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Found 1617 cases where Vaccine is HPV4 and Disabled

Case Details (Sorted by Age)

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VAERS ID: 270598 (history)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
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)  
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. - / 0 UN / -

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / - 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
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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 / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Viral sore throat
Preexisting Conditions: Unknown
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)  
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 / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
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)  
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. - / 0 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)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Surgical procedure
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)  
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 / - 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
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)  
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 / 0 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Obesity
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)  
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. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Mitochondrial cytopathy, Surgery
SMQs:

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cardiac septal defect
Preexisting Conditions:
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)  
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. - / 0 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)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MAXAIR
Current Illness: Asthma
Preexisting Conditions:
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)  
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 / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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 / 2 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
Died? No
Permanent Disability? Yes
Recovered? 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
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
Diagnostic Lab Data: unknown
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? 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
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)  
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 / 1 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Tobacco user
Preexisting Conditions:
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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 / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Isoniazid
Current Illness:
Preexisting Conditions:
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)  
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. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Nervous system disorder
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Nervous system disorder
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Obesity
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - UN / IM

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

Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Fibromyalgia
Preexisting Conditions:
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)  
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. - / - UN / UN

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

Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / 1 UN / UN

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

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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 - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Lyme disease
SMQs:, Dementia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Headache, Migraine
SMQs:, Dementia (broad)

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

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

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

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - UN / UN

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

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

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

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

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Postural orthostatic tachycardia syndrome
SMQs:, Dementia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - UN / SYR

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)

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

Administered by: Other       Purchased by: Other
Symptoms: Bedridden, Injury, Wheelchair user
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

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

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

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

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

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

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

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

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

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

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

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

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Phototherapy
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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Rheumatoid arthritis; Sjogren''s Syndrome
Preexisting Conditions:
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)  
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. - / - UN / UN

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

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

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 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)  
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. - / - UN / UN

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

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

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
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:
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: 677070 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2015-05-01
Submitted: 2017-01-06
   Days after onset:616
Entered: 2017-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Asthenia, Chemotherapy, Ovarian germ cell teratoma
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Ovarian malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Chemotherapy (The patient was treated with "6 rounds of chemotherapy" with several medications including Cisplatin, Etopside and Bleomycin.); Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: US0095075131611USA013398

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) for prophylaxis. 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. A call was placed to registered nurse on 05-JAN-2017, the nurse was unwilling to provide any information and asked than no more correspondence be sent. No further information is available. Additional information cannot be requested as the reporter is unwilling to provide any further information.; Sender''s Comments: US-009507513-1611USA013398:, MERCK 1611USA013398:Mfr number.


VAERS ID: 680132 (history)  
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. - / - UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Autoimmune disorder, Disability, Malaise, Myofascitis
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: 689343 (history)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: 303298 (history)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 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)  
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. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Facial spasm, Lacrimation increased
SMQs:, Dystonia (broad), Lacrimal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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 / - UN / UN

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

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

Administered by: Unknown       Purchased by: Unknown
Symptoms: Polyneuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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 / 0 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN52070 / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylphenidate Hcl
Current Illness: Attention deficit hyperactivity dis
Preexisting Conditions:
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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Autoimmune disorder
Preexisting Conditions:
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)  
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. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Chills, Fatigue, Insomnia
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Budesonide; Formoterol fumarate
Current Illness:
Preexisting Conditions: Unknown
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 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)  
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. - / 0 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)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 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)  
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 / - UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER MX199 / - UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1695U / 0 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
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: 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)  
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. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Post viral fatigue syndrome
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Autism spectrum disorder
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)  
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. - / 2 UN / SYR

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 2 UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: HPV vaccine, Immunisation
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)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
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
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
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)  
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. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
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)  
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. - / - 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOLDORM
Current Illness: Sleep disorder; Immunisation
Preexisting Conditions: 11/18/2008, GARDASIL, Immunisation
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
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 sl


VAERS ID: 519661 (history)  
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 / 2 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
Died? No
Permanent Disability? Yes
Recovered? 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
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)  
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 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Orthostatic hypotension
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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: 533373 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-04-01
Onset:2014-05-01
   Days after vaccination:30
Submitted: 2014-06-09
   Days after onset:39
Entered: 2014-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Electromyogram normal, Fall, Gait disturbance, Headache, Lymphadenopathy, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 33 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 04/2014, Electrocardiogram, Normal; 04/2014, Electroencephalogram, Normal; 04/2014, Electromyogram, Normal; 04/2014, Nuclear magnetic resonace imaging, Normal;
CDC Split Type: WAES1406COL004448

