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VAERS ID: 620620 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-02-16
Onset:0000-00-00
Submitted: 2016-01-12
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Disturbance in attention, Dizziness, Dyskinesia, Dyspnoea, Exercise tolerance decreased, Fatigue, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Musculoskeletal pain, Nausea, Postural orthostatic tachycardia syndrome, Presyncope, Social problem, Syncope, Tic, Tilt table test positive, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (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) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Fulfills the diagnostic criteria for POTS during tilt table test. Blood pressure measurement, decrease greater than 20/10 mmHg; Heart rate, increases greater than 40 bpm
CDC Split Type: WAES1601DNK002808

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016000050) on 08-JAN-2016. Case received from physician via health Authority on 05-Jan-2016 under reference number DK-DKMA-WBS-0002162. Case received from a physician via health Authority on 05-Jan-2016 under reference number DK-DKMA-WBS-002162. A 13-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 08-Oct -2013, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 17-Dec-2013, GARDASIL (batch number J0101618, Dose 3) via intramuscular route on 16-Feb-2015. The patient experienced Can not ride as she did earlier on an unknown date, faints 1-2 times per week on an unknown date, Involuntary muscle movement on an unknown date, Shortness of breath on an unknown date, Nausea on an unknown date, headache in 2013, problem keeping a social network on an unknown date, Postural orthostatic tachycardia syndrome on an unknown date, dizziness in 2015, numb areas in fingers and arms on an unknown date, Exhausted / fatigue on an unknown date, shaking/tics in right hand on an unknown date, near fainting 1-2 times per day on an unknown date, concentration problems on an unknown date, Cognitive disorder on an unknown date, can not go to school on an unknown date and shoulder pain on 07-OCT-2015. The patient''s outcome was reported as Not Recovered/Not Resolved. The HA has received the report from the hospital and another physician. The patient has reported to the center that she was vaccinated 5 times, unknown dates. She describes that the symptom started in 2013, when she developed headache that lasted approximately for a month. In 2015 the headache returned and is now constant, but varies in intensity. Dizziness started also in 2015. She describes that she faint in average 1 time per week. Tilt table test shows that she fulfills the diagnostic criteria for POTS. The patient describes that this has consequences for her, she has problem keeping her social network, and can not go to school and she can not ride as she used to. Until vaccination she was riding 5-6 times per week, 1-1,5 h per time. Diagnostic criteria for POTS. Heart rate increases greater than or equal to 30 bpm 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 greater 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 the hospital uses further criterion 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. Other vaccines or medicines: Not known. The other physician reports the following: headache, dizziness constant, fainting 1-2 times per week, near fainting 1-2 times per day, tiredness, shaking/tics in right hand, numb area in fingers and arm. She can not read or write, as the headache and dizziness get worse. Concentration problems. She has not been in school for 6 months. Medical record 07-Oct-2015: Medical history She has fainted today again at home. She had 5 minutes before got up from the sofa, walked around in the house, and goes to lie down, next thing she remember is the she woke up on the floor and has shoulder pain. No warning that she should faint. Thus no sensation of warmth, redness, sweating tendency, increased dizziness, or vision disturbance before she faint. She has constant headache, does not wake up of it, but has headache when she wakes up. The headache has over the last months increases. It got worse when she should read or write. Turn of the subtitles from the TV, but can follow when she watch TV, and does not get worse headache. There are attempted physiotherapy of this (optapening of shoulder, manipulation of the neck, stretching exercises) no effect. Has been seen by optician, that does not find a need of glasses. Is constant dizzy, dizziness of nautical character. Better when she lie down with her eyes closed, but doesn''t disappear totally. No double vision. The symptoms are so profound that she has only been school a few days since the summer break. Has previously liked school, has good friends. Parents are very concerned, see their daughter that has been very active and now only sit at home. Are worried that she has something in her head and which a scan of the head. DKMA comment: The HA has been in contact with the treating physician to clarify the vaccination dates. From the medical records they can inform that she was vaccinated 08-Oct-2013, 17-Dec-2013 and 16-Feb-2015.


VAERS ID: 620631 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-01
Onset:2011-03-01
   Days after vaccination:0
Submitted: 2016-01-12
   Days after onset:1778
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN40800 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood test, Chest pain, Computerised tomogram, Depression, Dizziness, Dysmenorrhoea, Dyspnoea, Endoscopy upper gastrointestinal tract, Fatigue, Feeling abnormal, Gluten sensitivity, Headache, Irritable bowel syndrome, Lethargy, Lumbar puncture, Menstruation irregular, Migraine, Nausea, Nuclear magnetic resonance imaging, Rash, Sleep disorder, Syncope, X-ray, X-ray gastrointestinal tract
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601IRL002529

Write-up: Information has been received Sanofi Pasteur MSD (SPM) with (MFR# IE-1577272925-2016000040) on 08-JAN-2016. This case was received from the RA health authority on 05-JAN-2016. Initial report was received by the RA on 21-DEC-2015 from a member of the public which concerns a 15 year old female patient who experienced Headache, Nausea, Chest pain, Dyspnoea, Back pain, Rash, Abdominal pain upper, Arthralgia, Dizziness, Syncope, Fatigue, Lethargy, Feeling abnormal, Sleep disorder, Gluten sensitivity, Irritable bowel syndrome (IBS), Menstruation irregular, Dysmenorrhoea, Migraine and Depression following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None. The reporter indicated that the patient was perfectly healthy prior to vaccine. The patient was vaccinated with three doses of GARDASIL on 18-JAN-2011 (batch no. NN33040), 01-MAR-2011 (batch no. NN40800) and 24-MAY-2011 (NN40800). On 01-MAR-2011, the patient started to experienced headaches, nausea, chest pain, shortness of breath, back pain, rash, stomach cramps, pain in joints, dizziness, fatigue, lethargy, brain fog, irregular sleep, gluten intolerance, IBS, irregular periods and very painful, migraines and depression. Corrective treatment: Painkillers, depression tablets, steroids, magnesium, vitamin B complex, calcium and liquid silver. The patient was also given inhalers for asthma and was tried on a number of therapies for IBS. The patient was hospitalised for various tests, had a camera up and down, bloods taken, a lumbar puncture, X-rays, CT scans, MRIs. At the time of reporting the patient''s symptoms were persisting. The patient outcome was not recovered/not resolved.


VAERS ID: 620648 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-12
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Angiopathy, Arthralgia, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased, Loss of personal independence in daily activities, Muscular weakness, Nausea, Palpitations, Photophobia, Postural orthostatic tachycardia syndrome, Presyncope, Syncope, Tilt table test positive, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Fulfill the diagnostic criteria for POTS with tilt table test.
CDC Split Type: WAES1601DNK003031

Write-up: Information has bee received from Sanofi Pasteur MSD (SPM) (manufacturer control # 2016000048) on 08-JAN-2016. Case received from a physician via health authority on 05-Jan-2016 under reference number DK-DKMA-WBS-0002164. A 14-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route in 2011, GARDASIL (batch number unknown, Dose 2) via intramuscular route in 2011, GARDASIL (batch number unknown, Dose 3) via intramuscular route in 2011. The patient experienced Joint pain in 2011, Headache in 2011, Syncope on an unknown date, Near syncope on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Dyspnosea on effort on an unknown date, Fatigue extreme on an unknown date, Cognitive dysfunction on an unknown date, Limb weakness on an unknown date, Vascular abnormalities on an unknown date, Light sensitivity to eye on an unknown date, Blurred vision on an unknown date and POTS on an unknown date. Vaccination dates not known (probably in 2011), therefore not possible for a time relationship between the vaccine and that symptoms. First symptoms were joint pain and headache a couple of months after 3 dose, thereafter the other reported symptoms. During tilt table test is the patient fulfilling the diagnostic criteria for POTS. The patient has previously danced on high level, but has stopped due to joint pain. The patient describes reduced function, and has a lot of sick leave from her education (30-35 % absence). Diagnostic criteria for POTS. Heart rate increases greater than or equal to 30 bpm 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 greater 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 the hospital uses further criterion 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. Other vaccines or medicines: Not known. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620746 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-09-12
Submitted: 2016-01-19
   Days after onset:1224
Entered: 2016-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased appetite, Depression, Fatigue
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601IRL005248

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer number# IE-1577272925-2016000210 on 15-JAN-2016. This case was received from the health authority on 13-Jan-2016. Initial report was received by the HA on 14-DEC-2015 from a Community Pharmacist concerning a 14 year old female patient who experienced decreased appetite, depression, abdominal pain and fatigue following vaccination with GARDASIL. The patient was not receiving any concomitant medications. The patient''s medical history/concurrent conditions were not reported. The patient was vaccinated with three doses of GARDASIL (lot numbers # also reported as "GO19345", "HO08259", "HO13055") intramuscularly between 12/Sep/2012 and 06/Jun/2013. On 12/Sep/2012, the patient developed anorexia, depression, abdominal pain and fatigue which the reporter considered to be persistently or significantly disabling/incapacitating. The events was also considered to be medically significant. At the time of reporting the patient outcome was reported as not recovered/not resolved. Lot numbers # G019345, H008259 and H013055 are valid on 18-JAN-2016.


VAERS ID: 620868 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-05-20
Onset:2015-05-20
   Days after vaccination:0
Submitted: 2016-01-21
   Days after onset:246
Entered: 2016-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Dizziness, Haemorrhage, Headache, Hypoaesthesia, Immune thrombocytopenic purpura
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601IRL007335

Write-up: Information has been received from Sanofi Pasteur MSD [IE-1577272925-2016000290] on 20-JAN-2016. This case was received from the health authority on 15-JAN-2016. Ref IE-HPRA-2015-025523. Initial report was received by the HA on 15-DEC-2015 from a member of the public (patient herself) concerning a 14 year old female patient who experienced hypoaesthesia, headache, dizziness, contusion and immune thrombocytopenic purpura following vaccination with GARDASIL. The patient was not receiving any concomitant medications. The patient had no medical history/concurrent conditions. The patient was vaccinated with three doses of GARDASIL (lot number NM1142D, NM1142D, NN0199O) at a dose of 0.5 ml each time on dates between 20-MAY-2010 and 31-DEC-2010. After the first vaccination on 20-MAY-2010, the patient''s arm was numb and she developed ''constant'' headaches and dizziness. In the weeks after the vaccination, the patient developed ''bleeding and bruising all over the body''. The patient''s GP was contacted and she was sent to the emergency department and subsequently hospitalised. The patient has been attending hospitals and specialist/consultants for the past 6 years and is being treated (unspecified) for idiopathic thrombocytopenic purpura (ITP). The reporter indicated that the patient has ''no understanding where the disorder (ITP) came from'' and that she is at ''high risk of haemorrhaging and prolonged bleeding''. At the time of reporting the patient was not recovered.


VAERS ID: 630655 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-11-11
Onset:2009-11-16
   Days after vaccination:5
Submitted: 2016-03-07
   Days after onset:2303
Entered: 2016-03-07
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, Amnesia, Craniocerebral injury, Dizziness, Dysarthria, Emotional distress, Haematoma, Headache, Impaired work ability, Nausea, Nervous system disorder, Pain, Seizure, Skin abrasion
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603CAN002762

Write-up: Information has been received from a lawyer regarding a case in litigation concerning a 14 year old female patient, who on 11-NOV-2009 was vaccinated with her first dose of GARDASIL (dosage, lot number and route of administration not provided). On 16-NOV-2009, the patient experienced a seizure and was taken to the emergency department presenting with slurred speech, hematoma, nausea, and abrasions. On or about February or March 2010, the patient was administered a second dose of GARDASIL, and a third dose was administered in or about May 2010 (dosages, lot numbers and routes of administration not provided). The patient suffered further seizures on or about 29-JUL-2010 and 12-NOV-2012. As a result, the patient sustained serious personal injuries including, but not limited to: traumatic brain injury, neurological damage and disorder, memory loss, headaches, and lightheadedness (onset not provided), as well as seizures, slurred speech, hematoma, abrasions and nausea. As a result of the injuries suffered, the patient has experienced pain and suffering and loss of the amenities of life and has been forced to undergo and will continue in the future to require lengthy and painful therapy and treatments for her rehabilitation. As a further result of her injuries, the patient has suffered and will continue to suffer loss of income as a result of being restricted in her ability to work, and required ongoing care to assist with all activities of daily living. The outcome of the seizures, lightheadedness, headache, memory loss, neurological damage and disorder, traumatic brain injury, abrasions, nausea, hematoma and slurred speech is unknown. Upon internal review, seizures (16-NOV-2009, 29-JUL-2010 and 12-NOV-2012) were determined to be medically significant. Seizures, traumatic brain injury, neurological damage and disorder, slurred speech, hematoma, abrasions, memory loss, headaches, lightheadedness, and nausea were considered to be disabling. Additional information has been requested.


VAERS ID: 631925 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-15
Entered: 2016-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Arthropathy, Dizziness, Headache, Immune system disorder, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604DNK009322

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number DK-1577272925-2016003711) on 14-APR-2016. Please remember to use the Worldwide unique case identification number for this case: DK-DKMA-ADR 23359847. Also, please note that information should not be deleted from the case (especially not the Patient Characteristics). Case received from a lawyer via health authority on 11-Apr-2016 under reference number DK-DKMA-ADR 23359847. The HAs received the patient''s initial notification to the patient insurance. The patient insurance has not taken a decision in the case. A 14-year-old female adolescent patient received GARDASIL (batch number unknown) in 2010. The patient experienced dizziness in 2012, nausea in 2012, joint pain in 2012, headache in 2012, migraine in 2012, reduced immune system in 2012 and reduced joint function in 2012. The reactions started gradually in 2012 with much reduced immune defence, migraine. The patient contacted the physician several times and was prescribed PRIMPERAN 20 mg for nausea in 2013 and IMIGRAN for migraine in 2013. It culminated in 2015, with hospitalization with dizziness, reduced joint function, nausea and migraine. The patient was discharged with a prescription of EMEPERAL, without improvement. Symptoms of dizziness, joint pain, headache and migraine. The patient has been on sick leave since October 2015 and is still not back. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 634213 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-13
Onset:2012-03-14
   Days after vaccination:1
Submitted: 2016-05-03
   Days after onset:1511
Entered: 2016-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. GO14502 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dyspnoea, Fatigue, Head injury, Headache, Injection site swelling, Palpitations, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604IRL017976

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # IE-1577272925-2016004775) as part of business agreement on 28-APR-2016. This case was received from RA in Ireland (Ref no. IE-HPRA-2016-026477) on 27-APR-2016. Initial case received from a consumer/other non health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number NN40800) on 14-SEP-2011, GARDASIL (batch number NP26080) on an unknown date, GARDASIL (batch number GO14502) on 13-MAR-2012. Concomitant medications: None. Medical history/concurrent conditions: Not reported. The patient experienced headaches, swelling of injection site, difficulty breathing, severe chest pain, postural tachycardia syndrome, palpitations, seizures - with many bangs on the head on 14-MAR-2012, constantly fainting and chronic fatigue on an unknown date. The reporter assessed the causal relationship between Headache, Swelling of injection site, Difficulty breathing, Chest pain, Postural orthostatic tachycardia, Palpitations, Seizures, Fainting, Chronic fatigue and GARDASIL as Unknown. Corrective treatment: The patient has attended GPs and hospitals and has commenced sodium, SSRI medication and an additional medication (to be confirmed). The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 635288 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-29
Onset:2008-12-01
   Days after vaccination:33
Submitted: 2016-05-05
   Days after onset:2711
Entered: 2016-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activities of daily living impaired, Angiopathy, Cognitive disorder, Dizziness, Dry eye, Dyskinesia, Dyspnoea, Fatigue, Headache, Heart rate increased, Loss of consciousness, Muscular weakness, Nausea, Neuralgia, Orthostatic intolerance, Palpitations, Photophobia, Sleep disorder, Tilt table test normal, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Have examinations and/or laboratory tests been conducted: Yes. Tilt Table Test: The patient does not meet the diagnostics criteria for POTS but it showed high resting heart rate. On an unknown date the patient experienced high resting heart rate.
CDC Split Type: WAES1605DNK002329

Write-up: Information has been received from Agency (DKMA) (DK-DKMA-WBS 0003322) via SPMSD (manufacturer control # DK-1577272925-2016004920) on 04-MAY-2016. Case received from a physician on 29-APR-2016. A 14-year-old female adolescent patient received GARDASIL (batch number lot not rep, Dose 1) via intramuscular route on 29-OCT-2008, GARDASIL (batch number lot not rep, Dose 2) via intramuscular route on 02-JAN-2009, GARDASIL (batch number lot not rep, Dose 3) via intramuscular route on 14-MAY-2009. the patient experienced blurred vision on 01-DEC-2008, fatigue extreme on an unknown date, orthostatic intolerance on an unknown date, High resting heart rate on an unknown date, headache on an unknown date, neuropathic pain on an unknown date, blacked out on an unknown date, dizziness on an unknown date, palpitations on an unknown date, nausea on an unknown date, abdominal pain on an unknown date, dyspnea on an unknown date, disordered sleep on an unknown date, Cognitiv dysfunction on an unknown date, involuntary muscle movement on an unknown date, limb weakness on an unknown date, vascular abnormalities on an unknown date, dry eyes on an unknown date, feeling bloated on an unknown date, light sensitivity to eyes on an unknown date, impaired functioning on an unknown date and have been absent from school a lot due to sickness. the school year 2008/2009 she was on sick leave for 3 months. Have had to abandon training and tried to so Higher Preparatory Examination on an unknown date. Approximately 1 month after the first vaccination the patient experienced that she found it difficult to see and focus her eyes. Subsequently, the other reported symptoms followed. According to a tilt table test at our office the patient does not fulfill the diagnostic criteria for POTS, however shows a high resting heart rate. Clinically appearance of a patient with orthostatic intolerance. Patient reports decreased level of functioning and a lot of sick leave. During the school year 2008/2009, she was on sick leave for three months. Has had to abandon training and tried to do Higher Preparatory Examination in single subjects. Other vaccines: Do not know. Other Medicines: Do not know. the patient was admitted to hospital on an unspecified date. Additional investigations included Tilt table test not meet POTS criteria on an unknown date. the patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 635400 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-02
Onset:2009-10-01
   Days after vaccination:91
Submitted: 2016-05-09
   Days after onset:2412
Entered: 2016-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Back pain, Discomfort, Disturbance in attention, Dizziness postural, Fatigue, Headache, Infection susceptibility increased, Influenza like illness, Muscle contractions involuntary, Muscle spasms, Nausea, Oropharyngeal pain, Palpitations, Vision blurred, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus, immunisation; Hypermobility syndrome, Hypermobilitet
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Carried out studies and / or laboratory tests: No
CDC Split Type: WAES1605DNK002395

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number # 2016004929) as part of business agreement on 04-MAY-2016. Case received from a HCP via Health Authority on 02-MAY-2016 with the reference number DK-DKMA-WBS-0003335. Case from a physician. A 14-year-old female adolescent patient received GARDASIL, (batch number LOT NOT REP, Dose 1) via intramuscular route on 04-Jul-2008, GARDASIL, (batch number unknown, Dose 2) on 04-Feb-2009, GARDASIL, (batch number unknown, Dose 3) on 02-Jul-2009. The patient experienced Arthralgia in OCT-2009, back pain in OCT-2009, fasciculation skeletal muscle in 2010, discomfort bodily, most legs in 2011, influenza symptoms of joint pain/cramps in 2010, infection tendency in 2010, tiredness in 2010, headache in 2012, visual disturbance, difficulty focusing in 2012, orthostatic dizziness in 2012, concentration difficulty in 2012, throat pain in 2010, abdominal pain in 2011, nausea in 2011, palpitations in 2012, influenza symptoms of joint pain / cramps in 2010, difficulty concentrating in 2012 and could not complete high school, is on education aid on an unknown date. The patient had a medical history of Hypermobility syndrome. The patient''s outcome was reported as not recovered/not resolved. History around adverse reaction: Could not complete high school, is on education aid. Other vaccines: No. Other medicines: Yes.


VAERS ID: 635490 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-11
Entered: 2016-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Chest pain, Electrocardiogram, Fatigue, Headache, Hypotension, Myalgia, Scan brain, Sensory disturbance, Syncope, Tilt table test, Visual impairment, Vocal cord paralysis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient has gone through blood tests, scanning of the brain, ECG, blood pressure measuring during one day, tilt table test, neurologist, countless doctor visits, examination at two different hospitals.
CDC Split Type: WAES1605DNK004651

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control # 2016004995) as a business agreement on 09-MAY-2016. Case received from a consumer/other non health professional via in Denmark on 04-May-2016 under reference number DK-DKMA-ADR 23455519. A 14-year-old female adolescent patient received GARDASIL, batch number unknown in 2010). The patient experienced Fainting in 2011, Sensory disturbances in 2013, headache in 2011, visual disturbances in 2011, chest pain in JUL-2011, tiredness in 2011, muscle pain in 2012, Paralysis of the right vocal cord in 2014, too low blood pressure in 2013, joint pain in 2012 and has been close to drop out of school due to absence on an unknown date. The patient has not been treated for the adverse events. The patient has not been hospitalized due to the adverse events. Other medication: No. The patient has during the last school year struggled through the school days and has been close to dropping out of school due to sick leave. The patient has gone to bed as soon as she came home from school and have not managed to do things for a longer period of time. The patient has gone through blood tests, scanning of the brain, ECG, blood pressure measuring during one day, tilt table test, neurologist, countless doctor visits, examination at two different hospitals. The names of the physicians at the hospitals has not been reported. MA has requested medical confirmation. The patient recovered from Paralysis of the right vocal cord in 2014. He/She had not recovered from Fainting, Sensory disturbances, headache, joint pain, tiredness, muscle pain, too low blood pressure, visual disturbances. Case outcome is Not recovered/not resolved.


VAERS ID: 642084 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-13
Onset:2009-09-01
   Days after vaccination:19
Submitted: 2016-05-24
   Days after onset:2457
Entered: 2016-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Agitation, Amnesia, Anxiety, Arthralgia, Confusional state, Depression, Disturbance in attention, Dizziness, Dyspnoea, Fatigue, Headache, Malaise, Muscular weakness, Myalgia, Nausea, Nightmare, Sleep paralysis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1605IRL011279

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-2016005356) on 23-MAY-2016. This case was received from RA (Ref no. IE-HPRA-2016-026661) on 18-MAY-2016. Initial case received from a consumer/other non-health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number unknown) on 03-JUN-2009, GARDASIL (batch number unknown) via intramuscular route on 13-AUG-2009 and 22-DEC-2009. The patient was not receiving any concomitant medications. The patient''s medical history/concurrent conditions were not reported. The patient experienced nausea, headaches, fatigue, muscle weakness, fainting, difficulty breathing, confusion, dizziness, joint pain, aching muscles, generally feeling unwell (for years after injection), memory loss, depression, anxiety, nightmares, agitated, sleep paralysis and difficulty to concentrate in September 2009/3 months post injection. The patient reported that she has received various psychiatric medications for years to treat the reactions. The patient is also receiving inhalers for breathing difficulties which she did not need prior to vaccination with GARDASIL. The patient is also attending a rheumatologist and a physiotherapist for an unspecified bone/muscle condition. The reporter assessed the causal relationship: between Nausea, Headache, Fatigue, Muscle weakness, Fainting, Difficulty breathing, Confusion, Dizziness, Joint pain, Muscle ache, Generally unwell, Memory loss, Depression, Anxiety, Nightmares, Agitated, Sleep paralysis, Concentration ability impaired and GARDASIL as Unknown. The patient reported that she cannot do ''normal'' things that other 21 year old girls can do due to the reactions experienced. The patient had a passion for every aspect of dancing and use to enter competitions regularly, but the patient had to stop after all this came on as her bones and muscles were too sore and she was ''way to tired'' to continue. The patient feels that she has very little quality of life compared with other people of her age. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 643233 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-01-28
Onset:0000-00-00
Submitted: 2016-06-20
Entered: 2016-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010357 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Condition aggravated, Depression, Headache, Influenza like illness, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation; Depression, concurrent condition of depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: About 6 months after vaccination, she has been diagnosed with depression with complicating eating problems. The patient''s sister also had depression studies and / or laboratory tests: Yes Psychologist and psychiatrist; 2015, Body temperature, fever
CDC Split Type: WAES1606DNK008033

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577292925-2016006287) on 16-JUN-2016. Case received from a HCP (physician) via HA with the reference nrs. DK-DKMA-WBS-0003732 / DK-DKMA-ADR 23518733 on 14-JUN-2016. A 14-year-old female adolescent patient received GARDASIL, (batch/lot number J010357, Dose 1, expiry date: 02-DEC-2015) via intramuscular route on 28-JAN-2015. SIDE EFFECTS: The patient experienced influenza like symptoms, fever, headache, general malaise and 1 year duration of complaints, which contributed to 25% of school absenteeism on an unknown date. HISTORY AROUND side effect: Onset of symptoms after the first vaccination. 1 year duration of complaints, which contributed to 25% of school absenteeism. The patient had a concurrent depression in JUL-2015. About 6 months after vaccination, she had been diagnosed with depression with complicating eating problems. The patient''s sister also had depression. Other vaccine: No. Other medicine: No. The patient''s outcome was reported as recovering/resolving.


