National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Found 2135 cases where Vaccine is HPV4 and Disabled

Case Details (Sorted by Age)

This is page 1 out of 3

Result pages: 1 2 3   next


VAERS ID: 270598 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-16
Entered: 2007-01-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA01070

Write-up: Information has been received from a physician concerning a female who was intramuscularly, vaccinated with the second dose of HPV vaccine. Subsequently the patient developed an anaphylactic reaction (swelling of the throat, itching of hands and feet). At the time of the report, it was not reported if the patient recovered. The physician determined that the patient''s anaphylactic reaction (Swelling of the throat, itching of hands and feet) was considered to be immediately life threatening, disabling and an other important medical event. Additional information has been requested.


VAERS ID: 274360 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-19
Entered: 2007-03-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

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

Life Threatening? No
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: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA01318

Write-up: Initial and follow up information has been received from a Licensed Practical nurse and a physician concerning a female patient who was vaccinated with a first dose of Gardasil. She developed hives within 2-3 hours of receiving the injection. Unspecified medical attention was sought. The patient was not recovered. The nurse considered hives to be disabling she was not available for follow up, and when the physician was contacted, he could not provide any information regarding why the nurse considered the event disabling. He had not been able to contact the patient. He had no further information regarding her outcome. Additional information has been requested.


VAERS ID: 278266 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-28
Onset:2007-04-02
   Days after vaccination:5
Submitted: 2007-05-08
   Days after onset:36
Entered: 2007-05-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Hypersensitivity, Hypoaesthesia, Pain, Pain in extremity, Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), 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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0705MYS00002

Write-up: Information has been received from a physician concerning a female who on approximately 15-JAN-2007 was vaccinated with Gardasil. On 28-MAR-2007, the patient was vaccinated with a second dose of Gardasil. On 02-APR-2007 the patient experienced itchiness and red spots on whole body. After seven days of itchiness, the patient received an injection to reduce the allergic response on the whole body. On approximately 28-APR-2007 the patient still experienced itchy palms and feet. Additionally the patient experienced aching and numbness in both hands and feet. She complained that it was hard to complete the housework due to aching and numbness. On approximately 01-MAY-2007 the patient experienced red spots and itchiness on face. Subsequently, the patient recovered from itchiness and red spots on whole body. However, the patient''s itchy palms and feet as well as aching and numbness persisted. The red spots and itchiness on face also persisted. The reporter felt that itchiness and red spots on whole body, itchy palms and feet, aching, numbness, red spots and itchiness on face were related to therapy with Gardasil. Aching and numbness were considered to be disabling. No further information is available.


VAERS ID: 279592 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-24
Entered: 2007-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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:
CDC Split Type: WAES0705USA01964

Write-up: Information has been received from a licensed visiting nurse via a nurse practitioner. The nurse practitioner was told by a friend that a female patient was vaccinated with Gardasil and two weeks alter developed a blood clot. Subsequently the patient died. The cause of death was from the blood clot. The reporting licensed visiting nurse considered the blood clot to be immediately life-threatening and disabling. Additional information has been requested.


VAERS ID: 288901 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Florida  
Vaccinated:2007-08-04
Onset:2007-08-04
   Days after vaccination:0
Submitted: 2007-08-23
   Days after onset:19
Entered: 2007-08-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (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: Unknown
Current Illness: Viral sore throat
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA02529

Write-up: Information has been received from a physician assistant concerning a female patient who in June 2007, was vaccinated with a first dose of Gardasil. On 04-AUG-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 658100/0525U). Illness at the time included a sore throat (viral syndrome). On 07-AUG-2007 three days later, the patient developed hives, joint pain, was itchy, tenderness in joints, arthralgia, fever and weakness. On 09-AUG-2007, the patient came in to see the physician. The physician put the patient on steroids and loratadine (CLARITIN) (manufacturer unknown). No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. The nurse practitioner wasn''t sure if the patient''s symptoms were related to the viral syndrome or the vaccine. No product quality complaint was involved. Hives, joint pain, was itchy, tenderness in joints, arthralgia, fever and weakness were considered to be disabling. Additional information has been requested.


VAERS ID: 290186 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: West Virginia  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 2007-09-07
   Days after onset:98
Entered: 2007-09-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0210U / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site induration, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Synovitis
SMQs:, Extravasation events (injections, infusions and implants) (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Magnetic resonance 08/05/2007 - of right humerus revealed, "Synovitis of glenohumeral joint"
CDC Split Type: WAES0708USA05339

Write-up: Information has been received from a registered nurse concerning a female with no pertinent medical history who on 01-JUN-2007 was vaccinated intramuscularly in the right deltoid with a second dose of Gardasil (Lot #0210U). There was no illness at the time of vaccination. The patient''s mother reported the patient''s arm had been sore since injection 01-JUN-2007 and the pain extended to the elbow. A small induration could be felt at the site. The patient was treated with ADVIL, gabapentin, LIDODERM patches, prednisone, and ice. On 06-JUL-2007 and 16-JUL-2007 the patient was seen in the physician''s office. On 05-AUG-2007 an magnetic resonance imaging (MRI) was performed on the right humerus findings of the proximal humerus are nonspecific and can be related to trauma, infection or neoplasm and should be correlated with clinical findings. There is synovitis of the Glenohumeral joint, which again could be reactive, post-traumatic, or infectious in etiology. On 30-AUG-2007, it was noted that the patient was doing "much better." It was reported that the patient had no problems with the first injection of Gardasil. It was reported that the patient''s sister had the Gardasil injections with no problems. The nurse considered the painful arm and injection site induration to be persistent and significant disabling events. Additional information has been requested.


VAERS ID: 295685 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-01
Onset:0000-00-00
Submitted: 2007-11-05
Entered: 2007-11-06
   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: Colitis
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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: Unknown
CDC Split Type: WAES0710USA06540

Write-up: Information has been received from a Nurse Practitioner concerning a female with no pertinent medical history and no prior drug reactions who, in February 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient''s second dose of Gardasil was administered in March 2007. The nurse practitioner reported that the patient developed colitis after she received her second dose of Gardasil. The lot numbers were not known. As of 30-OCT-2007, the patient had not recovered from the colitis. The reporter considered the colitis to be disabling. Additional information has been requested.


VAERS ID: 297400 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-11-09
Onset:2007-11-09
   Days after vaccination:0
Submitted: 2007-11-19
   Days after onset:10
Entered: 2007-11-20
   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: Erythema, Hypoaesthesia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
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: WAES0711USA02882

Write-up: Information has been received from a physician concerning a female who on 09-NOV-2007 was vaccinated with Gardasil. On 09-NOV-2007 the patient''s arm was red and her arm went numb. The physician sent the patient to the emergency room where she remained for 6 hours. While in the emergency room, the patient developed tachycardia. She was treated with diazepam (Valium) to calm her down. The patient recovered on 10-NOV-2007; however, it was also reported that the patient''s arm was numb for 3 days before the feeling came back. The physician considered the patient''s red arm, numb arm and tachycardia to be disabling. Additional information has been requested.


VAERS ID: 303112 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Iowa  
Vaccinated:0000-00-00
Onset:2007-11-26
Submitted: 2008-01-07
   Days after onset:42
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), 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? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA01715

Write-up: Information has been received from a medical assistant (MA), concerning a female patient (age not specified) with no pertinent medical history and no known allergies, who was vaccinated (date not specified) with the third dose of Gardasil (lot # not reported). There was no concomitant medication. After the third vaccination, on 26-NOV-2007 (time duration to onset not specified), the patient experienced headaches, and dizziness that has been so severe, that "she needed to sit down very often." At the time of this report, the patient had not recovered. The MA considered the events to be serious as disabling/incapacitating. Additional information has been requested.


VAERS ID: 309587 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-15
Entered: 2008-04-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
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: WAES0804USA02502

Write-up: Information has been received from a medical assistant concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil, 0.5 mL, once, IM. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced seizure. Unspecified medical attention was sought. The reporting medical assistant was not sure if this was the patient''s first or second dose of Gardasil, but the patient definitely has not had the third dose yet. Subsequently on an unspecified date, the patient recovered from seizure. No product quality complaint was involved. Seizure was considered to be disabling. Additional information has been requested.


VAERS ID: 311858 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-05-07
Entered: 2008-05-08
   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: Gait disturbance, Paralysis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Unknown
CDC Split Type: WAES0805USA00174

Write-up: Information has been received from a nurse within the doctor''s office concerning a female patient who was vaccinated with a second dose of GARDASIL. The nurse reported that she heard from her aunt that a patient received the GARDASIL injection and experienced paralysis and could not even cut her own dinner after the injection was administered. The patient had to walk with a cane and also went to physical therapy. She did not receive the vaccine at the reporting nurse''s office. No further information was known. The paralysis was considered to be disabling. Additional information is not available.


VAERS ID: 312966 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-05-21
Entered: 2008-05-22
   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: Gait disturbance, Neurological symptom
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre 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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA03518

Write-up: Information has been received from a health care professional concerning a female (age unknown), who was vaccinated with a dose of GARDASIL. Subsequently, the patient experienced neurological changes and had difficulty walking. It was reported that she would not receive her third dose. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. The reporter considered the neurological changes and difficulty walking to be disabling. Additional information is not available.


VAERS ID: 316080 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-06-11
Entered: 2008-06-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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? 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: WAES0806USA00853

Write-up: Information has been received from a physician, who heard from another physician, that a female (age unreported) who was vaccinated with a dose of GARDASIL, became paralyzed. The reporter considered the paralysis to be disabling. It was reported that the patient has not recovered. Additional information has been requested.


VAERS ID: 316585 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Alabama  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-06-13
Entered: 2008-06-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA02386

Write-up: Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced arthralgias. On an unspecified date the patient was vaccinated with a third dose of GARDASIL. Subsequently, the patient experienced symptoms of GUILLAIN-BARRE syndrome.The patient sought unspecified medical attention. At the timf of the report, the patient had not recovered. No product quality complaint was involved. Follow-up information indicated that the physician did not know the name of the patient. The physician reported that he received infromation on the event through a contact of a friend and he did not have additional infromation on the patient. The physician considered the symptoms of GUILLAIN-BARRE syndrome and arthralgia to be disabling. This is a consolidation of two reports concerning the same patient. Additional information has been requested.


VAERS ID: 317868 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-06-27
Entered: 2008-06-30
   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: Blood pressure decreased, Coma
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Unknown
CDC Split Type: WAES0806USA07657

Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, two weeks after vaccination the patient went into a coma and her blood pressure was "dropping a lot." The patient was reported to be a cousin of a patient of the reporting physician and is not a patient of the reporting physician. Information regarding the patient''s health care provider was not provided. The patient sought unspecified medical attention. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Coma and blood pressure dropped were considered to be disabling. Additional information is not expected.


VAERS ID: 319289 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-15
Entered: 2008-07-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Surgical procedure
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA01601

Write-up: Information has been received from a physician concerning a female with a history of dental procedure in which paralysis occurred who was vaccinated with GARDASIL IM. The patient developed paralysis after vaccination. The patient was considered to be disabling. The patient sought medical attention. Additional information has been requested.


VAERS ID: 321166 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:2008-05-13
Onset:0000-00-00
Submitted: 2008-08-01
Entered: 2008-08-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 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? 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: Unknown
CDC Split Type: WAES0807USA04374

Write-up: Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of GARDASIL. Subsequently, the patient experienced seizure like symptoms. The patient sought unspecified medical attention from the physician. The physician reported that the patient was not going to continue the rest of the series. The patient recovered on an unspecified date. The physician considered the seizure like symptoms to be disabling. Additional information has been requested.


VAERS ID: 321507 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2008-07-01
Submitted: 2008-08-06
   Days after onset:36
Entered: 2008-08-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0807USA05324

Write-up: Information has been received from a physician concerning a female who received the three doses of GARDASIL. Recently in July 2008, the patient had soft tissue pain and swelling over the injection site which has persisted since the third injection. The patient complained of pain when raising her arm. The patient was referred to physical therapy. Soft tissue pain and swelling over the injection site and pain when raising her arm, were considered to be disabling. Additional information has been requested.


VAERS ID: 321509 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Illinois  
Vaccinated:2008-07-24
Onset:2008-07-24
   Days after vaccination:0
Submitted: 2008-08-06
   Days after onset:13
Entered: 2008-08-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Myelitis transverse, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA00015

Write-up: Information has been received from a physician concerning a female between 9 and 18 years of age who on approximately 24-JUL-2008 was vaccinated with a dose of GARDASIL. The patient developed paralysis immediately after the vaccination. She was taken to a hospital and diagnosed with transverse myelitis. She is still in the hospital. The patient''s outcome was unknown. Transverse myelitis was considered disabling. No further information is available.


VAERS ID: 324904 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-08-01
Onset:2007-08-01
   Days after vaccination:0
Submitted: 2008-08-14
   Days after onset:379
Entered: 2008-08-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
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: WAES0807USA03705

Write-up: Information has been received from a physician''s assistant concerning a female with no drug reactions/allergies, who in August 2007, was vaccinated intramuscularly with a first dose of GARDASIL (lot # not reported) 0.5 mL. There was no concomitant medication. In August 2007 after the GARDASIL was administered, the patient experienced immediate severe pain at the injection site of the left arm. Due to the pain, the patient was unable to participate in sports. The pain resolved in one week without requiring treatment. The patient contacted the physician''s office via phone. The patient has not received the second or third dose of GARDASIL. No further information was available. Immediate severe pain at the injection site was considered to be disabling. Additional information has been requested.


VAERS ID: 328504 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-01
Onset:0000-00-00
Submitted: 2008-10-14
Entered: 2008-10-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bed rest, Blood test, Drug exposure during pregnancy, Premature labour, Ultrasound foetal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0810USA01669

Write-up: Information has been received from a Registered Nurse for the Pregnancy registry for GARDASIL concerning a female with a history of obesity who in September 2007, was vaccinated with the first dose of GARDASIL (lot 658556/1060U). The patient became pregnant at the end of November 2007. The patient''s estimated date of confinement was 03-SEP-2008, and the patient delivered on 20-AUG-2008. At some unspecified point in the pregnancy, the patient experienced premature contractions and was treated with bed rest. Unspecified blood tests and fetal ultrasounds were performed. No other information was available at this time. Upon internal review, premature contractions which required bedrest was considered disabling. Additional information has been requested.


VAERS ID: 349456 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-06-17
Entered: 2009-06-18
   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: Mitochondrial cytopathy, Surgery
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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cardiac septal defect
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA01886

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL. The patient received the first dose of GARDASIL and a week and half later she was scheduled to have heart surgery due to a hole in a heart that patient already had. Then after surgery the patient started to experience illness on a mitochondrial level. The physician stated that the patient was hospitalized due to surgery but did not specify how long the patient was in the hospital. Illness on a mitochondrial level was considered to be immediately life-threatening and disabling. At the time of this report, the patient was recovering. No further information is available.


VAERS ID: 350863 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2009-02-01
Submitted: 2009-07-06
   Days after onset:154
Entered: 2009-07-07
   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: Anxiety, Burning sensation, Dementia, Grunting, Hallucination, Heart rate increased, Hyperhidrosis, Hyperventilation, Insomnia, Panic attack, Tic, Weight decreased
SMQs:, Anaphylactic reaction (broad), 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), Dementia (narrow), Dyskinesia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MAXAIR
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA00186

Write-up: Information has been received from a physician concerning a female patient with asthma who on an unknown date, was vaccinated with the first dose of GARDASIL. Concomitant therapy included MAXAIR. A couple of days later after receiving GARDASIL, the patient started presenting with anxiety, dementia, panic attacks, loss of sleep, weight loss, hallucinations and hyperventilation. The patient was put on antidepressants (unspecified) and her symptoms got worse and she was taken to the ER on 02-FEB-2009. After the antidepressants the patient experienced burning, sweating, tics, rapid heart beat and vocal grunt and was admitted to the psychiatric hospital. The patient will not receive further doses of GARDASIL. The patient was released since she was feeling a little better and started eating, however she is showing early signs of dementia. The patient''s adverse experiences were considered to be disabling. Additional information has been requested.


VAERS ID: 355626 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-26
Entered: 2009-08-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0572X / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Hemiparesis, Neurological symptom
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA04182

Write-up: Information has been received from a cardiac surgeon concerning a female who was vaccinated with a dose of GARDASIL (lot #660618/0572X). Subsequently the patient developed hemiparesis, headaches and "other neurological symptoms". At the time of the report, the patient''s outcome was unknown. The cardiac surgeon considered hemiparesis, headaches and "other neurological symptoms" to be were considered to be disabling since they have become longstanding and incapacitating. This is one of several reports received from the same source. A lot check has been requested. Additional information has been requested.


VAERS ID: 355833 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-27
Entered: 2009-08-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Nervous system disorder
SMQs:

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: WAES0908USA04199

Write-up: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL. Subsequently the patient experienced atypical headaches and neurological disorder. The outcome of the patient was unknown. Atypical headaches and neurological disorder were considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 359040 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-30
Entered: 2009-10-01
   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: Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA03751

Write-up: Information has been received from a physician who "heard from a patient that someone related to her friend", a female, who was vaccinated with her second dose GARDASIL on an unspecified date. Subsequently the patient required assistance in walking. The patient might have been treated at a hospital. At the time of the report, the patient''s status was unknown. Follow up information on 25-SEP-2009 has been received through a phone call from a physician. The physician stated that she did not know any information of the patient. She would ask the person who report the case to get the patient''s adverse experience. Required assistance in walking was considered to be disabling. The Health Care Professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number, date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. No further information is available at this time. Additional information has been requested.


VAERS ID: 364710 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-02
Entered: 2009-11-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Coma, Neurological symptom
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: WAES0910USA02673

Write-up: Information has been received from a physician who heard from a Nurse concerning a young female who was vaccinated on an unspecified date with GARDASIL (Lot number was not available). The reporter stated that the patient experienced neurological side effects and entered a coma for a length of time after receiving GARDASIL. It also was stated that the patient "had gone through a lot of things but they felt it was from GARDASIL because of process of elimination". It was reported that "unspecified test" were performed on an unknown dates. The reporter mentioned that the patient was hospitalized for an unspecified length of time. At the time of reporting the patient had not recovered. "Attempts are being made to verify the existence of an identifiable patient". Additional information had been requested. Patient was hospitalized.


VAERS ID: 365296 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2009-04-01
Onset:2009-04-01
   Days after vaccination:0
Submitted: 2009-11-04
   Days after onset:217
Entered: 2009-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0650X / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Computerised tomogram, Migraine, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None. 11/16/09: Neurology consult received for date of service 5/8/09. PMH: Concussion. 11/24/09 ER records received for date 4/14/09, 4/24/09, 4/28/09, 4/29/09. PMH: migraines
Allergies:
Diagnostic Lab Data: Unknown. 11/16/09: Neurology consult received for date of service 5/8/09. Labs and diagnostics: None. 11/24/09 ER records received for date 4/14/09, 4/24/09, 4/28/09, 4/29/09. Diag/Labs: blood test WNL.
CDC Split Type: WAES0910USA04077

Write-up: Information has been received from an office manager concerning her daughter with no pertinent medical history and no known allergies who on April 2009, was vaccinated with the second dose of GARDASIL. There was no concomitant medication. In April 2009, two days after administration of the second dose of GARDASIL, the patient experienced migraines, syncope and aches. It was reported that the patient''s symptoms "come and goes and go with different durations". On an unspecified date a computerized tomography was performed; results were not reported. The patient''s mother stated that her daughter had to miss one month of school. At the time of reporting the patient had not recovered. The reporting office manager considered that migraines, syncope and aches were disabling. Additional information has been requested. 11/16/09: Neurology consult received for date of service 5/8/09. Dx: HA''s and Migraine HA''s Assessment: Initially she sees spots that resolve, then she becomes dizzy, followed by HA pain. Pain starts in R frontal region, with eye pain then becomes diffuse throughout her head. She experiences nausea, photophobia, feet and ankles become tingly with diffuse weakness and fatigue. All sx. resolve once the HA resolves. HA''s occur monthly. Hx. of migraines for one year lasting hours to days. Migranes intensified after a concussion with a brief loss of consciousness 1 yr. ago. Tension HA''s occur up to a couple of times per wk. Most recent migraine lasted for a few weeks. Taking Frova, Amitryptyline and Compazine prn. 11/24/09 ER records received for date 4/14/09, 4/24/09, 4/28/09, 4/29/09. DX: migraine. Chief c/o migraine HA, nausea, x2 wks. Assessment:WNL, pt tx, and dc w/ sx resolved.ER visit on 4/29/09 DX: migraine HA. Pt c/o ongoing HA/migraine x3wks. HA moves to different locations of head. Pt states sharp pain/pressure, nausea, light/sound sensitive. Pt. states have blacked out a couple of times.


VAERS ID: 366877 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-11
Entered: 2009-11-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Heart rate irregular, Muscle spasms, Myalgia, Nausea, Rash, Syncope, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA00519

Write-up: Information has been received from a physician who reported that a mother chose to stop her daughter''s GARDASIL due to "bad press". The article was in newspaper on 29-OCT-2009 concerning three girls, known as the "GARDASIL Girls" had experiences after receiving the vaccine. On an unspecified date the patient who was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date she experienced charley horse, spasms and pain in muscles with fainting, nausea, irregular heartbeat and rash since she received GARDASIL. Now she was using a wheelchair. The patient''s outcome was not reported. Upon internal review, using wheelchair was considered to be disabling. This is one of three reports from the same source. No additional information is available.


VAERS ID: 370627 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-25
Entered: 2009-11-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Laboratory test, Pancreatectomy, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (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: unknown
Current Illness:
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: WAES0911USA03001

Write-up: Information has been received concerning a female patient "maybe college-age" with unspecified medical history, drug reactions or allergies, who in 2008 was vaccinated with a dose of GARDASIL (route and lot # unknown). Concomitant medication unspecified. On 17-NOV-2009, a news station reported that the patient reported that she received GARDASIL and on an unspecified date she became tired all of a sudden, she also suddenly developed lupus and her pancreas had to be taken out. She possibly might need chemotherapy in the future. Unspecified lab diagnostic studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Attempts are being made to verify the existence of an identifiable patient. No further information is available.


