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Found 1645 cases where Vaccine is HPV4 and Disabled

Case Details (Sorted by Age)

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VAERS ID: 503489 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-12-07
Onset:2010-01-01
   Days after vaccination:25
Submitted: 2013-09-23
   Days after onset:1360
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Fatigue, Hypoaesthesia, Lumbar puncture abnormal, Myelitis, Nuclear magnetic resonance imaging abnormal, Restlessness, Sensory disturbance, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation; GARDASIL, Immunisation
Diagnostic Lab Data: Lumbar puncture, not provided; Nuclear magnetic resonance imaging, myelitis
CDC Split Type: WAES1309DNK007724

Write-up: Case received from a health care professional via the Health Authorities on 12-Sep-2013 the references DK-DKMA-ADR 2223706 and DK-DKMA-EFO6812. Case is medically confirmed. A 16-year-old female patient (weight 80 kg, height 172 cm) had received a complete vaccination series with three doses of GARDASIL IM on 26-Nov-2008 (D1, lot-no. not reported), on 15-Feb-2009 (D2, lot.no. not reported) and on 07-Dec-2009 (D3, lot-no. not reported). On an unspecified date in Dec-2009, the patient developed expressed tiredness, concentration difficulty, problems with sensation in the legs and numbness from the navel down starting in the left leg and unrest. On 23-Dec-2009, the patient was hospitalised due to fainting and effects on vision. The cause of the events was not found. In January 2010, the patient was referred to a neurologist. MRI and lumbar puncture were performed. MRI revealed myelitis. At the time of reporting, the patient had not recovered from myelitis. The patient had recovered from fainting and effects on vision in an unspecified timeframe. The outcome of all other events was unknown.


VAERS ID: 515286 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-07-01
Onset:2013-04-25
   Days after vaccination:298
Submitted: 2013-12-02
   Days after onset:221
Entered: 2013-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Blood test normal, Computerised tomogram head normal, Decreased appetite, Depression, Dizziness, Dyspnoea, Endoscopy upper gastrointestinal tract normal, Fatigue, Headache, Hypoaesthesia, Malaise, Nausea, Palpitations, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: (Unknown date) Blood test, head computer tomography (CT) and gastroscopy: No abnormality; Endoscopy upper gastrointestinal tract, No abnormality
CDC Split Type: WAES1311JPN011543

Write-up: Initial information has been received from a physician via PMDA concerning a 16 year old female patient. Notes on the medical history interview were unknown, since the patient had received the vaccination at another hospital. She had no relevant family history. On 22-APR-2013, the patient received the third vaccination with GARDASIL (MSD) IM (intramuscular) injection (Lot No.: 9QN04R) (Expire date not reported) for prophylaxis against uterine cervical cancer (dose not reported). Information on other concomitant medications was not reported. On an unspecified date, the patient received the first vaccination GARDASIL (IM). On an unknown date, the patient received the second vaccination of GARDASIL (IM). On 22-APR-2013, as stated above, the patient received the third vaccination of GARDASIL (IM). On 25-APR-2013, at 8:00 am, the patient developed dressed state or autonomic nervous system inbalance. Headache, slight fever, palpitations, shortness of breath, dizziness and general malaise were also observed as well as queasy and inappetence. When the patient went to school, she got tired and had to stay in bed for a while. In addition, transient numbness in hands and feet was observed. On an unspecified date, a blood test, head computer tomography (CT) and gastroscopy showed no abnormality. On 02-NOV-2013, the patient was recovering from depressed state, autonomic nervous system imbalance and numbness in hands and feet. Reporter''s comment: The symptoms were considered to be adverse reactions to GARDASIL. The reporting physician considered depressed state, autonomic nervous system imbalance and numbness in hands and feet as serious due to disability. The reporting physician felt that depressed state, autonomic nervous system imbalance and numbness in hands and feet were related to GARDASIL, and there were no other causes of depressed state and autonomic nervous system imbalance. Information has been received for a direct report from the PMDA regarding a case provided by the physician. Additional information has been requested.


VAERS ID: 518673 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-01
Onset:0000-00-00
Submitted: 2014-01-08
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-SS-A antibody positive, Anti-SS-B antibody positive, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Arthralgia, Asthenia, Blood count normal, Blood test abnormal, DNA antibody negative, Joint effusion, Polyarthritis, Rheumatoid factor positive, Synovitis, Systemic lupus erythematosus, Ultrasound joint, Ultrasound scan abnormal
SMQs:, Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Parotitis; 07/2013, GARDASIL, Drug Reaction: Parotitis
Diagnostic Lab Data: Anti-cyclic citrullinated peptide antibody, Negative; Antinuclear antibody, $g1280 not provided; Autoantibody test, SSA, SSB positive; Blood count, Normal; 12/17/2013, Blood pressure, 11/8 not provided; Blood test, Moderate inflammatory syndrome; DNA antibody, Negative; Rheumatoid factor, Positive; Ultrasound scan, Joint effusion
CDC Split Type: WAES1401FRA002192

Write-up: Information received from Sanofi Pasteur MSD (SPM) (E2013-11458) on 30-DEC-2013. Case received from a health care professional via MSD company in a foreign country on 30-Dec-2013: A 16-year-old female patient had received the first dose of GARDASIL (batch number not reported) in Jul-2013 and the second dose of GARDASIL in Sep-2013. On 17-Dec-2013, she was seen by a physician because she had developed inflammatory polyarthralgia of hands, wrists, feet, shoulders and knees which had started two months before the consultation. It was associated with night arousals and functional disability for some gestures. There was no peripheral vascular disease and no photosensitization. She also experienced slight asthenia. Physical examination on the same day showed blood pressure at 11/8, heart and pulmonary auscultation unremarkable. Joint examination showed a synovitis aspect in metacarpophalangeal joints (MCP) of both hands, probable synovitis in wrists and patellar shock. Cutaneous mucosal examination was normal. Weight was stable. Biological examination showed blood count normal and moderate inflammatory syndrome. The clinical picture was suggestive of an inflammatory polyarthritis of probable autoimmune origin (lupus?). According to the reporter, the causal relationship with GARDASIL could not be ruled out. Treatment with PLAQUENIL bid was initiated due to the pain. The patient was seen again on 26-Dec-2013. A joint echography had been performed. The result confirmed joint effusion of metacarpophalangeal joint thumb, left and right interphalangeal proximal joint and moderate bilateral knee effusion. Autoimmune work-up showed antinuclear antibodies $g1280 with positive autoantibody test for SSA and SSB, anti-DNA antibodies negative, anti-cyclic citrullinated peptide antibodies negative and rheumatoid factor positive. Inflammatory polyarthritis of probable autoimmune origin was diagnosed, with probable early stage of lupus. As the patient experienced pain, corticotherapy was introduced and progressively tapered down during one month: prednisone 30 mg per day then 20 then 10 mg day. Treatment with PLAQUENIL bid was carried on. Dietary precautions were reminded. Search for proteinuria and anticoagulant would be checked up at the next work-up. To be noted that the patient had a medical history of 3 flares-up of parotitis. She had no surgical history. Her mother and grandmother had a medical history of cervical cancer. At the time of reporting, the patient had not recovered.


VAERS ID: 532282 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-29
Entered: 2014-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gait disturbance, Wheelchair user
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1405FRA014400

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # FR-1577272925-E2014-04663) on 27-MAY-2014. Case received from a consumer on 24-May-2014: A 16-year-old female patient (relative of the reporter) experienced walking difficulties on an unspecified onset of time after receiving a dose of GARDASIL (batch number not reported) on an unspecified date. She was using a wheelchair. At the time of reporting, she had not recovered.


VAERS ID: 534189 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-08
Onset:0000-00-00
Submitted: 2014-06-18
Entered: 2014-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Arthralgia, Chest pain, Dyspnoea, Fatigue, Mood altered, Premature menopause, Syncope, Vulvovaginal dryness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1406BEL008420

Write-up: Information has been received from a physician via SPMSD (Sender case report number BE-1577272925-E2014-05249) on 16-JUN-2014. Case received from a healthcare professional (physician) on 12-Jun-2014. Initial information was reported to him by 2 other healthcare professionals of a hospital (Gynecologist assistant). Medically confirmed. As per internal review, the case was considered serious (criterion: disability, considering the ovarian failure). A female patient was diagnosed with premature ovarian failure when she was 22 years old. She had received the GARDASIL (batch numbers not reported) in 2007 and in 2008. Since vaccination, she also had complaints such as fainting, pain in joints, important fatigue, shortness of breath, pain in chest and change in mood. Further investigations had been performed but results were not yet available at the time of reporting. There was no information on the medical history of the patient. The outcome was not reported. Follow-up request was done by phone on 12-Jun-2014 to the physician, but at the time of reporting, no further information was available. Additional information was received for the reporting healthcare professional on 13-Jun-2014: Initials and birthdate (26-Nov-1991) of the patient were reported. She was administered the first dose of GARDASIL on 17-Oct-2007. Dose 2 was administered on 21-Jan-2008 and dose 3 was administered on 08-Aug-2008. Batch numbers were unknown. Medical history: nothing relevant, hormonal contraceptives for brief period, normal menstrual cycle. No familial antecedents for premature menopause. In 2013, the patient experienced symptoms of vaginal dryness, fainting, fatigue, chest pain, pain in joints, shortness of breath and change in mood, fluctuating in intensity. Patient had amenorrhea. According to the reporting healthcare professionals, there was no link with the vaccination. Patient will be seen again in the near future at the consultation to discuss the results of the ongoing investigations.


VAERS ID: 619686 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-30
Onset:0000-00-00
Submitted: 2015-12-18
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Constipation, Loss of personal independence in daily activities, Migraine, Neck pain, Pain, Pain in extremity, Sensory disturbance, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1512DNK008888

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-2015000994) on 16-DEC-2015. Case received from a lawyer at patient insurance via health authority on 14-DEC-2015 under reference number DK-DKMA-ADR 23271844 and 15-10316. The patient insurance has not taken a decision yet. A 20-year-old female patient adult patient received GARDASIL (batch number unknown, Dose 1) on 13-NOV-2008, GARDASIL (batch number unknown, Dose 2) on an unknown date, GARDASIL (batch number unknown, Dose 3) on 30-APR-2009. The patient experienced vision disturbance in 2014, pain in back in 2014, pain in neck in 2014, pain in arms and legs in 2014, sensory disturbance in 2014, constant migraine in 2014, constipation in 2014, Cannot stay up longer periods of time, cannot go for a walk, cannot do sports in 2014 and constant pain in whole body in 2014. The case was assessed as serious due to disability. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 619832 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-22
Entered: 2015-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acne, Arthralgia, Cognitive disorder, Dizziness, Fatigue, Headache, Menstruation irregular, Muscular weakness, Orthostatic intolerance, Palpitations, Pollakiuria, Syncope, Tilt table test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions:
Diagnostic Lab Data: Have examinations and/or laboratory tests been performed: During tilt table test at the reporter''s department orthostatic intolerance is seen - but the patient does not fulfill the diagnostic criteria for POTS.
CDC Split Type: WAES1512DNK009841

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-2015001033) on 17-DEC-2015. Case received from a physician via HA on 15-Dec-2015 under the reference number DK-DKMA-ADR 23275663 and DK-DKMA-WBS-0002036. A 16-year-old female adolescent patient received GARDASIL, (batch/lot number, expiration date unknown) via intramuscular route on an unknown date. The patient experienced Knee pain in FEB-2012, Syncope in MAR-2013, Headache on an unknown date, Dizziness on an unknown date, Palpitation on an unknown date, Urinary frequency aggravated on an unknown date, Acne vulgaris on an unknown date, Tiredness on an unknown date, cognitive dysfunction mild on an unknown date, weakness upper limb on an unknown date and Irregular periods on an unknown date. The reporter does not know the patient''s vaccination dates - therefore it is not possible to relate whether there is a temporal relationship between the vaccine and symptom debut. The patient describes that the first symptom was knee pain, which started in Feb-2012, which became worse and worse. Subsequently, the other reported adverse reactions developed. During tilt table test at the reporter''s department orthostatic intolerance is seen - but the patient does not fulfill the diagnostic criteria for POTS. At the examination the patient informs that she faints a couple times per month. The patient was on sick leave 2 months after symptom debut. The case was assessed as serious due to disability. At the time of reporting, the patient was recovering/resolving from knee pain. The patient had not recovered from the other reactions.


VAERS ID: 619865 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-22
Entered: 2015-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acne, Arthralgia, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dyskinesia, Dyspnoea, Dysuria, Fatigue, Headache, Hypoaesthesia, Infection, Insomnia, Loss of personal independence in daily activities, Muscular weakness, Nausea, Orthostatic intolerance, Palpitations, Sensory disturbance, Syncope, Tilt table test normal, Vaccination site swelling
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test at Syncope center, normal examination is seen.
CDC Split Type: WAES1512DNK010823

Write-up: Information has been received from SPMSD (MFR control no. DK-1577272925-2015001279) on 21-DEC-2015. Case received from a physician via HA on 18-Dec-2015 under the reference number DK-DKMA-WBS-0002098 and DK-DKMA-ADR 23278869. A 16-year-old female adolescent patient received GARDASIL, batch/lot number unknown, Dose 1 via intramuscular route in 2009, GARDASIL, batch/lot number unknown, Dose 2 via intramuscular route in 2010, GARDASIL, batch/lot number unknown, Dose 3 via intramuscular route in 2010. The patient experienced Headache in DEC-2009, Dizziness on an unknown date, Joint pain on an unknown date, Orthostatic intolerance on an unknown date, Palpitations on an unknown date, Nausea in 2012, Abdominal pain in 2011, Numbness arms and legs on an unknown date, Constipation on an unknown date, Diarrhea on an unknown date, Voiding dysfunction on an unknown date, Acne on an unknown date, Dyspnoea on an unknown date, Insomnia on an unknown date, Fatigue, extreme tiredness on an unknown date, Cognitive impairment in 2012, Involuntary muscle movement in 2013, Infections recurrent on an unknown date, swelling at all vaccinations in 2009, Throat infections in 2009, urinary tract infections in 2009, Syncope recurrent on an unknown date, Weakness of limbs on an unknown date, Sensory disturbance on an unknown date and Fired due to sickness absence on an unknown date. The patient developed swelling at all vaccination, headache and experienced subsequently both throat and urinary tract infections. Subsequently, the other reported symptoms developed. The patient has many syncopes. At tilt table test, at syncope center, a normal examination is seen. The patient describes extreme tiredness, weakness of limbs, sensory disturbance to a degree that it is difficult to manage her education as hairdresser, fired due high sickness absence. The hair dresser school prolonged the education, now graduated but has changed work due to that she cannot use her arms. Now she works part time with helping disabled people. The patient was admitted to hospital on an unspecified date. At the time of reporting, the outcome was unknown for the reactions swelling at all vaccinations, throat infections, syncope recurrent, weakness of limbs and sensory disturbance. The patient had not recovered from the other reactions.


VAERS ID: 620137 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-15
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cognitive disorder, Depression, Diarrhoea, Muscular weakness, Nausea, Neuralgia, Palpitations, Photophobia, Psychomotor hyperactivity, Tilt table test positive, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test at the syncope centre (unknown date) : showed accentuated heart rate response to orthostatic stress connected with well-known orthostatic discomfort - but the patient does not meet the diagnostic criteria for POTS. Heart rate unknown date) : increased greater than or equal to 30 bmp from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg).
CDC Split Type: WAES1512DNK010882

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number # 2015001190) as part of business agreement on 21-DEC-2015. Case received from a physician on 17-Dec-2015. A 14-year-old female adolescent patient received GARDASIL (batch number unknown) via intramuscular route on 08-Oct-2008. The reported patient''s birth date (05-MAR-1993) was inconsistent with the reported patient''s age. Other suspect products included: GARDASIL (batch number unknown, Dose 2) administered via intramuscular route on 15-Apr-2009. The patient experienced Fatigue in 2008, headache in 2008, Syncope on an unknown date, near syncope in 2008, Dizziness in 2008, Palpitations on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Cognitive function abnormal on an unknown date, Muscular hyper excitability on an unknown date, Limb weakness on an unknown date, Orthostatic intolerance in 2008, Diarrhea on an unknown date, Hypersensitivity to bright light on an unknown date, Blurred vision on an unknown date, Neuropathic pain on an unknown date and Depression on an unknown date. Other vaccines or medicines: unknown. Patient finds it difficult to relate to the precise temporal relation between the vaccine and the onset of symptoms, but the patient was vaccinated in 2008 and soon after had symptoms. The first symptom was increased fatigue. Subsequently, other reported symptoms developed. Tilt table test at the syncope centre shows accentuated heart rate response to orthostatic stress connected with well-known orthostatic discomfort - but the patient does not meet the diagnostic criteria for POTS. The syncope center uses the following criteria to diagnose POTS: Heart rate increases greater than or equal to 30 bmp from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). Symptoms worsen with standing and improved with recumbence. Symptoms last great than or equal to 6 months. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition, further criterion is applied in patients between 12-19 years: requires a heart rate increase of greater than 40 bpm to make the diagnosis, the reasons for this is that young people have a stronger physiological heart rate response when standing up. The additional criterion is used to avoid false positives.


VAERS ID: 619733 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-03-18
Onset:0000-00-00
Submitted: 2015-12-24
Entered: 2015-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Arthralgia, Back pain, Blood test normal, Constipation, Disturbance in attention, Dizziness, Dyskinesia, Dysuria, Fatigue, Food intolerance, Gait disturbance, Headache, Hyperacusis, Insomnia, Joint lock, Joint range of motion decreased, Joint stiffness, Loss of personal independence in daily activities, Muscle disorder, Muscular weakness, Musculoskeletal stiffness, Neuralgia, Pain in extremity, Peripheral coldness, Postural orthostatic tachycardia syndrome, Psychomotor hyperactivity, Tilt table test positive, Vascular malformation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: The patient has undergone blood tests to see if she has vitamin deficiency, arthritis, liver or anything else, however, all the blood tests showed normal (date unspecified). Tilt table test, POTS, more information is available with the sender about this lab test.
CDC Split Type: WAES1505DNK011177

Write-up: Information was received from Sanofi Pasteur MSD (DK-1577272925-E2015-04762) on 23-DEC-2015. Case received from consumer via Health Authorities on 29-Apr-2015 under the reference number DK-DKMA-ADR 22964176 and DK-DKMA-EFO11770. The primary reporter was a consumer. A 17 year old female patient in generally good health, had received dose 1 and 2 of GARDASIL (batch number not reported) via unspecified route of administration in unspecified site of administration on 22-Aug-2008 and 18-Mar-2009 and later on 15-Oct-2009 she developed sore joints in back, knees, fingers, wrist, ankles, neck and shoulders, weak joints in back, knees, fingers, wrist, ankles, neck and shoulders, on a not reported date back locks it stiffens completely, lasting headache (last up to 7 days), joints ability aggravated severely and stiffens completely in cold, cold hands and feet even though the rest of the body is warm, pain in back, severe pain in knee, severe pain in wrist, severe pain in ankles and severe pain in fingers. The patient has weak and sore joints in the back, knee, finger, wrists, ankles, neck and shoulders, that occur both unprovoked and during ordinary movements such as walking up stairs, cycling, and during regular walks. Generally, it has been an increased weakness in the joints, which have made it more difficulty to move throughout the years. The patient has difficulties walking up stairs, cannot cycle or go for a walk without problems, or clean the house at home without severe pain in back, knee, ankles, wrist, fingers etc. It started with the patient''s knee were sore at runs and jumps, when she was 17 years old, which resulted in that she did not participate in P.E. Previously, she has been very active and has eaten normally throughout the years. The patient''s joint function deteriorate particularly by cold. Then they stiffen up completely. The joints become affected in a similar fashion when sitting still too much. It does not help to either move or keep still (after a film at the movies, she has difficult to get out of the chair, as the back and knee lock). The patient often has cold hands and feet, despite the rest of the body being warm. Occasionally, the patient has headaches that last several days (up to 7 days). The symptoms concerning the patient''s joints have only become worse. When she was 17 years old, she trained actively in a fitness center and today it has become a challenge in general just to walk up the stairs to the center due to decreased function in virtually all the joints of the body. The patient has not taken hazardous material, does not smoke and has not been to high risk countries with diseases and has otherwise not been severely ill or exposed to a severe accident. The patient has been to three different physiotherapists as well as three rheumatologists and has consulted two GPs. No physician or physiotherapist has been able to explain the patient''s weak joints in regards to the patient''s relatively young age (22 years old today, the patient was 17 years old when it started). It has only been concluded that the problem started directly after that the patient received the HPV vaccines against cervix cancer (GARDASIL). The patient has not been hospitalized due to the adverse reactions. No other medicines. The patient has undergone blood tests to see if she has vitamin deficiency, arthritis, liver or anything else, however, all the blood tests showed normal. At the time of reporting, the outcome was unknown for severe pain in ankles, severe pain in fingers, severe pain in knee, whereas the outcome for all other reactions was not recovered. Follow up received by HA on 15-DEC-2015. The HA received a spontaneous follow up on 15Dec2015 from the Syncope Center at the hospital, report (DK-DKMA-WBS-0002037 / DK-DKMA-ADR 23275664) has been found to be a follow up to this case, not previously sent to MAH, but is now merged to this case. Adverse reactions: Abdominal pain, dizziness, fatigue, headache, involuntary muscle m


VAERS ID: 620280 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-23
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Arthralgia, Blood pressure decreased, Cognitive disorder, Concussion, Condition aggravated, Disturbance in attention, Dizziness, Dry eye, Dysmenorrhoea, Dyspnoea, Dysuria, Fatigue, Headache, Loss of personal independence in daily activities, Myalgia, Nausea, Neuralgia, Orthostatic intolerance, Palpitations, Presyncope, Skin disorder, Sleep disorder, Social avoidant behaviour, Tilt table test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Concussion; 2013, Headache, aggravation in headache following concussion
Diagnostic Lab Data: Tilt table test: during tilt table test at the syncope center hospital, it''s seen that the patient has a tendency for falling blood pressure but does not fulfill the diagnostic criteria for POTS
CDC Split Type: WAES1512DNK012393

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [MFR # DK-1577272925-2015001424] on 23-DEC-2015. Case received from a physician via health authority on 22-DEC-2015 under reference number DK-DKMA-WBS-0002160 and DK-DKMA-ADR 23279987. A 15-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 19-SEP-2012, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 22-NOV-2012, GARDASIL (batch number unknown, Dose 3) via intramuscular route on 23-JAN-2013. The patient experienced fatigue in 2013, Headache in 2012, neuropathic pain on an unknown date, muscle pain on an unknown date, joint pain on an unknown date, near syncope on an unknown date, dizziness on an unknown date, palpitation on an unknown date, nausea on an unknown date, lower abdominal pain on an unknown date, voiding difficulty on an unknown date, skin disorder on an unknown date, shortness of breath on an unknown date, pain menstrual on an unknown date sleep disorder on an unknown date, cognitive disorder on an unknown date, dry eyes on an unknown date, concentration problems on an unknown date, tendency for falling blood pressure on an unknown date, she has no that many friends any more as this affected her social life on an unknown date, 33% absence from school on an unknown date, orthostatic intolerance with tendency for falling blood pressure on an unknown date and orthostatic intolerance with tendency for falling blood pressure on an unknown date. The patient describes that she has developed aggravation of headache after 3 dose at that time, the patient received a concussion and she does not remember the exact time due to that. In addition nausea and extreme tiredness, abdominal pain and concentration problems. During tilt table test at the syncope center hospital, it''s seen that the patient has a tendency for falling blood pressure but does not fulfill the diagnostic criteria for POTS. The patient describes that this has had major consequences for her in terms to absence. She has been absence 33% from school. She has not that many friends as this has had effect on her social life. The patient had a medical history of: -headache in 2013 -concussion. The patient''s outcome was reported as Not Recovered/Not Resolved. Other medicines or vaccines: unknown.


VAERS ID: 620841 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-26
Onset:0000-00-00
Submitted: 2016-01-20
Entered: 2016-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dyskinesia, Dysuria, Fatigue, Hyperhidrosis, Increased tendency to bruise, Loss of personal independence in daily activities, Muscular weakness, Nausea, Neuralgia, Sleep disorder, Social avoidant behaviour, Syncope, Tilt table test normal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Product used for unknown indication
Preexisting Conditions:
Diagnostic Lab Data: Have examinations and/or laboratory rests been performed: Tilt table test showed normal examination of the autonomous nervous system.
CDC Split Type: WAES1601DNK006692

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016000256) on 19-JAN-2016. Spontaneous case received from a physician via HA on 14-Jan-2016 under the reference number DK-DKMA-WBS-0002380 and DK-DKMA-ADR 23309718. A 16-year-old female adolescent patient received GARDASIL batch number unknown, Dose 1 via intramuscular route on 16-Dec-2008, GARDASIL, batch number unknown, Dose 2 via intramuscular route on 03-Feb-2009, GARDASIL, batch number unknown, Dose 3) via intramuscular route on 26-May-2009. The patient received concomitant administration of HAVRIX on 26-Jan-2008. The patient experienced Abdominal pain in 2009, Obstipation on an unknown date, Neuropathic pain on an unknown date, Syncope on an unknown date, Dizziness on an unknown date, Nausea on an unknown date, Diarrhea on an unknown date, Voiding difficulty on an unknown date, Easy bruising on an unknown date, Sleep disorder on an unknown date, Fatigue on an unknown date, Cognitive disorder on an unknown date, Involuntary muscle movement on an unknown date, Weakness of right arm in the morning on an unknown date, Vomiting in 2009, Sweating increased on an unknown date, large absence from high school, approx 30% every year on an unknown date and her social life is still very affected by her condition on an unknown date. The patient was admitted to hospital on an unspecified date. The patient describes symptom debut in the beginning of 2009, i.e after 2nd vaccine. She began developing stomach problems, stomach pain and vomiting. Subsequently, the other symptoms developed. In the period before she received the vaccinations, she played football approx 10 hours per week. As a result of her symptoms she has large absence from high school approx 30% every year. Her social life is still very affected by her condition. The tilt table test showed normal examination of the autonomous nervous system. Other medications: Unknown. Additional investigations included Tilt Table Test normal n/a on an unknown date. At the time of reporting, the patient was recovering/resolving from Neuropathic pain. The outcome was unknown for the reactions Diarrhea, Voiding difficulty, Easy bruising, Sleep disorder, large absence from high school, approx 30% every year. The patient had not recovered from the other reactions.