VAERS ID: 643756 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-11-15
Onset:2008-01-01
   Days after vaccination:47
Submitted: 2016-06-23
   Days after onset:3095
Entered: 2016-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0513U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, CSF test, Cataplexy, Fatigue, Narcolepsy, Sleep study, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation; Hepatitis B immunisation; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Evaluated at neurological unit sleep clinic, CSF examination etc.
CDC Split Type: WAES1606DNK010760

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR Control number DK-1577272925-2016006419) on 22-JUN-2016. Case received from a physician via HA on 17-Jun-2016 under the references DK-DKMA-WBS-0003767 / DK-DKMA-ADR 23524876. A 14-year-old female adolescent patient received GARDASIL (batch number: NE47600, lot number: 655376/0572F, expiration date: 05-MAY-2009, Dose 1) via intramuscular route on 10-Sep-2007, GARDASIL (batch number: NG25940, lot number: 0513U, expiration date: 02-APR-2010, Dose 2) via intramuscular route on 15-Nov-2007, GARDASIL (batch number: NG25940, lot number: 0513U, expiration date: 02-APR-2010, Dose 3) via intramuscular route on 02-Jun-2008. The received concomitant administration of: ENGERIX-B 1 DF on 22-Aug-2009, TICOVAC on 10-Sep-2012. The patient experienced Narcolepsy, Cataplexy, Tiredness and Had to give up studies on university on an unknown date. The process of the adverse events: Symptoms occurred gradually. During 9th grade she developed tiredness which became more pronounced in high school. Initially it was interpreted as a reaction on a school change, lack of sleep and change of diurnal rhythm between weekdays and weekend. During high school she had increasingly difficult to stay awake during class. After high school she worked for two years and could partly compensate by keep doing things. The primarily problems she experienced during transport, at meetings or when watching television/cinema, where she fell asleep quickly. Started subsequently at the university, but experienced that she fell asleep after 5-10 min of the lecture and could not stay awake through group tasks or homework. Had to give up the studies and has been working untrained at a caf? ever since. Due to suspicion of narcolepsy she was referred to evaluation in 2015 and had the diagnose at the neurological unit at hospital in the beginning of 2016. She was told that medication such as Ritalin in could ease the symptoms to a certain extent but that she would not be able to carry out a long-term education at university level and that she should avoid having a sedentary profession in the future. Other medication: No. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 644089 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-01
Onset:0000-00-00
Submitted: 2016-07-04
Entered: 2016-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acupuncture, Asthenia, Decreased appetite, Dizziness, Dry eye, Fatigue, Food intolerance, Gastrointestinal disorder, Headache, Hypertonic bladder, Impaired work ability, Loss of personal independence in daily activities, Malaise, Muscle spasms, Muscular weakness, Myalgia, Nausea, Paraesthesia, Peripheral coldness, Photophobia, Postural orthostatic tachycardia syndrome, Restless legs syndrome, Temperature intolerance, Temperature regulation disorder, Underweight, Vision blurred, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607DNK000203

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (2016006715) on 30-JUN-2016. Case received from a lawyer via HA on 27-JUN-2016, case number: 16-5278. A female adolescent patient experienced POTS, Overactive bladder, Difficulty focusing eyes, cannot get sharp focus, very Light sensitivity to eye, Often Headache, Constant Nausea, Problems with gastrointestinal system, Food intolerance, Constant Fatigue, Muscle weakness, Restless legs, Temperature regulation disorder, Decreased appetite, Underweight (have lost 17 kg), Loss of weight 17 kg, Dry eyes, Muscle spasms, Cold hands and feet, Dizziness, Tingling feet/hands, Muscle pain, Malaise, feels bad in summer temperatures and Had to drop out of 2 g. of high school. Full sick leave from August-2015 on an unknown date. PIC has sent the patient''s initial report. PIC has not yet decided in the matter. Side effects: The patient is diagnosed with POTS at Hospital. Overactive bladder. Cannot focus sharply. Is very sensitive to light. Often has headaches. Constant nausea. Problems with the gastrointestinal system. Hypersensitivity to food. Constant fatigue. Muscle weakness. Restless legs. Problems with the regulation of body temperature. Reduced appetite. Very underweight (have lost 17 kg) and cannot gain back. Dry eye. Muscle spasms. Cold feet and hands. The patient feels bad in summer temperatures. Dizziness. Tingling in the fingers. Muscle pain. Treatment of side effects: The patient takes medicine for high pulse and salt tablets. Goes to the physiotherapist, and has previously tried acupuncture without effect. She has also been to dietician and eat recommended diet. History around side effects: The patient has been ill since spring 2009, and has had to drop out of high school in 2nd grade because of side effects. She has since started up in high school again, and with the help of school counselors and management, made it through with a very high absenteeism. When she finished high school summer 2015 she started in a part-time job because she had not the energy to start an education. After 2 weeks, she had to stop her part-time work because she could not handle it. Since then, in August-2015, she had a full-time sick leave and have gone home because she cannot handle a regular job. Right now she goes and waits to be considered a resource through the municipality, for ultimately being approved for flexible working arrangements. Criteria for diagnosis of POTS: Heart rate increases greater than or equal to 30 bpm 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 greater 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, the hospital uses further criteria for patients between 12-19 years: Requires a heart rate increase of greater than 40 bpm to make the diagnosis, on the grounds that young people have a stronger physiological heart rate response to standing up. The use of any additional criteria to avoid false positives (Agency comment: Uncertain whether this criteria is used, it is not know when the survey was conducted, and thus how old the patient was on the survey). The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 644201 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-11-02
Onset:0000-00-00
Submitted: 2016-07-05
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP39110 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cataplexy, Epstein-Barr virus test positive, HLA marker study positive, Headache, Hypotonia, Narcolepsy, Nuclear magnetic resonance imaging brain normal, Somnolence, Thyroid function test normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Blood iron decreased
Allergies:
Diagnostic Lab Data: Human Leukocyte Antigen (HLA) marker study (date unspecified): Positive for DQB1 and DRB1; Nuclear magnetic resonance imaging brain (15-APR-2014): normal; Thyroid function test (??-NOV-2013): normal; Epstein-Barr virus test (??-NOV-2013): infectious mononucleosis positive; Thyroid function test (??-JAN-2016): normal
CDC Split Type: WAES1607FRA000895

Write-up: Information has been received from a Sanofi Pasteur (MSD) (manufacturer control# 2016006758) as part of a business agreement on 01-JUL-2016. Case received from a other health professional under the CA report ref number PP2016304 on 28-Jun-2016. A 15-year-old female adolescent patient received GARDASIL, batch number unknown, Dose 1 via intramuscular route on 28-Apr-2011, GARDASIL, batch number unknown, Dose 2 via intramuscular route on 18-Jun-2011, GARDASIL, batch number NP39110, Dose 3, expiry date in April 2012 via intramuscular route on 02-Nov-2011. Other suspect products included PANDEMRIX, batch/lot number A81CA103A, Dose 1 administered via intramuscular route on 17-Dec-2009. The patient experienced narcolepsy, Catalexy and headache on an unknown date. The female patient had received one dose of PANDEMRIX (antigen batch number AFLSA093AA, adjuvant batch number: AA03A215BA). It was not known whether she had received a second dose. Both GARDASIL and PANDEMRIX were well tolerated. No excessive daytime sleepiness but headache were mentioned following each injections. The patient had a medical history of Low iron level. Additional investigations included: Infectious Mononucleosis positive n/a in Nov-2013. Thyroid Function Test normal n/a in Nov-2013. Nuclear Magnetic Resonance Imaging Brain normal n/a on 15-Apr-2014. Thyroid Function Test normal n/a in Jan-2016. Hla Marker Study positive for dqb1 and drb1 n/a on an unknown date. In 2012, as she was 15 years old, she presented with first signs of excessive daytime sleepiness, without having sleep insufficiency, no concomitant infection nor associated to mood disorder. Since 2013, she also presented with tonus decreased triggered by emotions. Diagnosis of type 1 narcolepsy was established in November 2013. No family history. Episodes of cataplexy first with low frequency but triggered by laughing became more and more frequent and pervasive: one every two other day in Feb 2015 and event night in Jan 2016 (partial or complete cataplexy). First cured with methylphenidate alone (up to 60 mg/day) then associated to ANAFRANIL (20 mg/day). This was stopped in Jan 2016 and EFFEXOR was prescribed (75 mg) as well as Modiopal. Modiopal was stopped because was not effective and WAKIX was prescribed in Jun 2016. ADEPAL (contractive pill) was used since several years. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 644235 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-21
Onset:2013-06-01
   Days after vaccination:72
Submitted: 2016-07-05
   Days after onset:1130
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013135 / 3 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Epistaxis, Fatigue, Feeling abnormal, Headache, Hyperacusis, Mobility decreased, Muscular weakness, Nausea, Quality of life decreased, Vision blurred, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607IRL000466

Write-up: Information has been received from Sanofi Pasteur MSD (reference # IE-1577272925-2016006866) on 01-JUL-2016. This case was received from RA (Ref no. IE-HPRA-2016-027090) on 29-Jun-2016. Initial case received from a consumer/other non-health professional which concerns a 14-year-old female adolescent patient received GARDASIL (batch number G019345) on 20-Sep-2012, GARDASIL (batch number H008259) on 15-Nov-2012, GARDASIL (batch number H013135) on 21-Mar-2013. The patient received concomitant administration of BOOSTRIX on 21-Mar-2013. Medical history/concurrent conditions: None. The patient experienced Headaches, Dizziness, Loss of power of limbs, Nosebleeds, Blurred vision, Fatigue, Noise sensitivity, Brain fog, Vomiting and Nausea on 01-Jun-2013 72 days Post Administration. The reporter added that her daughter has lost her quality of life. She has been poorly since 2013 and to this day is no better. She was a healthy, outgoing girl involved in sports and socializing with her friends. Now most days she can hardly get out of bed. The patient''s outcome was reported as Not Recovered/Not Resolved. The reporter assessed the causal relationship between Headache, Dizziness, Weakness of limbs, Nosebleeds, Blurred vision, Fatigue, Sound sensitivity increased, Foggy feeling in head, Vomiting, Nausea and GARDASIL as Unknown.


VAERS ID: 673480 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-06-02
Onset:2015-11-05
   Days after vaccination:156
Submitted: 2016-09-12
   Days after onset:311
Entered: 2016-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K022803 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody positive, Blood creatine phosphokinase normal, Erythema, Raynaud's phenomenon
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation, HPV vaccination was administered in a healthy teenager
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Antinuclear antibody (ANA), (unknown date): 1:320. Blood creatinine phosphokinase (CPK), (unknown date): normal. 01/15/2016, Antinuclear antibody, 27 U/L; 03/15/2016, Antinuclear antibody, 37 U/L
CDC Split Type: WAES1609DEU005095

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR# DE-1577272925-2016009015) on 09-SEP-2016. Spontaneous case report received from a physician via Agency (reference DE-DCGMA-16170726) on 05-SEP-2016: A female 14-year(s)-old patient (weight: 52kg, height: 173 cm), was vaccinated with GARDASIL, (batch no.: K009460) for Primary immunization, Intramuscular on 26-JAN-2015; and GARDASIL, (batch no.: K022803) for Revaccination, Intramuscular on 02-JUN-2015. Concomitant medication was not reported. On 05-NOV-2015 after vaccination the patient developed Erythema facial and Raynaud''s syndrome and Antinuclear antibody positive, lasting for unknown. The patient showed disabling/incapacitating and showed other medically important condition. Diagnosis was confirmed by CPK normal, and Antinuclear antibody titer 1:320 (normal range less than 1:80). The patient''s test results included antinuclear antibody Mi-2 37 U/L on 15-JAN-2016 and on 15-MAR-2016. The reporter considered the events an induction of an autoimmune disease which is intermittent in the cold. Raynaud - Syndrome constituted as dead finger and purple erythema in the face along with significantly increased antinuclear antibodies and evidence of the antibody Mi-2. The patient had not recovered at the date of reporting. No further information awaited.


VAERS ID: 673776 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-03-24
Onset:2010-08-24
   Days after vaccination:153
Submitted: 2016-09-19
   Days after onset:2218
Entered: 2016-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Diarrhoea, Dizziness, Dry mouth, Dyspnoea, Dysuria, Fatigue, Hot flush, Hyperhidrosis, Hyperventilation, Lactose intolerance, Memory impairment, Migraine, Nasopharyngitis, Nausea, Palpitations, Pneumonia, Presyncope, Sleep disorder, Syncope, Tension headache, Tilt table test normal, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examinations or lab samples: Tilt table test shows that the patient does not fulfill the diagnostic criteria for POTS.
CDC Split Type: WAES1609DNK007725

Write-up: Information has been received from Sanofi Pasteur-MSD (SPM) (Mfr # DK-1577272925-2016009185) on 15-SEP-2016. Case received from a physician via HA on 12-SEP-2016 under reference numbers DK-DKMA-ADR 23635681 / DK-DKMA-WBS-0004426. A 14-year-old female adolescent patient received GARDASIL (batch number Not available, Dosed 1) via intramuscular route on 20-JAN-2010, GARDASIL (batch number, Not available, Dose 2) via intramuscular route on 24-MAR-2010, GARDASIL, (batch number Not available, Dose 3) via intramuscular route on 03-NOV-2010. The patient experienced Abdominal pain, Migraine headache, Tension headaches, Syncope, Near syncope, Dizziness, Palpitation, Nausea, Diarrhea, Lactose tolerance test abnormal, Voiding difficulty, Hyperventilation, Shortness of breath, Fatigue, Dry mouth, sleeping disorder, memory difficulty, frequent colds, Pneumonia, Hot flashes, Sweating abnormal, worsening of joint pain, Difficulty focusing eyes and Tiredness on an unknown date. The patient reported that her first symptom started 4-6 months after 2nd vaccine dose in the form of abdominal pain and diarrhea. Then the other reported symptoms followed. Before vaccinations the patient ran / strength-trained about one and half to 2 hours daily. Still exercises around 4 times per week, but her body feels more tired. Patient has been absent many times from studies due to migraines and fatigue. Patient has started assistant training and also works in the weekends. She always goes home with a headache after work and school and often takes a nap after school or work due to tiredness. Does not have the energy to meet with friends due to tiredness. Other vaccines: No. other medicines: Unknown. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 675728 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-12
Onset:2009-10-01
   Days after vaccination:142
Submitted: 2016-12-30
   Days after onset:2647
Entered: 2016-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1941U / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chronic fatigue syndrome, Postural orthostatic tachycardia syndrome
SMQs:, Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: diclofenac
Current Illness: Endometriosis; Human papillomavirus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DK0095075131612DNK012920

Write-up: ADVERSE REACTION: Postural orthostatic tachycardia syndrome (POTS), chronic fatigue syndrome. THE COURSE REGARDING THE ADVERSE REACTION: Last GARDASIL administrated on 12-MAY-2009, during the autumn of 2009 increasing symptoms. OTHER VACCINES: No. Criteria for the diagnosing of POTS: 1) Heart rate increases greater than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). 2) Symptoms worsen with standing and improved with recumbence. 3) Symptoms last greater than or equal to 6 months. 4) Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition Hospital /(where the patient is followed) uses further a criterion for patients between 12-19 years: Requires a pulse increase greater than 40 bpm to make the diagnosis, with the justification, that young people have a stronger physiological pulse response to standing up. They use this additional criterion to avoid false positive.


VAERS ID: 696553 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-12-10
Onset:0000-00-00
Submitted: 2017-05-25
Entered: 2017-05-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Disability, Gait disturbance, Immediate post-injection reaction, Muscular weakness, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131705FRA011583

Write-up: This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2014, the patient was vaccinated with GARDASIL (lot number: J014463, expiry date unknown) dose 1, intramuscular as prophylactic vaccination. Immediately post vaccination (in 2014), patient experienced skin rash. On 10-DEC-2014, patient received a second dose of GARDASIL (unknown lot number), intramuscular as prophylactic vaccination. Following the second dose the patient experienced life threatening myasthenia impacting her life expectancy. She was still invalid with difficulty to walk. On an unknown date, the patient went to the hospital regularly. The outcome of myasthenia was not resolved and rash was unknown. The reporter did not assess the causality of the events with GARDASIL, however the physician who prescribed and administered the vaccine (who is different from the reporter) had assessed the events as not related to vaccine. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL Vaccine and the reported event cannot be established. The onset date of the event is not provided. No medical history and concurrent conditions. The report includes as non serious the event of Rash. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of two countries, continues to monitor the safety profile of the product.


VAERS ID: 700619 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-10-21
Onset:2011-11-01
   Days after vaccination:11
Submitted: 2017-06-22
   Days after onset:2060
Entered: 2017-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Back pain, Biopsy skin abnormal, Delayed sleep phase, Dissociative identity disorder, Dizziness, Fatigue, Gait disturbance, Headache, Hypoaesthesia, Hypokinesia, Hypophagia, Inappropriate schedule of drug administration, Insomnia, Irritable bowel syndrome, Movement disorder, Muscular weakness, Orthostatic intolerance, Pain in extremity, Postural orthostatic tachycardia syndrome, Regressive behaviour, Schizophrenia, Sleep disorder, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Skin tumours of unspecified malignancy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma chronic (Chronic pediatric asthma but it settled down when she entered junior high school.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131706JPN009441

Write-up: Information was received from a lawyer regarding a case in litigation concerning a 14 year old female patient (currently 19 years old). The patient''s medical history included chronic pediatric asthma (but it settled down when she entered junior high school). No information was provided regarding concomitant medication. On 20-SEP-2011, at 14 years old (eighth grade), the patient was vaccinated with her first dose of GARDASIL (lot number, dosage, and route of administration not provided). She was vaccinated with her second dose of GARDASIL (lot number, dosage, and route of administration not provided) on 21-OCT-2011 at age 14 (eighth grade). On 15-OCT-2012, at 15 years old (ninth grade), the patient was vaccinated with her third dose of GARDASIL (lot number, dosage, and route of administration not provided). Summary of damage caused by vaccination included: Physical and mental symptoms: Pain described as: For about half a month from the second vaccination (approximately November 2011), the patient developed pain in the back, feet and arms on some days. Sleep disorder: Described as insomnia or became unusually sleepy. Others: Headache, vomiting, abdominal pain, dizziness, symptoms of infant regression, symptoms of multiple personality, etc. (unspecified). Treatment course: Around 4 months after the second vaccination (approximately February 2012), she often could not wake up in the morning. Then she visited a nearby hospital because of symptoms of headache, vomiting, abdominal pain, and dizziness that appeared around 5 months after the second vaccination (approximately March 2012) and was diagnosed with irritable bowel syndrome. Since these symptoms continued after that, she visited a department of psychosomatic medicine and was diagnosed with schizophrenia and sleep disorder. However these symptoms did not improve at all with unspecified drug therapy. Three months after the third vaccination (January 2013), symptoms of infant regression appeared. Symptoms of multiple personality also appeared but disappeared 2 weeks later. She visited an ENT clinic because the symptoms of dizziness were strong. Although she was diagnosed with orthostatic dysregulation, no change occurred to the symptoms after unspecified drug therapy. Around October 2013, the patient began to get tired unusually easily. She was barely able to eat and had difficulty in walking. In January 2015, she visited a local hospital. A skin biopsy confirmed a decrease in the intraepidermal nerve fiber density and she was diagnosed with postural orthostatic tachycardia syndrome (POTS) and delayed sleep-phase syndrome in addition to muscle weakness and motor syndrome of slow movement. After that, she received steroid pulse therapy and immune-absorption therapy, while repeating the admission to and discharge from the same hospital. While her symptoms were considerably relieved by these therapies, the symptoms of headache and numbness and weakness of the left leg still continue. She visits the same hospital once a month to receive drug therapy. Because of the above symptoms, she was no longer able to go to school when she moved on to the ninth grade in April 2012. Due to a continued state of absenteeism, she transferred to a high school with correspondence courses. She went on to a local university in April 2016 but was having difficulty in attending classes because of the above symptoms. Upon internal review, schizophrenia was determined to be medically significant. Pain in the back, pain in the feet, pain in arms, sleep disorder/delayed sleep-phase syndrome, headache, vomiting, abdominal pain/irritable bowel syndrome, dizziness/orthostatic dysregulation, insomnia, symptoms of infant regression, symptoms of multiple personality, schizophrenia, tired unusually easily, barely able to eat, had difficulty in walking, POTS, muscle weakness, motor syndrome of slow movement, numbness of the left leg, and weakness of the left leg were considered to be disabling. Additional information has been requested.


VAERS ID: 702963 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-07-25
Onset:2016-02-19
   Days after vaccination:2035
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1882U / 3 RA / UN

Administered by: Other       Purchased by: 0
Symptoms: Human papilloma virus test positive, Immune system disorder, Papilloma viral infection, Smear cervix abnormal, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131706DEU005494

Write-up: This spontaneous report was received from a physician via a company representative, concerning a 15 years old female patient. The patient''s medical history and concurrent conditions were not reported. On 17-DEC-2009, the patient was vaccinated with her first dose of GARDASIL, lot # 1316U, batch # NH38490, expiration date: 26-AUG-2010, for prophylaxis. Subsequently, on 23-FEB-2010, the patient received her second dose of GARDASIL, lot # 1427U, batch # NH17960, expiration date: 14-SEP-2010. Then, on 25-JUL-2010, the patient was vaccinated with her third dose of GARDASIL, lot # 1882U, batch # NJ08310, expiration date: 04-DEC-2010, as well for prophylaxis (route and anatomical location of administration were unknown for all doses). Concomitant medications were not reported. In approximately 2011 (reported as "one year after vaccination"), the patient experienced human papilloma virus (HPV) infection (vaginal smear test: HPV16 and HPV18 test positive). The physician wanted to ask whether it made sense to vaccinate the patient now with GARDASIL 9. At the time of reporting, the outcome of papilloma viral infection was unknown. The causality assessment between the papilloma viral infection and GARDASIL was not provided. Follow-up information has been received from the physician via a company representative on 23-MAY-2017. On 19-FEB-2017, an Hybrid Capture HPV DNA Assay was done and revealed the following results: HPV-DNA, probe A "low risk" HPV Types 6, 11, 42, 43, 44: not detectable; HPV-DNA, probe B "high/intermediate risk" HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68: detectable and HPA-DNA of high/intermediate risk types was detectable. It was recommended to repeat the testing with in an interval of about 6 months. No information was provided; however, specifying the respective high/intermediate risk types of which DNA was detected, it was confirmed that HPV types 16 and 18 were positive. A follow-up with an earliest aware date of the initial document was received. Therefore, case # DE-009507513-1705DEU014020 is being deleted from our files on GARDASIL and corrected under the case DE-009507513-1705DEU005494. Follow-up information was received from the physician on 26-Jun-2017: Vaccination history according to the excerpt of the vaccination record which was provided by the physician: Varilrix on 13-Jan-1999 and 09-Feb- 2010, FSME vaccination on 10-Sep-1999, 16-Feb-2000 (TicoVac), 28-Mar-2001 and 06-Apr-2006 (Encepur Kinder), meningococcal C vaccination on29-Mar-2007 (NeisVac-C) and 04-Dec-2012 (Menveo). The 1st and 2nd vaccination doses of GARDASIL were administered intramuscularly in the right upper arm, the 3rd vaccination dose was administered intramuscularly in the left upper arm. According to the physician the laboratory who had performed the hybrid capture HPV DNA assay confirmed that all high risk types which are listed on the report were detected. The treating gynecologist refused to re-vaccinate with GARDASIL 9 since the immune system of the patient was obviously weakened. The adverse event reported by the physician was "Non-Responder". On an unknown date in 2015, the patient had a HPV positive smear. On an unknown date in 2016 HPV-DNA of high / intermediate risk types were detectable in a hybrid capture HPV DNA assay (Human papilloma virus test positive). The physician considered the event to be serious due to persistent or significant disability or incapacity since the patient is a carrier of high risk HPV types. She also mentioned that a result of PAP IIID was found several times in the PAP test (Smear cervix abnormal). At the time of report it was unclear if a conization has to be done. The outcome of events Human papilloma virus test positive, Smear cervix abnormal and Therapy non-responder was unknown. Causality was not reported. The reporting physician requested information on whether re-vaccination of the patient with GARDASIL 9 would make sense and whether the boyfriend of the patient would have also to be vaccinated. She also requested information about studies regarding non-responder with GARDASIL and administration in men.