Write-up: This spontaneous report as received from a consumer refers to her daughter of unknown age. In May 2013, the patient was vaccinated with the first 0.5 ml dose GARDASIL (lot # not reported) intramuscularly. The consumer reported that in May 2013, on the same day of vaccination, the patient experienced vomit, headache and fever, for this reason the patient was sent home and could not stay at school. Three months after first does in approximately August 2013 (also reported as September 2013), the patient was hospitalized due to pain in right leg, strong headache and high fever. The patient was hospitalized for 5 days with diagnosis of swollen lymph. The second 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly was applied in April 2014. On the next days of the same months (April), the patient was hospitalized again with the symptoms that she had in September of 2013 during her first hospitalization. The patient stayed hospitalized for 2 and a half weeks, and was reviewed by a pediatrician, neurologist, psychiatrist and therapist. Also were done a electromyography, electrocardiogram, electroencephalogram and resonant column header with completely normal results. After several studies, it was not found any reason for the pain, the patient was discharged with a diagnosis of neuropathy, despite still showing severe pain and difficulty to walk. The patient presented syncope when she was leaving the hospital and fell down from the wheelchair. The patient received acetaminophen as treatment during the weekend without changes in the symptoms. The next week the patient was hospitalized again. According to the patient''s mother the girl had been hospitalized for 10 days without changes in her condition. Since May 2014 "a month ago", the patient had difficult to walk and had been in bed during this time. At the time of the report, the outcome of swollen lymph, headache, fever, vomit and neuropathy was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 535601 (history)  
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. - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? 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
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)  
Age:   
Gender: Female  
Location: Foreign  
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. - / 1 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
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: 545357 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-01
Onset:2013-02-01
   Days after vaccination:0
Submitted: 2014-09-26
   Days after onset:601
Entered: 2014-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Uveitis, Visual acuity reduced, Visual acuity tests abnormal, Visual field defect, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: On an unknown dates, visual acuity test showed: 1.0 and 0.3 (units not provided)
CDC Split Type: WAES1409JPN011905

Write-up: Initial information has been received from a physician concerning a female (an adult) who on February 2013 (date unspecified) was vaccinated with HPV vaccine (manufacturer unknown) injection, route reported as parenteral, dose, injection site were not reported. No concomitant medications were reported. In February 2013 (date unspecified) the patient was vaccinated with HPV vaccine (manufacturer unknown). In February 2013 (date unspecified), a few days after vaccination, the patient felt difficulty seeing. Visual impairment developed. On an unspecified date, the patient was seen by the reporting physician (ophthalmologist). Visual field defect and visual acuity reduced (declined from 1.0 to 0.3) were observed. The patient had symptoms like uveitis. As of reporting date 22-SEP-2014, visual impairment had resolved/recovered. The patient told that the physician who performed the vaccination considered the relationship of the adverse event to the HPV vaccine (manufacturer unknown) as unknown. The reporting physician did not assess the relationship of the adverse event to HPV vaccine (manufacturer unknown). The reporting physician considered the visual impairment as serious (disability). Additional information has been requested.


VAERS ID: 545839 (history)  
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. - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Fatigue; Depression; Anxiety
Preexisting Conditions: Fibromyalgia; Irritable bowel syndrome
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)  
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. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Pain
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 2014, Wheelchair user
Preexisting Conditions:
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)  
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. - / 0 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 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: 607376 (history)  
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. - / 2 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
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 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: 619907 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-21
Entered: 2015-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acne, Chest pain, Cognitive disorder, Decreased activity, Dizziness, Dyspnoea, Dysuria, Fatigue, Headache, Hypertonia, Hyperventilation, Hypoaesthesia, Menstrual disorder, Muscular weakness, Nausea, Orthostatic intolerance, Palpitations, Sleep disorder, Tilt table test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: At tilt table test at our department orthostatic intolerance is seen- but the patient does not fulfill the diagnostic criteria for POTS.
CDC Split Type: WAES1512DNK010259

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2015001034) on 18-DEC-2015. Case received from a physician via HA on 15-Dec-2015 under the reference number DK-DKMA-WBS-0002028 and DK-DKMA-ADR 23274783. A 16-year-old female patient adolescent patient received GARDASIL (batch number unknown) via intramuscular route on an unknown date. The patient experience Tiredness in FEB-2014, Headache on an unknown date, Chest pain (non-cardiac) on an unknown date, numbness in arms on an unknown date, Dizziness on an unknown date, Palpitation on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Acne on an unknown, Sleep disorder on an unknown date, Voiding difficulty on an unknown date, Cognitive disturbance on an unknown date, Muscle hyper excitability on an unknown date, Muscle weak lower limb on an unknown date, Hyperventilation on an unknown date, Dyspnea on an unknown date, Menstrual disorder on an unknown date, ortostatic tolerance on an unknown date and significant fall in activity level on an unknown date. The reporter does not have the patient''s vaccination dates, therefore it is not possibly certain to relate to a temporal relationship between the vaccine and symptom debut. The patient describes that the first symptom was increased tiredness and started in Feb-2014. Subsequently, the other reported adverse reaction develop. Significant fall in activity level and sick leave from work/education. At tilt table test at the reporter''s department orthostatic intolerance is seen - but the patient does not fulfill the diagnostic criteria for POTS. Unknown whether there are other vaccines or medications. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620132 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Orthostatic intolerance, Syncope, Tilt table test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions:
Diagnostic Lab Data: A tilt table test shows orthostatic intolerance, but the patient does not fulfill the criteria POTS.
CDC Split Type: WAES1512DNK010957