VAERS ID: 373827 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New York  
Vaccinated:2008-10-09
Onset:2009-08-12
   Days after vaccination:307
Submitted: 2009-12-16
   Days after onset:126
Entered: 2009-12-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Gastroschisis
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Folic acid; FLAGYL
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA01240B1

Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 22 year old female with bacterial vaginosis who was vaccinated intramuscularly with the first 0.5 dose of GARDASIL in the left upper arm in August 2008 her first month of previous pregnancy, reported in (WAES # 0809USA00445), the second dose of GARDASIL in her right upper arm in October 2008 with no other vaccines was given on this date and the third dose of vaccine on her left arm on 04-NOV-2009. Concomitant therapy included 250 mg FLAGYL for bacterial vaginosis infection, folic acid 3 weeks after the visit and the flu vaccine in her right arm. The patient delivered a male child by caesarean section due to gastroschisis 3 months ago. Child had complication gastroschisis, abdominal defect, which required surgery and longer stay at the hospital after birth. Child was being seen by specialist. Follow up information was received from the physician concerning the patient with no obstetric history as well as no medical history or concurrent conditions who was vaccinated with her first, second and third dose of GARDASIL on 05-AUG-2008, 09-OCT-2008 and 04-NOV-2009 respectively. Concomitant therapy included FLAGYL folic acid from 07-AUG-2008 and influenza virus vaccine on 04-NOV-2009. Amniocentesis indicated that the patient was 4.5 months pregnant (LMP: 12-AUG-2008; EDD: 19-MAY-2009). The results of the amniocentesis were "negative". On 12-AUG-2009, at 25 weeks of gestation, the patient delivered an abnormal male baby weighting 4 pounds, 18 cm in length with head circumference of 35. The baby was born by caesarean section with gastroschisis. The mother had not complication during pregnancy and needed caesarean section because of the baby''s gastrochisis. The mother did not experience any infections or illnesses during pregnancy. The infant was still in NICU as of today. Other medication used during this pregnancy included prenatal vitamin, 1 tablet, daily. Follow up information was received from the physician via telephone on 09-NOV-2009 concerning the patient received the second pregnancy and had an outcome of a 3 month premature delivery with a baby with gastroschisis. It was reported that LMP was not known and the patient conceived sometime in February 2009, ast least 2 months after receiving her second dose of vaccine. The physician arrived at this approximate date working backwards from her Cesarean delivery date of 14-AUG-2009 (also reported baby was born on 12-AUG-2009) three months "early". It was reported that the baby had had surgery (date not provided) for gastroschisis, was still in NICU, had gained weight and was "doing well". He also said the mother had recovered from her Cesarean she was doing fine. This is an amended report. The word "previous" before the word pregnancy in the sentence in the first paragraph regarding the other pregnancy/WAES# for this patient was added. "Other medication used during this pregnancy included prenatal vitamin, 1 tablet daily" was added in the third paragraph in the narrative. Bacterial vaginosis was added as a concurrent condition. The mother''s experience has been captured in WAES# 0911USA01240B1. The reporter considered gastroschisis, premature and small for dates baby to be disabling and life threatening and gastroschisis to be other important medical events. This information was previously sent in WAES# 0911USA01240 on 04-DEC-2009. Additional information had been requested. This information was previously sent in WAES# 0911USA01240 on 04-DEC-2009.


VAERS ID: 374323 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2008-02-04
Onset:2008-05-21
   Days after vaccination:107
Submitted: 2009-12-18
   Days after onset:576
Entered: 2009-12-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1287U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Drug exposure before pregnancy, Foetal disorder, Pregnancy test positive, Ultrasound abdomen normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Tobacco user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hearing test, Newborn hearing screen; failed--left; Apgar score, 02/13/09, 8/9
CDC Split Type: WAES0807USA03163B1

Write-up: Information has been received from a health professional, for the Pregnancy registry for GARDASIL, concerning a male baby patient whose 24 year old mother with tobacco use and a history of 1 pregnancy and 1 live birth was vaccinated intramuscularly with the first, second and third 0.5 ml doses of GARDASIL on 03-DEC-2007, 04-FEB-2008 and 04-JUN-2008, respectively (lot # of the 2nd dose: 655327/1287U; lot # of 3rd dose: 655604/0052X). There was no concomitant medication. The mother was two weeks pregnant while receiving the third dose of GARDASIL. The pregnancy test was positive. On 23-SEP-2008, ultrasound was performed with normal result. On 15-OCT-2008, maternal serum alpha-fetoprotein (MSAFP) was performed with negative result. On 13-FEB-2009 (Weeks from LMP: 39), the baby was born with congenital anomaly cleft palate, weight: 8 pounds 3 oz and Apgar score 8/9. As of 01-JUL-2009, the outcome of cleft palate was unknown. Follow-up information was received from a nurse who reported that the baby was born with congenital anomaly cleft palate and cleft lip, height: 22 inch. The baby visited a cleft craniofacial center on 18-FEB-2009 and visited an audiology center on 09-JUN-2009. At the time of reporting, the outcome of cleft palate and cleft lip were unknown. Follow-up information was received from a nurse via medical records indicating that the baby''s Apgar was 8 at 1 minute, 9 at 5 minutes. Birth weight was 8 pounds and 5 ounces. He failed the newborn hearing screen of the left. The baby was born with cleft lip unilateral complete and cleft palate unilateral complete. On 25-FEB-2009, the infant was 12 days old. This was a well visit. It was noted that the cleft lip and palate would be repaired when the child was 4-6 months of age. On 04-SEP-2009 the patient had cleft lip repaired and had myringotomy with tubes. On 17-NOV-2009 the patient presented for a scheduled 9 months well child visit. He had ear tubes. Physical exam showed tympanic membranes normal landmarks, no fluid or erythema bilaterally. At the time of this report, the patient''s outcome regarding cleft palate was unknown. The reporting health professional considered cleft palate and cleft lip to be other important medical events and disabling. The mother''s experience has been captured in WAES #0807USA03163. The baby also experienced adverse events after being vaccinated with hepatitis B vaccine (manufacturer unknown) (WAES#0912USA01491). Additional information is not expected. All available medical records will be provided upon request.


VAERS ID: 375363 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-28
Entered: 2009-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Disability, Impaired work ability
SMQs:

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: WAES0912USA02381

Write-up: Information has been received from a consumer that read an article "maybe last summer" concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown) and she was "messed up". The consumer did not remember what specific adverse effects the patient experienced but the patient could no longer work. At time of this report the patient outcome was unknown. Mess up/adverse event was considered to be disabling. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.


VAERS ID: 376847 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-01-13
Entered: 2010-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0070X / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Arthropathy, Haematology test normal, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Eosinophilic pneumonia (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? No
Previous Vaccinations:
Other Medications: Isoniazid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematology, "blood work" was normal
CDC Split Type: WAES1001USA00365

Write-up: Information has been received from a physician concerning a female patient with no pertinent medical history and no known allergies who on an unknown date was vaccinated with a second dose of GARDASIL (Lot # not reported). Concomitant therapy included isoniazid, 2 months prior to getting first dose of GARDASIL, had been on isoniazid for 4 months total. A few days after receiving the second dose of GARDASIL, the patient experienced diffused muscle pain, arthralgia, knees hurt, difficulty with joints and had headaches. The physician believed significant disability because the patient "could not function anymore and not getting out of the house". The physician also mentioned that the patient did not have any problems after the first dose of GARDASIL. The patient sought medical attention by an office visit. A "blood work" test was performed which was normal. At the time of the report, the outcome of the patient was not recovered. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, lot numbers and date of event. No further information is available.


VAERS ID: 380223 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-09
Entered: 2010-02-12
   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: Hypoaesthesia, Nervous system disorder
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1002USA01143

Write-up: Information has been received from a physician, who reported that she heard from patient, that a local physician had a teenaged patient who experienced dehabilitating numbness in the arm and neurological disorders (unspecified) after administration of GARDASIL vaccine (dose in series, route and lot number not reported). In follow-up, the physician stated that the patient events were not verified by her. The physician considered severe numbness in the arms as disabling. The patient outcome at the time of the report was unknown. It was unknown if the patient sought medical attention. The healthcare professional contacted during telephone call, could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. This is one of several reports from the same source. No further information is available.


VAERS ID: 380224 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-09
Entered: 2010-02-12
   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: Hypoaesthesia, Nervous system disorder
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1002USA00766

Write-up: Information has been received from a physician, who reported that she heard from patient, that a local physician had a teenaged patient who experienced dehabilitating numbness in the arm and neurological disorders (unspecified) after administration of GARDASIL (dose in series, route and lot number not reported). In follow-up, the physician stated that the patient events were not verified by her. The physician considered severe numbness in the arm as disabling. The patient outcome at the time of the report was unknown. It was unknown if the patient sought medical attention. The healthcare professional contacted during telephone call, could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. This is one of several reports from the same source. No further information is available.


VAERS ID: 380227 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-09
Entered: 2010-02-12
   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: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: unknown
Current Illness:
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1002USA00013

Write-up: Information has been received from a physician concerning a female patient (age not reported), who was vaccinated with a dose of GARDASIL (dose and lot not reported). Physician stated that a patient experienced severe numbness in her arm for 2 weeks after administration of GARDASIL. This occurred 1 to 2 years ago. In follow-up, the physician stated that she had no available information concerning the patient, since she was vaccinated and treated at another office. The physician considered that severe numbness in her arm was disabling. The patient''s outcome at the time of the report was unknown. Patient sought medical attention via office visit. The healthcare professional contacted during telephone call, could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. This is one of two reports from the same source. No further information is available.


VAERS ID: 383173 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-19
Entered: 2010-03-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Human papilloma virus test positive, Menstrual disorder, Papilloma viral infection, Precancerous cells present
SMQs:

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: WAES1003USA02406

Write-up: Information has been received via the internet from a consumer concerning his or her daughter who was vaccinated with 2 doses of GARDASIL (lot number, date, route and site not reported). Approximately a year later the patient had tested positive for high-risk HPV. The patient suffered SEVERE side effects from them which incapacitated her for 2 1/2 months. The patient continued to experience menstrual problems even though it had been over a year. At the time of the report, the patient had precancerous, high-risk HPV. It was reported that the reporter believe that the patient''s HPV was the result of the vaccines because the patient did not have HPV when she received the vaccines. Severe side effects and menstrual problems were considered to be disabling. This is one of several reports received from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.


VAERS ID: 386487 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:2009-10-01
Onset:2009-10-01
   Days after vaccination:0
Submitted: 2010-04-30
   Days after onset:211
Entered: 2010-05-03
   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: Blood creatine phosphokinase abnormal, Blood test, Full blood count abnormal, Myalgia, Viral infection, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (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: Unknown
Current Illness:
Preexisting Conditions: Obesity
Allergies:
Diagnostic Lab Data: Serum creatine kinase, over 1000; complete blood cell, probably viral infection
CDC Split Type: WAES1004USA03404

Write-up: Information has been received from a physician concerning a female patient with a history of obesity who on an unknown date, was vaccinated with a dose of GARDASIL (series, route and lot number unspecified). It was reported that the patient received other vaccines but which ones were unspecified. A week after the vaccination, "sometime in October or November 2009", the patient experienced muscle pain in their arms and legs so the patient went to the emergency room. At the emergency room, the patient had to be put in a wheel chair because of the muscle pain. A serum creatine kinase (CPK) test was performed an the levels were over 1000. A blood work test was performed and the results were not provided. A complete blood cell count (CBC) work up was performed and the results were that probably the patient had a viral infection (unspecified). The physician reported that the patient stopped the series of GARDASIL and had recovered (date not reported). The patient was initially seen by another physician. Viral infection was considered to be disabling by the physician. Additional information has been requested.


VAERS ID: 387159 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-10
Entered: 2010-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Nervous system disorder, Wheelchair user
SMQs:

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: WAES1005USA00437

Write-up: Information has been received from a physician who reported that one of his patient''s mother mentioned that at some point last year, in 2009, a young woman was vaccinated with a dose of GARDASIL (lot # not reported) and the patient developed neurologic disorders. Unspecified medical attention was sought. The patient went through many tests and was currently in a wheelchair. At the time of this report, the patient''s outcome was unknown. Neurologists did not believe that it was due to receiving GARDASIL. Neurologic disorder was considered to be disabling by the reporter. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.


VAERS ID: 390440 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2007-06-30
Submitted: 2010-06-09
   Days after onset:1075
Entered: 2010-06-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adrenal disorder, Arrhythmia, Bedridden, Convulsion, Decreased activity, Gastrointestinal disorder, Malaise, Migraine, Photophobia, Pupillary disorder, Sensory loss, Transient ischaemic attack, Vision blurred
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA00692

Write-up: Information was received from an online magazine who reported that a consumer said that on an unspecified date her daughter was vaccinated with GARDASIL. It was reported that late June 2007, her daughter''s life changed after GARDASIL. The patient went from a vibrant, active college student, to a bedridden, chronically ill, young woman with seizures, GI tract problems, constant migraines, blurred vision, abnormal pupil reaction, loss of feeling in both legs, heart arrhythmia, TIAs, eye sensitivity, exhausted adrenals and the list just kept growing. At the time of the report, the patient''s outcome was unknown. It was unknown if the patient sought medical attention. Seizures was considered to be an other important medical event and bedridden was considered to be disabling. No further information is available.


VAERS ID: 391646 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2008-04-01
Onset:2008-04-01
   Days after vaccination:0
Submitted: 2010-06-28
   Days after onset:818
Entered: 2010-06-29
   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: Abdominal pain upper, Acne cystic, Activities of daily living impaired, Alopecia, Arthralgia, Asthenia, Blood test normal, Computerised tomogram normal, Convulsion, Crying, Depression, Disturbance in attention, Dizziness, Fatigue, Gaze palsy, General physical health deterioration, Joint stiffness, Menstrual disorder, Migraine, Muscle twitching, Myalgia, Nausea, Pain, Pallor, Psychiatric symptom, Scan brain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (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), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA03314

Write-up: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor''s offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn''t been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter''s life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn''t want to do anything but lay around. She was starting to demonstrate signs of depression; she didn''t want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn''t concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn''t able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn''t enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it''s cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient''s outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.


VAERS ID: 392717 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-07-12
Entered: 2010-07-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: 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? 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: WAES1007USA00325

Write-up: Information has been received from a physician concerning one of her patient''s parents who heard that a female patient, on an unspecified date, received a dose of GARDASIL injection (Lot#: not reported) and she became paralyzed. The physician stated that it was not one of her patients. The outcome of the patient was not reported. Paralysis was considered to be disabling. No further information is available.


VAERS ID: 397213 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-01
Entered: 2010-09-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Cholecystectomy, Gallbladder disorder
SMQs:, Acute pancreatitis (broad), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1008USA03608

Write-up: Information has been received from a physician concerning a female patient who on unspecified date was vaccinated IM with 0.5ml of GARDASIL. The patient got terrible pain in upper quadrant above the gall bladder after receiving GARDASIL (Number of doses unspecified). Her mother took her to several gastroenterologists (names and locations unspecified). Quite a few lab diagnostics tests were performed, the results were not reported. "The patient was hospitalized and finally got her gall bladder removed."It was stated "there was a problem with her gall bladder". After the surgery, she was getting better. The adverse event was considered to be disabling and other important medical event by the reporter. Additional information has been requested.


VAERS ID: 397437 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-02
Entered: 2010-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: WAES1008USA04132

Write-up: Information has been received from a physician that he heard from a parent of one of his patients who also heard from elsewhere concerning a female who was vaccinated with a 0.5ml dose of GARDASIL, IM. "Some time passed, then she died". The cause of death was not reported. The patient received unspecified medical attention. Died was considered to be disabling and immediately life-threatening. No further information is available.


VAERS ID: 399488 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-08-04
Entered: 2010-09-08
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Myalgia, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA02026

Write-up: Initial and follow up information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the approximately second dose of GARDASIL (lot #, route and site of administration not reported). Subsequently, the patient developed hives, joint pain and muscle aches. The patient was having debilitating problems and now dependent on steroids. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. Hives, joint pain, muscle aches and debilitating problems were considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 410326 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-11-24
Entered: 2010-11-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA02092

Write-up: Information has been received from a nurse practitioner and a registered nurse that a female who in 2007 was vaccinated with the first dose of GARDASIL (lot number not provided), in 2008 was vaccinated with the second dose of GARDASIL (lot number not provided), in 2009 was vaccinated with the third dose of GARDASIL (lot number not provided). It was reported that the patient had received the GARDASIL vaccinations at another physician''s office. On 16-AUG-2010 the patient experienced the first grand mal seizure. The registered nurse stated that the patient has had a "bad year". The patient was a junior in high school and was "pretty much homebound at this time", per the patient''s mother. The patient has seen a neurologist and a cardiologist (name of physicians were unknown to the reporter). At time of the report, the patient''s outcome was unknown. Grand mal seizure was considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 410853 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-06-01
Onset:0000-00-00
Submitted: 2010-11-30
Entered: 2010-12-01
   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: Asthenia, Convulsion, Dizziness, Eye pain, Feeling abnormal, Loss of consciousness, Movement disorder, Nausea, Pain in extremity, Photophobia, Speech disorder, Syncope, Walking aid user, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Fibromyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA03558

Write-up: This information has been received from a physician who received the information from a consumer that provided him a link to a forum concerning a female patient with fibromyalgia who was vaccinated with GARDASIL first dose in June of 2007 and her second dose in August of 2007. The adverse reactions began slowly, a fainting spell within 24 hours for no reason, then a few days later - the patient''s suddenly couldn''t move or speak though her eyes remained open and she could hear. A floating sensation (also reported as "nausea") came over her, and then slowly she began to lose consciousness. This lasted about five to eight minutes. The person she was with thought she had died. After she came to, she thought the whole episode was somehow related to her fibromyalgia in a new way. Nothing like it had ever happened before to her. One week later, the patient suddenly experienced, hammering pain ran up and down her thighs and calves. This lasted about 15 minutes, and it ended as abruptly as it came on. The leg pain would come and go the rest of the summer, but in a much less intense manner (also reported as "constant pain"). In approximately the SEP- 2008 the patient experienced light hurts her eyes. At the time of reporting, the patient had not recovered from constant pain, seizures, nausea, weakness and dizziness and needed wheelchair or crutches and a walker to get around. The patient had recovered from fainting, could not move or speak, loss of consciousness, and strong pain down and up in thighs and shins. The outcome of light hurts eyes was unknown. The reporter felt that all adverse events were related to the therapy with GARDASIL. Constant pain, seizures, nausea, weakness and dizziness was considered to be disabling. Upon internal review "couldn''t move or speak" was considered to be other important medical events. This is one of two reports from the same source. No further information is available.


VAERS ID: 412282 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-12-08
Entered: 2010-12-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: WAES1011USA03821

Write-up: Information has been received from a nurse practitioner, who mentioned a magazine''s article concerning 70 young female patients who, on an unspecified date, were vaccinated with a dose of GARDASIL (lot #, expire date and route not reported), 0.5 ml. On an unspecified date the patients died from "neurological causes" after being given GARDASIL. "Neurological disorders" were considered to be immediately life-threatening and disabling by the nurse practitioner. Additional information has been requested. This is one of two reports from the same source. Attempts are being made to verify the existence of identifiable patients. This is one of two reports from the same source.


VAERS ID: 412933 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-12-15
Entered: 2010-12-16
   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: Abnormal behaviour, Brain injury, Convulsion, Cytogenetic analysis, Gait disturbance, Laboratory test, Memory impairment, Metabolic function test, Mood altered, Movement disorder, Respiratory arrest, Tic
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA01990

Write-up: Information has been received from a consumer who had received the information from the internet. The information in the internet was received by a consumer concerning her healthy daughter who was vaccinated with the first and second dose of GARDASIL shortly after the patient experienced seizures. The firstly seizure caused the patient to loss breath and she was hospitalized for 4 months. The patient experienced brain damage, memory deficiency, behavioral problems, extreme mood changes, walking disorder, tics and seizures. The patient had lost one year of school and would be able to return to school only when the medication would better control her seizures. The patient underwent 4 months of tests to detect metabolic disorders, genetic disorders and several rare conditions with no results yet. By the time of this report the outcome is unknown. The reporter felt that seizures, brain damage, memory deficiency, behavioral problems, extreme mood change, walking disorder and tics were related to therapy with GARDASIL. No further information is available.


VAERS ID: 413697 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-12-28
Entered: 2010-12-29
   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: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: WAES1012USA02761

Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). The physician was visiting his dentist and was talking to the dental hygienist about GARDASIL. The dental hygienist said she had a friend whose daughter died after getting the second dose of GARDASIL. It was unknown if the patient sought medical attention. The reporter considered death to be disabling and life-threatening. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, hospital name (if applicable), and healthcare provider name and contact information. Additional information has been requested.


VAERS ID: 414723 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-01-13
Entered: 2011-01-14
   Days after submission:1
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, Autonomic nervous system imbalance, Fatigue, Gastric disorder, Orthostatic hypotension, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), 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? 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: WAES1011USA00219

Write-up: Information has been received from a physical therapist concerning three female patients who on an unspecified date were vaccinated with a dose of GARDASIL (lot# not reported). It was reported that on an unspecified date, the patients were suffering from dysautonomia. At the time of the report, the patients'' outcomes were unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the physical therapist concerning a current 13 year old female patient who developed orthostatic hypotension, tachycardia, "tummy trouble", fainting, and chronic fatigue after she received GARDASIL (lot and date unknown). She did not go to school for long periods of time because of these symptoms. The physical therapist stated that this condition has been "life altering". At the time of this report, the patient''s outcome was unknown. Orthostatic hypotension, tachycardia, "tummy trouble", fainting and chronic fatigue were considered to be disabling. This is one of several reports received from the same source. No further information is available.


VAERS ID: 421085 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2011-03-01
Onset:2011-03-01
   Days after vaccination:0
Submitted: 2011-04-13
   Days after onset:42
Entered: 2011-04-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Fall, Head injury, Loss of consciousness, Speech disorder
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), Dementia (broad), Psychosis and psychotic disorders (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), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA00869

Write-up: Information has been received from a registered nurse concerning a female patient who in March 2011 "sometime in March" was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (Lot number not reported). Concomitant therapy included DTAP (unspecified). The nurse reported that in March 2011 "sometime in March" after received the first dose of GARDASIL intramuscularly, the patient experienced passing out, falling and hitting her head. She was taken to an unspecified hospital, received unspecified treatment and stayed there for an unspecified duration. The patient had been released from the hospital and was currently having speech problems and had short term memory loss. Therapy with GARDASIL was discontinued. At the time of the report, outcome of the patient was unknown. It was reported that the patient was not reintroduced to the therapy. Passing out, fall, hitting her head, speech problems and short term memory loss were considered to be disabling. Additional information has been requested.


VAERS ID: 422580 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-09
Entered: 2011-05-10
   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: Chemotherapy, Rheumatoid arthritis
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA00573

Write-up: Information has been received from a physician concerning her daughter who approximately 2 years ago, in approximately 2009 was vaccinated with the first dose of GARDASIL. Within one month after vaccination, the patient was diagnosed with rheumatoid arthritis. The patient never received any additional doses of GARDASIL. The patient continued to see a specialist for her condition and had been undergoing chemotherapy with methotrexate (manufacturer unknown). Upon the time of the report, the patient was not recovered. Rheumatoid arthritis was considered to be disabling and an other important medical event by the physician. Additional information has been requested.


VAERS ID: 429262 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2011-02-01
Onset:0000-00-00
Submitted: 2011-08-04
Entered: 2011-08-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
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: WAES1104USA01919

Write-up: Information has been received from a physician''s assistant concerning a female patient who in approximately February 2011 ("around two months ago"), was vaccinated with a first 0.5 ml dose of GARDASIL. Subsequently the patient said her arm where the injection was given, it swelled up and she had a lot of pain about 5 days around the injection site. The swelling continued for days as well. She had limited use in her arm because of the swelling. It was reported after 5 days the adverse events improved. The patient did not want to continue the second and third dose. At the time of reporting, the patient was fine. The patient did not seek medical attention. The "arm where the injection was given, swelled up" was considered to be disabling ("She had limited use in her arm because of the swelling"). No further information is available.


VAERS ID: 433517 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-07
Entered: 2011-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: WAES1109USA00208

Write-up: Information has been received from an office manager concerning a female patient (a mailman''s daughter) who on an unknown date, received GARDASIL (lot# and expiration date not provided). It was unknown which dose in the series it was. It was reported that "up to a few weeks ago" (in 2011), the patient experienced becoming paralyzed in the legs after receiving GARDASIL. The patient had sought unspecified medical attention. At the time of report, the outcome of the adverse event was unknown. Paralyzed in the legs was considered to be "probably" significant disability or incapacity by the reporter. Additional information has been requested.