VAERS ID: 628667 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:0000-00-00
Submitted: 2016-02-04
Entered: 2016-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dry mouth, Dyskinesia, Dysmenorrhoea, Dysuria, Fatigue, Headache, Hyperventilation, Influenza like illness, Malaise, Muscular weakness, Nausea, Neuralgia, Palpitations, Photophobia, Presyncope, Skin disorder, Sleep disorder, Syncope, Temperature intolerance, Tilt table test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test showed that the patient does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome.
CDC Split Type: WAES1602DNK002034

Write-up: Information has been received from SPMSD (Sender''s case unique identifier DK-1577272925-2016000712) was 03-FEB-2016. Case received from a physician via HA on 29-Jan-2016 under the reference number DK-DKMA-WBS-0002523 and DK-DKMA-ADR 23326773. A 15-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route in May-2008, GARDASIL (batch number unknown, Dose 2) via intramuscular route in Jul-2008, GARDASIL (batch number unknown, Dose 3) via intramuscular route in Nov-2008. The patient experienced abdominal pain in 2008, headache on an unknown date, neuropathic pain on an unknown date, syncope on an unknown date, dizziness on an unknown date, near syncope on an unknown date, palpitation on an unknown date, nausea on an unknown date, obstipation on an unknown date, diarrhea on an unknown date, voiding difficulty on an unknown date, skin disorder on an unknown date, pain menstrual on an unknown date, hyperventilation on an unknown date, sleep disorder on an unknown date, fatigue on an unknown date, cognitive disorder on an unknown date, involuntary muscle movement on an unknown date, weakness of limbs on an unknown date, temperature intolerance on an unknown date, light sensitivity to eye on an unknown date, dry mouth on an unknown date, flu like symptoms on an unknown date and could not complete her 2nd studies due to sickness absence on an unknown date. The patient cannot remember the symptom debut. She described that her abdominal pain started in 2008, same year as she received all three vaccinations. Subsequently, the other symptoms developed. As a result of the above the patient could not complete her 2nd education due to sickness absence (syncope). She is on sick leave and has moved back with her parents. Unknown whether there were other medications or vaccines. Additional investigations included Tilt Table Test does not fulfill diagnostic criteria for POTS n/a on an unknown date. The time of reporting, the outcome was unknown for the reaction could not complete her 2nd studies due to sickness absence. The patient had not recovered/resolved from the other reactions.


VAERS ID: 630817 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-07
Entered: 2016-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Electrocardiogram PQ interval, Electrocardiogram QT interval normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Electroencephalogram normal, Fatigue, Postural orthostatic tachycardia syndrome, Tilt table test positive, Tricuspid valve incompetence
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test (11-JAN-2016): Postural orthostatic tachycardia syndrome (POTS); Unit: N/A. Electrocardiogram (Unspecified date): sinus rhythm, normal frequency, normal QTc time and PQ time. Mild tricuspid insufficiency with normal pressure in the small circulatory system. Normal at vena cava inferior. normal at aorta root, arcus aortae and ascending and descending aorta (Unit: N/A). Holter registration (Unspecified date): has shown normal findings; Unit: N/A. Electroencephalogram (approximately September 2015 (reported as end of September): showed normal finding; Unit: N/A.
CDC Split Type: WAES1603SWE001707

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR Control No: 2016001797) on 02-MAR-2016. Case received from a physician via HA on 29-FEB-2016 under the reference number SE-MPA-2016-001174. A 16-year-old female adolescent patient received GARDASIL (batch number unknown) in 2012. The patient experienced POTS in 2012. A report from a physician concerning a 16-year-old girl. The following is described: Syncope debut in connection to GARDASIL vaccination 2012. Interpreted as vasovagal reaction. No previous syncope, is not a smoker, no previously known allergy. The patient has had recurrent syncope, 8 episodes since 2012, has been greatly bothered by this. Previously trained dancing and boxing but stopped due to unusual tiredness. ECG sinus rhythm, normal frequency, normal QTc time and PQ time. Mild tricuspid insufficiency with normal pressure in the small circulatory system. Normal at vena cava inferior. Normal at aorta root, arcus aortae and ascending and descending aorta. Holter registration has shown normal findings. EEG in the end of September showed normal finding. Tilt Table test 11-Jan-2016 showed postural orthostatic tachycardia syndrome. After start with GLUTRON, she has become better with less dizziness attacks, however still increased tiredness. Concomitant medication with oral contraceptives, drug not specified. The HA has assessed the report as "unclassifiable", as relevant information is missing for assessment of a reasonable temporal relationship (in accordance to decision at HA 03-Nov-2015). Additional investigations included Tilt Table Test POTS N/A on 11-Jan-2016. The patient''s outcome was reported as Not Recovered/Not Resolved. The HA assessed the causal relationship between Postural orthostatic tachycardia syndrome and GARDASIL as unknown.


VAERS ID: 642450 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-05-13
Onset:2014-07-01
   Days after vaccination:49
Submitted: 2016-06-02
   Days after onset:702
Entered: 2016-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006698 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Dizziness, Fatigue, Headache, Impaired work ability, Nuclear magnetic resonance imaging brain, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: Blood tests taken by her physician, MR cerebrum performed by private neurologist.
CDC Split Type: WAES1606DNK000118

Write-up: Information has been received from Sanofi Pasteur (MFR# DK-1577272925-2016005643) on 31-MAY-2016. Case received from a physician via Health Authority on 26-MAY-2016 under reference number DK-DKMA-ADR 23494337. A 16-year-old female adolescent patient received GARDASIL, lot number J008568, expiry date 30-NOV-2015, Dose 1) via intramuscular route on 14-MAR-2014, GARDASIL (batch number J006698, expiry date 30-SEP-2015, Dose 2) via intramuscular route on 13-May-2014, GARDASIL (batch number J006698, expiry date 30-SEP-2015, Dose 3) via intramuscular route on 08-SEP-2014. The patient experienced pain in both thighs on an unknown date in July 2014, headache on an unknown date in June 2014, tiredness on unknown date in 2014, dizziness, intermittent on unknown date in 2014 and impaired work ability on an unknown date. Has not been able to complete high school or college. Other Vaccines: No. Other Medicines: No. The patient''s outcome was reported as Unknown for Impaired work ability.


VAERS ID: 643128 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-01
Onset:0000-00-00
Submitted: 2016-06-10
Entered: 2016-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Endometriosis, Fibromyalgia, Intervertebral disc protrusion, Mental disorder, Mobility decreased, Myalgia, Scoliosis, Spinal disorder, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606COL001201

Write-up: This spontaneous report has been received from the journalist in a published newspaper, referring to a 16 year old female patient. The patient''s relevant medical history, current conditions and concomitant medications were not reported. On an unknown date in April 2013, the patient was vaccinated with first dose of GARDASIL, injection (dosing details were not reported) (lot not reported). On an unknown date in September 2013, the patient was vaccinated with the second dose of GARDASIL, injection (dosing details were not reported) (lot not reported) injection. On unknown date, the patient experienced scoliosis, herniated disc and endometriosis. The physician suspected that she also experienced fibromyalgia, a disease that caused chronic muscle pain and tenderness throughout the body. The patient stated that many doctors told her that she had an autoimmune disease, but the diagnosis was not certain, it was as rule out, they did not know (per verbatim). The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. Follow-up information has been received from the patient via the journalist on 06-JUN-2016. The patient reported that some days she could not get out of her bed, she couldn''t do physical activity because she was diagnosed with scoliosis, herniated disc and spinal problems. When she lost of mobility in the legs, a neurologist told her "get out of bed" and she could not do it. The neurologist told her mother that the patient had a psychological disease, that she was very spoiled. The outcome of all events was not reported. The causality between the events and GARDASIL was not provided. The reporter considered loss of mobility in the legs to be a disability event. Upon internal review, loss of mobility in the legs and autoimmune disease were considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected since follow up has been received. Reporter, event and narrative were updated.


VAERS ID: 646818 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-20
Onset:2014-09-24
   Days after vaccination:2195
Submitted: 2016-08-08
   Days after onset:684
Entered: 2016-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Disturbance in attention, Dizziness, Fatigue, Headache, Memory impairment, Nausea, Nuclear magnetic resonance imaging, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: MRI scan; CT scan; numerous blood tests; Neurologists; Physiotherapists; Various alternative treatments; Dentists; Ear-Nose-Throat physician; Checked vision.
CDC Split Type: WAES1605DNK013332

Write-up: Information has been received from SPMSD (manufacturer control # DK-1577272925-2015000316) on 04-AUG-2016. Case received from a consumer/other non health professional via HA on 03-DEC-2015 under the reference DK-DKMA-ADR 23223265 and DK-DKMA-WBS-0001601. A 22-year-old female adult patient received GARDASIL (batch number unknown, Dose 1) in 2008, GARDASIL, (batch number unknown) in 2008. The patient experienced headache on 25-SEP-2014, dizziness on 25-SEP-2014, visual disturbance on 25-SEP-2014, nausea on 25-SEP-2014 and fainting in October 2014. The patient has not been treated for the adverse reactions. The patient has not been hospitalized due to the adverse reactions. No other medications. The patient''s outcome was reported as not recovered/not resolved. Follow up received from Patient Insurance Company (PIC) via HA on 01-AUG-2016 under the reference 16-1667: This is the patient''s initial claim. PIC has not reached a decision in the case yet. The patient''s initials is changed. Vaccination dates for GARDASIL has been added. Description of the pharmaceutical injury: The adverse events occurred from one day to another on 24-SEP-2014. Since that she has had constant headache, with changing intensity, localized in the forehead. Furthermore dizziness, nausea, chronic fatigue, visual disturbances, fainted several times, memory impairment and concentration impairment, symptoms gets worse during physical activity. Continued problems: Constant headache, with changing intensity, localized in the forehead. Furthermore dizziness, nausea, chronic fatigue, visual disturbances, memory impairment and concentration impairment, symptoms get worse during physical activity. Continued treatment of the pharmaceutical injury: Headache center at specialist physician. Has tried different medications, pain management training and diet change. Continue to be offered different medicines and is still under diet change. Patient has been on full-time sick leave during the period July 2016 to January 2016 (disabling). MA comments: Start date for the adverse events changed from 25-SEP-2014 to 24-SEP-2014. Added events: Chronic fatigue, Memory impairment, Concentration impairment.


VAERS ID: 673707 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-03-05
Onset:2015-12-01
   Days after vaccination:271
Submitted: 2016-09-13
   Days after onset:286
Entered: 2016-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Deja vu, Electrocardiogram abnormal, Generalised tonic-clonic seizure
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Electroencephalogram (EEG) (01-AUG-2016): present (units: NA); Electroencephalogram (EEG) (02-AUG-2016): performed (units: NA)
CDC Split Type: WAES1609DEU006226

Write-up: Information has been received from SPMSD [case report # DE-1577272925-2016009043] on 12-SEP-2016. Spontaneous case report received from a physician via Health Authority (reference DE-DCGMA-16170752) on 07-Sep-2016: A 17-year-old female adolescent patient received GARDASIL, (batch/lot number unknown, Dose 1) via intramuscular route on 17-Sep-2014, GARDASIL, (batch/lot number unknown, Dose 2) via intramuscular route on 20-Nov-2014, GARDASIL, (batch/lot number unknown, Dose 3) via intramuscular route on 05-Mar-2015. The patient experienced Anxiety on 15-Dec-2015, Deja Vu-experiences on 15-Dec-2015, generalised tonic-clonic seizure on 05-May-2016, 427 days Post Administration and generalised tonic-clonic seizure on 02-Aug-2016, 516 days Post Administration. The patient was admitted to hospital on an unspecified date. Additional investigations included: Electroencephalogram present on 01-Aug-2016, Electroencephalogram performed on 02-Aug-2016. The patient recovered from generalised tonic-clonic seizure on an unknown date. The patient''s outcome was reported as Unknown. The reporter assessed the causal relationship: between Deja vu and GARDASIL as reasonable possibility; between generalised tonic-clonic seizure and GARDASIL as reasonable possibility; between generalised tonic-clonic seizure and GARDASIL as reasonable possibility; between anxiety state and GARDASIL as reasonable possibility. According to the HA narrative: A female 17-years old patient was vaccinated with GARDASIL, (batch/lot no.: was not reported), Intramuscular on 17-Sep-2014. Concomitant medication included: GARDASIL (on 20-Nov-2014), GARDASIL (on 05-Mar-2015). 19 months after the first vaccination the patient developed anxiety state (in Dec-2015) and Deja vu experiences (in Dec-2015) and generalised tonic-clonic seizure (on 05-May-2016) and generalised tonic-clonic seizure (on 02-Aug-2016), lasting for unknown. The patient showed disabling/incapacitating and was hospitalized. Diagnosis was confirmed by EEG (result: present, unit: NA). Treatment included adjustment to lamotrigine administration. The patient had recovered at the date of reporting. At the time of the report, the outcome of the events of anxiety state and Deja vu experiences were unknown. No further information awaited. Upon internal review the company decided to code as suspect the 2nd and 3rd doses of GARDASIL which were coded as concomitant by the health authorities.


VAERS ID: 673773 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-06-11
Onset:0000-00-00
Submitted: 2016-09-19
Entered: 2016-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Anxiety, Arthralgia, Cognitive disorder, Depression, Dizziness, Dyspnoea, Dysuria, Fatigue, Headache, Influenza like illness, Muscle spasms, Muscular weakness, Nausea, Night sweats, Palpitations, Skin disorder, Sleep disorder, Tilt table test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions:
Diagnostic Lab Data: Examinations and/or laboratory tests conducted? Tilt table test shows that she does not fulfill criteria for Postural Orthostatic Tachycardia Syndrome (unit: NA).
CDC Split Type: WAES1609DNK007664

Write-up: Information has been received from SPMSD (MFR Control No. 2016009193) as part of a business agreement on 15-SEP-2016.Case received from a physician via HA on 12-Sep-2016. A 16-year-old female adolescent patient received GARDASIL, (batch number and lot unk, Dose 1) via intramuscular route on 05-Mar-2008, GARDASIL (batch number and lot unk, Dose 2) via intramuscular route on 11-Jun-2008 and GARDASIL (batch number and lot unk, Dose 3) via intramuscular route on 22-Jan-2009. The patient experienced Headache, Lower abdominal pain, Dizziness, Palpitation, Nausea, Voiding difficulty, Skin disorder, Shortness of breath, Sleep disorder, Fatigue, Cognitive disorders, Cramps in legs, weakness of legs, Flu like symptoms, Night sweats, Pain in hips, Anxiety, Depression and Only works 27 hours per week due to her symptoms on an unknown date. Process of the adverse events: The patient informs that her first symptoms occurred after the second vaccine. The first symptom she experienced was headache and she struggles with it on a daily basis. The patient was elite athlete in gymnastics since the age of 10-12 years. It is not clear how dedicated she was to the sports when she received the vaccinations. As a consequence the patient has developed depression and anxiety. She only works 27 hours per week due to her symptoms. No other vaccines or medications given. Additional investigations included Tilt Table Test does not fulfill Pots criteria n/a on an unknown date. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 673477 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-12-23
Onset:2010-06-23
   Days after vaccination:182
Submitted: 2016-09-12
   Days after onset:2273
Entered: 2016-12-19
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal distension, Angiopathy, Appetite disorder, Blood test, Dizziness, Dyskinesia, Fatigue, Headache, Immune system disorder, Influenza like illness, Nausea, Tic, Vitiligo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: Syncope center had conducted blood testes and measured the blood pressure and has had a long discussion with the patient regarding her adverse events.
CDC Split Type: WAES1608DNK013974

Write-up: Information has been received from Sanofi Pasteur MSD [DK-1577272925-2016008513] on 08-SEP-2016. Case received from a consumer/other non health professional via HA on 24-AUG-2106. A 16-year-old female adolescent patient received GARDASIL, (batch number unknown) on 17-Feb-2010, GARSDASIL, (batch number unknown) on 23-Dec-2009. The patient experienced the immune system was weakened, tics, upset stomach and Vitiligo on 01-JAN-2010. The patient has not been treated for the adverse events. The patient''s outcome was reported as Not Recovered/Not resolved. FOLLOW UP (version 002): Duplicate received 05Sep2016 from Hospital (DK-DKMA-WBS-0004424 / DK-DKMA-ADR 23635678). Side effects: Vitiligo, flu-like symptoms, headache, dizziness, nausea, fatigability, involuntary muscle movement, appetite disorder, vascular disorder, bloating, fatigue. Circumstance around the side effects: About a half year after the first vaccine the patient experiences Vitiligo (large white area on the chin with aggravation). In addition, recurrent flu symptoms each month. The following is in addition to the other reported symptoms. By tilt table test on Hospital the patient does not meet the diagnostic criteria for POTS. The patient reports that she repeatedly at various schools through the years received warnings because of frequent disease. Patient describes that she quickly becomes mentally exhausted by being social. Batch no: Not available, Lot UNK OTHER VACCINES: Not known. OTHER MEDICINE: Not known. The following information is added to the case on the basis of the duplicate: Severity criteria disability / incapacity, adverse reactions (flu-like symptoms, headache, dizziness, nausea, fatigability, involuntary muscle movement, appetite disorder, vascular disorder, bloating,), GARDASIL route (intramuscular). The following information is changed in the case on the basis of duplicate: The case had been medically confirmed and serious, the start date of the adverse reaction Vitiligo is changed to 23Jun2010. MA comment: The duplicate was identified before being accepted by MAH. MAH has therefore not accepted DK-DKMA-ADR 23635678 as a new case.


VAERS ID: 674560 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-04-13
Onset:2015-10-17
   Days after vaccination:187
Submitted: 2016-12-23
   Days after onset:433
Entered: 2016-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Blindness transient, Central nervous system lesion, Disability, Multiple sclerosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Retinal disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: IE0095075131612IRL011015

Write-up: Initial report was received by the regulatory authority (HA# IE-HPRA-2016-028845) on 07-DEC-2016 from a member of the public (MOP) which concerns herself a 16 year old female patient who experienced Blindness transient & Central nervous system lesion following vaccination with Gardasil for Prophylaxis. Concomitant medications: None. Medical history/concurrent conditions: Not reported. The patient was vaccinated with 3 doses of Gardasil (only one batch number was provided as K024837) via intramuscular route between 02-OCT-2014 and 13-APR-2015. On 17-OCT-2015, 6 months after the 3rd vaccine, the patient experienced visual loss and plaques noted on brain. The reported indicated that multiple sclerosis (MS) was suspected. The patient''s vision returned to normal after 1 week but the plaques still remain on the patient''s brain. Events of visual loss and plaques noted on brain were considered to be serious as disability, visual loss also considered to be medically significant.


VAERS ID: 270362 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-11
Onset:2006-11-01
   Days after vaccination:21
Submitted: 2007-01-10
   Days after onset:70
Entered: 2007-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Gastrointestinal disorder, Lymphadenopathy, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: YAZ
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00486

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 11 Oct 2006 was vaccinated with the first, 0.5 ml dose of HPV vaccine. Concomitant therapy included YAZ. On 11 Dec 2006, the patient received the second, 0.5ml dose of HPV vaccine (lot 653650/0696F). About three weeks after the first dose, approximately 01 Nov 2006, the patient experienced Gastrointestinal problems including, diarrhea, vomiting and decreased appetite. The patient had a swollen right intraglandular lymph node. The patient had lost 12 pounds since the start of her symptoms. The patient was hospitalized overnight and treated for dehydration with intravenous fluids on 12 Nov 2006, 18 Nov 2006 and 31 Dec 2006. laboratory evaluation revealed normal complete blood count and normal ultrasound of the pelvic area. The patient was referred to a gastrointestinal physician but had not been examined yet. At the time of the report, the patient had not recovered. The patient sought medical attention. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be disabling. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be other important medical events (OMIC). Additional information has been requested.


VAERS ID: 272940 (history)  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2006-12-22
Onset:2006-12-22
   Days after vaccination:0
Submitted: 2007-02-22
   Days after onset:62
Entered: 2007-02-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 0 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Insomnia, Medical device complication, Musculoskeletal pain, Pain, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: X-ray 02/12?/07 - No bony abnormalities
CDC Split Type: WAES0702USA03448

Write-up: Information has been received from a physician and an office manager concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of Gardasil (lot#654540/0800P). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with safety mechanism. On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an X-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. At the time of the report, the patient had not recovered. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. Additional information has been requested.


VAERS ID: 273357 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2007-01-05
Onset:2007-01-05
   Days after vaccination:0
Submitted: 2007-03-01
   Days after onset:55
Entered: 2007-03-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Malaise, Pallor, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA04223

Write-up: Information has been received from physician concerning a 16 year old female patient who on approximately 05-JAN-2007 ("7 weeks ago") was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. The physician reported that the patient stated she "did not feel well when checking out and turned white and fainted when being taken back into the examining room." The physician clarified that the patient "did not lose consciousness or hit her head because he caught the patient." He confirmed the patient fainted "within 5 minutes" of the vaccination, and remained "groggy for up to 30 minutes" after the vaccination. The patient was then "considered recovered," and left the office. The physician considered the events to be disabling. Additional information has been requested.


VAERS ID: 273513 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-03-06
   Days after onset:82
Entered: 2007-03-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / -

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Neck pain, Pain in extremity, Pain in jaw
SMQs:, Retroperitoneal fibrosis (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN
Current Illness: Penicillin allergy
Preexisting Conditions: Drug rash
Diagnostic Lab Data: NONE
CDC Split Type: WAES0703USA00049

Write-up: Information has been received from a physician concerning a 17 year old female patient with a history of rash after taking amoxicillin, who on 14-DEC-2006 was vaccinated with the first dose, 0.5 ml, in the right arm, of Gardasil. Concomitant therapy included (ORTHO TRI-CYCLEN). In December 2006 (date not specified), the patient "experienced pain at left angle of jaw, neck pain and mid back pain. "The physician reported that the "mother treated daughter with ibuprofen and within 36 hours symptoms improved. The physician stated "the client did not report this reaction at the time. "On 20-FEB-2007 a second dose , 0.5ml, in the left arm, of Gardasil was administered. On 25-FEB-2007, the patient called the office, "complaining of pain at left angle of jaw, mid back pain, and pain in the right deltoid, upper aspect of the right arm, the opposite arm" of where she received the vaccination. At the time of this report it was unknown if the patient had recovered. The physician considered the events to be significantly disabling. Additional information has been requested.


VAERS ID: 275251 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2007-03-15
Onset:2007-03-15
   Days after vaccination:0
Submitted: 2007-03-29
   Days after onset:14
Entered: 2007-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 0 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Muscle twitching, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. 7/7/2009 Neuro consult received. (+) PPD age 5. OCs.
Diagnostic Lab Data: Unknown. 7/7/2009 Neuro consult received. Labs and Diagnostics: EEG abnormal. MRI brain WNL.
CDC Split Type: WAES0703USA03961

Write-up: Initial and follow-up information has been received from a Medical Assistant concerning a 17 year old female patient who on 15-MAR-2007 was vaccinated IM with her first dose of Gardasil, lot #654702/0011U. The reporter reported soon after the injection "her arm hurt really bad" and was stiff. On 16-MAR-2007 the patient developed sporadic twitching of her whole body. The reporter stated that the patient "looked as if she had Tourette syndrome. " On 17-MAR-2007 the patient was examined in the emergency room and was released a few hours later. She was examined by her primary physician and gynecologist. She had an appointment with a neurologist. She has not had any improvement in her symptoms of sporadic twitching, however arm pain and stiffness were subsiding. The reporter considered the events to be disabling because the patient was unable to perform her activities of daily living for a week. Additional information has been requested. 7/7/2009 Neuro consult received for 3/20/07-4/13/07 with DX: Intermittent myoclonus. Pt presented for consult after developing twitching in the L leg and shoulder which developed on 3/16/07, one day after receiving HPV vax in R deltoid. Pt also c/o shoulder pain and RUE pain making it difficult to use the R arm. Pt c/o increasing frontal H/A since that time as well. Plantar responses were flexor on the right and extensor on the left. Intermittent jerky movement mostly upper part of body toward left shoulder and rarely in the legs. F/U 3/30/07 with continued H/A and blurred vision but improvement in twitching. RUE pain improved, but now sharp pain in top of neck. Tx with Naproxen which was later d/c due to epigastric pain. Topamax started. 7/14/09 PCP records recd. Seen 3/19/07 for dx: motor twitching. See neuro records. 7/17/09 ER records received DOS 3/17/07 to 3/18/07. Assessment: Shoulder Twitching. Patient presented with sudden onset left shoulder twitching (intermittent). Left shoulder muscle pain. Ativan prescribed, symptom improved, and patient discharged.


VAERS ID: 277112 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2007-01-05
Onset:2007-01-05
   Days after vaccination:0
Submitted: 2007-04-19
   Days after onset:103
Entered: 2007-04-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site swelling, Rash pruritic, Scab, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA01525

Write-up: Information has been received from a registered nurse at a dermatology office, concerning a 17 year old female patient who on 20-SEP-2006 was vaccinated with the first dose of Gardasil (Lot #653736/0868F), and on 05-JAN-2007, with the second dose of Gardasil (Lot #655165/1425F) at an OB-GYN office. The nurse reported that on 05-JAN-2007, following the second vaccination, the patient, immediately got at bump on the right arm," by approximately 19-JAN-2007 ("within 2 weeks of the vaccination"), the patient''s "arm was cabby, scaly and bigger, than spread to whole body and face;" the patient developed a severe rash with itching. Prior to the first visit at the dermatology office, the nurse confirmed that the patient reported she had received treatment (date not specified) from a clinic, involving 2 courses of methylprednisone and cephalexin. On 27-JAN-2007, when the patient initially visited the dermatology office, the nurse indicated that the rash "looked like a sunburn that had peeled, was swollen, flaked and scabbed." Treatment on 27-JAN-2007 included an injection of DEPO-MEDROL), MOISTEREL cream (OTC). At the time of this report, it was unknown if the patient had recovered; the patient had a follow up visit scheduled at the dermatology office for 17-APR-2007. The reporter considered the severe rash with itching, peeling, swelling, flaking and scabbing to be disabling as the patient had missed school, and also an other medical event. Additional information has been requested.