Write-up: Information has been received from Sanofi Pasteur MSD (MFR # 2015001191 on 21-DEC-2015. Case received from a physician on 17-Dec-2015 under the report ref number DK-DKMA-ADR 23278239. A female adolescent patient of unknown age received GARDASIL, (batch number unknown) via intramuscular route in 2009. The patient experienced Syncope in 2009, Fatigue on an unknown date and Orthostatic intolerance on an unknown date. Additional investigations included Tilt Table Test orthostatic intolerance n/a on an unknown date. Other HA comment: A tilt table test shows orthostatic intolerance, but the patient does not fulfill the criteria POTS. Other vaccines or medicines: unknown. The patient has experienced syncope almost daily since vaccinations, comes in standing position and not lying/sitting, probably since vaccination in 2009. The reporter does not have vaccination dates (probably 2009), hence an assessment of a temporal connection between start of symptoms and vaccination is not possible.


VAERS ID: 620134 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dry eye, Dyspnoea, Dysuria, Fatigue, General physical health deterioration, Headache, Hyperhidrosis, Hyperventilation, Influenza, Muscular weakness, Myalgia, Nausea, Neuralgia, Orthostatic intolerance, Palpitations, Photophobia, Presyncope, Sensory disturbance, Sleep disorder, Tilt table test positive, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test at syncope center hospital, is orthostatic intolerance seen but the patient does not fulfill the diagnostic criteria for POTS.
CDC Split Type: WAES1512DNK011536

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2015001269) on 22-DEC-2015. Case received from a physician via health authority on 18-Dec-2015 under reference number DK-DKMA-WBS-0002091. A 18-year-old female adult patient received GARDASIL, (batch number unknown) via intramuscular route on 21-Aug-2013, GARDASIL, (batch number unknown) via intramuscular route on 21-Aug-2013, GARDASIL, (batch number unknown) via intramuscular route on 21-Sep-2012, GARDASIL, (batch number unknown) via intramuscular route in 2007. The patient experienced Fatigue extreme in DEC-2007, Flu symptoms on an unknown date, Headache on an unknown date, Muscle pain on an unknown date, Joint pain on an unknown date, Neuropathic pain on an unknown date, Near syncope on an unknown date, Dizziness in DEC-2007, Palpitation on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Obstipation on an unknown date, Diarrhea on an unknown date, Voiding dysfunction on an unknown date, Dyspnoea on an unknown date, Hyperventilation on an unknown date, Sleep disorder on an unknown date, Cognitive dysfunction on an unknown date, Limb weakness on an unknown date, Sensory disturbance in arms and legs on an unknown date, Sweating abnormal on an unknown date, Dry eyes on an unknown date, Feeling bloated on an unknown date, Blurred vision on an unknown date, Light sensitivity to eyes on an unknown date, Orthostatic intolerance on an unknown date, reduced general function on an unknown date and it has taken 7 years to do a secondary education on an unknown date. She can not remember if she has received 4 or 5 doses. She got the first dose during the period March-June 2007 and maybe one more 2 months later. She did not got the third dose. Since she had not been fully vaccinated in 2007, she got three doses in 2012-2013. First symptoms Christmas 2007, is remarkable tired and dizzy. Afterwards the other symptoms. Tilt table test shows orthostatic intolerance, but she did not fulfill the criteria for POTS. The patient describes a reduced general function and has had a lot of sick leave. It took 7 years to perform the secondary education. Other medicines or vaccines: Unknown. Additional investigations included Tilt Table Test orthostatic intolerance on an unknown date. The patient''s outcome was reported as Not Recovered/Not Resolved. Upon medical review the company decided to code the extra dose given and vaccination error.


VAERS ID: 620175 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Dysuria, Eczema, Fatigue, Headache, Orthostatic intolerance
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1512DNK011219

Write-up: Information has been received from SPMSD (case report # DK-1577272925-2015001195) on 21-DEC-2015. Case received from a physician on 17-Dec-2015. A female patient of unknown age received GARDASIL, (batch/lot number and expiration date unknown) via intramuscular route in 2010. The patient experienced Headache in 2010, Orthostatic intolerance on an unknown date, Voiding difficulty on an unknown date, Eczema on an unknown date, Fatigue extreme on an unknown date and Cognitive dysfunction on an unknown date. Shortly after her first and only dose of GARDASIL, the patient develops headache and since then the other reported symptoms develop. The patient cannot remember vaccination dates, but believes it was in 2010 and remember that the headache came shortly after.


