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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: 293703 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-08-28
Onset:2007-08-29
   Days after vaccination:1
Submitted: 2007-09-17
   Days after onset:19
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Gait disturbance, Impaired work ability, Laboratory test normal, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: LAMICTAL; CHANTIX
Current Illness: Sulfonamide allergy; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory - negative
CDC Split Type: WAES0709USA00048

Write-up: Information has been received from a physician concerning a 23 year old female with a sulfonamide and penicillin allergy and no other pertinent medical history who on an unspecified date received her second dose of Gardasil. Subsequently, she had joint pain. She was seen by a rheumatologist, but unspecified tests came back negative. Subsequently, she recovered. on 28-AUG-2007 the patient was vaccinated with her third dose of Gardasil, 0.5 mL (Lot # 658556/1060U). Concomitant therapy included lamotrigine (LAMICTAL) and varenicline tartrate (CHANTIX). On 29-AUG-2007 after receiving her third dose of Gardasil, the patient complained of generalized joint and muscle pain. The pain was so strong that she could not walk. She had to stay in bed and was not able to go to work. The physician noted the patient had no problems with the first dose of Gardasil and only had joint pain after second dose and after the third dose, pain reappeared all over her body. The patient called the physician and sought medical attention. Patient Quality Complaints (PQC) were not involved. The physician considered generalized joint and muscle pain to be disabling because the patient could not walk. Additional information has been requested. In follow-up it was reported by the physician, that the patient a 23 year old, female with a sulfonamide and penicillin allergy and no pertinent medical history and no illness at the time of vaccination who on 28-AUG-2007 was vaccinated intramuscularly into the left arm with the third dose of GARDASIL, (Lot # 658556/1060U). It was reported that on 29-AUG-2007, the patient at first had joint pain in both hands and then generalized muscle pain and joint pain throughout the whole body. It was reported that the patient felt better and recovered on 31-AUG-2007. Additional information has been requested.


VAERS ID: 292239 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2007-05-22
Onset:2007-09-05
   Days after vaccination:106
Submitted: 2007-10-04
   Days after onset:29
Entered: 2007-10-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bladder spasm, Blood test normal, Computerised tomogram normal, Cystoscopy, Laboratory test, Nuclear magnetic resonance imaging normal, Smear cervix normal, Ultrasound pelvis abnormal, Urinary incontinence, Uterine leiomyoma
SMQs:

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: Knee operation
Allergies:
Diagnostic Lab Data: cervical smear 09/10/07 - negative, diagnostic laboratory 09/10/07 - STD''s (normal limits), diagnostic laboratory 09/10/07 - blood work (normal limits), computed axial 09/10/07 - pelvic (negative), vaginal ultrasound - pelvis cyst on spleen, fibroid tumor in uterus (small), ultrasound, magnetic resonance 09/29/07 - pelvis and spine (spinal tumor negative), (procedure unspecified) 09/18/07 - cystopy (negative), cervical smear - no pain
CDC Split Type: WAES0709USA04688

Write-up: Information has been received from a nurse''s 20 year old daughter with no drug reactions/allergies and a history of knee operation in 2003 who in December 2006, was vaccinated with a first dose of Gardasil (lot# unknown). In mid January 2007 the patient had a second dose of Gardasil. On 22-MAY-2007 the patient had a third dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). It was also reported that the patient''s mother had cervical cancer 14 years ago at the age of 35. On 05-SEP-2007 the patient experienced bladder spasms on the first day of college. It was also reported that the patient was experiencing urinary incontinence. None of the medication have helped the bladder spasms. On 10-SEP-2007 the patient was seen in the emergency room. On 10-Sep-2007 the patient had a PAP smear, was tested for STD''s, had various blood work done all within normal limits and a pelvic computed axial tomography scan which all came back negative. All labs and tests were coming back within normal limits. On 18-Sep-2007 a cystopy was performed in a urologist office and was negative. On 26-Sep-2007 a magnetic resonance imaging of the pelvis and spine was performed (looking for spinal tumor) which was negative. On an unspecified date an ultrasound and vaginal ultrasound of pelvis showed a cyst on spleen and a fibroid tumor in the uterus which was very small. A PAP smear was performed and there was no pain, no pelvic inflammatory disease noted. The patient is currently on acetaminophen (+) hydrocodone bitartrate (VICODIN0, morniflumate (FLOMAX), amitriptyline hydrochloride (ELAVIL) and azithromycin (Z-PAK). At the time of reporting the patient had not recovered. No additional information was available. Bladder spasms and urine incontinence were considered to be disabling. The patient must stand during college classes. Additional information has been requested.


VAERS ID: 296713 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-08
Entered: 2007-10-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA01029

Write-up: Information has been received from a nurse practitioner concerning an approximately 19 year old female who was vaccinated IM with a first dose of Gardasil. Subsequently, the patient was diagnosed with Guillain-barre syndrome and was hospitalized. The patient''s Guillain-Barre syndrome persisted. No product quality complaint was involved. Guillain-barre syndrome was considered to be disabling and immediately life-threatening. Additional information has been requested. Additional information is not expected.