VAERS ID: 436684 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-03
Entered: 2011-10-04
   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: Bedridden, Biopsy, Blood aluminium increased, Blood test, Carbohydrate intolerance, Coeliac disease, Glucose tolerance impaired, Hypoaesthesia, Lumbar puncture, Mobility decreased, Reaction to preservatives, Toxicologic test abnormal, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA02730

Write-up: Information has been received from a consumer concerning her daughter, who on an unspecified date was vaccinated with a first dose of GARDASIL (lot #, dose and route not reported). The mother reported that on an unspecified date her daughter experienced vomiting within 12 hours of receiving her first dose of the vaccine. The vomiting had not stopped since then. The consumer reported that her daughter had 90% of the post-marketing side effects in the prescribing information. On an unspecified date her daughter experienced a 30 pound weight loss and could no longer eat anything with gluten, sugar, preservatives or carbohydrates. She was starting to experience numbness in both feet. At some unidentified time her daughter was in bed for 5 months. She also reported that her daughter had a toxic level of aluminum in her system. She was hospitalized for 17 days; lab diagnostic studies included biopsy, spinal taps and unspecified blood tests (results not provided). At the time of the report the patient had not recovered from the adverse events. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in her feet, was in bed for 5 months and toxic level of aluminum were considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information is not expected.


VAERS ID: 440061 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-25
Entered: 2011-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Childhood disintegrative disorder, Educational problem, Learning disorder, Reading disorder
SMQs:, Dementia (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: WAES1110USA02911

Write-up: A consumer obtained the information from a website concerning a female student patient who was an honor roll student in the seventh grade, failing in the eighth grade and starting high school in a special education class in diapers who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and route not provided). On an unspecified date, the patient was reading at a fifth grade level with maybe the comprehension of fourth grader. She was kicked out of school that year in just the third week. At the time of this report, the patient''s outcome was unknown. Upon internal review "she was reading at a fifth grade level with maybe the comprehension of fourth grader and she was kicked out of school" were considered to be disabling. No further information is available.


VAERS ID: 445119 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-09
Entered: 2011-12-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune disorder, Chronic fatigue syndrome, Depression, Disinhibition
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA00219

Write-up: Information has been received from a nurse practitioner student (who was also a registered nurse) concerning a female who on an unspecified date ("a couple years ago") was vaccinated with the first dose of GARDASIL (Lot# was unspecified) (intramuscularly, dose not reported). With in days the patient showed signs of an unknown auto immune disorder. The nurse said they also showed signs of chronic fatigue syndrome, depression, possible retardation and a general lack of inhibition. The patient sought unspecified medical attention. Therapy with GARDASIL was discontinued. The patient''s adverse events were considered to be disabling by reporter. At the time of reporting, the outcome was unknown. Additional information has been requested.


VAERS ID: 451952 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-03-15
Entered: 2012-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Coma, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), 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: WAES1203USA00909

Write-up: Information has been received from a retired physician concerning a female patient (young girl) (age unknown) who on an unknown date was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). The physician stated that he knew that the patient had a reaction to GARDASIL. On an unknown date, the patient fainted in the office (name of the office unspecified) and later was hospitalized, released (date unspecified). At the time of reporting, the patient had not recovered and was hospitalized and in coma. Coma was considered to be immediately life-threatening and disabling per retired physician. No further information is available.


VAERS ID: 452264 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-03-21
Entered: 2012-03-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES1203USA01919

Write-up: Information has been received from a Physician''s Assistant (P.A.) who overheard a conversation, which stated a female patient, who on unknown date was vaccinated with a dose of GARDASIL (lot#, dose and route not reported). It was reported that the patient following vaccination of GARDASIL, "was in a wheelchair for 3-4 months". The patient sought unspecified medical attention. At the time of reporting, the patient''s status was unknown. "Was in a wheelchair for 3-4 months" was considered to be disabling. Additional information is not expected.


VAERS ID: 456563 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-05-30
Entered: 2012-05-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Blood mercury abnormal, Life support
SMQs:, Acute central respiratory depression (broad), Respiratory failure (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: Serum mercury test, extremely high levels of mercury in her blood stream
CDC Split Type: WAES1205USA04900

Write-up: Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (site, dose and lot# not reported). No other vaccines were administered on the same date. It was reported that the pharmacist heard about this adverse experienced from a mom of a patient who was vaccinated with GARDASIL. She said the mom told her that after her daughter got vaccinated at a physician''s office, the daughter had a serious adverse event and ended up in the hospital on life support. They were treating her for extremely high levels of mercury in her blood stream. This happened right after she received the GARDASIL vaccine. Extremely high levels of mercury in her blood stream were considered to be significant disability and life threatening by the reporter. Additional information has been requested.


VAERS ID: 457410 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-13
Entered: 2012-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Lyme disease
SMQs:, Dementia (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: Unknown
CDC Split Type: WAES1208USA01077

Write-up: Information has been received from a licensed practical nurse concerning a female patient of colleague age who on an unspecified date was vaccinated with her first dose of GARDASIL (lot # not reported). Two months later or a short time after, the girl was diagnosed with Lyme disease and they did not know that she had Lyme disease. They were claiming that the GARDASIL exacerbated the Lyme disease and saying the vaccination brought the symptoms on of the Lyme disease. She got vaccinated and all the sudden her symptoms came out to the point where she could not work or go to school. They thought it could have been an auto-immune response but they did not know for sure. The only thing that they thought might have triggered her symptoms becoming a parent was her vaccination of GARDASIL. The provider told the patient not to get any more GARDASIL vaccines so they were not completing the series. The patient went and saw a specialist because of the Lyme disease symptoms. At the time of the report, the patient had not recovered. Upon internal review, Lyme disease was considered to be disabling. Additional information has been requested.


VAERS ID: 516088 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-09
Entered: 2013-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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? 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: WAES1312USA002470

Write-up: This spontaneous report as received from a journalist refers to a young female patient of unknown age. On an unknown date, the patient was vaccinated with a dose or doses of GARDASIL (route, dose and lot # not reported). On an unknown date, the patient experienced paralyzed from the waist down after receiving GARDASIL. At the time of the report, the patient''s outcome was unknown. The reporter considered paralyzed from the waist down to be disabling. Upon internal review paralyzed from the waist down was considered to be medically significant. Additional information is not expected.


VAERS ID: 516169 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-11
Entered: 2013-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disability, 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? 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: WAES1312USA003517

Write-up: This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. It was reported that the nurse had seen an unspecified video on "You Tube" regarding unspecified patient who had suffered paralysis after receiving unspecified doses of GARDASIL at an unspecified time and date. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, route and dosage were not reported). On an unknown date the patient experienced paralysis. The outcome of paralysis was unknown. The event ''paralysis'' considered to be significant disability. Upon internal review the event ''paralysis'' was considered to be medically significant. Additional information has been requested.


VAERS ID: 516644 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-16
Entered: 2013-12-16
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, Headache, Migraine
SMQs:, Dementia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA005382

Write-up: This spontaneous report as received from nurse practitioner (as informed by the mother of an unspecified patient) refers to a male patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (lot#, route of administration, dosage were not reported). No concomitant medication was reported. On an unknown date, the patient experienced a severe headache, a migraine after receiving the second dose of GARDASIL. The patient sought medical attention. The patient was seen in the emergency room. The headache lasted for one week and the patient was unable to attend school. It was also reported by the physician that the headache was severe. On an unspecified date, headache was resolved and the outcome of migraine was unknown. The event severe headache was considered serious as it had caused disability (patient was unable to attend school). Additional information has been requested.


VAERS ID: 516782 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-17
Entered: 2013-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Premature menopause
SMQs:, Fertility disorders (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: WAES1312USA007548

Write-up: This spontaneous report was received from a nurse refers to a female patients 2 cousins of unknown age. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient experienced premature ovarian failure. The event of premature ovarian failure was considered as serious due to significant disability or incapacity. It was reported that when the response was requested, the representative stated that premature ovarian failure could present incapacity to become pregnant, at least temporarily for each patient. The outcome of the event premature ovarian failure was unknown. The reporter did not provide the causality between the event and the suspect drug. This is one of the two reports received from the same reporter. Additional information has been requested.


VAERS ID: 516783 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-17
Entered: 2013-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Premature menopause
SMQs:, Fertility disorders (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: WAES1312USA006462

Write-up: This spontaneous report was received from a nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient experienced premature ovarian failure. The patient reported that 2 of her cousins also experienced premature ovarian failure some time after receiving GARDASIL. The event of premature ovarian failure was considered as serious due to significant disability or incapacity. It was reported that when the response was requested, the representative stated that premature ovarian failure could present incapacity to become pregnant, at least temporarily for each patient. The outcome of the event premature ovarian failure was unknown. The reporter did not provide the causality between the event and the suspect drug. This is one of the two reports received from the same reporter. Additional information has been requested.


VAERS ID: 521594 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-03
Entered: 2014-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Antisocial behaviour, Back pain, Condition aggravated, General physical health deterioration, Insomnia, Pain, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Hostility/aggression (narrow), 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: WAES1401USA014798

Write-up: This spontaneous report as a part of social media received from a Twitter user who refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported). It was reported that the patient had matching symptoms to those mentioned in the report with MARRS# 1401USA014506. It was reported that on unspecified date the patient finished the GARDASIL vaccine series, and her health went downhill from there. Her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. It was reported that she has been in pain for years, she was visiting multiple doctors, who gave her pain remedy that did not work, they did not have any explanation for patient''s severe back pain or leg pain. She stated that the pain would not go away. It was reported that she could not walk, she could not sleep, she could barely have friends. The patient was on a strict diet and vitamin regimen to cleanse her body. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. This is one of the several reports received from the same source. Upon internal review, the event she could not walk was considered to be disabling. Additional information is not expected.


VAERS ID: 527304 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-01
Entered: 2014-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES1403USA014219

Write-up: This spontaneous report as received from a Registered Nurse refers to 213 female patients of unknown age. The patient''s current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). On an unknown date, the reporter stated that the patients who took GARDASIL suffered permanent disability. At the time of the report outcome of permanent disability was unknown. The reporter considered the events as permanent disability. Additional information has been requested.


VAERS ID: 536633 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-15
Entered: 2014-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
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: WAES1407USA006221

Write-up: This spontaneous report as received from a healthcare worker via a company representative reported that an unspecified doctor in their office stated that his daughter''s friend (female, age unknown) who on an unspecified date was vaccinated with GARDASIL (dose, route and lot # not reported). It was unknown which of the three-doses in the series was received by the patient, and if the GARDASIL series was completed. On an unspecified date after receiving GARDASIL, the patient experienced a seizure. It was reported that the patient was no longer able to drive and also had other unspecified incapacities after the event occurred. The outcome of the adverse event was unknown. The healthcare worker considered the event to be significant disability or incapacity. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.


VAERS ID: 538908 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-05
Entered: 2014-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Wheelchair user
SMQs:

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: WAES1408USA001101

Write-up: This spontaneous report was received from a Journalist refers to a female patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot # were not reported). On an unknown date, the patients experienced unspecified adverse effects that have left them wheelchair bound, after receiving GARDASIL. The outcome of unspecified adverse effects that have left them wheelchair bound was unknown. This is one report of several reports from the same source (MARRS # 1408USA001063). This case was considered medically significant due to patient disabling. Additional information has been requested.


VAERS ID: 538973 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-06
Entered: 2014-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Wheelchair user
SMQs:

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: WAES1408USA001063

Write-up: This spontaneous report was received from a Journalist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL for (dose, route and lot # were not reported). On an unknown date, the patient experienced unspecified adverse effects that has left her wheelchair bound, after receiving GARDASIL. The outcome of unspecified adverse effects that has left her wheelchair bound was unknown. This is one report of several reports from the same source (MARRS # 1408USA001101). This case was considered medically significant due to patient disabling. Additional information has been requested.


VAERS ID: 541768 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-29
Entered: 2014-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA014775

Write-up: This spontaneous report was received from a physician assistant, via a company representative, concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. In approximately 2013 (reported as about a year ago) the patient was vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician assistant reported to the representative, "about a year ago, approximately in 2013, 1 week after receiving GARDASIL the anonymous patient (demographics unknown) developed Guillain-Barre and was hospitalized". The outcome of "Guillain-Barre" was reported as recovered on an unknown date. Patient sought medical attention. The physician assistant considered the event as serious due the disability. Upon internal review the event "Guillain-Barre" was considered as Medically significant. Additional information has been requested.


VAERS ID: 545750 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-30
Entered: 2014-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013194

Write-up: This spontaneous report has been received from a physician via the field employee refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with GARDASIL. No concomitant therapy was reported. Physician reported that there was a video, where a girl stated that she had difficulty walking (disability) after her second dose of GARDASIL on an unspecified date. Whether the patient sought medical attention was not specified. No product quality complaint was involved. The physician heard about that video from his patients. The present status and the outcome of the event was unknown. The reporter causality assessment was not reported. Additional information is not expected.


VAERS ID: 563595 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-04
Entered: 2015-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Postural orthostatic tachycardia syndrome
SMQs:, Dementia (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1502USA000852

Write-up: This spontaneous report as received from a consumer refers to a currently 17-year-old female, who was the reporter''s cousin in law''s daughter. The patient''s medical history and concurrent conditions were not reported. On an unknown dates, the patient was vaccinated with 3 doses of GARDASIL (doses, routes of administration, anatomical locations, lot# and exp. dates were not reported). Concomitant therapies were not reported. On an unknown date, reported as "several years ago", the patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS). History and details of the diagnosis were not specified. It was reported that the patient was athletic and was playing sports at the time her symptoms started. Since diagnosis the patient was unable to play sports and her activities were limited. The patient was visiting acupuncturist to help her with the symptoms. The outcome of the events was unknown. The relatedness between vaccination with GARDASIL and the events was unknown. Upon internal review, the event of being unable to play sports and limited activities was considered to be disabling. Additional information has been requested.


VAERS ID: 583885 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-30
Entered: 2015-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Intensive care, Malaise
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? 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: WAES1506USA013728

Write-up: This spontaneous report as received from a registered nurse (R.N.) via a field representative refers to a male patient of an unknown age. The patient''s medical history and drug allergies were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL (intramuscular, dose, lot# and expiration date were not reported). It was not confirmed if this was the first time the patient was vaccinated with GARDASIL. The patient''s concomitant medication was not specified by the reporter. It was reported that in approximately 2015 (reported as a few weeks ago), the patient became "ill" after receiving GARDASIL and was admitted to an unspecified hospital (in the Intensive Care Unit) for about a week. While in the hospital the patient was diagnosed with Guillain-Barre syndrome. It was reported that unspecified diagnostic tests were performed and that an unspecified treatment was given for the adverse event. The outcome of Guillain-Barre syndrome was reported as recovering. Causality assessment between the event of Guillain-Barre syndrome and GARDASIL was not provided. The reporter considered the event of Guillain-Barre syndrome as medically significant, disabling and life threatening (based on the physician''s diagnosis). Additional information has been requested.


VAERS ID: 592257 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-31
Entered: 2015-08-31
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, Asthenia, Muscle atrophy
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: WAES1508USA011202

Write-up: Information has been received from a physician via company representative referring to a female patient of unknown age. The patient''s pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose, strength and route unknown). On an unknown date after the vaccination the patient experienced muscle atrophy. The field representative did not know whether the patient received GARDASIL or GARDASIL 9 therefore the event was being taken for GARDASIL. The field representative also reported that the physician said it was debilitating and that the patient used to be a swimmer, and he/she guessed the patient didn''t or couldn''t swim anymore so the field representative would consider that there was significant disability/incapacity. The outcome of the event was unknown. The reporter considered muscle atrophy was attributed to GARDASIL. Additional information is not expected as the physician refused to be contacted.


VAERS ID: 594950 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-14
Entered: 2015-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Paraplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: WAES1509USA005240

Write-up: This spontaneous report was received from a physician via company representative refers to an unspecified child female patient of unknown age. The patient''s medical history, concurrent conditions and concomitant medications were not reported. It was reported that unspecified mother of a child stated to the physician that she did not want to give her child the GARDASIL, because her friends neighbor''s daughter was vaccinated (date unspecified) with the dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not reported) and became paraplegic (details unspecified). The physician said the mother informed him that this was described in the newspapers (unspecified). The outcome of the adverse event and the causality between the adverse event and GARDASIL were not provided. Upon internal review, paraplegia was considered to be disabling. Is not expected as there was no consent for the follow-up.


VAERS ID: 596331 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2010-09-01
Submitted: 2015-09-14
   Days after onset:1839
Entered: 2015-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Adverse event
SMQs:, Dementia (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: WAES1509USA006034

Write-up: This initial spontaneous report was received from the patient''s mother referring to her daughter; a female patient of unknown age. There was no pertinent medical history or drug allergies/drug reactions reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL injection (strength, dose, route, lot # and expiration date were not provided). There was no concomitant medication described. The reporter stated that since on an unknown date in September 2010, her daughter had been "out of school" due to developed unspecified symptoms after receiving GARDASIL. At the time of the report, the outcome of adverse event was not recovered. The relatedness between the adverse event to GARDASIL was not reported. Upon internal review adverse event was considered as disabling. Additional information has been requested.


VAERS ID: 596168 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-18
Entered: 2015-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pain, Walking aid user
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509USA009427

Write-up: This unconfirmed, spontaneous report was received from a scientist via a company representative refers to a female patient of unknown age. The company representative heard a news story on television channel. On an unknown date, the patient was vaccinated with second dose of GARDASIL or GARDASIL 9 (dose, frequency, indication and route of vaccination were not reported). On an unknown date, the patient began experiencing constant nausea and chronic pain, which required her to walk with a cane, after being administered her second dose. The patient has been seen by many physicians for her situation. The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, chronic pain was considered to be disabling. This is one of several reports received from the same reporter. Additional information is not expected, because contact details were not provided.


VAERS ID: 607442 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-04
Entered: 2015-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Fall, Fatigue, Immune system disorder, Impaired driving ability, Impaired work ability, Malaise, Quality of life decreased, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511USA002404

Write-up: This spontaneous report as received from a consumer''s mother via Sanofi Pasteur MSD refers to her daughter of unknown age. The reporter stated that her daughter was once a young healthy cheerleader. Beauty pageant queen, and a personal trainer. She loved life and was very active with a promising career ahead of her. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). There was no concomitant medication provided. On an unknown date, her health rapidly declined. She ended up in a wheelchair not able to walk for two years and her immune system was shot, so she got sick all of the time. She could not work, drive, or live a normal life. She fall all of the time and it was all that she could do to get a shower and eat without being exhausted. The primary reporter also stated that GARDASIL had ruined her daughter''s life. The outcome of abasia, malaise, fall, immune system disorder was unknown, and the outcome of impaired work ability and daily living impaired was not recovered as she still cannot live a normal life. The reporter considered abasia, activities of daily living impaired, impaired work ability, malaise, fall, fatigue and immune system disorder to be related to GARDASIL. Upon internal review, she was not able to walk for two years, impaired work ability and daily living impaired were determined to be serious due to disability. Additional information is not expected because the reporter details were not provided.


VAERS ID: 607445 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-05
Entered: 2015-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511USA001864

Write-up: Information has been received from a physician via a company representative referring to a female patient in her 20''s. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose and lot# were not reported). On an unknown date the patient experienced multiple sclerosis. The patient sought medical attention by seeing the physician. The outcome of multiple sclerosis was unknown. Causality was not reported. Upon reporter''s assessment and internal review, the event of multiple sclerosis was considered to be medically significant. Additional information is not expected because the physician would not like to be contacted.


VAERS ID: 611323 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-23
Entered: 2015-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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? 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: WAES1511USA011898

Write-up: This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age (the neighbor of the physician''s mother). The patient''s medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an unidentified Merck HPV vaccine (name and lot number not provided) (GARDASIL or GARDASIL 9 could not be ruled out). Concomitant therapy was not reported. It was reported that on an unspecified date the patient was "paralyzed" after being administered the vaccine. The outcome of "paralyzed" was unknown. It was unknown if the patient sought any medical attention. Upon internal review, the event of "paralyzed" was considered to be medically significant and resulted in disability. Additional information has been requested.


VAERS ID: 614359 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-11
Entered: 2015-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bedridden, Injury, Wheelchair user
SMQs:, Accidents and injuries (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512USA004683

Write-up: This spontaneous report as received from other source as part of a marketing research-program, refers to unspecified patients of unknown demographics. The medical history and concurrent conditions of the patients were not reported. On an unknown date, the patient was vaccinated with GARDASIL of unknown strength (dose, frequency, lot number not reported). Concomitant medications were not reported. The reporter was sharing the experiences of some of the GARDASIL vaccine injury patients and stated that some patients who had GARDASIL have been in wheel chairs and bed bound. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. The reporter considered the events to be disabling. Additional information has been requested.


VAERS ID: 615619 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-18
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512USA009178

Write-up: This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. This report refers to a 949 patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients experienced an unspecified disability. At the time of this report, the outcome was unknown. The reporter considered the event as disabled. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.


VAERS ID: 615622 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-18
Entered: 2015-12-18
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, Adverse event, Disability
SMQs:, Dementia (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: WAES1512USA007926

Write-up: This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. Patient''s mother claimed that her daughter, a female patient of an unknown age, received a dose of GARDASIL (dose, route, lot # and expiration date were not provided) on an unknown date. On an unknown date, the patient needed permanent care. At the time of this report, the outcome of adverse event was reported as unknown. The event was considered to be disabled. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.


VAERS ID: 615711 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-20
Entered: 2015-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event
SMQs:

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: WAES1512USA008923

Write-up: Information has been receive from a consumer via Corporate Twitter and an online article, referring to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, (dose, lot# and route not reported). The article reported a mother claimed her daughter experienced horrendous adverse event which needed permanent care after receiving GARDASIL. The outcome of the event was unknown. The reporter considered the event to be disability. Additional information has been requested.


VAERS ID: 618365 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
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. - / UNK UN / UN

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

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: WAES1601USA002681

Write-up: This spontaneous report as received via social media from an unspecified reporter, who obtained the information from the articles published on a web page, refers to many female patients of unknown age. The patients'' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with unknown doses of GARDASIL (lot #, expiry date, route and site of administration were not reported). Concomitant medications were not reported. On unknown dates, many of patients experienced disability. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL (it was reported that vaccine "disabled many women"). This is one of two reports received from the same reporter. Additional information has been requested.


VAERS ID: 619115 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-15
Entered: 2016-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: WAES1601USA003641

Write-up: Information has been received from an unspecified reporter via social media referring to thousands of unspecified female patients. On unknown dates the patients were vaccinated with GARDASIL (dose, lot # and route were unknown). On unknown dates. the patients were killed and disabled by therapy with GARDASIL. Outcome of disability was unknown. It was unknown if autopsies were performed. Additional information has been requested.


VAERS ID: 620522 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-25
Entered: 2016-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Infection, Lyme disease, Refusal of treatment by patient, Wheelchair user
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601USA006167

Write-up: This spontaneous social media report was received from a patient''s parent via web page and refers to a female patient of unknown age. The patient''s medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient was diagnosed with co-infector and Lyme illiterate state. The patient was refused a standard anti-biotic treatment. There was some "permed ant damage" from going years without treatment. The patient underwent alternative, non-invasive treatment. The outcome of adverse events was reported as drastic improvement as the patient went from asking for a wheelchair to applying to college within days. The relatedness between adverse events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that they caused permanent damage. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 623547 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-24
Entered: 2016-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Gait disturbance, Mobility decreased, Nervous system disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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: Phototherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1602USA009955

Write-up: This spontaneous report as received from a physician via company representative refers to a female adolescent patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in 2015 (reported as around 6 months ago), the patient was vaccinated with GARDASIL (dose, route and site of administration, lot and expiration date were unknown). It was unspecified if this was the first, second or third shot in the GARDASIL series. On an unknown date in 2015 (reported as "shortly after" receiving the GARDASIL), the patient began to experience neurological problems, including "difficulty walking and getting around". The patient sought unspecified medical attention. These symptoms had led to a significant change in the adolescent''s lifestyle, including the need to quit cheerleading. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review the events of difficulty in walking and mobility decreased were considered to be disabling. Additional information has been requested.


