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Found 6884 cases where Vaccine is HPV4 and Serious

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VAERS ID: 291286 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-07-11
Onset:2007-07-11
   Days after vaccination:0
Submitted: 2007-09-24
   Days after onset:75
Entered: 2007-09-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Migraine, Nuclear magnetic resonance imaging, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: Seasonal allergy 9/5/08-record received-8/07-continues to C/O bilateral hip pain for over a year intermittent in nature with clicking and popping.
Preexisting Conditions: Concussion 9/5/08-records received-PMH:head injury 1/07.
Allergies:
Diagnostic Lab Data: magnetic resonance 09/04?/07 - not reported, diagnostic laboratory 09/04?/07 - not reported 9/5/08-records received-Normal GI series.
CDC Split Type: WAES0709USA02505

Write-up: Information has been received from a consumer concerning her 14 year old daughter with seasonal allergies and a history of concussion (January 2007) who on 11-JUL-2007 was vaccinated with the first 0.5 mL dose of Gardasil. There was no concomitant medication. On approximately 11-JUL-2007, "soon after beginning therapy," the patient experienced migraines and developed a low grade fever. On 28-AUG-2007 and 01-SEP-2007, the patient went to an emergency room. On 12-SEP-2007, the patient was vaccinated with the second 0.5 mL dose of Gardasil. The patient continued to experience migraines and a low grade fever. On 04-SEP-2007, the patient was hospitalized. On an unspecified date, magnetic resonance imaging (MRI) and unspecified blood work were performed on the patient. It was reported that the patient was hospitalized for a total of five days. At the time of this report, the patient''s migraines and low grade fever persisted. Additional information has been requested. 9/05/08-records received-routine office visit 7/11/07-C/O irregular periods, premenstrual symptoms and menstrual discomforts. Right and left hip pain.Moody. 8/8/07-C/O migraine headaches for 1-2 weeks. 8/07-continues to C/O bilateral hip pain for over a year intermittent in nature with clicking and popping. PE normal. 11/02/07-allergic rhinitis, headaches, asthma. 1/3/08-C/O abdominal pain. Headaches improved. 2/20/08-ovarian cyst, prescribed birth control pills. 4/5/08-C/O back pain.


VAERS ID: 291301 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-09-11
Onset:2007-09-11
   Days after vaccination:0
Submitted: 2007-09-13
   Days after onset:2
Entered: 2007-09-25
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 3 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain, Chest X-ray, Chest X-ray normal, Computerised tomogram abnormal, Dehydration, Dizziness, Full blood count, Urinary system X-ray, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rx prescribed by pts. GYN to moderate periods.
Current Illness: None
Preexisting Conditions: Idiopathic lower extremity edema
Allergies:
Diagnostic Lab Data: Abd/pelvic CT - small amt fluid in cul-de-sac - o/w negative; - KUB; - CXR; CBC; WBC 21,600 with 87 polys/4 bands 10/4/07-diagnostic reports received for DOS 9/11-9/12/07-WBC 21.6, Poly 87, Glucose 170, Bilirubin total 1.45, urine ketones 40, mono positive, Blood culture no growth. EBV CAPSID IgM positive.CT abdomen and pelvis trace amount fluid in cul-de-sac, left ovary slightly larger than right. Consistent with mittelschmerz. Leukocytosis 21,600. Amylase 50 and lipase 15. Mono test positive.
CDC Split Type:

Write-up: Pt developed abd. pain, vomiting within 1 hr of vaccine administration. Also was lightheaded (dizzy) - evaluated in ER and admitted for IV hydration (dehydrated) 11/6/07-records received for DOS 9/11-9/12/07-DC DX: Vomiting resolved. Dehydration resolved. Admitted with complaint of vomiting and abdominal pain which began yesterday suddenly.