VAERS ID: 293095 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-10-01
Onset:2007-10-01
   Days after vaccination:0
Submitted: 2007-10-05
   Days after onset:4
Entered: 2007-10-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Medication errors (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Rheumatoid arthritis; General symptom; Scoliosis; Hypertension; Diabetes; Seafood allergy; Allergy to nuts; Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00638

Write-up: Information has been received from a physician''s assistant concerning a 50 year old female with rheumatoid arthritis, "shogun''s syndrome", scoliosis, hypertension, diabetes, seafood allergy, allergy to nuts (almonds) and multiple medications drug hypersensitivity (unspecified) who on 01-OCT-2007 was vaccinated with a first dose of Gardasil. Concomitant medication was unspecified. On 01-OCT-2007, within one or two hours after being vaccinated, the patient experienced respiratory distress. The patient went to the emergency room and was treated for an allergic reaction. She was given epinephrine injection, albuterol inhaler, and (Benadryl). At the time of reporting, 02-OCT-2007, the patient was still experiencing mild to moderate respiratory distress. The reporter considered the respiratory distress and allergic reaction as serious to disability, immediately life-threatening, and as Other Important Medical Events because epinephrine injection was required. Additional information has been requested.


VAERS ID: 298860 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-11
   Days after vaccination:7
Submitted: 2008-01-07
   Days after onset:118
Entered: 2007-10-15
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0530U / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness, Nuclear magnetic resonance imaging, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (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, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOLTRIN; PROVERA
Current Illness: 12/18/07-records received-Vaginal bleed for 2 weeks after IUD placement. History of diarrhea one week ago which remained for 3 days and resolved spontaneously.
Preexisting Conditions: Pregnancy termination. 12/18/07-records received-HX cervical cancer 6 years ago.
Allergies:
Diagnostic Lab Data: Magnetic resonance 09/07/07 results not reported 12/18/07-records received-Labs: lymphs 51.2, mono 11.6, sed rate 25. Urinalysis WBC 188, RBC 27, e. coli. Pregnancy test positive. CSF protein 56, culture negative.
CDC Split Type: WAES0709USA01558

Write-up: Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested. 12/18/07-records received for DOS 9/10-9/28/07- DC DX: Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk. PE: reflexes absent in both lower and upper extremities. This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008. Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007. On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported. On 14/SEP/2007, the patient was given a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered. It was unknown if the prescriptions wore taken by the patient. On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed. She presented to the emergency room, with Guillain Barre syndrome where she was examined. On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting, the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event) immediately life-threatening, required hospitalization, and was disabling. A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release. Additional information is not expected.


VAERS ID: 293409 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-06-28
Onset:2007-07-12
   Days after vaccination:14
Submitted: 2007-10-16
   Days after onset:96
Entered: 2007-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Granuloma, Hypoaesthesia, Injection site mass, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Tremor, Ultrasound scan abnormal
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hypoglycaemia (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: Levora
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: upper extremity X-ray ?/?/07 - fluid collection; magnetic resonance ?/?/07 - fluid collection in left arm; ultrasound ?/?/07 - guided aspiration revealed granulomatous reaction
CDC Split Type: WAES0710USA02817

Write-up: Information has been received from a dentist concerning his 19 year old daughter with penicillin allergy who on 28-Jun-2007 was vaccinated with her third dose of Gardasil. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA). On 12-Jul-2007 the patient experienced a large tender lump at the injection site in her left deltoid muscle. The area became progressively more painful with pain radiating up to the left shoulder and clavicle and down to the left ring finger. The patient was seen in the office and referred to an orthopedist. X-rays and an MRI of the left arm revealed fluid collection. Ultrasound guided aspiration revealed granulomatous reaction. The pain continued to worsen and on 10-Oct-2007 the patient experienced transient numbness of left hand lasting 15 minutes and hand tremor lasting 5 hours. The patient was scheduled to have a neurologic evaluation on 12-Oct-2007. It was reported that the patient''s adverse events were disabling. The patient has not recovered at this time. No further details were provided. Additional information has been requested.


VAERS ID: 293413 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-07-05
Onset:2007-09-03
   Days after vaccination:60
Submitted: 2007-10-16
   Days after onset:43
Entered: 2007-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0523U / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0601U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Dizziness, Headache, Multiple sclerosis, Myelitis transverse, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Vestibular 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? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA
Allergies:
Diagnostic Lab Data: magnetic resonance - MS w/ transverse myelitis[[address]]Labs and Diagnostics: Thoracic/lumbar CT c/w transverse myelitis T11-L1-2. [[name]] MRI (+) for lesions c/w demyelinating process in cerebral hemispheres, corpus collosum, brain stem and cerebellum. CSF with WBC 58, RBC +, lymphs 57, monos 40 and protein 45.7. Myelin basic protein high at 9.0, no oligoclonal bands, CSF cx and gram stain (-), csf viral tests all (-)[[address]]
CDC Split Type: WAES0710USA02905

