hospitalized. The duration of the stay was not provided. The physician reporting was not the physician who administered the vaccine but the treating physician. At the time of the report the patient had recovered. Additional information has been requested.


VAERS ID: 280163 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-05-01
Onset:2007-05-04
   Days after vaccination:3
Submitted: 2007-05-31
   Days after onset:27
Entered: 2007-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
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
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0705USA04839

Write-up: Information has been received from a nurse practitioner who heard from an emergency room (ER) nurse that an 11 year old female was vaccinated "within in the past month" in approximately May 2007 with a first dose of Gardasil. Subsequently, 3 days after vaccination the patient presented to an ER. She experienced cardiac arrest, required lung bypass (ECMO) and "may not have expired." It was also reported by the same nurse that the physician from the hospital said that "the death was due to an anaphylactic reaction to Gardasil." The anaphylactic reaction and cardiac arrest were considered to be life threatening by the reporter. Additional information has been requested.


VAERS ID: 280233 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Indiana  
Vaccinated:2007-04-19
Onset:2007-04-26
   Days after vaccination:7
Submitted: 2007-06-01
   Days after onset:36
Entered: 2007-06-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Angiogram normal, Antinuclear antibody, Borrelia burgdorferi serology negative, Cardiolipin antibody, Diagnostic procedure, Diplopia, Full blood count normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate normal, Syphilis test negative, VIth nerve paralysis, Vision blurred, Visual acuity tests normal
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Allergic reaction to antibiotics; Sulfonamide allergy
Preexisting Conditions: records received 6/6/07-HX:possible hypertension, seasonal allergies, dysmenorrhea and possible diabetes. Prescribed metformin but does not take it.
Allergies:
Diagnostic Lab Data: angiography 04/29?/07 - within normal limits, diagnostic laboratory 04/29?/07 - within normal limits, diagnostic laboratory 04/29?/07 - Sarcoidosis: within normal limits, magnetic resonance 04/29?/07 - within normal limits, visual acuity test 04/29?/07 - within normal limits, spinal tap 04/29?/07 - within normal limits, diagnostic laboratory 04/29?/07 - Myasthenia gravis: within normal limits, Lyme disease assay 04/29?/07 - within normal limits, serum ANA 04/29?/07 - within normal limits, erythrocyte 04/29?/07 - within normal limits, cardiolipin antibody 04/29?/07- within normal limits, complete blood cell 04/29?/07 - within normal limits, Rapid plasma reagin 04/29?/07 - within normal limits records received 6/6/07-Glucose 116. Blood Pressure 142/128. CSF 1 WBC. Sed rate normal. Tensilon test negative. CXR normal, Oribtal MRI negative. Brain MRA normal. Maxillary sinusitis. ANA EIA negative. Cardiolipin IgA <7. Lyme negative. ACE 19. CSF culture no growth.Acetylch REc Ab negative. MS panel negative.
CDC Split Type: WAES0705USA04014

Write-up: Information has been received from a physician and a 20 year old female consumer with Ceclor and sulfonamide allergy who on 19-APR-2007 was vaccinated with the first dose of Gardasil, IM. Concomitant medication was not reported. On approximately 26-APR-2007 ("within a week of receiving the vaccination), the patient reported that she had continued blurred vision "MS type symptoms" and had a 3 day hospital stay. A physician reported that on 29-APR-2007, the patient developed double vision which became progressively worse. The patient was diagnosed with sixth cranial nerve palsy. The patient had numerous diagnostic tests performed which included MRI''s, an angiogram, lumbar puncture, visual tests and blood tests including a complete blood count, metabolic profile, antinuclear antibody (ANA) test, anticardiolipin antibody, sedimentation rate and blood test to rule out syphilis, Myasthenia Gravis, Sarcoidosis and Lyme disease. All of these test results were within normal limits. The patient was treated with steroids and was improving. Additional information has been requested. 06/06/07-records received from facility for DOS 5/1-5/2/07-DC DX: Left cranial nerve VI palsey on left. Mild hypertension. On 4/29/07 while watching TV noticed double vision on looking to left. Gradual onset. On 4/30/07 woke with double vision when looking in all directions. Double vision is with one image side by side to the other image. MRI brain showed right hemispheric lesion. Ophthamologist noted optic nerve lesion. Headache come on after having double vision. No eye pain no numbness or weakness.


VAERS ID: 280260 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2007-05-22
Onset:2007-05-22
   Days after vaccination:0
Submitted: 2007-06-04
   Days after onset:13
Entered: 2007-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB149AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0451U / 2 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture, Cellulitis, Erythema, Full blood count, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: hydrocortisone cream to face and benzoyl peroxide to face
Current Illness: none
Preexisting Conditions: acne, eczema, acanthosis nigricans,extreme over weight
Allergies:
Diagnostic Lab Data: cbc with differential, blood cultures, nasal swab for mrsa records received 6/12/07- Fasting Glucose 100. Hemoglobin A1c 5.5. Serum insulin level elevated in mid 30s. Wound culture no growth. Blood culture no growth. C-Reactive Protein 55.20. Nose culture negative for MRSA.
CDC Split Type:

Write-up: patient came into clinic on 5/24/07 to have reaction evaluated.cellulitis of left arm was diaagnosed, erythema,warmth, diffuse induration, no fever, about 15-20 cm. patient hospitalized 5/24-27/07 given iv ancef and vancomycin, blood cultures and nasal swab cultures done both negative, cbc and differential-wnl, patient discharged home on bactrim and keflex 06/12/07-records received for DOS 5/24-5/27/07-DC DX:Left upper arm cellulitis, resolving. Obesity, rule out metabolic syndrome. HX of present illness:erythema, warmth and induration diffusely over lateral left upper arm. Temperature on admission 37.3 and remained afebrile for duration of hospital stay. WBC 6.6 with normal differential. Question of metabolic syndrome versus prediabetes. Given this cellulitis reaction and the patient''s obesity there was a question of an immunocompromised host.