VAERS ID: 705188 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-09-08
Onset:2015-09-08
   Days after vaccination:0
Submitted: 2017-07-24
   Days after onset:685
Entered: 2017-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006781 / 2 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Anxiety, Arthralgia, Back pain, Constipation, Depression, Disturbance in attention, Dizziness, Educational problem, Exercise tolerance decreased, Fatigue, Henoch-Schonlein purpura, Hyperaesthesia, Irritable bowel syndrome, Joint stiffness, Loss of personal independence in daily activities, Myalgia, Nausea, Pain, Peripheral swelling, Personality change, Rash, Renal function test normal, Tearfulness
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GARDASIL; loperamide; mebeverine
Current Illness: 2010, Gluten sensitivity, 2010, Causes bloating, pain and diarrhoea; Immunisation; Gluten free diet
Preexisting Conditions: 2010, Diarrhoea, 2010, Caused by gluten sensitivity; 2010, Abdominal distention, 2010, Caused by gluten sensitivity; Bronchiolitis; 2010, Pain, 2010, Caused by gluten sensitivity; Benign congenital hypotonia, Following an episode of bronchiolitis; BECOTIDE; Bronchiolitis, No adverse event; Albuterol, Bronchiolitis, No adverse event
Allergies:
Diagnostic Lab Data: On an unknown date: Blood pressure test was performed and the result was unknown. Renal function test was performed and the result was unknown. Blood pressure measurement, normal; Renal function test, normal
CDC Split Type: GB2017110427

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of swelling of limb in a 14-year-old female patient who received DTPa vaccine. Co-suspect products included GARDASIL (batch number K006781, expiry date unknown) and GARDASIL (batch number K006781, expiry date unknown). The patient''s past medical history included diarrhoea (2010, Caused by gluten sensitivity), bloating (2010, Caused by gluten sensitivity), bronchiolitis, pain (2010, Caused by gluten sensitivity) and benign congenital hypotonia (Following an episode of bronchiolitis). Previously administered products included BECOTIDE with an associated reaction of no adverse event and Albuterol with an associated reaction of no adverse event. Concurrent medical conditions included gluten sensitivity (2010, Causes bloating, pain and diarrhoea), routine immunization and gluten free diet. Additional patient notes included She was 8 lbs. 13 when she was born. She has not had a reaction to any other vaccines. Concomitant products included Loperamide and mebeverine. On 8th September 2015, the patient received DTPa vaccine (unknown). On an unknown date, the patient started GARDASIL (intramuscular) at an unknown dose and frequency. On 8th September 2015, the patient received the 2nd dose of GARDASIL (intramuscular). In September 2015, less than a day after receiving DTPa vaccine, the patient experienced Henoch-Schonlein purpura. On 1st October 2015, 23 days after receiving DTPa vaccine, the patient experienced fatigue (serious criteria hospitalization, disability and other), depression (serious criteria hospitalization, disability and other), joint pain (serious criteria hospitalization, disability and other) and skin rash (serious criteria hospitalization, disability and other). In October 2015, less than a week, the patient experienced abdominal pain. In May 2016, less than a year after receiving DTPa vaccine, the patient experienced anxiety (serious criteria hospitalization, disability and other). On an unknown date, less than a month after receiving DTPa vaccine, the patient experienced swelling of limb (serious criteria hospitalization, disability and other), bloating (serious criteria hospitalization, disability and other), loin pain (serious criteria hospitalization, disability and other), personality change (serious criteria hospitalization, disability and other), diarrhoea (serious criteria hospitalization, disability and other), dizziness (serious criteria hospitalization, disability and other), touch sensitivity increased serious criteria hospitalization, disability and other), constipation (serious criteria hospitalization, disability and other), tearfulness (serious criteria hospitalization, disability and other), exercise capacity decreased (serious criteria hospitalization, disability and other), stiffness joints (serious criteria hospitalization, disability and other), nausea (serious criteria hospitalization, disability and other), irritable bowel syndrome (serious criteria hospitalization, disability and other), concentration impaired (serious criteria hospitalization, disability and other) and muscle pain. On an unknown date, the outcome of the swelling of limb, bloating, personality change, diarrhoea, dizziness, touch sensitivity increased, constipation, tearfulness, exercise capacity decreased, stiffness joints, irritable bowel syndrome and concentration impaired were unknown and the outcome of the loin pain was recovered/resolved and the outcome of the anxiety, fatigue, depression, nausea, joint pain, skin rash, Henoch-Schonlein purpura, abdominal pain and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the swelling of limb, bloating, loin pain, personality change, diarrhoea, dizziness, anxiety, touch sensitivity increased, fatigue, constipation, tearfulness, exercise capacity decreased, depression, stiffness joints, nausea, joint pain, skin rash, irritable bowel syndrome, concentration impaired, Henoch-Schonlein purpura, abdominal pain and muscle pain to be related to DTPa vaccine. Additional information: It was unknown if the reporter considered the Henoch-Schonlein purpura, swelling of limb, bloating, loin pain, personality change, diarrhoea, dizziness, touch sensitivity increased, anxiety, fatigue, constipation, tearfulness, exercise capacity decreased, depression, stiffness joints, nausea, joint pain, skin rash, irritable bowel syndrome, concentration impaired, abdominal pain and muscular pain to be related to DTPa vaccine. Initial information received from physician via regulatory authority on 17th July 2017. On the day of the vaccine itself, the patient experienced left loin pain, which lasted 4 days. At the time parents did not associate it with the vaccine and did not see the GP because it did not last a week. The patient was subsequently seen as an emergency by her GP and the paediatricians and diagnosed with Henoch-Schonlein purpura (HSP). She had been in bed almost the whole time since then. The patient remains very unwell with severe fatigue, abdominal pain, nausea and now muscular pain in her right arm when elevating it. She is able to get up for about an hour before having to go back to bed and sleep. Information from duplicate case folder: Loin pain, Henoch Schonlein purpura, ache, abdominal pain generalised. On the day of the vaccine she developed loin pain (which she described as back pain). It resolved over the weekend so I didn''t take her to the general practitioner. She was then under the weather (clingy and tearful) for a couple of weeks, but not unwell enough to go to the general practitioner. She developed intermittent abdominal pain- continuing. This was followed by nausea and fatigue, and she then developed the purpuric rash. She was diagnosed by her general practitioner and sent to the paediatricians. Since then she has been extremely fatigued - she can get up for about an hour, then has to lie down and rest / sleep. She developed muscle pain in her upper arm, which hurts when she tries to reach for or lift even light items. Seek advice details: I requested an urgent general practitioner appointment because I was concerned she had appendicitis. Follow up received: 7 months ago she developed moderately severe depression and anxiety. She is receiving psychotherapy through mental health services. This is completely out of character for her. Her personality has changed in addition to her physical resilience. She now has problems at school and with friendships. Her academic progress is also affected. Dizziness or lightheadedness, bloating, difficulty concentrating intolerance of exercise, prolonged pain, stiffness in affected joints, intolerance of touch of affected limb, irritable bowel syndrome, diarrhoea or constipation and swelling of painful limbs. Follow up received: She has now been diagnosed with anxiety and depression and is under the care of mental health services - ongoing. Yes, she continues to experience flare ups of the rash, joint pain and abdominal pain with episodes of fatigue lasting 2-3 days. She had this reaction to her second vaccine. She had mild symptoms with her first vaccine, but it was not clear from the leaflet we were given that this was a contraindication and that she should not have had the second vaccine. I am aware of the Henoch Schonlein purpura statistics. The majority of these cases are under the age of 10, and are self-limiting. They are also triggered by a viral or bacterial infection - she has had neither of these, the abdominal pain started within a week of the vaccination and the rash appeared about 3 weeks after the vaccination when she was diagnosed. I have read that vasculitis is a risk with this vaccine - and I am very anxious that other children are kept safe from side effects such as what my daughter has suffered. She had this reaction to her second vaccine. She had mild symptoms with her first vaccine, but it was not clear from the leaflet we were given that this was a contraindication and that she should not have had the second vaccine. My daughter has gone from being a national level skier, able to train, self-educate and enjoy life at ski school to a child unable to sustain physical activity without exhaustion the following day. Follow-up information has been received from the consumer regarding her daughter, a 14 year old female patient on 23-JAN-2017. The patient received co-suspect diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (Manufacturer unknown) on 08-SEP-2015, along with dose 2 of the GARDASIL. It was reported that since 01-OCT-2015, the patient was unwell with fluctuating symptoms of joint pain, abdominal pain, skin rashes, fatigue and depression (Previously reported as May-2016) affecting her daily living activities including 8 weeks of school followed by a part time time table and being a national level skier with previous top 5 placings in April 2015. This is a corrected report. This report was previously submitted with the incorrect Worldwide unique case identification number ''GB-MHRA-ADR 23178687'', and this new follow-up submission is to provide the correct identification number ''GB-1577272925-E2015-11397''. ''GB-MHRA-ADR 23178687'' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique Identifier with ''GB-MHRA-ADR 23178687'' now correctly referenced as an Report Duplicate Additional information has been requested. Co-suspect, event onset dates added and narrative updated.


VAERS ID: 719463 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / UN

Administered by: Unknown       Purchased by: 0
Symptoms: Antiphospholipid syndrome, Depression, Dizziness, Fatigue, Hypotension, Incomplete course of vaccination, Loss of personal independence in daily activities, Nausea, Postural orthostatic tachycardia syndrome
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Medication errors (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131710AUS001306

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR 403021) concerning a currently 19 year old female patient. On 10-MAR-2012 the patient was vaccinated with the first dose of GARDASIL, frequency 1 of 3, for prophylaxis (lot # reported as HO16278, route and expiration date were not provided). No concomitant medications to report. On an unknown date (also reported as "a few weeks after 1st dose in 2012"), the patient experienced persistent and severe nausea, lightheadedness, dizzy, overwhelming fatigue, and low blood pressure (antiphospholipid syndrome and postural orthostatic tachycardia syndrome). Severity of side effect: Caused significant or long term incapacity. Sought from a health professional was advised. There was no other illness prior to having that vaccination. The reporter stated that the patient was an elite athlete at the time of vaccination, and that she was too ill to have the subsequent doses at school as per schedule. The patient ended up missing so much school so the reporter "was afraid she would not complete her schooling, not to mention destroying her teenage years, giving up her beloved sport and the resulting depression that accompanied this illness". The reporter described that it took 18 months for a diagnosis to be made. The patient''s outcome for antiphospholipid syndrome and postural orthostatic tachycardia syndrome was not recovered. The agency considered the events to be possibly related to GARDASIL and to be serious due to incapacity/disabling.


VAERS ID: 720454 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: 0
Symptoms: Abdominal pain, Back pain, Blindness, Depressed mood, Dizziness, Dyspnoea, Endoscopy normal, Fatigue, Feeding tube user, Fibromyalgia, Laboratory test normal, Malabsorption, Nuclear magnetic resonance imaging normal, Pain, Palpitations, Paraesthesia, Pelvic pain, Ultrasound scan normal, Weight decreased, Weight gain poor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: AMITRIPTYLINE HYDROCHLORIDE; CERAZETTE; ferrous sulfate; FULTIUM D3; gabapentin; naproxen; omeprazole; vitamin D (unspecified)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Human papilloma virus immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131710GBR006101

Write-up: Seek advice details: I have been under the care of numerous consultants for the past two years. I have been diagnosed with fibromyalgia and malabsorption, also severe weight loss. I am now undergoing cardio testing. Currently under Gastroenterology, Rheumatology, Pain Management Clinic, Dietician and Hydrotherapy Services. No weight gain since illness began. Numerous magnetic resonance imaging and ultrasound scans, endoscopy, tube feeding for 9 days on 3500 calories (no weight gain), testing for Crohn''s, celiac, lupus, arthritis, thyroid, tumor and multiple sclerosis all negative. Unable to retain vitamin D, B and C, about to start vitamin B injections. Referral to cardiology for 24 hour electrocardiogram due to palpitations and recent recurring loss of vision upon standing. FU: Patient has been in my care for several years with several health conditions. My personal involvement started 2 years ago with lower back pain that started several months prior to this. Following from this chronic lower back pain she also complained of generalized aches and pains, poor weight gain and low mood. Patient also had abdominal pain, pelvic pain, widespread paresthesia and tingling in her limbs and severe fatigue. More recently in the last 6 months she complains of palpitations, shortness of breath and feeling faint. She has been under the care of several specialists including; pediatricians, rheumatologists, neurologists, gastroenterologists and more recently a cardiologist. Now been diagnosed with fibromyalgia but no cause has been found for her weight loss and her weight is currently maintained with nutritional support. She has had several normal investigations. Patient is complex with multiple symptoms and if you would like, and with the patients permission, a copy of her medical records may be more enlightening.


VAERS ID: 723827 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-12-02
Onset:2015-12-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L018079 / 2 UN / UN

Administered by: Other       Purchased by: 0
Symptoms: Borrelia test negative, Electromyogram normal, Limb discomfort, Muscular weakness, Neuralgia, Neurological examination normal, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depigmentation spot (2010: achromic spot under the right scapula; possible post Lyme disease scar, although there was no notion of tick bite.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131611FRA009355

Write-up: This information has been received from SANOFI PASTEUR (MFR control# FR-1577272925-2016011780) on 18-NOV-2016. Case received from a consumer/other non-health professional via health authority under the ref number LM20160926 on 03-NOV-2016. The reporter was a relative of the patient. A 14-year-old female adolescent patient received GARDASIL batch number K012356, Dose 1) on 01-OCT-2015, GARDASIL, batch number L018079, Dose 2) on 02-DEC-2015. Following the second dose of GARDASIL: pain in the arm and hand on the vaccination side. Third dose was not administered. Since, recurring episodes and sometimes it was impossible for the patient to hold a pen. On an unspecified date in September 2016 : still presenting episodes, numerous and painful. Two Magnetic resonance imaging (MRI) (brain and cervical) but unspecified results. No specific medical care. The patient''s outcome was reported as Not Recovered/Not Resolved. Follow up received information has been received from the consumer (non-medically confirmed) via the health authority on 23-OCT-2017. Medical history: no medical nor surgical history, normal psychomotor development. On an unspecified date in 2010: achromic spot under the right scapula; possible post Lyme disease scar, although there was no notion of tick bite. Various serological blood tests of Lyme: P18, P39, P41 on an unspecified date in 2016 and on an unspecified date in 2018 lgG Lyme was negative. The patient reported that she lacked of strength in the hands even apart from painful phases. Clinical picture evoked neuropathic pain. 2 MRI (skull and cervical): normal on an unspecified date in May 2016. On an unspecified date in May 2017: normal neurological exam, dosage of CPK was normal, setting up a treatment by amitriptyline (LAROXYL). Updated information in October 2017: Neuropediatric monitoring consultation on an unspecified date in August 2017. Since the vaccination, painful phenomenon of the right upper limb occurring several times per week, without particular schedule, as episode, that could last quarter of an hour and located on the external face of the arm and sometimes associated with a loss of the sensitivity of the forearm. Electric shock type pain or lancinating up to the shoulder; no triggering factor. Right-handed, continued to use the right upper limb but frank discomfort with prolonged writing. Since August 2017: phenomena similar on the upper left limb. Normal electromyography (EMG), no visual disturbances, no oculomotor abnormalities, no orofacial nor lower limbs praxis; no sphincter disorder. Imputability for both the events were reported as C1 S3 I2. Lab data, event information and narrative updated.


VAERS ID: 266371 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2006-10-03
Onset:2006-10-06
   Days after vaccination:3
Submitted: 2006-11-06
   Days after onset:31
Entered: 2006-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen LO
Current Illness:
Preexisting Conditions: Hypersensitivity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA14679

Write-up: Information has been received from a physician and the mother of a 15 year old female with a history of hypersensitivity reactions to allergens. On 10/3/06, the pt was vaccinated IM with the first dose of 0.5ml of HPV vaccine (lot 653650/0702F. Concomitant therapy included Ortho Tri Cyclen LO started on 10/6/06. On 10/06/06, the pt developed widespread itching and hives of both upper and lower extremities. The pt did not experience respiratory symptoms. The pt was self treated with Benadryl with only mild improvement. A nurse in the local ER was consultated by phone but the pt did not require hospitalization. The symptoms resolved after one week and the pt had not experienced further problems. On 10/13/06 the pt had recovered from the event. The physician considered the event to be serious as disabling. Additional information has been requested.


VAERS ID: 271366 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Unknown  
Location: Connecticut  
Vaccinated:2006-11-10
Onset:2006-11-11
   Days after vaccination:1
Submitted: 2007-01-26
   Days after onset:76
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Crohn''s disease
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03418

Write-up: Information has been received from a physician concerning a patient (age and gender unknown) with Crohn''s disease who on 10-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine (yeast) (Lot # 653978/0955F). On 11-NOV-2006 the patient had a flair up of Crohn''s disease after receiving the Gardasil vaccine (yeast). The flair up was so severe that the patient had to be out of school for a month. The patient sought unspecified medical attention. No product quality complaint was involved. At the time of this report, the patient was recovering. The flair up of Crohn''s disease was considered to be disabling. Additional information has been requested.


VAERS ID: 275899 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-03-12
Onset:2007-03-19
   Days after vaccination:7
Submitted: 2007-04-09
   Days after onset:21
Entered: 2007-04-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Feeding disorder, Movement disorder, Tic
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: (therapy unspecified), fentanyl, TOPAMAX
Current Illness: Turner''s syndrome; Migraine; Hypertelorism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA00353

Write-up: Information has been received from a physician concerning a 15 year old female patient with Opitz syndrome (hypertelorism-hypospadias), Turner''s syndrome and migraines who was on 12-MAR-2007 vaccinated with a first dose of Gardasil, lot #654389/0961F (dose not reported). Concomitant therapy included TOPAMAX, fentanyl and other "unknown medications". On 19-MAR-2007 the patient developed a movement disorder characterized by "verbal and bodily" tics. On 20-MAR-2007 patient was hospitalized and treated with IV fluids. Unspecified laboratory tests were normal. She was seen by a neurologist who felt her tics were volitional because she could stop them when asked. Another neurologist felt the tics were not volitional because they occurred in her sleep. At the time of this report, the patient had not recovered. The physician considered the events to be disabling since she was unable to feed herself. Additional information has been requested.


VAERS ID: 276081 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-03-01
Onset:2007-03-01
   Days after vaccination:0
Submitted: 2007-04-11
   Days after onset:40
Entered: 2007-04-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Drug administered at inappropriate site, Gait disturbance, Muscular weakness, Pain, Paraesthesia, Sciatic nerve neuropathy, Sensory disturbance, Similar reaction on previous exposure to drug
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amitriptyline hydrochloride,MAXALT(RIZATRIPTAN BENZOATE)
Current Illness: Migraine, Tension headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA01018

Write-up: Information has been received from a physician concerning a 15 year old female with migraines and tension headaches who in January 2007, was vaccinated intramuscularly into the right leg (also reported as "buttocks") with a first dose of GARDASIL. Concomitant therapy included amytripaline (manufacturer unknown and rizatriptan benzoate. In March 2007, a second dose of GARDASIL was administered intramuscularly into the left leg (also reported as "buttocks"). The physician reported that "a few days to a week after each dose the patient developed a sciatic neuropathy". It was further reported that the neuropathy of the right leg had resolved completely over a few weeks (approximately January 2007 or February 2007). The neuropathy of the left leg had improved, but has not resolved. The physician noted that the patient was still having weakness in the left leg and loss of deep tendon reflex at the level of the left ankle. She also had sensory complaints and tingling when touched at the lateral distal lower extremity. The pain was improved however. The patient was reported to still have a limp. It was also reported that the patient was able to attend school but was unable to participate in physical activities due to the sciatic neuropathy. The physician felt that the patient''s experiences were disabling. Additional information has been requested.


VAERS ID: 280392 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Iowa  
Vaccinated:2006-11-01
Onset:2007-05-01
   Days after vaccination:181
Submitted: 2007-06-04
   Days after onset:34
Entered: 2007-06-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 2 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Autoimmune thrombocytopenia, Evans syndrome, Leukopenia
SMQs:, Haemolytic disorders (narrow), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy; Eczematous dermatitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA04412

Write-up: Information has been received from a physician concerning a 15 year old female with penicillin allergy and eczematous dermatitis who on 01-NOV-2006 was vaccinated with a second dose of Gardasil (lot #656049/0187U). On 01-MAY-2007, "roughly at the end of this vaccination series," the patient developed autoimmune thrombocytopenia and leukopenia. The patient was diagnosed with Evan''s Syndrome. The patient was hospitalized for 5 days treated with platelets, immunoglobulin and prednisone. At the time of the report, the patient had not recovered. The reporting physician considered Evan''s syndrome and leukopenia to be immediately life-threatening and disabling events. The reporting physician reported that he was not personally certain the Gardasil of the events. Additional information has been requested.


VAERS ID: 281378 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 2007-06-11
   Days after onset:10
Entered: 2007-06-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0244U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Grand mal convulsion, Lethargy, Oxygen supplementation, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions: Absence seizure
Allergies:
Diagnostic Lab Data: none
CDC Split Type: WAES0706USA00635

Write-up: Information has been received from a physician concerning his 15 year old niece, with no known drug allergies and no history of seizures, who on 01-JUN-2007 was vaccinated with Gardasil (lot # 656051/0244U). There was no concomitant medication. On 01-JUN-2007, within 2 to 3 seconds of receiving the first dose of Gardasil, the patient had a vasovagal reaction and sought unspecified medical attention. No laboratory/diagnostic tests were performed. The fainting lasted for 1 to 2 minutes and then she had a tonic clonic seizure that lasted 4 to 5 seconds. The patient was lethargic for about 1/2 hour. The patient was given oxygen and pulse ox. On 01-JUN-2007, the patient recovered from vasovagal reaction and tonic clonic seizure. The physician considered one or more of the events to be disabling and/or an other important medical event. Additional information has been requested.


VAERS ID: 295176 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-31
Entered: 2007-11-01
   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: Dizziness, Gait disturbance, Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doryx
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA05676

Write-up: Information has been received from a physician, concerning her relative, a "15 or 16" year old female student with acne, who on an unknown date was vaccinated with the second dose of Gardasil (lot # not provided). Concomitant therapy included doxycycline byclate (DORYX). Following the vaccination, the student experienced arm pain, lightheadedness, generalized body numbness and a shuffling gait. The student also planned to see her family physician. At the time of this report, the student had not recovered from the events. The physician considered the events to be disabling, as the student had missed time in school. Additional information has been requested.


VAERS ID: 299825 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: New York  
Vaccinated:2007-10-21
Onset:2007-10-22
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:23
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 02502AA / 3 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: asthma. NKDA.
Allergies:
Diagnostic Lab Data: A magnetic resonance imaging (MRI) was performed, results not reported. Labs and Diagnostics: LP (-), CT WNL, MRI WNL, blood tests all WNL (done at previous ER visit). Urine Tox screen (-).
CDC Split Type: WAES0710USA07046

Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, "about a week ago", the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized. At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested. 03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax. H/A associated with nausea, dizziness, light and noise sensitivity. Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics. PE WNL.


VAERS ID: 297034 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2007-08-01
Onset:2007-10-01
   Days after vaccination:61
Submitted: 2007-11-15
   Days after onset:45
Entered: 2007-11-16
   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: Anaemia haemolytic autoimmune, Antibody test positive, Antinuclear antibody positive, Cold agglutinins positive, Epstein-Barr virus antibody positive, Fatigue, Haemoglobin decreased, Jaundice, Mycoplasma serology positive, Transfusion
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Vasculitis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: diagnostic laboratory - Positive antibodies to Mycoplasma; hemoglobin - 5; Epstein-Barr virus - Positive (IgM); serum ANA - Positive; cold agglutinin test - Positive
CDC Split Type: WAES0711USA01791

Write-up: Information has been received from a physician concerning a 15 year old female with no known medical history, drug reactions/allergies or concomitant medication use who at the end of August 2007 (exact date unknown), was vaccinated (site and route not reported) with the 1st dose of Gardasil (dose and lot# not reported). In the beginning of October 2007, the patient became very tired and later jaundiced with a low hemoglobin at 5. Laboratory evaluations revealed IgM positive to Epstein Barr virus, positive cold agglutinins, positive antibodies to mycoplasma and positive antinuclear antibodies (ANA). The patient was admitted to the hospital with Autoimmune Hemolytic Anemia for 2.5 weeks with blood transfusions given. The patient was discharged from the hospital (exact date not reported). The patient had been receiving steroids for approximately one week and was undergoing a steroid taper. The physician felt that the patient''s tiredness, jaundice and Hemolytic Anemia were considered disabling and life threatening and other important medical events. No ongoing hemolysis at the time. At the time of this report the patient was recovering. Additional information has been requested.