VAERS ID: 277669 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2007-04-18
Onset:2007-04-18
   Days after vaccination:0
Submitted: 2007-04-30
   Days after onset:12
Entered: 2007-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure normal, Dizziness, Fatigue, Feeling hot, Heart rate normal, Pallor, Paraesthesia, Sensation of heaviness, Syncope, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Syncope; Immunisation
Diagnostic Lab Data: Blood pressure 04/19/06 90/60, total heartbeat count 04/19/06 60
CDC Split Type: WAES0704USA04219

Write-up: Information has been received from a physician concerning a 17 year old female patient with past episodes of fainting with vaccinations who on 18-APR-2007 was vaccinated IM in the left arm with her first dose of Gardasil, lot #657617/0384U. After receiving the injection the patient fainted, which lasted a few seconds. The patient was completely white in the face and she complained that entire body felt like she was burning up. She was not warm to touch and did not have a fever. The patient kept asking for water. She regained color to her face 15 minutes later. She felt tingling for one hour or so both legs and arms and was very dizzy. Her eyes were closed for approximately 1 hour and she felt exhausted. The patient was given smelling salts and when asked if she was aware of what was being done to her, she "smelled violets". She had a fan on her for 30 minutes and she started to feel better. Her blood pressure was taken 2 or 3 times for approximately one hour and her pulse was also monitored. "Blood pressure reading (90/60 normal for patient). Pulse (60 normal for patient) for first 15 to 30 minutes after reaction was very faint." She was very alert one hour later (eyes open and talking) but complained of her legs feeling heavy. The patient had to be wheeled out to her car. The physician did not believe the patient hyperventilated to bring these reactions on herself. The physician believed giving the patient smelling salts, monitoring the blood pressure, pulse and putting the patient in front of a fan to cool her down was another medical event and the patient''s experience was disabling because she went to bed and not able to do anything for rest of the day. Additional information has been requested.


VAERS ID: 281539 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-05-30
Onset:2007-05-30
   Days after vaccination:0
Submitted: 2007-06-12
   Days after onset:13
Entered: 2007-06-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0387U / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Pain in extremity, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: ultrasound 06/04/07 - thrombosis in the left arm records received 6/21/07-Color duplex ultrasound of upper extremity venous system demonstrated acute deep vein thrombosis in left arm.
CDC Split Type: WAES0706USA00602

Write-up: Information has been received from a nurse concerning a 17 year old female who on 30-MAY-2007 was vaccinated with Gardasil (Lot #657621/0387U). There was no concomitant medication. On 30-MAY-2007 the patient developed impressive swelling and pain in her left shoulder down to her wrist. This occurred after the patient went swimming. It was reported that "the swelling gets less when the arm is not used but comes back when the patient uses the arm". A physician in the office told the patient to elevate and ice the arm in the area for a couple of days, but this did not help. On 04-JUN-2007 a Doppler ultrasound was performed which revealed thrombosis in the arm. It was reported that the swelling and pain were disabling to the patient. The patient''s swelling and pain persisted. No further information is available at this time. Additional information has been requested. 6/21/07-records received for DOS 6/11 and 6/17/07- Letter from PCP indicated that DVT is not thought to be due to vaccine it has probably been present for a few weeks. unfortunately it began to grow around the time of HPV thus the apparent association. Received HPV 5 days ago from this visit of 6/4/07-developed impressive swelling and pain that day while swimming. Arm literally twice normal size with pitting edema into arm pit. Swelling lessesn when not using arm but returns when she tries to swim or exerices. PE:left arm with non pitting swelling over entire arm, skin over arm is warm and well perfused fingers are cool on both hands but well perfused. ROM fine. Treatment, thrombolysis and mechanical thrombectomy, subclavian vein was virtually completely freed of thrombus. An underlying compression of the vein at the thoracic inlet was documented


VAERS ID: 281660 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2007-05-15
Onset:2007-05-15
   Days after vaccination:0
Submitted: 2007-06-11
   Days after onset:27
Entered: 2007-06-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 0 UN / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC, VITAMINS
Current Illness:
Preexisting Conditions: Drug hypersensitivity to Benzaclin; underwent ear irrigation during visit.
Diagnostic Lab Data:
CDC Split Type: 200702108

Write-up: This information was received from manufacturer on 07 June 2007 under the manufacturer number WAES0705USA03292. "Information has been received from a physician, concerning a 17 year old female patient, with a drug hypersensitivity to clindamycin/benzylperoxide (BENZACLIN), who on 15-MAY-2007 was vaccinated with Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included ADACEL, cetirizine hydrochloride (ZYRTEC) and vitamins (unspecified medications, over the counter). The physician reported that the patient "Seemed fine" immediately after the vaccine was administered, but 5 to 10 minutes later when she was checking out, the patient "fainted and almost hit her head on the counter;" she was unconscious for a few seconds. The patient was taken to the emergency room for evaluation and was released and considered to be recovered on the same day, 15-MAY-2007. The physician considered the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event. Additional information has been requested."


VAERS ID: 282848 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2007-02-27
Onset:2007-02-27
   Days after vaccination:0
Submitted: 2007-06-25
   Days after onset:117
Entered: 2007-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Depression, Dizziness, Similar reaction on previous exposure to drug
SMQs:, Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0706USA03288

Write-up: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.


VAERS ID: 293413 (history)  
Age: 17.0  
Gender: 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 / 0 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0601U / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA
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: 299543 (history)  
Age: 17.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2007-11-08
Onset:2007-11-09
   Days after vaccination:1
Submitted: 2007-12-12
   Days after onset:33
Entered: 2007-12-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody, Aspartate aminotransferase decreased, Blood creatine phosphokinase increased, C-reactive protein normal, Complement factor C3, Full blood count normal, Gait disturbance, Hypokinesia, Laboratory test normal, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Coeliac disease
Preexisting Conditions: Headache; No reaction to previous exposure to drug
Diagnostic Lab Data: complete blood cell 11/12/07; erythrocyte 11/12/07 3; serum C-reactive 11/12/07 normal; serum ANA 11/12/07 less then 80, blood chemistry 11/12/07 normal-except serum aspartate aminotransferase; plasma aspartate 11/12/07 75; plasma creatine kinase 11/12/07 2739; component C3 test 11/12/07
CDC Split Type: WAES0712USA00194

Write-up: Information has been received from a physician concerning a 17 year old female with coeliac disease and no drug allergies and a history of headaches, who, on 08-NOV-2007 was vaccinated with a first dose of (previously reported as a second dose) on Gardasil. Concomitant suspect therapy included cyproheptadine hydrochloride (MSD), tablet for the treatment of headache (duration and dose not reported). On 09-NOV-2007 (previously reported as 08-NOV-2007 later in the day) the patient experienced bilateral calf pain. It was reported that the patient "couldn''t walk." On 12-NOV-2007 (also reported as 4 days later) the patient was seen in the office with bilateral calf pain, marked calf tenderness, and difficulty getting out of bed. There was no treatment prescribed. Laboratory diagnostics were performed with the following results: complete blood count was normal, sedimentation rate was 3, c-reactive protein was normal, antinuclear antibodies were less than 80, chemistry profile was normal except serum aspartate aminotransferase which was 75, and creatine phosphokinase was 2739. A component C3 test was performed with no results provided. On 14-NOV-2007 the patient recovered. No product quality complaint was involved. The physician considered the bilateral calf pain and difficulty getting out of bed/couldn''t walk to be disabling. Additional information has been requested.


VAERS ID: 300493 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-22
Onset:2007-03-27
   Days after vaccination:5
Submitted: 2007-12-14
   Days after onset:262
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Formication, Laboratory test, Pain in extremity, Paraesthesia, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown 7/3/08-records received-PMH: frequent sinus infections. Fracture left foot 2/07.
Diagnostic Lab Data: diagnostic laboratory, 03/29?/07, clear; ultrasound, results not reported 7/3/08-records received-Abdominal x-ray, constipation. D-dimer elevated 0.98. Ultrasound lower extremity veins normal.CSF oligoclonal bands none. Lyme titer negative. strep throat culture negative.
CDC Split Type: WAES0711USA02944

Write-up: Information has been received from a pediatrician concerning a 17 year old female who on 22-MAR-2007 was vaccinated with a first dose of Gardasil co administered with therapy included MENACTRA on a different arm. On 27-MAR-2007 the patient complained of pain in the thigh and a "creepy, crawly, tingling feeling". She went to the local emergency room (ER). She was admitted to the hospital on 29-MAR-2007. According to the pediatrician all diagnostics came back clear (not further specified). She underwent an ultrasound (results not reported). The patient was seen by a neurologist who hinted a touch of Guillain-Barre. All conditions resolved by early May. The patient did not continue with the series of Gardasil. The pediatrician considered Guillain-Barre to be disabling. Additional information has been requested. 7/3/08-records received- DC summary is not included in a short stay DOS 3/29-3/30/07.Principal diagnosis of this admission: Guillain-Barre syndrome. Presented with C/O dysesthesias and weakness. One 3/19/07 onset of sore throat, Received vaccinations on that date. Continued to C/O upper respiratory infection symptoms with sinus type headace. Developed discomfort in legs and burning, aching sensation. Tired and generally weak. PE:diffuse motor weakenss in arms and legs. Deep tendon reflexes brisk. Suggests peripheral neuropathy. 10/10/08-reviewed by CDC CISA staff who determined that this is NOT GBS


VAERS ID: 303008 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2007-10-01
Onset:2007-10-01
   Days after vaccination:0
Submitted: 2008-01-17
   Days after onset:108
Entered: 2008-01-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Emotional distress
SMQs:, Depression (excl suicide and self injury) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP=Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02992

Write-up: Information has been received via the Merck pregnancy registry, from a physician, concerning a 17 year old female patient who was 2-3 weeks pregnant in October 2007, when she was vaccinated with the first dose of Gardasil (lot # not reported). On 13-JAN-2008, the patient had a miscarriage and was hospitalized (details and dates not provided). The physician stated that the patient was "traumatized." At the time of this report, the outcome of miscarriage and patient traumatized was unknown. The physician considered the miscarriage to be disabling/incapacitating due to the patient being traumatized. Additional information has been requested.


VAERS ID: 303189 (history)  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2008-01-06
Onset:2008-01-08
   Days after vaccination:2
Submitted: 2008-01-18
   Days after onset:10
Entered: 2008-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Activities of daily living impaired, Alanine aminotransferase normal, Albumin globulin ratio normal, Anorexia, Aspartate aminotransferase normal, Blood albumin decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Chills, Diarrhoea, Epstein-Barr virus antibody negative, Fatigue, Full blood count normal, Haematocrit normal, Haemoglobin normal, Headache, Hysterectomy, Insomnia, Laboratory test, Laboratory test normal, Mean cell volume normal, Mean platelet volume normal, Myalgia, Nausea, Pharyngolaryngeal pain, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROZAC; vitamins (unspecified)
Current Illness: Anxiety
Preexisting Conditions: None
Diagnostic Lab Data: complete blood cell - normal; diagnostic laboratory SMA - normal: monospot - negative; Epstein-Barr virus, normal; serum glucose, 01/10/08, 106; serum creatinine, 01/10/08, 0.83 mg/dl; serum sodium, 01/10/08, 139 mmol/; serum chloride, 01/10/08, 102 mmol/; serum calcium, 01/10/08, 9.1 mmol/; serum albumin, 01/10/08, 4.3 g/dL; white blood cell, 01/10/08, 5.0; LY- 17.9; MO 11.3; CR 70.8; LY 0.9; MO 0.6; WBC count, 01/10/08, 5.0; serum Epstein-Barr virus, 01/10/08, negative; serum alanine, 01/10/08, 14 U/L; serum aspartate, 01/10/08, 16 U/L; serum alkaline, 01/10/08, 76 U/L; total serum bilirubin, 01/10/08, 0.6mg/dL; serum albumin/globulin, 01/10/08, 1.6; serum globulin test, 01/10/08, 01/10/08, 2.7 g/dL; mean platelet volume, 01/10/08, 8.4 fl
CDC Split Type: WAES0801USA02310

Write-up: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.


VAERS ID: 307343 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-03-04
Onset:2008-03-05
   Days after vaccination:1
Submitted: 2008-03-18
   Days after onset:12
Entered: 2008-03-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1448U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Hallucination, Headache, Hyperaesthesia, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADDERALL TABLETS
Current Illness: Attention deficit disorder; drug hypersensitivity
Preexisting Conditions: No reaction on previous exposure to vaccine. PMH: Broken nose. Allergic to cough/cold meds.
Diagnostic Lab Data: Unknown. Labs and Diagnostics: CT Abd & pelvis-no acute findings. CXR WNL. Chem WNL. LFTs WNL except Alk Phos 71. CBC WNL. UA WNL except trace ketones. Blood and UC (-). Labs and diagnostics: CBCs with normal WBCs but high monos(17) and eosinophils (9). Chemistry WNL. Alk phos (51)and CK (32) low. Blood cx (-). UC (-). CRP 3.81. Lyme (-). VZV IgG (+). VZV IgM (-). LP WNL. Head CT (-). Labs and Diagnostics: Vit D 25OH 22.2. Vit B12 1475. Antigliadin IgG 60.98. PFTs WNL. Lyme IgG/IgM (+). Lyme C6 peptide (+).
CDC Split Type: WAES0803USA01494

Write-up: Information has been received from a registered nurse concerning her 17 year old daughter with attention deficit disorder and an allergy to over-the-counter cold preparations, who on 04-MAR-2008 at 16:30 was vaccinated with a third dose of Gardasil. Concomitant therapy included ADDERALL TABLETS. On 05-MAR-2008, eight hours post vaccination the patient experienced a high fever, hallucinations, severe back pain, severe headache, skin sensitivity, nausea and vomiting and was hospitalized. It was reported that the patient tolerated the first and second doses of Gardasil well. At the time of the report, the patient had not recovered. No product quality complaint was involved. The high fever, hallucinations, severe back pain, severe headache, skin sensitivity, nausea and vomiting were considered to be disabling. Additional information has been requested. 4/10/2008 MR received for ER visit 3/5/2008 with DX: Primary DX: R Flank Pain. Additional DX: Fever-unknown origin. Pt presented to ER from MD''s office with fever, chills, sudden onset R sided flank pain, nausea and vomiting. Pt reports fatigue and weakness as well. PE (+) for tenderness at the R CVA, fever, and pain. D/C home in improved condition. 5/13/2008 MR received for DOS 3/6-8/2008 with no clear D/C DX. Rheumatology Impression is: Back pain that is probably of a systemic problem. ID consult Impression: Fever and infection of the back, r/o sacroilitis, r/o vertebral osteomyelitis, r/o non-infectious etiology. Pt presented unable to walk 2'' to back pain. Pain is localized to SI joint area. 5/06/2008 MR received for ER visit 3/10/2008 with DX: Headache. Pt presented following D/C from inpt stay with worsening h/a assoc with neck and back pain. 07/21/2008 MR received from Allergy/Immunology consult dated 3/12/2008 to 6/20/2008 with DX: Gardasil induced vasculitis. On the evening of the 3rd Gardasil vax pt awoke with fever, feeling delusional with aching chills. Pt continued to have fevers, excrutiating headaches and back pain which worsened following LP. PE (+) for glassy eyes, dehydration, unable to stand, diffuse weakness. Pulse increased from 50 to 90 upon standing. Started on Prednisone with 80-90% improvement. Seen again 6/20/08 with improvment of sx of vasculitis. Reports post-exercise exhaustion.


VAERS ID: 308330 (history)  
Age: 17.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2008-01-26
Onset:2008-02-02
   Days after vaccination:7
Submitted: 2008-03-26
   Days after onset:52
Entered: 2008-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1448U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Full blood count normal, Laboratory test normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia, Thyroid function test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: magnetic resonance 02?/??/08 - head and spine normal; complete blood cell 02?/??/08 - normal; blood chemistry 02?/??/08 - normal; thyroid function test 02?/??/08 - normal 6/3/08-records received-MRI thoracic spine, mild degenerative disc changes. MRI lumbar spine normal and cervical lordosis. EEG normal.
CDC Split Type: WAES0803USA03845

Write-up: Information has been received from a physician, concerning a white female student (age not reported), with no pertinent medical history, who on 23-NOV-2007 was vaccinated with the first dose, and on 26-JAN-2008 was vaccinated, IM, with the second dose of GARDASIL (lot #659653/1448U). The physician noted that on 06-NOV-2007, the patient had been vaccinated with a dose of HAVRIX and a dose of MENACTRA. There was no illness at the time of vaccination. On 02-FEB-2008 the patient experienced paresthesias of both feet and up her legs, with some weakness, that continued through the month. On 26-FEB-2008 she experienced "pins and needles" of her arms and shoulders. The patient visited the physician, and on an unknown date, diagnostic testing included a magnetic resonance imaging (MRI) of the head and spine, a complete blood count (CBC), blood chemistries and a thyroid panel, all with normal results. At the time of this report, the outcome of the events was not recovered. The physician considered the events to be serious as disabling or incapacitating. Additional information has been requested. 6/3/08-records received-seen on 2/6/08 with C/O chronic back pain (pine and needles) both legs, hip and ankle. Trouble sleeping. Began on Monday. Feels unbalanced when standing. Urinary incontinence. PE Babinski decreased on right. Unable to stand on tiptoes. Romberg wobbly. Reflexes normal. Sensation in left toe dull. 4/30/08 symptoms continue but improving now intermittent. Neurologist: post viral syndrome. Flu vaccine administered in November along with Gardasil. Meningitis vaccine in November.


VAERS ID: 308331 (history)  
Age: 17.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2007-10-01
Onset:2007-11-01
   Days after vaccination:31
Submitted: 2008-03-26
   Days after onset:146
Entered: 2008-03-27
   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: Activities of daily living impaired, Biopsy skin abnormal, Condition aggravated, Hepatic function abnormal, Polyarteritis nodosa, Renal impairment, Skin lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Interstitial lung disease (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CELEBREX
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: renal function study elevated; skin biopsy medium vesicle vasculitis; hepatic function tests elevated
CDC Split Type: WAES0803USA03854

Write-up: Information has been received from a physician, concerning a 17 year old female patient with an allergic reaction to CECLOR and no other pertinent medical history, who in August 2007, was vaccinated with the first dose and in October 2007 was vaccinated with the second dose of GARDASIL (lot #''s not reported). After the second dose, in November 2007, the patient''s mother noticed early lesions. In February 2008, the patient was administered the third dose of GARDASIL (lot # not reported). Concomitant therapy also possibly initiated in February 2008 ("a few weeks ago") included CELEBREX. Following the third vaccination of GARDASIL, the lesions worsened. Diagnostic studies included liver functions tests, elevated; renal function test, normal, a skin biopsy, medium vesicle vasculitis. The physician indicated the patient had polyarteritis nodosa, which he described as "another name" for medium vesicle vasculitis. The patient was a runner, and was uncomfortable and had difficulty running due to the symptoms. The patient''s polyarteritis nodosa persisted. The physician considered the event to be disabling/incapacitating. Additional information has been requested.


VAERS ID: 308667 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2008-02-20
Onset:0000-00-00
Submitted: 2008-03-31
Entered: 2008-04-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy, Erythema nodosum, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: biopsy, 03/??/08, erythema nodosum
CDC Split Type: WAES0803USA04427

Write-up: Information has been received from a physician concerning a 17 year old female patient with a penicillin allergy, who on 20-FEB-2008 ("five weeks ago"), was vaccinated with the first dose of GARDASIL (lot # not reported). In March 2008, 3 to 4 weeks after the vaccination, the patient developed a rash. The rash was very painful and was confirmed by biopsy as erythema nodosum. At the time of this report, the patient had not recovered. The physician felt that erythema nodosum which was very painful, was considered to be disabling. Additional information has been requested.


VAERS ID: 311000 (history)  
Age: 17.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2008-02-19
Onset:2008-02-21
   Days after vaccination:2
Submitted: 2008-04-25
   Days after onset:63
Entered: 2008-04-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPAMAX; EFFEXOR
Current Illness: Depression
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA04062

Write-up: Information has been received from a physician concerning a 17 year old female patient with depression and no known drug allergies, who on 19-FEB-2008 was vaccinated with the first dose of Gardasil. Concomitant therapy included EFFEXOR and TOPAMAX. On 21-FEB-2008 the patient developed urticaria after administration of her first dose of Gardasil. The patient was examined in the Emergency Room and was treated with epinephrine and prednisone. She was not admitted and was released the same day (date unknown). No diagnostic laboratory testing was performed. It was reported that she was currently taking prednisone and an antihistamine. At the time of this report, the outcome had not recovered. No product quality complaint was involved. The reporting physician considered the urticaria to be disabling, due to the patient''s mental stress. Additional information has been requested.


VAERS ID: 311859 (history)  
Age: 17.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2008-03-20
Onset:2008-04-15
   Days after vaccination:26
Submitted: 2008-05-07
   Days after onset:22
Entered: 2008-05-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1486U / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Impaired driving ability, Muscle disorder
SMQs:, Rhabdomyolysis/myopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none
Diagnostic Lab Data: Unknown. Labs and Diagnostics included in report: CBC WNL. ESR 19. ANA (-). CH50 91n. C3 115.8n. C4 26.3n. EBV c/w past infection (Capsid Ag IgG 7.01, Nuclear Ab IgG 16.99. ) Labs and Diagnostics: MRI brain WNL- no eveidence of demyelination. MRI thoracic and lumbar spine WNL. EMG WNL. Urine myoglobin <1. CPK 46 WNL. Lyme titre (-). 9/15/08 Additional labs received from hospital. Parvovirus IgG (+) 6.89. Lyme (-).
CDC Split Type: WAES0805USA00463

Write-up: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM. In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn''t drive". Unspecified medical attention was sought. At the time of reporting it was unknown if the patient had recovered. When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car". Additional information has been requested. 8/19/08 To be linked to 311859 and 316857. 8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks. Not weak; doubt Guillain-Barre syndrome. PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely). PE WNL except 4+ DTRs in the lower extremities.


VAERS ID: 315899 (history)  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2008-01-29
Onset:2008-02-04
   Days after vaccination:6
Submitted: 2008-06-10
   Days after onset:126
Entered: 2008-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1522U / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Gastrointestinal disorder, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none. PMH: anemia. abcess foot. Allergy to sulfa.
Diagnostic Lab Data: MRI, EEG, MRA, CT SCAN. Labs and Diagnostics: Head CT WNL. EEG WNL. CXR WNL.
CDC Split Type:

Write-up: My daughter has been having seizures since she had her second Gardasil vaccination. She also had intestinal problems for approximately four weeks immediately after vaccination. She continues to have seizures. 6/16/2008 MR received for 2 ER visits 3/31 and 4/10 2008 with DX: Dystonic Reaction, Anxiety (3/31) and Seizure, Costochondritis (4/10). Initially presented with uncontrollable shaking and stiffness episodes several times/hr. Some diarrhea/ vomiting recently. MD observed tonic-clonic motions of the neck muscle. Pt remained awake. Seen again 4/10 with c/o of seizure with sharp chest pain. Tremors noted of the upper body. Recently started on Topamax for Seizure 7/15/2008 MR received for DOS 5/14-19/2008 with D/C DX: Non-epileptic seizures. Pt presented with ~6 week hx of episodes of unresponsiveness, jaw tremors with arm flexing which began 6 weeks after 2nd Gardasil vax. Pt has no recollection of events. Episodes down from 15-25/day to 1-2/day after starting Topamax and Keppra. Pt c/o post-ictal h/a and confusion. Pt had multiple events without EEG changes during hospitalization. Weaned from Keppra and Topamax and d/c.


VAERS ID: 316075 (history)  
Age: 17.0  
Gender: Female  
Location: Maryland  
Vaccinated:2008-06-02
Onset:2008-06-02
   Days after vaccination:0
Submitted: 2008-06-11
   Days after onset:9
Entered: 2008-06-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure, Injection site pain, Pruritus, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: tuberculin purified protein
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure, 06/02/08 - result not reported
CDC Split Type: WAES0806USA00594

Write-up: Information has been received from a consumer concerning her 17 year old daughter who on 02-JUN-2008 was vaccinated with a first dose 0.5 mL of GARDASIL. Concomitant therapy included tuberculin purified protein derivative and meningococcal vaccine (manufacturer unknown). The mother reported that on 02-JUN-2008 her daughter fainted after she was vaccinated with her first dose of GARDASIL. She also developed itching on her hand and soreness at the injection site. The patient sought unspecified medical attention. The patient''s blood pressure was obtained (results not reported). A telephone call was placed to the doctor''s office to obtain more information. At this time no additional information was available. The patient was recovering. The reporter considered the events syncope, patient experienced itching on her hand and soreness at the injection site to be disabling. Additional information has been requested.


VAERS ID: 318399 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2007-07-13
Onset:2007-08-10
   Days after vaccination:28
Submitted: 2008-07-07
   Days after onset:332
Entered: 2008-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Autoimmune disorder, Biopsy muscle abnormal, C-reactive protein increased, Computerised tomogram normal, Fasciitis, Myositis, Red blood cell sedimentation rate increased, Serology normal
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none. PMH: TMJ. NKDA.
Diagnostic Lab Data: EST 80; CRP 50; Hgb 8.3. Muscle biopsy showed myofasciitis. Bone marrow bx, CT chest/abd/pelvis negative. Multiple serologies for other autoimmune entities negative. Labs and Diagnostics: Hgb 8.7. Hct 27.2. Platelets 499K. ESR 64. ANA (-). RF 14. CRP up to 43.78. Complement C3 167. Lyme (-). Chest, abd and pelvic CT WNL. Bone marrow Bx (-). Bx L forearm (+) for lymphocytic infiltrate muscle $gfascia and (+) perivascular lymphocytes w/o necrosis. L shoulder X-ray WNL. MRI C-spine WNL. MRI L forearm (+) edema muscle & fascia.
CDC Split Type:

Write-up: autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks postvaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. 07/09/2008 Office notes received from Rheumatologist from 9/7/2007 to 4/03/2008 with DX: Myositis/Fasciitis L arm. Pt developed L shoulder pain and decreased ROM in 8/2007 which has persisted. Pt then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. PE (+) for TMJ pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the L forearm. Pain upon dorsiflexion of L wrist. Swelling noted on L forearm. Started on Pred. Much improved by 10/11/07 with Pred taper scheduled. Increased pain with decreased pred. Dose increased and Methotrexate started. Episode of inflammation L leg (ankle and shin pain) 4/2008.


VAERS ID: 320560 (history)  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-25
Entered: 2008-07-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Skin laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA04414

Write-up: Information has been received from a physician concerning a 17 year old female on an unknown date was vaccinated with the second dose of GARDASIL. After getting the second dose, the patient fainted and hit her head (causing a gash on her head). The patient sought medical attention. The patient''s outcome was not reported. Patient fainted and hit her head (causing a gash on her head) were considered to be disabling by the reporting physician. Additional information has been requested.