Write-up: Information has been received from a physician concerning a female who on 05-JUL-2007 was vaccinated with Gardasil (Lot # not reported). Suspect secondary therapy included Varivax (Oka/Merck). On 03-SEP-2007 the patient came back into the office with headache, bodyache, and tingling in hands. She then came back in on 10-SEP-2007 and 11-SEP-2007 with more pronounced symptoms of dizziness and ataxia. She had an MRI and was diagnosed with multiple sclerosis with transverse myelitis. On 13-SEP-2007 the patient was hospitalized, length of hospitalization was not provided. The patient''s multiple sclerosis persisted. Multiple sclerosis was considered to be disabling. Additional information has been requested. 8/14/2008 MR received for DOS 9/13-17/2007 with D/C DX: Multiple Sclerosis (most likely dx, monophasic at present). Pt presented with 1 week hx of generalized weakness and numbness in the bilateral fingers, 1 episode of urinary retention requiring catheterization and ataxia beginning 9/10/07. On exam, dysmetria, ataxia, R lower extremity weakness and nystagmus, pupillary defect (R$gL) noted. Tx with solumedrol with improvement in dysthesias and strength. F/u as outpt.


VAERS ID: 293736 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2007-10-04
Onset:2007-10-06
   Days after vaccination:2
Submitted: 2007-10-18
   Days after onset:12
Entered: 2007-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aneurysm, Haemorrhage intracranial, Headache, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown 11/9/07-records received-CT evidence of intraventricular bleed in frontal horns of lateral vetricles bilaterally with clot extending to foreman no monro bilaterally with evidence of hydrocephalus dilated lateral ventricles bilaterally. evidence of bleed in third ventricle and fourth ventricle evidence of probable subarachnoid hemorrhage in basal cisterns and sylvian cisterns bilaterally. 12/06/07-records received- PEG placement for failed swallow study. VEEG negative for seizures.
CDC Split Type: WAES0710USA02452

Write-up: Information has been received from a physician concerning a 13 year old female with no relevant medical history reported who on 04-OCT-2007 was vaccinated with the first dose Gardasil (lot 656049/0187U). On 06-OCT-2007, the patient was seen at the office complaining of severe headache and vomiting. The patient was transferred to the hospital by ambulance and was admitted. A diagnosis of cranial bleeding due to an aneurysm was made. The patient underwent surgery. At the time of reporting, the patient was recovering. The patient''s aneurysm and intracranial bleeding were considered disabling, immediately life-threatening, and other important medical events. Additional information has been requested. 11/09/07-records received for DOS 10/6/07-seen in ED of transfering facility-Acute 4 hour onset o occipital headache, constant crescendo-decresendo. Nausea vomiting, Headache exacerbated with movement of head, radiating to neck. Awake, alert, oriented X3. 12/06/07-records received from receiving facility for DOS 10/09-10/31/07-DC DX:SAH/IVH secondary to right paravermian/posterior fossa AVM. Procedure:angio cerebral artery-and suboccipital craniectomy, resection of tumor, surgical resection placement of VP shunt. Transferred to rehabilitation facility


VAERS ID: 293737 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-09-19
Onset:2007-09-19
   Days after vaccination:0
Submitted: 2007-10-18
   Days after onset:29
Entered: 2007-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain, Insomnia, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), 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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: ultrasound 10/15/07 - solid mass
CDC Split Type: WAES0710USA03109

Write-up: Information has been received from a healthcare worker concerning a 22 year old female who was vaccinated with three doses of Gardasil. The first dose on 20-MAR-2007 (lot #655503/0012U), the second dose on 30-MAY-2007 (lot #657736/0389U) and the third dose on 19-SEP-2007 (lot #658563/1063U). There was no concomitant medication. on 19-SEP-2007 the patient experienced 1.5 cm "knot" in her left deltoid at the injection site and pain at the injection site. The injection site is extremely tender to touch, with some redness and slightly blue in color. The patient is having problems sleeping because of the pain. The first and third doses were administered in her left deltoid and the second dose was administered in her right deltoid. On 15-OCT-2007 an ultrasound of the injection site area was performed which showed a solid mass. It was reported that the patient''s events were considered to be disabling. No further information is available. Additional information has been requested.


VAERS ID: 294227 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-09-13
Onset:2007-09-13
   Days after vaccination:0
Submitted: 2007-10-23
   Days after onset:40
Entered: 2007-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass, Injection site pain
SMQs:, 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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA03234

Write-up: Information has been received from a medical assistant concerning a 22 year old female with no pertinent medical history who on 22-FEB-2007 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot # 654702/0011U), on 26-APR-2007 with the second dose of Gardasil in the left deltoid (lot # 657622/0388U) and on 13-SEP-2007 with the third dose of Gardasil in the left deltoid (lot # 658563/1063U). There was no concomitant medication. On 13-SEP-2007 the patient developed pain and a large lump in her left deltoid at the injection site. The patient was seen in her physician''s office on 05-OCT-2007 and was instructed to take cephalexin (KEFLEX) and diphenhydramine hydrochloride (BENADRYL) and apply warm compresses. At the time of this report, the outcome of the events was unknown. The reporter felt that the events were disabling. Additional information has been requested.


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