VAERS ID: 297531 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-01
Onset:2007-09-01
   Days after vaccination:0
Submitted: 2007-11-20
   Days after onset:80
Entered: 2007-11-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Dysgeusia, Fall, Grand mal convulsion, Headache, Immediate post-injection reaction, Memory impairment, Nausea, Personality change, Vision blurred
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: pneumonia as infant
Allergies:
Diagnostic Lab Data: Labs and diagnostics: MMSE (+) for missing 2 orientation questions and 3 recall questions. Brain MRI (+) for cerebellar tonsillar ectopia. ? Chiari malformation. MRI pituitary WNL. EEG WNL.
CDC Split Type: WAES0711USA03218

Write-up: Information has been received from a pharmacist concerning his 15 year old daughter who in September 2007 was vaccinated with Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). A couple minutes after getting the vaccination, the patient suffered a grand mal seizure and fell on the ground in the office. She recovered from the grand mal seizure and was sent home. The pharmacist''s wife reported that a couple weeks after the vaccination, her daughter could not focus and would forget things. The symptoms caused problems in school, and her grades dropped. It was also reported that the patient had bad headaches, a lack of concentration, a change in personality, nausea and tasted blood in her mouth. In the last two weeks, the symptoms worsened. The patient is having daily headaches and petit mal seizures. She is going to be seen by a neurologist. At the time of this report, the symptoms persisted. The pharmacist considered his daughter''s symptoms to be disabling. Additional information has been requested. 3/24/2009 MR received from CDC. Case re-opened. Neuro consult 11/26/07 with dx: post vaccination encephalopathy. Pt may be having absence seizures. Generalized seizure after injection. Pt is intellectually impaired at this time. Per MR, pt had a tonic-clonic seizure a few minutes s/p Gardasil vax in 9/2007. Post-ictal and sore afterwards. since that time pt has had recurring staring spells, memory loss, dramatic drop in school grades (As to Fs), constant fatigue and confusion. Pt reports some visual disturbance of the L eye, H/As, occasional numbness of the hands and sphincter control issues. Currently being tx for UTI 2'' to blood in the urine. Not fully oriented on exam. PE WNL. 3/31/09 Additional records received from above neuro which include a neuropsychological eval dated 11/29-12/19/2007 with DX: Conversion D/O. Adverse reaction to HPV vaccine.


VAERS ID: 300497 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-10-11
Onset:2007-10-21
   Days after vaccination:10
Submitted: 2007-12-14
   Days after onset:54
Entered: 2007-12-18
   Days after submission:4
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, Back pain, Borrelia burgdorferi serology, Chest pain, Full blood count, Musculoskeletal pain, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: complete blood cell - no provided; erythrocyte - not provided; Lyme disease assay - not provided; serum rheumatoid factor - not provided
CDC Split Type: WAES0711USA04684

Write-up: Information has been received from a pharmacist concerning her 15 year old daughter who plays sports, with a penicillin allergy and sulfonamide allergy and no pertinent medical history who in August 2007, was vaccinated with her first dose of Gardasil. On 11-OCT-2007 the patient received her second dose of Gardasil. On 21-OCT-2007, ten days after receiving her second dose, the patient developed myalgia. The patient had unexplained muscle pain which started from her shoulder and traveled to her back and then to her chest. This event was considered to be a significant disability, as she was not able to play basketball. Laboratory tests included: complete blood count, sedimentation rate, lyme disease titer, and a rheumatoid arthritis test (results not reported). The patient''s myalgia persisted. Medical attention was sought, the patient saw the physician. Additional information has been requested.


VAERS ID: 302709 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-12-31
Onset:2007-12-31
   Days after vaccination:0
Submitted: 2008-01-14
   Days after onset:14
Entered: 2008-01-15
   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: Computerised tomogram normal, Head injury, Loss of consciousness, Syncope, X-ray
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Liver transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: computed axial - head and neck - no results reported; X-ray - no results reported
CDC Split Type: WAES0801USA00501

Write-up: Information has been received from a mother concerning her 15 year old daughter who has had a liver transplant. There were multiple concomitant medications but none were specified. On 31-DEC-2007 the patient was vaccinated with her first dose of Gardasil. The mother reported that her daughter fainted within 10 minutes after receiving the vaccination. She passed out for about 1 minute after hitting her head. She was seen in the emergency room and required 7 staples in her head to close the wound she received. A CT of the head and neck was performed, as well as X-rays. No results were reported. Her head injury was considered to be immediately life-threatening and disabling. Additional information has been requested.


VAERS ID: 308429 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Kansas  
Vaccinated:2007-10-17
Onset:2007-10-17
   Days after vaccination:0
Submitted: 2008-03-27
   Days after onset:162
Entered: 2008-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1265U / 2 GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Amnesia, Biopsy heart, Cardiac arrest, Electrocardiogram, Implantable defibrillator insertion, Loss of consciousness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pulse absent, Speech disorder, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 34 days
   Extended hospital stay? Yes
Previous Vaccinations: headache and dizziness~HPV (Gardasil)~1~15.70~Patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: list is too extensive, will need to send separately. 4/24/08-records received-CT negative. Drug screen positive for benzoidiazepines and phencyclidine. EKG inversion T waves, QTc prolongation. Premature ventricular contraction. CPK elevation 566 with elevated MR fraction of 6.9. Liver enzymes elevated. Echo, exercise stress test and cardiac cath all negative.
CDC Split Type:

Write-up: Cardiac arrest, no pulse, clinically dead, for several minutes until EMT arrived and used defibrillator paddles to re start heart. Ambulance to Hospital for about 4 to 5 hours. Transported by ambulance to facility. Unconscious for 2 days sedated. After she awoke she was unresponsive to family and friends, impaired speech, memory loss and no ability to walk for about 10 days. The first night the many test were run and continued through 29 day stay at the hospital. Treatment included pills, physical therapy, stress testing, 24 hour monitoring of heart and attendant care. EKG, Biopsy of heart, injection of dye to heart, MRI of Brain and Heart. A permanent defibrillator connecting to the heart. 05/05/08-DC summary received for DOS 10/18/11/13/07-DC DX: Ventricular fibrillation, cardiac Arrest. Placement of cardiac defibrillator (internal), pacemaker generator and lead system. 4/24/08-records received-10/18/07-presented to ED with cardiac arrest, ventricular fibrillation. Playing basketball, suddenly had shaking of right arm and deep breaths. Fell down. CPR began, cardioversion successful. Never fully regained consciousness. Respiratory failure. Intubated on ventilator. Extubated. Fentanyl drip. Hypertension since arrival.


VAERS ID: 308597 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-07-23
Onset:2007-09-04
   Days after vaccination:43
Submitted: 2008-03-28
   Days after onset:206
Entered: 2008-03-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0171U / 1 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Influenza like illness, Lumbar puncture, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL
Current Illness: Convulsion disorder; Petit mal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: spinal tap, 09/04?/07
CDC Split Type: WAES0803USA01553

Write-up: Initial and follow up information has been received from a physician concerning a 15 year old female patient with a seizure disorder of petit mal convulsions, who was vaccinated on 23-JUL-2007, with her first dose of Gardasil (lot# 655620/0171U). Concomitant therapy included LAMICTAL. On 04-SEP-2007, at 10:10 am, the patient experienced flu-like symptoms and myalgia. The patient sought medical treatment, and a lumbar puncture was performed (results not specified). Treatment included MOTRIN, 800mg, STAT, diazepam and LORTAB. On 18-OCT-2007, the events resolved. Physician decided to discontinue the series with Gardasil. The physician considered the events serious as persistent/significant disability or incapacity. Additional information is not expected. Additional information has been requested.


VAERS ID: 311687 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Iowa  
Vaccinated:2007-10-06
Onset:2007-11-01
   Days after vaccination:26
Submitted: 2008-05-05
   Days after onset:186
Entered: 2008-05-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1061U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood thyroid stimulating hormone normal, Body temperature increased, C-reactive protein normal, Cough, Disturbance in attention, Epstein-Barr virus antibody negative, Fatigue, Headache, Hypersomnia, Lethargy, Lymphadenopathy, Malaise, Pharyngitis, Pharyngitis streptococcal, Pharyngolaryngeal pain, Pneumonia, Red blood cell sedimentation rate normal, Sinusitis, Somnolence, Stomach discomfort, Streptococcus identification test negative, Streptococcus identification test positive, Tonsillitis, Viral infection, Vomiting, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Prednisone
Current Illness: Drug hypersensitivity; Penicillin allergy; Allergic reaction to antibiotics
Preexisting Conditions: Adverse drug reaction
Allergies:
Diagnostic Lab Data: diagnostic laboratory 03/28/08 normal limits; serum Epstein-Barr negative; Streptococcus oralis 01/18/08 negative; Streptococcus group A 01/18/08 positive; WBC count 01/16/08 8000 shift to left; serum TSH 03/28/08 normal; serum C-reactive 03/28/08 normal; erythrocyte 03/28/08 normal; body temp 02/03/08 103.3 degr
CDC Split Type: WAES0804USA02237

Write-up: Initial and follow up information has been received from a physician and a registered nurse, concerning a 15 year old Caucasian female patient with allergies to penicillin, cefadroxil monohydrate (DURACEF) and cefalexin (KEFLEX), who on 23-JUL-2007 was vaccinated with her first dose of GARDASIL (lot# 658094/0524U). On 08-OCT-2007 the patient was vaccinated with her second dose of GARDASIL (lot# 658558/1061U). Concomitant therapy referred to use of an albuterol inhaler, and a nebulizer with prednisone. On 12-NOV-2007, the patient visited the physician with complaints of sore throat, enlarged cervical nodes, slight cough and headache, and was diagnosed with pharyngitis, with onset noted as 05-NOV-2007. Treatment included azithromycin (Z-PAK). On 05-JAN-2008, she visited the office again with sore throat, upset stomach, headache, lethargic and sleeping more than normal. She was again diagnosed with pharyngitis, and with fatigue and lethargy. A strep test and mononucleosis test were negative. Treatment was to watch and repeat testing, if not better by the end of the week. The patient was having trouble staying awake to do her school work, and was feeling ill. On 10-JAN-2008, visited the office with complaints of feeling tired all the time, abdominal pain and headache; she was diagnosed with a viral systemic illness. Treatment include eating healthy, and gradually increasing physical activity. On 16-JAN-2008, she visited the office with a sore throat, cough and headache, tired easily, but she was afebrile. She reported taking ibuprofen prn. Her tonsils were enlarged and exudative and she was diagnosed with acute tonsillitis and lymphadenopathy. A strep and mono test were negative; white blood count (WBC) was 8,000 with left shift. Treatment included cefprozil (CEFZIL) for 10 days. On 17-JAN-2008, however, the strep culture had grown positive group A beta strep. On 28-JAN-2008, the patient still had a sore, swollen throat and headache, but no fever, visited the office, and was diagnosed with streptococcal sore throat, persistent. The cefprozil (CEFZIL) for 10 days had completed, and cephalexin (KEFLEX) was initially ordered, though the mother reported her daughter could not take this, as she had an "allergy" to the medication that caused her to vomit. On 29-JAN-2008, clindamycin, 300mg, tid, was ordered for 10 days. The physician informed the patient''s mother that a viral episode could last for 6-8 weeks, and could occur one after another. On 04-FEB-2008, the patient again visited the office with complaints of a temperature the previous day of 103.3, and vomiting once. She was continued on clindamycin, prednisone, albuterol nebulizers, and alternating acetaminophen (TYLENOL) with ibuprofen (MOTRIN). The diagnosis continued as viral systemic illness, with fever and cough. The plan was to rest, continue with nebulizers or inhaler with prednisone. On 08-FEB-2008, the patient was "not any worse but not any better either," and was on the last day of clindamycin (also mentioned that she had been taking nebulizers with prednisone). She was diagnosed with pneumonia, probably bacterial. Ciprofloxacin (CIPRO) 500 mg, bid was ordered for 10 days, with a prednisone refill. The patient''s mother had asked several times previously, and again asked for a school excise for her daughter. On 11-MAR-2008, the patient visited the office with complaints of severe headache, that worsened with lights, feeling tired, worn out, stomach ache and difficulty concentrating in school. She reported taking acetaminophen (TYLENOL), ibuprofen and naproxen (ALEVE), without much relief. She was diagnosed with sinusitis, and treatment included CIPRO for 20 days, and a nasal spray for 7 days. On 17-MAR-2008, the patient''s mother called the physician about her daughter''s continued headache and upset stomach; she was informed that the drainage from sinusitis could be causing the upset stomach. The mother reported that she did not think her daughter had sinusitis; an ear, nose, throat (ENT) referral was suggested, though not followed up on. On 28-MAR-2008, labs were ordered, including thyroid stimulating hormone (TSH), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), with another letter faxed to the school related to absences and treatment. The patient continued to have fatigue. On 02-APR-2008, the lab results were well within normal limits. On 07-APR-2008, the mother called and reported that she had done some "research" and found similar symptoms with the GARDASIL series (no details provided). The RN indicated that "the most acute time frame was from 12-NOV-2007 through 11-MAR-2008." She added that the mother of the patient has been researching the internet, and feels that there is a relationship between the symptoms her daughter is experiencing, as a possible side effect, and added that her daughter would not receive the third dose in the series. The RN indicated that the patient had not recovered from the events. The RN considered the events to be persistently disabling/incapacitating and serious as an other important medical event. Additional information has been requested. All medical records will be available upon request.


VAERS ID: 314881 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2008-03-17
Onset:2008-03-26
   Days after vaccination:9
Submitted: 2008-06-03
   Days after onset:69
Entered: 2008-06-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1446U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Full blood count normal, Laboratory test normal, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown. PMH: asthma.
Allergies:
Diagnostic Lab Data: diagnostic laboratory, negative; complete blood cell, negative[[address]]Labs and Diagnostics: CT Brain scan unremarkable. MRI cervical spine w/ straightening of cervical lordosis and incidental adenoidal hypertrophy. CXR WNL. CBC, UA and Chem WNL. Hgb 11.9 and Hct 36.0. CK 97. CKMB 0.5 and 0.6. Troponin 0.04. Lyme Ab (-). Blood cx (-)[[address]]
CDC Split Type: WAES0805USA06024

Write-up: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with her first and only dose of GARDASIL 0.5 mL. There was no concomitant medication. Subsequently "one week after vaccination" the patient developed total body paralysis and was hospitalized and all the lab tests which included a complete blood cell count came back negative. Several days after the hospitalization, the patient got better and was released. The reporter considered that total body paralysis to be disabling. Additional information has been requested. 6/25/2008 MR received for ER visit 3/26/2008 with DX: Quadriparesis-resolved. Pt developed a h/a, took a nap and awoke with inability to move all 4 extremities. Parent reports that this is the 3rd episode of these sx. During triage, unable to move 4 extremities. 1 hr later continued to have some motor and sensory deficits. Tingling reported in legs. Able to move toes after several hours and ambulating with slow unsteady gait and jerky movements in several more. D/C with resolution of sx in ~6 hrs from arrival.


VAERS ID: 316982 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-04-13
Onset:0000-00-00
Submitted: 2008-06-16
Entered: 2008-06-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0017U / 1 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0388U / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2225AA / 1 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Blood test, Fibroadenoma of breast, Surgery, Ultrasound breast
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: blood work; breast ultra sound
CDC Split Type:

Write-up: surgical removal of giant fibroidenoma from left breast. Further plastic surgery required. Tumor was 14cm by 13cm by 6cm.


VAERS ID: 319810 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-08-06
Onset:2007-09-20
   Days after vaccination:45
Submitted: 2008-07-18
   Days after onset:302
Entered: 2008-07-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-09-20
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: 1 prior seizure 8/2007. 4/28/09 Additional records received from PCP at CDC''s request. Pt in for OV 1/30/07 with c/o allergy sx and requesting HPV#1-given 0012U. Returned 3/22/07 for HPV#2-given 1427F with Boostrix AC52B012AA. Mild URI 4/25/07. OV 6/12/07 in F/U to ER visit for seizure on 6/11/07. Syncope noted. Sent for tests. OV 6/28/07 Echo and blood work reportedly WNL. Syncope again noted. PE WNL. OV 7/5/07 EEG normal. EIA? Retuned 8/6/07 for HPV#3 given 0012U. PFTs reportedly normal.
Allergies:
Diagnostic Lab Data: Unknown. Labs and Diagnostics: Tox screen (-).
CDC Split Type: WAES0807USA02139

Write-up: Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope. She was taken to an emergency room and released. The patient was vaccinated with a second dose of GARDASIL (unspecified time). Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided). The patient was vaccinated with a third dose of GARDASIL at 15 years old. Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause. The physician has asked the mother for the autopsy report. The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling. Additional information has been requested. 2/13/09 Autopsy report received. COD: Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder. Pulmonary congestion and edema. Passive visceral congestion. 2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired.


VAERS ID: 321626 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2008-07-29
Onset:2008-07-29
   Days after vaccination:0
Submitted: 2008-08-04
   Days after onset:6
Entered: 2008-08-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB238AA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1967U / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2663AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: "Tingling/numbness" (B) legs. Mostly in pinkie toe.


VAERS ID: 323263 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-11-06
Onset:2008-08-18
   Days after vaccination:286
Submitted: 2008-08-25
   Days after onset:7
Entered: 2008-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Depression, Dizziness, Headache, Insomnia, Nuclear magnetic resonance imaging brain, Oedema peripheral, Pain, Tremor, X-ray limb
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: magnetic resonance - brain; upper extremity X-ray; laboratory test 10/22/08-records received-CBC and chemistry WNL. 12/31/08-records received-Complement C3, C4, CK, metabolic panel , CBC, sed rate, C-reactive protein normal, rheumatoid factor negative, ANA positive. Vitamin D deficiency.
CDC Split Type: WAES0808USA03971

Write-up: Information has been received from a medical assistant concerning a 15 year old female with allergy to CEFZIL and no relevant medical history who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). In November 2007, the patient experienced headaches, stomach ache, dizziness, shakiness, dull and sharp aches all over. The patient also experienced joint pain all over, swelling of the right thumb, depression and insomnia. The patient had been set up with an appointment with a rheumatologist. Laboratory tests (included unspecified lab work, MRI of brain and X-ray of right hand (results unspecified). At time of this report, the patient''s events persisted. According to the reporter, the patient''s events prevented her from school schedule and were considered to be disabling. Additional information has been requested. 10/22/08-records received-presented on 8/8/08 with C/O headache,stomach ache, dizzy and shaking on and off for a while. Generalized pain. Abdominal pain. DX gastritis. Dizziness. 8/18/08 continues with C/O headaches and body aches. DX: arthrlagias, polymyalgias. Swelling of right thumb. Cephalgia. Dep ression. Insomnia. 9/3/08 continues with cephalgia, myalgias and depression.10/1/08-C/O abdominal pain. 12/31/08-records received for DOS 11/10/08-C/O arthralgia/back pain left limb pain. Vitamin D deficiency.


VAERS ID: 324292 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Delaware  
Vaccinated:2007-11-19
Onset:2007-11-20
   Days after vaccination:1
Submitted: 2008-08-29
   Days after onset:282
Entered: 2008-09-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2458BA / 6 RA / SC
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Headache, Immediate post-injection reaction, Lethargy, Malaise
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: None PMH: cupping of optic disc. Eye itch & burn. Hypermetropia, painful menses, using contraception to regulate. Excision of chalazia bilateral lower eyelids. Adopted. Family hx cancer. HPV #2 given 1/29/08, Lot # 1265U; HPV #3 given 6/10/08, Lot # 1757Y, RA.
Allergies:
Diagnostic Lab Data: Eye exams (2 different Opt.)
CDC Split Type:

Write-up: Severe headaches (immed. after 1st course) continuing almost daily. Joint aches, extreme malaise and lethargy. (2 visits to eye specialist - reported to physician). 9/23/08 Reviewed PCP medical records & vaccine records. PCP office called parent for status check as they were unaware of any problems patient had. Office states patient had severe HA after 1st & 3rd HPV vaccines. Parent reports patient is completely asymptomatic now. Eye exam of 12/31/07 reveals clear vision & no pain. 1/26/2010 Headaches have lessend but still occurring.


VAERS ID: 329113 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-17
Entered: 2008-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0810USA02003

Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with GARDASIL and lost her vision in "2007". The physician was not the patient''s provider. The physician found this case out from a ski instructor who taught blind children. The event was reported as disabling. Attempts are being made to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.


VAERS ID: 336853 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Colorado  
Vaccinated:2007-08-18
Onset:2007-08-18
   Days after vaccination:0
Submitted: 2009-01-07
   Days after onset:508
Entered: 2009-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Behcet's syndrome, Vulval ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Vulval ulceration; West Nile viral infection
Preexisting Conditions: Mouth ulceration; Canker sores oral; Viral infection PMH: PCOS, ? DMII on oral meds. Allergy: sulfa.
Allergies:
Diagnostic Lab Data: Diagnostic laboratory, STD testing LABS: pathergy test neg. ESR 32(H), CRP 10.5(H). CBC, chemistry, LFTs WNL. HSV/PCR neg. HSV I (+), HSV II(-). Biopsy vulvar lesion.
CDC Split Type: WAES0812USA02633

Write-up: Information has been received from a physician concerning a female patient with a history of mouth ulcers who on an unknown date was vaccinated with a dose of GARDASIL, lot # unspecified. The patient came back to the physician''s office 4 hours after getting GARDASIL with "vulvar ulcers" diagnosed as "bipolar aphthosis". The physician stated that the patient had gotten the shot when she was experiencing symptoms of West Nile virus; however it was not diagnosed after she had been given GARDASIL. The patient became sexually active "shortly before" she got GARDASIL. At the time of reporting, the outcome of the event was unknown. Follow-up information was received from the physician who reported that the patient had a history of canker sores. The physician also reported that the patient had a viral illness (not specified) prior to receiving the third dose of GARDASIL. The physician stated that the patient had experienced bipolar aphthosis every month for over one year. Follow-up information was received from the physician, who reported that the patient was vaccinated with the third dose of GARDASIL IM, on 18-AUG-2007. The physician reported that within 4 hours of vaccination, the patient had the first outcome of nonherpetic vulvar ulcers. Major work up negative. Presumed to be bipolar aphthosis. At the time of reporting, the patient had not recovered. The patient had numerous cultures and laboratories (unspecified) and a presumptive positive West Nile virus test. The physician considered the event to be disabling. This is one of two reports from the same source. No further information is available. 2/17/09 Received Immunology Clinic records of 7/15-9/26/2008. FINAL DX: Bechet''s disease Records reveal patient did not have symptoms when initially evaluated. Valtrex d/c. Had bout of depression w/suicidal ideation. Being seen by counselor & tx w/meds. Developed oral canker sores that waxed & waned & by 9/18 had over 40+ vulvar ulcers w/exudate & bilateral lymph node adenopathy. Depression aggravated by eruption, fever 100.5, flu like s/s of aches/pain all over. Developed fine erythematous rash over face & skin next day that waxed & waned. Continues to self cath. Tx w/steroid burst & antibiotics. Improved w/steroids 2/18/09 Received ID clinic records of 4/12-5/21/2008 which revealed no new information. 1/20/09 Received PCP office records 4/8-12/3/2008. FINAL DX: suspect bipolar aphthosis Records reveal patient had cleaned out pond 8/2007. Dx w/WNV & had recurring symptoms since then of: 7-14 day menses, facial warmth, painful oral & vaginal lesions, dysuria requiring self catheterization. Lesions are blisters that ooz yellow fluid & also red bumpy itchy rash on trunk & arms. Skin painful during these episodes. Fevers up to 101,(+) inguinal nodes, axillary nodes. Not sexually active. Tx w/antivirals, pain meds & antigout med. Referred to ID 2/5/09 Received GYN medical records of 8/28/2007-11/25/2008. FINAL DX: Bechet''s syndrome records reveal patient seen 8/28/07 in f/u on vulvar operations that were felt to be response to viral illness. Patient was feeling better, lesions were resolving w/o pain. RTC 10/15/07 w/vaginal lesions; numbness & tingling of LEs; intermittent recurrent vision loss; and mouth lesions x 3 days. Referred to Neuro. RTC 12/10/07 & record states pt w/known West Nile virus x approx 5 mo. RTC 2/28/08 w/hirsutism & acne. Added yaz to glucophage & valtrex already on. Labs ordered. RTC 3/17/08 w/recurrent vaginal lesions x 2 days & sore throat x 2 weeks. Records state HSV IgM (+) 12/2007. Patient had self d/c valtrex due to increased depression. Dx w/HSV outbreak w/superimposed cellulitis. RTC 7/08 & referred to university specialist. RTC 10/29 & given trial of colchicine as recommended by specialist. RTC 11/25/08 w/recurrent outbreak of vulvar ulcers most c/w Bechets. Tx w/meds.