VAERS ID: 631149 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-13
Entered: 2016-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Condition aggravated, Immobile, Laboratory test abnormal, Paralysis, Rheumatoid arthritis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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: No other medications
Current Illness: Rheumatoid arthritis; Sjogren''s Syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Physical examination, given a diagnosis of rheumatoid arthritis
CDC Split Type: WAES1604USA006608

Write-up: This spontaneous report as received from a currently 29 years old female patient who was a certified medical assistant (C.M.A.) refers to herself via a field employee. The patient''s concurrent conditions included Sjogren''s syndrome and rheumatoid arthritis. On unknown dates, the patient was vaccinated with a first and a second dose of GARDASIL and on an unknown date in 2007, she was vaccinated with a third dose of GARDASIL (doses, routes of administration, lot # and expiration dates were not provided). The patient did not take any concomitant medications. On an unknown date (reported as "several months" after the patient received the third dose in the GARDASIL series), she felt paralyzed due to severe joint pain all over her body. The patient also felt immobilized for an unspecified amount of time prior to receiving treatment with unspecified doses of methotrexate (manufacturer unknown), Sulfa and prednisone (manufacturer unknown) for an unspecified amount of time. On an unknown date, the patient had a follow up appointment with her physician where the physician ran some unspecified tests and gave a diagnosis of rheumatoid arthritis. The physician also told the patient that her rheumatoid arthritis was "dormant in her body" prior to receiving the GARDASIL series and the vaccine could have possibly triggered the rheumatoid arthritis. At the time of the report, the patient still had the rheumatoid arthritis, was on an unspecified dose of XELJANZ and was no longer on the treatment with methotrexate (manufacturer unknown), Sulfa and prednisone. The event of rheumatoid arthritis was considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 636336 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2009-05-01
Submitted: 2016-05-20
   Days after onset:2576
Entered: 2016-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES1605USA009602

Write-up: Information was received from a physician via an Internet article regarding cases in litigation concerning female patients of unknown ages, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010, there were reported to be 213 cases of permanent disability (unspecified) that occurred after GARDASIL vaccination. 213 cases of permanent disability was considered to be disabling. This is one of several reports from the same source. Additional information is not expected.


VAERS ID: 636965 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-25
Entered: 2016-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1605USA010338

Write-up: This spontaneous report was received from an unspecified reporter via an online post that refers to an unspecified number patients of female patients of unknown age. Information regarding the patients'' medical history and current condition were not provided. The online article states that patients were vaccinated with GARDASIL and then developed chronic health problems (adverse event), several hundred young women had died and thousands more were permanently disabled. There were cases of sudden death following the vaccination. Syncope was also mentioned to be the most common adverse reaction after use of GARDASIL. The outcome of the adverse event, disability and syncope was unknown. The causality assessment was not provided. Upon internal review, sudden death and disability was considered to be medically significant. Permanent disability was considered to have caused significant incapacity/disability. The case is linked to 1605USA011079 (same reporter link). Additional information has been requested.


VAERS ID: 646389 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2013-07-01
Onset:0000-00-00
Submitted: 2016-07-29
Entered: 2016-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Allodynia, Alopecia, Anxiety, Asthenia, Autoimmune thyroiditis, Balance disorder, Blood potassium decreased, Chest pain, Cough, Dizziness, Dyspnoea, Ear pain, Electrocardiogram QT prolonged, Electrolyte substitution therapy, Electromyogram abnormal, Exercise tolerance decreased, Familial periodic paralysis, Hypokalaemia, Mineral supplementation, Muscle spasms, Nasopharyngitis, Nausea, Nerve injury, Nystagmus, Seizure, Sinusitis, Temperature intolerance, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Retroperitoneal fibrosis (broad), Torsade de pointes, shock-associated conditions (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (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), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electromyography (EMG test) results (unknown date): nerve damage; Potassium results (unknown date): low, hypokalemia
CDC Split Type: WAES1607FRA011670

Write-up: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient''s new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto''s, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto''s, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.


VAERS ID: 648864 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-22
Entered: 2016-08-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES1608USA011013

Write-up: Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient''s mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690). The patient''s mother reported that according to the internet 2000 girls had the same problem (alopecia) (MARRS # 1608USA010994), 200 died (MARRS # 1608USA011010) and 65 had neurological problems and they were in wheelchairs. No further information was reported. Neurological problems and they were in wheelchairs was considered to be disabling. Additional information is not expected. Information was received via a business partner.


VAERS ID: 650239 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-26
Entered: 2016-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Impaired quality of life, Muscle disorder
SMQs:, Rhabdomyolysis/myopathy (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: WAES1608USA007985

Write-up: This solicited report was received from a consumer and refers to a female patient of unknown age enrolled in a market research. the patient''s concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. It was stated that the patient was an extremely talented and dedicated dancer, who on an unknown date began to have major muscular issues and at the time of the report she was no longer able to dance. the outcome of the events was not reported. the relatedness between the events and GARDASIL was not reported. Additional information is not expected as the reporter refused additional contact.


VAERS ID: 656460 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-28
Entered: 2016-09-28
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, Dyspnoea, Headache, Loss of consciousness, Mobility decreased, Pain, Seizure, Throat tightness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (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), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (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: WAES1609USA012094

Write-up: This spontaneous report was received from a registered nurse who was notified by a field representative of a page referring to a male patient of unknown age. The patient''s concurrent conditions or concomitant medications were not reported. It was reported that the patient was an active and healthy child. On an unspecified date, the patient got vaccinated with GARDASIL (dose number, dose, frequency, anatomical location, lot number and expiration date were not reported). It was reported that since receiving the vaccine, on an unspecified date, the patient could not go to school or play sports, some days he struggled to just get out of bed and that his life had changed. It was also reported that on a good day he has 5 seizures a day and that on a bad day he can have up to 30. He was in constant pain and had severe headaches. He also had issues where his throat closes up and he passes out because he could not breathe. His regular doctors and the hospital said they could not help the patient or did not know how to treat his vaccine injury. Therefore, the parents were seeking for homeopathic treatment. They did not have choice and felt that it was on the patient''s best interest. However, that route was extremely expensive. The patient was from a one income family and had 4 siblings. He can not be left alone, and they have had to completely change his diet which causes the grocery bill to double, and they were beginning to receive the mounds of bills from his doctor and hospital visits. The outcome of the events was unknown. Upon internal review, can''t go to school or play sports, struggles to just get out of bed. Live for his active child has changed was considered to be disabling and loss of consciousness and Seizures were considered to be medically significant events. Additional information is not expected as the reporter did not give consent for follow up.


VAERS ID: 660965 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2014-03-01
Onset:2014-04-01
   Days after vaccination:31
Submitted: 2016-10-21
   Days after onset:934
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Coeliac disease
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610USA010938

Write-up: This spontaneous report was received from a Nurse via a company representative referring to a female patient of unknown age. The patient''s pertinent medical history, concurrent conditions and concomitant therapies were not reported. In March 2014, the patient was vaccinated with a dose of GARDASIL (Dose, route, lot # and expiration date were not provided). In April 2014 (reported as a month later), the patient lost her ability to walk and play sports and was home-bound and could not go to school. In November 2015, the patient was diagnosed with coeliac disease. It was stated that the patient was placed on a "special diet" and that 2 weeks after she started the diet she was fine and back to normal. At the time of reporting, the outcome of abasia was unknown. The causality assessment between the events and GARDASIL was not provided. Upon internal review, coeliac disease was determined to be medically significant. Additionally, abasia was determined to be medically significant and disabling. Additional information has been requested.


VAERS ID: 669324 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2015-05-01
Submitted: 2016-12-02
   Days after onset:581
Entered: 2016-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chemotherapy, Laboratory test, Ovarian germ cell teratoma
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Ovarian malignant tumours (narrow), Non-haematological malignant tumours (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: No other medications
Current Illness: Immunisation; Asthma; Chemotherapy, The patient was treated with "6 rounds of chemotherapy" with several medications including Cisplatin, Etoposide and Bleomycin.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Several unspecified lab/diagnostic testing (Unknown date) - Results not provided. Lab diagnostics studies performed: "Adhesives" (Unknown date) - Results not provided.
CDC Split Type: WAES1611USA013398

Write-up: This spontaneous report was received from a nurse refers to an adult female patient of unknown age. The patient''s current condition included asthma. There were no medical history, drug reactions/allergies and concomitant medications reported. On unknown dates prior to 2015, the patient was vaccinated with GARDASIL and M-M-R II (dosing details not provided). Approximately in May 2015, the patient was diagnosed with immature ovarian teratoma. Nurse reported that the patient was seen and treated by unspecified healthcare providers, and had several unspecified lab/diagnostic testing at unspecified locations on unspecified dates. The patient required medical attention and was treated with six rounds of chemotherapy with several medications including cisplatin, etoposide and bleomycin. However, the patient was not hospitalized. Nurse stated that the patient was incapacitated for an unspecified reason for an unspecified amount of time after an unspecified treatment for immature ovarian teratoma. Outcome of the event was reported as not recovered. Nurse reported that it was decided to re-vaccinate the patient with M-M-R II on unspecified date in September or October 2016, due to possible effect of chemotherapy treatment on the immunity of measles, mumps and rubella. It was unknown whether the patient was re-vaccinated or not. Reporting nurse had not assessed the causality of the event with respect to both vaccines, GARDASIL and M-M-R II. Nurse considered the event to serious due to disability. Upon internal review, the event immature ovarian teratoma was considered to be medically significant. Additional information has been requested.


VAERS ID: 671273 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-10
Entered: 2016-12-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Disability, Immobile
SMQs:

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: US0095075131612USA003241

Write-up: This spontaneous report was received from a consumer via social media refers to some female patients of unknown age. There is no information of concomitant medication, medical history and concurrent condition. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis. On an unknown date, the patients ended up crippled (disability). The outcome of disability was unknown. Causality assessment was not provided. This case has been linked with the MARRS case no. 1612USA004594 as E2B Linked Report. Additional information has been requested. Sender''s Comments: US-009507513-1612USA004594.


VAERS ID: 680132 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-30
Entered: 2017-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Autoimmune disorder, Disability, Malaise, Myofascitis
SMQs:, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131701USA010389

Write-up: This spontaneous report was received from a social media by a physician (who is the father) refers to female patient (who is the daughter) of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL. The consumer stated that the patient went from a varsity lacrosse player to chronically ill, steroid dependent with autoimmune myofascitis (disability) after taking the GARDASIL. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.


VAERS ID: 684167 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2017-01-16
Onset:2017-01-16
   Days after vaccination:0
Submitted: 2017-02-28
   Days after onset:43
Entered: 2017-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Inflammation, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Hypersensitivity (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131702USA010202

Write-up: This spontaneous report has been received from a pharmacy student referring to a 15 year old female patient. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, the patient was vaccinated with a third dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, reported as "immediately after the third dose", the patient experienced in the vaccinated left arm and fingers pain and tingling for a month. The pain did not resolve and became worse. Therefore on an unknown date a nuclear magnetic resonance imaging (MRI) was performed and "showed inflammation". The pharmacy student also reported that the "pain spiked to 10 out of 10" and the patient could not use her arm, the reporter suspected that the patient could have osteomyelitis. The patient went to the emergency room on an unspecified date and then on 19-FEB-2017 the patient was hospitalized in a local hospital for control the pain, the patient''s treatment included TYLENOL, TORADOL and morphine. At the time of reporting the outcome of pain and tingling in her arm was not recovered and the outcome of osteomyelitis and inflammation was unknown. The reporter stated that the osteomyelitis, pain and tingling in the patient''s arm cause disability. The relatedness between the events and GARDASIL was not reported. Upon internal review osteomyelitis was considered to be a medically significant event. Additional information has been requested.


VAERS ID: 686325 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-17
Entered: 2017-03-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Antibody test, Antinuclear antibody negative, Arthralgia, Chest X-ray, Continuous positive airway pressure, Cough, Dyspnoea, Fatigue, Headache, Muscle contracture, Myalgia, Pneumonia, Rash, Rash macular, Red blood cell sedimentation rate normal, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131703USA006442

Write-up: This spontaneous report was received from a physician and refers to a "24 or 25" year old female patient. The patient had no pertinent medical history, drug reactions or allergies. Approximately in 2014 (reported as "2 and 1/2 years ago"), the subject received an injectable dose of GARDASIL for human papillomavirus (HPV) prevention (dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On an unspecified date in 2014 (reported as a few weeks after receiving GARDASIL, the patient experienced pneumonia with the following symptoms: Fatigue; muscle pain; joint pain; diffuse macular rash covering her trunk and arms; contractures of her hands and feet (muscle contracture); difficulty breathing, short of breath, coughing and headache. On an unspecified date, the patient sought medical attention and she was hospitalized by unspecified healthcare providers at an unspecified location. It was reported that the patient had multiple laboratory diagnostics and studies which included: An antinuclear Antibody test (ANA) and erythrocyte sedimentation rate which were normal; and urine tests, a chest x-ray and unspecified "titers" which results were not provided. Moreover, the patient was treated with unspecified antibiotics, unspecified inhalers, and with a continuous positive airway pressure (CPAP) machine; and she received occupational, physical and respiratory therapies (all on unspecified dates). At the time of the report, the patient had not recovered from myalgia, arthralgia, rash macular, muscle contracture and pneumonia. The relatedness between GARDASIL and the events of myalgia, arthralgia, rash macular, muscle contracture and pneumonia was not reported. The reporter considered the events of myalgia, arthralgia, rash macular, muscle contracture and pneumonia to be disabling and life threatening events. Moreover, upon internal review, the event of pneumonia was considered to be medically significant. This is one of two reports from the same reporter. Additional information has been requested.


VAERS ID: 689343 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-04
Entered: 2017-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Acne, Anogenital warts, Arthralgia, Autoimmune disorder, Disability, Feeling abnormal, Muscle tightness, Nervous system disorder, Pain in extremity, Papilloma viral infection, Paraesthesia, Tension
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131703USA014588

Write-up: This spontaneous report was received from a male patient currently in his 40''s (reported as 40 plus years old) reporting on himself. The patient''s medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient received injections from multiple bottles and he belief that one of them may had been a dose of GARDASIL route reported as injection, as prophylaxis (Strength, dose, lot # and expiration date were not reported), however, it was also reported that the physician told the patient that he was not given GARDASIL. On an unknown date, the patient experienced joint pains (arthralgia), his hands were painful and disabled for over 20 days (pain in extremity), he experienced tingling in his arms and they tense up (paraesthesia), when he was asleep, his muscles tighten up (muscle tightness), he developed human papillomavirus (HPV 1) (papilloma viral infection), genital warts (anogenital warts) and pimples (acne), when he exercises he felt like his body was being injured (feeling abnormal), autoimmune issues (autoimmune disorder) and nerve problems (nervous system disorder). The patient was given 2 bottles of (VALTREX) for the HPV 1 but it did not work. The patient received unspecified treatment for the other events. The outcome of autoimmune disorder, arthralgia, paraesthesia, muscle tightness, acne, anogenital warts, papilloma viral infection, feeling abnormal, nervous system disorder and pain in extremity was unknown. The reporter did not provide the causality between the events and GARDASIL. The event autoimmune issues was determined to be medically significant. Additional information is not expected as no contact details were provided.


VAERS ID: 693245 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-05
Entered: 2017-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: 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? 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: US0095075131705USA001904

Write-up: This spontaneous report was received from a consumer via an online article concerning her daughter, a female patient of unknown age. The patient''s current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing details, lot and expiration date unknown) for prophylaxis. On an unknown date, the patient experienced paralysis. The outcome of paralysis was unknown. The reporter warned that GARDASIL vaccine was to blame for her daughter''s paralysis (reporter causality: related). Upon internal review, the event of paralysis was considered to be serious as disability and medically significant. Additional information is not expected as reporter contact details are not available.


VAERS ID: 693672 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-09
Entered: 2017-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Fatigue, Loss of personal independence in daily activities
SMQs:, Dementia (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: US0095075131705USA002414

Write-up: This spontaneous report was received from an unspecified source, concerning a 12-year-old patients from unknown genders, posted in an online article. The patients'' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was mentioned that ''''totally perfect patients were now in their beds, too tired to went to school '''' (disability). No further information was cited. The relatedness between disability and vaccination with GARDASIL was not provided. The event of disability was assessed as serious. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender''s Comments: US-009507513-1705USA002408: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830.


VAERS ID: 698411 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-06
Entered: 2017-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Adverse event
SMQs:

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: US0095075131706USA000362

Write-up: This spontaneous report was received from a physician via a company representative concerning an unspecified patient of an unknown age and gender. The patient''s concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL intramuscularly (dose, frequency, lot number and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). The physician reported that he was hearing that somebody in a town close, on an unknown date, experienced an unspecified disabling effect (adverse event). At the time of reporting, the outcome of the event was not reported. The causal relationship between the event and GARDASIL was not reported. The reporter considered the adverse event as a disabling event. Additional information is not expected as there are no contact details available.


VAERS ID: 700491 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-21
Entered: 2017-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Epilepsy, Loss of personal independence in daily activities, Seizure
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131706USA006831

Write-up: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient''s concurrent conditions, any known allergies or reactions, medical history or concomitant medications. In approximately 2014, (reported as two or three years ago), the patient was vaccinated with GARDASIL, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician was informed by the patient''s mother that the patient with no prior history of seizures "experienced seizures three weeks after receiving GARDASIL". Due to the events, the patient sought medical attention. Therefore, she "was seen by a neurologist" on unspecified date and was diagnosed as epileptic and needed help showering on an unspecified date (reported as "now"). The patient received unspecified treatment for the event. At the time of reporting, the patient had not recovered from epilepsy. The causal relationship between the event and therapy with GARDASIL or GARDASIL 9 was not reported. Upon internal review epilepsy was considered to be a medically significant and disabling event. Additional information is not expected because there was no consent to contact physician.


VAERS ID: 700842 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-23
Entered: 2017-06-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Disability
SMQs:

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: US0095075131706USA010923

Write-up: This spontaneous report was received from a social media via company representative regarding a female patients of unknown age. There was no information about patient''s concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients had become disabled (adverse event). Additionally it stated that the pharmaceutical companies which made the GARDASIL, as well as the Department of Health and Human Services which hold patents and earns profits from the GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, disability was determined to be medically significant event. The patients had become disabled(adverse event ) was considered to be disabling by the reporter. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained.; Sender''s Comments: US-009507513-1706USA010924: US-009507513-1706USA010923:


VAERS ID: 707904 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Disability, Laboratory test
SMQs:

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: US0095075131708USA004517

Write-up: This spontaneous report as received from a consumer refers to a 28 year old female patient (also reported as unspecified family member). The patient''s medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient received unspecified number of doses of GARDASIL (lot # and expiry date were not reported), back when it first came out and experienced side effects from the vaccine and is now bedridden(disability). The reporter states that that no one was able to figure out what''s wrong with the patient despite all the tests performed. The outcome of the adverse events were considered as not recovered. Causality assessment was not provided. No PQC involved. No further information was provided.


VAERS ID: 733921 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Muscular weakness, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131801USA003410

Write-up: This spontaneous report was received from Physician Assistant via company representative referring to an adolescent female patient of unknown age (reported as "14 or 15"). The patient''s medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On the other hand, it was also reported other suspect therapy, an unspecified birth control that was given to the patient at the same time she received the vaccine. On an unknown date, (reported as "within a few weeks"), the patient experienced headaches, syncope, muscle weakness, incontinence, and was unable to control her bladder, so she was treated at a hospital. At the time of the report, the outcome of muscular weakness, headache, syncope and urinary incontinence was reported as not recovered. Muscular weakness, headache, syncope and urinary incontinence were determined as disabling by the reporter.


VAERS ID: 734029 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-10
Onset:2018-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Heart rate increased, Hypoaesthesia, Neck pain, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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: Albuterol
Current Illness:
Preexisting Conditions: Non smoker; nurse
Allergies: Sulfa; BOTOX (anaphylaxis)
Diagnostic Lab Data: I will be going into my PCP to follow up
CDC Split Type:

Write-up: I went to my gynecologist''s office the morning of 1/10/18 for an annual check up and was given the GARDASIL vaccine. Within 10 minutes I experienced an episode of syncope and rapid heart beat and I went to the ED department to sit with the Triage nurse. Soon thereafter I experienced numbness and tingling in my arms which has not dissipated. I also experienced extreme pain at the back of my neck that lasted for about 24 hours. I am currently struggling with what feels like arthritis in my hands. All of this happened the day the GARDASIL vaccine was given to me.


VAERS ID: 741292 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2017-01-01
Onset:2017-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Borrelia test, Gait inability, Nausea, Pain in extremity, Paraesthesia, Pharyngitis streptococcal, Walking aid user
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament 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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131803USA007137

Write-up: This spontaneous report has been received from a consumer who is the patient''s mother referring to a 19 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies, or concurrent conditions. She was taking no concomitant medications. In June 2016, the patient was vaccinated with the first dose of GARDASIL by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. She received the vaccine three times at 0, 2 and 6 months. She received her third dose on January 2017. In January 2017, the patient developed strep throat. She also experienced joint pain and could not walk on her legs and had to use crutches. The patient also had tingling and pain in her extremities and sporadic waves of nausea. Additionally, the patient''s mother mentioned that "she may have chronic fatigue syndrome." The patient was treated with pain killers and was seen by a pain management doctor. She was tested for Lyme disease (results not specified). At the reporting time, the outcome of all the events was not recovered. The mother felt GARDASIL caused her daughter''s health issues. She indicated she had contacted an attorney. Could not walk on her legs, had to use crutches was considered disabling. Additional information has been requested.


VAERS ID: 750554 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2018-05-01
Submitted: 0000-00-00
Entered: 2018-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 4 - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Asthenia, Blood test abnormal, Borrelia test, C-reactive protein increased, Extra dose administered, Fall, Fatigue, Grip strength decreased, Hypoaesthesia, Laboratory test abnormal, Lyme disease, Pain management, Rheumatoid factor, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Medication errors (narrow)

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:
Other Medications: PROZAC; vitamins (unspecified)
Current Illness: Diaphragmatic hernia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131805USA008616

Write-up: This spontaneous report was received from a pharmacy technician who was the patient''s mother, referring to her 29 year old daughter. The patient''s historical drugs and medical history were not reported. The patient''s concurrent conditions included diaphragmatic hernia. The patient''s concomitant therapies included unspecified birth control, PROZAC and multivitamins. The patient did not have any drug reactions or allergies. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL for prevention (strength, dose, route, frequency, lot#, expiration date and indication were not reported) (extra dose administered). On an unknown date, after the fourth dose, the patient began to have some nerve problems, described as lost all feeling in her feet, hands and arms, her fingers were always numb (hypoaesthesia), loss of grip, fell down steps from this during college, had so many different issues (adverse event) and she was getting more debilitating (asthenia). On an unknown date (reported as "years ago"), an unspecified test of Lyme''s (results not provided), chronic fatigue (results not provided) and Guillain-Barre syndrome were performed from an unspecified healthcare worker; the results for Guillain-Barre syndrome were that some markers came up positive, but not all markers that were needed to be diagnosed. On an unknown date, a neurologist did an unspecified nerve study on an unspecified date (results not provided). On an unknown date, the patient saw an unknown physician to manage her pain. On an unknown date in May 2018 (reported as "in the last month"), the patient had a rheumatoid arthritis (RA) blood test blood work for autoimmune disorder performed by an unspecified healthcare worker, which resulted in very high levels of C-Reactive Protein (CRP) (reported as "went up another 10") and the multibiomarker Disease Activity (VECTRA) test was very high too (blood test abnormal). The patient sought medical attention and received treatment. At the time of reporting, the outcome of hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia and adverse event, Lyme disease and chronic fatigue was reported as not recovered. Additionally, the reporter was unsure if she attributes these events to GARDASIL. Hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia, adverse event, Lyme disease and chronic fatigue were considered disabling events. Upon internal review, Lyme disease was determined to be a medically significant event. This is one of several reports received from the same reporter. Sender''s Comments: US-009507513-1805USA009284.