VAERS ID: 320561 (history)  
Age: 17.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-01-01
Onset:2008-05-27
   Days after vaccination:512
Submitted: 2008-07-25
   Days after onset:59
Entered: 2008-07-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anal haemorrhage, Anogenital warts, Proctalgia, Smear cervix
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pollen allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA04489

Write-up: Information has been received from a physician concerning a 17 year old female with pollen allergy who in approximately 2007 was vaccinated with two doses of GARDASIL. On 10-JUN-2008, the patient was taken to the ER with a complaint of anal pain and bleeding starting about 1-2 weeks before the ER visit. The patient was diagnosed with severe anal warts. On an unspecified date, the patient had a PAP test performed (results not provided). Out patient surgery was done with good results. The patient missed school as a result of the surgery. On an unknown date the patient recovered. The reporting physician considered the severe anal warts to be disabling and an other important medical event. The physician noted the mother of the patient believed that her daughter''s anal warts were caused by GARDASIL. Additional information has been requested.


VAERS ID: 321638 (history)  
Age: 17.0  
Gender: Female  
Location: Colorado  
Vaccinated:2008-06-16
Onset:2008-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2008-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0070X / 1 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Echocardiogram, Full blood count, Headache, Lumbar puncture, Neurological examination, Ophthalmological examination, Optic neuritis, Prothrombin time, Rheumatoid factor
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PPD
Current Illness: None
Preexisting Conditions: Chronic ankle sprain 2/08 to 5/08
Diagnostic Lab Data: MRI x 2; ophthalmology evaluations, neurology, visual evoked response, spinal tap, CBC, PT/PTT, cardiogram, RA, ANA, infections 8/12/08-records received- LP opening pressure 23. Sed rate increased 21, CSF RBC increased 62.0, culture negative. Visual evoked response borderline evoked response because of borderline interocular difference at 32 minutes of arc. MRI which was normal.
CDC Split Type:

Write-up: Patient developed left optic nerve neuritis June 29, 2008. Also, chronic headache. 8/12/08-records received for DOS 7/3-7/8/08-DC DX: Optic neuritis versus pseudotumor. Presented to ED with 3 week history of blurred vision of left eye and headache. One week prior patient saw eye doctor who noted swelling of optic nerve unilaterally and referred for MRI which was normal.


VAERS ID: 325286 (history)  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-10-15
Onset:2007-10-16
   Days after vaccination:1
Submitted: 2008-08-14
   Days after onset:303
Entered: 2008-08-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0530U / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Allergy test negative, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: doxepin hydrochloride; TILIA FE; XYZAL; MACROBID
Current Illness: Urinary tract infection
Preexisting Conditions: Penicillin allergy
Diagnostic Lab Data: allergy test, ?/?/08, Negative
CDC Split Type: WAES0807USA04035

Write-up: Information has been received from a consumer concerning her daughter, an 18 year old female with penicillin allergy who on an unspecified dates was vaccinated with the first and second doses of GARDASIL. The patient did not experience any adverse symptoms after the first and second dose of GARDASIL. In March 2008, was vaccinated with the third dose of GARDASIL, intramuscular, in the left upper arm. There was no concomitant medication. In March 2008, since the patient received the third dose of GARDASIL she developed redness, swelling and tenderness at the injection site of the left upper arm within hours of receiving it. The injection site reaction resolved in a few days without treatment. Since then, the patient has experienced intermittent episodes of widespread hives. The patient was examined by her primary care physician, as well as an allergist, who both prescribed antihistamines and a short-course of unspecified steroids. Contact information for the primary care physician and allergist were not provided. The allergist performed allergy testing, which was negative. The patient continues to experience the episodes of hives. The patient is scheduled to be evaluated by a dermatologist on 21-JUL-2008. No further information available at this time. Additional information has been requested. Conflicting follow-up information was received from a physician, who reported that on 15-OCT-2007 the patient was seen and was vaccinate dwith the third dose of GARDASIL. The physician reported that the patient started on therapy with MACROBID for the treatment of Urinary tract infection. The patient called the reporter on 16-OCT-2007 because she had a sweeling near the shot side and some swelling and some other symptoms in her hand. The patient had a welt on her right arm that was approximately 4 cm in diameter right at the injection site. It was raised just a couple of millimeters over the surface. Her hand on that side, right, was a little puffy. The patient was seen by the physician on 16-OCT-2007. Since this was the third dose of GARDASIL, the physician told the patinet that her series was complete. The physician suspected that the patient may be having a reaction to a chemical , preservative, or protein in the injection. The patient was advised to apply some caladryl or topical BENADRYL and take BENADRYL at night since it was likely to make her sleepy during the day. No additional information is expected. This is in follow-up to report(s) previously submitted on 8/14/2008; 10/8/2008. Follow up information has been received from physician, concerning the female patient with no illness at the time of vaccination, who on 11-APR-2007 was vaccinated with the first dose of GARDASIL (Lot number 657617/0384U) IM in the right deltoid. On 15-JUN-2007, the patient was vaccinated with the second dose of GARDASIL (Lot number 675622/0388U) IM in the right deltoid and on 15-OCT-2008 with the third dose of GARDASIL (Lot number 0530U) IM in the right deltoid. Concomitant therapy included XYZAL, doxepin hydrochloride and TILIA FE. On 16-OCT-2007, the patient experienced and allergic reaction after the third dose of GARDASIL. After the patient received the vaccine her arm swelled. On the next day, on 17-OCT-2007, the patient developed hips on her hips and developed sore/ulcer in her mouth and in her lips. On 25-OCT-2007 it was reported to the responsible physician and on 26-OCT-2007 the patient sought medical attention at office for evaluation and treatment. On an unknown date, was performed a complete blood cell count, comprehensive metabolic panel, serum immunoglobulin E test, thyroid peroxidase antibody and GGPD and C-reactive protein test (results not provided). The hives was considered to be disabling and an other important medical event by the physician since the patient had hives daily for one year and was currently treated. No further information is available.


VAERS ID: 323677 (history)  
Age: 17.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-12-21
Onset:2008-01-25
   Days after vaccination:35
Submitted: 2008-08-28
   Days after onset:215
Entered: 2008-08-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0387U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antibody test positive, Arthralgia, Fibula fracture, Laboratory test abnormal, Peripheral coldness, Raynaud's phenomenon, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Accidents and injuries (narrow), Vasculitis (broad), Hypersensitivity (broad), Arthritis (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None PMH: periorbital cellulitis age 3. HPV #1 0960F, given 6/28/07, HPV #2 0960F given 8/29/07. Menactra U2107AA, given 6/28/07. Smoker, depression/anger, occasional ETOH, contraception. UTI w/normal renal US, avulsion fibula fx, migraine HA, scoliosis, dysmenorrhea.
Diagnostic Lab Data: diagnostic laboratory, positive SM/RNP antibody; Smith antigen, positive LABS: WBC 12.27(H), ANC 9.77(H). ESR 34(H). CRP 5.30(H). ANA ab IgG 1:5120(H), SSA/RO IgG 118(H), ribonucleic protein IgG .1 Throat c/s neg. IgG 1740(H), RF 50.7(H), C4 13(L). Haptoglobin 190(H).
CDC Split Type: WAES0808USA04680

Write-up: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U). Concomitant therapy included MENACTRA. In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists. The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud''s lupus. Smith antigen antibodies test indicated positive. SM/RNP antibody was positive. The patient''s Raynaud''s lupus persisted. No product quality complaint was involved. Raynaud''s lupus was considered to be disabling due to numbness and joint pain. Additional information has been requested. 10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP. Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement. 9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination. RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before. Also complaining of numbness of hands. Exam revealed tender lymph nodes, reddened throat. Dx w/viral illness. RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA. Boyfriend had mono. RTC 12/21 for final HPV. C/O spotting few days prior to menses for past several cycles. RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms. Dx w/probably Raynaud''s. RTC 2/25 for hands turning purple when cold then white & painful. When warm, hands get red, sweaty & swollen. Also c/o facial acne. RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose. Dx w/pharyngitis, probably viral. RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive. Dx w/probable connective tissue/autoimmune disorder. Encouraged to d/c oral contraceptiives & switch to IUD. Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.


VAERS ID: 325585 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2007-12-01
Onset:2008-01-01
   Days after vaccination:31
Submitted: 2008-09-18
   Days after onset:260
Entered: 2008-09-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Autoimmune disorder, Headache, Malaise, Myalgia, Systemic lupus erythematosus
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (narrow), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA01973

Write-up: Information has been received from a consumer concerning her daughter a 17 year old female who on an unspecified dates was vaccinated with the first and second doses of GARDASIL. In December 2008, the patient was vaccinated with a third dose of GARDASIL. Around January 2008, the patient developed headaches and muscle aches. She has a pending diagnosis of lupus. The patient has been in and out school due to sickness and autoimmune systems issues. Upon internal review, lupus was determined to be an other important medical event. Additional information has been requested.


VAERS ID: 326953 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-07-07
Onset:2008-07-07
   Days after vaccination:0
Submitted: 2008-09-28
   Days after onset:83
Entered: 2008-10-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0072X / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain lower, Activities of daily living impaired, Arthralgia, Electrocardiogram, Erythema, Headache, Immunisation reaction, Malaise, Oral intake reduced, Ovarian cyst, Pelvic pain, Pyrexia, Ultrasound scan, Urine analysis, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: My daughter never had any health problems before the GARDASIL shot. I took her to the OB/GYN to get her on birth control pills hoping it would shorten her period. The doctor put her on YAZ and that seem to work just fine until we decided a few months later to get this shot. PMH: none. on Yaz
Diagnostic Lab Data: EKG, 9/15/08; Urine test, 7/7/08, 8/11/08, 9/15/08; Doctor exam, 7/7/08, 8/11/08, & 9/15/08; Ultrasound, 9/15/08
CDC Split Type:

Write-up: My daughter had the first GARDASIL shot on 7/7/08. 7 to 10 days later she began having severe pains and cramping in her pelvic area along with redness, fever, vomiting, and joint pains. Her doctor said it was just a reaction to the shot and after examining her told her to go home and take TYLENOL for headaches, pains, etc because she was the first case he had seen this severe and didn''t know what to do other than to examine her once a month. Every week she has experienced severe joint pains, cramps, not feeling well enough to eat, etc. She lost 10 lbs. Since she is 17 years old and only weighed 105 lbs that didn''t set well with me. She is naturally skinny. The gynecologist still doesn''t know what to do with my daughter''s pains. He did an EKG, ultrasound, urine test and they all came back ok. The ultrasound showed an enlarged cyst on one of her ovaries. This is getting ridiculous in the fact that she can no longer lead a normal life due to weekly pains and not feeling well. Isn''t there anything she can take to reverse the medicine''s side effects as I see this as being a lifetime adventure for her. PLEASE ADVISE on what I as a parent can do next. I feel this is all the medicine''s fault because my daughter Never had anything wrong with her until after having this shot. I don''t like reading all the articles about this shot and seeing that the company tries to blame every day life events or happenings for causing the bad things to happen to these girls. It is definitely the GARDASIL Shot that has caused the adverse health of these young girls having problems. 12/29/2008 PCP records received for several OVs between 9/29/08 and 11/10/2008. Pt initially presented with c/o painful joints, cramping chest pain. ROS (+) for fever, chills, fatigue, 10 lb weight loss, abdominal pain, nausea, vomiting, H/A, eye pain, ear pain, sore throat, congestion, runny nose and Flu-like sx since Gardasil vax in July. Pt also reports sleep disturbance, joint pain and swelling, morning stiffness, myalgias, anxiety and depression. Missed 5 days of school. PE (+) for joint tenderness and ache. Assessment: Joint disease-multiple joints. Pain in Limb. Loss of Weight. AC Maxillary sinusitis. Nausea with vomiting. F/U 10/13/08 with no improvement. furthe heartburn, abdominal pain and bloating note with loss of appetite. Assess: Esophagela Reflux. Abdominal Pain-Epigastric. Bloating. F/U 11/10/08 Abdominal pain, nausea and vomiting improved on meds. Assess: Esophageal leukoplakia. Nausea with vomiting. Irregular menstruation.


VAERS ID: 333441 (history)  
Age: 17.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2007-05-02
Onset:2007-05-02
   Days after vaccination:0
Submitted: 2008-11-26
   Days after onset:574
Entered: 2008-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0314U / 0 RL / UN

Administered by: Private       Purchased by: Private
Symptoms: Abnormal loss of weight, Electrocardiogram normal, Full blood count normal, Headache, Nuclear magnetic resonance imaging normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills or Nuva Ring without problems
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Neg MRI/CBC/ EKG 2007 and 2008. Labs and Diagnostics: MRI brain WNL
CDC Split Type:

Write-up: Frontal headache began day of first dose of GARDASIL vaccine (05-02-2007) - Neurologist consulted 07/2008 after headache continued daily/constantly x over 1 yr - Neurologist states likely migraine cycle triggered by HPV vaccine - Condition now worsened to debilitating status for several days in a row. 5/12/10 Follow up: Residual migraine headaches with syncope and neurological signs. 1/21/2009 MR received from neurologist. Pt seen for several visits between 11/17/08 and 12/10/08 in f/u for Classic migraine. Seen 11/17/08 for migraine h/a sx which began 6 days prior including nausea and visual disturbance. ROS (+) for fatigue, blurred vision, eye pain, photophobia, dizziness, tachycardia, acid reflux sx of heartburn, nausea and vomiting, back pain, ataxia, confusion, fainting, headaches, memory loss, paresthesias, speech disorder, tremors, vertigo and weakness. PE WNL. DX: Classic migraine. F/u 11/20/08 with no relief of sx-still with global H/A and nausea. Recent syncopal event with ER visit. ROS now includes tinnitus, tooth pain, limb pain, myalgias. Tx with steroid, promethazine and dyphenhydramine. F/U 12/10/08 Migraine now resolved. ROS (+) for unintentional wt loss. On multiple meds. 1/29/2010 Chronic headache-migraine.


VAERS ID: 333822 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-08-25
Onset:2008-08-25
   Days after vaccination:0
Submitted: 2008-12-03
   Days after onset:100
Entered: 2008-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0053X / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Facial bones fracture, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA00008

Write-up: Information has been received from a nurse practitioner concerning a 17 year old female patient who on 25-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 0053X). There was no concomitant medication. It was reported that the patient fainted 1 to 2 minutes after receiving the dose. Patient hit her face on the wall and broke her nose which was considered to be disabling. Patient sought medical attention with the nurse practitioner. Additional information has been requested.


VAERS ID: 335275 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2008-07-02
Onset:2008-07-02
   Days after vaccination:0
Submitted: 2008-12-12
   Days after onset:163
Entered: 2008-12-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Dilatation atrial, Dilatation ventricular, Dyspnoea, Echocardiogram abnormal, Mitral valve incompetence, Tachycardia, Tricuspid valve incompetence
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Echocardiography, 11/26/08, right dilated atrium and ventricle with mitral valve and tricuspid regurgitation LABS: Cardiac cath abnormal.
CDC Split Type: WAES0812USA01810

Write-up: Information has been received from a physician assistant concerning an 18 year old female who on 12-OCT-2007 was vaccinated with the first dose of GARDASIL, the second dose of GARDASIL on 08-FEB-2008, and the third dose of GARDASIL on 02-JUL-2008 (lot numbers and routes were not specified). Concomitant therapy included YASMIN. It was reported that on 02-JUL-2008 after the administration of her third dose the patient experienced shortness of breath and tachycardia upon exertion. The patient has experienced two seizures, the first one was two weeks ago and the second one 3 days ago. An echocardiogram performed on 26-NOV-2008 showed right dilated atrium and ventricle with mitral valve and tricuspid regurgitation. The patient''s heart rate increased from 80 to 150 after a short walk in the physician''s office on 05-DEC-2008. Patient was admitted into the hospital on 05-DEC-2008. Shortness of breath, tachycardia, seizures, resulted in hospitalization and were considered to be disabling and immediately life-threatening. Additional information has been requested. 12/23/08 Reviewed hospital medical records of 12/5-12/12/2008. FINAL DX: severe pulmonary hypertension, etiology unknown; seizure vs pseudoseizure secondary to hypoxia & tachycardia; mild obesity. Records reveal patient experienced SOB, chest pain x approx 6 wks, syncope & seizures x 2. Cardiac consult done.Tx w/meds & improved.


VAERS ID: 337302 (history)  
Age: 17.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2008-12-31
Onset:2009-01-02
   Days after vaccination:2
Submitted: 2009-01-13
   Days after onset:11
Entered: 2009-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0279X / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: 2/2/09-records received- Dysuria, left flank pain times 5 days. After first dose of Keflex felt lightheaded, fall to ground with whole body shaking.
Preexisting Conditions: None 2/2/09-records received- PMH: GTC seizure at 8 years of age andmultiple episodes of passing out with exercise and hypoglycemia. Urinary tract infection. Staph knee infection last year.
Diagnostic Lab Data: Unknown 2/2/09-records received-Renal ultrasound normal. Labs WNL. MRI brain normal.
CDC Split Type: WAES0901USA00986

Write-up: Information has been received from a nurse practitioner concerning a 17 year old female with no medical history and drug allergies who on 31-DEC-2008 was intramuscularly vaccinated with the third 0.5 ml dose of GARDASIL. She had no problems after receiving the 1st and 2nd doses of GARDASIL. At 22:30 on 02-JAN-2009, 48 hours later, the patient experienced seizure type activity and convulsions, 2 more occurred by 23:30 during which time she was taken to the hospital. It was decided in the emergency room to take the patient to a hospital early on 03-JAN-2009. The patient had a total 13 seizures type activities or convulsions but it was unclear the specific time frame. Laboratory tests included an magnetic resonance imaging, ultrasound of the kidney, and "lots of unspecified lab work" (one of the results were normal kidney function). The patient has one more episode after being discharged from the hospital on 04-JAN-2009. The patient was put on XANAX and her mother felt it had helped control the seizure type activity and convulsions. The patient started KEFLEX and AZO for urinary tract infection on 02-JAN-2009. The seizures type activities or convulsions was considered to be disabling. Additional information has been requested. 2/2/09-records received for DOS 1/3-15/09-DC DX: Spells. presented to ED with difficulty breathing, rash and episodic jerking. Rash on back, chest and neck and felt short of breath. Rash would come on with shaking and improve when shaking stopped.


VAERS ID: 338050 (history)  
Age: 17.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2009-01-12
Onset:2009-01-12
   Days after vaccination:0
Submitted: 2009-01-22
   Days after onset:10
Entered: 2009-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0063X / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Body temperature increased, Headache, Influenza serology negative, Mononucleosis heterophile test negative, Pyrexia, Rash maculo-papular
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ciprofloxacin
Current Illness: Urinary tract infection
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory, 01/15?/09, rapid influenza test negative; Diagnostic laboratory, 01/15?/09, mononucleosis test negative; Temperature measurement, 01/12/09, 102 F
CDC Split Type: WAES0901USA02024

Write-up: Information has been received from a physician concerning a 17 year old female with no drug allergies who had recent urinary tract infection and completed a course of ciprofloxacin on 10-JAN-2009. She was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL on 12-JAN-2009. The patient developed a severe headache a few hours after receiving GARDASIL. The next day she developed a fever of 102F and a maculopapular rash on her face and trunk. On 14-JAN-2009 the patient developed abdominal cramping. She was examined in the office on 15-JAN-2009. A "rapid influenza test and monocyte test" were negative. Unspecified blood work was pending. The patient had been unable to attend school due to the severity of the headache. The patient did not recover at the time of reporting. No further information provided. Headache, fever, maculopapular rash and abdominal cramping was considered to be disabling. Additional information has been requested. 1/29/09-Follow-up from Merck on 1.28.09: PCP''s nurse reported that the patient was given a Medrol Dose Pak and the symptoms of headache, rash, abdominal pain and fever resolved within a week


VAERS ID: 339249 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-12-22
Onset:0000-00-00
Submitted: 2009-02-06
Entered: 2009-02-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Facial bones fracture, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA00465

Write-up: Information has been received from a physician''s assistant concerning a 17 year old female who "within the last month and a half", on approximately 22-DEC-2008, was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided). It was reported that after receiving GARDASIL, the patient fainted and broke her nose on the floor. Unspecified medical attention was sought. It was reported that the vaccine was discontinued "within the last month and a half". The outcome of the patient was not reported. The reporter considered the patient''s events to be disabling. Additional information has been requested.


VAERS ID: 340882 (history)  
Age: 17.0  
Gender: Female  
Location: Nevada  
Vaccinated:2007-03-13
Onset:2007-03-13
   Days after vaccination:0
Submitted: 2009-02-28
   Days after onset:718
Entered: 2009-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Agitation, Alopecia, Alpha-1 anti-trypsin normal, Amenorrhoea, Anaemia, Arrhythmia, Arthralgia, Asthenia, Autoimmune disorder, Body temperature decreased, C-reactive protein normal, Cardiovascular insufficiency, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Cyanosis, Dizziness, Dyspepsia, Dysphagia, Epstein-Barr virus infection, Epstein-Barr virus test negative, Fatigue, Feeling cold, Furuncle, Gait disturbance, Gout, Haematocrit normal, Haemoglobin normal, Headache, Heart rate decreased, Hepatitis C, Hepatitis C antibody positive, Hormone level abnormal, Hypoaesthesia, Hypoglycaemia, Hypotension, Hypothyroidism, Irritability, Lymphadenopathy, Melanosis coli, Movement disorder, Muscle fatigue, Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Nausea, Orthopnoea, Pain, Pain in extremity, Pallor, Pancreatitis, Pancytopenia, Platelet count decreased, Pulse abnormal, Skin discolouration, Somnolence, Speech disorder, Spleen disorder, Swelling face, Synovial cyst, Tachycardia, Thrombocytopenia, Tinnitus, Urinary tract infection, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver infections (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Agranulocytosis (narrow), Angioedema (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypothyroidism (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Myelodysplastic syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none 3/18/09-records received-Recurrent sinusitis, status post rhinoseptoplasty. hepatitis C. Questionalbe history of Epstein-Barr virus infection. Gastroesophageal reflux disease.
Diagnostic Lab Data: Diagnosed with: Thrombocytopenia, Pancytopenia, Ammenorrhea, Hypothyroidism, Anemia, low blood pressure, Autoimmune Disorder, partial organ failure, digestive disorder, Epstein Barre, Orthopnoea, hormonal imbalance, urinary tract infection, Gout, Pancreatitis, alarmingly low heart rate (34 pbm). 3/18/09-records received-CT chest negative. CT abdomen and pelvis normal, large amount of stool noted borderline splenomegaly otherwise unremarkable. Echocardiogram pending. White count 3.5, hemoglobin 11.6, hematocrit 34.7 and platelets 78,000. EBV negative. CRP 0.6. Hepatitis C antibody positive. Alpha-1antitrypsin 136. Reticulocyte count normal.
CDC Split Type:

Write-up: AFTER FIRST GARDASIL VACCINE (administered 9/13/06): experienced dizziness, light-headed, nauseous, headaches, leg cramps, and shooting leg pain. AFTER SECOND GARDASIL VACCINE (administered 11/13/06): experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. AFTER THIRD GARDASIL VACCINE (administered 3/13/07): experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive problems, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.). TREATMENT: had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for me. Recently have been referred to a clinic. (scheduled appt. for 3/30/09). 3/18/09-records received for DOS 5/18-5/20/08-DC DX: Chronic constipation. Exercise induced asthma. Cyanosis. Pancytopenia. Presented to ED with increased generalized weakness and constipation since 2/08.Taking a Chinese herbal formula for chronic fatigue astra lsatis. Possibility of viral syndrome secondary to hepatitis C. PE: differential in pulses bilaterally, cyanotic in extremities pulse ox O2 saturation 87% at exercise but increased at rest. Follow-up: Leg pain, numbness, stiffness, partial organ failure, anemia low platelets, cardiac arrhythmia, low body temperature, EBV onset, Hep C onset, UTIs, pancreatitis, amenorrhea, melanosis coli, gout, boils, Baker''s cyst, swollen glands hypothyroidism, hypoglycemia, chronic somnolence episode tachycardia, dysphagia, orthopnea, thrombocytopenia.


VAERS ID: 344345 (history)  
Age: 17.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-07-12
Onset:2007-09-26
   Days after vaccination:76
Submitted: 2009-04-17
   Days after onset:569
Entered: 2009-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Blood follicle stimulating hormone normal, Blood insulin normal, Blood luteinising hormone normal, Blood test abnormal, Blood thyroid stimulating hormone normal, Corneal abrasion, Depression, Disturbance in attention, Dizziness, Dysuria, Fatigue, Headache, Hyperacusis, Hyperaesthesia, Hypokinesia, Lymphocyte count decreased, Mean cell haemoglobin concentration, Migraine, Muscle spasms, Musculoskeletal stiffness, Myalgia, Osteosclerosis, Pain, Paraesthesia, Paranasal sinus hypersecretion, Parosmia, Photophobia, Pyrexia, Sinusitis, Spinal X-ray, Tenderness, Urinary tract infection, Urine analysis abnormal, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (narrow), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mircette,multi vitamin, zantac. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. Zantac, tetracycline, Celebrex, birth control pills, fish oil, multivitamins, tramadol. Enbrel, Bactrim.
Current Illness: Seasonal allergies, acne
Preexisting Conditions: acne, GERD, Allergic ceftin, dioxicillian. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. Heartburn, tennis elbow, knee pain, chronic fatigue. PMH: environmental allergies, obesity, hirsutism, acne, on BCP.
Diagnostic Lab Data: Positive sacroilitis 10-08.MRI 12-08 Diagnosed migrains, chronic fatigue, depression 4-09 5/27/09 Rheumatology records DOS 5/19/09. LABS and DIAGNOSTICS: MRI sacrum - sacroiliitis. Additional MRI of sacrum and X-ray lumbar spine - pending. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. LABS and DIAGNOSTICS: Anti-CCP (-), Rheumatoid factor (-), HLA-B27 (+), ESR 22 mm/Hr (H), C-reactive protein 1.7 mg/dL (H), X-ray - bilateral mild sclerosis and sacroiliitis. CBC - MCHC 34.7 g/dL (H). Urinalysis - blood trace, bacteria trace. 4/20/09 Medical records LABS: 7/07 FSH, insulin, TSH, glucose, LH all WNL. MRI of 10/07 abnormal. 1/17/09 labs: WBC 11.0(H), neutros 80.0% (H), lymphs 16.0(L); ESR 17(N); CRP 5.8(H).
CDC Split Type:

Write-up: Initial fatigue, headaches, muscle cramps, muscle pain, sound sensitivityafter 1st shot. Increased in severity of all symptons. After 3 rd shot signficant increase in pain. Hip pain. Light,touch,smell sensitivity, chronic fatigue, tingling in hands, feet, sometimes all over body, faintness, joint spasmas. Poor, limited concentration. 5/27/09 Rheumatology records DOS 5/19/09. FINAL DIAGNOSIS: none provided. Post vaccination diffuse joint pain, lower back pain. Eye pain with photosensitivity. Recurrent urinary tract infections. Dysuria. Tenderness to lumbar spine. Decrease in lumbar flexibility. Tenderness at sacroiliac joints. Referral to ophthalmology and OB/GYN. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. FINAL DIAGNOSIS: Spondyloarthropathy with positive HLA-B27 and sacroiliitis, ankylosing spondylitis. Post vaccination developed low back pain, respiratory infection, pain left hip/buttock region. Decreased range of motion left hip. Hurts to walk. Pain has recurred in left knee and elbow. Fatigue. Mouth sores. Later presents with nausea, vision changes, photophobia. Urinary frequency. Muscle twitching and pain in some joints. Pain with stressing of sacroiliac joint. 4/20/09 Received PCP medical records of 5/22/07-11/02/2007. FINAL DX: none provided Records reveal patient experienced bronchitis when see 5/22/07. RTC 7/12/07 for HPV #1, lot # 0522U, IM/LA. RTC 9/26/07 for HPV #2 lot # 1060U, IM/RA. RTC 5/15/08 w/HA, fatigue, fever & sinus drainage. Dx w/sinusitis & tx w/antibiotic, nasal spray & antihistamine. 05/15/08 received HPV #3, lot 1757U IM/LA, and meningitis vax & Hep A vax (no lot #s provided for those). RTC 10/7/08 w/corneal abrasion right eye. Tx w/antibiotics. Ortho consult done 10/9/07 for right elbow pain x 10 mo s/p sledding accident 1/07 & dx w/sprain, probable ulnar collateral ligament tear. MRI revealed large tear of common flexor attachment at medial humeral epicondyle & referred for surgery. Tx w/injection & splinting but felt to need surgery later. No further records available. Follow-up received states - I am responding to your inquiry requesting follow-up on my daughter. Re: how or if my daughter recovered from this vaccine. The answer is clearly no. My daughter''s condition has continued to deteriorate over the past year. We have struggled to find provider who are even willing to consider the possibility her illness is a result of this vaccine. Included with this information is a copy of disability papers. Dr. has filled out in an attempt for my daughter to receive disability services. She is barely able to attend classes due to severity of her pain and levels of chronic fatigue. My brilliant A+ daughter is lucky to get up out of bed. Pt who trained 4 plus days a week in martial arts has trouble getting out of bed on a daily basis. I canot begin to express my anger and sadness about how this vaccine has affected the quality of my daughter''s life. We plan on seeking additional consultation with a neurologist and endocrinologist based upon ongoing problems. It has been difficult to find any type of medication that will alleviate my daughter symptoms. If you have any specialist whom you believe might be able to assist my daughter I would greatly appreciate that information. I have also included the additional vaccines my daughter received and their lot numbers. Attached are list of doctors that have treated her within the last year.