VAERS ID: 340357 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2009-01-16
Onset:2009-01-22
   Days after vaccination:6
Submitted: 2009-02-13
   Days after onset:22
Entered: 2009-02-23
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0575X / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Bronchitis, Electrocardiogram normal, Influenza like illness, Loss of consciousness, Malaise, Mydriasis, Pain, Pallor, Pyrexia, Tooth injury
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: not at time of vaccination
Current Illness: None
Preexisting Conditions: allergic to Amoxicillin
Allergies:
Diagnostic Lab Data: EKG, normal; Chest X-ray, showed bronchitis 3/16/09-records received-WBC 3.2, Hgb 14.9, neutrophils elevated 77.8, lymphocytes decreased 15.4, glucose 110. Chest x-ray normal.
CDC Split Type:

Write-up: Patient received her 1st GARDASIL shot on 1-16-09. She received no other shots and was on no medication. On 1-20-09, patient woke up with flu-like symptoms fever, upper respiratory congestion, body aches, and weakness. On 1-22-09, patient was treated at urgent care for her flu-like symptoms and bronchitis. She was given a 1st dose of Azithromycin, PREDNISONE and MUCINEX mid-morning. After sleeping for 2 1/2-3hours, patient got up, sat down to eat felt ill, got up, and passed out, hitting her two front teeth and severing them. She went by ambulance to hospital ER, although she regained consciousness right away, her skin was a strange white color and her pupils were dilated. She has had no other problems since her ER treatment, but her two front teeth had to be replaced with crowns. 3/16/09-ED records received for DOS 1/22/08-presented with C/O lightheadness, syncope, nausea, felt faint, brief loss of consciousness. Abrasions on inner lips, oral laceration, suturing required. Dental injury. Impression: syncope.


VAERS ID: 340833 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Maine  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-02-26
Entered: 2009-02-27
   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: Activities of daily living impaired, Arthralgia, Back pain, Headache
SMQs:, Retroperitoneal fibrosis (broad), Dementia (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA03735

Write-up: Information has been received from a physician concerning a 15 year old female with no medical history and drug allergies who, on an unspecified date, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient had experienced hip pain, lower back pain and headache after receiving the first dose of GARDASIL. It was noted that she had experienced pain in both of her hips but the left side had more pain than the right. The pain in her hips had made it difficult for the patient to participate in her soccer games. The patient sought medical attention and was seen by physician. The lot numbers and dates of administration were unknown. At the time of reporting (20-FEB-2009) the patient was recovering. The reporter considered the adverse experiences to be disabling. Additional information has been requested.


VAERS ID: 342378 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Virginia  
Vaccinated:2008-08-20
Onset:2008-10-01
   Days after vaccination:42
Submitted: 2009-03-20
   Days after onset:170
Entered: 2009-03-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0063X / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Blood test, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None. PMH: none. NKDA
Allergies:
Diagnostic Lab Data: diagnostic laboratory, Stomach empty test - No results available; computed axial, No results available; diagnostic laboratory, Blood test - No results available. Labs and diagnostics: Upper GI WNL. CBC WNL. Chem WNL. H. pylori (-). BX of esphagus and stomach WNL. Some inflammation of lamina propria of duodenum. Upper GI (+) for small ring shadow of distal stomach with SB follow through WNL. Head CT WNL. US abd WNL. HIDA scan WNL. CT abd and pelvis WNL. Gastric emptying study WNL. X-ray abd (+) for increased stool. EGD WNL.
CDC Split Type: WAES0903USA02570

Write-up: Information has been received from a consumer concerning her 15 year old daughter with no past medical history and no drug reactions or allergies who in August 2008, was vaccinated with the first dose of GARDASIL. In October 2008, the patient received the second dose of GARDASIL. There was no concomitant medication. The consumer reported that the patient developed a low grade fever and felt "sick" the day after receiving her second dose of GARDASIL. During October and November of 2008, the patient experienced intermittent "stomaches", nausea and vomiting. Starting December of 2008 until the time of this report, she had experienced persistent extreme stomach pains and vomiting. The patient had been examined by three gastroenteriologists who were not able to determine the cause of her symptoms. She had missed 60 days of school. Lab diagnostics studies included a stomach empty test, CAT scan and blood tests with no results available. At time of this report, the patient had not recovered. The patient sought medical attention by an office visit. Upon internal review, low grade fever, felt "sick", intermittent "stomaches", nausea, vomiting and persistent extreme stomach pains were considered to be disabling. Additional information has been requested. 3//25/09 MR received from parent which include several GI consults and diagnostic testing. Per MR pt began having intermittent vomiting in Sept 2008. Usually at night waking pt, accompanied by abdominal pain, H/A and associated with shaking/shivering/chills. Occ nausea. 6-7 lb wt loss. ROS (+) for fatigue and chest pain. PE WNL except for eczematous rash on hip, iliac crest and axilla. Some improvement with Reglan but now c/o dizziness. W/U essentially (-). No final DX. 2nd GI consult seen 1/9/09. PE (+) for tenderness to palpation of the epigastrium, RUQ and RLQ. Has missed 28 school days since Sept 08. Labs and diagnostics: Upper GI WNL. CBC WNL. Chem WNL. H. pylori (-). BX of esphagus and stomach WNL. Some inflammation of lamina propria of duodenum. Upper GI (+) for small ring shadow of distal stomach with SB follow through WNL. Head CT WNL. US abd WNL. HIDA scan WNL. CT abd and pelvis WNL. Gastric emptying study WNL. X-ray abd (+) for increased stool. EGD WNL.


VAERS ID: 345220 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2009-03-06
Onset:2009-03-06
   Days after vaccination:0
Submitted: 2009-04-14
   Days after onset:38
Entered: 2009-04-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Dizziness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02323

Write-up: Information has been received from a physician concerning a 15 year old female who on 06-MAR-2009 was vaccinated with GARDASIL IM 0.5ml. Concomitant therapy included a recent shot of DEPO-PROVERA. The patient experienced dizziness on 06-MAR-2007, 07-MAR-2009 and 09-MAR-2009. The physician did not say if there was any dizziness occurring on 08-MAR-2009. The patient "had to leave school". The patient sought unspecified medical attention. Dizziness was considered to be disabling. Additional information has been requested.


VAERS ID: 348729 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-11-14
Onset:2009-03-05
   Days after vaccination:842
Submitted: 2009-06-08
   Days after onset:94
Entered: 2009-06-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Blood product transfusion, Demyelination, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown 8/14/2009 MR rec''d from PCP. Allergy to Ceclor and tree nuts. 9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09. Asthma, T/A, myringotomy bilateral.
Allergies:
Diagnostic Lab Data: Unknown. 8/14/2009 MR rec''d from PCP. Labs and Diagnostics: EMG abnormal. CSF protein increased. 9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09. LABS and DIAGNOSTICS: CSF Culture - No Growth. CSF - Protein 165 mg/dL (H). Hepatitis B Surface Antibody 39.5 mIU/mL (H). Urinalysis - Ketones Trace, Sp. Grav 1.036 (H), Protein 1+. Crystals 20-50, Bacteria 1+. EMG - Abnormal.
CDC Split Type: WAES0906USA00536

Write-up: Information has been received from a physician concerning a 15 year old female patient who on 14-NOV-2006, 16-JAN-2007 and on 12-JUN-2007 was vaccinated with the first, second and third doses of GARDASIL (Lot # not reported). It was reported that in "March 2009" the patient experienced weakness, pain in her legs and hips and the patient sought medical attention with the physician, then she was admitted to the hospital for three days on 07-APR-2009. It was reported that the patient was diagnosed with "acute demyelinating disease". The physician noted that the patient received gamma globulin for three days. It was reported that the patient was recovering but not fully recovered. The reporting physician considered "acute demyelinating disease" to be disabling. The Health Care Professional contacted during telephone follow up could not supply the following information: patient name and Lot numbers. Additional information has been requested. The patient was hospitalized. 8/14/2009 MR rec''d from PCP which includes Neuro consult in f/u to hospitalization with DX: CIDP/sub-acute polyradiculopathy. Pt developed fever, cough, cold sx, abdominal pain, H/A and stuffy ears 2/9/2009. Flu (+). Dx: Viral Flu. Returned 3/5/09 with c/o hip pain, numbness/weakness in both feet, muscle stiffness. Had recent knee injury. Worsening by 4/2/09 and referred to neurologist. Admitted 4/23-29 with dx CIDP. Tx IVIG. Neuro f/u 5/22/09 with almost complete resolution of sx. 9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09. Assessment: Chronic Inflammatory Demyelinating Polyneuropathy (possibly secondary to influenza illness) Patient presents with bilateral upper and lower extremity weakness, influenza diagnosed 2/10/09. Fatigue, bilateral hip and calf pain. Range of motion decreased in lower extremiities. Reflexes absent. Wide-based stance. IVIG. Improved.


VAERS ID: 350235 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-06-13
Onset:2009-06-13
   Days after vaccination:0
Submitted: 2009-06-25
   Days after onset:12
Entered: 2009-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1312X / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Blood glucose normal, Lethargy, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: vital sign, 06/13/09, normal; blood glucose, 06/13/09, normal
CDC Split Type: WAES0906USA02614

Write-up: Information has been received from a Physician Assistant (P.A) concerning a 15 year old female patient who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # not reported). It was reported that the patient fainted right after receiving the first dose of GARDASIL on 13-JUN-2009. It was reported that the patient was was brought to the emergency room and stayed there for a few hours. The patient was not admitted to the hospital. The patient sought medical attention with the Physician Assistant. There was a blood work performed (results not provided). It was reported that the adverse event had improved at the time of the report. All telephone attempts to contact the reporter have been unsuccessful. Follow up information was received from a Physician Assistant (P.A) on 23-JUN-2009 via telephone reported that the patient with no pertinent medical history or known drug allergies was vaccinated with the first dose of GARDASIL (Lot # 661846/1312X) on 13-JUN-2009. On 13-JUN-2009 the patient was very anxious and hadn''t eaten since the night before. There were no concomitant medications and no other vaccinations given that day. After having fainted for only a few seconds, the patient was monitored in the office for the next 45 minutes. The vital signs and blood sugars were normal, but the patient was nauseous, lethargic and pale. She was transported to the emergency room. It was unknown what tests - other than blood work - were performed. The event was considered disabling for about five hours. The patient had fully recovered. The reporter considered fainted, nauseous, lethargic and pale to be significant disability/disabling. No further information is available.


VAERS ID: 350858 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2008-09-04
Onset:0000-00-00
Submitted: 2009-07-06
Entered: 2009-07-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB264A / 2 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0250X / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Cough, Eye oedema, Eye swelling, Inappropriate schedule of drug administration, Malaise, Nausea, Vaccine positive rechallenge, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA05239

Write-up: Initial information has been received from a physician concerning a 14 year old female patient who received the second dose of GARDASIL and experienced "swelling and edema of the eye" and saw treatment at ER where she was given BENADRYL. The physician stated that she had the same experience after the first dose. The patient was due for her third dose in about a week and she was planning on receiving it. The swelling resolved after about a week, the patient had recovered. Follow up information has been received from a registered nurse concerning the 15 year old (initial reported as 14 year old) female patient who on 04-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 0250X) and concomitantly received the second dose of HAVRIX (Lot # AHAVB264A). On 02-JAN-2009, the patient received the second dose of GARDASIL (lot# 0947X). On 24-Jun-2009, the patient was seen by the physician with complaints of a cough and wheezing. At the time of the physician''s visit the patient''s father stated that after the patient had received the first dose of GARDASIL, the patient was ill and nauseous and missed 1 week of school. The patient also had swelling and edema of both eyes. After the patient received the second dose of GARDASIL, the patient had swelling and edema of both eyes. The patient went to the Emergency Room and was treated with BENADRYL (route unknown to the reporter). The patient was not admitted to the hospital. The registered nurse stated that the patient was scheduled to receive the third dose of GARDASIL on 29-JUN-2009. The registered nurse requested to speak with a Merck physician prior to administering the third dose of GARDASIL to the patient. Follow up information has been received from a memo indicated that a Merck physician had spoken to the registered nurse. They have decided to not administer the third dose on 29-JUN-2009. Missing 1 week of school was considered to be disabling by the physician. Additional information has been requested.


VAERS ID: 351867 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-07-23
Onset:2008-07-25
   Days after vaccination:2
Submitted: 2009-07-17
   Days after onset:357
Entered: 2009-07-20
   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: Amnesia, Areflexia, Asthenia, Brain oedema, Confusional state, Demyelination, Disorientation, Dysstasia, Electroencephalogram, General physical health deterioration, Guillain-Barre syndrome, Hypokinesia, Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Presyncope
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Optic nerve disorders (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: spinal tap, no permanent damage
CDC Split Type: WAES0907USA02007

Write-up: Information has been received from a nurse practitioner. The nurse practitioner reported that "she was sent an email by one of her patient''s mothers who received it from another mother stated that a 15 year old female patient, who was not patient of the nurse practitioner, on 23-JUL-2008 was vaccinated with the first dose of GARDASIL and then two days later the patient almost passed out and was weak for hours. Through the rest of the summer and school year the patient complained that she could not run as fast and was weak. Then on October 17, 2008 the patient received her second dose of GARDASIL and on October 21st the patients mother received an urgent message from the school nurse to take her daughter immediately to her pediatrician. The patient was experiencing confusion, was disoriented, barely could stand, had no reflexes in her feet, and couldn''t remember anything that happened that day. The patient was then taken to her pediatrician''s office who advised her to see a neurologist. A week later when she saw the neurologist they did a EEG and a MRI because they thought she had a brain tumor, and the patients memory was slowly coming back. Then a second MRI was done which showed she had a demyelination that usually occurs either with GUILLAIN BARRE or with multiple sclerosis. Then later on the patient was diagnosed with GUILLAIN BARRE. The patient was given a spinal tap which showed no permanent damage, inflammation of her brain is going down, she has no debility". GUILLAIN BARRE was considered to be disabling by the nurse practitioner. Additional information has been requested.


VAERS ID: 359622 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2008-01-02
Onset:2009-03-29
   Days after vaccination:452
Submitted: 2009-10-05
   Days after onset:190
Entered: 2009-10-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1522U / 3 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Blood amylase increased, Blood test normal, Gallbladder operation, Laboratory test, Lipase increased, Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: PMH: none; Allergies: NKDA.
Allergies:
Diagnostic Lab Data: diagnostic laboratory 08/31/09, Blood tests were normal; serum amylase test, 03?/??/09, 3200; serum lipase test, 03?/??/09, 2000 01/07/10 and 01/08/10 MR and DC summary received for DOS 03/29/09-04/01/09. DX studies: no electrolyte abnormalities, amylase 860, lipase 206; Abd. U/S: normal.
CDC Split Type: WAES0909USA04548

Write-up: Information has been received from a Registered Nurse concerning her 16 year old daughter who on 29-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 29-AUG-2007 she received second dose of GARDASIL (lot # not reported). On 02-JAN-2008 she received third dose of GARDASIL (lot # not reported). On 29-APR-2009 the patient experienced acute pancreatitis and was hospitalized. On an unspecified date the patient recovered from acute pancreatitis. Laboratory test revealed: Amylase level: 3200 and lipase level 2000. Follow up information has been received on 30-SEP-2009 via telephone call from Medical Assistant (the patient''s mother) (previously reported as Registered Nurse). The Medical Assistant stated that her daughter received first dose of GARDASIL (lot # 657736/0389U) on 29-JUN-2007. On 29-AUG-2007 she received second dose of GARDASIL (lot # 657736/0389U). On 02 - JAN-2008 (previously reported as 02-JAN-2007) she received third dose of GARDASIL (lot # 659055/1522U). The patient did not receive any concomitant vaccinations when GARDASIL vaccinations were administered. The Medical Assistant stated that the patient experienced abdominal pain on 29-MAR-2009. The patient was taken to the hospital but was not admitted. Later that day, the patient was taken to other hospital. The patient was admitted with complaint of abdominal pain on 29-MAR-2009 (previously reported as 29-APR-2009) and was diagnosed with acute pancreatitis. The patient was discharged on 01-APR-2009. The patient had recovered. The name of the Primary Care physician was provided. The patient complained of abdominal pain, (date not reported). In May 2009 the patient had her gall bladder removed (hospitalization dates unknown to reporter). On an unspecified date the patient recovered. On 31-AUG-2009, the patient complained of abdominal pain and was taken to the hospital. The patient''s blood tests (test unspecified) were normal. The patient was not admitted to the hospital. The Medical Assistant stated that the patient had experienced abdominal pain "now and then". The mother (medical assistant) felt that acute pancreatitis was immediately life-threatening and was disabling. "A lot check has been initiated." Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lots number 653055/15220 and 657736/0389U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information received from the physician indicated that patient was vaccinated with her first and second doses into her left arm at 15:00 on 29-JUN-2007 and 29-AUG-2007, respectively. She received her third dose in her right arm at 15:00 on 02-JAN-2008. It was reported that the 29-MAR-2009 hospitalization lasted 4 days. On 04-MAY-2008 the patient had recurrent pancreatitis and was treated at the hospital again. The physician stated there was no evidence of any relation to HPV rL1 6 12 16 18 VLP vaccine (yeast) given 2 years later. The patient recovered on SEP-2009. The physician felt that acute pancreatitis and recurrent pancreatitis were immediately life-threatening and they required medical/surgical intervention. No further information is available. 01/07/10 and 01/08/10 MR and DC summary received for DOS 03/29/09-04/01/09. DX: Acute pancreatitis. Pt NPO, clear diet. Tx: IVF, Dilaudid, Zofran, Hydrocodone. Pancreas enzyme levels high on admission, but improved on discharge. Pt started a normal diet. Pt improved and discharged home. Pt to follow up with GI specialist.


VAERS ID: 360163 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Illinois  
Vaccinated:2009-02-13
Onset:2009-03-03
   Days after vaccination:18
Submitted: 2009-10-08
   Days after onset:218
Entered: 2009-10-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0650X / 3 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody negative, Blood thyroid stimulating hormone normal, C-reactive protein increased, Parvovirus B19 serology negative, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor increased, Rheumatoid factor positive
SMQs:, Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: Hypothyroidism; Eczema; Acne
Preexisting Conditions: Adverse drug reaction. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09. PMH: Eczema, hypothyroidism, acne, tonsillectomy, fracture of R radius, NKDA.
Allergies:
Diagnostic Lab Data: serum rheumatoid factor, 08/18/09, 347 IU/m, erythrocyte, 08/18/09, 41 mm/h; erythrocyte, 06/09/09, 17 mm/h; serum ANA, 06/09/09, negative; serum rheumatoid factor, 06/09/09. 38 IU/M; serum C-reactive, 06/09/09, 1.06 mg/d; serum cyclic citrulline, 06/09/09, 20 unit; erythrocyte, 05/02/09, 11 mm/h; serum rheumatoid factor, 05/02/09, 21 IU/m; serum C-reactive, 05/02/09, 0.26 mg/d; serum B19 virus IgM, 05/02/2009, <0.9; serum TSH, 05/02/09, 3.36 mIU/. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09. Labs and diagnostics: Rheumatoid Factor 347 (H), Sed. rate 41 (H), C-Reactive protein-1.06 (H). BUN 22 (H), Glucose 100 (H), WBC 16.7 (H), Hgb 11.0 (L), Neutorphil 76.2% (H), Lymphocyte 17.5% (L), Neutrophil absolute 12.7 (H), Monocyte absolute 1.0 (H), Peptide (CCP) AB (IGG) 20 (H). Venous blood flow UNI- no evidence of DVT. X-ray Right hand-Negative.
CDC Split Type: WAES0909USA01491

Write-up: Information has been received from a medical assistant concerning a 16 year old female with hypothyroidism, eczema and acne who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL (0.5ml, IM). The patient received the second dose of GARDASIL (0.5ml, IM) on unspecified date. On 13-FEB-2009 the patient received the third dose of GARDASIL (0.5ml, IM). The patient was diagnosed with viral or early rheumatoid arthritis by a rheumatologist. Her symptoms began 1 month after the third vaccination. The rheumatologist evaluated the patient in May 2009 where he said it was either viral arthritis or early rheumatoid arthritis. The rheumatologist said the patient was not in acute distress but joints were sensitive. The rheumatologist said he was leaning to early rheumatoid arthritis because of the duration of symptoms. At the reporting time the patient had not recovered. Follow-up information has been received from a clinical manager: The patient had previous drug reaction (vomiting) to codeine and CEFTIN. The patient was vaccinated with GARDASIL series as following: the first dose on 06-JUN-2008, lot# 658558/1061U; the second dose on 28-JUL-2008, lot# 658558/1061U; the third dose on 13-FEB-2009, lot# 661764/0650X; no other vaccines given on these dates. Concomitant therapy included SYNTHROID. The consult report from a rheumatologist from May 2009 showed "early rheumatoid arthritis". The report from the rheumatologist from 25-AUG-2009 showed that the patient was started on ENBREL, 50 mg weekly and methotrexate, 12.5 mg weekly for rheumatoid arthritis (RA). Follow-up information was received from the medical assistant via medical records indicating that the patient was a student and was vaccinated with three doses of GARDASIL IM in the left arm. The patient''s symptoms occurred on 03-MAR-2009. On 02-MAY-2009 parvovirus B-19 antibody (IGM) was negative (<0.9), rheumatoid factor was 21 IU/ml, C-reactive protein was 0.26 mg/dl, thyroid-stimulating hormone (TSH) was 3.36 mIU/L and sed rate was 11 mm/h. She was diagnosed with rheumatoid arthritis at the end of May 2009. On 09-JUN-2009 rheumatoid factor was 38 IU/ml, C-reactive protein was 1.06 mg/dl, cyclic citrullinated peptide IgG antibody was 20 unites, sed rate was 17 mm/h and antinuclear antibodies was negative. On 18-AUG-2009 rheumatoid factor was 347 IU/ml and sed rate was 41 mm/h. At the time of reporting, the patient had not recovered from rheumatoid arthritis. The reporter considered rheumatoid arthritis to be disabling. Additional information is not expected. All available medical records will be provided upon request. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09 Dx: Rheumatoid Arthritis Assessment: Per rheumatologist: Pt. c/o pain in feet and hands and wrists since 8/08. Her fingers have started to swell and she has significant morning stiffness. For several weeks she has been stiff when she wakes up and it is difficult to get out of bed, with the stiffness lasting several hours. There is no family history of arthritis. On exam she has multiple tender small joints in her hands. Her MCP and PIP joints are swollen. There is tenderness in the wrists. She is tender over the metatarsal area of the feet and the area has trace swelling. There is a possibility of another autoimmune disease such as lupus or other inflammatory arthritis. Medrol Dosepak prescribed with plan to switch to Naprosyn BID. Also started on Methotrexate weekly, sulfasalazine and folic acid. Later switched to Enbrel weekly.


VAERS ID: 369060 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Illinois  
Vaccinated:2009-09-18
Onset:2009-11-07
   Days after vaccination:50
Submitted: 2009-11-19
   Days after onset:12
Entered: 2009-11-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9116111 / 3 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0671Y / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Full blood count normal, Laboratory test normal, Metabolic function test normal, Nuclear magnetic resonance imaging, Pregnancy test urine negative
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? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: Learning disability; Cognitive impairment
Preexisting Conditions: FMH: Patient has first cousin with epilepsy./rem 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. Sickle Cell Trait (+). "Shakes a lot". Head trauma in 2002 and 2003. Learning difficulty. Behavioral problems. Stutters.
Allergies:
Diagnostic Lab Data: Magnetic resonance, results pending; computed axial, normal; diagnostic laboratory, normal 11/23/2009: LABS and DIAGNOSTICS: Cat scan WNL, BMP WNL, CBC WNL, urine pregnancy test negative and urine drug screen negative. 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. LABS and DIAGNOSTICS: CBC - MPV 11.5 FL (H) MONO ABS 0.5 CT/MM3 (L), MICRO 2+, ANISO 1+, TARG 1+, HYPO 1+, G.PLT Present. CHEM - ALT 9 IU/L (L) Prolactin 30 NG/ML (H). CT Brain - WNL.
CDC Split Type: WAES0911USA02419

Write-up: Information has been received from a physician concerning a 15 year old female patient with no drug reactions/allergies and a history of learning disability and cognitive impairment who on 23-JAN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 660557/0072X). There was no concomitant medication. On 20-MAR-2009 the patient received the second dose of GARDASIL (lot # 660557/0072X) and on 18-SEP-2009 the patient received the third dose of GARDASIL (lot # 663452/0671Y). On 07-NOV-2009 the patient developed a seizure and was hospitalized for 2 to 3 days. The physician saw the patient on 13-NOV-2009 "today" and the patient''s mother said the patient was "fine". The patient was on an unspecified antiseizure medication. A neurology consult was pending. MRI results were pending, cat scan and blood tests were normal. Seizure was considered to be immediately life-threatening and disabling. Additional information has been requested. 11/23/2009 Out-patient progress notes and laboratory test reports received for DOS 09/18/2009-11/13/2009. Assessment: Seizure Disorder Patient had generalized seizure (2 episodes). Hospitalized 11/07/2009 through 11/09/2009. Progress note of 11/13/2009 notes patient alert and oriented X3 and neuro intact. 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. Assessment: Generalized Tonic/Clonic Seizure. Mother heard strange noise, found patient stiff, head turned to left. Tonic/Clonic movements of limbs followed by postictal state. Urinary incontinence. Presents unresponsive. Seizure in ER. Cold sensation. Headache. Hand grasp weak. Slow to answer questions.