VAERS ID: 754928 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-16
Onset:2012-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Apathy, Arthralgia, Asthenia, Blood cholesterol increased, Blood glucose normal, Blood test normal, Borrelia test negative, Chronic fatigue syndrome, Fatigue, Feeling abnormal, Full blood count normal, Hypersomnia, Immunology test normal, Menstrual disorder, Mobility decreased, Mood swings, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Lipodystrophy (broad), Arthritis (broad), Tendinopathies and ligament 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:
Other Medications: ZOLOFT; LORYNA
Current Illness:
Preexisting Conditions: High cholesterol; PMDD; Generalized anxiety disorder
Allergies: Ragweed
Diagnostic Lab Data: Tested for all autoimmune diseases, normal levels. Normal CBC and blood levels. Lyme disease negative. Diabetes negative. Extremely high cholesterol.
CDC Split Type:

Write-up: My life changed forever in 2012. My mother and I thought we were making the right choice. I received the 3 part series of the GARDASIL vaccine starting in February of 2012 and through August of 2012. After the vaccine, I started sleeping so much and my menstrual cycles worsened. I had massive mood swings and I never felt good or had energy the same ever again. In February of 2013, I was diagnosed with Chronic Fatigue Syndrome. I have been tested negative for Lyme and all other autoimmune diseases, as well as blood panels and CBC counts. After visiting several doctors, they asked if I got the GARDASIL vaccine and determined from other reports of side effects in the area that my CFS was a result of a vaccine injury from the GARDASIL. Over the years this has gotten worse, into my college years now I experience severe joint pain, muscle aches, exhaustion after completing simple tasks, lack of motivation, etc. I am still being tested every year for things such as autoimmune diseases and they still don''t have an answer, just that it''s chronic fatigue syndrome. Ever since I got this vaccine I have not been the same person. My family had to sit back and watch me change from an energy filled girl to someone who could sleep forever and has joint pain so bad sometimes she can''t move. Diet changes, exercise and pills haven''t helped. None of this was ever present until AFTER I received the GARDASIL vaccine.


VAERS ID: 782216 (history)  
Form: Version 2.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue, Loss of personal independence in daily activities, Pain
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: USMERCK1404USA005105

Write-up: This spontaneous report as received from a mother refers to a 15 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (lot number not reported) for prophylaxis. On an unknown date after the first dose of the vaccine, the patient experienced unexplained pain and fatigue. After the second dose, the pain (disability) and fatigue (disability) worsened to the point patient could not attend school. It was reported at first the family did not suspect the vaccine. Doctors couldn''t explain her reaction either. However, when the family mapped out her absences from school, they realized they started and intensified in the days after receiving the vaccine. The reporter stated that there''s a big difference between correlation and causation and she understand that. But it seemed very clear at that point. Doctors told reporter that reactions to the vaccine do happen. The family filed a report with the FDA''s Vaccine Adverse Event Reaction System (VAERS). The outcome of unexplained pain, fatigue, the pain (disability) and fatigue (disability) worsened to the point patient could not attend school was unknown. The reporter considered the events to be related to GARDASIL. Follow-up information has been received on 25-OCT-2018 in the form of a social media post. It was noted that this was in memory of the female patient. No specific details were provided regarding date of death or cause of death. Upon internal review in memory of the patient (death) was considered a medically significant event. Pain and fatigue worsened to the point patient could not attend school were considered disabling. Additional information is not expected. It has been determined that case#1404USA003032 is a duplicate of case#1404USA005105. Therefore, case#1404USA003032 is being deleted from our files and consolidated into case#1404USA005105.; Sender''s Comments: US-009507513-1404USA003032: voided case; Reported Cause(s) of Death: death.


VAERS ID: 303298 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-01
Onset:2007-12-01
   Days after vaccination:0
Submitted: 2008-01-22
   Days after onset:52
Entered: 2008-01-23
   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: Blood creatinine increased, C-reactive protein increased, Erythema, Mobility decreased, Musculoskeletal pain, Oedema, Red blood cell sedimentation rate increased, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: X-ray ??Dec07 Normal; serum c-reactive protein ??Dec07 slightly increased; sedimentation ??Dec07 slightly increased
CDC Split Type: WAES0801USA02757

Write-up: Information has been received from a health professional concerning a female patient who in December 2007, was vaccinated IM into deltoid with a second dose of GARDASIL. No problem was encountered during injection. 48 hours after vaccination, the patient experienced pain in the shoulder. Pain worsened over a week with the occurrence of mobility impairment of the upper limb. The shoulder was described as red and oedematous on palpation. X-ray was normal, sedimentation rate and serum c-reactive protein (CRP) test were slightly increased. the patient was seen in rheumatology on 11-JAN-2008; results were awaited. The reporting physician considered the event disabling for over 6 days, repercussion on the patient''s job. The outcome was not reported. The other business partner numbers include: E2008-00196 additional information is not expected.


VAERS ID: 341230 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-01
Onset:0000-00-00
Submitted: 2009-03-05
Entered: 2009-03-06
   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: Facial spasm, Lacrimation increased
SMQs:, Dystonia (broad), Lacrimal disorders (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902ISR00024

Write-up: Information has been received from a physician concerning a female who in August 2008, was vaccinated with GARDASIL second dose. In August 2008, five or six days post vaccination, the patient experienced facialis. Therapy with GARDASIL was interrupted. The reporter indicated that the patient is improving but still cannot completely closed the eye and the eye is teary. The reporter indicated that the reporting attending physician felt that facialis was not related to therapy with GARDASIL second dose. The reporter felt that he cannot relate facialis to therapy with GARDASIL second dose. Upon medical internal review facialis was considered to be disabling and other important medical event. Additional information has been requested.


VAERS ID: 369063 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-01
Onset:2009-08-01
   Days after vaccination:0
Submitted: 2009-11-19
   Days after onset:110
Entered: 2009-11-20
   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: Embolism venous, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal 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: Unknown
CDC Split Type: WAES0911USA02488

Write-up: Information has been received from a physician concerning a $g40 year old female, who in August 2009, was vaccinated IM with 0.5 ml first dose of GARDASIL (dose and lot number not reported). This report was part of a study. Two months after the vaccination (approximately in October 2009), the patient had a visual problem that after consulting with her ophthalmologist, the patient was diagnosed with eye thromboemboli. The patient went to the physician for medical care and the visual problem was only recovered by 10%. In October 2009, the patient went again to the physician for medical care but seeing a different doctor and the patient was diagnosed with venous thromboemboli. At the time of the report the outcome of the patient was not recovered. At this time, relationship of eye thromboemboli vena to study therapy is unknown. The physician felt that the Thrombo emboli vena was considered to be disabling. Additional information has been expected.


VAERS ID: 373657 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-06-01
Onset:2009-06-01
   Days after vaccination:0
Submitted: 2009-12-15
   Days after onset:197
Entered: 2009-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK41620 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Disability, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
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: WAES0912RUS00002

Write-up: Information has been received from a physician concerning a female who in June 2009, was vaccinated with GARDASIL. In June 2009, the patient experienced arm pain. In September 2009, the patient recovered from arm pain. The reporter felt that arm pain was related to therapy with GARDASIL. Arm pain was considered to be disabling. No further information is available.


VAERS ID: 391278 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-22
Entered: 2010-06-23
   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: Polyneuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA02831

Write-up: Case received from a gynecologist on 16-JUN-2010. A female patient developed polyradiculoneuritis after she had received an injection of GARDASIL (batch number not reported) on an unspecified date. The reporter specified that the patient was the daughter of a patient of his. Unspecified investigations were performed in hospital. The physicians who took care of the patient did not incriminate GARDASIL. On the other hand, the patient''s mother was convinced that there was a link with the vaccine. According to the reporter, the patient had "settled in handicap". He could not provide any further information regarding this case. At the time of reporting, the patient had not recovered. Polyradiculoneuritis was considered to be disabling. Other business partner numbers included E2010-03761. No further information is available.


VAERS ID: 393258 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-07-20
Entered: 2010-07-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cervical dysplasia, Hysterectomy, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
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: Cervical smear, ??09, normal (before vaccination); cervical smear, ??Mar?10, CIN III (after 3 doses of GARDASIL vaccination)
CDC Split Type: WAES1007TWN00025

Write-up: Information has been received from a physician concerning a 35 year old female who was vaccinated with 3 doses of GARDASIL in 2009. The patient''s cervical smear was normal before vaccination. However, the patient''s cervical smear showed abnormal (cervical intraepithelial neoplasia iii) after 3 doses of vaccination. The patient was hospitalized and received laparoscopic assisted vaginal total hysterectomy on 18-Mar-2010. Subsequently, the patient recovered from cervical intraepithelial neoplasia iii. Cervical intraepithelial neoplasia iii was considered to be disabling. No further information is available.


VAERS ID: 411223 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-08-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2010-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injury, Multiple sclerosis, Paralysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: WAES1011USA03381

Write-up: Information has been received from a physician concerning a female patient who on 15-AUG-2007 was vaccinated with unspecified dose of GARDASIL (lot# not reported) and a second dose of MENACTRA. It was reported that on 25-JUN-2007 the patient received the first dose of MENACTRA. Subsequently the patient developed paralysis and right sided numbness initially diagnosed as possible acute disseminated encephalomyelitis and eventually as multiple sclerosis as a result of receiving the vaccines on 25-JUN-2007 and 15-AUG-2007. The patient alleged that she experienced the residual effects of injuries more than 6 months. The patient''s multiple sclerosis persisted. The reporter felt that multiple sclerosis was related to therapy with GARDASIL and MENACTRA. Multiple sclerosis was considered to be disabling. No further information is available.


VAERS ID: 434427 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-25
Onset:2011-07-29
   Days after vaccination:34
Submitted: 2011-09-14
   Days after onset:47
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB963AA / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN52070 / 1 UN / IM

Administered by: Other       Purchased by: Other
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: Methylphenidate Hcl
Current Illness: Attention deficit hyperactivity dis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0747263A

Write-up: This case was reported by a physician via a regulatory authority (# 2011-02931) and described the occurrence of sensory disturbances in a 15-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), GARDASIL (non-gsk). Concurrent medical conditions included attention deficit hyperactivity disorder. Concurrent medications included CONCERTA since a long time, due to attention deficit hyperactivity disorder. On 25 June 2011, the subject received 1st dose of ENGERIX B (1 ml, intramuscular, unknown site of injection) and 1st dose of GARDASIL (.5 ml, intramuscular, unknown site of injection). On 29 July 2011, 34 days after vaccination with ENGERIX B and GARDASIL, the subject experienced sensory disturbances at the left side of the face, which ranged from the hair line to the middle of the cheek. For clarification of the complaints, a consultation of a neurologist was arranged; however no explanation for the complaints of the subject was found. The patient did not received specific therapy. The regulatory authority reported that the event was disabling. At the time of reporting, the event was unresolved. The regulatory authority reported that the event was possibly related to vaccination with ENGERIX B and was unlikely related to vaccination with GARDASIL. Further details will be provided by the Regulatory Authority whenever available.


VAERS ID: 440882 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-31
Entered: 2011-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Autoimmune disorder, Dysstasia, Impaired work ability, Malaise, Multiple sclerosis, Nervous system disorder
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (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: Unknown
Current Illness: Autoimmune disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA02522

Write-up: Information has been received from a newspaper article, as part of a business agreement with CSL (local case reference # AUS/11/1397), concerning a female patient who on an unspecified date was vaccinated with GARDASIL (lot # not provided). On an unspecified date the patient was vaccinated with GARDASIL (lot # not provided) and began feeling sick after her first shot of the vaccine, which "immunises" against human papillomavirus (HPV), the most common cause of cervical cancer. She had a full auto-immune and neurological attack. At stages she was unable to stand and walk. Doctors believed she had multiple sclerosis, and she was forced to quit her job and put her career on hold. The patient''s family had a history of auto-immune disease. At the time of this report the patient''s outcome was not reported. Multiple sclerosis was considered to be disabling. Upon internal review, Multiple sclerosis was determined to be an other important medical event. This is one of several reports from the same source. Additional information is not expected.


VAERS ID: 443463 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-22
Entered: 2011-11-23
   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: Anxiety, Chills, Fatigue, Insomnia
SMQs:, 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: Unknown
CDC Split Type: WAES1111USA02622

Write-up: Information has been received from an agency via CSL (local reference# NZL/11/0100) concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL (lot# unspecified). On an unknown date, the patient experienced rigors, insomnia, anxiety and fatigue. At the time of report, the patient had not recovered from the events. Rigors, insomnia, anxiety and fatigue were considered as persisting disability by the agency. The original reporting source was not provided. No further information is available.


VAERS ID: 443784 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-28
Entered: 2011-11-29
   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: Depressed level of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
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: Albuterol; Budesonide; Formoterol fumarate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1111USA02675

Write-up: Information has been received from health authority (local reference # NZL110109) concerning a patient (age and gender unknown) who on an unknown date was vaccinated with a dose of GARDASIL (lot number, route and dose not reported). Concomitant therapy included budesonide, formoterol fumarate and albuterol. On an unspecified date the patient experienced syncope and consciousness decreased. At the time of reporting the patient had not recovered. The reporter felt that syncope and consciousness decreased related to therapy with GARDASIL. Syncope and consciousness decreased were considered to be disabling by the agency. The original reporting source was not provided. No further information is available.


VAERS ID: 443785 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-28
Entered: 2011-11-29
   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: Amnesia, Muscle twitching, Muscular weakness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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? 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: WAES1111USA02669

Write-up: Information has been received from an agency (local reference No. NZL/11/0105) concerning a patient (age and gender unknown) who an unknown date was vaccinated with a dose of GARDASIL (lot number, route and dose not reported). On an unspecified date the patient experienced nausea, faintness, muscle weakness, twitching and memory loss. At the time of reporting the patient had not recovered. Nausea, faintness, muscle weakness, twitching and memory loss were considered to be disabling by the agency. The reporter felt that nausea, faintness, muscle weakness, twitching and memory loss were related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.


VAERS ID: 443788 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-28
Entered: 2011-11-29
   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: Abdominal pain, Pelvic inflammatory disease
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1111USA02627

Write-up: Information has been received from health authority (local reference No. NZL/11/0104) concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported. No other medications were reported. On an unspecified date, the patient experienced abdominal pain and pelvic inflammation. At the time of the report, the patient''s abdominal pain and pelvic inflammation persisted. The reporter felt that abdominal pain and pelvic inflammation were related to therapy with GARDASIL. Abdominal pain and pelvic inflammation were considered to be disabling by the agency. The original reporting source was not provided. No further information is available.


VAERS ID: 443797 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-28
Entered: 2011-11-29
   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: Arthralgia, Headache, Lymphadenopathy, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1111USA02625

Write-up: Information has been received from health authority (local reference No. NZL/11/0102) concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported). On unspecified date, the patient experienced paraesthesia, lymphadenopathy, arthralgia, headache and muscle weakness. At the time of the report, the patient''s paraesthesia, lymphadenopathy, arthralgia, headache and muscle weakness persisted. Paraesthesia, lymphadenopathy, arthralgia, headache and muscle weakness were considered to be disabling by the agency. The reporter felt that paraesthesia, lymphadenopathy, arthralgia, headache and muscle weakness were related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.


VAERS ID: 443800 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-28
Entered: 2011-11-29
   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: C-reactive protein increased, Headache, Myalgia, Paraesthesia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: serum c-reactive protein, positive
CDC Split Type: WAES1111USA02623

Write-up: Information has been received from health authority (local reference No. NZL/11/0101) concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported). Other medications were not reported. On an unspecified date, the patient experienced c-reactive protein positive, paraesthesia, headache, fever and myalgia. At the time of the report, the patient had not recovered. C-reactive protein positive, paraesthesia, headache, fever and myalgia were considered to be disabling by the agency. The reporter felt that c-reactive protein positive, paraesthesia, headache, fever and myalgia were related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.


VAERS ID: 446594 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-22
Onset:0000-00-00
Submitted: 2011-12-27
Entered: 2012-01-03
   Days after submission:7
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, Blindness, Blood potassium decreased, Dizziness, Headache, Malaise, Tachypnoea, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Serum potassium, low level
CDC Split Type: WAES1112USA02960

Write-up: Information received from Merck through agency on 14-DEC-2011. The information was gathered was retrieved from an internet article, a blog about GARDASIL. Case not medically confirmed. According to the article, a female patient, who was 13 years old when she was vaccinated with either the first or the second dose of GARDASIL, received the first dose on 22-SEP-2008 (batch number: NG432200, dose, route not reported). She received the second dose of 24-NOV-2011 (batch#N643220, dose, route not reported). After vaccination (date not reported, it was not reported whether the patient presented the adverse events after the first dose or the second dose of vaccine), she was unable to do physical education. Her medical test showed a low level of potassium- she had tremors, she got sick, she had headaches and experienced loss of sight and dizziness. After being admitted to the emergency unit of the hospital she discharged after 7 hours resting. She had advised to see a psychologist, but her mother said her daughter was not a crazy girl. Her condition became worsening almost always when she had her menstrual cycle. The patient also presented with shaking and tachypnea that took her to the hospital. According to the reporter the patient had not recovered. To be noted that the diagnosis reported was incapacity which was added as serious criteria. The reported batch number for both dose 1 and dose 2 did not exist and the closer batch number distributed was NG43220 (lot # 168U). Other business partner number included: E2011-08230. No further information reported.


VAERS ID: 449954 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-01
Onset:2009-11-01
   Days after vaccination:396
Submitted: 2012-02-17
   Days after onset:838
Entered: 2012-02-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS D0305 / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER MX199 / UNK UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1695U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Blood pressure increased, Fatigue, Headache, Hypertension, Malaise, Myalgia, Paralysis, Poor quality sleep
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1202USA01908

Write-up: Case received from the local Health Authorities on 02-FEB-2012 under the reference number LY20111250. This was a case of misuse (TETRAVAC administered in a 17-year-old patient). Case not medically confirmed. The patient''s mother reported to the local HA that her 17-year-old daughter had received the third dose of GARDASIL (lot # 1941U, batch number NJ17150) on 10-APR-2009, a dose of TETRAVAC (batch number D0305) on 18-AUG-2009 and a dose of IMMUGRIP (batch number MX199) on 16-NOV-2009. All the reported vaccinee were administered via intramuscular route. In November 2009, the patient developed the following adverse events which lasted for 18 months: - physical fatigue which "worsened from week to week over the first months" and which was described as "continuous during the day and night with unresting sleep". - Malaise described as ''more and more frequent at the beginning and accompanied by "a sharp rise in blood pressure". They could occur at any time of the day and night. - Muscle pain in legs and then in her whole body. - "very violent" headaches (relieved by ibuprofen 400 mg) which occurred most often at night or after waking up. They could last all day and were increasingly recurrent. In August 2010, the patient experienced palsy which ''initially affected her whole body except her face for 30 to 90 minutes and could occur at any time''. When total paralysis stopped on an unspecified date, paralysis of legs following minimal exertion and paralysis of hands which could last half a day appeared. In December 2010 she was diagnosed with arterial hypertension which lasted for 4 months. The reported reactions had an impact on her daily life; i.e. she was unable to engage in physical or leisure activities and she had to quit school for a year. The patient had received the first dose of GARDASIL (lot # 1695U; batch number NH36010) on 01-OCT-2008 and the second one (lot #1941U; batch number NJ02770) on an unspecified date, both via intramuscular route. At the time of reporting the patient had recovered without sequelae. To be noted that the local Health Authorities specified in the structured fields that the onset date was 01-NOV-2009 for fatigue, malaise, muscle pain and headache, 01-AUG-2010 for palsy and 01-DEC-2010 for arterial hypertension whereas they reported in their narrative that those reactions began in November 2009, in August 2010 and in December 2010 respectively. Although the Health Authorities considered this case as not serious, upon medical review the company assessed it as serious due to the serious criteria ''other medically significant condition'' and ''disabling''. Furthermore IMMUGRIP was reported as concomitant by the Health Authorities but the company decided to code it as suspect. The Health Authorities assessed the causal relationship between the reported reactions and vaccinations with GARDASIL and TETRAVAC as doubtful according to the method of assessment. In this case not medically confirmed, the presentation of neurologic event was not clear and no information was reported regarding the investigations performed. The case cannot be fully assessed. Other business partner number included E2012-00730. No further information is available.


VAERS ID: 456466 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-05-25
Entered: 2012-05-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Paralysis, Wheelchair user
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? 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: WAES1205USA03425

Write-up: Information has been received from a receptionist in the doctor office (local reference # ZAF-12-0119) concerning a about female (the daughter of one of their patients'' sister) who on an unknown date was vaccinated with a dose of GARDASIL, (dose, route and Lot # unknown). The receptionist stated that the patient was now paralyzed and was in a wheelchair. The receptionist said that now this person was telling everyone that they should not get the vaccine and that they should go onto the internet and see what shocking news there was about GARDASIL. Paralysation was determined to be disabling. I found only this closing statement in the sop but I''m not sure the reported did not want to give more information about the patient.


VAERS ID: 458600 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-10-01
Submitted: 2012-07-02
   Days after onset:640
Entered: 2012-07-03
   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: Fatigue, Post viral fatigue syndrome
SMQs:

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: Autism spectrum disorder
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA05009

Write-up: This case was received from the health authority on 25-JUN-2012. ADR 21714883. This case was medically confirmed. A female patient of unknown age with a history of autism spectrum disorder received an injection of HPV (manufacturer, lot number and batch number not reported), route and site not reported, on an unreported date. On an unspecified date in October 2010, post vaccination, the patient developed post viral syndrome (chronic fatigue). At the time of reporting the patient was not yet recovered. The event was considered to be serious due to disability/incapacity. Other business partner numbers include E2012-04155.


VAERS ID: 460468 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-26
Entered: 2012-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Deafness permanent
SMQs:, Hearing impairment (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: WAES1207FRA010130

Write-up: Case received from a gynecologist on 20-Jul-2012 and medically confirmed. A female patient (age unspecified) reported to her physician that she had experienced hearing loss following the injections of the three doses of GARDASIL (batch numbers not reported) on unspecified dates, which led to permanent partial deafness. The patient needed to be lifted with an hearing aid. It is noteworthy that the reporting physician did not see any causal relationship, but the patient and her mother noted a coincidence between the symptoms and the vaccine and consequently suspected the vaccine.


VAERS ID: 486663 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-12
Entered: 2013-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Dizziness
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1303DEU005073

Write-up: Case was received from a healthcare professional on 05-Mar-2013. Case is medically confirmed and poorly documented. A female patient of unspecified age received a dose of GARDASIL (lot-no. not reported) on an unspecified date in May (year not reported). On an unspecified date in Jan (year not reported) she developed balance disorder and dizziness. Patient had 50% reduced earning capacity/disability. She was treated in a rehabilitation centre for ten months. Duration and outcome were not reported. Upon medical judgment the company considered to assess this case as serious.