VAERS ID: 620179 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Muscle spasms, Muscular weakness, Nausea, Orthostatic intolerance, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions: Vomiting (during examination). Patient informs that she has "things in the luggage: - has a hard life but actually been well - experience significant deterioration in existing symptoms and new ones developed new after HPV vaccine. Cannot described it closer than that.
Diagnostic Lab Data:
CDC Split Type: WAES1512DNK010815

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-2015001182) as part of business agreement on 21-DEC-2015. Case received from a physician via the Health Authority on 17-Dec-2015 under the reference DK-DKMA-WBS-0002083. A female adult patient of unknown age received GARDASIL, (batch number unknown, Dose -1) via intramuscular route in 2013. The patient experienced Pain burning on an unknown date, Muscle spasms / muscle cramps on an unknown date, Nausea on an unknown date, Diarrhea on an unknown date, Orthostatic intolerance on an unknown date, Syncopal attack on an unknown date and Muscle weakness on an unknown date. The patient had a medical history of Vomiting. Due to pain and much muscle cramps and is so muscle weakened the tilt table test cannot be carried out. Throwing up - probably due to pain - when attempting to implement examination. Reporter is not fully aware of the timing. Patient informs that she has "things in the luggage" - had a hard life but actually been well - experienced significant deterioration in existing symptoms and new ones developed new after HPV vaccine. Cannot describe it closer that that. Other medicines/vaccines: unknown. Vaccinated with GARDASIL in 2013. Outcome is not recovered.


VAERS ID: 619740 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-24
Entered: 2015-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Chest discomfort, Cognitive disorder, Disturbance in social behaviour, Dizziness, Dysuria, Fatigue, Food allergy, Food intolerance, Headache, Impaired work ability, Influenza, Loss of personal independence in daily activities, Menstruation irregular, Muscular weakness, Nausea, Skin disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions: Antidepressant therapy, Antidepressants throughout many years before the vaccines
Diagnostic Lab Data: Have examinations and/or laboratory tests been performed: unknown
CDC Split Type: WAES1512DNK011992

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-2015001271 as part of a business agreement on 22-DEC-2015. Case received from a physician via HA on 18-Dec-2015 under the reference number DK-DKMA-ADR 23278731 and DK-DKMA-WBS-0002043. A 17-year-old female adolescent patient received GARDASIL, (batch/lot number and expiration date were unknown, Dose 1) via intramuscular route on 09-Sep-2008, GARDASIL, (batch/lot number and expiration date were unknown, Dose 2) via intramuscular route on 18-NOV-2008, GARDASIL, (batch/lot number and expiration date were unknown, Dose 3) via intramuscular route on 29-Apr-2009. The patient experienced Food intolerance / Allergy and sensitivity against food items in 2008, Headache on an unknown date, Dizziness on an unknown date, Chest tightness on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Voiding difficulty on an unknown date, Skin disorder on an unknown date, Irregular menstrual cycle on an unknown date, Fatigue on an unknown date, Cognitive disorder on an unknown date, limb weakness on an unknown date, Frequent flu on an unknown date, cannot manage the social life on an unknown date and cannot manage education/work on an unknown date. The patient describes that she developed the following symptoms after GARDASIL vaccines. Allergy and sensitivity against food items - she has been hospitalized. Subsequently, the other reported symptoms developed. Sick absence for 1/2 years - cannot manage education/work or the social life. Antidepressants throughout many years before the vaccines. Unknown whether there are other vaccines or medications. The patient was admitted to hospital on an unspecified date. The patient had a medical history of Antidepressant therapy. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620274 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-26
Entered: 2015-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Acne, Angiopathy, Arthralgia, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dry eye, Dry mouth, Dyskinesia, Dyspnoea, Dysuria, Eczema, Fatigue, Headache, Hyperhidrosis, Hyperventilation, Loss of consciousness, Muscle spasms, Muscular weakness, Myalgia, Nausea, Palpitations, Photophobia, Pyrexia, Syncope, Tilt table test normal, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Dystonia (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 (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test (??-??-????): The patient does not fulfill the diagnostic criteria for POTS.
CDC Split Type: WAES1512DNK011489