VAERS ID: 374963 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-05-14
Onset:2009-07-10
   Days after vaccination:788
Submitted: 2009-12-24
   Days after onset:167
Entered: 2009-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 2 RA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Arthralgia, Musculoskeletal pain, Rheumatoid arthritis, Rheumatoid factor positive
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: RA factor found in blood tests, positive for Rheumatoid Arthritis
CDC Split Type:

Write-up: Pain in shoulders mostly and other joints, knees, feet, elbows, jaw.


VAERS ID: 375693 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2008-01-08
Onset:2008-03-01
   Days after vaccination:53
Submitted: 2010-01-03
   Days after onset:673
Entered: 2010-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 1 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdomen scan, Abdominal pain upper, Acne, Anxiety, Blood test, Computerised tomogram, Depression, Dyspepsia, Fatigue, Feeling abnormal, Influenza like illness, Malaise, Myalgia, Stool analysis, Ulcer, Urine analysis, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Dementia (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Muscle Aches
Preexisting Conditions: Allergies-Sulfur Drugs
Allergies:
Diagnostic Lab Data: All kinds of blood labs, x-rays, stomach scans, ct scan, urine/stool analysis
CDC Split Type:

Write-up: Between 1st & 2nd shot of Gardasil patient developed severe stomach pain, cramping, and burning that lasted weeks. Muscle aches and overall feeling of not being well. In August 2009 patient had flu like symptoms, anxiety, depression, fatigue, ulcers, acne, overall feeling of illness or impending death.


VAERS ID: 376004 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2009-06-22
Onset:2009-06-25
   Days after vaccination:3
Submitted: 2010-01-05
   Days after onset:194
Entered: 2010-01-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702X / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Aura, Blood potassium decreased, Dizziness, Dyskinesia, Dyspnoea, Erythema, Facial palsy, Fatigue, Feeling abnormal, Feeling hot, Flushing, Heart rate increased, Hypoaesthesia, Hypokalaemia, Joint contracture, Loss of consciousness, Memory impairment, Muscle spasms, Musculoskeletal stiffness, Myalgia, Palpitations, Panic attack, Paraesthesia, Postictal state, Respiratory rate increased, Sinus bradycardia, Somnolence, Speech disorder, Staring, Tachypnoea, Tremor, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; ALLEGRA; ALEVE; vitamins (unspecified)
Current Illness: Penicillin allergy; asthma; smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 09/06/09, 142/105, initial; blood pressure, 09/06/09, 124/84, discharged; electrocardiogram, 09/06/09, see narrative; physical examination, 09/06/09, normal; blood pressure, 09/08/09, 116/70; diagnostic laboratory, 09/08/09, cardiology: palpitations and increased heart rate; blood pressure, 10/22/09, 126/64; blood pressure, 11/18/09, 118/80; physical examination, 11/18/09, eyes: ERRLA; blood pressure. 11/20/09, 122/79; physical examination, 11/20/09, normal; physical examination, 11/18/09, Psych: mood appropriate; physical examination, 11/18/09, alert, oriented and fatigue; physical examination, 10/22/09, normal; physical examination, 09/08/09, normal; neurological, 09/08/09, confusion and numbness; neurological, 09/06/09, dizziness, numbness and difficulty with speech; body temp, 09/06/09, 99.4, initial; body temp, 09/08/09, 99.1; arterial blood O2, 09/08/09, 98; serum potassium, 09/06/09, 3.3; respiratory rate, 11/20/09, 16; total heartbeat count, 11/20/09, 70; body temp, 11/20/09, 99; arterial blood O2, 11/18/09, 95; total heartbeat count, 11/18/09, 68; body temp, 11/18/09, 98.0; total heartbeat count, 10/22/09, 80; body temp, 10/22/09, 92.3; total heartbeat count, 09/08/09, 59; total heartbeat count, 09/06/09, 115, initial; pulse rate, 09/06/09, 62, discharged; arterial blood O2, 09/06/09, 100, discharged; respiratory rate, 09/06/09, 16, discharged; arterial blood O2, 09/06/09, 100, initial; respiratory rate, 09/06/09, 28, initial
CDC Split Type: WAES0909USA04914

Write-up: Information has been received from a physician concerning a 15 year old female patient, who on 22-JUN-2009 was vaccinated with the first 0.5 ml dose of GARDASIL, intramuscularly. Concomitant therapy included ALEVE and ALLEGRA. On 25-JUN-2009 the patient had a 5 minute period where she was unresponsive, her fingers were stiff and she was generally dazed. On 18-AUG-2009 the patient was given a second 0.5 ml dose of GARDASIL, intramuscularly. On 20-AUG-2009 she had a similar episode that lasted 15-20 minutes. On 06-SEP-2009, the patient had another episode that lasted 30-40 minutes. She was brought to an ER. The hospital staff told her that they thought that is was a panic attack and told her to take potassium supplements. The mother decided to not complete the series. At the time of reporting the patient had recovered. Follow up information has been received from a physician via medical records concerning the patient with penicillin allergy and smoker who on 22-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot number 0702X) IM in the left deltoid and on 18-AUG-2009 with the second dose of GARDASIL (Lot number 0162Y) IM in the right deltoid. Concomitant therapies included albuterol and multivitamin. On 06-SEP-2009, the patient presented to the emergency room with chief complaint of possible anxiety, trouble breathing. The patient was sitting in church and began having trouble breathing. Patient began increased breathing. The patient began tingling of face and contracture of hands. The patient had trouble talking. The episode resolved after breathing slowed. At the ER, the patient felt hot. The patient had similar episode recently at school, 2 weeks ago stated by the mother and lasted 10 minutes. The patient''s initial temperature was 99.4, pulse 115, respiration 28, blood pressure 142/105 and SaO2 100 and the discharge pulse rate was 62, respiration 16, blood pressure 124/84 and SaO2 was 100. Electrocardiogram was performed and showed sinus bradycardia with a heart rate of 58 bmp. The neurological/physiological evaluation showed dizziness, numbness and difficulty with speech. The physical exam was normal. Blood work revealed the patient''s potassium level was 3.3 and she received 20mEq of KCL. At 20:48, the patient was discharged stable, and was ambulatory. The admitting diagnosis was short of air and the clinical impression was palpitations, anxiety and hypokalaemia. On 08-SEP-2009, the patient''s blood pressure was 116/70, temperature 99.1, pulse 59, RR 16 and SO2 98. The patient had facial paralysis and was seen in her physician''s office. Regarding the patient''s history present illness, she had a first episode at 05:00 of being glassy-eyed with hand cramp and increased breathing; the second episode was at 10:00, with the same symptoms (occurred at school); and with the third episode she went to the emergency room very glassy-eyed, she could not follow directions, and her hand and mouth were cramped. She did not remember all of event and she was sleepy when she came out of it. Review of systems showed: neurological as confusion and numbness, respiratory as tachypnic with no SOA, cardiological as palpitations and increased heart rate. The patient''s past medical history and family history was unchanged. The physician''s clinical impression was questionable seizure activity, "doesn''t sound anxiety-related, especially with a history of head trauma". Physical exam (general, head, eyes, cardiac and physiological) was performed and normal. Patient had neuro exam and if negative, will have cardiac evaluation. On 22-OCT-2009, the patient''s blood pressure was 126/64, temperature 92.3 and pulse 80. The patient did not have further episodes and doing fine. The patient''s past medical history, social history and family history unchanged and the impression was questionable seizure-like activity post GARDASIL. The patient had physical exam, general and psychological were performed and normal. Physician instructed patient not to receive third dose of GARDASIL. On 18-NOV-2009, the patient''s blood pressure was 118/80, temperature 98.0, pulse 68, RR 16 and SO2 95. At 11:55, the patient had an episode, the patient felt hot, appeared red in color with shaking and facial paralysis. The patient''s history of present illness: she remained upright, she did not collapse. Her last meal was at 07:00 am and she had a soft drink at 10:15. The patient had finger constructions, muscles still sore and had no new anxieties. At 12:08, the patient''s face flushed and did not space out. Regarding the past medical history, the social history and family history unchanged. The physical exam showed: GEN, alert and oriented and fatigue; eyes: pupil, ERRLA and psych: mood appropriate. Physician''s impression was "recurrent episode". Physician wanted an EEG and her labs checked. On 20-NOV-2009 the patient presented to the ER at 15:10. The history of present illness was described as chief complaint of seizure, single episode, witnessed by her classmates. The patient was sitting in class, had an aura then a questionable seizure. The patient had generalized motor activity and then fatigue as postictal symptom and did not have injury. The patient''s last menstrual period was on 01-NOV-2009. The patient had previous seizures as past medical history. The patient was treated with KEPPRA 500mg, oral, daily started 2 days ago. In the patient''s physical exam, general appearance, EENT, neck/back, respiratory, CVS, abdomen, skin, extremities and neuro/psychological were normal. The clinical impression was seizure-like activity with stable condition and disposition at home. Regarding the emergency department documentation, the patient arrived at 14:40, ESI level 3, arrived by ambulance and the chief complaint was new seizure. The patient''s temperature was 99.5, pulse 70, respiration 16, blood pressure 122/79 and weight 130 lbs. The assessment for airway, breathing, breath sounds, circulation, skin and disability were normal. The patient received a 20 gauge IV in the ambulance and her accucheck was 100 prior to arrival to the ER. The patient did not have chronic illness. The notes stated that at 14:45, the patient had seizure at school, had one last Wednesday, had seizure in September and the patient saw the physician on Wednesday. At 14:50, ambulatory to bathroom and was steady on feet. At 15:20, was instructed by the physician about medications. At 14:45, the patient''s eyes open evaluation was 4 in Glasgow coma scale, best verbal response was 5 and best motor response was 6. At 15:20, eyes open was 4, best verbal response was 5 and best motor response was 6. The patient was discharged to home in stable condition with the ER''s Clinical Impression of Seizure-like activity. Seizure activity was considered to be disability by the reporter. Additional information has been requested.


VAERS ID: 379853 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-02-28
Onset:2007-10-01
   Days after vaccination:215
Submitted: 2010-02-05
   Days after onset:858
Entered: 2010-02-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1213F / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 2 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2562AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Benign intracranial hypertension, Bronchitis, CSF pressure increased, Decreased activity, Headache, Lumbar puncture, Muscle twitching, Nausea, Paraesthesia, Rash, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown ``02/15/10 LABS and DIAGNOSTICS: Ct-normal, MRI-abnormal (abnormal clivus), LP-abnormal (elevated opening pressure), CSF cult-neg., Bone scan-normal (no abnormality or bony lesion of the clivus), Three-view cervical spine x-ray-normal (no evidence of instability), Venography MR of brain- neg (congenitally small L. transverse & sigmoid sinuses[normal variant], No evidence of thrombosis or occlusion of sinuses of brain), Thyroid antibody thyroid function test-normal, Iron studies-normal, Vit A- WNL, ANA-neg., .
CDC Split Type: WAES1001USA03372

Write-up: Information has been received from a health professional concerning her daughter an 18 year old female who in October 2007, was vaccinated with the first dose of GARDASIL (lot number not reported). There were no pertinent medical history and drug reactions/allergies. Concomitant therapy included RECOMBIVAX HB (unspecified). The healthcare worker reported that her daughter developed "stabbing head pain associated with a twitch" in approximately October 2007 about 2 weeks after she received her first dose of GARDASIL. The patient had been diagnosed with pseudotumor cerebri which limited her physical activity and she was hospitalized. The patient''s pseudotumor cerebri persisted. The patient underwent lumbar puncture to relieve fluid pressure. Multiple unspecified blood tests and diagnostic studies were performed with results not report. Pseudotumor cerebri was considered to be disabling, immediately life-threatening and an other important medical event by the healthcare worker. Follow up information was received from a healthcare professional who reported the patient was vaccinated with the first dose of GARDASIL on 28-FEB-2007, the second dose of GARDASIL on 15-OCT-2007, and the third dose of GARDASIL on 01-JUL-2008 (lot numbers not reported). Concomitant vaccine included MENACTRA received on 28-FEB-2007 and VAQTA (unspecified) received on 28-FEB-2007 and 15-OCT-2007 (lot number not reported). At the 28-FEB-2007 office visit, the patient had bronchitis. At the 15-OCT-2007 office visit, there was no mention of any adverse event. On 23-OCT-2007, the patient was seen for hives and ZYRTEC was given. On 30-OCT-2007, the patient complained of pins and needles all over, rash was gone. On 28-NOV-2007, the patient complained of blurred vision, and a neuro consult was directed. In November and December 2007, the patient was admitted to the hospital (no other details available). In November 2008, the patient was admitted for nausea, vomiting and headache (no other details). On 05-JUN-2009, the patient was last seen in their office. Additional information has been requested.


VAERS ID: 381241 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2009-01-09
Onset:2009-02-15
   Days after vaccination:37
Submitted: 2010-02-24
   Days after onset:374
Entered: 2010-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 6050X / 1 LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Arthralgia, Rheumatoid arthritis
SMQs:, Arthritis (narrow)

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

Write-up: Started having joint pains that have steady and progressively gotten worse. She is now currently being seen by a Rheumatologist at Hospital and being treated for Rheumatoid arthritis symptoms, although she is not actually diagnosed with the disease as yet.


VAERS ID: 390807 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-07-30
Onset:2009-07-30
   Days after vaccination:0
Submitted: 2010-06-14
   Days after onset:319
Entered: 2010-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0558X / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Blindness transient, Blood test, Computerised tomogram, Convulsion, Dizziness, Electrocardiogram, Electroencephalogram, Fatigue, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Ovarian cyst, Paraesthesia, Paralysis, Postural orthostatic tachycardia syndrome, Syncope, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: EKG; video EEG; CAT scan; urinalysis; MRI; MRA; multiple blood work-ups
CDC Split Type:

Write-up: My formerly healthy 15 yr. old daughter received her one and only dose of the GARDASIL vaccine on July 30, 2009. Since then, she has been plagued with headaches, fatigue, dizziness, numbness and tingling of the legs and feet, non-epileptic seizures, temporary paralysis/blindness, fainting, ovarian cysts, etc. She was hospitalised once and has been to the ER 5 times. She missed nearly the entire school year due to her adverse reaction to the vaccination. She has been evaluation by a psychologist and a psychiatrist both of whom state she is psychologically healthy and well-adjusted. She was recently diagnosed with POTS by a cardiologist. She is on numerous medications and cannot be left alone. I have since learned that there are thousands of other girls experiencing the same thing. If it''s not the vaccine, what is it? Please take this vaccine off the market for further study before more innocent lives are compromised.


VAERS ID: 396220 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-03-23
Onset:2010-08-08
   Days after vaccination:503
Submitted: 2010-08-20
   Days after onset:12
Entered: 2010-08-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0651X / 1 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Anxiety, Aphasia, Arrhythmia, Asthenia, Cerebrovascular accident, Chest pain, Chorea, Convulsion, Electrocardiogram abnormal, Fatigue, Headache, Immunoglobulin therapy, Lethargy, Lupus-like syndrome, Memory impairment, Myalgia, Nausea, Nervous system disorder, Pyrexia, Renal disorder, Syncope, Systemic lupus erythematosus, Tremor, Vasculitis cerebral
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), 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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Electrocardiogram, 06/??/10, arrhythmias
CDC Split Type: WAES1008USA01851

Write-up: Information has been received from a physician concerning her 15 year old daughter with no pertinent medical history or drug allergies who in September 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). No concomitant medications were reported. It was reported that in September 2009, very soon after the injection of GARDASIL, the patient developed fatigue and nausea. When the patient was on leaving the physician''s office she experienced syncope. The patient began having symptoms of high fever, headache and sore muscles. The patient was lethargic for months after she received GARDASIL. In June 2010 the patient had chest pain and went to the Emergency Room where she was diagnosed with anxiety. The EKG showed arrhythmias. The patient became weak and had to quit the Track Team at school. In June 2010 the patient was tired and lethargic and began to forget things. Approximately three weeks ago, in approximately August 2010, the patient developed a tremor in her left hand and she was unable to speak. The patient developed chronic seizures with chorea. On 08-AUG-2010 the patient was admitted to hospital. On 15-AUG-2010 the patient developed a stroke and was non verbal. The patient was diagnosed with drug induced systemic lupus erythematous with chorea. It was reported that there was central nervous system (CNS) involvement and the patient had vasculitis of the brain. The physician did not report what type of diagnostic testing the patient had received. The patient was being treated with ten different medications reported as follows: intravenous immune globulin (IVIG), antibiotics, anti hypertensive medications due to kidney involvement and high doses of IV prednisone. The physician stated that today, on 17-AUG-2010, the patient was to begin chemotherapy with IV cytotoxin for a duration of 24 hours. Currently, the patient had her voice back and was able to move all of her extremities except the left arm. As of 16-AUG-2010 the patient had not recovered from drug induced systemic lupus erythematosus with chorea, anxiety and arrhythmias. The patient was presently in hospital. The reporter felt that drug induced systemic lupus erythematosus with chorea was related to therapy with GARDASIL. Drug induced systemic lupus erythematosus with chorea, anxiety and arrhythmias were considered to be disabling, another important medical event and immediately life-threatening. Additional information has been requested.


VAERS ID: 398110 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-07-15
Onset:2009-07-15
   Days after vaccination:0
Submitted: 2010-08-04
   Days after onset:385
Entered: 2010-09-08
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Condition aggravated, Eczema, Fatigue
SMQs:, Dementia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Eczema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA02568

Write-up: Information has been received from a pharmacist concerning a 15 year old female with eczema who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL. On 15-JUL-2009 the patient experienced extreme fatigue and an exacerbation of pre existing eczema after her first dose. The patient sought medical attention. Severe fatigue was considered to cause a disability because the patient could not get out of bed. At the report time the patient had not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.


VAERS ID: 405873 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-06-22
Onset:2008-07-23
   Days after vaccination:397
Submitted: 2010-10-28
   Days after onset:827
Entered: 2010-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0319U / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2296AA / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Rash pruritic, Type 1 diabetes mellitus
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: 2 Hospitals diagnosed with Diabetes Type 1.
CDC Split Type:

Write-up: Had strange itchy rash months before diagnosis, doctors recommended taking Claritan, did not diagnose. Also had DM Type 1 symptoms months before diagnosis.


VAERS ID: 415253 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-01-21
Entered: 2011-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA01378

Write-up: Information has been received from a physician concerning a 15 year old female patient he heard about (it was unknown if this was a patient of a clinical colleague or an acquaintance of him), that "was healthy as a horse" who on an unspecified date was vaccinated with GARDASIL (it is unknown which dose this was in the series). The physician reported that "within two weeks of administration of the vaccine she is in the hospital with seizures and is a picture of death". At the time of the report, the patient had not recovered. The patient''s symptoms were considered to be disabling and immediately life-threatening by the physician. No further information is available.


VAERS ID: 425246 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-05-26
Onset:2011-05-26
   Days after vaccination:0
Submitted: 2011-06-10
   Days after onset:15
Entered: 2011-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0180AA / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Dyspnoea, Feeling abnormal, Headache
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1106USA00881

Write-up: Information has been received from a certified medical assistant concerning a 15 year old female patient with no pertinent medical history and no drug reactions or allergies who on 26-MAY-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL in her right arm (lot # 667878/0180AA, expiration: 08-MAR-2013). There was no concomitant medication or vaccines administered on 26-May-2011. The certified medical assistant reported that on 26-MAY-2011 ("the same day") the patient began to experience shortness of breath, which the patient described as "she walked a few steps and she could not catch her breath". The patient was a dancer who normally danced 4 times per week, she had been unable to dance or perform daily activities due to the shortness of breath. The dyspnea was not improving and shortness of breath was reported as "severe". The certified medical assistant also reported a constant headache, and just an overall feeling of being "off". No treatment was given for the adverse events and no lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. The patient was referred to her primary physician for follow-up. The reporter considered the events to be disabling as the patient was having difficulties with her activities and routines. Additional information has been requested.


VAERS ID: 425342 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-03-17
Onset:2008-03-18
   Days after vaccination:1
Submitted: 2011-06-13
   Days after onset:1182
Entered: 2011-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1446N / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Paralysis, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1106USA00358

Write-up: Information has been received from a nurse, concerning her daughter, a 17 year old female (relevant medical history unspecified), who in 2010 ("last year") was vaccinated with the second dose of GARDASIL (lot #, route and injection site not reported). There were no other vaccinations or concomitant medications at the same visit. In 2010, the day after the vaccination, the patient became paralyzed from the waist down and lost feeling in her legs. She was taken to the Emergency Room (hospital unknown). She was not admitted and 3-5 days later she recovered. Vaccination with GARDASIL was discontinued after the second dose. Paralyzed from the waist down and lost feeling in legs was considered to be significant disability or incapacity by the reporter. Additional information has been requested.


VAERS ID: 437141 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-08-25
Onset:2011-09-01
   Days after vaccination:7
Submitted: 2011-10-06
   Days after onset:35
Entered: 2011-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0841AA / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Asthenia, Blood test normal, Chest pain, Computerised tomogram normal, Convulsion, Dyskinesia, Dyspnoea, Dysstasia, Grip strength decreased, Head titubation, Laboratory test normal, Nuclear magnetic resonance imaging normal, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (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 symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypersensitivity; Heavy periods
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory, 09/??/11, blood work normal; computed axial, 09/26/11, negative; magnetic resonance, 09/26/11, negative
CDC Split Type: WAES1109USA03241

Write-up: Information has been received from a consumer (patient''s mother) and the physician concerning a 15 year old female patient with allergy to BENADRYL, with heavy menses and no medical history who on 25-AUG-2011 (not 16 or 17 days prior to 28-SEP-2011 as reported by consumer), was vaccinated with the first dose of GARDASIL (lot number: 668262/0841AA, route not reported). There was no concomitant medication. Consumer reported that one week after her daughter was vaccinated, she experienced shortness of breath and 14 days after vaccination, she also started to experience "seizures" every 45 minutes. Consumer described the seizures as, "she jumps up and down and her chest hurts". Consumer reported that the seizures lasted for 30 seconds. Consumer also reported that while her daughter was sleeping, she experienced tremors in the legs, arms and head, and that in addition to the seizures, her daughter also felt weak, and she could "barely stand up or hold a pencil". Consumer and the physician reported that the patient went to two different emergency rooms before seeing the reporting physician, and, "the bloodwork is all normal". Physician reported that the patient did not receive any treatment for the adverse events. On 26-SEP-2011, the patient was seen by the reporting physician for the events and it was reported that the physician saw no seizure activity but could confirm tremors and weakness. A computed axial tomography (CT) and magnetic resonance imaging (MRI) were negative. The patient was referred to a pediatric neurologist. Consumer reported that her daughter had an appointment today to see a pediatric neurologist. The reporting physician could not address the life threatening criterion, but did not feel the events were disabling. No inpatient hospital confinement. The physician reported that, the patient had not recovered. Additional information has been requested.


VAERS ID: 443714 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-01-20
Onset:2011-03-01
   Days after vaccination:40
Submitted: 2011-11-28
   Days after onset:272
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0664Z / 1 UN / UN

Administered by: Unknown       Purchased by: Military
Symptoms: Amenorrhoea, Smear cervix, Ultrasound scan
SMQs:, Fertility disorders (broad)

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

Write-up: My daughter was given the Gardasil shot this year, she has stopped her period completely and has not recovered it. She had the last shot in October of 2011 and still no period so I got concerned and took her two different Dr.''s. My daughter has has two ultrasounds and a pap smear to see what is going on. I have her going to an actual OB/GYN and having her seen and see if there is a way to force her period other than medicines, we already have tried that. My daughter had healthy periods and was regular till she received the shot and I am upset and concerned because it wasn''t written as a side affect. I have did research online and my daughter is not the only one, there are a number of females that has experienced the same thing and are also concerned.