VAERS ID: 504912 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2013-09-30
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, Disability, Fatigue, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309GBR012812

Write-up: This case was identified as part of a phone call in program on a national television show during which GARDASIL vaccination was discussed on 20-Sep-2013, this case reported by the patients mother. This case is not medically confirmed. A female patient, who was 15 at the time of reporting, with a family history of cancer who previously danced competitively, played sports at school and was bright and healthy received GARDASIL vaccine, batch route and site not reported on an unreported date. An unreported time post vaccination, on an unreported date, it was as if a grenade had gone off in the patients body and she experienced muscle weakness, excruciating joint pain and was tired. The patient could only attend school for 2 hours per day, sometimes 5 hours a day. The patients mother stated that the patient was disabled and if she does not get better she will never be able to work or hold down a job. The patient had not recovered at the time of reporting.


VAERS ID: 510757 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-31
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nervous system disorder, Pain, Quality of life decreased
SMQs:

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
Preexisting Conditions: HPV vaccine, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK014548

Write-up: Case of adverse event received from patient via company representative on 24-Oct-2013. The primary reporter was a patient. A female patient (age and gender not reported) via not reported route of administration in not reported site of administration on an unspecified date and later on (not reported date), she developed severe neurological disorder, quality of life decreased and excruciating pain every day. The patient has written to the company as she has developed severe adverse events post vaccination. She thinks that she might die prematurely because of the vaccine. No one has given her a clear diagnose and no one can tell her what the future holds for her. It was reported that she has been affected physically and in a way that is indescribable. The three HPV injection that she has received has ruined her life. Patient had previously received two doses of HPV vaccine on unspecified dates. No medical history reported. At the time of reporting, the patient had not recovered.


VAERS ID: 516108 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-25
Onset:2010-03-02
   Days after vaccination:585
Submitted: 2013-12-10
   Days after onset:1379
Entered: 2013-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Cognitive disorder, Dysgraphia, Headache, Paralysis, Photopsia, Speech disorder, VIIth nerve paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (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: TRINORDIOL
Current Illness: Immunisation; Contraception
Preexisting Conditions: 03/28/2008, GARDASIL, Dose 2; 01/19/2008, GARDASIL, Dose 1
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA004242

Write-up: Information was received from Sanofi Aventis on 06-DEC-2013. Case received from a physician on 03-Dec-2013: A female patient (age unspecified) had received the three doses of GARDASIL (batch number not reported) on 19-Jan-2008, on 28-Mar-2008 and on 25-Jul-2008. She was concomitantly taking Trinordiol. On 21-Feb-2010, she presented with very severe half sided headache. On 02-Mar-2010, she experienced a first episode of cerebrovascular accident with speech disorder, understanding disorder, writing disorder, visual flash and right hemicorpus, right face and right hand paralysis. When she came back home, her parents took her to the emergency care unit but the symptoms had resolved. She experienced another episode on the following day with the same symptoms and vomiting. She was seen at the emergency care unit but no information on this consultation was reported. Since then, the patient has been continuously experiencing headache which started as soon as she woke up with invalidating more severe flare-ups. The patient was given Laroxyl but there was little improvement. Diagnosis of migraine was not selected. To be noted that she had no relevant medical or vaccinal history. She was taking Luteran. At the time of reporting, she was followed by a neurologist. Neither the neurologist nor the general practitioner found a cause for these events. Taking an oral contraceptive was not suggested as a risk factor for the occurrence of a cerebrovascular accident. The patient had no associated risk factor and was not a smoker. At the time of reporting, the half sided headache was not resolved and the outcome for cerebrovascular accident and vomiting was not provided.


VAERS ID: 517475 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-23
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA010366

Write-up: Case received via a media press article and from a lawyer on 17-Dec-2013. Case linked with serious cases E2013-11075, E2013-11083, E2013-11084 and E2013-11086. Within the context of 9 complaints filing concerning the occurrence of adverse events following vaccination with the GARDASIL (information mentioned in the media press), it was reported by the complainants'' lawyer, via the media press, that in the weeks or months following vaccination with GARDASIL (batch numbers not reported), a female patient presented with a very disabling myasthenia. The patient was aged between 18 and 24 years, or approximately 40. At the time of reporting, the outcome was unknown. No further information was available which could enable a duplicate search of the case.


VAERS ID: 517691 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-26
Entered: 2013-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Systemic lupus erythematosus
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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA010586

Write-up: Information has been received from SPMSD (FR-1577272925-E2013-11083) on 20-DEC-2013. Case received via a media press article and from a lawyer on 17-DEC-2013. Case linked with serious cases E2013-11075, E 2013-11084, E2013-11086 and E2013-11087. Within the context of 9 complaints filling concerning the occurrence of adverse events following vaccination with GARDASIL (information mentioned in the media press), it was reported by the complainants'' lawyer, via the media press, that in the weeks or months following vaccination with GARDASIL (batch numbers not reported), a female patient presented with a very disabling lupus (coded as systemic lupus erythematosis as no further information was available). The patient was aged between 18 and 24 years, or approximately 40. At the time of reporting, the outcome was unknown. No further information was available which could enable a duplicate search of the case.


VAERS ID: 517800 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-27
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA010466

Write-up: Case received via a media press article and from a lawyer on 17-Dec-2013 from Sanofi Pasteur (reference # FR-1577272925-E2013-11075) on 20-DEC-2013. Case linked with serious cases E2013-11083, E2013-11084, E2013-11086 and E2013-11087. Within the context of 9 complaints filing concern the occurrence of adverse events following vaccination with the GARDASIL (information mentioned in the media press), it was reported by the complainants'' lawyer, by the media press, that in the weeks or months following vaccination with GARDASIL (batch numbers not reported), 4 female patients presented with a very disabling Verneuil''s disease. The patients were aged between 18 and 24 years, or approximately 40 for one of them. At the time of reporting, the outcome was unknown. No further information was available which could enable a duplicate search of the case.


VAERS ID: 517896 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-27
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypersomnia
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA010459

Write-up: Case received via a media press article and from a lawyer on 17-Dec-2013 from Sanofi Pasteur MSD (reference # FR-1577272925-E2013-11086) on 20-DEC-2013. Case linked with serious cases E2013-11075, E2013-2013-11083, E2013-11084 and E2013-11087. Within the context of 9 complaints filing concerning the occurrence of adverse events following vaccination with GARDASIL (information mentioned in the media press), it was reported by the complainants'' lawyer, via the media press, that in the weeks or months following vaccination with GARDASIL (batch numbers not reported), a female patient presented with a very disabling idiopathic hypersomnia. The patient was aged between 18 and 24 years, or approximately 40. At the time of reporting, the outcome was unknown. No further information was available which could enable a duplicate search of the case.


VAERS ID: 517960 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-01
Onset:0000-00-00
Submitted: 2013-12-30
Entered: 2013-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Gait disturbance, Gastroenteritis, Guillain-Barre syndrome, Immunoglobulin therapy, Impaired work ability, Laboratory test, Paraesthesia, Paralysis, Tremor
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA010580

Write-up: Case received via a media press article and from a lawyer on 17-Dec-2013. Case linked with serious cases E2013-11075, E2013-11083, E2013-11086 and E2013-11087. Within the context of 9 complaints filing concerning the occurrence of adverse events following vaccination with GARDASIL (information mentioned in the media press), it was reported by the complainants'' lawyer, via the media press, that in the weeks or months following vaccination with GARDASIL (batch numbers not reported), a female patient presented with a very disabling Guillain Barre syndrome. The patient was aged between 18 and 24 years, or approximately 40. At the time of reporting, the outcome was unknown. No further information was available which could enable a duplicate search of the case. Follow-up information received on 23-Dec-2013 via media press as an interview of a patient from Sanofi Pasteur MSD (reference # FR-1577272925-E2013-11084) on 27-DEC-2013. Upon internal review the case has been identified as a duplicate of case E2013-11068 (same first name, same city, same event, legal claim). A today 19 year old female patient reported that as secondary-school pupil she had received the second dose of GARDASIL in Aug-2008. Three months later, she presented with tingling in feet then in calves and thighs and from day to day she found more and more difficult to walk. She had first related the events to a gastroenteritis. Three to 4 days later, symptoms aggravated and she was unable to walk. She consulted her physician who referred her to the Emergency unit. Several unspecified tests were done and she was kept under observation. She was treated with immunoglobulins and from the time the drug was efficient the symptoms spread to the arms. She was diagnosed with Guillain-Barre syndrome. The patient was hospitalized several months. She was completely paralyzed for 1 week, from head to foot. Then she went through rehabilitation and was able to move again and do things by herself. Then she went to high school associated to rehabilitation to go on with her education and rehabilitation. At first she did not assess the events to be related to GARDASIL as she thought it was the gastroenteritis as she was told by the physicians, that did turn back to her body and make her sick. Afterwards she contacted a lawyer who assessed the events as related to the vaccine. The patient reportedly had sequelae, i.e. tremor in hands that is disabling for her work in lab. She also had orthotic insoles but she sometimes walked better without them.


VAERS ID: 518237 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-02
Entered: 2014-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Pain in extremity, Pyrexia, Wheelchair user
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312JPN011984

Write-up: Initial information has been received from a consumer concerning a female patient who received a dose of GARDASIL IM injection drug (vaccination date, frequency not reported). Information on concomitant medications was not reported. On an unspecified date, the patient developed numbness in left hand and pain in right hand, numbness, pyrexia, pain in right foot, and became a wheelchair user. Pain other than the vaccination site : Yes pain lasting for more than 3 months : Yes. Duration from the latest vaccination to the onset of the event: 3 days. At the time of this report, the outcome of numbness in left hand, pain in right hand, numbness, pyrexia, pain in right foot and wheelchair use. Upon internal review, wheelchair use was considered serious due to disability. The reporter felt that numbness in left hand, pain in right hand, numbness, pyrexia, pain in right foot and wheelchair use were related to GARDASIL. Additional information is not expected.


VAERS ID: 519504 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-27
Onset:2009-02-01
   Days after vaccination:5
Submitted: 2014-01-15
   Days after onset:1809
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test normal, Colour blindness, Diplopia, Dysaesthesia, Fatigue, Gait disturbance, Hemiparesis, Hypoaesthesia, Lumbar puncture abnormal, Multiple sclerosis, Muscle spasms, Neuralgia, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Pain, Papillitis, Paraesthesia, Polymerase chain reaction, Sensory disturbance, Sleep disorder, Urinary tract disorder, Visual acuity reduced, Visual acuity tests abnormal, White matter lesion
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular infections (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOLDORM
Current Illness: Sleep disorder; Immunisation
Preexisting Conditions: 11/18/2008, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: On 25 May 2009: the visual acuity of the left eye was measured at 0.05/10. The rest of the neurologic status was without abnormality. Lumbar puncture performed on 25 May 2009: pleocytosis (62/mm3) with proteinorrachia in the standard and intrathecal synthesis of IgG oligoclonal bands. MRI brain performed on 28 May 2009: showed a decade of lesions of the white matter with right frontal lesion. PCR and blood test (date not reported): were negative for infectious agents or antinuclear antibodies. MRI performed on 01-Sep-2009: the decade of white matter lesions were still present, showed three new left frontal lesions (right frontal lesion disappeared), one right temporal lesion, and two lesions of the left anterolateral part of the spine up to C4 and C5. MRI performed on 28-Jan-2010: showed a progression of multiple sclerosis (MS) lesions at the supra-tentorial level and diffuse demyelinating lesions of the spinal cord with a medullar lesion up to C5. An ophthalmological control performed on 12-May-2010, during the optic neuritis and papillitis episodes, showed a visual function on the upper limit of the normal on both sides. MRI performed on 13-Aug-2010, 03-Mar-2011, and 15-Mar-2012: showed no signs of active disease (relative stability of lesions).
CDC Split Type: WAES1401CHE005672

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # CH-1577272925-E2014-00151) on 08-JAN-2014. Case reported by a consumer to the Health Authorities on 08-Jan-2014 under the reference number 2013-06444. Case not medically confirmed. A female patient (weight and height not reported) had received a second dose of GARDASIL (batch number not reported) on 27-Jan-2009 via intramuscular route (site of administration not reported). The patient''s medical history included medication with contraceptives (several pills prescribed, registered trademarks unknown) since 2009. The patient had no other health disorder. The patient received a first dose of GARDASIL (batch number not reported) on 18-Nov-2008. The patient''s family medical history included a case of multiple sclerosis on one of the twin sons of the maternal great aunt of the patient. The patient''s mother reported that her daughter experienced burn-like pains and numbness in arms and legs since Feb-2009, some weeks after the second dose of GARDASIL administration, which occurred intermittently within the following months and which not responded well to anti-inflammatory medications. The mother make the link between vaccination and the daughter''s symptoms after seeing a TV show related to a complaint initiated by a patient diagnosed with multiple sclerosis and who experienced the first symptoms of the disease after a vaccination with GARDASIL. On 25 May 2009, the patient was hospitalised for a left optic neuritis. The first symptoms occurred on 22 May 2009 (progressive decrease of visual acuity, disturbed vision of colors). The visual acuity of the left eye was measured at 0.05/10. The rest of the neurologic status was without abnormality. Corticotherapy IV was administered to the patient, leading to an important improvement of visual acuity. Other exams performed (brain MRI and cerebrospinal fluid analysis) were compatible with an inflammatory condition, but nothing could be concluded. A control exam (MRI, in neurologic consultation) was scheduled at 3 months. The brain MRI performed on 01-Sep-2009 was compatible with a progression of inflammatory lesions of the white matter. Diagnostic criteria for a multiple sclerosis were present. The evolution was defined by remission and relapse of the disease. A second flare occurred on 07-Sep-2009: the patient experienced legs hypoesthesia with strength loss and walking disturbances, and diplopia on 17-Sep-2009. A third flare on Dec-2009 was characterized by a right very moderate papillitis. A fourth flare probably in Jun-2010 was characterized by sensory troubles. A fifth flare occurred in Aug 2010, with crural-brachial-facial dysesthesia and hypoesthesia, urinary symptoms and fatigue. No other flare was reported since then. The details concerning the motor, sensory and visual symptoms during these years were not provided but the neurologic status performed on May-2012, far away from the last flare, showed no real strength loss or sensory troubles. There were pains like sensations of burn and "needles in the back", at the level of the lower limbs and palmar sides of the hands. These pains were described at the time of the reporting as omnipresent, with strong exacerbations episodes, and were associated with spasms, occurring during the night in arms and legs. The ophthalmologic control performed on 12-May-2010, during optic neuritis and papillitis episodes, showed a visual function on the upper limit of the normal on both sides. The patient received the following therapies: IV corticotherapy during flares, (REBIF, 44 micrograms, via subcutaneous route, 3 times per week from 14-Oct-2009 to Mar-2013), which was replaced by TYSABRI (started on 30-Mar-2013), GILENYA (started since the mid of 2013). The treatment for the pain of intermittent symptoms included SAROTEN (since Dec-2009), and NEURONTIN (since Apr-2010, due to aggravation of paroxystic symptoms like left facial hemiparesia). The patient also received for sleep disturbances ZOLDORM. At the time of reporting, the patient had an autonomous life, though with daily pains. She had physical activity and followed a medical secretary online training course. At the time of reporting, multiple sclerosis and neuropathic pain were considered as not recovered. The patient recovered from optic neuritis on 12 May 2010. According to the Health Authority, the events were possibly related to the vaccination. The Health Authority considered the case as serious (disability).


VAERS ID: 519661 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2010-04-30
Onset:0000-00-00
Submitted: 2014-01-16
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1693U / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abscess, Breast mass, Fatigue, Headache, Hidradenitis, Multiple sclerosis, Nodule, Nuclear magnetic resonance imaging brain normal, Pain, Skin lesion, Temperature intolerance
SMQs:, Optic nerve disorders (broad), Demyelination (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: Ethinyl estradiol (+) levonorgestrel
Current Illness: Non-tobacco user; Immunisation
Preexisting Conditions: Menarche, at 12 year old; 11/06/2009, GARDASIL
Allergies:
Diagnostic Lab Data: MRI brain (15-JUL-2010): Normal
CDC Split Type: WAES1401CHE006605

Write-up: Information has been received from Sanofi Pasteur [manufacturer control # CH-1577272925-E2014-00139] on 08-JAN-2014. Case reported by a pharmacist to the Health Authorities on 08- Jan-2014 under the reference number 2013-06303. Case medically confirmed. A female patient born (weight: 63 kg; height not reported) had received a second dose of GARDASIL (batch number NH55610 and lot number 1693U) on 11-Dec-2009 and a third dose of GARDASIL (batch number NH55610 and lot number 1693U) on 30-Apr-2010, via intramuscular route (site of administratoin for both doses not reported). The patient''s medical history included menarche at 12 years old. The patient was non smoker. The first dose of GARDASIL (batch number NJ35180). The patient had no health problem until the end of 2009 and she was not taking any medications. No case of hidradenitis suppurativa was reported in the patient''s family. Since Jan-2012, the patient was taking a contraceptive pill with Ologyn (1 dosage form once daily). On an unspecified date, but at the latest in Christmas 2009, the patient developed cutaneous lesions: abcessed nodules between the breasts and on groin folds/genital area, associated with burn-like pains, whereas there was no lesions before Nov-2009. The lesions persisted and evolved into nodules in the breasts. A Verneuil disease (also called hidradenitis suppurativa or acne inversa) was diagnosed in 2012 by a dermatologist. On an unspecified date, but clearly exacerbated after the third GARDASIL injection on 30-Apr-2010, the patient developed headaches, heat intolerance and fatigue. At the time of reporting, the patient did not recover from fatigue and headaches, which partly responded to antalgic medications (paracetamol, ibuprofen). The patient did not completely recover from heat intolerance but slightly improvement occurred since 2010. Pain due to cutaneous abscesses and headaches was very pronounced and caused school absenteeism (around 3 to 5 days of absenteeism per month). The patient''s mother reported these symptoms to the pharmacist and made the link between her daughter''s symptoms and GARDASIL vaccination after seeing a TV show focused on a complaint initialized by a female patient in this country. This patient was diagnosed with multiple sclerosis which first developed after GARDASIL vaccination. Two cases of Veneuil disease were also reported on this occasion. The mother was very concerned for her daughter. A MRI brain performed on 15-Jul-2010 showed no abnormality. At time of reporting, the patient was recovering from heat intolerance and had not yet recovered from the other events. The Health Authority coded "Sweet gland disorder", "Abscess", "Headache", "Fatigue" and "Heat intolerance". The Company added "hidradenitis suppurativa" (reported diagnosis) as an additional event. According to the Health Authorities, the reactions were possibly related to the vaccination. The Health Authorities considered the case sa serious (disabling). Additional information is expected.


VAERS ID: 526689 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-25
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Orthostatic hypotension
SMQs:, Cardiomyopathy (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403SWE011186

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-02490) on 21-MAR-2014. Case was received from a health professional via the Health Authorities on 19-Mar-2014 under the reference MPA-2014-001995. Case is medically confirmed. Primary source was a physician. A female patient (gender, weight, height not reported) with no medical history reported received a dose of GARDASIL (batch/lot no. H022294, expiry date 30-JUN-2015) via not reported route and site of administration on an unspecified date. On an unspecified date, the patient developed orthostatic hypotension. At the time of reporting, the patient had not recovered.


VAERS ID: 535601 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-01
Entered: 2014-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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

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: WAES1406BRA014042

Write-up: This spontaneous report as received from a company representative, who has a friend which mother heard from a priest the following case, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. On an unknown date the patient experienced crippled (disability). The outcome of crippled was reported as not recovered/not resolved. Additional information is not expected because the Company Representative did not have the contact of the primary reporter.


VAERS ID: 536493 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2014-04-24
Onset:2014-04-30
   Days after vaccination:6
Submitted: 2014-07-12
   Days after onset:73
Entered: 2014-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions: Varicella, 2-3 years old
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1407AUS004067

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a Male patient of unkonwn age. Previous varicella disease 2-3 year old. On 24-APR-2014 the patient was vaccinated with GARDASIL dose 1, intramuscular. Other suspect therapies included VARILRIX dose 1. On 30-APR-2014, the patient experienced red spots with white head on back, shoulders and small amount on neck, itchy (disability). School has excluded child for 1 week parent seeking advice. Advised to wait until lesions dry before returning to school. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to GARDASIL. Additional information is not expected.


VAERS ID: 541683 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-16
Onset:0000-00-00
Submitted: 2014-08-29
Entered: 2014-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Monoplegia
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: WAES1408COL016770

Write-up: This spontaneous report as received from a consumer via social media refers to her daughter of unknown age. On an unknown date the patient was vaccinated with a second dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not provided). No concomitant medications were reported. On an unknown date, after few date after vaccination the patient experienced paralysis in leg that causes an inability to walk. The outcome of the events was not reported. The relatedness between the events and GARDASIL was not reported. Both the events were considered disabling by reporter. Upon internal review paralysis in leg was considered medically significant event. Additional information is not expected because there is no possibility to contact the reporter.


VAERS ID: 542161 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-01
Onset:2013-05-10
   Days after vaccination:374
Submitted: 2014-09-02
   Days after onset:480
Entered: 2014-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Insomnia, Limb injury, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409BRS000484

Write-up: This spontaneous report as received from a physician through a company representative concerning a female patient of unknown age with contraception. In May-2012 the patient was vaccinated with GARDASIL dose 1, .5 ml, intramuscular when the patient used to live abroad. In July 2012 the patient experienced left leg pain. In MAY-2013 the patient experienced can''t walk and can''t sleep. Subsequently, the patient had to come back. On an unknown date the patient experienced twisted foot due to pain. The outcome of can''t walk, twisted foot, can''t sleep and left leg pain (grade 9 to 10) was reported as not recovered/not resolved. The relatedness of patient''s adverse events were not reported. Additional information is not expected. No contact available for follow up.


VAERS ID: 542404 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-01
Onset:0000-00-00
Submitted: 2014-09-04
Entered: 2014-09-04
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, Dysstasia, Muscle atrophy, Muscle spasms, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examination for four extremities-resutls awaited
CDC Split Type: WAES1409COL000492

Write-up: This spontaneous report as received from a consumer refers to a female patient of unknown age with HPV. On November 2013 the patient was vaccinated with GARDASIL dose 1.5 ml, intramuscular. A few days after the vaccination, the patient presented with muscle aches and was transferred to the health center network. On an unknown date the patient mentioned that her feet hurt, gave her cramps. Patient stated that the part of her legs, ''above the knees'' also hurt and she ''dropped much''. She had difficulty to stand and her parents helped her for 3 months with her day-to-day activities that she was not able to do. Experienced the events (disability). The Pediatric Neurologist ordered a few priority examinations for 4 extremities. Until the first days of August it was possible to take the examinations and results were awaited. In the hospital, patient was diagnosed with loss of muscular mass, on an unspecified date. An examination was needed to study the nervous system of the patient. The outcome of the events was unknown. The causality of the events was unknown. Additional information has been requested.