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [MFR #DK-1577272925-2015001353] on 22-DEC-2015. Case received from a physician via health authority on 21-DEC-2015 under reference number DK-DKMA-WBS-0002168. A female adolescent patient of unknown age received GARDASIL, (batch number unknown) via intramuscular route in 2009. The patient experienced Syncope/recurrent syncope in 2009, Headache on an unknown date, Muscle pain in arms and legs on an unknown date, Joint pain on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Nausea on an unknown date, Abdominal cramps on an unknown date, Voiding dysfunction on an unknown date, Eczema (arms) on an unknown date, Acne on an unknown date, Dyspnoea on an unknown date, Hyperventilation on an unknown date, Fatigue extreme on an unknown date, Cognitive dysfunction on an unknown date, Involuntary muscle movement on an unknown date, Limb weakness on an unknown date, Subfebrilia on an unknown date, Vascular abnormalities on an unknown date, Sweating abnormal on an unknown date, Dry eyes on an unknown date, Dry mouth on an unknown date, Feeling bloated on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Light sensitivity to eyes on an unknown date, Blurred vision on an unknown date, reduced function on an unknown date, loss of consciousness on an unknown date, loss of consciousness preceded by cramps on an unknown date, Eczema (eyes) on an unknown date and a lot sick leave from her education (3/4 on sick leave) on an unknown date. The exact vaccination dates not known (probably 2009) therefore it is not possible to assess the time relationship between the vaccine and the reactions. The first symptom was fainting and started after the second dose. Afterwards the other reported symptoms. During tilt table test the patient did not fulfill the diagnostic criteria for POTS. The patient described loss of consciousness preceding of cramps. She describes reduced function and has a lot of sick leave from her education (3/4 on sick leave) goes to medical exams each time. The patient has received all three doses. Other medicines or vaccines not known. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620290 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-28
Entered: 2015-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Angiopathy, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dry eye, Dry mouth, Headache, Hyperhidrosis, Photophobia, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Test or examinations: unknown; Body temperature, fever
CDC Split Type: WAES1512DNK012413

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [MFR # DK-1577272925-2015001420] on 23-DEC-2015. Case received from a physician via health authority on 22-DEC-2015 under reference number DK-DKMA-WBS-0002122 and DK-DKMA-ADR 23278244. A female adolescent patient of unknown age received GARDASIL (batch number unknown) via intramuscular route on an unknown date. The patient experienced abdominal pain on an unknown date, fever on an unknown date, headache on an unknown date, vascular disorder on an unknown date, cognitive disorder on an unknown date, dizziness on an unknown date, sweating abnormal on an unknown date, dry eyes on an unknown date, dry mouth on an unknown date, bloated feeling on an unknown date, abdominal cramp on an unknown date, diarrhea on an unknown date, obstipation on an unknown date and light sensitivity to eye on an unknown date. Abdominal cramps started after 1 dose with high fever. She has not reported the vaccination dates. The other symptoms afterwards. The patient''s outcome was reported as Not Recovered/Not Resolved. Other vaccines or medicines: Unknown.


VAERS ID: 620354 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-10-05
Onset:0000-00-00
Submitted: 2015-12-29
Entered: 2015-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. AHPVA143DA / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Motor dysfunction
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN178875

Write-up: This case was reported by a physician via sales rep and described the occurrence of motor dysfunction in a 20-year-old female subject who received CERVARIX (batch number AHPVA122BA, expiry date unknown), (batch number AHPVA100CA, expiry date unknown) and (batch number AHPVA143DA, expiry date unknown). On 19th March 2011, the subject received the 1st dose of CERVARIX (intramuscular) .5 ml. On 23rd April 2011, the 2nd dose was .5 ml. On 5th October 2011, the 3rd dose was .5 ml. On an unknown date, unknown after receiving CERVARIX, the subject experienced motor dysfunction (serious criteria disability) and weakness generalised (serious criteria disability). On an unknown date, the outcome of the motor dysfunction and weakness generalised were unknown. It was not reported if the reporter considered the motor dysfunction and weakness generalised to be related to CERVARIX.


VAERS ID: 620838 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-03
Onset:0000-00-00
Submitted: 2016-01-19
Entered: 2016-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chest pain, Fatigue, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1601IRL005900

Write-up: Information has been received from Sanofi Pasteour (MSD) (case report number IE-1577272925-2016000215) as part of a business agreement on 15-JAN-2016. This case was received from the health authority on 13-Jan-2016. Initial report was received by the HA on 16/Dec/2015 from a Community Care Doctor concerning a female patient who experienced chest pain, fatigue, asthenia and palpitations and following vaccination with GARDASIL. Concomitant medications, if any, were not reported. The patient''s mother reported to the community care doctor that the patient had been well prior to vaccination. The patient was vaccinated with GARDASIL (lot numbers H008259, H008259, expiration date not reported and lot number H013137, expiration date 31-MAR-2015) (corrected on 15-JAN-2016) at unreported doses on 03/Oct/2012, 05/Dec/2012 and 27/Mar/20163. From the end of Oct/2012, the patient developed "chronic chest pain" with fatigue, weakness, anergia and palpitations which the reporter considered to be persistently or significantly disabling/incapacitating. The patient underwent investigations (unspecified) in hospital on 29/Oct/2015 but no explanation for the reactions was determined. At the time of reporting the patient outcome was reported as not recovered/not resolved. Upon internal review, the GARDASIL batch numbers reported by the HA as :HO08259, HO08259, HO13137" have been corrected as H008259, H008259, H013137.