VAERS ID: 348547 (history)  
Age: 17.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2008-06-20
Onset:2009-02-23
   Days after vaccination:248
Submitted: 2009-02-23
   Days after onset:0
Entered: 2009-06-05
   Days after submission:101
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1740U / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Congenital anomaly, Laboratory test normal, Ultrasound scan abnormal
SMQs:, Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: received 3rd injection when 2 weeks preg did not know about pregnancy at this time
Current Illness:
Preexisting Conditions: During pregnancy no other medication or vaccine given/received gard 3rd injection when 2wks pregnant.
Diagnostic Lab Data: Seen on ultra sound before birth. Laboratory had labs done found no genetic defect/instructed to register on this website
CDC Split Type:

Write-up: Baby born without legs on 2/23/09.


VAERS ID: 353026 (history)  
Age: 17.0  
Gender: Female  
Location: Washington  
Vaccinated:2009-01-02
Onset:2009-03-11
   Days after vaccination:68
Submitted: 2009-08-04
   Days after onset:146
Entered: 2009-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0651X / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Activities of daily living impaired, Blood product transfusion, Dizziness, Evans syndrome, Headache, Idiopathic thrombocytopenic purpura, Palpitations, Platelet count decreased, Pyrexia, Red blood cell count decreased, Vision blurred, White blood cell count decreased
SMQs:, Haemolytic disorders (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: allergies to penicillin. ''Easy bruiser". Penicillin allergy. ''Ear tubes'', dental extractions.
Diagnostic Lab Data: ITP/Evans Syndrome... Will eventually turn into Lupus. LABS and DIAGNOSTICS. 1/2/09 to 3/18/09: Platelets 63 (L). 4/9/09 to 4/27/09: CBC - RBC 3.27 X10''3 (L) Hemoglobin 10.2 g/dl (L) Hematocrit 30.3% (L) Platelets <5 X10''3 (L) Myelocytes 1% (H) Retic Count 3.6% (H) ABS Retic Count 116.4 X10''3 (H). CHEM - Glucose 72 mg/dl (L) SGPT 9 U/l (L) Alkaline Phos 41 U/l (L) Bilirubin Dir 0.3 mg/dl (H). Protime 14.9 sec (H) Protime INR 1.3 (H) APTT 51.8 sec (H). ESR 88 mm/hr (H). WBC 2.3 X10''3 (L). Lupus Anticoagulant by Russell Viper Venom (+). Bone Marrow Biopsy and Aspirate - abnormal. Complement - C3 44 mg/dl (L), C4 7.2 mg/dl (L). Immunology/Serology - Anti DNA Quant 37.6 IU/ml (H) Complement CH50 41 CAE (L). EBV AB to Early IgG 3.01 IV (H) B2
CDC Split Type:

Write-up: Was doing fine after first after first shot, received 2nd series and next day went to dr. from school complaining of blurred vision, sick to stomach, and bad headache, fever and heart palpitations. Felt like was going to pass out. Went to dr. had tests and was in bed for 3 days. Blood tests came back low.. White, red and platelets.. Told 2 wait and be tested again in a few weeks. When tested again was sent to hospital and then diagnosed with ITP Syndrome and given medication.. Did not work, so then was hospitalized because blood was so low at serious risk for a stroke, was given another dose of globin and spent night at hospital.. A few weeks later, took blood tests again everything was still low, was put on highest dosage of Prednisone 4 3 weeks.. Blood levels raised and stabilized 4 a few weeks.. Latest has been diagnosed with ITP/Evans Syndrome and told would probably turn into Lupus, will have to visit hospital on a regular basis to be monitored.. A permanant disease, Rheumatologist and blood disorder doctors from 2 major hospitals agree this illnes was created by the Gardasil Vaccine and written in their reports. 8/10/09 PCP medical records received DOS 1/2/09 to 3/18/09. Assessment: Low platelet count. Hives/urticaria thighs and lower legs, itching after tanning session. Has started oral contraceptives. Heart palpitations, nausea, feverish. Headache, ears hurt, lightheaded. Looks pale. Excused from PE. 8/10/09 Hospital records and Oncology/Hematology consult, Rheumatology Consult, DOS 4/9/09 to 4/27/09. Assessment: Thrombocytopenia, anemia, neuropenia, positive lupus anticoagulant, elevated PT/PTT. Patient presents with thrombocytopenia, anemia, excessive vaginal bleeding. Had bad ''virus'' with fevers, cough, headache, poor sleeping and sweating. Missed school. IVIG therapy. Hair is falling out. Energy levels decreased, pale, diffuse bruises, petechia over lower legs. Tightness in neck. Wheezing. 8/10/09 Hematology consult - second opinion, Rheumatology report DOS 4/21/09 to 5/19/09. Assessment: Evan syndrome (autoimmune hemolytic anemia and thrombocytopenia. Patient initially presented with scattered petechia and bruising involving all surfaces of body. Bruising has significantly decreased. 8/10/09 Discharge summary DOS 4/25//09: Assessment: Thrombocytopenia, vaginal bleeding, thrombocytopenia, Autoimmune disorder NOS, hemolytic anemia. Patient presented with platelet count <5. IVIG administered. 4/9/09 Hospital short stay, Pediatric Hematology Clinic visits DOS 4/15/09 to 7/14/09 Assessment: Autoimmune hemolytic anemia and thrombocytopenia. Patient presents with hair coarse and falling out, pale, thrombocytopenia. Headaches, breakthrough vaginal bleeding. 9/4/09 ICD-9 Codes: 287.5 Thrombocytopenia unspecified, 283.9 Acquired hemolytic anemia unspecified, 279.4 Autoimmune disease not elswhere classified, 623.8 Noninflammatory disorder of vagina.


VAERS ID: 354639 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2008-06-03
Onset:2008-06-21
   Days after vaccination:18
Submitted: 2009-08-01
   Days after onset:406
Entered: 2009-08-19
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0063X / 2 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Alopecia, Arthralgia, Dizziness, Dry skin, Dysmenorrhoea, Fatigue, Headache, Rash, Rash generalised, Raynaud's phenomenon, Systemic lupus erythematosus, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Systemic Lupus Erythematosus; Raynaud''s. 9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. LABS and DIAGNOSTICS: ANA (+), ds-DNA 38 IU/mL (+), SSA (+), SSB (+). ESR 30 (H). C3 74 (L). Complement C4C 5 mg/dL (L). 24 hr Urine - Protein Total 768 mg/24 hr (H) Protein/Creatinine Ratio 667 mg/g creat (H). CHEM - Glucose 104 mg/dL (H) Potassium 3.6 mmol/L (L) Calcium 8.7 mg/dL (L) Albumin 3.5 g/dL (L) AST 11 U/L (L). Urinalysis - Cloudy, Protein 3+, Squamous Epithelial Cells 20-27 HPF (H), Bacteria many.
CDC Split Type:

Write-up: Fatigue, dry skin, extreme fatigue, light headed, headache, increased menstrual cramps, Raynaud''s disease, weight loss, hair loss, joint pain, facial rash, extreme joint pain, body rash. 9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. Assesment: Systemic Lupus Erythematosus. Vitiligo. Patient presented with progressive fatigue and weight loss with impaired functional capacity. Joint pain, swelling, and stiffness at PIPs, MCPs and wristes. Malar rash and Raynauds of feet. Leukopenia, anemia. Inflammatory polyarthropathy.


VAERS ID: 355418 (history)  
Age: 17.0  
Gender: Female  
Location: Arizona  
Vaccinated:2009-08-05
Onset:2009-08-06
   Days after vaccination:1
Submitted: 2009-08-25
   Days after onset:19
Entered: 2009-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0671Y / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U291944 / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0726Y / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Computerised tomogram normal, Dizziness, Fatigue, Nausea, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR
Current Illness:
Preexisting Conditions: None 9/3/09 Medical records received w/PMH: right knee surgery. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 PMH: several syncopal episodes till age 8.
Diagnostic Lab Data: computed axial, 08/18/09, negative; laboratory test, 08/18/09, negative 9/3/09 Medical records received w/LABS: CBC, CMP, CT brain WNL. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 Diagnostics: MRI brain(-), EEG(-), blood testing WNL.
CDC Split Type: WAES0908USA03202

Write-up: Information has been received from a physician concerning a 17 year old female patient who on 05-AUG-2009 was vaccinated intramuscular with the first and only dose of 0.5ml GARDASIL (lot # 663452/0671Y). Secondary suspected therapy included VARIVAX administered on 05-UG-2009. Other concomitant therapy included ADVAIR and MENACTRA administered on 05-AUG-2009. On 06-AUG-2009 the patient developed exertional vertigo and extreme fatigue. The patient was a Division 1 softball player and she had not been able to participate due to these symptoms. On 18-AUG-2009 the patient had syncope and ended up in the emergency room. she was not admitted. She will be seen in the office on 19-AUG-2009. The patient had sought the physician for medical attention on 11-AUG-2009. The patient had not recovered. The patient''s exertional vertigo, extreme fatigue and syncope were considered to be disabling. Follow up information has been received from the physician concerning the 17 year old female patient who on 15-AUG-2009 had concomitantly received the second dose of VARIVAX (LOT# 664701/0726Y) and MENACTRA (LOT # U291944). On 18-AUG-2009, the patient had syncope and was taken to the Emergency room. The patient had a CT scan and laboratory tests. All testing was negative. The patient was not admitted to the hospital. The patient was seen by the physician on 19-aug-2009. The patient complained of nausea, dizzy and light-headedness on exertion. The physician stated that he was going to refer the patient to a cardiologist for evaluation. Additional information has been requested. 9/3/09 Received ER medical records of 8/18-8/19/2009. FINAL DX: dizziness w/evidence of mild heat exhaustion; possible HPV vaccine side effects. Remained stable & d/c to home w/PCP f/u. Records reveal patient experienced dizziness & malaise since vaccines, with nausea & vomiting while playing sports on day of admission. 9/8/09 Received PCP record of 8/19/09 & vaccine records. FINAL DX: syncopy & nausea Records reveal seen in ER w/neg w/u. Recovered. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 Neuro consult. DX: syncopal episodes of undetermined etiology. Poss. Adverse rx to gardasil vax. Presenting SX: c/o dizziness and sick to stomach since 8/09. h/o syncopal episode seen in ER. c/o at time of onset of episodes of vision changes, hot/sweaty sensation, nausea, just prior to syncope. Pt. also c/o HA. Diagnostics ordered. 10/15/09. Neuro consult. Final DX: vasovagal episode associated with response to vax injection.


VAERS ID: 355419 (history)  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-11-06
Onset:2009-07-31
   Days after vaccination:633
Submitted: 2009-08-25
   Days after onset:25
Entered: 2009-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1210U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood product transfusion, Contusion, Haemorrhage, Idiopathic thrombocytopenic purpura, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: hematology, 11/??/07, normal; platelet count, 10/03/08, 190,0; platelet count, 07/30/09, 21,00
CDC Split Type: WAES0908USA03204

Write-up: Information has been received from a consumer concerning her 19 year old daughter who in Summer 2007 was vaccinated with the first dose of 0.5ml GARDASIL. No information was provided for the second dose of 0.5ml GARDASIL. On 06-NOV-2007 the patient was vaccinated with the third dose of 0.5ml GARDASIL. There was no concomitant medication. On 31-JUL-2009 the patient developed "Idiopathic Thrombocytic Purpura". The consumer stated that "when blood passes through the patient''s spleen the antibodies are killing her platelets causing massive bruising and internal bleeding". The patient was hospitalized on 31-JUL-2009 for 4 days. The patient''s platelet count was back up after hospitalization, but was going back down again. Laboratory included blood work without result. The patient had not recovered. Additional information has also received from a medical assistant reported that the patient was vaccinated with the first, second and third dose of GARDASIL separately on 05-MAR-2007 (lot # 655849/0263U), 06-JUL-2007 (lot# 658100/0525U) and 06-NOV-2007 (lot # 655154/1210U). No other vaccines given concomitantly. In September 2008, the patient was placed on birth control. Information has also been received from a physician reported that in November 2007, the patient''s blood work was normal. On 03-OCT-2008, the patient''s platelet count was 190,000. On 30-JUL-2009, the platelet count decreased to 21,000 and the patient was hospitalized the next day it''s on 31-JUL-2009. The patient was treated with IV immunoglobulin and steroids. Patient was currently on the titrating dose of prednisone. The physician considered the condition to be disabling but not life threatening. The physician dose not know if GARDASIL was the cause of this event. The patient referred to a hematologist. The receptionist of the hematologist reported that their office was not treating the patient so that the patient might have been treated elsewhere. Additional information has been requested.


VAERS ID: 355627 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-07-01
Onset:0000-00-00
Submitted: 2009-08-26
Entered: 2009-08-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Deafness, Deafness unilateral, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA03811

Write-up: Information has been received from a pharmacist concerning a 17 year old female with unspecified drug reactions/allergies and medical history, who was vaccinated with a third dose of GARDASIL in July-2009 ("6 weeks" since vaccination) (route and lot number not reported). The pharmacist mentioned the patient experienced ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by visit physician''s office. Ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts were considered to be disabling. Additional information has been requested.


VAERS ID: 357350 (history)  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-08-21
Onset:2009-04-12
   Days after vaccination:600
Submitted: 2009-09-15
   Days after onset:156
Entered: 2009-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 3 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test normal, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Was in Hospital for 5 days, they ran all the relevant test for blood clots. Then went to clinic, and they ran numerous tests related to blood clots and she does not have any risk factors associated with blood clotting.
CDC Split Type:

Write-up: Blood Clot in lung on 4-12-2009 and will have to be on blood thinners rest of her life. She is currently on 15mg of warifin daily to keep her blood thinned between 2-3 INR.


VAERS ID: 359446 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-10-02
Entered: 2009-10-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA03644

Write-up: Information has been received from a physician, that was informed by a patient, that someone else experienced temporary blindness within one or two days after receiving the second 0.5 ml dose of GARDASIL. The pt was reported to be female between 16 and 18 years old. No further information was provided. The physician was not the treating physician of this patient and does not wish to be contacted regarding this case. The reporting physician considered temporary blindness to be disabling. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.


VAERS ID: 359858 (history)  
Age: 17.0  
Gender: Female  
Location: Ohio  
Vaccinated:2009-07-02
Onset:2009-07-07
   Days after vaccination:5
Submitted: 2009-10-06
   Days after onset:91
Entered: 2009-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1131X / 0 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Body temperature increased, Decreased appetite, Diarrhoea, Dizziness, Fatigue, Headache, Influenza like illness, Local swelling, Lymphadenopathy, Nausea, Oropharyngeal pain, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Drug hypersensitivity
Preexisting Conditions: PMH: Migraines, Asthma Allergies: Amoxicillin, Augmentin, Omnicef, Sulfa
Diagnostic Lab Data: oral T, 102.3 Lab: CBC, Lipid profile, CMP, LDH, ESR, CMV titer, IgM titer, Toxoplasmosis serology WNL, TSH 5.1 high, Cat scratch panel. Mono-test, PPD, EBV, ANA negative, ACE normal, Monocyte ct 15.6 high, Basophil ct high at 2.05, Thyroglobulin antibody test high at 127.8, Strep Test positive, Serum Cortisol, Thyroid studies WNL Dx studies/Xrays: CXR mild rt hilar lymphadenoapthy is suspected, CT neck bilateral cervical lymphadenopathy with enlarged tonsils, Pelvic US normal Labs: FSH and LH high, HCG neg
CDC Split Type: WAES0907USA00374

Write-up: Information has been received from a physician concerning a female who on 02-JUL-2009 was vaccinated intramuscularly with a dose of GARDASIL (lot no. not reported). After vaccination, on an unknown date, the patient started experiencing flu like symptoms and had swelling in her groin area. Subsequently, the patient recovered. Follow up information has been received from a licensed practical nurse who regarding a 17 year old female at 134 pounds weight and 52 inches with drug allergies to AUGMENTIN, OMNICEF, BACTRIM who on 02-JUL-2009 was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot#661954/1131X) at 11:50 am. It was reported that 5 - 7 days following GARDASIL first injection on 07-JUL-2009, the patient experienced cervical lymphadenopathy, sore throat, headache, dizziness, fever (TM 102.3), hives, nausea, diarrhea and loss of appetite. On an unknown date some symptoms dissipated but the patient had prolonged (10 weeks) of out cervical lymphadenopathy, fatigue and dizziness. Extensive work-up by a hematologist, ENT (ears, nose, and throat), infectious disease and endocrinology. At the time of the report the patient was improving. the liscensed practical nurse considered the patient''s experience to be disabling. Additional information has been requested. 10/19/2009 records from PCP, ENT, Hematologist and Endocrinologist visits. Patient 5 days post vaccine had sx of: cervical lymphadenopathy, headache, sore throat, fever, urticaria, nausea, diarrhea, dizziness , malaise, fatigue and anorexia. Initially dx''d with strep pharyngitis and was on ABX x 2 and Medrol dose pak, lymph node size decreased at first but then rebounded and have continued to enlarge since then. PE notes tender , mobile bilateral enlarged cervical lymph nodes appox 2-3 cm. ED visit 9/10/2009: sx frequent urination, hematuria. DC Dx UTI, Tx''d with ABX/Pyridium. Final Dx: Hashimoto''s Thyroiditis, Viral lymphadenitis with mono-like illness. Tx: modify activities/rest. 11/5/2009 records from OB-GYN MD 5-8/2009, with c/o''s amenorrhea


VAERS ID: 361318 (history)  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-10-20
Onset:2007-10-20
   Days after vaccination:0
Submitted: 2009-10-17
   Days after onset:728
Entered: 2009-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram, Convulsion, Fatigue, Hypertension, Injection site pain, Loss of consciousness, Migraine, Nausea, Nuclear magnetic resonance imaging brain, Pain in extremity, Palpitations, Paraesthesia, Quality of life decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: allergic codeine, pcn
Diagnostic Lab Data: MRI, MRV, CAT SCANS, numerous blood work studies, EEG, EKG, Holt monitor, tilt table testing.
CDC Split Type:

Write-up: severe pain at injection site, since that time has started blacking out, seizures, migraines, heart palpitations, blood pressure control problems, nausea, severe pain in extremities, tingling in arms and legs,severe tiredness, low quality of life. 11/4/09 Medical records received for date 6/5/08 to 10/28/09. 6/5/08 Pt established care at PCP with initial c/o multiple syncopal episodes in past few wks. Mostly when changing positions lying/sitting. DX: syncope, irreg. menses, sinusitis, insomnia. Multiple OV for c/o syncope, body aches, dizziness, chest pain, ear pain, DX: syncopal episodes, orthostatic HTN, muscle pain, chest pain, tachycardia, depression/anxiety, autonomic dysfunction.


VAERS ID: 368235 (history)  
Age: 17.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-12-21
Onset:2008-01-14
   Days after vaccination:24
Submitted: 2009-11-17
   Days after onset:673
Entered: 2009-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 42484AA / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alopecia, Asthenia, Blood pressure decreased, Condition aggravated, Convulsion, Dizziness, Electroencephalogram normal, Fatigue, Feeling cold, Immune system disorder, Listless, Loss of consciousness, Malaise, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none 12/29/09 PMH: Asthma; Allergic to Bactrim.
Diagnostic Lab Data: No diagnosis to date. All tests are inconclusive for any problems. Clear EEGs. No heart problem. Never used any drugs. Always healthy until this. 12/29/09 Diagnostics: Normal MRI and EEG
CDC Split Type:

Write-up: Patient woke up feeling faint and cold. She was light headed and complained at school to several people that she felt faint. Then she did faint and she had a seizure that lasted 2 minutes. She was taken to the hospital by the paramedics. MRI, EEG all tests were normal. No explanation for this event. Next shot is June 2008. Patient appears immune-compromised. She is constantly sick and complains of fatigue. She returns to college. She is sick from Sept thru Dec. No amount of antibiotics helps. Her hair is falling out. She is pale, listless, without energy. On Dec 27, 2008, she passes out again, first thing in the morning after feeling cold and faint. Again she suffers a seizure and is unconscious for 2 minutes. She is taken to the hospital and no explanation can be found for this drop in blood pressure, syncope and seizure. Eleven months later she has another episode exactly like the first two. Throughout the year she has suffered from unexplained drops in blood pressure. She has never regained her energy level and is often sick with sinus infection like symptoms, but her sinuses are clear (x-ray) and no amount of antibiotics help. When she received the second Gardasil shot she also received the Menactra vaccine. 12/29/09 Pediatric Medical records received for DOS 01/02/08-01/05/10. PCP notified by school that pt. had first seizure activity on 01/18/08 and was transported by ambulance to hospital. DC home to f/u with neurologist, MRI and EEG. Reported instances of seizure activity on 12/30/08, 01/01/09 and 11/25/09. Referrals to allergist, cardiologist and neurologist.


VAERS ID: 372223 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2009-02-01
Onset:2009-08-01
   Days after vaccination:181
Submitted: 2009-12-08
   Days after onset:129
Entered: 2009-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. AHAVB329BA / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Condition aggravated, Fatigue, Headache, Myalgia, Pain, Photophobia, Platelet count decreased, Rash, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Migraine headaches aproximately once a month
Diagnostic Lab Data: platelet count 61,000
CDC Split Type:

Write-up: Previously healthy 18 year old developed severe headaches and photophobia with severe fatigue, body pain especially left and right upper abdomen associated with thrombocytopenia (plt. 61K) and abdominal rash over several weeks. Patient was hospitalized with extensive work-up by infectious disease and neurological specialists. No source found but she gradually improved but continues with progressive muscle pain, fatigue and daily headaches 6 month later.