VAERS ID: 545839 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-30
Entered: 2014-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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

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: Fatigue; Depression; Anxiety
Preexisting Conditions: Fibromyalgia; Irritable bowel syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409AUS013872

Write-up: Information has been received from a physician via CSL (Manufacturer number # unknown) via company representative referring to a male patient of unknown age. The patient''s current condition includes anxiety, chronic fatigue and depression. The patient''s medical history included irritable bowel and fibromyalgia. On an unknown date the patient was vaccinated with 2 injections of GARDASIL, intramuscular (dose not reported). No other concomitant therapies reported. On an unknown date the patient claimed that the vaccine has disabled him (disability) and stated that the patient should have been warned of the possibility. It was reported that the patient also mentioned litigation. The outcome of disabled was unknown. The causality of the event was unspecified. Additional information is not expected.


VAERS ID: 545961 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-07-01
Onset:2014-07-01
   Days after vaccination:0
Submitted: 2014-10-01
   Days after onset:92
Entered: 2014-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Pain
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 2014, Wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409CRI014823

Write-up: This spontaneous report as received from a physician (information received via an email from consumer), refers to a female patient of unknown age. No concurrent conditions or medical history were provided. Approximately in July 2014 (reported as "two months ago"), the patient was vaccinated with the first dose of GARDASIL strength reported as: 0.5 ml injection, intramuscularly (dose, lot# and expiry date unspecified). Patient stated that she only took 1 dose. No concomitant medications were reported. The patient referred strong pain and inability to walk since approximately July 2014 (reported as "since 2 months ago"). According with the information reported by the patient, different kind of exams has been performed without result, for this reason she was using a wheelchair. The patient was hospitalized in 2014 (exact date not provided). The outcome for inability for walk and strong pain was unknown. The relatedness between the events and GARDASIL was not reported. The physician considered the inability for walk as serious (disabling). Additional information has been requested.


VAERS ID: 547673 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-13
Entered: 2014-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Balance disorder, Blood immunoglobulin A increased, Computerised tomogram normal, Dizziness, Gait disturbance, Headache, Laboratory test normal, Neurological symptom, Psychiatric symptom, Somnolence, Wheelchair user
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Vestibular disorders (broad), 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:
Allergies:
Diagnostic Lab Data: All of the tests performed on an unspecified dates had normal results, including a CAT, except IgA which resulted very high levels.
CDC Split Type: WAES1410ESP005160

Write-up: Information has been received for Sanofi Pasteur MSD (SPMSD) (manufacturer control number: E2014-09328) on 10-OCT-2014. Case received from a healthcare professional (a pharmacist0 on 08-OCT-2014. Case medically confirmed. A female patient (age not reported) received the first dose of GARDASIL (batch number, route and site not reported) on an unspecified date and after that, date not reported, she presented with neurologic symptoms. These symptoms worsened with each dose administered (number of doses not reported). According to the reporter the patient started with these symptoms one year and a half ago, exact date not reported. At the time of this reporting the patient was in a wheelchair because when she was standing she lost the equilibrium. The patient started with headache and also with some punctual abdominal pain. The patient also presented with: somnolence (onset not reported, she slept for 18 hours/day), gait disturbance and faintness (onset not reported). According to the reporter, the patient''s mother, who is a nurse, considered these adverse events related to the vaccination; although no physician who saw her (including the neurologist) considered it as related to vaccination. The neurologist thought that there was a psychiatric component. The neurologist didn''t provide a diagnosis because he didn''t know any syndrome with these symptomatology. The patient was directed to the psychiatrist but she was discharged from psychiatrist''s ward (it was not reported whether the patient was hospitalized or not). All of the tests performed on an unspecified dates had normal results, including a CAT, except IgA which resulted very high levels. At the time of reporting the patient had not recovered. According to the reporter, she considered the case as serious. Upon medical review the company considered the case as serious with disability and other medically important condition as criteria. No further information was reported.


VAERS ID: 559570 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-11-25
Entered: 2014-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Blood pressure fluctuation, Body temperature fluctuation, Headache, Hemiplegia, Loss of personal independence in daily activities, Malaise, Migraine, Myalgia, Pain, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2013, Spinal cord injury lumbar; 2013, Appendicectomy
Allergies:
Diagnostic Lab Data: Blood pressure, fluctuation no provided; Body temperature, fluctuation no provided
CDC Split Type: WAES1411DNK011302

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # E2014-11366) on 24-NOV-2014. Case received from patient insurance company (PIC) via Health Authorities on 18-Nov-2014 under the reference number DK-DKMA-ADR 22758660 and 14-9146. The primary reporter was a lawyer. A 13 year old female patient had received the first dose of GARDASIL, (batch number not reported) via unspecified route of administration in unspecified site of administration on 09-Jun-2010 and later on unspecified date in 2010 she developed migraine, reduced strength in the right arm and headache. The patient also received the second dose (on unspecified date) and third dose of GARDASIL on unspecified date in 2011 (batch number, route- and site of administration not reported). In addition, on unspecified date in 2013, she developed paralysis of the right side of the body and on unspecified date sensory disturbance, pain, temperature fluctuation, the body dose not work anymore/cannot perform gymnastics, no strength in right side, abdominal and muscle pain and blood pressure fluctuations. Case was received HA from PIC as the patients initial claim. PIC has not yet decided in the matter. Adverse reactions: Migraine attacks, sensory disturbance on the right side of the body - especially the right arm and strength of the hand. Major abdominal pain. Muscle pain. Blood pressure fluctuations or strange temperature changes in the body. Description: After HPV vaccine the patient develops severe headache - migraine attacks. A different body pain, strange sensory disturbances and major temperature fluctuations. Physician, Physiotherapy and Neurologist consultation without any help. Culmination in January 2013 with hospitalisation and half sided (right sided) paralysis symptoms. The right arm had by no means been 100% recovered or okay in October 2014 - has no strength on the right side. Has been very sick in 2013 and 2014 so she had to stop high school because of disease and hospitalisation. The patients medical history includes: during 2013 spinal cord examination punctured incorrectly. Fall of 2013 she had an appendix surgery - misdiagnosis. This case was assessed serious by HA due to hospitalisation and disability. At the time of reporting, the patient had recovered from paralysis of the right side of the body, whereas not recovered from all events.


VAERS ID: 573335 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-11-22
Onset:2011-11-24
   Days after vaccination:2
Submitted: 2015-01-02
   Days after onset:1135
Entered: 2015-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Anxiety, Arrhythmia, Asthenia, Biopsy skin abnormal, Blood test abnormal, Computerised tomogram abnormal, Electrocardiogram abnormal, Fatigue, Heart rate irregular, Hepatitis, Hernia, Hypoaesthesia, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Loss of consciousness, Loss of personal independence in daily activities, Lymphadenopathy, Memory impairment, Neck pain, Nervousness, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Parotid gland enlargement, Pyrexia, Radioisotope scan abnormal, Rash erythematous, Rash macular, Retinal detachment, Scan gallium abnormal, Speech disorder, Syncope, Ultrasound scan abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Hepatitis, non-infectious (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Skin tumours of unspecified malignancy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Vitamins (unspecified); TARIVID; LOXONIN
Current Illness: Metrorrhagia; Hypothyroidism; Seasonal allergy
Preexisting Conditions: Fexofenadine hydrochloride; Pranlukast
Allergies:
Diagnostic Lab Data: Gallium scintigraphy (28-JUN-2012): radioactive accumulation was found in liver, spleen and heels; Body temperature, increased. 06/28/2012, Biopsy skin, suspected sarcoidosis; 06/26/2012, Blood test, suspected sarcoidosis; 01/11/2012, Body temperature, increased degrees C, increased; 06/26/2012, Computerised tomogram, ''suspected'' sarcoidosis; 06/28/2012, Electrocardiogram, suspected sarcoidosis; 06/26/2012, Nuclear magnetic resonance imaging, suspected sarcoidosis; 06/28/2012, Radioisotope scan, radioactive accumulation was found in liver, spleen; 06/28/2012, Ultrasound scan, suspected sarcoidosis
CDC Split Type: WAES1412JPN013249

Write-up: This spontaneous report as report as received from a consumer refers to an adult female patient of with the poaceous pollen, hypothyroidism, metrorrhagia. From 22-NOV-2011 to 08-May-2012 the patient was vaccinated with three doses of GARDASIL (dose, lot number not reported) (first dose and third dose in left shoulder, second dose in right shoulder) intramuscular. Other concomitant therapies included vitamins (unspecified), TARIVID, LOXONIN. For poaceous pollen, the patient took medications such as ONON and ALLEGRA in the season of spreading pollen (for only about a month a year). For hypothyroidism, the patient had never taken any drugs because her thyroid function levels were slightly out of reference range and the patient sometimes visited the hospital for checking data on a blood test. Otherwise, the patient had no health problem and no need to take a break from working, household duties or childcare. On 22-NOV-2011 the patient received GARDASIL by accepting a physician''s recommend during a visit to clinic as it sounded good for preventing such a fearful cervical cancer. After the first vaccination, injection site was swollen as if it had induration and pain with hot feeling also occurred. Subsequently, pain subsided while itching occurred. It took about 1 week from onset of pain followed by itching to disappearance of symptoms. On 24-NOV-2011 (2 days after vaccination), the patient suddenly lost consciousness at home. In addition, the patient noticed irregular pulse with skipping, so the patient visited the medical center. Thereafter, numbness in hand also developed. Based on the symptoms, arrhythmia and numbness of hand, the patient wondered if she would have been experiencing cerebral infarction, so she sought medical attention at the orthopedic department of hospital. On 27-DEC-2011, the patient noticed that right parotid gland and lymph nodes of neck were swollen. Because she had severe pain on motion, she could not turn her head to the right. The affected area happened to swollen due to ear disease, oral disease and other various causes, so the patient visited an otorhinolaryngology, dental clinic and orthopedics one after another. However, the cause of those symptoms was undetermined. At the orthopedics, the doctor said that it might be hernia, and vitamins for nerve repair and TARIVID were prescribed without any improvement. Finally, the patient was placed on follow-up after prescribing LOXONIN as an analgesic. On 11-JAN-2012, the patient had fever of 40 degrees C and visited clinic where she received vaccination. Some visits were made for drip infusion of antibiotics, and fever declined within 3 to 4 days. On an unknown date red skin rash like blotches occurred mainly on hair line, scalp and around neck, and then the affected area moved to feet and hands. For other symptoms, on an unknown the patient was easy to get exhausted. In the morning, the patient had to lie down all day after going to the door to see my children off. The patient could not go to work and do the household duties. Physical strength was extremely decreased, and she wondered what happened to me. On 17-JAN-2012, the patient visited clinic for second vaccination. At that time, she told the physician that she had some symptoms such as neck pain, but vaccination was done after the physician judged that they might not problems. She received the vaccine on the right shoulder and she had almost the same symptoms she experienced with the first vaccination: severity of pain when inserting a needle, subsequent feeling of swollen and the condition of persisted pain and itching for approximately 1 week. Except syncope and fever, the patient had had the same symptoms she experienced after the first vaccination. Subsequently, arrhythmia, swollen lymph nodes and neck pain persisted and these symptoms made me nervous. Especially for swelling of cervical lymph node, she was told that it might be malignant lymphoma at some hospital while doing doctor shopping. The patient could not forget the word ''malignant lymphoma'' which remained in her head. On 02-MAY-2012, the patient visited community hospital for evaluations. However, the cause was unclear and she was placed on follow-up. On 08-MAY-2012, the patient received the third vaccination on the left shoulder. The patient had almost the same symptoms she experienced with the first vaccination: the severity of pain when inserting a needle, subsequent feeling of swollen and the condition of persisted pain and itching for approximately 1 week. The patient became more forgetful and made speech errors compared with the previous status and was filled with anxiety. On 11-JUN-2012, the patient visited hospital again. On 26-JUN-2012, the patient collapsed because of dizziness and was transferred to the hospital emergently. At that time, ADETPHOS, MERISLON and GRANDAXIN were prescribed after being suggested the possible Meniere''s disease. After taking the medications for approximately 1 month, severe dizziness causing me collapsing was improving. However, compared to the pre-vaccination state, the patient got motion sickness easily, so that she could not see the movies with any rotating motion in the scenes. Various tests including MRI, CT and blood test were done. Based on the results, she was told that it could not be determined, but sarcoidosis was suspected from the overall point of view. The patient''s symptoms seemed to look like manifestations of sarcoidosis such as skin eruption. However, the confirmation of characteristic cells was necessary to make definitive diagnosis of sarcoidosis. In her case, there were no such cells found on the investigation, so she was diagnosed as ''suspected'' sarcoidosis. Regarding swollen lymph node, she was told there were many lumps around neck and biopsy should be performed, resection of affecting skin area for further examination. However, because the lesions were in the neck, one of the most risky areas, the biopsy could not be done in the hospital. So the patient was referred to the teaching hospital. On 28-JUN-2012, the patient was underwent the further examinations at teaching hospital: electrocardiography, echography and skin biopsy. Gallium scintigraphy was also done, detecting inflammatory areas by injecting radioactive material and investigating its accumulation in the body area. In her case, radioactive accumulation was found in liver, spleen and heels. However, since the specific cells that indicated sarcoidosis could not be detected, the diagnosis of ''suspected sarcoidosis'' was made again. The patient''s condition could not be certified as an intractable disease because it was not a definite diagnosis of sarcoidosis. Subsequently, the patient was underwent examinations many times for searching the cause. In approximately November 2013, the patient underwent a surgery for retinal detachment after retinal inflammation was indicated. The patient heard that some of patients who received GARDASIL lost their vision. The patient visited ophthalmology department regularly after surgery, but her fear of decreased vision could not be disappeared. Memory impairment and making speech errors as mentioned above had noticed since 2014. And numbness and pain of heels had occurred since March 2014. At the time of the report on 24-DEC-2014, the patient recovered from ''swelling with induration and pain with hot feeling on vaccination site'', ''itching'', ''pyrexia of 40 degrees C'', ''Feeling of swelling and persisted pain and itching for around 1 week (developed on 17-JAN-2012)'', ''Feeling of swelling and persisted pain and itching for around 1 week (developed on 08-MAY-2012)'' and ''sudden loss of consciousness''. The outcome of ''irregular pulse with skipping'', ''numbness of hands'', ''swelling of parotid gland and lymph nodes of neck on the right side'', ''neck pain'', ''Syncope'', ''hernia'', ''Energy decreased'', ''nervous'', ''Anxiety'', ?easy to get exhausted'', ''suspected sarcoidosis'', ''inflammation in liver, spleen and heels'', "indicated possible Meniere''s disease", ''susceptible motion sickness'', ''increase in forgetfulness'', ''making speech errors'', ''retinal inflammation'', ''retinal detachment'' and ''numbness and pain in heels'' was unknown. Dizziness was resolving. The reporting consumer did not assess the causalities of ''Swelling with induration and pain with hot feeling on vaccination site'', ''itching'', ''Pyrexia of 40 degrees C'', ''Feeling of swelling and persisted pain and itching for around 1 week (developed on 17-JAN-2012)'', ''Feeling of swelling and persisted pain and itching for around 1 week (developed on 08-MAY-2012)'', ''Sudden loss of consciousness'', ''irregular pulse with skipping'', ''Numbness of hands'', ''Swelling of parotid gland and lymph nodes of neck on the right side'', ''Neck pain'', ''Syncope'', ''hernia'', ''Energy decreased'', ''nervous'', ''Anxiety'', ''Easy to get exhausted'', ''Suspected sarcoidosis'', ''inflammation in liver, spleen and heels'', "indicated possible Meniere''s disease", ''Susceptible motion sickness'', ''increase in forgetfulness'', ''Making speech errors'', ''Retinal inflammation'', ''Retinal detachment'', ''Numbness and pain in heels'' and ''Dizziness'' to GARDASIL. Upon internal review, sudden loss of consciousness and retinal detachment was considered to be serious due to other important medical condition and disabling, respectively. Easy to get exhausted was serious due to disability. Additional information is not expected.


VAERS ID: 574787 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2013-03-14
Onset:2013-03-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2015-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H011989 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Aggression, Allodynia, Cardiac murmur, Educational problem, Fatigue, Heart rate irregular, Homeopathy, Liver disorder, Menstruation irregular, Nervous system disorder, Obsessive-compulsive disorder, Ovarian disorder, Pain in extremity, Palpitations, Paraesthesia, Paranoia, Psychiatric evaluation abnormal, Renal disorder, Stereotypy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Fertility disorders (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: No other medications
Current Illness: Immunisation; Autism
Preexisting Conditions: Hyperthyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1502GBR003198

Write-up: Information has been received on 03-Feb-2015 from health authority. GB-MHRA ADR 22842015. The case is not medically confirmed as it was reported by a consumer. A 16 year old female patient (weight 58.06 kg), with medical history of autism recently diagnosed and hyperthyroidism, was vaccinated with a first dose of Gardasil, (batch/lot number H008041) on 13-Sep-2012, with a second dose of GARDSAIL (batch/lot number H008041) on 11-Oct-2012 and with a third dose of GARDASIL (batch/lot number H0011989) on 14-Mar-2013, route and sites of administration not reported. In Oct-2012, the patient started spinning her hands around, complaining about a tingling pain in her wrists and hand which did not last more than a few days so the patient''s parents carried on as before. On 16-Mar-2013, she complained about feeling completely drained and she also developed a strange form of what the patient''s parents described as obsessive compulsive disorder around sniffing. If she heard anyone sniff, it would bring on the intense pain in her hands and feet. On an unspecified date after the third dose, this became paranoid to the point she had to have all windows in the house closed in case someone walked past and sniff and she also developed lethargy like she had myalgic encephalopathy, according to her mother. The patient became aggressive with her family and pets she would drag around. On an unspecified date after the third dose of vaccine, the patient developed abnormal behavior as she would open and shut the passenger car door whilst driving and have to have the window down when travelling, the patient completely changed. She absconded many times and she once became so scared that she ran out of the house naked and into some local woods as the reporter had to call the Police to find her and bring her home. The patient consulted the family''s general practitioner who referred her to see a psychiatrist. The psychiatrist gave her anti-anxiety medication and serotonin pills which temporarily helped but did not identify any underlying cause. One and unreported date, the reporter noticed that the patient seemed to have an irregular heartbeat and found she was skipping 4 beat out of every 10. The patient consulted to hospital where they told her she had a systolic heart murmur which started on 16-Mar-2013 and was not life threatening. The patient consulted homeopathic toxicologist who said that her nervous system, ovaries, kidneys and liver were damaged. Two months later, the toxicologist said she had done all she could for the patient. the patient''s periods, which had stopped on an unreported date after the third dose of vaccine, came back for the first time in six months but then stopped again two months later. The patient''s mother had to pull the patient out of school and have to home tutored. The results from her exams which she took before the vaccine were significantly better than her final result. She started college a few months ago but had to drop out because of her phobia hearing people sniff and she was now home learning. At the time of reporting, the patient had not recovered from heart murmur, loss of energy, obsessive-compulsive disorder and pain in extremities and the outcome of the other adverse events was unknown. The case was considered as serious due to the patient''s disability and to be medically significant.


VAERS ID: 576015 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-03-17
Entered: 2015-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Headache, Lethargy, Vision blurred, Wheelchair user
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), 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? 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: WAES1503AUS006746

Write-up: Information has been received from a reporter''s daughter classmate via bioCSL as part of a business agreement (manufacturer control # not provided) on 13-MAR-2015, concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (route, dosage, dose no. and lot no. unknown). On an unknown date after receiving GARDASIL the patient experienced lethargy, difficulty focusing, dizziness, joint pain, stomach cramps and headache. The patient needed to be in a wheelchair for 2 years due to the severity of her symptoms (disability). The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.


VAERS ID: 576714 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-01
Onset:0000-00-00
Submitted: 2015-04-06
Entered: 2015-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Dysuria, Headache, Hyperhidrosis, Memory impairment, Muscular weakness, Palpitations, Postural orthostatic tachycardia syndrome, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (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), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 07/2009, HPV vaccine (unspecified), first as trial dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1504DNK002080

Write-up: Information has been received on SPMSD (MFR no. DK-1577272925-E2015-03110) as part of business agreement on 03-APR-2015. Case retrieved from a News Site via company representative on 30-Mar-2015. The primary reporter was a patient. Case is invalid as there is no contactable reporter. A currently 25 year old female patient with no medical history, had received a dose of HPV vaccine (MFR unk, batch number not reported) via unspecified route of administration in unspecified site of administration on unspecified date and later on 1 month post-vaccination she developed, headache, dizziness and palpitation every day. She has urination problems, facial impurities, dyspnoea, sweating and daily sleeping problems. Memory problems or concentration difficulty is a constant discomfort for the patient. Both arms and legs have weakened. She has otherwise always danced a lot and worked at a fitness center, which included almost daily workout. Six months post-vaccination last dose she went on sick leave - and the two following years. She is trying to complete an education that can only be done because she intakes a lot of medication and receives help from fellow students and internships. The patient was diagnosed later with POTS. The patient has previously received the first HPV vaccine as trail dose (MFR unk, batch number not reported) on unspecified day in July 2009. At the time of reporting, the patient was not recovered (however not on sick leave).


VAERS ID: 576720 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2010-08-01
Onset:0000-00-00
Submitted: 2015-04-06
Entered: 2015-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Dizziness, Headache, Initial insomnia, Insomnia, Loss of personal independence in daily activities, Memory impairment, Micturition urgency, Muscular weakness, Nausea, Palpitations, Poor quality sleep, Skin infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular 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: Immunisation, Tension headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1504DNK002076

Write-up: Information has been received from SPMSD(MFR no. DK-1577272925-E2015-03104) as part of business agreement on 03-APR-2015. Case retrieved from a News Site via company representative on 30-Mar-2015. The primary reporter was a patient. This case is invalid as there is not contactable reporter. A currently 28 year old female patient with a medical history of sporadic tension headaches, had received the first dose of GARDASIL (batch number not reported) via unspecified route of administration in unspecified site of administration on unspecified day in August 2010 and later on unspecified date she developed headache, dizziness, palpitation, nausea, urination urgency of, skin infection, sleep difficult, concentration and memory impairment and muscle weakness. According to the patient, she has round the clock mild headache, but get weekly bouts of severe tension headaches. Approximately once a week she suffers from dizziness. In pressed or stressful situations she also develops palpitation. The nausea follows her constantly in periods. She often feels the need to urinate, even though she cannot. Facial skin, back and chest is very impure. She gets spontaneous infections in the hair follicles - especially on the arms and legs. Every night she has trouble falling asleep, and she is never rested when she wakes up. She tries to maintain a normal circadian rhythm and sleeps six to 10 hours a day. In total she spends 14 -16 hours a day lying down or in bed. She can only concentrate for two to four minutes at a time and have virtually no short-term memory. Both arms and legs have weakened. Before she was otherwise very physically active. Today she cannot take care work or education. Before vaccination the patient had sporadic tension headaches, maybe once a month, but was otherwise completely healthy. Upon medical review the company judged relevant to consider this case as serious due to disability (cannot take care of work or education). At the time of reporting, the patient was not recovered.


VAERS ID: 578274 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-01
Onset:2014-04-01
   Days after vaccination:31
Submitted: 2015-05-07
   Days after onset:401
Entered: 2015-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disability, Fatigue, Joint swelling, Muscle swelling, Pain, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Haemodynamic oedema, effusions and fluid overload (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505AUS001027

Write-up: This spontaneous report as received from a consumer''s friend refers to a female patient in her mid forties. In approximately March 2014, the patient was vaccinated with a dose of GARDASIL (strength, dose, route and site of administration, lot# and expiry date were not provided), along with other unspecified vaccines, prior to an overseas trip. In approximately April/May 2014, the patient started to experience symptoms such as fatigue, weight gain, she had swollen joints, sore joints and muscles. The patient also developed a crippling pain, she was unable to walk 5 meters from the bedroom to the lounge chair on her really bad days and some days was unable to get out of bed, which were considered to be disabling conditions. The consumer had seen multiple specialists and was treated with prednisone, anti-inflammatories and multiple pain relieving medications. At the time of report, the patient still had fatigue, sore joints, sore muscles and weight gain. The outcome of the other events were unknown. The patient suspected that her illness and symptoms that she had been suffering from over the past year were related to the GARDASIL as she saw an online article and felt that the vaccine contributed to her conditions. Additional information has been requested.


