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This is VAERS ID 263204

Case Details

VAERS ID: 263204 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2006-07-18
Onset:2006-07-18
   Days after vaccination:0
Submitted: 2006-09-14
   Days after onset:58
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640F / 1 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Deafness, Dizziness, Dysarthria, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pallor, Shock, Skin papilloma, Speech disorder, Syncope, Tinnitus, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri cyclen Lo
Current Illness:
Preexisting Conditions: Pap smear abnormal, Dysplasia, Breast Prosthesis user. 7/18/07-records received-HX papular condyloma.
Allergies:
Diagnostic Lab Data: Blood pressure 7/18/06 130/80 records received 7/18/07-Positive yeast vaginal culture. BX on 5/30/07-mild sysplasia/HPV
CDC Split Type: WAES0608USA02804

Write-up: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described the pt as being very dramatic. It was further reported that the pt reported seeing genital warts to the nurse practitioner, however, the nurse did not feel these were related to the vaccine. Additional information has been requested. 7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma. 1/4/10 Lack of concentration, hearing loss, blurred vision-ringing in ears. All of these we are aware of.


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