VAERS ID: 374324 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-01-09
Onset:2008-03-26
   Days after vaccination:77
Submitted: 2009-12-18
   Days after onset:632
Entered: 2009-12-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Bedridden, Bone scan, Bowel movement irregularity, Colonoscopy, Computerised tomogram, Diplegia, Electromyogram normal, Fall, Hypoaesthesia, Mass, Nausea, Nuclear magnetic resonance imaging, Ovarian cyst, Pain, Staphylococcal infection, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NUVARING
Current Illness: Seasonal allergy; drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Bone scan, no results provided; colonoscopy, no results provided; computed axial, no results provided; magnetic resonance, no results provided; electromyography, 11/18?/09, patient was stable and no neurological symptoms were noted
CDC Split Type: WAES0912USA01364

Write-up: Information has been received from a physician''s administrator, a registered nurse, a medical assistant and a consumer concerning her 17 year old daughter with seasonal allergies and allergy to BENADRYL and BACTRIM who on 14-MAR-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. 655618/0186U) administered in her left arm. On 09-JUL-2007 the patient received a second dose of GARDASIL (Lot No. 654272/0319U) administered in her right arm and on 09-JAN-2008 received a third dose of GARDASIL (Lot No. 657872/0515U) administered on her left arm. Concomitant medication included NUVARING. On 26-MAR-2008 the patient developed a "bump" on her thigh. In June 2008 the patient developed a MRSA infection, confirmed on 29-SEP-2008. On 02-JUL-2008 the patient experienced bowel movement issues. The patient''s mother mentioned that the patient is in constant pain which she described as 6 on a scale of 1-10. She also had periodic paralysis of her lower extremities and her "muscles go numb and she falls all the time". She had abdominal pain and nausea and had developed ovarian cysts. The patient saw a pediatric surgeon for her ovarian cysts. The physician''s administrator indicated that the condition had "nothing to do" with GARDASIL. The mother mentioned that the patient was almost completely bedbound. It was reported that the patient''s boyfriend had a breakout of MRSA on 17-FEB-2009. The medical assistant stated that in March 2009 the patient was seen for the last time after a "well check-up". The patient was hospitalized twice in the summer of 2009 for an unknown reason (length of stay unspecified). The patient had been to the neurologist and had tests done on her muscles and her bones and no one could "figure out what''s wrong with her". The medical assistant did not have any information surrounding the patient''s paralysis, ovarian cysts, or hospitalizations. Bone scan, colonoscopy, CT scans and MRI tests were performed with no results provided. On 18-NOV-2009 the patient was seen by a neurologist. An EMG was done along with a physical exam. The patient was stable and no neurological symptoms were noted. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 380852 (history)  
Age: 17.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2008-11-25
Onset:2008-12-19
   Days after vaccination:24
Submitted: 2010-02-21
   Days after onset:429
Entered: 2010-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0650K / 1 - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal pain upper, Computerised tomogram head, Condition aggravated, Convulsion, Drug level, Haematology test, Nausea, Nuclear magnetic resonance imaging, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 39 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Trileptal
Current Illness: none noticed directly after receiving vaccine, however on December 19th, 2008 patient began having multiple seizures and was seen in the Emergency room on that date and many times subsequent to that and eventually had craniectomies x2 for status epilepticus
Preexisting Conditions: previously healthy, past medical history of epilepsy diagnosed at age 8 and well controlled on oral antiepileptic drugs
Diagnostic Lab Data: hematology, head CT, MRI, medication levels,
CDC Split Type:

Write-up: sudden onset of stomachache, nausea and vomiting and multiple (10 plus) seizures


VAERS ID: 394027 (history)  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-10-01
Onset:2007-10-01
   Days after vaccination:0
Submitted: 2010-07-29
   Days after onset:1032
Entered: 2010-07-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain operation, Convulsion, Depression, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES1007USA02866

Write-up: Information has been received from a consumer concerning her 17 year old daughter with no known drug allergies who in October 2007, was vaccinated with a first dose of GARDASIL. There was no concomitant medication. The patient''s mother also mentioned how terrible GARDASIL had been in ruining her daughter''s life. A few days after receiving the first shot, the patient fell into a deep depression. In January 2008 the patient received a second dose of GARDASIL and at that point the patient fell into an even deeper depression and began having seizures. In June 2008 the patient received a third dose of GARDASIL and apparently at that point she became a full blown epileptic. On an unspecified date the patient was hospitalized (length of stay and hospital demographics not provided); the patient sought unspecified medical attention. It was also reported that the patient has had brain surgery twice. At the time of the report, the patient had not recovered. No laboratory or diagnostic studies were performed. The health professional contacted during telephone follow-up could not supply the following information: dates of vaccination, dose number, lot number, date of event, recovery status, hospital name, and other healthcare provider name and contact information. The health professional stated that the GARDASIL vaccinations were in fact given at their office, but at earlier dates than reported by the consumer. The reporter considered the events "fell into deep depression", "became a full blown epileptic", "how terrible GARDASIL had been in ruining her daughter''s life" and "began having seizures" to be disabling. Additional information has been requested.


VAERS ID: 398605 (history)  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2009-06-08
Onset:2009-06-08
   Days after vaccination:0
Submitted: 2010-08-04
   Days after onset:422
Entered: 2010-09-08
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1129X / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Nausea, Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Penicillin allergy; Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA02999

Write-up: Information has been received from a registered nurse concerning a 17 year old female with allergies to penicillin and DESOGEN and no pertinent medical history who on 08-JUN-2009 and 08-AUG-2009 was vaccinated IM with the first (lot# 661952/1129X) and the second (lot# 661046/0381X) 0.5ml doses of GARDASIL. There was no concomitant medication. The nurse reported that the patient experienced nausea within 24 hours of receiving her first dose of GARDASIL. She also experienced nausea, vomiting, and diarrhea within 24 hours of receiving her second dose of GARDASIL on 08-AUG-2009. She was still experiencing symptoms on 13-AUG-2009 and was treated with PHENERGAN and IMMODIUM. No lab diagnostics study was performed. At the time of the report, the patient''s outcome was unknown. Nausea (both episodes), vomiting and diarrhea were considered to be disabling. Additional information has been requested.


VAERS ID: 410698 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2010-09-02
Onset:2010-09-21
   Days after vaccination:19
Submitted: 2010-11-29
   Days after onset:69
Entered: 2010-11-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aplastic anaemia, Biopsy bone marrow, Blood test, Immunosuppressant drug therapy, Malaise
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Myelodysplastic syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA01838

Write-up: Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history who on 02-SEP-2010 was vaccinated with the first dose of GARDASIL (lot number not provided). There was no concomitant medication. The physician reported that the patient presented to the hospital on 21-SEP-2010 feeling "ill". The patient was diagnosed with aplastic anaemia. The physician reported that the patient was hospitalized and treated with a course of anti-thymocyte globulin and immunosuppressive therapy, including cyclosporine and prednisone to depress her immune system. At the time of the report the patient had been released and was recovering while still being treated with immunosuppressant. Laboratory tests performed included bone marrow biopsy and blood work with no results provided. The aplastic anaemia was considered to be disabling and immediately life-threatening by the physician. Additional information has been requested.


VAERS ID: 413440 (history)  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2010-11-08
Onset:2010-11-08
   Days after vaccination:0
Submitted: 2010-12-20
   Days after onset:42
Entered: 2010-12-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0768Z / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Bone scan abnormal, Complex regional pain syndrome, Computerised tomogram abnormal, Dysphagia, Dyspnoea, Joint effusion, Muscle atrophy, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Streptococcal infection, Streptococcus test positive, Walking aid user, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NECON
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance, 11/09?/10, Fluid on the patient''s hip; computed axial, 11/09?/10, Fluid on the patient''s hip; bone scan, 11/09?/10, Fluid on the patient''s hip; diagnostic laboratory, 11/08?/10, Positive for a strep infection; WBC count, 11/08?/10, Elevated
CDC Split Type: WAES1012USA01863

Write-up: Information has been received from a physician and from a licensed practical nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-NOV-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination at that time. The nurse stated that on 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained of difficulty breathing and was unable to swallow. The patient was seen in the emergency room. It was reported that the patient was positive for a strep infection (not specified). The patient''s white blood cell (WBC) count was elevated. The patient was treated with a penicillin shot and was sent home and was not admitted to the hospital. Approximately twelve hours later on 09-NOV-2010, the patient experienced left leg pain (also reported as bilateral lower extremity pain) and weakness on. The patient was seen in the hospital and was admitted. The patient was hospitalized on 09-NOV-2010. The patient had a magnetic resonance imaging (MRI), computed axial tomography (CT) scan and a bone scan. The tests revealed fluid on the patient''s hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged on 14-NOV-2010 on NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required a walker for ambulate due to muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require a walker to ambulate due to muscular was considered by a physician to be disabling. Additional information has been requested.


VAERS ID: 418725 (history)  
Age: 17.0  
Gender: Female  
Location: Illinois  
Vaccinated:2010-09-21
Onset:2010-11-18
   Days after vaccination:58
Submitted: 2011-03-14
   Days after onset:115
Entered: 2011-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB446BA / 0 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0565Z / 0 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Chemotherapy, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Splenectomy, Weight increased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: platelet count, 11/18/10, 1(100; platelet count, had gone up and down based on the prednisone dosing
CDC Split Type: WAES1103USA00608

Write-up: Information has been received from a physician concerning a 17 year old female with no drug allergies and no pertinent medical history who on 21-SEP-2010 was vaccinated with her only dose of GARDASIL (lot# 666162/0565Z, expired date on 15-SEP-2012) IM. Concomitant therapy included HAVRIX (Lot #AHAVB446BA) on the same day as GARDASIL. On 18-NOV-2010 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP). After this she was hospitalized. She had not recovered. She had experienced "weight gain with prednisone use". The patient was considered to be disabling as she was not able to play contact sports. Blood test was performed (but no results were provided). Patient''s platelet count on 18-NOV-2010 was 1 (1, 000). Since that time the platelet count had gone up and down based on the prednisone dosing. Patient had already received a few doses of intravenous immune globulin (IVIG) and recently was placed on a chemotherapeutic agent (no cancer involved). In February 2011, patient underwent a splenectomy. When asked if the event was life threatening, the physician said she did not know. The physician gave the location of the hospital and reported that the patient was initially referred to another pediatric hematology/oncology physician. The patient was also being seen by another specialist at another hospital, but the physician did not have that contact information available. Additional information has been expected.


VAERS ID: 421582 (history)  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2010-11-01
Onset:2010-11-01
   Days after vaccination:0
Submitted: 2011-04-21
   Days after onset:171
Entered: 2011-04-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02226

Write-up: Information has been received from a nurse practitioner concerning a patient''s nephew, a 17 year old male consumer who she "thought" was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested.


VAERS ID: 425130 (history)  
Age: 17.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-02-07
Onset:2011-02-22
   Days after vaccination:15
Submitted: 2011-06-08
   Days after onset:105
Entered: 2011-06-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Arthritis, Blood immunoglobulin G, Inflammation, Joint swelling, Oedema peripheral, Pain in extremity, Parvovirus B19 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA03008

Write-up: Information has been received from a registered dietician concerning her 17 year old daughter who on 07-FEB-2011, was vaccinated with the first dose of GARDASIL (route not reported) (lot number 666987/1016Z). "Shortly after the first dose" (on an unknown date), the daughter developed severe inflammation and pain in her fingers, toes and wrists. On 11-APR-2011, was vaccinated with the second dose of GARDASIL (route not reported) (lot number 667866/1437Z). "After the second dose" (on an unknown date), the pain and inflammation became worse. The dietician stated her daughter had been a gymnast and she initially felt her pain was from this, but rheumatologist had stated it might be linked to GARDASIL. The dietician reported that at one point, her daughter was not able to tie her own ponytail because of the pain. When her daughter laid her hand flat and putted pressure on it, she had pain. At the time of the report the patient had not recovered. Follow up information has been received from the mother of the patient the registered dietician and the physician. The mother who reported that her daughter did not received any concomitant vaccinations when the GARDASIL were administered. There was no family history of arthritis. On 25-MAY-2011, the daughter had been seen by her pediatrician. The mother reported that her daughter had pain in her hands, wrist and toes and intermittent swelling in her ankles. The mother reported that her daughter was "trying to push through to maintain her activities". The daughter was undergoing testing and the diagnosis was unknown at that time (no results were provided). The patient''s next appointment with the rheumatologist would be in early June. At the time of the report the patient had not recovered. A worker from the physician''s office reported that the patient developed joint inflammation two months after the GARDASIL vaccination had been administered. The office worker reported that the physician was not sure if the joint inflammation was related to GARDASIL. Follow up information has been received from the mother of the patient and a certified medical assistant. The medical assistant who reported that the patient with no allergies or drug reactions and no pertinent medical history was vaccinated in 07-FEB-2011 and on 11-APR-2011, with GARDASIL intramuscularly. (The medical assistant provided conflicting information that the first dose on 07-FEB-2011 was lot #1437Z). There was no concomitant medication. The medical assistant stated that starting "in February or March", the patient developed joint pain and swollen toes. The mother of the patient stated best guess was that first symptoms pain, swelling, arthralgia, arthritis mostly in wrist and fingers appeared 15-20 days after her first dose. The medical assistant reported that a specialist ruled out rheumatoid arthritis. The medical assistant reported that these problems made it difficult for the patient to get around. The medical assistant reported that on 25-MAY-2011, the patient came to the office. A serum B19 virus immunoglobulin G antibody test was performed (no results were provided). The patient did not receive any treatment for the event. As of 31-MAY-2011, the medical assistant stated that the patient had not recovered. Also reported by the mother of the patient on 01-JUN-2011, as the symptoms had been getting better, but were not 100% improved (still had pain and swelling). The events of joint pain and swollen toes were considered to be disabling by the certified medical assistant. Additional information has been requested.


VAERS ID: 451195 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2010-11-08
Onset:2010-12-20
   Days after vaccination:42
Submitted: 2012-03-06
   Days after onset:442
Entered: 2012-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0765Z / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abasia, Asthenia, Blood test, Dizziness, Gait disturbance, Headache, Malaise, Nuclear magnetic resonance imaging, Pain, Paralysis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: birth defects on hands and feet (familial ectrodactly disease) allergy to pcn, cephalexin, cefzil and nickel
Diagnostic Lab Data:
CDC Split Type:

Write-up: THE FIRST "SEVERE" EPISODE WAS ON THE DATE ABOVE, PATIENT WAS EXTREMELY WEAK AND UNSTEADY ON HER FEET. SHE HAD BEEN FEELING ILL FOR A COUPLE WEEKS PRIOR TO THIS, SHE WAS SORE, HEADACHE AND DIZZY. THE NEXT DAY 12/21/10 SHE COULD NOT WALK AT ALL AND THIS WAS THE FIRST PARALYSIS. SHE WAS ADMITTED TO THE HOSPITAL, A NEUROLOGIST WAS CALLED IN, SHE HAD MRI AND BLOOD WORK.


VAERS ID: 495032 (history)  
Age: 17.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2013-01-08
Onset:2013-01-08
   Days after vaccination:0
Submitted: 2013-06-23
   Days after onset:165
Entered: 2013-06-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015859 / 1 AR / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4422AA / 4 AR / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Disturbance in attention, Exercise tolerance decreased, Fatigue, Feeling abnormal, Laboratory test, Migraine, Nausea, Pain, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ciproheptadine
Current Illness:
Preexisting Conditions: Asthma; Gastrointestinal issues
Diagnostic Lab Data: Tilt table test and many other labs/tests
CDC Split Type:

Write-up: Pots (Postural Orthostatic Tachycardia Syndrome); Chronic fainting, fatigue, body pain, migraine, nausea, exercise intolerance, brain fog, difficulty concentrating - worsened after second dose.


VAERS ID: 501696 (history)  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2013-07-23
Onset:2013-07-23
   Days after vaccination:0
Submitted: 2013-09-06
   Days after onset:45
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB692CA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1495AA / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4258AA / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Face injury, Fall, Loss of consciousness, Tonic clonic movements, Tooth fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO MICRONOR 0.35 MG
Current Illness: NONE
Preexisting Conditions: AMOXICILLIN-DRUG ALLERGY
Diagnostic Lab Data: ER VISIT; DENTAL VISIT
CDC Split Type:

Write-up: PATIENT WALKED TO FRONT DESK APPROXIMATELY 5 MINUTES AFTER VACCINES ADMINISTERED TO SCHEDULE APPT FOR NEXT VACCINES. THE NURSE OPENED THE CHECK OUT WINDOW AND NOTICED PT FALLING DOWN AND HIT FACE ON COUNTER. BOTH DOCTOR AND NURSE IMMEDIATELY WENT AROUND TO FRONT LOBBY AND NOTICED PT PASSED OUT ON FLOOR WITH 2-3 SECONDS OF TONIC/CLONIC MOVEMENT. SHE WAS AWAKE AND ANSWERING QUESTIONS WITHIN 30 SECONDS. EMS CALLED. MD NOTICED TOOTH WAS CHIPPED. EMS TRANSPORTED PT TO HOSPITAL VIA AMBULANCE.


VAERS ID: 536484 (history)  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-04-20
Onset:2012-04-20
   Days after vaccination:0
Submitted: 2014-07-13
   Days after onset:814
Entered: 2014-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incomplete course of vaccination, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1407USA004541

Write-up: This spontaneous report was received from physician''s assistant via field employee regarding an 17 years old male patient (age reported as 17 years at the time of vaccination). There was no information on patient''s medical history and drug reactions or allergies. On 20-APR-2012, the patient was vaccinated with GARDASIL intramuscular injection single standard dose intramuscularly taken intramuscularly. There was no concomitant medications. On 20-APR-2012, the patient fainted after his first dose with GARDASIL (disability) (reported as significant disability or incapacity: "syncope"). The patient decided not to continue with the series with GARDASIL after having this reaction. The lab diagnostics studies performed was unknown. No treatment was given. The patient did not seek any medical attention. There was no product quality complaint involved. On an unknown date the patient recovered from the event. The causality of the event with GARDASIL was unknown. Additional information has been requested.


VAERS ID: 541052 (history)  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2013-05-15
Onset:2013-07-14
   Days after vaccination:60
Submitted: 2014-08-25
   Days after onset:407
Entered: 2014-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H012973 / 0 RL / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tonic Clonic Grand Mal Seizure.


VAERS ID: 542739 (history)  
Age: 17.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-07-19
Onset:2011-07-25
   Days after vaccination:6
Submitted: 2014-09-06
   Days after onset:1139
Entered: 2014-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0057AA / 0 RA / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U4007AA / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, Cardiac stress test abnormal, Dizziness, Dyspnoea, Fatigue, Headache, Palpitations, Postural orthostatic tachycardia syndrome, Pyrexia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Other ischaemic heart disease (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: POTS and connective tissue issues not yet diagnosed. Chronic blurry vision, frequent headaches, and loss of balance and fatigue.
CDC Split Type:

Write-up: After running a half marathon one month prior, and within days of Gardasil dose #1 (Lot #0057AA) administered on 7/19/2011, patient could not finish her daily 3 mile run due to extreme lack of ability to catch breath, fatigue, and dizziness. Needed to be rescued. # months after the vaccination, because she was still struggling to walk up a flight of stairs by mid October (approx 3 months after Gardasil dose) she had no stamina and landed in the emergency room with severe head-ache, spiked fever and racing heart rate that could not be managed. Still severe symptoms when returned home for winter break. Primary Physician referred patient for a Pulmonary Stress test early January 2012. Heart rate did not return to rest and she was admitted to the Cardiac unit. In hospital 5 days. Diagnosed with POTS and put on a beta blocker. Could not return to college for spring semester. Ongoing and new and debilitating symptoms keep appearing, with no answers.


VAERS ID: 545670 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-09-10
Onset:2014-09-10
   Days after vaccination:0
Submitted: 2014-09-29
   Days after onset:19
Entered: 2014-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Bacterial test negative, Blood test normal, Borrelia test negative, Disability, Fatigue, Full blood count normal, Mononucleosis heterophile test negative, Muscular weakness, Myalgia, Nausea, Pain, Pharyngitis streptococcal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Dementia (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 09/2014, Bacterial test, Normal; 09/2014, Blood test, Normal; 09/2014, Full blood count, Normal
CDC Split Type: WAES1409USA013183

Write-up: This spontaneous report was received from a physician referring to a 17 year old female patient who is also her niece. Pertinent medical history and drug allergies were reported as none. On approximately 10-SEP-2014 (reported as about 2 weeks ago) the patient was vaccinated with GARDASIL dose 1 (dose/ route not reported). Concomitant medication was reported as none. On 10-SEP-2014, 15 minutes after vaccination, the patient experienced nausea, muscle weakness and muscle pain. The physician stated that the patient was only able to do 15 minutes of moderate activity (disability), whereas before vaccination she was healthy and energetic. The physician stated that the patient saw an unspecified physician who treated her with unspecified antibiotics for "strept throat" and there was no improvement in symptoms. The physician stated that the patient had a blood test for mono, Lyme disease and a CBC (complete blood count) which she stated was normal. The reporter indicated that the patient had missed 7 or 8 days of school because of fatigue and pain (disability). The patient sought medical attention. There was no intervention required to prevent seriousness criteria. The event was not life-threatening. There was no hospitalization reported. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unspecified. No PQC reported. Additional information is not expected.


VAERS ID: 552456 (history)  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2014-04-03
Onset:2014-07-21
   Days after vaccination:109
Submitted: 2014-11-06
   Days after onset:108
Entered: 2014-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS JR737 / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 3D425 / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J007954 / 1 LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Coagulation test abnormal, Compartment syndrome, Deep vein thrombosis, Drug hypersensitivity, Fasciotomy, Leg amputation, Local swelling, Surgery
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 28 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tri- sprentec; citalopram
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Blood work- Factor V Leiden positive, heparin allergy
CDC Split Type:

Write-up: Entire right leg swelled. Iced and elevated. Next day she was diagnosed with a DVT from abdomen to ankle. 6 surgeries within 7 days, including fasciotomies for compartment syndrome of the calf and eventually AK amputation of right leg.


VAERS ID: 554463 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-11-07
Onset:0000-00-00
Submitted: 2014-11-19
Entered: 2014-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Pyelonephritis, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pyelonephritis; Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 11/10/2014, Ultrasound scan, discovered to be pregnant
CDC Split Type: WAES1411USA005530

Write-up: This spontaneous prospective pregnancy report as received from a physician, refers to an approximately 16 year old female patient. Patient''s current condition included pyelonephritis for which she had been treated in the past. On 07-NOV-2014 the patient was vaccinated with GARDASIL dose 3. The patient received her first dose of GARDASIL on 22-FEB-2010 and second dose of GARDASIL on 22-AUG-2013. Other suspect therapies included hepatitis A virus vaccine (unspecified) and influenza virus vaccine (unspecified), administered on 07-NOV-2014. Concomitant medication included unspecified birth control. Patient sought medical attention on 10-NOV-2014, she was hospitalized for pyelonephritis (hospitalization, disability) and was discovered to be pregnant by ultrasound upon admission to hospital. The patient became pregnant with last menstrual period (LMP) of 09-AUG-2014 and estimated delivery date (EDD) of 16-MAY-2015. Initial exposure to GARDASIL was at 13 week(s). Physician stated that the patient was currently disabled and incapacitated because she was receiving unspecified intravenous pain medication and unspecified antibiotic as treatment. The physician agreed to be contacted for further information on the patient''s hospitalization. Outcome of the events was not reported. The pregnancy outcome was outcome pending. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.


VAERS ID: 568531 (history)  
Age: 17.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2009-08-26
Onset:2010-05-20
   Days after vaccination:267
Submitted: 2015-03-06
   Days after onset:1751
Entered: 2015-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1497X / 0 UN / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Dizziness postural, Gait disturbance, Immunology test, Mobility decreased, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~UN~0.00~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: Scoliosis.
Diagnostic Lab Data: Autoimmune testing in 2013
CDC Split Type:

Write-up: Barely able to walk, cannot bend, cannot stand without getting dizzy, losing weight.


VAERS ID: 569096 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-03-12
Entered: 2015-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Removal of foreign body, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1503USA005331

Write-up: This spontaneous report as received from a receptionist via a field representative refers to a 17 year old female patient who was not pregnant. Patient''s medical history and drug allergies were not specified by the reporter. On an unknown date (reported as years ago), the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not specified by the reporter). Concomitant medication was not specified by the reporter. On an unknown date, the patient experienced ongoing seizures after receiving GARDASIL. The reporter stated that seizures had been ongoing for multiple years and that the patient was having metal removed from her (date not specified), but it could not be confirm what metal fragments was being removed from the patient''s body. It was reported that the patient experienced significant disability or incapacity due to the adverse events. It was not specified by the reporter if any treatment was given for the adverse events. Laboratory tests were not specified by the reporter. The patient sought medical attention by an unspecified office visit. Product quality complaint (PQC) was not involved. The patient did not recovered from the adverse events at the time of the report. Causality assessment was not provided. Upon internal review the event of seizures was considered to be medically significant. Additional information is not expected due to lack of physician''s contact details.


VAERS ID: 595532 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-16
Entered: 2015-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Back pain, Dizziness, Malaise, Muscular weakness, Myalgia, Nausea, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1509USA006225

Write-up: Information has been received from a patient''s mother via an online article regarding her 17 year old daughter. There was no relevant medical history or drug reactions/allergies reported. The article stated that "two years ago" the patient''s pediatrician recommended the patient to get GARDASIL, which was given in 3 doses. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL (dose, frequency, route, lot# and expiration dates unspecified). After the first dose, the reporter said the patient was fine but after the second dose the patient was sick within a week at the doctors with nausea which had not left her to this day. The patient said "I have nausea 24/7, dizziness, 24/7 muscle pain, weakness in my legs, back pain, joint pain. Some days I have to walk with a cane". "The events had been going on for the past two years". The reporter said "it was devastating for her, because she can''t have a normal life". The patient''s health got so bad after getting GARDASIL. At the time of reporting, the patient was undergoing IV treatments once per week. Outcome of the events and causality were not provided. This is one of several reports from the same reporter. Upon internal review, the events of muscle pain, weakness in my legs, back pain, joint pain were considered as disable due to some days the patient had to walk with a cane. Additional information is not expected as no follow up available.


VAERS ID: 600845 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2015-09-22
Onset:2015-09-29
   Days after vaccination:7
Submitted: 2015-10-02
   Days after onset:3
Entered: 2015-10-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K010215 / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Asthenia, Cardiac monitoring, Depressed level of consciousness, Heart rate increased, Malaise, Postural orthostatic tachycardia syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter was given the first GARDASIL shot on Sept. 22, 2015 and one week later on Sept. 29, 2015 became sick. She was at school and had to have someone pick her up because she was very weak and felt like blacking out. We took her to the emergency room where she was put on IV meds to help control her heart rate that went over 150 3 or more times. She now has on a heart monitor and the Drs are leaning toward POTS. My child was healthy and active before I had her take this shot! I should have looked at all the warnings people have posted about GARDASIL.....I cannot believe the government can be so reckless with our children. I honestly felt that if the government allowed it and the Drs were encouraging it then everything should be fine. I took my "perfect" child and exposed her to possible HELL! I just pray she comes out of it.


VAERS ID: 602007 (history)  
Age: 17.0  
Gender: Female  
Location: Utah  
Vaccinated:2011-06-06
Onset:0000-00-00
Submitted: 2015-10-12
Entered: 2015-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Arthralgia, Deformity, Epstein-Barr virus test, Fatigue, Headache, Laboratory test, Mononucleosis heterophile test, Rheumatoid arthritis
SMQs:, Arthritis (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Seasonal allergies, asthma
Diagnostic Lab Data: Still being tested
CDC Split Type:

Write-up: Patient began having headaches, hurting in her joints and feeling extremely fatigued shortly after Gardasil vaccine was administered. No one thought it was attributed to the vaccine so she was treated with pain meds and tested for mono and Epstein Barr. It wasn''t until we heard of many other girls with the same symptoms after having the Gardasil shot that we realized that it was very probable that the vaccine had caused the symptoms. Her joint pain is now progressing to Rheumatoid arthritis and her fingers are becoming disfigured.