VAERS ID: 628400 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-29
Entered: 2016-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Dizziness, Fatigue, Headache, Nausea, Pain, Tic
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1601DNK011080

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-2016000507) as part of business agreement on 28-JAN-2016. Case received from a lawyer at patient insurance company via health authority on 25-Jan-2016 under reference number DK-DKMA-ADR 23324194. The health authority has received the patient''s initial notification under reference number 15-6079. The patient''s insurance has not taken a decision in the case. A female patient of unknown age received GARDASIL (batch number unknown, dose 1) in 2008, GARDASIL (batch number unknown, dose 2) in 2008, GARDASIL (batch number unknown, dose 3) in 2008. The patient experienced tiredness on an unknown date, pain on an unknown date, nausea on an unknown date, dizziness on an unknown date, headache on an unknown date, tics at the eyes on an unknown date, abdominal pain on an unknown date and had to give up high school on an unknown date. The patient received 3 doses in 2008 and developed thereafter the reported reactions, which led to that she had to give up high school. The patient has not recovered.


VAERS ID: 629513 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-18
Entered: 2016-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cognitive disorder, Dizziness, Fatigue, Irritable bowel syndrome, Menstruation irregular, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Fertility disorders (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions: Infectious mononucleosis
Diagnostic Lab Data:
CDC Split Type: WAES1602DNK07701

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-2016001209) as part of business agreement on 16-FEB-2016. Case received from a physician via HA on 12-Feb-2016 under the reference number DK-DKMA-ADR 23352446 and DK-DKMA-WBS-0002686. A female patient of unknown age received GARDASIL, (batch number unknown) on an unknown date. The patient experienced Fatigue extreme / tiredness on an unknown date, Headache on an unknown date, Dizziness on an unknown date, Irritable bowel syndrome on an unknown date, Abdominal pain on an unknown date, Irregular periods on an unknown date, Cognitive disorders / cognitive dysfunction on an unknown date and Muscular weakness on an unknown date. Uncertain progression - it has been a long time and the patient cannot with certainty inform of the vaccination dates. In addition, there has also been a mononucleosis infection after the vaccination. However - the patient experienced approx 1/2 year after the last and third vaccine the symptoms above. The worst symptoms that are still present and affect the patient''s daily life are stomach problems and tiredness + cognitive dysfunction. The reporter had agreed with the patient to report with the mentioned reservations. The patient had a medical history of Infectious mononucleosis. At the time of reporting, the patient had not recovered from Fatigue extreme / tiredness, Irritable bowel syndrome, Abdominal pain, and Cognitive disorders / cognitive dysfunction. The outcome was unknown for the other reactions.


VAERS ID: 629539 (history)  
Age:   
Gender: Female  
Location: Foreign  
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. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Back pain, Cognitive disorder, Dizziness, Dry mouth, Dyspnoea, Dysuria, Fatigue, Headache, Hyperventilation, Loss of personal independence in daily activities, Menstrual disorder, Muscle spasms, Muscular weakness, Neuralgia, Palpitations, Photophobia, Presyncope, Sleep disorder, Temperature intolerance, Tilt table test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Based on tilt table test the patient does not fulfill the diagnostic criteria for POTS.
CDC Split Type: WAES1602DNK010684

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-2016001456) on 22-FEB-2016. Abdominal pain, cognitive disorder, cramp muscle, dizziness, dry mouth, fatigue extreme, headache, hyperventilation, light sensitivity to eye, menstrual disorder, near syncope, neuropathic pain, palpitation, shortness of breath, sleep disorder, temperature intolerance, voiding difficulty, weakness of arms. Follow up information received on 17-Feb-2016 from the HA. Adverse events reported: Abdominal pain, cognitive disorder, cramp muscle, dizziness, dry mouth, fatigue extreme, headache, hyperventilation, light sensitivity to eye, menstrual disorder, near syncope, neuropathic pain, palpitation, shortness of breath, sleep disorder, temperature intolerance, voiding difficulty, weakness of arms. The patient informs, that her onset of symptoms started after dose 1 GARDASIL. She developed dizziness and vomiting. Thereafter, she suffered from stomach- and back pain and headache. The other symptoms has subsequently developed. The patient describes that she prior to the vaccination was a very active girl- energetic. As a consequence, she had high absence in school 7 to 9th grade. The tilt table test shows that the patient does not fulfill the diagnostic criteria for POTS. Other vaccines/medicines: unknown.


