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This is VAERS ID 280394

Case Details

VAERS ID: 280394 (history)  
Age: 20.0  
Gender: 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 / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
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.
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.


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