VAERS ID: 291485 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Colorado  
Vaccinated:2007-05-14
Onset:2007-05-25
   Days after vaccination:11
Submitted: 2007-09-26
   Days after onset:124
Entered: 2007-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 3 GM / UN

Administered by: Other       Purchased by: Other
Symptoms:
SMQs:

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? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: recurrent sinusitis (allergic) & tonsillar lymphadenopathy, lymphadenitis, 11/2006. Recurrent ear infections. PE tubes x 2. Allergy: PCN.
Allergies:
Diagnostic Lab Data: Unknown LABS: CT revealed chronic extensive multifocala sinusitis. Repeat CT of neck & chest revealed diffuse lymphadenopathy including spleen. Sed rate 31 (H). RA 95 (H). Monospot (+). CMV (-). EBV (H). Needle aspiration of lymph nodes revealed reactive disease. Blood c/s neg.
CDC Split Type: WAES0709USA03419

Write-up: Information has been received from a nurse concerning a 16 year old female patient who was vaccinated with a first dose of Gardasil, and subsequently developed flu-like symptoms. The patient also developed flu-like symptoms after getting the second dose of Gardasil. After getting the third dose of Gardasil, the patient developed kidney failure and underwent respiratory arrest resulting in hospitalization. At the time of the report the patient had not recovered. Additional information has been requested. 10/8/07 Patient demographics provided by CDC. 10/19/07 Reviewed hospital medical records which reveal patient experienced neck swelling, difficulty swallowing, cough, bloody sputum, facial pressure/pain, fatigue. Admitted 5/25-5/31/2007. ID & ENT consults done. Tx w/IV antibiotics & developed red man syndrome, antibiotics changed. Improved & d/c to home on continued IV antibiotics via PICC line. To f/u w/ENT & ID, & have repeat CT scan done. Records do not have evidence of respiratory arrest or renal failure reported by manufacturer. FINAL DX: Sinusitis, lymphadenitis, parotitis & Epstein-Barr virus. 11/16/07 Reviewed vax records from provider. VAERS database updated w/same.


VAERS ID: 291585 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-09-11
Onset:2007-09-13
   Days after vaccination:2
Submitted: 2007-09-21
   Days after onset:8
Entered: 2007-09-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2226AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2492BA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0851U / 2 RA / SC

Administered by: Private       Purchased by: Public
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: took Motrin night before
Current Illness: None
Preexisting Conditions: History of hematuria records received 10/15/07-PMH: born 32 weeks premature. Microscopic hematuria secondary from hypercalcemia. Poison ivy dermatitis. Cyst removed
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Child received Tdap, Varicella, Menactra and HPV #1 on 09/11/07. On 09/13/07 she woke up with angioedema of face. There was no difficulty breathing or swallowing. There was no seafood or nut ingestion. She took Motrin the night before and was hospitalized. Received IV steroids and discharged home the next day. 10/15/07-records received for DOS 9/13-9/14/07. DC DX: Angioedema. On day of admission noticed face swollen, with significant swelling of lips and lower face causing disfiguration and drooling. Self treated with Motrin. DC instructions include avoid Motrin and follow up with allergist


VAERS ID: 291804 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-07-13
Onset:2007-09-01
   Days after vaccination:50
Submitted: 2007-10-01
   Days after onset:30
Entered: 2007-10-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: IDDM, uncontrolled. Smoker. anemia.
Preexisting Conditions: Unknown PMH: IDDM, uncontrolled. Smoker. Right buttock abscess 8/31/07. Anemia. Father w/diabetes. ALLERGIES: PCN, cipro, ultram (hives).
Allergies:
Diagnostic Lab Data: Unknown Vitreous glucose 667 (H).
CDC Split Type: WAES0709USA04400

Write-up: Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of Gardasil (yeast, unknown lot number) and in July 2007, was vaccinated with the second dose of Gardasil. In September 2007, the patient died. No further details or symptoms were known regarding the patient''s death. The physician mentioned that an autopsy would be done however, had not received the results yet. The reporting physician felt that the patient''s death was not related to therapy with Gardasil. Additional information has been requested. 10/11/2007 Patient demographics provided by CDC. 10/15/07 Received vax record from pcp. VAERS database updated w/same. 10/15/07 Received pcp & hospital medical records from CDC which reveal patient experienced vomiting with elevated blood sugars who became unresponsive & pulseless. CPR started & taken to ER on 9/19/07. Resuscitation was unsuccessful & patient pronounced 9/19/07. 10/26/07 Reviewed autopsy report which reveals COD as diabetic ketoacidosis & manner of death as natural. Patient had been found by parent unresponsive at home. History of severe diabetes mellitus. Vitreous glucose 667 (H).