VAERS ID: 629695 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-29
Entered: 2016-02-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Memory impairment, Pain, Presyncope
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1602JPN012445

Write-up: Initial information has been received from a physician concerning a female patient (age unknown) who was intramuscularly vaccinated with GARDASIL injection drug (vaccinated date and dose indication). No information including underlying/concomitant disease and medical history was obtained. No other concomitant medication was reported. On an unknown date, the patient was intramuscularly vaccinated with recombinant GARDASIL intramuscular injection syringe for the first time. The patient had an episode of suspected memory impairment. On an unknown date, the patient was intramuscularly vaccinated with GARDASIL for the second time. The patient had an episode of suspected memory impairment. On an unknown date, the patient was intramuscularly vaccinated with GARDASIL for the third time. The patient had an episode of suspected memory impairment and pain like she was about to faint. At the time of the report on 24-FEB-2016, the outcome of memory impairment and pain was unknown. Reporter''s comment: It was unknown if the patient was vaccinated with GARDASIL or CERVARIX. The reporting physician considered that memory impairment was serious due to disability. The reporting physician considered pain as non-serious. The reporting physician did not assess the causal relationship of memory impairment and pain to GARDASIL. Additional information has been requested.


VAERS ID: 629668 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-01
Entered: 2016-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Disturbance in attention, Drug administered to patient of inappropriate age, Hypersomnia, Learning disorder, Medication error, Memory impairment
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1603DNK000348

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-2016001636) as a part of a business agreement on 01-MAR-2016. Case received from non-health professional via company representative on 28-Jan-2016. A female patient of unknown age received GARDASIL, (batch/lot number and expiration date were not reported) on an unknown date. The reporter (also close relative to the patient), informs that the patient unintentionally received HPV vaccination at the age of 15 months. 7 years has passed and it is believed that the patient might have developed some adverse events from the vaccination. Since it is very rare that such a little human being gets this condition and as no immediate information can be found of other cases on the internet, the reporter requests information regarding possible known adverse events. The reporter is obviously concerned about the things they have confirmed with the patient and seeks for help. The patient experienced patient unintentionally received HPV vaccination at the age of 15 months on an unknown date, Medication error on an unknown date, cognitive difficulties on an unknown date, memory problems on an unknown date, learning difficulties on an unknown date, retention difficulties on an unknown date and excessive sleep on an unknown date. The patient''s outcome was reported as unknown. Follow-up information received on 22-Feb-2016. The following has been reported: during the first years nothing unusual was observed, but when she started pre-school, she had difficulty concentrating even at small tasks and were guided by adults. Retaken 0 class since she did not seem mature enough and have difficulty understanding collective messages or messages which should be performed several tasks in a row. In 0 class a program was compiled which showed cognitive difficulties, problems with executive functions and working memory. She has excessive sleep, difficulty concentrating, retention difficulties, learning difficulties and memory problems. This applies not only in schools but just as much in everyday life, where even small things can be difficult to remember. The family''s physician has not yet been contacted, but will soon be. The reporter wishes to know if there are known cases of other children being vaccinated by accident. The patient is under investigation and will later on contact the Health Authority. Upon medical review, the company judged relevant to assess the case as serous due to seriousness criterion disability. The patient''s outcome was reported as unknown.


VAERS ID: 631663 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-16
Entered: 2016-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Orthostatic intolerance, Postural orthostatic tachycardia syndrome, Presyncope, Tilt table test positive
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test, POTS
CDC Split Type: WAES1603DNK007288

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016002357) on 15-MAR-2016. Case received from a physician on 11-MAR-2016. A female adolescent patient of unknown age received GARDASIL (batch/lot number lot not rep, Dose 1) on an unknown date. the patient experienced Postural orthostatic tachycardia syndrome on an unknown date, frequent near fainting on an unknown date and Daily orthostatic intolerance on an unknown date. Symptoms start after dose 1 of vaccine. the patient fulfills the criteria for POTS. A tilt table test shows a pulse increase 59 -$g 100 bpm with maximal heart frequency at 116 bpm and severe and known discomfort. In addition, frequent near fainting and severe daily orthostatic intolerance. Diagnostic criteria for POTS; Hear rate increase greater than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). Symptoms worsen with standing and improved with recumbence. Symptoms last greater than or equal to 6 months. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications) In addition, the hospital uses additional criterion with patients between 12-19 years old: required a heart rate increase of greater than 40 bpm to make the diagnosis, on the grounds that young people have a stronger physiological heart rate response to standing up. the use of any additional criterion to avoid false positives. the patient was admitted to hospital on an unspecified date. the patient''s outcome was reported as Not Recovered/Not resolved. Note to agency: Please do not return cases received from the Medicines Agency (DKMA) unless you received new information regarding the case. Please remember to use the worldwide unique case identification number for this case: DK-DKMA-WBS-0002735. Also, please not that information should not be deleted from the case (especially not the Patient Characteristics).