VAERS ID: 606015 (history)  
Age: 17.0  
Gender: Male  
Location: Louisiana  
Vaccinated:2015-10-12
Onset:0000-00-00
Submitted: 2015-10-30
Entered: 2015-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K016966 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Electrocardiogram normal, Palpitations, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: On 27-OCT-2015 and 28-OCT-2015 the patient''s blood pressure and heart rate were within normal limits. 10/2015, Heart rate, 177 bpm
CDC Split Type: WAES1510USA014921

Write-up: Information has been received from a physician and a nurse referring to a 17 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. The physician and the nurse reported that on 12-OCT-2015 the patient was vaccinated with a dose (dose number unspecified) of GARDASIL (dose not reported, lot # K016966 with expiration date in May 2017, intramuscular). There were no concomitant medications. The nurse noted that on an unspecified date after receipt of the GARDASIL (in October 2015), the patient began to experience intermittent heart palpitations and tachycardia. The nurse noted that the patient''s father recorded the patient''s beats per minute (while at home) to be 177 (in October 2015). The patient came to the office on 27-OCT-2015 to be assessed, and it was noted that the patient''s blood pressure and heart rate were within normal limits. The patient was sent home and on 28-OCT-2015, the patient again came to the office complaining of heart palpitations and tachycardia. The nurse stated that the patient''s assessment was again within normal limits and an electrocardiogram (EKG) was conducted and no results were available at the time of the call. Unspecified laboratory work would be conducted. The nurse stated that the patient would have an echocardiogram conducted "tomorrow" (29-OCT-2015) at the Hospital and had an appointment "next week" with a cardiologist. No product quality complaint (PQC) was involved. No treatment was given for the events. Outcome of the events was reported as not recovered. The reporter considered the events to be disabling due to the patient not going to school. Additional information has been requested.


VAERS ID: 620778 (history)  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2012-06-13
Onset:2012-12-12
   Days after vaccination:182
Submitted: 2016-01-26
   Days after onset:1140
Entered: 2016-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Abnormal weight gain, Blood cortisol increased, Fatigue, Hair growth abnormal, Injection site discomfort, Laboratory test, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abnormal, Pituitary tumour benign, Pituitary-dependent Cushing's syndrome, Radiotherapy, Skin striae, Surgery, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Malignancy related therapeutic and diagnostic procedures (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Slight discomfort at site of injection
Preexisting Conditions: None
Diagnostic Lab Data: Multiple lab tests and multiple MRI
CDC Split Type:

Write-up: Rapid weight gain, fatigue, hair growth on face and midsection, stretch marks on abdomen, elevated cortisol levels, MRI revealed pituitary adenoma. Two transphenodial surgeries and radiation followed. Diagnosed Cushings Disease.


VAERS ID: 625635 (history)  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-02-27
Onset:0000-00-00
Submitted: 2016-03-07
Entered: 2016-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 AR / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory, Heart rate increased, Postural orthostatic tachycardia syndrome, Pulmonary function test, Tilt table test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: inconsolable crying for 3 plus hours~DTaP (no brand name)~1~0.00~Patient
Other Medications: Lexapro 10 mg
Current Illness: No
Preexisting Conditions: Allergies
Diagnostic Lab Data: Table tilt test, lung function test, echocardiogram, Holter moniter.
CDC Split Type:

Write-up: About a month after first vaccine, started developing fast heart rate, shortness of breath and dizziness. Symptoms have continued to get worse over time. Recently diagnosed with POTS.


VAERS ID: 286272 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-08
Onset:2007-05-08
   Days after vaccination:0
Submitted: 2007-07-30
   Days after onset:83
Entered: 2007-07-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0138U / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Feeling hot and cold, Headache, Nausea, Unresponsive to stimuli
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin 04May07 - 10May07
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707AUS00226

Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 17 year old female who on 08-MAY-2007 was vaccinated with Gardasil (Lot # 655742/0138U, Batch # J0798, Expiry Date 07-AUG-2009). Concomitant therapy included amoxicillin (AMOXIL). On 08-MAY-2007 one minute post vaccination, the patient felt drained, felt hot and cold and experienced headache, nausea and was unresponsive to stimuli. At the time of reporting to the agency on 11-MAY-2007, the patient''s felt drained, feeling hot and cold, headache, nausea and unresponsive to stimuli persisted. The agency considered that felt drained, feeling hot and cold, headache, nausea and unresponsive to stimuli were possibly related to therapy with Gardasil. The original reporting source was not provided. Felt drained 1 minute post vaccination, feeling hot and cold, headache, nausea and unresponsive to stimuli were considered to be disabling by the agency. Additional information is not expected.


VAERS ID: 299382 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-08-03
Onset:2007-10-01
   Days after vaccination:59
Submitted: 2007-12-11
   Days after onset:71
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Multiple sclerosis, Nervous system disorder
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02198

Write-up: Information has been received from a pediatrician, concerning a 17 year old non-pregnant female student with no pertinent medical history or allergies, who on 03-AUG-2007 was vaccinated IM with the first dose of Gardasil (lot # not provided). There was no concomitant medication. In early October 2007, two months later, the patient experienced symptoms that evidenced a neurological disorder. A diagnosis of multiple sclerosis was determined, and the student was hospitalized (dates and duration not specified). Treatment included corticoids (non specified). Though the physician presumed the outcome of the student''s condition was not recovered, she acknowledged the outcome was unknown. The physician noted that the student would not be receiving future doses of Gardasil. The reporting physician considered multiple sclerosis to be serious as an other important medical event, as disabling/incapacitating, and as life-threatening. Additional information has been requested.


VAERS ID: 312159 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-05-12
Entered: 2008-05-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 28101 / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Genital ulceration, Serology negative
SMQs:, Severe cutaneous adverse reactions (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: HSV type 1 and/or 2 identification PCR ??Jun07 Comment: negative; HSV type 1 and/or 2 identification PCR ??Jun07 Comment: negative; clinical serology test Comment: negative at 6 weeks
CDC Split Type: WAES0805AUS00051

Write-up: Information was obtained on requested by the Company from the agency via a Public Case Detail Form and Case Line Listing concerning a 17 year old single female with one sexual partner, with no history of HSV infection who was vaccinated with GARDASIL. Subsequently after vaccination with GARDASIL, the patient developed genital ulceration which was described as severe deep genital ulcers on labia and perineum 2 weeks after vaccination with GARDASIL. In June 2007, 2 HSV PCR swabs done were negative. Serology was negative at 6 weeks. At the time of reporting on 17-OCT-2007 the patient had recovered from the genital ulceration. The agency considered that genital ulceration was possibly related to therapy with GARDASIL. Genital ulceration was considered to be disabling by the agency. The original reporting source was not provided. Subsequently the patient''s experience was reported to an article, 25-JAN-2008, page 6. Additional information is not expected.


VAERS ID: 335156 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-12-11
Entered: 2008-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Wheelchair user
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA01708

Write-up: Case received from an employee (no pharmacist) of pharmacy on 2-DEC-2008. This case is not medically confirmed, it is a hearsay case, with poorly information. The female employee of a pharmacy (no pharmacist) told that it was reported to her from male (no health care professional) that an about 17 year old female was sitting in wheel chair after being vaccinated with GARDASIL (lot, route and site not reported) on an unknown date. After vaccination she was sitting in a wheel chair. The male also reported that causality to vaccination was proofed. Neither the reason why the female was sitting in a wheel chair was reported nor if she still needs a wheel chair or not. As the female employee does not know the male reporter very well, and also in fear that with reporting this case she could get some trouble, it will not be possible to get further information. The outcome was not reported. Other business partner numbers include E200811252. No further information is available.


VAERS ID: 342699 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-11-22
Onset:2007-12-01
   Days after vaccination:9
Submitted: 2009-03-25
   Days after onset:479
Entered: 2009-03-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anogenital warts, Biopsy skin abnormal, Colposcopy abnormal, Gynaecological examination, Human papilloma virus test positive, Laboratory test abnormal, Papilloma viral infection, Rash pruritic, Smear cervix
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Not sexually active; Nulli gravida; Asthma exercise induced; Rhinitis allergic; Hypersensitivity; Menstruation irregular; Non-smoker
Preexisting Conditions: Family history of cancer
Diagnostic Lab Data: colposcopy, 04Feb08, suspicion of condylomata; skin biopsy, 04Feb08, bleeding controlled with Monsel solution; positive for HPV type(s) 16; gynecological examination, 04Feb08, see narrative for details; diagnostic laboratory test, 21Feb08, abnormal, HPV type 16 (+); Pap test, 04Feb08
CDC Split Type: WAES0902CAN00101

Write-up: Information has been received from an Agency and a physician concerning a 17 year old (grade 12) not sexually active female (no contact), nulli gravida, menstruation irregular, non-smoker, denies the use of alcohol, asthma, hypersensitivity (no details provided) and a family history of breast cancer, bone cancer and leukemia who on 22-NOV-2007 was vaccinated with GARDASIL (lot # field illegible). Concomitant medications included unspecified asthma medications and unspecified allergy medications. On approximately 29-NOV-2007 the patient experienced HPV type(s) 16 (initially reported as localized itchy rashes (areas of localization illegible)). On 04-FEB-2008 the patient underwent a gynecological examination which revealed an abnormal external genitalia. The patient had clusters of condylomatous like lesions down both sides of both labia majora. She had some isolated small condylomatous type lesions scattered about the perineal area (looked flat to the gynecologist). The patient''s vagina and cervix were grossly normal. A Pap smear was taken (no results provided). On 04-FEB-2009 a colposcopy was performed and on external genitalia the above areas were noted. The physician could not see any vascular markings. The gynecologist was suspicious that these were actually condylomata. Under local anesthetic a small one was removed using a punch biopsy. Bleeding was controlled with Monsel solution. It was reported that the punch biopsy was positive for HPV type(s) 16. Additional information has been received from a physician concerning a 17 year old female with asthma exercise induced (previously reported as asthma) and rhinitis allergic (previously reported as hypersensitivity). On approximately 01-DEC-2007 (previously reported as approximately 29-NOV-2007) the patient experienced HPV type(s) 16. The physician reported that the patient was without prior sexual activity (previously reported) presented with biopsy positive (previous reported) for type 16 condylomata on external genitalia within two weeks of receiving first dose of GARDASIL. On 21-FEB-2008 HPV type 16 (+) was abnormal. The physician was uncertain if HPV type(s) 16 was related to therapy with GARDASIL. HPV type(s) 16 was considered to be disabling by the physician (permanent increased risk of cancer given HPV exposure/infection). No further information is available. This is one of several reports received from the same source.


VAERS ID: 352132 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-24
Onset:2008-08-01
   Days after vaccination:8
Submitted: 2009-07-21
   Days after onset:354
Entered: 2009-07-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1172U / 2 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthritis, Chest pain, Neuralgia, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Pleurisy, Serology positive, Tendonitis, X-ray abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (narrow), Tendinopathies and ligament disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA02416

Write-up: Information has been received from a health professional concerning a 17 year old female who was vaccinated with the first dose of GARDASIL (Batch #NF56480/Lot #0251U) on 14-OCT-2007 and with the second dose (Batch #NF58550/Lot #0276U) on 15-JAN-2008). These were well tolerated. She was vaccinated with a third dose of GARDASIL (Batch #NH13130/Lot#1172U) injection route not reported, into the left upper arm on 24-JUL-2008. In August 2008 the patient experienced thoracic pain. Pleuritis and neuralgia were evoked as differential diagnosis. Pulmonary embolism and myocardial infarction were excluded. The patient recovered from thoracic pain after 4 weeks. Also in August 2008 the patient developed swelling of the left forefoot. In October 2008 diagnosis of enthesitis associated HLA B27 positive arthritis was established. Diagnosis was supported by serology, x-ray and MRI of the left foot (no detailed information provided). Unspecified treatment was carried out. The patient was not hospitalized. The patient had not recovered at the time of report. A persisting damage was reported. This was originally reported by a health professional. Other business numbers included E2009-05872. Additional information has been requested.


VAERS ID: 354024 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-12
Onset:2009-02-01
   Days after vaccination:295
Submitted: 2009-08-12
   Days after onset:191
Entered: 2009-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Colitis ulcerative, Colonoscopy abnormal
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific inflammation (broad), Ischaemic colitis (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OVRANETTE
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Colonoscopy, 01Feb09, severe distal ulcerative colitis
CDC Split Type: WAES0908USA01514

Write-up: Information has been received from a Health Authority (ref no: 20467369), via an agency as part of a business agreement, concerning a 17 year old female patient who on 12-APR-2008 was vaccinated intramuscularly with the third dose of GARDASIL (site and batch number not reported). Concomitant therapy included OVRANETTE. Details of the patient''s medical history have not been reported. The patient weighted 50 kg. The patient received three doses of GARDASIL (batch number not reported) between 13-OCT-2007 and 12-APR-2008. On 01-FEB-2009, eight months after the last dose, a colonoscopy was performed and the patient was diagnosed of severe distal ulcerative colitis. This was not responsive to treatment with steroid or balsalazide. The patient is now receiving treatment with azathioprine. The patient was not recovered. Both the reporter and the Health Authority considered this to be a serious due to disability and incapacity. No more information is available, this case is closed. Other business partner numbers include: E2009-07840.


VAERS ID: 356660 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-07
Onset:2009-07-27
   Days after vaccination:81
Submitted: 2009-09-04
   Days after onset:39
Entered: 2009-09-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alopecia
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; fluticasone
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA05040

Write-up: Information was obtained on request by the company from the agency via a Case Line Listing through CSL as part of a business agreement, concerning a 17 year old female who on 07-MAY-2009 was vaccinated with 0.5 ml of a dose of GARDASIL intramuscularly. Concomitant therapy included fluticasone and albuterol. On 27-JUL-2009 the patient experienced alopecia ( not severe). At the time of the report patient''s alopecia ( not severe) persisted. The agency considered that alopecia was unlikely related to therapy with GARDASIL. Alopecia ( not severe) was considered to be disabling. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 357135 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-01
Onset:2009-05-01
   Days after vaccination:0
Submitted: 2009-09-11
   Days after onset:133
Entered: 2009-09-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthritis reactive
SMQs:, Arthritis (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA00796

Write-up: This case was initially reported to the Agency by the Health Authority, reference no: 20485001 on 03-SEP-2009. This case concerned a 17 year old female patient. Details of the patient''s medical history and concomitant medication had not been reported. In May 2009 (exact date not reported), the patient received a dose of GARDASIL intramuscularly (batch number and site not reported). On an unreported date, two weeks post vaccination, the patient experienced reactive arthritis. The patient received treatment with DICLOFENAC and was then attending rheumatology. The patient had not recovered. Both the reporter and the Agency considered this to be a serious reaction due to disability and incapacity. This case is closed. Other business partner numbers included: E2009-08390. No more information is available.


VAERS ID: 360075 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-01
Onset:2009-08-01
   Days after vaccination:0
Submitted: 2009-10-07
   Days after onset:67
Entered: 2009-10-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myasthenia gravis
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910MYS00001

Write-up: Information has been received from a consumer concerning an approximately 17 year old female who in approximately August 2009 (two months ago) was vaccinated with the second dose of GARDASIL. In approximately August 2009, a few days after receiving the second dose of the vaccine, the patient was diagnosed with myasthenia gravis. The patient''s myasthenia gravis persisted. Myasthenia gravis was considered to be disabling. the administering physician did not say that the myasthenia gravis was related to the vaccine; causality is unknown. No further information is available.


VAERS ID: 364707 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-09-27
Submitted: 2009-11-02
   Days after onset:36
Entered: 2009-11-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1697U / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA03222

Write-up: Information has been received from a nurse concerning a 17 year old female who was vaccinated with a dose of GARDASIL (0.5ml, IM, lot# 1697U, batch# NJ02590). On 27-SEP-2009 the patient experienced intense itching on feet and hands and her feet was very swollen. The adverse events lasted 6 days. The patient was unable to attend school for 1 day. The patient was unable to wear close shoes. Therapy with GARDASIL was discontinued. The patient sought medical attention. At the time of the report, the patient had recovered on 02-OCT-2009. Intense itching on feet and same itching on hands and very swollen feet were considered to be disabling.


VAERS ID: 384964 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-03
Onset:2009-12-01
   Days after vaccination:120
Submitted: 2010-04-12
   Days after onset:131
Entered: 2010-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ02680 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amnesia, Dizziness, Muscle twitching, Muscular weakness, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA00674

Write-up: Information has been received from the agency via a Case Line Listing via CSL, as part of a business agreement, concerning a 17 year old female patient who on 03-AUG-2009, was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (Lot# NJ02680, batch# NJ46520). It was reported that in December 2009, < 1 year, the patient experienced nausea (severe), faintness (severe), muscle weakness (severe), twitching (severe) and memory loss (severe). At the time of the report, the patient had not recovered. The reporting agency considered that nausea (severe), faintness (severe), muscle weakness (severe), twitching (severe) and memory loss (severe) were disabling events. The relationship between nausea (severe), faintness (severe), muscle weakness (severe), twitching (severe) and memory loss (severe) and vaccination with GARDASIL was unclassified. Additional information is not expected.


VAERS ID: 385592 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-11
Onset:2008-01-31
   Days after vaccination:51
Submitted: 2010-04-20
   Days after onset:809
Entered: 2010-04-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0253U / 1 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diabetes insipidus, Laboratory test abnormal, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance imaging, diabetes insipidus was diagnosed; diagnostic laboratory test, endocrinological examinations : diabetes insipidus was diagnosed
CDC Split Type: WAES1004USA02225

Write-up: Case received from Health Authority on 12-APR-2010 (reference # PEI2010005944) : A 17 year old female on 04-OCT-2007 was vaccinated with the first dose of GARDASIL (lot # 1536F, batch # NG01520) which was well tolerated. On 11-DEC-2007 the patient received the second dose (IM, lot # 0253U, batch # NF58540) IM into the upper arm. On 31-JAN-2008 the patient was presented to a physician and diabetes insipidus was diagnosed which was confirmed by MRI and endocrinological examinations (not otherwise specified). The patient was treated ambulatory. Upon reporting form dated 02-MAR-2010 the patient had not recovered and "permanently damage" was ticked. Diabetes insipidus was considered to be disabling. Other business partner numbers included E2010-02328.


VAERS ID: 420002 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-03
Onset:2010-03-29
   Days after vaccination:634
Submitted: 2011-03-30
   Days after onset:366
Entered: 2011-03-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody increased, Arthralgia, C-reactive protein normal, Cryoglobulins present, HLA marker study, Haemoglobin normal, Inflammation, Musculoskeletal pain, Oedema peripheral, Pain, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid arthritis, Synovitis, Transaminases
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Raynaud''s syndrome
Preexisting Conditions: Otitis; Exeresis; Chillblains; Tick bite; Lyme disease; Chickenpox
Diagnostic Lab Data: Diagnostic laboratory test, 29Mar10, normal transaminase; Anti-MPO Ab, 29Mar10, negative; hemoglobin, 29Mar10, 11.5 g/dl; Serum ANA, 29Mar10, 1/80, dubious appearance of antinuclear antibodies with negative anti MPO and PR3 antibodies; Serum ANCA, 29Mar10, serum antineutrophil cytoplasmic antibody test (anti-PR3) -negative; Serum C-reactive protein, 29Mar10, 1 mg/L; Serum cyclic citrulline peptide IgG Ab, 29Mar10, 14 IU/mL; Whole blood HLA antigen test, 29Mar10, negative HLA B27; Serum cryoglobulins test, 29Mar10, active; Erythrocyte sedimentation rate, 29Mar10, 19 mm
CDC Split Type: WAES1103USA03412

Write-up: Case received from the Health Authorities on 22-MAR-2011 under reference number GR20110021. Case medically confirmed. A 17-year-old female patient, had received a dose of GARDASIL (batch number, site of administration not reported) via intramuscular route on 07-JAN-2009 and on 29-MAR-2010, she experienced arthritis rheumatoid. The patient had medical history of repeated otitis in 2009, benign naevus exeresis in December 2009, chilblains investigated in 2009, possible Raynaud syndrome since the age of 10, chicken pox during childhood, tick bite with positive test for Lyme''s disease treated with antibiotic therapy in 2008. She had received a first dose of GARDASIL on 03-JUL-2008 and the second dose on 02-AUG-2008. The patient had inflammatory polyarthralgia evolving since December 2009. Symptomatology started with tarsi arthralgia and heel pain which then extended to the hands, shoulders, buttocks, wrists and knees. Progressive apparition of finger and toe swelling with an inflammatory pattern and stiffness in the morning within 1 hour. VAS was at 7/10 in spite of treatment with BREXIN and paracetarrol, opium, LAMALINE. Treatment with non steroidal anti-inflammatory drugs with NABUCOX then SPIFEN then VOLTARENE 75 mg SR were ineffective whereas a week-long course of 40 mg daily orally of steroids at the end of February provided effective but temporary relief. On 29-MAR-2010, the patient saw her doctor, clinical examination evidenced hand and finger synovitis, painful bilateral patellar mobilisation without patellar shock and painful shoulder mobilisation. Laboratory test work-up: anti-CCP antibodies at 14 IU/mL, antinuclear antibodies at 1/80, dubious appearance of antinuclear antibodies with negative anti MPO and PR3 antibodies, negative HLA B27, active cryoglobulin, blood count showed hemoglobin at 11.5g/dl, ESR (erythrocyte sedimentation rate) at 19 mm and C reactive protein at 1mg/L, transaminases were normal. Patient was finally diagnosed with rheumatoid arthritis in March 2010. Treatment was started in mid-April 2010: methotrexate, speciafoldine, short courses of corticosteroids and non steroidal anti-inflammatory drugs. On 10-JAN-2011 patient was treated with methotrexate 15 mg a week subcutaneously, paracetamol and a course of non steroid anti-inflammatory drugs and PPI during flare-up. VAS at 5/10. Data in the literature did not clearly describe a risk of rheumatoid arthritis with GARDASIL. However, given the chronological sequence of events, a low imputability of GARDASIL in the onset of rheumatoid arthritis was retained. At the time of reporting, the patient had not yet recovered. The seriousness criterion reported by the HA was "disability". The Health Authorities assessed the causal relationship between the reported reaction and GARDASIL as "doubtful" according to the Foreign method of assessment. Other business partner numbers included: E2011-01990. Additional information has been requested.


VAERS ID: 425345 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-30
Onset:2009-03-01
   Days after vaccination:61
Submitted: 2011-06-13
   Days after onset:833
Entered: 2011-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Aphasia, Asthenia, Coordination abnormal, Disability, Gastrostomy, Headache, Movement disorder, Vasculitis cerebral
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA00764

Write-up: This case was received from the Health Authority on 02-JUN-2011. Reference number: ADR 21077360. This case was medically confirmed. A 17 year old female patient received the second dose of GARDASIL (manufacturer, lot and batch number not reported) i.m. on 30-DEC-2008. On an unspecified date in March 2009, approximately three months post vaccination, the patient developed headaches, weakness and lack of coordination. The patient had the first dose of GARDASIL (manufacturer, lot and batch number not reported) on 02-DEC-2008. The patient was eventually admitted to hospital in 2009 for long periods of time and was extensively investigated. The patient had a rare cerebral vasculitis of unknown cause. This was steroid responsive but the patient was unable to speak, walk or coordinate her movements. The patient was fed through a percutaneous endoscopic gastrostomy and was cared for 24 hours a day. At the time of reporting, the patient had not yet recovered (also reported as unknown). The reporter stated that whilst it clearly could not be proven that the patient''s illness was directly linked to GARDASIL vaccine she had a serious disability. The patient''s illness was rare and unexplained and her parents were convinced that it was caused by the vaccine. The events were considered serious due to hospitalization and disability. Other business partner number included: E2011-03389. No further information is available.


VAERS ID: 433363 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-08
Onset:0000-00-00
Submitted: 2011-09-04
Entered: 2011-09-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Arthralgia, Hypothyroidism, Laboratory test abnormal, Ovarian cyst, Pain, Sleep disorder
SMQs:, Haematopoietic erythropenia (broad), Hypothyroidism (narrow), Arthritis (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: Reported~HPV (Gardasil)~3~14.00~Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Tests resulted in disability status.
CDC Split Type:

Write-up: Joint pains, stabbing pains, ovarian cysts, anaemia, hypothyroid, sleep disorder.


VAERS ID: 451274 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-11
Onset:2012-02-12
   Days after vaccination:1
Submitted: 2012-03-07
   Days after onset:24
Entered: 2012-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0238Y / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Asthenia, Blood electrolytes normal, C-reactive protein normal, Diarrhoea, Epstein-Barr virus antibody negative, Frequent bowel movements, Full blood count normal, Headache
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Acute respiratory tract infection
Diagnostic Lab Data: Serum C-reactive protein, ??Feb?12, Normal range; Complete blood cell count, ??Feb?12, Normal range; Serum Epstein-Barr virus antibody test, ??Feb?12, Normal range; Serum electrolytes test, ??Feb?12, Normal range (Biochemical blood analysis)
CDC Split Type: WAES1203USA00085

Write-up: Information has been received from a pediatrician (local reference number: RUS/12/0050) concerning a 17 year old female patient with an active lifestyle, a history of acute respiratory viral infection (once in 1-2 years) in anamnesis, with no confounding factors (neither allergic nor inherited factors) and no chronic diseases, who on 22-JUN-2011, was vaccinated with the first dose of GARDASIL (batch number: NL40000, lot number: 0238Y), 0.5mL, intramuscularly. Approximately in 2011, the patient received the second dose of GARDASIL (batch number: NL40000, lot number: 0238Y), 0.5mL, intramuscularly. On 11-FEB-2012, the patient received the third dose of GARDASIL (batch number: NL40000, lot number: 0238Y), 0.5mL, intramuscularly. There was no concomitant medication. On 12-FEB-2012, the patient experienced clinical apparent weakness (also reported as acute weakness), headache, frequents stools (8-10 times per day) (also reported as liquid stool) and epigastric pains. Due to the events the following diagnostic tests were performed: hemogram, biochemical blood analysis (electrolytes), C-reactive protein test, Anti-Epstein-Barr virus (EBV) antibody test. All the values were within the normal range. All the events were lasting for 10 days and were resolved on 22-FEB-2012. Clinically apparent weakness (acute weakness), headache, frequent stools (8-10 times per day) (liquid stool) and epigastric pains were considered to be disabling by the physician. No further information is available.