VAERS ID: 291932 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-06-06
Onset:2007-06-06
   Days after vaccination:0
Submitted: 2007-10-02
   Days after onset:118
Entered: 2007-10-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Skin irritation, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: therapy unspecified; CREATINE POWDER; PRILOSEC
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04315

Write-up: Information has been received from a nurse practitioner concerning a 25 year old female with no medical history and no drug allergies, who on 06-JUN-2007 was vaccinated with a first dose of Gardasil (Lot# 658094/0524U). Subsequently, the patient developed local irritation. Concomitant therapy included "creatine" (CREATINE POWDER), "glutamine", "omnijust", and omeprazole (PRILOSEC). On 07-AUG-2007 the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil. On 07-AUG-2007 eight and a half hours after receiving the vaccination the patient developed hives and experienced difficulty breathing. The reaction occurred while she was running outdoors. The patient went to the emergency room and was released after being treated intravenously with diphenhydramine hydrochloride (BENADRYL). The patient recovered on an unspecified date. No product quality complaint was involved. The patient''s difficulty breathing was considered to be life threatening. Additional information has been requested.


VAERS ID: 292001 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-09-24
Onset:2007-09-26
   Days after vaccination:2
Submitted: 2007-10-03
   Days after onset:7
Entered: 2007-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Blood glucose normal, CSF culture negative, Dysaesthesia, Grip strength decreased, Lumbar puncture normal, Myelitis, Myelitis transverse, Protein total normal, Radiculitis, Somatosensory evoked potentials, Visual evoked potentials normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Demyelination (narrow)

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? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Claritin OTC PRN for allergy symptoms
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI spine revealed myelitis of the lower cervical and upper thoracic spinal cord and radiculitis of the cauda equina. Lumbar puncture CSF sample shows no WBC, normal protein and glucose, no evidence of viral or bacterial infection. Somatosensory evoked potential and visual evoked potential tests revealed no abnormalities. records received 11/13/07- ESR 8, CRP less than 0.3. MRI brain and spinal cord showed myelitis involving anterior aspect of lower cervical and upper thoracic spinal column from C6 to T1 and radiculitis of cauda equina. CSF glucose 43, protein 40, 0 WBC and 10 RBC. CSF culture negative and normal IgG index. Infectious disease titers were normal. Sensory evoked potentials normal. . Neurogenic bladder. Swallowing study mild dysphagia. Urine culture trace leukocyte esterase and 7 RBC with 1+ bacteria, E. coli .
CDC Split Type:

Write-up: 2 days after 2nd dose of Gardasil, patient developed dysesthesia in arm and decrease in grip strength, leg weakness, and difficulty voiding urine. Progressed to inability to ambulate within 5 hours. Patient admitted to Medical Center. MRI revealed inflammation around spinal cord consistent with transverse myelitis vs. Guillain Barre syndrome. Clinical physical exam supported diagnosis of Transverse Myelitis. Patient treated with IV Methylprednisolone 250mg q6hr x 5 days and subsequent oral steroid taper. Over course of hospitalization, currently 7 days in duration and continuing, patient has regained some upper extremity strength and improvement in sensory symptoms. Minimal lower extremity strength recovery at this point. Throughout course of hospitalization, patient has required bladder catheterization due to inability to void urine.11/13/07-records received for DOS 9/26-10/17/07-DC DX: Transverse myelitis. Urinary tract infection (UTI). Presented to ED with 24 hour history of progressive weakness and numbness. Unable to walk. Received Gardasil 2 dys prior to symptoms and tick bite 2 weeks prior to admission. She was also on a camping trip 5 days prior to admission. PE: weak grip strength, wrist flexors and extensors normal. Right leg proximal flexor strength 2/6 and left leg strength 0/5. Distal right leg strength 0/5. Subjective numbness at T4 and below. Reflexes 1+ bilaterally in upper and lower extremities. No dysarthria. High dose steroid treatment. PlasmapheresisTransferred to rehab facility