VAERS ID: 280392 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Iowa  
Vaccinated:2006-11-01
Onset:2007-05-01
   Days after vaccination:181
Submitted: 2007-06-04
   Days after onset:34
Entered: 2007-06-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Autoimmune thrombocytopenia, Evans syndrome, Leukopenia
SMQs:, Haemolytic disorders (narrow), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy; Eczematous dermatitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA04412

Write-up: Information has been received from a physician concerning a 15 year old female with penicillin allergy and eczematous dermatitis who on 01-NOV-2006 was vaccinated with a second dose of Gardasil (lot #656049/0187U). On 01-MAY-2007, "roughly at the end of this vaccination series," the patient developed autoimmune thrombocytopenia and leukopenia. The patient was diagnosed with Evan''s Syndrome. The patient was hospitalized for 5 days treated with platelets, immunoglobulin and prednisone. At the time of the report, the patient had not recovered. The reporting physician considered Evan''s syndrome and leukopenia to be immediately life-threatening and disabling events. The reporting physician reported that he was not personally certain the Gardasil of the events. Additional information has been requested.


VAERS ID: 280394 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-02-16
Onset:2007-02-16
   Days after vaccination:0
Submitted: 2007-06-04
   Days after onset:107
Entered: 2007-06-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0210U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Incontinence, Injection site erythema, Injection site swelling, Local reaction, Vaccine positive rechallenge
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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, 7 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: ELMIRON
Current Illness:
Preexisting Conditions: None. PMH: DJD of the back, asthma, polycystic ovaries, Interstitial Cystitis. Tonsillectomy. Episode of pharyngitis, nausea & vomiting in early April ''07. NKDA.
Allergies:
Diagnostic Lab Data: Unknown; Labs and Diagnostics: 4/23/07: CBC with WBCs of 3.4. Chemistry WNL, Mono screen (-), UA WNL. head CT normal. Labs and Diagnostics: Cervical MRI WNL. Lumbar MRI shows DDD. EMG 4/30/07 suggestive of early demyelinating peripheral neuropathy, possibly suggestive of GBS. CSF WNL.
CDC Split Type: WAES0705USA05082

Write-up: Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female patient, who on 16-FEB-2007 was vaccinated, IM with the first dose, 0.5ml, of Gardasil (Lot #655165/1425F). Concomitant therapy included ELMIRON. On 16-FEB-2007, the patient developed a local reaction of redness and swelling at the injection site. On 19-Apr-2007, the patient was vaccinated IM with the second dose, 0.5ml, of Gardasil (Lot # 210U). Following the second vaccination, the patient again developed a local reaction of redness and swelling. Sometime following the second vaccination, the patient also became incontinent and developed numbness in her legs, feet, hands, and arms. On 03-MAY-2007, the patient was diagnosed with Guillian Barre syndrome; the next day, 04-MAY-2007 she was hospitalized. The length of the hospital stay was unknown. On 17-MAY-2007, the patient was examined by her physician with some improvement of the symptoms noted, though she continued to experienced weakness. The reporter considered one or more of the events following the second vaccination, to be significantly disabling/incapacitating, to require hospitalization, and to have required intervention as an other significant medical event. Additional information has been requested. 06/19/2007 MR received for ER visit of 4/23/07 and hospitalization 5/3-10/07. ER visit of 4/23/07 for c/o weakness, paresthesias-numbness tongue, fingers and toes, impaired swallowing, balance difficulties and light-headedness. PE:WNL. Discharged from ED with DX of Anxiety and Dizziness. Returned to ER on 5/3/2007 with c/o 3 week hx of numbness to her tongue and feet. Increased paresthesias of her lower extremities including an episode of loss of bladder control. Developed anxiety/panic attack over worsening symptoms. Sent to ER for a full GBS workup. PE WNL except for DTR''s were not elicited in the lower extremities. Admitted with assessment of Paresthesias and loss of bladder control; R/O GBS. Final DX: Guillain-Barre Syndrome. Polycystic ovaries. Migraine headaches.


VAERS ID: 281880 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-16
Onset:2007-01-17
   Days after vaccination:1
Submitted: 2007-05-16
   Days after onset:118
Entered: 2007-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1150F / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: body temp 01/17/07 102.5 F
CDC Split Type: WAES0701USA03067

Write-up: Information has been received from a physician assistant concerning a 10 year old female with no allergies or medical history who on 22-APR-2002 was vaccinated with a first dose of Varivax without any problems and on 16-JAN-2007 was vaccinated SC in the left deltoid with a 0.5 mL second dose of Varivax (lot # 654131/1150F). Concomitant vaccination on the same day included a dose of Gardasil in the other arm. There was no illness at the time of vaccination. On 17-JAN-2007, the patient developed an injection site rash. The rash was described as a cellulitis that was swollen, warm, and tender to the touch. The patient was seen in the office on 18-JAN-2007 and the cellulitis was determined to be 4 cm in diameter and reported to be larger than it was on 17-JAN-2007. The patient had a fever of 102 degrees Fahrenheit on 18-JAN-2007. Unspecified medical attention was sought and the patient was told to take Benadryl and to use a warm compress. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. Follow-up information was received from the physician assistant who reported that on 17-JAN-2007, the patient had red, indurated, warm cellulitis of the left upper extremity around the injection site. It was greater than four inches in diameter with a central vesicle. Her temperature was 102.5. She was treated with Rocephin and Augmentin. The patient recovered on 19-JAN-2007. The patient''s experiences were considered to be disabling and other important medical events by the reporter. No further information is expected.


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