VAERS ID: 443777 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-11-17
Onset:2011-11-17
   Days after vaccination:0
Submitted: 2011-11-28
   Days after onset:11
Entered: 2011-11-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1317AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Chest pain, Dizziness, Drug screen, Electrocardiogram normal, Fatigue, Hyperhidrosis, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Blood pressure, 11/18/11, 138/8; diagnostic laboratory, 11/18/11, Blood test: Normal; chest X-ray, 11/18/11, CxR Normal; electrocardiogram, 11/18/11, Normal; blood pressure, 120/8
CDC Split Type: WAES1111USA02846

Write-up: Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies who on 19-JAN-2010, was vaccinated with a first dose of GARDASIL (lot number not reported), on 08-APR-2010 was vaccinated with a second dose of GARDASIL (lot number not reported) and on 17-NOV-2011 was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL (669795/1317AA, expiration date 13-OCT-2013). There was no concomitant medication. The physician reported that on 17-NOV-2011 the patient felt well after receiving the third dose until late in the evening 8 hours after vaccine administration the patient experienced syncope, dizziness, weakness, shakiness and chest pain. The patient was seen in the office the following day (on 18-NOV-2011) her blood pressure was 138/80 and was sweaty. The patient was sent to the emergency room where work up (blood tests, Chest X-Ray (CxR), Electrocardiogram (EKG)) were performed and all normal, urine drug screen was also performed (results not provided). The patient continued to feel tired dizzy and had a noticeable tremor of the right hand (BP 120/80). The physician inquired about recommendations regarding treatment for syncope, dizziness, weakness, shakiness and chest pain related to the third dose of GARDASIL given to the patient. At the time of the report the patient''s events persisted. No treatment was given for the events. A neurology consult was being request. Syncope, dizziness, shakiness, weakness and chest pain were considered to be disabling by the physician. Additional information has been requested.


VAERS ID: 449831 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-11-15
Onset:2011-12-30
   Days after vaccination:45
Submitted: 2012-02-13
   Days after onset:45
Entered: 2012-02-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0692AA / 1 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 454508 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Vermont  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-26
Entered: 2012-04-27
   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: Activities of daily living impaired, Amnesia, Conversion disorder, Convulsion, Headache, Injury, Loss of consciousness, Musculoskeletal chest pain, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (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), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Magnetic resonance, Brain: Conversion
CDC Split Type: WAES1204USA02620

Write-up: Information has been received from a consumer concerning currently 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot # and route not reported) 0.5 ml. There was no concomitant medication. Consumer reported that on an unspecified date, minutes after getting her second GARDASIL dose, the patient had a seizure and was taken to the emergency room (ER) of an unspecified hospital. They did a magnetic resonance imaging (MRI) of her brain and the diagnosis was a conversion, which was a misfiring of the electrons in her brain due to traumatic bodily injury. Since this happened, she had had headaches, passed out all the time. she had tingling in her hands and feet, blurry vision, pain in her rib area, and a loss of memory of the last three years. She went to an unspecified neurologist, who could not pin it to the vaccine. She had missed 55 days of school since the event started. The patient''s mother said that physician dismissed the idea that it was due to the vaccine, so she switched to an unspecified doctor in the same practice. The consumer had been to the emergency room (ER) multiple times. It was reported that the events occurred after reintroduction. It was also reported that these events were a significant disability. It was not know if the days of school the consumer missed were consecutive and if the patient was ever admitted to the hospital. At the time of the report, the patient''s outcome was unknown. Therapy with GARDASIL was discontinued after the events happened. Additional information has been requested.


VAERS ID: 458325 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2011-12-01
Onset:2011-12-01
   Days after vaccination:0
Submitted: 2012-06-27
   Days after onset:208
Entered: 2012-06-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Vascular test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Vascular evaluation, negative for thrombus
CDC Split Type: WAES1206USA03632

Write-up: Information has been received from a physician (neurologist) concerning a 15 year old female patient with no drug reactions or allergies and no pertinent medical history who in December 2011, was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular in the left deltoid (lot number not reported). There was no concomitant medication. The physician was reporting the patient was referred to her by primary care physician for evaluation on 20-JUN-2012 of persistent left arm paresthesia and muscle weakness following the first dose of GARDASIL in December 2011. The left arm pain diminished after 1 week, but muscle weakness, especially involving the pronator and supinator muscles and paresthesia had persisted. Therapy with GARDASIL was discontinued. There was no treatment given for persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and the left arm pain. At the time of the report the patient''s outcome was recovering. Vascular studies were performed on an unknown date, with a result of negative for thrombus. The patient sought medical attention via office visit. Therapy with GARDASIL was not reintroduced. Persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and left arm pain were considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 503294 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-08-14
Onset:2007-08-14
   Days after vaccination:0
Submitted: 2013-09-15
   Days after onset:2224
Entered: 2013-09-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 1 AR / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2183AA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abasia, Abdominal distension, Abdominal pain upper, Abnormal loss of weight, Activities of daily living impaired, Alopecia, Anxiety, Arthralgia, Autism, Back pain, Bladder disorder, Blindness, Blindness unilateral, Blister, Blood test, Bone pain, Chest pain, Chronic fatigue syndrome, Coccydynia, Computerised tomogram, Constipation, Convulsion, Deafness, Decreased appetite, Depression, Diarrhoea, Dizziness, Dysarthria, Dyslexia, Dyspnoea, Electroencephalogram, Erythema, Fatigue, Feeling abnormal, Feeling of body temperature change, Functional gastrointestinal disorder, Hallucination, Headache, Hemiplegia, Hepatomegaly, Hyperacusis, Influenza like illness, Injection site pain, Injection site pruritus, Laboratory test, Local swelling, Lumbar puncture, Migraine, Multiple chemical sensitivity, Muscle spasms, Muscle tightness, Muscle twitching, Myalgia, Nausea, Neoplasm, Neuralgia, Nuclear magnetic resonance imaging, Oedema, Oropharyngeal pain, Pallor, Panic attack, Paraesthesia, Parosmia, Personality change, Photophobia, Pneumonia, Pruritus, Pyrexia, Rash, Renal disorder, Sleep disorder, Swelling, Syncope, Temperature intolerance, Thrombosis, Tooth disorder, Tremor, Tumour excision, Urinary incontinence, Urinary tract infection, Uterine spasm, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EEG''s; Numerous testing. Blood work, MRI''s, CAT scans, lumbar punctures.
CDC Split Type:

Write-up: August 14, 2007 - lot # 0384U - afternoon shot injection site itchy, sore. Flu like symptoms. Sore joints and muscles in the months to follow. Exhaustion. Dr.''s office said the symptoms were normal. November 14, 2007 - lot # 0927U - afternoon shot. Injection site more itchy, sore, red, swelling. Flu like symptoms for days. Sore joints and muscles, headaches, hair loss, exhaustion. Dr. office was not worried about symptoms. February 14, 2008 - lot # 12APR10 - vomiting, shaking, feverish, itchy/sore injection site, redness, swelling entire arm. Sore joints, muscles, fatigue, hair loss (more) migraine, home from school 1 1/2 wks flu like symptoms. Many, many, many Dr. visits, hospitalization ER visits until October 2009 when she became paralyzed on right side, loss of vision, hearing loss. Stay for couple weeks, home recovery. Learned to walk again. Repeat of above January 2011. Week stay. Hospitalization for seizures (4 days). Medical diagnoses: Perfectly healthy until GARDASIL now suffers daily from: Leaky Gut Syndrome, pins/needles in extremities, dizziness, dental issues, brain fog, sensitivities to chemicals, chest pains, constipation/diarrhea, enlarged liver, sound sensitivity, anxiety, extreme pain tailbone, fainting, fevers and blisters, back pain, hot/cold intolerance, sleep problems, itching, joint pain, knee pain, light sensitivity, blindness (right side), depression, personality changes, panic attacks, loss of bladder control, bladder issues, muscle aches, spasms, muscle tension tumor in left tibia, paleness, chronic fatigue syndrome paralysis, pneumonia, severe nerve pain, shortness of breath, slurred speech, smell sensitivity, sore throat stomach pain, swelling/edema, tremors, random twitching of extremities, bloating, uterine spasms, blood clotting, numerous UTI''s, kidney problems, vision loss, stomach aches, nausea, rashes, appetite loss, vomiting, dyslexia, hallucinations, large weight loss, seizures, autistic behaviors. Tumor removed December 2010.


VAERS ID: 503396 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: California  
Vaccinated:2012-06-21
Onset:2012-06-26
   Days after vaccination:5
Submitted: 2013-09-21
   Days after onset:452
Entered: 2013-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1696AA / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electroencephalogram abnormal, Hemiparesis, Ischaemic stroke, Nuclear magnetic resonance imaging brain abnormal, Ventricular arrhythmia
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness: No
Preexisting Conditions: Diabetes, toe walker
Allergies:
Diagnostic Lab Data: Echo Cardio gram showing LV noncompaction cardiomyopathy; MRI of brain showing stroke right ischemic stroke; EEG showing ventricular arrthymias; He was transferred to another hospital
CDC Split Type:

Write-up: I do not know the time of the incident. But he presented to ER with left sided weakness. He was found to have had a stroke and to have LV noncompaction cardiomyopathy.


VAERS ID: 517633 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-07-26
Onset:2013-08-01
   Days after vaccination:6
Submitted: 2013-12-24
   Days after onset:145
Entered: 2013-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020692 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Balance disorder, Dizziness, Dysstasia, Gait disturbance, Headache, Nausea, Palpitations
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA009931

Write-up: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Patient was not pregnant. The patient had no pertinent medical history. Drug reactions/allergies were none. On 26-JUL-2013 the patient was vaccinated with GARDASIL, intramuscular (dose, dosage, lot not reported). Concomitant therapies included YAZ. On an unknown date of August-2013 the patient experienced headache, nausea, heart palpitations, dizziness and trouble with balance after receiving the vaccine. The patient has had difficulty standing (disability) and trouble walking (disability) and because of this has been out of school for 2 months. The patient saw the physician and sought medical attention. It was also reported that the patient will not continue with the series. The outcomes of the reported events were unknown at the time of the report. The events difficulty standing and trouble walking were considered to be serious due to disability. Additional information has been requested.


VAERS ID: 519290 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-10-19
Onset:2011-10-23
   Days after vaccination:4
Submitted: 2014-01-14
   Days after onset:814
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0476AA / 2 LA / SYR

Administered by: Public       Purchased by: Other
Symptoms: Abdominal pain upper, Asthenia, Back pain, Biopsy, Blood test, Dizziness, Dyspepsia, Endoscopy gastrointestinal, Fatigue, Headache, Hyperacusis, Hypersomnia, Muscle spasms, Nausea, Pain in extremity, Photophobia, Protein urine present, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Pills; Birth Control Patch-1 day; Birth Control Shot
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: 2 biopsies; GI scope; many blood tests; urine test-protein in urine
CDC Split Type:

Write-up: Nausea, vomiting, muscle spasms, excruciating headaches, fatigue, sleeping 20 hours per day, back and leg pain, sensitivity to light and sound, weakness, stomach cramps, lightheadedness, digestive issues.


VAERS ID: 526286 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-01-18
Onset:2013-06-01
   Days after vaccination:865
Submitted: 2014-03-20
   Days after onset:292
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0096Z / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Lupus-like syndrome, Wheelchair user
SMQs:, Systemic lupus erythematosus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA008798

Write-up: This spontaneous report as received from a physician via a field employee refers to a female teenager of unknown age. In June 2013 (9 months ago) the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose unspecified). The representative did not know which dose in the GARDASIL series the patient received "9 months ago". In June 2013 (9 months ago) the patient developed lupus-like symptoms and the patient was "basically wheel-chair bound". The field employee did not know any other details of the patient''s condition beyond the fact that the patient had not received a confirmed diagnosis. The patient had sought medical attention. The event outcome was reported as not recovered/not resolved. The reporter considered the event to be disability. Additional information has been requested.


VAERS ID: 528923 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New York  
Vaccinated:2011-03-08
Onset:2011-03-20
   Days after vaccination:12
Submitted: 2014-04-14
   Days after onset:1121
Entered: 2014-04-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0664Z / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal discomfort, Computerised tomogram head normal, Delusional perception, Drug screen negative, Electroencephalogram normal, Hallucination, Headache, Immediate post-injection reaction, Psychotic disorder, Pyrexia, Staring, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: EEG, CAT scan of brain, Street Drug Tested - negative
CDC Split Type:

Write-up: Immediate upset stomach, headache, fever - eleven days later - vomiting, hallucinating and delusional, 6 hour vertical blank stare, loss of faculties - full psychotic break. 4 wk. hospitalized and again 6 months later.


VAERS ID: 536399 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2014-07-07
Onset:2014-07-09
   Days after vaccination:2
Submitted: 2014-07-11
   Days after onset:2
Entered: 2014-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blindness unilateral, Echocardiogram abnormal, Ophthalmological examination abnormal, Pupil dilation procedure, Pupillary reflex impaired, Retinal artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine and Risperidone
Current Illness: Major Depression
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Patient was diagnosed with occlusion/thrombosis of retinal artery. He has been evaluated for stroke/hypercoaguability. Results are pending. Cardiac echo revealed minimal right to left shunting making thromboembolic event possible etiology.
CDC Split Type:

Write-up: Patient presented to the Emergency Room with acute onset of unilateral vision loss. Exam notable for absent pupillary reflex. Was transferred to an eye specialist. Dilated eye exam was suspicious for thrombosis of retinal artery.


VAERS ID: 541913 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-01
Entered: 2014-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA016371

Write-up: This spontaneous report was received from a physician via company representative refers to a 15 year old female patient. There was not pertinent medical history. On an unknown date the patient was vaccinated with the second dose of GARDASIL injection, 1 single shot, (lot number, expiration date, route and dosage were not reported). Concomitant therapy was not reported. The physician informed that on an unknown date within a month of receiving the second dose of GARDASIL the patient began experiencing severe shoulder pain. No adverse effects were reported with the first dose. The patient needed physical therapy as treatment for the adverse event, a magnetic resonance imaging (MRI) was performed as diagnostic study. The patient sought an unspecified medical attention for the adverse event. The reporter determined that the shoulder pain was significant disability or incapacity. Additional information has been requested.


VAERS ID: 546267 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2006-07-01
Onset:2006-07-01
   Days after vaccination:0
Submitted: 2014-10-02
   Days after onset:3015
Entered: 2014-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Abdominal pain upper, Appendicectomy, Attention deficit/hyperactivity disorder, Bladder scan, Cognitive disorder, Computerised tomogram, Cystitis interstitial, Emotional disorder, Food intolerance, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache, Hyperacusis, Hypotension, Laboratory test, Menstrual disorder, Mental impairment, Migraine, Nuclear magnetic resonance imaging, Ovarian cyst, Parosmia, Photophobia, Sleep disorder, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: Dizziness, felt like she was going to faint.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: MRIs; CT scans; ultrasound; lab work; bladder testing.
CDC Split Type:

Write-up: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.


VAERS ID: 558292 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2013-06-06
Onset:2013-08-01
   Days after vaccination:56
Submitted: 2014-12-16
   Days after onset:502
Entered: 2014-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021346 / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Bone scan, Nerve conduction studies, Nuclear magnetic resonance imaging, Organ failure, Pain, Ultrasound Doppler, Venogram, X-ray
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: Nerve Conduction Tests, Blood drawn numerous times, Bone Scan, Vein studies, Doppler scans, x-rays, MRIs
CDC Split Type:

Write-up: Patient began complaining of aches and pains. They were unexplained and no injury found. By the September the pain became too much and her body began to shut down.


VAERS ID: 566379 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Rhode Island  
Vaccinated:2013-08-21
Onset:2013-12-11
   Days after vaccination:112
Submitted: 2015-02-21
   Days after onset:437
Entered: 2015-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015555 / 3 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Confusional state, Convulsion, Dysarthria, Electroencephalogram, Epilepsy, Eye movement disorder, Fall, Gait disturbance, Head banging, Laboratory test, Nuclear magnetic resonance imaging, Speech disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to amoxil
Allergies:
Diagnostic Lab Data: Was diagnosed with Epilepsy by his Neurologist after bloodwork, EEG, MRI and other tests
CDC Split Type:

Write-up: Walking around, stumbling, mumbling, banging his head on a cabinet, falling over, eyes moving all over, slurred speak and then confusion. It lasted about 15 minutes and was considered a seizure in January 2014 following an ER visit due to a seizure.


VAERS ID: 567659 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2012-10-24
Onset:2013-02-09
   Days after vaccination:108
Submitted: 2015-03-02
   Days after onset:751
Entered: 2015-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013831 / 2 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Anal haemorrhage, Anal ulcer, Surgery
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Patient has had four surgeries to close the ulcer located near his anus. All have been unsucessful.
CDC Split Type:

Write-up: Went to have bowel movement and started bleeding profusely from anal area. No prior symptoms.


VAERS ID: 579217 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2009-08-13
Onset:2009-08-13
   Days after vaccination:0
Submitted: 2015-05-23
   Days after onset:2109
Entered: 2015-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0294Y / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test normal, Borrelia test negative, Complex regional pain syndrome, Deep brain stimulation, Dystonia, Fatigue, Fibromyalgia, Gait disturbance, Malaise, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain, Seizure like phenomena, Tic, Tourette's disorder, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Dyskinesia (broad), Dystonia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Aspergers Syndrome, Endometriosis, seasonal allergies, peanut allergy
Allergies:
Diagnostic Lab Data: Bloodwork to test for Lyme, MS, lupus, arthritis...all negative; MRI for lesions...negative; medications didn''t help; deep brain stimulation; wheelchair
CDC Split Type:

Write-up: After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice. An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can''t walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.


VAERS ID: 590336 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2013-06-25
Onset:2015-06-09
   Days after vaccination:714
Submitted: 2015-08-17
   Days after onset:69
Entered: 2015-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010668 / 3 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Dizziness, Electrocardiogram, Electroencephalogram, Moaning, Tachycardia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Birth Control Tripreverin
Current Illness: None
Preexisting Conditions: Yes. She was diagnosed with amplified pain syndrome in March of 2013. Pains in legs, foggy feeling, weakness. June 2016 Diagnosed with POTS.
Allergies:
Diagnostic Lab Data: EEG in hospital; EKG
CDC Split Type:

Write-up: Light headed, moaning weakness, trembling, tachycardia.


VAERS ID: 607813 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-10-12
Onset:2012-08-04
   Days after vaccination:297
Submitted: 2015-11-05
   Days after onset:1188
Entered: 2015-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Cardiac stress test normal, Dizziness, Echocardiogram, Electrocardiogram ambulatory, Electrocardiogram normal, Electroencephalogram normal, Epilepsy, Eye movement disorder, Hypotension, Impaired driving ability, Inappropriate schedule of drug administration, Loss of consciousness, Major depression, Moaning, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Pallor, Postictal state, Presyncope, Suicidal ideation, Syncope, Tilt table test, Tinnitus, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Reaction to food additive
Preexisting Conditions: Tonsillectomy
Allergies:
Diagnostic Lab Data: The patient had had 5 multi-day video electroencephalograph (EEG) sleep deprived assessments. These were all "normal". They placed him on anticonvulsant (as empirical therapy) but he is still having breakthrough events. One event was caught while the patient was wearing an electrocardiograph (ECG) Halter; his heart rate was 50 beats per minutes when it occurred but there was no evidence of serious erythema, or of vagal slowing. He had a magnetic resonance imaging (MRI) head up tilt table test, an Echocardiogram and a take-home ECG halter. The patient was also an emergency medical technician (EMT) and tracked his own blood pressure. His blood pressure was very low. He currently had a 24 hour blood pressure cuff on a halter. He had a stress today that came up "normal". They plan on running antibody assays with a rheumatologist. 10/12/2015, Blood pressure diastolic, 38; 10/10/2015, Blood pressure measure, 97 over 42; 10/10/2015, Heart rate, 52 bpm
CDC Split Type: WAES1511USA001865

Write-up: Information has been received from a father referring to his 15 year old male son. The patient had allergy to monosodium glutamate (MSG). The father noted that the patient was "normal before the shot". His medical history prior to the shot was clean and there was no history of epilepsy on either side of the family. He had no issues at birth and the only noteworthy event during his childhood was an uneventful tonsillectomy. On 12-OCT-2011, 26-OCT-2012 and 26-SEP-2013, the patient was vaccinated with the first, second and third dose of GARDASIL (1 dose, route: injection) in the deltoid separately. Lot numbers were reported as 1860AA, 0636AA and H011350 (unsure if lot numbers were provided in dose order). On 04-AUG-2012, the patient was found unconscious on the laundry room floor and seemed stiff and postictal. Then on the same day, the patient was hospitalized. However, the first observed occurrence for his loss of consciousness happened in March 2013. On 08-MAR-2013, the patient was admitted for the emergency room. The patient had experienced multiple adverse experiences after completing therapy with GARDASIL including relapsing syncope with reoccurring tonic clonic movements. Description of the Syncope events: Each event followed the same template. The patient heard a gradual increase in roaring in his ears. He became lightheaded and pallor developed in his face. This "pre-syncope period" lasted for about 15 seconds. During the Syncope phase, his eyes roll upwards and he experienced tonic clonic movements for about 20-30 seconds. There was some vocalization (groaning). These events reoccurred on about a monthly basis over the last three years. He could recognize when an event will occur and can reverse the pending effect by lying down and bicycling his feet in the air. He had experienced these events while sleeping, while awake, while defecating, and one occurred after the patient moved from a sauna to take a shower. He has had two events at a hall cafeteria while ingesting a meal. Sleep deprivation seemed to make him more susceptible. All events occurred while he in a sedentary state and most events occurred in the late evening to early morning. On unknown dates, the patient also experienced, major depression and suicidal ideation. Cardiovascular adverse experience included hypotension. The patient had been "effectively diagnosed with epilepsy" and was "on anti-consultants empirically". These issues had caused major lifestyle complications which included restrictions on driving, swimming, bathing and the implied diagnosis of epilepsy was a major concern for the family. The patient had also admitted to the emergency room on 22-APR-2013, 28-MAR-2014 and 12-JAN-2015. The patient had had 5 multi-day video electroencephalograph (EEG) sleep deprived assessments. These were all "normal". They placed him on anticonvulsant (as empirical therapy) but he is still having breakthrough events. One event was caught while the patient was wearing an electrocardiograph (ECG) Halter; his heart rate was 50 beats per minutes when it occurred but there was no evidence of serious erythema, or of vagal slowing. He had a magnetic resonance imaging (MRI) head up tilt table test, an Echocardiogram and a take-home ECG halter. The patient was also an emergency medical technician (EMT) and tracked his own blood pressure. His blood pressure was very low. On Saturday 10-OCT-2015, the father measured his blood pressure at "97 over 42" and "his heart-rate was 52 beats per minute". He measured a diastolic blood pressure of 38 when he "woke up on 12-OCT-2015". He currently had a 24 hour blood pressure cuff on a halter. He had a stress on reporting day that came up "normal". They plan on running antibody assays with a rheumatologist. The outcome of events was reported as not recovered/not resolved. Upon internal review, suicidal ideation and epilepsy were considered to be medically significant. Additional information has been requested.


VAERS ID: 629804 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2013-07-22
Onset:2013-07-24
   Days after vaccination:2
Submitted: 2016-03-29
   Days after onset:979
Entered: 2016-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Amenorrhoea, Anti-Muellerian hormone level, Autonomic nervous system imbalance, Contusion, Dizziness, Fatigue, Headache, Hypoaesthesia, Menstrual disorder, Muscle spasms, Mydriasis, Pain, Pallor, Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: giant urticaria, petechiae, epistaxis, achiness, malaise, fatigue~Varicella (Varivax)~2~10.83~Patient|fatigue, achiness, develop
Other Medications: fexofenedene for seasonal allergies and reactions to insect stings/bites Sibling received the IPV and DTaP in separate injections. He also experienced previous and subsequent vaccine reactions but my session is about to time out.
Current Illness: No known illness at the time of the vaccination.
Preexisting Conditions: Seasonal allergies, possible hyper mobility, previous immediate vaccine reaction to varicella booster(giant urticaria followed by petechiae, nose bleeds, fatigue and achiness lasting for months)
Allergies:
Diagnostic Lab Data: AMH levels and tilt table testing and full assessment available upon request.
CDC Split Type:

Write-up: Increased bruising noted. 8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods. Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs. 9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue. Menstrual period very very light, again. 10/23/2013 HPV #2 given. 11/2013 amenorrhea. Began to notice periods of facial and extremity duskiness and pallor along with above symptoms. Numbness and tingling also noted. 12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman. Amenorrhea continues along with other symptoms. 6 through 8/2014 diagnosed with POTS/Dysautonomia.


VAERS ID: 631572 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-02
Entered: 2016-04-14
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Nonspecific reaction, Personality change
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXPLANON; TOPAX; XANAFLEX; IMITREX; BOTOX injections in forehead and neck; gabapentin; GEODON; ZOFRAN; trazodone; LAMICTAL; daily vitamin; magnesium; MOTRIN; APAP; ZANTAC; PEPCID AC
Current Illness:
Preexisting Conditions: Migraines. Possible Schizoaffective disorder, anxiety, depression, fibromyalgia, herniated discs lower spine, chronic back pain, hyperlypasemia. No known allergies. Had none of these health issues or problems prior to the GARDASIL series. I wish I never allowed the vaccinations to be given. I believe this series of vaccinations has greatly contributed to my daughter''s health issues.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter has had several odd and unusual health issues since having these vaccinations. She was an otherwise healthy and happy child prior to this. She has had a complete turn around in personality and numerous health issues of unknown origin. I can only attribute many of these to this vaccine.