VAERS ID: 293701 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: New York  
Vaccinated:2007-05-09
Onset:2007-05-20
   Days after vaccination:11
Submitted: 2007-09-17
   Days after onset:120
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: CSF oligoclonal band present, Guillain-Barre syndrome, Intervertebral disc degeneration, Nuclear magnetic resonance imaging abnormal, Sinusitis, Urinary tract infection
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

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? Yes, 55 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Homosexuality; Sexually active
Preexisting Conditions: Unknown PMH: remote grand mal seizure several years ago w/no etiology. PE 1990''s. Asthma. GERD. Gay w/steady partner. Allergic: sulfa. Substance abuse
Allergies:
Diagnostic Lab Data: Unknown LABS: CSF: protein 62 (H), glucose 52 (N), oligclonal bands neg, c/s neg. MRI of brain WNL except for sinus inflammation. MRI of c-spine & l-spine revealed degenerative changes. CXR WNL. Abdominal x-ray abnormal. EMG/NCS report included but no interpretation available.
CDC Split Type: WAES0708USA04356

Write-up: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of Gardasil. Subsequently, after vaccination, the patient developed Guillain-Barre syndrome and was hospitalized. It was reported that the patient "recently had plastic surgery and is now in rehab." The patient''s outcome was unknown. Additional information has been requested. 4/1/08 Received only partial medical records of 5/23-6/04/2007. FINAL DX: Guillain Barre syndrome. No d/c summary available. Records indicate patient experienced 2-3 days of neck & back pain & tingling in his legs followed by weakness which became profound until patient fell & was unable to move either leg, also had weakness of both arms along w/facial numbness. Had HA, cough, runny nose & sore throat & recent dx of URI tx w/antibiotics. Had nausea x 1 wk & difficulty voiding & swallowing. Had brief episode of diarrhea 1 week prior. Was on business trip from out of state. Admitted to ICU. Neuro & pulmonary consults done. Exam revealed hyporeflexia. Tx w/plasmapheresis. Developed N/V. Feeding tube placed. Transferred to inpatient rehab w/foley cath. 5/6/08 Received hospital medical records of 6/4-7/11/2007. FINAL DX: Guillain-Barre syndrome; neuropathic pain; debility; asthma; dysphonia. Also developed URI; UTI; hypersensitivity vasculitis, all resolved. Records reveal patient experienced improvement during this rehab hospitlization. Improved to be able to ambulate w/walker. Continued to awaken at night w/leg spasms & have erectile dysfunction. Transferred to another rehab hospital. This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up Information has been received from two physicians concerning a 56 year old sexually active male homosexual (previously reported as female) with a "questionable" history of illicit substance abuse. At the time of this report, the patient was recovering. Additional information has been requested.


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: 293712 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2007-08-22
Onset:2007-08-22
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:26
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 1 LA / IJ

Administered by: Private       Purchased by: Other
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pruritus, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Unknown
CDC Split Type: WAES0708USA04571

Write-up: Information has been received from a physician concerning a 19 year old female who on 22-AUG-2007 was vaccinated by injection with the first 0.5 mL dose of Gardasil. On 22-AUG-2007, after the patient received her first dose of Gardasil experienced "anaphylactic reactions including swelling of the throat." The patient sought unspecified medical attention. Subsequently, the patient recovered from anaphylactic reactions and swelling of the throat. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. In follow-up it was reported by the physician concerning a 19 year old female with no illness at the time of vaccination and no pre-existing allergies, birth defects, or medical conditions whose reported weight was 130 pounds and whose reported height was 66 inches who on 22-AUG-2007at 3:00 p.m., was vaccinated by injection into the left arm with the first 0.5 mL dose of GARDASIL, (lot # 686094/05240). It was reported that 15 minutes after the vaccine was administered the patient had throat swelling, itching, vomiting x 1. The patient was treated for "anaphylaxis" with SOLU-MEDROL, BENADRYL and prednisone. There was no decrease in blood pressure (BP) and no changes in respiratory status. The patient recovered on 22-AUG-2007. The reporter determined the patient''s anaphylactic reaction to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. in addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.


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