VAERS ID: 476511 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-12
Onset:2007-12-12
   Days after vaccination:0
Submitted: 2012-12-05
   Days after onset:1820
Entered: 2012-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0311U / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdomen scan normal, Abdominal pain, Abdominal pain lower, Activities of daily living impaired, Alanine aminotransferase increased, Anti-thyroid antibody, Antinuclear antibody negative, Anxiety, Apolipoprotein B, Appendicectomy, Arthralgia, Babinski reflex test, Bladder pain, Blood albumin normal, Blood alkaline phosphatase normal, Blood cholesterol normal, Blood creatine, Blood electrolytes normal, Blood fibrinogen normal, Blood homocysteine normal, Blood thyroid stimulating hormone normal, Blood triglycerides, Bone pain, Brain scan normal, C-reactive protein increased, Cardiac function test normal, Cardiac stress test abnormal, Cardiovascular disorder, Colonoscopy normal, Colposcopy, Complement factor normal, Computerised tomogram head normal, Computerised tomogram normal, Cranial nerve disorder, Cryoglobulins present, Crystal urine present, Culture stool negative, Culture urine negative, Daydreaming, Depression, Discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram abnormal, Electrophoresis protein normal, Eosinophil percentage increased, Fatigue, Fibrin normal, Full blood count abnormal, Gamma-glutamyltransferase normal, Gastrointestinal disorder, Haemoglobin normal, Headache, High density lipoprotein normal, Hot flush, Human chorionic gonadotropin normal, Hyperthermia, Hypertriglyceridaemia, Hypoaesthesia, Illusion, Immunology test normal, Impaired driving ability, Laboratory test abnormal, Loss of consciousness, Lymphocyte percentage decreased, Lymphocyte percentage increased, Lymphopenia, Malaise, Memory impairment, Migraine without aura, Nausea, Neck pain, Neurological examination normal, Neutrophil percentage decreased, Neutrophil percentage increased, Night sweats, Ophthalmological examination normal, Optic nerve disorder, Ovarian cyst, Pain, Pain in extremity, Paralysis, Photophobia, Platelet count normal, Pollakiuria, Polymerase chain reaction, Porphyrins urine normal, Presyncope, Protein urine absent, Pyrexia, Red blood cell sedimentation rate increased, Renal function test normal, Romberg test, Serum ferritin normal, Sleep disorder, Speech disorder, Spinal pain, Syncope, Thyroid function test normal, Transaminases, Tremor, Ultrasound Doppler abnormal, Ultrasound Doppler normal, Ultrasound abdomen, Ultrasound pelvis abnormal, Urine analysis normal, Urine cytology normal, Vaccination complication, Venous thrombosis limb, Vertigo, Visual acuity reduced, Vomiting, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Dyslipidaemia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Other ischaemic heart disease (broad), Vestibular disorders (narrow), Vasculitis (broad), Lipodystrophy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MINIDRIL
Current Illness: Immunisation; Non-tobacco user
Preexisting Conditions: Gastroesophageal reflux disease; Asthma; --/--/2008, Ovarian cystectomy; Drug hypersensitivity; 10/27/1997, Infectious mononucleosis; 10/27/1997, Varicella; 06/--/2007, Lymphadenopathy; Measles virus vaccine live (+) mumps virus vaccine, Prophylaxis; Diphtheria inactivated (unspecified) (+), Prophylaxis; Hepatitis B vaccine rHBsAg, Prophylaxis; Penicillin (unspecified), Urticaria
Diagnostic Lab Data: T (date not specified) abdominal ultrasound: not contributory. On 18-Dec-2008, brain CT scan and thoracic-Abdominal-Pelvic CT scan were normal. Pelvian ultrasound tomography on 25-Aug-2008 did not show any anomaly, but pelvian ultrasound tomography on 11-Feb-2009 showed an ovarian cyst of 65x55 mm in diameter. 20-Oc-2008: Derived methoxylate dose: results pending. 09-Dec-2008: DPIG normal; ASCA and ACA negative; Type III cryoglobulin, polyclonal, very discrete lymphocytary type: discrete isolated NK lymphopenia; 11-Feb-2009: pelvic ultrasound thick endometrium, liquidian cyst of the right ovary (65x55), normal uterus; 04-Jun-2010: venous echodoppler of upper limb showed right superficial vein thrombosis very localized. Stress test was perfo
CDC Split Type: WAES1212FRA000148

Write-up: Information received initially from local Health Authorities on 07-Aug-2008 under the reference number MA20081366 updated on 12-Jul-2011, 8-Sep-2011 and on 23-Nov-2011 with new reference MA20112491. Other medically confirmed information received from the general practitioner on 8-Aug-2008 (case identified on 12-Jul-2011 as duplicate of E2008-07617 and consolidated) and on 9-Dec-2008. Medical expertise received on 3-Oct-2011 and final report on 13-Jan-2012. Not medically confirmed data retrieved from a daily newspaper on 11-Jul-2011. Information received from the lawyer on 22-Jul-2011, 8-Sep-2011, 15-Sep-2011 and 29-Sep-2011. (A compensation claim was lodged on 08-Jul-2011 with the regional commission of compensation for medical mishaps). A 17-year-old female patient had received the first dose of GARDASIL (batch number NG14100) on 12-Dec-2007, the second dose (batch number NG34100) on 20-Feb-2008 and the third dose (batch number NH13360) on 03-Jun-2008. Medically confirmed sources (HA and GP) reported in Aug-2008 that the patient experienced 48 hours after D1 fever, abdominal cramps and pain during two days, fever and abdominal pain (reported as pain at the level of the left colonic frame) or digestive disorder on unspecified time after D2 which lasted respectively 1 day and a few days, and fever up to 40 degrees C for 3 days and abdominal pain (reported as pain in the left colonic frame inducing walking discomfort) for 1 day after D3. The patient was hospitalized for one day. Information received from the GP in 2011 reported that the patient experienced nausea, vomiting, abdominal pain and bone pain after D3. The GP reported that the patient presented with cephalgia and that cephalgia occurred after manipulation by an ostheopath (unspecified date). Nausea, vomiting, abdominal pain and bone pain were reoccurring. Information received in 2011 from the HA reported that the patient experienced malaise one day after D3 as well as persistent cephalgia and persistent arthralgia and persistent arthralgia. As reported in 2008 by the GP, the patient recovered from fever, nausea and vomiting and as per HA from fever and abdominal pain after D3. To be noted that initial report to HA specified that administration of the first dose of GARDASIL had been uneventful. HA reported that as of 7-Aug-2008 the patient consulted gynaecologist and a gastroenterologist, and had an abdominal ultrasound, all were not contributory. On 07-Aug-2008, the patient was admitted to the emergency unit for standard work-up. PCR was normal, fecal culture was negative. Calcium oxalate cristals were found in urine. Not medically confirmed sources in 2011 reported that the patient experienced fever, nausea and vertigo in the evening after D1. It was reported that as from Dec-2007, the patient developed gastrointestinal disorders characterized by very severe abdominal pains preventing her from walking, associated with nausea and vomiting. These pains have led to regular hospitalizations up to now. She also experienced vertigo abdominal pain and vomiting after D2, felt continuously unwell and was hampered by light after D3. It was specified that the patient did not suffer from any pathology before the vaccination with GARDASIL. On an unspecified onset of time, the patient presented with iterative abdominal pain, very significant cephalgia, hypoaesthesia, and left eye photophobia. To be noted that according to the reporter those symptoms were linked to GARDASIL injections. Hospital report from 29-Oct-2008: On admission, the patient experienced severe cephalgias which sometimes became acute with sensation of occipito-parietal irradiation on the left and glasses. Iterative abdominal pain led her three times at the Emergency Unit Care. It was associated for the last 10 months with nausea and painful and disabling flare-up. Clinical examination: tendon reflexes present, sharp, and symmetrical. Free motion of joints, systolic murmur on the route of the right primary carotid.


VAERS ID: 493509 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-07-01
Onset:0000-00-00
Submitted: 2013-06-06
Entered: 2013-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Laboratory test normal, Mental disorder, Pain
SMQs:, Dementia (broad), Arthritis (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JASMINE; KESTIN
Current Illness:
Preexisting Conditions: Vesicoureteric reflux, Patient medical history of nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide. Anorexia nervosa, Patient medical history of nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide. 03/--/2012, GARDASIL, The patient had received the first dose of GARDASIL (batch number unknown) via intramuscular route in Mar-2012; Contraception; Drug hypersensitivity, Patient medical history of nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide.
Diagnostic Lab Data: Laboratory test (unknown date): normal. Several exams were performed to make a differential diagnosis: -~Rheumatologic exam was normal (no pathology was diagnosed by the rheumatologists) -~Laboratory test were normal -~No fall or recent trauma was reported -~Psychiatric disorder evoked but no evaluation performed.
CDC Split Type: WAES1306FRA000733

Write-up: Case received from the Health Authorities in a foreign country under reference number GR20130236 on 31-May-2013. Case medically confirmed. A 17-year-old female patient had received the second dose of GARDASIL (batch number unknown) via intramuscular route in Jul-2012. About 4 days post-vaccination, she experienced arthralgia (mechanical-like pain) in both hips and sacroiliac joints. Pain was constant and worsened at exertion. The patient had had several corrective treatments: level 1 analgesic, NSAID''s, corticosteroid and weak opiods. Several exams were performed to make a differential diagnosis: -Rheumatologic exam was normal (no pathology was diagnosed by rheumatologist) -Laboratory tests were normal -No fall or recent trauma was reported -Psychiatric disorder evoked but no evaluation performed. At the time of reporting, the patient still experienced pain and was treated with LAMALINE. The patient had received the first dose of GARDASIL (batch number unknown) via intramuscular route in Mar-2012. Her medical history included nervosa anorexia, vesicoureteral reflux in childhood and allergy to sulfamide. At the time of reporting, the patient was taking oral contraceptive, JASMINELLE and KESTIN. Family medical history included spondylitis in the patient''s father. The patient had received concomitantly a dose of VAXIGRIP (batch number not reported)on 27-Dec-2012. The Health Authorities searched the literature regarding duration of arthralgia after vaccination and only limited information was available. However, pain seemed to regress after few days/months with anti-inflammatory. Therefore, according to the Health Authorities, arthralgia could only be slightly ascribed to the vaccine. Considering the symptom''s length and family medical history of the patient, chronic inflammatory disease could not be ruled out. Considering the patient''s medical history, psychiatric disorder could not be ruled out. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the adverse event: "suspicion of psychiatric disorder" which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction (s) and vaccination as doubtful (C1 S1 I1) according to the Foreign method of assessment.


VAERS ID: 514917 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-07
Onset:2012-09-07
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:446
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Computerised tomogram abnormal, Diplopia, Dizziness, Eye swelling, Fatigue, Headache, Immediate post-injection reaction, Infection, Influenza like illness, Malaise, Muscle swelling, Myalgia, Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain, Postural orthostatic tachycardia syndrome, Presyncope, Pyrexia, Streptococcal infection, Syncope, Tilt table test positive, Ultrasound scan normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 06/12/2012, GARDASIL, Immunisation
Diagnostic Lab Data: Tilt table test: At the pulse eligibility criteria for POTS; Ultrasonography: Nothing abnormal; MRI: Swelling of the eye muscle; CT Scan: Swelling of the eye muscle
CDC Split Type: WAES1311DNK010488

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-E2013-09568) on 19-NOV-2013. Case of adverse event received from a non-health care professional via Health Authorities on 19-Nov-2013 under the reference number DK-DKMA-ADR 222692536 and DK-DKMA-EFO7381/ DK-DKMA-EFO7132. The primary reporter was a patient. Case is medically confirmed. A 17 year old female patient (weight: 60 kg; height: 170 cm) with no other health problems in general, had received the second dose of GARDASIL (batch/lot number H019870) via intramuscular route of administration in not reported site of administration on 07-Sep-2012 and later on, 07-Sep-2012, she developed influenza like symptoms for 4-5 days and double vision. On 09-Sep-2012 she developed POTS. On an unspecified date in Sep-2012 she experienced near syncope, abdominal pain, dizziness, tiredness and malaise. On an unspecified date in Oct-2012 she had fainting and then in Nov-2012 (date not specified) she developed muscle pain, joint pain and tendency to frequent infections. In Jun-2013 (date not specified) she had high fever and streptococcal infections. In Jul-2013 (date not specified) she developed headache and swelling of right eye/swelling of eye muscle. All symptoms increases in intensity towards the summer 2013. Patient description: In connection to the GARDASIL vaccination on 07-Sep-2012, adverse reactions occur such as dizziness and influenza-like symptoms for 4-5 days. In October she had fainting and dizziness attacks (contradictory: HA coded onset of dizziness Sep-2012). From an unspecified date in Nov-2012 to Apr-2013 she developed recurrent infectious diseases (HA did not code cessation date), joint and muscle pain. May/Jun-2013 she had abdominal pain on the left side for a month (contradictory: HA coded onset in Sep-2012). Ultrasonography was performed at Hospital which showed nothing. No diagnosis. Jun-2013 she had acute streptococcal infection, high fever. She received penicillin treatment. Jul-2013 she had a severe headache, swelling in the right eye and double vision (contradictory: HA coded onset of double vision 07-Sep-2012). She was admitted to Hospital (dates not specified) where MRI and CT scan were performed, with the result swelling of the eye muscle. She received prednisolone to treat. No diagnosis made incidentally. Aug-2013 she had acute streptococcus infection with high fever and received penicillin (antibiotics, other MFR) treatment. The patient was referred to another hospital for further assessment and POTS investigation. The patient also received physiotherapy as treatment for the adverse reactions. She had no other medications (no additional information provided). HA received follow up information on 30-Oct-2013 from a physician at Syncope Centre (Hospital). ADVERSE REACTION: Postural orthostatic tachycardia syndrome. Immediately after the second GARDASIL vaccine near syncope (she has never experienced near syncope/syncope before). In the following days she had additional symptoms: headache, malaise, tiredness, dizziness, severe abdominal pain. All symptoms increased in intensity towards summer 2013 and the symptoms are now subsiding again. Tilt table test was performed in Oct-2013 fulfill the pulse eligibility criterias for POTS - but she is actually in a quite well condition in orthostatic stress. It is described by other groups, providing assessment and treatment for POTS patients, that the clinical improvement is seen when pulse regulation comes into place. In the progression she has had tendency to recurrent/frequent infections - especially sore throat. She had the rare/special eye disease with swelling of the eye muscle, improved after prednisolone treatment. She has not had other vaccines and medication (no more information provided). Comment by agency: Version 1 (report from the patient) has not been sent to the agency. Version 2 is created when agency received a report from the physician. At the time of reporting, the outcome


VAERS ID: 524444 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-09-01
Submitted: 2014-03-04
   Days after onset:1645
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal hypomotility, Impaired gastric emptying
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402SWE013607

Write-up: Information has been received from the Sanofi Pasteur (SPMSD) (manufacturer control number E2014-01689) on 27-FEB-2014. Case was received from a health professional via the Health Authorities on 25-Feb-2014 under the reference MPA-2014-001510. Case is medically confirmed. Primary source was a physician. A 17-year-old female patient (weight, height not reported) with no medical history reported received a dose of GARDASIL, (batch number not reported) via not reported route and site of administration on an unspecified date. On an unspecified date in Sep-2009, the patient experienced intestinal pseudo-obstruction and gastroparesis. At the time of reporting, the patient had not recovered.


VAERS ID: 529133 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-10-01
Onset:0000-00-00
Submitted: 2014-04-23
Entered: 2014-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Depression, Dysarthria, Polycystic ovaries, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Fertility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1404GBR011643

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control #E2014-03528) on 18-APR-2014. This case was received from health authority on 16-Apr-2014. GB-MHRA ADR 22495078. The case is medically confirmed as it was reported by a pharmacist. A 17 year old female patient, with no medical history reported, received a first dose of GARDASIL (batch number not reported) route and site of administration not reported in 01-Oct-2009, and in 2011, two years after the first dose, the patient was diagnosed with polycystic ovarian syndrome. On an unreported date after the vaccine, the patient experienced blurred vision, slurred speech and depression. The patient had no family history of polycystic ovarian syndrome. At the time of reporting, the patient had recovered from blurred vision and slurred speech and she had not recovered from depression and polycystic ovarian syndrome. The regulatory authority reported the vaccine start date as 01-Oct-2009 and the vaccine end date at 01-Apr-2010 which was inconsistent with the administration of vaccine. The regulatory authority considered that case serious due the patient''s disability.


VAERS ID: 529474 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-30
Onset:2013-04-01
   Days after vaccination:641
Submitted: 2014-04-28
   Days after onset:392
Entered: 2014-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis, Myelitis, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 03/03/2011; Gardasil, Immunisation
Diagnostic Lab Data: 01/--/2014; Nuclear magnetic resonace imaging; 2 lesions on T2 N/A
CDC Split Type: WAES1404FRA012488

Write-up: Case received from the Health Authorities on 18-Apr-2014 under the reference number TO20140544. An 18-year-old female patient had received a dose of GARDASIL )batch number unknown) via intramuscular route on 30-Jun-2011, and before that she had also received a dose of HEPATITIS B vaccine (manufacturer unknown, batch number unknown) via intramuscular route at the end of February 2011. She had no relevant medical history. She had a family medical history with second generation female cousin from her mother side who suffered from multiple sclerosis. She had received a previous dose of GARDASIL (batch number unknown) via intramuscular route on 03-Mar-2011. On 24-Apr-2013, a myelitis was diagnosed with 4 hypersignals found on the T2 brain sections. In January 2014, a checkup MRI showed the appearance of 2 new lesions in T2. Bouts of the disease were disseminated in space and time. She was diagnosed with multiple sclerosis. Her biological workup was not available. There was no non-drug induced etiologies. The patient recovered from sequelae. She was treated with Copaxone on 19-Feb-2014. One month later, she no longer presented with evolutive signs and the treatment was bearable. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations as doubtful (C1 S2 I1) according to the foreign method of assessment.


VAERS ID: 536242 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-11
Onset:2009-08-25
   Days after vaccination:532
Submitted: 2014-07-10
   Days after onset:1780
Entered: 2014-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1537F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal migraine, Arthralgia, Bedridden, Complex regional pain syndrome, Endoscopy upper gastrointestinal tract normal, Goitre, Headache, Hyperprolactinaemia, Hypothyroidism, Myxoedema, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (narrow), Hyperthyroidism (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 08/2013, Endoscopy upper gastrointestinal tract, normal
CDC Split Type: WAES1310DNK012679

Write-up: Information has been received from SPMSD (manufacturer control# E2013-07867) on 25-OCT-2013. Case received from healthcare professional via health authority on 07-Oct-2013 under the reference number EFO7070 and 22261384. The primary reporter was a physician. A 18-year old female patient had received the third dose of GARDASIL (batch number NF27890, LOT # 1537F, expiration date: 15-DEC-2009) via intramuscular route of administration in not reported site of administration on 11-Mar-2008 and later on 25-Aug-2009 she developed abdominal migraine. The patient was previously vaccinated with GARDASIL dose 1 (batch number NE47600, LOT# 655376/0572F, expiration date: 05-MAY-2009) and 2 (batch number NE60490) on 07-Aug-2007 and 09-Oct-2007 respectively. The patient was up to the summer of 2008 healthy, sane and functional. It is reported in the narrative from the health authority that the reaction started 6 month after the third injection, which is not consistent with the coded dates. At the time of reporting, the outcome was unknown. Information has been received from SPMSD (manufacturer control# E2013-07867) on 08-JUL-2014. Follow-up information received from HA on 03-Jul-2014. HA received further information from HCP on 03-Jun-2014 (Ref: DK-DKMA-EFO9400). Duplicate identified by HA and merged before publication of the master case. It was reported that the patient developed: reflex dystrophy in 2009, nausea in Jun-2008, pain in the ankles and other joints in Jun-2008, autoimmune urticaria in 2008, autoimmune hypothyroidism- myxedema with goiter in 2011, hyperprolactinaemia in 2011 and headache in 2008. The patient was up to the summer of 2008 healthy, sane and functional but due to overloading developed pain in feet, after which she developed chronic pain, which exacerbated in 2009, when she was bedridden for a long time. Investigated regarding suspicion of development of complex regional pain syndrome type 1 - reflex dystrophy. Furthermore, she has had constant nausea and was diagnosed with abdominal migraines. Has in addition been diagnosed with myxedema with goiter (autoimmune hypothyroidism), autoimmune urticaria, and hyperprolactinemia. Furthermore headaches almost daily. All of this occurred after the last vaccine starting in summer 2008. Patient suspect event that it may due to HPV vaccines. The timing is the development of different symptoms over time, starting in summer 2008. Patient is now followed by pain and anesthesia clinic, endocrinology clinic, gastro medical clinic and dermatology clinic. She has applied for a disability pension in April 2014. The patient has since 2008 to today gone through an intensive investigation of repeated tests, scans, blood tests, etc. Latest survey is for POTS (postural tachycardia syndrome) with tilt table test and heart rate at syncope center at Hospital-near normal test 05-Mar-2014. MR cerebrum- August 2013. Showing small 8 mm corpus pineale cyst. August 2013- gastroscopy, celiac disease tests and lactose intolerance gene test - all normal. Patient age at the start of the side effects was updated to 17 years. HA decided to upgrade the case to serious on the severity criterion Disability/ Incapacity. Outcome for the new reactions headache, hyperprolactinaemia, hypothyroidism, joint pain, nausea, reflex sympathetic dystrophy and urticaria was not recovered and outcome for chronic pain was unknown.


VAERS ID: 541711 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-03-01
Submitted: 2014-08-29
   Days after onset:180
Entered: 2014-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Bedridden, Dizziness, Headache, Mobility decreased, Vomiting, Wheelchair user
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408COL016787

Write-up: This spontaneous report was received from a mother of 17 year old daughter. On an unknown date the daughter was vaccinated with a second dose of GARDASIL, dose 0.5 ml (also reported as "strength") intramuscularly (lot number not reported). Subsequently the patient began to feel severe headaches, vomiting, dizziness and severe back pain. The patient''s mother reported that since March 2014 (exact date unspecified)(also reported as "since seven months ago") the patient was bedridden, using a wheelchair. From 19-AUG-2014 (reported also as "from eight days ago") the patient began to lose mobility in her hands, which was worrying her. The outcomes of the severe headache, vomit, dizziness, severe back pain, leg mobility loss and hand mobility loss were reported as not recovered/not resolved. The outcome of bedridden to a wheelchair was not reported. The relationship between the GARDASIL and the events was not reported. The reporting consumer felt that the events: severe headache, vomit, dizziness, severe back pain, leg mobility loss and hand mobility loss caused disability. Upon internal review the events: bedridden to a wheelchair were assessed to cause disability. Additional information is not expected because no follow-up was required or available.


VAERS ID: 553998 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-19
Onset:2012-08-01
   Days after vaccination:74
Submitted: 2014-10-31
   Days after onset:821
Entered: 2014-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acoustic stimulation tests normal, Activities of daily living impaired, Asthenia, Atonic seizures, Deafness, Deafness bilateral, Dizziness, Fear of crowded places, Gait disturbance, Headache, Hypoacusis, Hypoaesthesia, Laboratory test normal, Malaise, Memory impairment, Muscular weakness, Nausea, Nuclear magnetic resonance imaging normal, Photophobia, Schizophrenia, Seizure, Visual field defect
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYPREXA
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 08/2012, Acoustic stimulation tests, found no abnormalities; 2012, Medical observation, no abnormalities; 08/2012, Nuclear magnetic resonance imaging, without abnormalities
CDC Split Type: WAES1410JPN015952

Write-up: This spontaneous report as received from a physician refers to a 17 year old female patient with no concomitant disease, medical history. On 19-MAR-2012, the patient was vaccinated with a first dose of GARDASIL (dose and lot # not reported) intramuscularly and on 19-MAY-2012, the patient received the second dose of GARDASIL (dose and lot # not reported) intramuscularly. Concomitant therapies included ZYPREXA. One month later, in July 2012, the patient experienced malaise, headache and weakness. In August 2012, she became hard of hearing and visited hospital (otolaryngology). A diagnosis of moderate deafness was given. Then she visited another hospital (brain surgery) where MRI examination was performed without abnormalities. Then the patient visited another hospital (neurology) due to dizziness and feeling queasy. Then she visited another hospital (psychosomatic medicine). In the same month, she experienced visual field constriction and visited another hospital (ophthalmology) without abnormalities. She became deafness bilaterally while hearing test found no abnormalities. In the middle of September 2012, deafness resolved. On an unspecified date in 2012, the patient experienced unspecified symptoms on the back and weakness of hands. She became having difficulty in walking and tend to absent from school. Examinations on internal medicine found no abnormalities. As of 2013, she was able to keep attending to school. In January 2014, her parents heard from some of her friends that the patient had hallucination, talking strange things. The patient visited another hospital (stress clinic) where a diagnosis of schizophrenia was given. On an unspecified date in 2014, the patient became bad at memorization and visited another hospital where olanzapine was prescribed. She also experienced atonic seizures and numbness of limbs. She became unable to go to school. The patient was wearing sunglasses in the house due to photophobia and she seemed to have a fear of crowd of people. On an unspecified date, she also experienced convulsion. As of 28-OCT-2014, the patient was recovered from deafness. The outcome of malaise, headache, weakness, dizziness, feeling queasy, difficulty in walking, hallucination, bad at memorization, numbness of limbs, photophobia and convulsion was not recovered. The outcome of visual field constriction, weakness of hands, schizophrenia, atonic seizures and school refusal was unknown. Reporter comments: The patient asked the association who commented that her symptoms might be due to GARDASIL. The reporting physician felt that malaise, dizziness, feeling queasy, headache, weakness, deafness, difficulty in walking, photophobia, convulsion, hallucination, bad at memorization and numbness of limbs were related to GARDASIL. The reporting physician did not assess the relationship of visual field constriction, weakness of hands, schizophrenia, atonic seizures and school refusal to the vaccine. The reporting physician felt that malaise, dizziness, feeling queasy, headache, weakness, deafness, difficulty in walking, photophobia, convulsion, hallucination, bad at memorization and numbness in limbs were serious due to disability. The reporting physician did not assess the seriousness of visual field constriction, weakness of hands, schizophrenia, atonic seizures and school refusal. Upon internal review atonic seizures, convulsion and bilateral deafness were determined as serious due to an other important medical event. Additional information has been requested.


VAERS ID: 619313 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-06-01
Submitted: 2015-12-07
   Days after onset:1650
Entered: 2015-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1512SWE003603

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR Control No: 2015000232) on 04-DEC-2015. Case received from a physician via HA on 27-Nov-2015 under reference number SE-MPA-2015-007670. A 17-year-old female adolescent patient received GARDASIL, (batch number unknown) in 2011. The patient experienced Epilepsy on 01-JUN-2011. Short report from neurophysician. Shortly after vaccination (in 2011, exact date unknown), debut of primary generalized epilepsy. The patient suspects causality between vaccination and debut of disorder, and the physician cannot rule out the possibility. The patient''s outcome was reported as Not Recovered/Not Resolved. The HA assessed the causal relationship between Epilepsy and GARDASIL as Reasonable Possibility.


VAERS ID: 620110 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-11-01
   Days after vaccination:2
Submitted: 2015-12-23
   Days after onset:3339
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Constipation, Decreased appetite, Disturbance in attention, Dizziness postural, Dyskinesia, Dysuria, Eating disorder, Fatigue, Headache, Hypersensitivity, Hyperventilation, Loss of personal independence in daily activities, Lymphadenopathy, Memory impairment, Menstruation irregular, Muscular weakness, Nausea, Pain, Palpitations,