VAERS ID: 579453 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-26
Entered: 2015-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ28270 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Disturbance in attention, Educational problem, Myalgia, Pain, Vitamin B12 decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, Dose 2 (batch no. not reported) was given via not reported route and site of administration, toleration was not reported; GARDASIL, Immunisation, Dose 1 (batch no. not reported) was given via not reported route and site of administration, toleration was not reported
Allergies:
Diagnostic Lab Data: Investigation, without finding any cause of pain; Investigation, slightly low B12 vitamin
CDC Split Type: WAES1505DNK011372

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control #E2015-05392) on 22-MAY-2015. Case was received from health care professional via the Health Authorities on 19-May-2015 under the references DK-DKMA-ADR 22980153 and DK-DKMA-EFO11903. Case is medically confirmed. The primary reporter was a physician. A female patient (adolescent; age at time of event, weight and height not reported) with no medical history received three doses of GARDASIL, (batch # NK14370, lot # NJ28270, expiration date: 30-SEP-2011) intramuscularly into not reported site of administration on an unspecified date. One of the three vaccines was given on 27-Aug-2009. The patient had developed jumping muscle pain and jumping joint pain since the third HPV vaccination. She had been seen by a rheumatologist and neurologist without finding any cause to the pain. She referred herself to practice approximately one year after 3 vaccinations. She had trouble coping with her education because of pain and difficulty concentrating. Paraclinical investigation was performed. Slightly low B12 vitamin was found. After correction the symptoms were unchanged. No other medication was reported. At the time of reporting, the patient had not recovered.


VAERS ID: 580607 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-01
Entered: 2015-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Disturbance in attention, Dizziness, Fatigue, Headache, Hypersensitivity, Nausea, Pain, Scan brain, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Hypersensitivity (narrow), Arthritis (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DNK000020

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control no DK-1577272925-E2015-05717) as part of business agreement on 28-MAY-2015. Case received from a consumer or other non health professional via the Health Authorities on 25-May-2015 under the reference number DK-DKMA-ADR 22995500 and DK-DKMA-EFO12070. Case is not medically confirmed. A 14-year-old female patient (weight: 45 kg, height: 156 cm) with no medical history reported had received a dose of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on an unspecified date in 2007. On an unspecified date in 2009, the patient experienced stomachache. In 2011, the patient developed dizziness, fainting and tiredness. In 2012, the patient also developed stinging in the chest, pain in the joint, concentration impairment and pain in the body. In 2014, she suffered from allergy/hives and severe nausea. On an unspecified date she had headache. Brain scan was performed on an unspecified date. No test result was provided. No other medicines were reported. At the time of reporting, the patient had not recovered. The patient was hospitalization. The agency considered this case is serious as all events were disabling/incapacitating.


VAERS ID: 581448 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-04
Entered: 2015-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Basedow's disease, Blood thyroid stimulating hormone decreased, Dizziness, Endocrine test abnormal, Exercise tolerance decreased, Fatigue, Hiatus hernia, Irritable bowel syndrome, Pregnancy, Silent thyroiditis, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (narrow), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Noninfectious diarrhoea (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: CILEST; TERBASMIN TURBUHALER
Current Illness: Immunisation
Preexisting Conditions: Thyroid dysfunction in pregnancy; Diphtheria and tetanus vaccine, (06-Oct-2008)
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DNK001146

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Case Report N. DK-1577272925-E2015-05968) on 01-JUN-2015. Case received from healthcare professional via Health Authorities on 28-May-2015 under the reference number DK-DKMA-ADR 23006766 and DK-DKMA-EFO12181. The primary reporter was a physician. A female patient with a medical history of postpartum thyreoidit/graves hyperthyreose, had received 3 doses of GARDASIL (D1. 06-Oct-2008 batch number reported as NJ001850, D2 not reported date batch number reported as NJ001850, D3 2009 batch number NJ50800, lot 0773X, expiration date: 16-JUN-2011) via intramuscular route of administration in unspecified site of administration later on in 2009 she developed reduced strength and in 2010 tiredness, dizziness, abdominal pain, and visual disturbance. The patient was previously a elite gymnast. She had to stop approx. 1 month after the last dose due to reduced strength. One year after the third dose, debute of daily abdominal pain (strength varies), unexplained visual disturbance, tiredness periodic and recurring tiredness 2 weeks to a couple of months. Dizziness, connected to tiredness, other unspecified symptoms (not specified only mentioned by the HA in the narrative). Tiredness and dizziness worsen after pregnancy and also during. The patient has been referred to Hospital, syncope center. The patient has been examined by gastroenterologist in 2010, diagnosed with post infectious colon irritable. Other gastroenterologist have found esophageal hernia. Has been seen by ophthalmologist in 2010, vision not abnormal. Referred to endocrinology due to low TSH and high free hormones, postpartum thyroidit or graves hyperthyreose. TSH normal before pregnancy. Concomitant medication: CILEST, TERBASMIN TURBOHALER, DT vaccine (06-Oct-2008). Upon medical review the company decided to code colon irritable and esophageal hernia, mentioned by the HA in the narrative but not coded. At the time of reporting, the patient had not recovered.


VAERS ID: 581478 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-05
Entered: 2015-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test abnormal, Diagnostic aspiration, Lumbar puncture, Lymphadenectomy, Lymphadenopathy, Pain, Paraesthesia, Positron emission tomogram, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Arthritis (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: No other medications
Current Illness: Immunisation; Stress
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data: No blood tests or other examinations could show rheumatic or neurological disorder. The physician performed a fine needle biopsy and when the results came, the patient was referred to the ENT department at hospital for removal of the swollen lymph nodes. Hereafter, the patient was sent further to the hematological department due to "skewed" blood tests and was evaluated for chronic lymphatic leucemia and malignant lymphoma. The patient underwent ultrasound scan, CT-scan and PET/CT scan, lumbar puncture (extraction of cerebrospinal fluid and bone tests). Approx. 1-year evaluation at the hematological department, the patient was discharged, as they could not find anything concretely malignant. The conclusion was "something reactive" and the patient shall turn to her own doctor, if the symptoms continue.
CDC Split Type: WAES1506DNK002899

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (company# DK-1577272925-E2015-06116) on 04-JUN-2015. Case received from Patient Insurance Company (PIC, reference number 15-3843) via the Health Authorities on 01-JUN-2015 under the reference number DK-DKMA-ADR 22995536. Case is not medically confirmed. Primary source was a lawyer. A female patient (weight, height not reported) with a medical history of stress and premature birth had received three injections of GARDASIL (batch number not reported) on an unspecified dates around autumn 2007 via intramuscular route(also reported as unknown) into not reported sites of administration. On an unspecified date in 2012, the patient developed paresthesia in hands and arm up to shoulders, immense joint pain in all joints (especially hand, elbow, shoulder, knee, ankle). On an unspecified date, the patient developed pain in hands and arms ("stabbing and excessive"), swollen lymph nodes (especially in throat) and removal swollen lymph nodes. The patient had received pain relief medication and 1 time intensive prednisolone treatment. PIC has not yet made a decision regarding the case. In autumn 2007, the patient received the HPV-vaccines after her friend died of cervical cancer the same year. Immediately after, the patient did not receive any symptoms from the vaccines. However, after labor and stress, the patient experienced severe symptoms that started as paresthesia in hands followed by immense joint pain in all joints - especially in hand-, elbow- and shoulder joint, knee and ankle joint. At the same time, the paresthesia "moved" upwards so that they in the end were highly painful in hands and arms up to shoulders. Evaluation at hospital showed no rheumatic disorder, thereafter the patient was sent for evaluation for carpal tunnel syndrome at another hospital and was assigned to the neurological department. No blood tests or other examinations could show rheumatic or neurological disorder. The patient visited afterwards- at her own expense - a private clinic, where they meant that it was neuritis. They could not either show anything. The patient became discharged from evaluation at hospital without any conclusions, as she wanted to come back to the job market - despite constant persistent paresthesia in hands and arms. In the course of the spring, the patient turned to her GP with swollen lymph nodes, especially in throat, and was referred to Ear-Nose-Throat (ENT) physician. The physician performed a fine needle biopsy and when the results came, the patient was referred to the ENT department at hospital for removal of the swollen lymph nodes. Hereafter, the patient was sent further to the hematological department due to "skewed" blood tests and was evaluated for chronic lymphatic leukemia and malignant lymphoma. The patient underwent ultrasound scan, CT-scan and PET/CT scan, lumbar puncture (extraction of cerebrospinal fluid and bone tests). After approx. 1-year evaluation at the hematological department, the patient was discharged, as they could not find anything concretely malignant. The conclusion was "something reactive" and the patient shall turn to her own doctor, if the symptoms continue. The patient had still paresthesia in arms and hands. The patient has throughout the progression made aware of that she back in 2007 received the HPV-vaccines, but had been met by odd looks-both due to the long time that passed without symptoms, and because "one", according to the patient, still did not recognize adverse reactions at GARDASIL vaccines. The patient had the entire time been convinced that it was the vaccines that wreck havoc in her system - especially since she had been examined in all directions - without them finding anything. And she could understand that (extremely) many girls suffer from the symptoms after HPV-vaccination, and she therefore meant that she has received a part of a confirmation that it was extremely harmful! Especially since virus often lay latently in the body and waits for a "weak" moment for the immune system, the patient means, that her chronic symptoms and varying pain are due to the vaccines. At the time of reporting, the patient had not recovered from paresthesia and pain. The outcome for the other events was unknown.


VAERS ID: 584822 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-08-01
Submitted: 2015-07-03
   Days after onset:701
Entered: 2015-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fatigue, Headache, Hypotension, Vitamin D decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Vitamin D, Low
CDC Split Type: WAES1507DNK000362

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-E2015-07450) on 30-JUN-2015. Case received from Non-Health Care Professional via Health Authorities on 25-Jun-2015 under the reference number DK-DKMA-ADR 23004476 and DK-DKMA-EFO12165. The case in not medically confirmed. The primary reporter was a consumer. A 13-year old female patient (weight: 62 kg; height: 178 cm) had received the first, second and third dose of GARDASIL (batch numbers: not reported) via intramuscular route of administration in unspecified site on not reported dates. On unspecified days in Aug-2013, she developed headache, dizziness and unusual tiredness. On unspecified dates, she developed low pressure and abnormally low vitamin D. The patient has received the following treatments for the adverse reactions: Vitamin D, acupuncture. The patient has not been hospitalized due to the adverse reactions. The patient danced 3-5 times per week, tended to her school. Now, the patient cannot dance anymore due to headache and dizziness, and cannot tend to her school full time. She is referred to center. Agency has requested medical confirmation. The case is serious as the serious criteria disability is coded by HA. No other medications. No information on other vaccines provided. Tests and procedures: Yes. Various blood tests that showed inexplicably low vitamin D (not further specified). The patient has no relevant medical history. At the time of reporting, the patient had not recovered.


VAERS ID: 584994 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-08
Entered: 2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bedridden, Cardiac disorder, Chronic fatigue syndrome, Electrocardiogram ambulatory abnormal, Hypersomnia, Loss of personal independence in daily activities, Malaise
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ECG (unknown date): Heart condition
CDC Split Type: WAES1507GBR003303

Write-up: I am writing to you as I feel there is an issue with the Human Papilloma Virus (HPV) vaccine. Since my daughter had her last vaccine she has become very ill. Her life is now bedridden. She has been diagnosed with chronic fatigue syndrome and can sleep 20 hours a day if left and I have to help her bath, dress and completely look after her. We have no support. We have seen lots of specialists and no one will agree it is the vaccine here. The side effect list is very small but my daughter has them all. She has now had a 24 hours electrocardiogram (ECG) and it showed that she now has a heart condition. Now she is being referred to a cardiologist in case she has postural orthostatic tachycardia syndrome (POTS). She is unable to attend school on a daily basis and this has affected her education. The HPV vaccine is being studied and they have made the connection that thousands of girls world wide are becoming ill from being very healthy and playing sports to being unable to walk for long like my daughter. We have to wait months for each referral and no one wants to hear or even talk to me about this. Our daughter has no support and we are alone in this situation. What does the future hold for my daughter? Being stuck in bed with her illness is not good. Being in pain and heart problems from being health and fit scares us. My life is on hold because she needs me here to wash her hair and get her in the bath, cook for her and the list goes on.


VAERS ID: 607349 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-13
Entered: 2015-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acne, Androgens increased, Balance disorder, Blood oestrogen increased, Consciousness fluctuating, Diplopia, Disorientation, Disturbance in attention, Dizziness, Dry eye, Dry mouth, Dry skin, Dyspnoea, Excessive cerumen production, Fatigue, Feeling hot, Headache, Hormone level abnormal, Hypersomnia, Liver function test abnormal, Loss of personal independence in daily activities, Malaise, Milk allergy, Paraesthesia, Progesterone decreased, Pyrexia, Sensory loss, Thyroid disorder, Vision blurred
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Ocular motility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508DNK005261

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control #E2015-09141) as part of business agreement on 12-AUG-2015. Case received from non-health care professional via Health Authorities on 07-Aug-2015 under the reference number DK-DKMA-ADR 23077960. The primary reporter was a patient. A female patient (DOB not reported) with no information on medical history provided, had received 2 doses of HPV vaccine type 6, 11, 16, and 18 (Mfr unknown, batch number not reported) via i.m route of administration in unspecified site of administration on a not reported date and later on a not reported date she developed extreme acne, activities of daily living impaired, androgens high, difficulties balancing, blurred vision, cognitively disoriented, concentration impairment, waving in and out of consciousness, difficulty breathing, dizzy, double vision, dry eyes, dry mouth, dry skin, loads of ear wax, extreme tiredness, feeling hot, fever that made her sleep loads, hair loss, extreme headaches that over 8 months turned into strong pressure headaches, she was told that her liver values looked like those of strong alcohol, hormonal imbalance, malaise, milk protein allergy, feels like she couldn''t feel her little toe and two fingers, oestrogen increased, pain, pins and needles in hands and feet, progesterone decreased, protein allergy, excessive sleep, temperature regulation disorder and thyroid disorders. The patient only received 2 HPV-vaccines, because she felt so unwell. Extreme tiredness, slept constantly more than 18 hours in a 24 hour period for approximately 8 months. Fever that made her sleep loads and was waving in and out of consciousness. Extreme headaches that over 8 months turned into strong pressure headaches. She only have mild headache now, but she hardly had headaches before. Pain and aches. Feels like she couldn''t feel her little toe and two fingers. Thyroid problems, took thyroxine for a while (not further specified). Breathing problems, she was asked to use an inhaler, which she still does. Hormone imbalances, high levels of androgens and oestrogen and low levels of progesterone. She was asked to take the pill as she had a coil (not further specified). Extreme acne. She has always had acne, but never this bad. Vision problems; blurred vision, but main problem was double vision that occurred especially when tired, so constantly. Pins and needles in hand and feet. Completely unable to regulate body temperature, sometimes felt like lying in the snow to cool down, but felt it would be socially strange. Dry eyes, mouth and skin in addition to loads of ear wax. Cognitively disoriented. Dizzy and difficulties balancing. Unable to concentrate. Unable to focus. Unable to process information. Hair loss, she has very thick hair and it is only by looking back that she can see that she was losing. She was diagnosed with thyroid problems, hormone imbalances, protein allergy and it was suspected that a tick could have bitten her due to her nerve problems. She was told that her liver values looked like those of strong alcohol, this attributed to milk protein. The patient felt a bit better after she stopped all intake of milk products, but not much and the result was not constant. Most physician seem to think that she had mental problems. Further, the patient informs that she has been examined by 10-13 different physicians without correct diagnose. The patient and close relative started to suspect HPV-vaccine, when they in Oct-2012 read an article about this and for the first time they recognize the symptoms the patient have had during almost 6 years. The patient was a very happy, sporty and dynamic girl. The HPV-vaccine totally changed her active life and has in addition resulted in loss of one year study, a daily fight to save her strength to do the most essential. She has through years tried to figure out the reason for her symptoms and sudden weakness both psychological and mentally and thus, a loss of faith in herself and the health care. Agency comment: the reporter has not mentioned which HPV vaccine she has received, hence the active substance human papilloma virus is coded and it is not, based on the report, possible to find out who her physician/s are and therefore no medical confirmation request will be performed. However, a request has been sent to the reporter to be informed if she was vaccinated with GARDASIL, SILGARD or CERVARIX and information about her physician. At the time of reporting, the patient had recovered from extreme tiredness, recovering from extreme headaches that over 8 months turned into strong pressure headaches, not recovered from difficulty breathing and malaise. However, the outcome for all other events was unknown. The case has been assessed as serious to the "disability" criteria.


VAERS ID: 607369 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-25
Onset:2015-08-06
   Days after vaccination:650
Submitted: 2015-08-13
   Days after onset:7
Entered: 2015-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Demyelinating polyneuropathy, Diarrhoea, Dizziness, Headache, Hypoaesthesia, Mobility decreased, Movement disorder, Pyrexia, Quadriplegia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-06
   Days after onset: 0
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: 10/2013, Body temperature, Fever
CDC Split Type: WAES1508COL004387

Write-up: This spontaneous report was received from the local news (local radio, television, and online newspaper) concerning to a female patient of approximately 19 to 20 years (discrepancy among media news). Information regarding the patient''s medical history, concurrent conditions or concomitant therapy was not provided. On an unspecified date in May 2013, the patient was vaccinated with the first dose of GARDASIL 0.5 ml injection (strength, lot number and expiration date were not provided), 0.5 ml intramuscular. Subsequently, on an also unspecified date in May 2013, after the vaccination, the patient experienced muscle numbness, movement disorder (no specific description was provided) and dizziness. On 25-OCT-2013, the patient was vaccinated with the second dose of GARDASIL 0.5 ml injection (strength, lot number and expiration date were not provided), 0.5 ml intramuscular. On the same month, also after vaccination, the patient experienced headache, diarrhoea, vomiting and pyrexia. Later, on an unknown date in 2014, the patient experienced mobility decreased in her limbs. Then on the same year, she got quadriplegic and, according to the news, in 2014, she was diagnosed with demyelinating polyneuropathy (there was no exact description or clear information concerning when or where the diagnosis was given). In 2015, the patient experienced the first respiratory arrest and recovered from it on an unknown date in the same year. Consequently, on 06-AUG-2015 at 19:-00, the patient experienced the second respiratory arrest and died from it. It was unknown if an autopsy was performed. At the time of this report, the patient had not recovered from quadriplegia. The outcome of demyelinating polyneuropathy, vomiting, pyrexia, headache, dizziness, diarrhoea, hypoaesthesia, movement disorder and mobility decreased was unknown. Additional information is not expected because contact information is not available.


VAERS ID: 607376 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-14
Entered: 2015-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Arthralgia, Depressed mood, Fatigue, Feeling abnormal, Feeling cold, Memory impairment, Migraine, Pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508DNK004637

Write-up: Information has been received from Sanofi Pasteur (MSD) (SPM) (manufacturer control # E2015-09140) as part of business agreement on 11-AUG-2015. Case received from non-healthcare professional via Health Authorities on 07-Aug-2015 under the reference number DK-DKMA-ADR 23100854, 15-4764 (patient insurance company). The primary reporter was a lawyer. A adolescent female patient had 3 doses of GARDASIL (batch number not reported) via IM route of administration in not reported site of administration on unspecified date and later on unspecified date she developed tiredness, joint pain, lower abdomen pain, memory impairment, freezing, depressed/feel like her life is destroyed, migraine, pain in whole body, pain in leg. The HA has received the patient''s initial notification to the insurance company. The insurance company has not taken a decision in the case yet. The patient has reported adverse reaction after GARDASIL vaccination. She can not remember the vaccination dates, but reports that the reaction developed after the vaccinations. She reports that she has much pain in lower abdomen, legs and the whole body, she can not remember, she is so tired that she cannot hang together, she has migraine, and is depressed, all her life is destroyed. She is freezing. Joint are hurting. She can not do anything due to pain and tiredness. She cries alot and has constant migraine and strong pain. She is on 100% sick leave due to the reactions. No information on medical history reported. At the time of reporting, the outcome was unknown for freezing, memory impairment and pain in leg and not recovered for all other reactions.


VAERS ID: 607647 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-14
Onset:0000-00-00
Submitted: 2015-08-20
Entered: 2015-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gait inability, Urinary incontinence, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre 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: Papilloma viral infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508COL008397

Write-up: This spontaneous report as received from a lawyer via compliance director from the company regarding a female patient of unknown age who received GARDASIL injection (start date and route of administration not provided). On an unspecified date after being vaccinated with GARDASIL, the patient presented with urinary incontinence and inability to walk ("the patient has to use a wheelchair"). Infections and neurological issues or damages were discarded according with the information related by the reporter. The action taken with GARDASIL, in response to the events is unknown and the outcome of the events is unknown. Also the causality in relationship to the events is unknown. No further information was provided. It was also noted, no additional information will be required. The event of inability to walk was considered disabling by the reporter. Additional information is not expected.


VAERS ID: 608826 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-03-27
Submitted: 2015-09-03
   Days after onset:160
Entered: 2015-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Back pain, Hypersomnia, Oropharyngeal pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509IRL001689

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-E2015-09931) on 02-SEP-2015. Serious case received from the RA under referenced IE-HPRA-2015-024379 on 28-AUG-2015. This case is not medically confirmed as the reporter was a consumer. A female adolescent patient, no medical history and concomitant medication reported, received an injection of GARDASIL (batch/lot number not reported), via IM route, series site not reported, on unreported date. On 26-OCT-2014, 3 weeks post vaccination, the patient experienced painful knee joints. The reporter indicated that the pain was ongoing every day and has moved to her hips and back since second dose of the vaccine (unreported date). Corrective treatment was paracetamol and NUROFEN but the reporter indicated that these medications were not much use for the pain. On 27-MAR-2015, the patient developed sleepiness and she was not able to socialize with her family or friends, stayed in her room and slept a lot. Since 24-APR-2015, the patient had sporadic sore throat recurring for days at a time. At this time of the reporting the outcome was not recovered. The RA considered the case serious for disability reasons.


VAERS ID: 608912 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-01
Onset:0000-00-00
Submitted: 2015-09-07
Entered: 2015-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Disturbance in attention, Dizziness, Dysstasia, Fatigue, Laboratory test normal, Loss of consciousness, Memory impairment, Muscle spasms, Myalgia, Nausea, Postural orthostatic tachycardia syndrome, Respiratory arrest, Syncope, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), 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), Dystonia (broad), Acute central respiratory depression (narrow), 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), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509DNK003026

Write-up: Information has been received from Sanofi Pasteur MSD (MFR # E2015-09953) on 04-SEP-2015. Case received from Non-Health Care Professional on 31-Aug-2015. The case is not medically confirmed. The primary reporter was a patient. A female patient had received three doses of GARDASIL, (batch numbers not reported) via not reported route of administration in not reported site of administration on unspecified day in Jan-2009, unspecified day in Mar-2009 and 25-Sep-2009. On not reported date after D1, she developed extremely tired all the time. On not reported date after D2, she developed severe abdominal pain. On not reported date after D3, she developed difficulty remembering things, concentration problems, nausea, dizziness, muscle pain in legs, cramps around the b