VAERS ID: 632624 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Washington  
Vaccinated:2015-06-25
Onset:2015-06-25
   Days after vaccination:0
Submitted: 2016-04-23
   Days after onset:303
Entered: 2016-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006960 / 1 UN / SYR

Administered by: Private       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Dizziness, Fatigue, Headache, Malaise, Muscular weakness, Nausea, Pain in extremity, Vomiting, X-ray, X-ray with contrast upper gastrointestinal tract
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Omeprazole
Current Illness: Yearly physical
Preexisting Conditions: Ulcer
Allergies:
Diagnostic Lab Data: X-rays, upper GI, blood work
CDC Split Type:

Write-up: Vomting, joints hurt, frequent headaches, general feeling of unwell, feeling dizzy, painful hands, feet, arms, legs, nausea, muscle weakness, tiredness, missing more school from not feeling good.


VAERS ID: 650279 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: New York  
Vaccinated:2015-07-20
Onset:2015-10-31
   Days after vaccination:103
Submitted: 2016-08-31
   Days after onset:305
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. L009445 / UNK LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K016966 / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal distension, Abdominal pain, Colitis ulcerative, Colonoscopy, Culture stool, Enema administration, Full blood count, Laboratory test, Nuclear magnetic resonance imaging abdominal, Rectal discharge, Rectal haemorrhage, Stool analysis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Colonoscopy, MRI of abdomen, stool analysis and culture, CBC, GI analysis
CDC Split Type:

Write-up: Blood and mucus from rectum, abdominal cramping, bloating and pain. Diagnosed with ulcerative colitis and is currently on hydrocortisone enemas qd, Melamine rectal suspension qd and Pentasa 500mg two capsules by mouth three times daily.


VAERS ID: 683800 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-27
Onset:0000-00-00
Submitted: 2017-02-23
Entered: 2017-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Myoclonic epilepsy, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LAMICTAL
Current Illness:
Preexisting Conditions: Epilepsy; Amoxicillin; no familial history
Allergies:
Diagnostic Lab Data: EEG
CDC Split Type:

Write-up: My daughter experienced a tonic clonic seizure. She was diagnosed with epilepsy. After consulting with the doctor we established she was likely having absence and myoclonic seizures since around 2014. She had her last GARDASIL shot on 11-27-2013. There is no familial history of seizures and she does not follow the typical JME seizure pattern.


VAERS ID: 698118 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2008-09-09
Onset:2008-11-01
   Days after vaccination:53
Submitted: 2017-06-05
   Days after onset:3138
Entered: 2017-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 90649 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain upper, Acne cystic, Alopecia, Anxiety, Apoptosis, Cervicectomy, Cervix carcinoma, Constipation, Cow's milk intolerance, Depression, Food intolerance, Fungal infection, Gallbladder pain, Hypoaesthesia, Menstrual disorder, Pain, Raynaud's phenomenon, Skin discolouration, Streptococcal infection, Temperature intolerance, Tremor, Urinary tract infection, Vitamin B12 decreased, Weight increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Gallbladder related disorders (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Uterine and fallopian tube malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Do not currently have them...need to get them from out of state doctor
CDC Split Type:

Write-up: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud''s Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI''s, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).


VAERS ID: 705914 (history)  
Form: Version 2.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2008-10-13
Onset:2009-01-15
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2017-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500540P / 4 NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0548X / 3 LA / IM

Administered by: Private       Purchased by: 0
Symptoms: Menarche, Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Patient fainted after receiving Typhoid, Tetanus (Td 7yrs-adult), and Hepatitis A (1st of 2 doses) vaccination injections in the
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient''s first menstrual cycle occurred weeks after the vaccine, and has been very irregular ever since. The patient is now 24 years old and still has irregular menstrual cycles. It is currently unknown whether sterility has occurred. However, reproductive viability seems questionable as the menstrual cycles do not exceed 21 days on average. The typical range is 17-22 days per cycle.


VAERS ID: 725058 (history)  
Form: Version 2.0  
Age: 15.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2013-02-19
Onset:2013-07-10
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2017-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1359AA / 1 UN / UN

Administered by: Private       Purchased by: 0
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Gastric disorder, Headache, Impaired driving ability, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Not before vaccine
Allergies: PCN
Diagnostic Lab Data: EEG, Neurologist
CDC Split Type:

Write-up: Patient has to take (Propranolol ER) 60 mg 2x''s daily (TOPAMAX) 100 mg 2x''s daily has headaches, stomach issues, anxiety, jerking spells. Did EEG showed underlying seizure disorder all issues started after taking first shot. She hasn''t and can''t get driver''s license due to this issue.


VAERS ID: 734102 (history)  
Form: Version 2.0  
Age: 15.0  
Gender: Male  
Location: Washington  
Vaccinated:2017-11-24
Onset:2017-11-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. N010497 / 2 RA / IM

Administered by: Private       Purchased by: 0
Symptoms: Blood test normal, Disturbance in attention, Dizziness postural, Fatigue, Loss of personal independence in daily activities, Mononucleosis heterophile test negative, Nausea
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Patient got hives after receiving the HIB vaccine when he was very young (2?).
Other Medications: occasional fish oil, probiotics, daily multi vitamin. Miralax.
Current Illness: none
Preexisting Conditions: chronic constipations (IBS-constipation), mild asthma, ocular migraines with occasional vertigo
Allergies: None
Diagnostic Lab Data: Blood draw was taken to rule out Mono, panels all came back normal. Blood pressure was taken lying down/sitting/standing up. He missed two weeks of school and then went on winter break, during which he rested and improved, but back at school the symptoms returned. He was withdrawn from school on 1/12
CDC Split Type:

Write-up: Patient began to complain of dizziness and nausea upon standing and loss of ability to concentrate at school or on homework. General fatigue and exhaustion.


VAERS ID: 286414 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-15
Onset:2007-05-17
   Days after vaccination:2
Submitted: 2007-07-31
   Days after onset:75
Entered: 2007-08-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bedridden, Muscle spasms, Neck pain
SMQs:, Dystonia (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sertraline HCl Unk - Unk
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707AUS00225

Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form. The patient was a 15 year old female who on 15-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included sertraline HCl. On 17-MAY2007 the patient experienced painful muscle spasm in neck which was diagnosed as "acute wry neck" by a physician. The patient was bedridden for 2 days. On 23-MAY-2007, it was reported to the agency that the patient still had a sore neck but no where near as severe as before. The agency considered that painful muscle spasm in possibly were related to therapy with Gardasil. Painful muscle spasm in neck was considered to be disabling by the agency. Additional information is not expected.


VAERS ID: 299033 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-30
Onset:2007-09-19
   Days after vaccination:112
Submitted: 2007-12-06
   Days after onset:78
Entered: 2007-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crohn's disease, Intestinal perforation, Peritonitis
SMQs:, Gastrointestinal premalignant disorders (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01297

Write-up: Information has been received from a physician, concerning a 15 year old female patient, who in December 2006 was vaccinated with the first dose, in January 2007 with the second dose, and on 30-MAY-2007 with the third dose of Gardasil (lot #654740/0859F; batch NE26610). On 19-SEP-2007, approximately 3 and 1/2 months after the third vaccination, the patient experienced peritonitis, secondary to perforation of the small intestine, and was hospitalized. A diagnosis of Crohn''s disease was determined. The patient had not prior history of related symptoms before the events occurred. At the time of this report, the patient had not recovered from the events. The reporting physician felt that Crohn''s disease was possibly induced by therapy with Gardasil. The physician considered the events to be immediately life-threatening, and significantly disabling/incapacitating. Other business partner numbers included: E2007-08859.


VAERS ID: 322817 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-23
Onset:2008-04-23
   Days after vaccination:0
Submitted: 2008-08-20
   Days after onset:119
Entered: 2008-08-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1949U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808AUS00146

Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail Form concerning a 15 year old female who on 23-APR-2008 was vaccinated with the first dose of GARDASIL (Batch # K0532, Expiry date 12-JUN-2010, Lot # 659053/1949U). On 23-APR-2008, 6 hours after vaccination with GARDASIL, the patient experienced chest pain. It was described as thoracic pain that has failed to settle to date. At the time of reporting to the agency on 14-MAY-2008 the patient had not yet recovered from the chest pain. The agency considered that chest pain was possibly related to therapy with GARDASIL. The original reporting source was not provided. Chest pain was considered to be disabling by the reporting agency. Additional information is not expected.


VAERS ID: 337814 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-07-23
Onset:2008-03-01
   Days after vaccination:222
Submitted: 2009-01-20
   Days after onset:325
Entered: 2009-01-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1518F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Dissociative disorder, Electroencephalogram normal, Facial pain, Headache, Nuclear magnetic resonance imaging normal, Sensory disturbance, Spinal X-ray normal
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: electroencephalography, 24Oct08, Showed no changes; Physical examination, 28Nov08, normal results; Magnetic resonance imaging, showed normal results; Spinal X-ray, showed normal results
CDC Split Type: WAES0901USA01666

Write-up: Information has been received from a foreign health authority (reference No. PEI2008021013) concerning a 15 year old female patient with history of headache (onset some years ago, at least since March 2007) and family anamnesis of migraine (patient''s mother) was vaccinated with a first dose of GARDASIL (batch number NF2330, lot #1518F), route and site not reported on 23-JUL-2007, with a second dose of GARDASIL (batch #NG00010, lot # 1401F) on 27-OCT-2007 and with a third dose of GARDASIL (batch # NF58540, lot # 0253U) on 18-FEB-2008. The frequency of the pre-existing headache increased during the last years and the patient developed chronic headaches and took frequently analgesics. CCT in April-2008 showed normal results. Tension headache and development of headache due to analgesics were suspected. Atypical face pain and dissociative sensory disturbance were diagnosed when the patient presented at the physician practice for follow-up examination on 24-OCT-2008. EEG on 24-OCT-2008 showed no changes. MRI and x-ray cervical spine showed normal results. Examination at an ENT physician was pending at the time of reporting. As the sensory disturbance (hemihypaesthesia) was limited to the median area a psychogenic cause was suspected, but the final cause could not clarified. At a control on 28-NOV-2008 the physical examination revealed normal results. Several therapies including acupuncture and osteopathy have been tried, but without success. HA coded only cephalgia. File closed. Other business partner number include: E2009-00147. No further information is available.


VAERS ID: 338236 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:2008-12-07
   Days after vaccination:36
Submitted: 2009-01-23
   Days after onset:47
Entered: 2009-01-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Diplopia, Headache, Nasopharyngitis, Nuclear magnetic resonance imaging abnormal, Paresis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Magnetic resonance imaging, 18Dec08, hyperintense enhancement in the caudal salivary nucleus left
CDC Split Type: WAES0901USA02992

Write-up: Information has been received from Health Authority on 15-JAN-2009 (reference #2009-00031) concerning a 15 year old female adolescent who was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL (batch number not reported, site of administration not reported) in October 2008. In November 2008 she received the second 0.5 ml dose of GARDASIL, IM. From 07-DEC-2008 until 11-DEC-2008 she developed headache. On 11-DEC-2008 she noted a diplopia, which was progressive and she had symptoms of common cold. A paresis of the left abducent nerve was diagnosed. On 18-DEC-2008 an MRI showed hyperintense enhancement in the caudal salivary nucleus left. An acute disseminated encephalitis was diagnosed. Other business partner numbers include E2009-00291. No further information is available.


VAERS ID: 339684 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-23
Onset:2008-12-25
   Days after vaccination:2
Submitted: 2009-02-13
   Days after onset:50
Entered: 2009-02-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1941U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal neoplasm, Azotaemia, Chemotherapy, Coma, Haemorrhage, Rhabdomyosarcoma, Surgery
SMQs:, Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA01285

Write-up: Information has been received from a Foreign Authority (reference number DK-DKMA-20090203) concerning a 15 year old female patient who was vaccinated intramuscularly with the first dose of GARDASIL (lot # 1941U, batch # NJ01850, site of administration not reported) on 23-DEC-2008. It was reported that the patient experienced rhabdomyosarcoma on 25-Dec-2008. She was diagnosed with rhabdomyosarcoma (date of diagnose not reported). The sarcoma presumably had its origin in the patient''s uterus (not confirmed). The patient was hospitalized (date not reported) and placed in coma (date not specified) at the hospital intensive unit. The patient''s abdomen was opened due to an inoperable, rapidly growing tumor which at the time of acute operation had grown rapidly to the size of a full term pregnancy (date not specified). The patient received chemotherapy (onset date not specified) and experienced complications in form of uraemia and bleeding (not further specified). The course of the disease was reported as unexpectedly fast and aggressive. Initially, before the expansion of the abdomen, the adverse event was interpreted as appendicitis. At the time of report to the Health Authorities the condition of the patient was stable and she was scheduled to be taken out of coma the next day (date not reported). It was reported that the patient was healthy and did not suffer from any known diseases at the time of vaccination. The patient received no concomitant vaccinations or medication. At the time of report the patient had not recovered. Other business partner numbers include: E2009-01070. No further information is available.


VAERS ID: 340966 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-17
Onset:2007-11-17
   Days after vaccination:31
Submitted: 2009-03-02
   Days after onset:471
Entered: 2009-03-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiolipin antibody positive, Condition aggravated, Osteonecrosis, Red blood cell sedimentation rate increased, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Osteonecrosis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: chloroquine
Current Illness: Systemic lupus erythematosus
Preexisting Conditions: Steroid therapy
Allergies:
Diagnostic Lab Data: Erythrocyte sedimentation rate, 17Nov07, increased; Cardiolipin antibody test, 17Nov07, increased
CDC Split Type: WAES0902USA04284

Write-up: Information has been received from a physician concerning a 15 year old female with systemic lupus erythematosus (diagnosed at 14 years old) maintained on chloroquine. The patient received seven weeks of steroids at the onset of her disease after which she passed into remission. In September 2007, the patient received her first dose of GARDASIL. On approximately 17-OCT-2007 was vaccinated with the second dose of GARDASIL via I.M. On 17-NOV-2007 the patient developed reactivation of her SLE disease with elevation of ESR, anticardiolipin antibodies (IgM) and bilateral avascular necrosis of femoral heads. As of 24-FEB-2009 the patient symptoms persisted. The patient''s bilateral avascular necrosis of femoral heads persisted. The outcome of the patient''s reactivation of the SLE was not reported. The avascular necrosis of the femoral heads was considered to be disabling and Other Important Medical Event by the physician. No further information is available.


VAERS ID: 360946 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2009-01-01
   Days after vaccination:31
Submitted: 2009-10-14
   Days after onset:285
Entered: 2009-10-15
   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: Anxiety, Arthralgia, Asthenia, Convulsion, Dizziness, Influenza, Monoplegia, Myalgia, Neurological examination abnormal, Pain in extremity, Paralysis, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: neurological examination, paralysis of extremities
CDC Split Type: WAES0910USA01110

Write-up: Information has been received on 06-OCT-2009 by Health Authority (HA ref. DK-DKMA-20092549) concerning a 15 year old female who in ultimo December 2008, was vaccinated with the first dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). There was no concomitant medication. It was reported that on 01-JAN-2009 the patient experienced muscular pain, convulsions, joint pain, dizziness and weakness. The patient was diagnosed with influenza by the doctor from the emergency service and received treatment with PANODIL (manufactured by GlaxoSmithKline, dose not reported, no dates reported). According to the patient''s parents, the symptoms were not consistent with influenza, thus the patient''s GP was contacted a few days later. The patient was referred for a neurological examination that revealed no abnormalities except paralysis of extremities. It was not specified which examinations that were performed or the date of neurological examination. One week later, the patient''s condition had not improved. The patient was seen by a reflexologist who stated that the patient was "cold" (not further specified). The patient was treated with warmth, reflexology and diet advice (not further specified). It was reported that patient''s condition improved slowly and the patient recovered on an unspecified date. It was reported that the symptoms returned in February 2009 (not further specified), and that the patient also experienced anxiety due to the uncertainty regarding causality. The neurological examination was repeated with the same conclusion (no abnormalities except paralysis of extremities). After a week, the symptoms had declined and the patient recovered. In primo March 2009, the patient was vaccinated with the second dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). No adverse reactions were reported. In primo May 2009, the patient was vaccinated with the third dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). It was reported that on 18-MAY-2009 the patient experienced convulsions, joint pain, dizziness and weakness. The patient recovered on an unspecified date. In ultimo June 2009, the patient experienced dizziness and pain in hands after low intense physical activity. Immediately rest improved the patient''s condition rapidly (not further specified). Psychiatric examination excluded functional disorder. It was reported that the patient had not recovered. Convulsion, muscular pain, anxiety, joint pain, weakness, dizziness and transient paralysis of limb were considered to be disabling by the reporter. Other business partner number included: E200909365. Additional information has been requested.


VAERS ID: 422164 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-11
Onset:0000-00-00
Submitted: 2011-05-03
Entered: 2011-05-04
   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: CSF oligoclonal band present, Central nervous system lesion, Demyelination, Encephalopathy, Lumbar puncture, Multiple sclerosis, Multiple sclerosis relapse, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Visual acuity reduced, Visual evoked potentials abnormal, Walking disability, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Spinal tap, ??Oct?10, Oligoclonal bands; Neurological examination, ??Oct?10, Abnormal results; Magnetic resonance imaging, ??Oct?10, Suspected acute demyelinating encephalopathy; Visual evoked potential, ??Oct?10, Abnormal
CDC Split Type: WAES1104USA04016

Write-up: Case received from a consumer on 18-APR-2011. Case not medically confirmed. A 15 year old female patient had received a first dose of GARDASIL (batch number not reported) on an unspecified date and following vaccination the patient developed multiple sclerosis experiencing 3 relapses in 2 months. According to the reporter, the patient''s father, the patient had serious sequelae. Additional information received from the Health Authorities on 22-APR-2011 under the reference number BX20110458. Case medically confirmed. The patient had received a first dose of GARDASIL (batch number not reported) intramuscularly on 11-OCT-2010 and experienced the first symptoms 2 to 3 weeks after vaccination. The patient had experienced 4 acute demyelinating attacks since that time. An MRI was performed resulting in suspect acute demyelinating encephalopathy with lesions, a lumbar puncture revealed oligoclonal bands and a neurological examination showed abnormal results. Visual evoked potentials were altered. The patient was diagnosed with multiple sclerosis. The patient would had been hospitalized twice (to be confirmed) and she received twice 3 days of corticosteroid bolus IV injection. The patient received a second dose of GARDASIL (batch number not reported) on 13-DEC-2010. Patient''s family medical history included her brother, father and grand father with insulin dependent diabetes mellitus and cousins with immune dysfunction disease. At then time of the reporting, the patient had not recovered and the outcome was reduced visual acuity and walking disability: wheelchair user. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful (C1 S1 11) according to the method of assessment. Multiple sclerosis was considered by agency to be disabling. Other business partner numbers included: E2011-2535. No further information is available.


VAERS ID: 425781 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-03
Onset:2010-06-01
   Days after vaccination:271
Submitted: 2011-06-20
   Days after onset:384
Entered: 2011-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER A81CA257A / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Arthropathy, Asthenia, Cataplexy, Confusional state, Disturbance in attention, Dyssomnia, Fight in school, HLA marker study, Hypnagogic hallucination, Insomnia, Joint injury, Laboratory test normal, Limb injury, Middle insomnia, Muscular weakness, Narcolepsy, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Otitis media, Sleep disorder, Sleep paralysis, Sleep study, Sleep study abnormal, Somnolence, Spinal column injury
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sleep difficult; Allergy to animal
Preexisting Conditions: Otitis media serous; Injury
Allergies:
Diagnostic Lab Data: Diagnostic laboratory test, 26Jan11, Biological work-up was normal; Sleep study, Normal hypnogram; Sleep study, 4 sleep latency test: she felt asleep in 3 min and paradoxical sleep cycles were observed 3 times; Sleep study, 16/24, In Epworth scale without medication; Magnetic resonance imaging, Normal; Sleep study, 15/24, In Epworth scale with MODIODAL; Diagnostic laboratory test, Genotyping was DRB1 07, DQB1 03 on one of the genes and DRB1 13, DQB1 06 on the other
CDC Split Type: WAES1106USA01848

Write-up: Case received from the Health Authorities on 08-JUN-2011 under the reference number: PP20110180. Case medically confirmed. A 15 year old female patient had received a dose of yellow fever virus vaccine on 07-DEC-2006, the first dose of GARDASIL (lot and batch number not reported) on 03-SEP-2009 and the second dose of GARDASIL (lot and batch number not reported) on 09-FEB-2010. On 15-DEC-2009, the patient received a dose of PANDEMRIX (batch number A81CA257A), and on 12-JUL-2010, she received the third dose of GARDASIL (lot and batch number not reported). In January 2009 as the patient was going to another country for 3 months, she was found to have difficulty in getting asleep from the first night on, in a context of seromucous otitis. Then she woke up at night every two hours. These insomnias persisted for almost two years. In June 2010, the patient developed somnolence at the end of the school academic year. In September 2010, when the patient went back to school, she started to fight in classroom not to get asleep and to have extended naps on Wednesdays afternoons - i.e. during two hours - from which she woke up confused. In December 2010, the hypersomnolence clearly increased, associated with frank concentration disorders in classroom, with her mind going blank, getting asleep once during an exam, and getting asleep once or twice a day in classroom, in the beginning and end of day. The patient experienced excessive somnolence during the whole academic year 2009-2010, with her mind going blank and difficulty to get up in the morning. At the time of reporting, the following symptoms were present: significant diurnal somnolence with an Epworth scale at 16/24 without medication and 15/24 with 300 mg of MODIODAL, need of 2 to 3 naps a day with medication, one with medication. The patient had short and restful naps - rares hypnagogic hallucinations: auditory (first name, alarm clock), sensation of a presence (somebody coming into her room), sensation of a body sleeping next to her or of a tee-shirt on her body - sleep paralysis: only one episode at three times during the night, in a context of fatigue - cataplexies: the patient experienced weakness sometimes when laughing, as well as one atypical knee giving away. There was no fall - dyssomnia: initially the patient presented with sleep disorder and did not get asleep before 2 am, associated with phases of two hours of sleep interrupted by long awakening, and sensation of excessive sleepiness in the morning. Since the patient had been taking MODIODAL, she had more continuous sleeps with easier awakenings. Dysexecutive disorders: attention disorders. It bothered her in the acquisition of a new and more complex strategy, the patient worked in an automatic way. On a biological level, genotyping was DRB1 07, DQB1 03 on one of the genes and DRB1 13, DQB1 06 on the other. A brain magnetic resonance imaging (MRI) was performed and was normal. Biological work-up performed on 26-JAN-2011 [Due to memory limitations, the remainder of this text could not be compared.] AN-2011 was normal. To be noted that the patient was allergic to cat hair. There was no familial history of narcolepsy. She had experienced several traumas in 2010 (knee, coccyx, finger). At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations with PANDEMRIX as doubtful (C1 S2 11) according to the method of assessment. Additional information received on 14-JUN-2011: A sleep night study was performed in another ward and resulted in normal hypnogram (no further information was available). The patient''s night sleep was correct but during the 4 sleep latency tests she felt asleep in 3 minutes on average and paradoxical sleep cycles were observed 3 times. This was characteristic of narcolepsy. Cataplexy started in February 2011. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations with PANDEMRIX as doubtful (C1 S2 11) according to the method of assessment. Narcolepsy and cataplexy were considered to be disabling. Other business partner number included: E2011-03559. No further information is available.


VAERS ID: 435763 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-25
Onset:2011-07-29
   Days after vaccination:34
Submitted: 2011-09-26
   Days after onset:59
Entered: 2011-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AABVB963AA / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN52070 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA
Current Illness: Attention deficit disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA01837

Write-up: Case received from the Health Authorities on 13-SEP-2011 under the reference number 2011-02931 via the local site Sanofi Pasteur MSD. A 15-year-old female patient, who had been taking CONCERTA for Attention Deficit Syndrome without any problems for a long time, had received the first dose of GARDASIL, (batch number NN52070) 0.5 ml. Secondary suspect therapy included the first dose of ENGERIX B, other manufacturer (batch number, AABVB963AA) 1 ml both via intramuscular route on 25-JUN-2011. On 29-JUL-2011 the patient developed sensory disturbances over the left side of her face that extended from the hairline to the middle of the cheek. An appointment was made with a neurologist to diagnose the symptoms, but there was no explanation for the patient''s symptoms. The patient was not given any specific treatment, and the symptoms have persisted until the present time. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as unlikely concerning GARDASIL and possible concerning ENGERIX B. Sensory disturbance was considered to be disabling by the reporter. Other business partner numbers included: E2011-05553. No further information available.


VAERS ID: 453102 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-12-22
Onset:0000-00-00
Submitted: 2012-04-05
Entered: 2012-04-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Blood count, Blood culture negative, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, C-reactive protein increased, Complement factor C3, Complement factor C4, DNA antibody negative, Differential white blood cell count, Finger deformity,