VAERS ID: 632378 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-01
Onset:0000-00-00
Submitted: 2016-04-20
Entered: 2016-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amnesia, Influenza like illness, Nausea, Somnolence, Wheelchair user
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1604IRL007993

Write-up: Information has been received from Sanofi Pasteur MSD on 12-APR-2016. Case received from a consumer/other non-health professional on 07-APR-2016. This case is linked to E2015-09282. A female patient of unknown age received GARDASIL (batch number unknown, Dose 1) in October 2013, GARDASIL (batch number unknown, Dose 2) in November 2013. GARDASIL (batch number unknown, Dose 3) in March 2014. The patient became wheelchair user on an unknown date, flu like symptoms on an unknown date, loose her memory on an unknown date and nauseas on an unknown date. The reporter stated the patient got vaccine in October 2013, second dose in November 2013 and third dose in March 2014. They started to notice a problem after 10 days after the vaccine and didn''t make the link. The patient never recovered from then. Started off with flu like symptoms and then she was starting to loses her memory and feel nausea. Her health declined significantly after the third dose. Hasn''t changed since then. The reporter says she has to use a wheelchair. She sleeps during the day and awake at night, The reporter stated before vaccination the patient went to school, played on sports and now she doesn''t. The patient''s outcome was reported as Not recovered/Not resolved.


VAERS ID: 642552 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-03
Entered: 2016-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient, Blindness unilateral, Deafness, Mobility decreased
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606COL001114

Write-up: This spontaneous report was received from a journalist regarding a female patient of unknown age. The patient''s medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (via intramuscular route, dose and lot # were not reported). On an unknown date, the patient experienced immobility as she could not move her legs. The patient must have been in a wheelchair. On an unknown date, the patient experienced unilateral blindness, blindness transient (three times) and deafness. The outcome of the event "could not move her legs (immobility)", unilateral blindness and deafness was reported as recovered/resolved (on an unspecified day). The outcome of the event blindness transient was reported as not recovered/not resolved. The relatedness between the events and the therapy with GARDASIL was not provided. The reporter considered the events "could not move her legs (immobility)", unilateral blindness, and deafness to be medically significant and disabling. The reporter considered the event of blindness transient to be medically significant. This is one of several reports received from the same source. Additional information is not expected as no follow up is required.


VAERS ID: 644093 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-15
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Disability, Mental disorder
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607VNM006550

Write-up: This solicited information has been received from an unknown source via the Company regarding unspecified number of patients of unknown demographics enrolled in a study. The patients'' concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL. There was over-immunization (also reported as disorderly immunization) anaphylaxis and mental (details unspecified) with GARDASIL vaccine that led to permanent or temporary disability of these patients. The outcome of the events were unknown at the time of this report. The causality assessment of the events were not provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.


VAERS ID: 646130 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2016-05-05
Onset:2016-05-12
   Days after vaccination:7
Submitted: 2016-07-28
   Days after onset:77
Entered: 2016-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K010050 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Bone pain, Chronic fatigue syndrome, Headache, Hepatic pain, Injection site pain, Loss of personal independence in daily activities, Memory impairment, Muscular weakness, Myalgia, Pain, Palpitations, Paraesthesia, Postural orthostatic tachycardia syndrome, Renal pain, Spinal pain, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Chelidonium extract; hawthorn; ibuprofen; MERCILON; acetaminophen, Benzylpenicillin
Current Illness: Immunisation; Human papilloma virus
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607GBR011050

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number # 2016007569) as part of business agreement on 26-JUL-2016. This case was received from the RA on 21-Jul-2016 under reference numbers GB-MHRA-ADR 23560715/ GB-MHRA-EYC 00142401. Case received from a consumer/other non health professional on 21-Jul-2016. A 13-year-old female adolescent patient received GARDASIL (lot/batch number K010050) via parenteral route on 05-May-2016. The patient received concomitant administration of Chelidonium Extract on an unknown date, Hawthorn/01349301/) on a unknown date, ibuprofen on an unknown date, MERLICON on an unknown date, ''Milk thistle seed'' on an unknown date, Multivitamin/0097801/) on an unknown date, Paracetamol on an unknown date, Penicillin/00000901/) on an unknown date. On 12-May-2016, 7 days post administration, the patient experienced postural orthostatic tachycardia syndrome, visual disturbance, frontal headache, occipital headache, chronic fatigue syndrome, spleen pain, liver pain, kidney pain, pelvic bone pain, spinal pain, Injection site muscle pain, Forearm muscle pain, generalized muscle weakness, paraesthesia, trigger point pain, palpitations and memory impaired. The patient was unable to commit to normal day to day activities. The patient''s symptoms worsened daily and pain was increased to a point where she was admitted to hospital 3 nights. The patient''s outcome was reported as not recovered/not resolved. Postural orthostatic tachycardia syndrome; visual disturbance, frontal headache; occipital headache; chronic fatigue syndrome; spleen pain; liver pain; kidney pain; pelvic bone pain; spinal pain; injection site muscle pain; forearm muscle pain; generalized muscle weakness; paraesthesia; trigger point pain; palpitations and memory impaired. Unable to commit to normal day to day activities. Symptoms worsened daily. Pain increased to a point where she was admitted to hospital for 3 nights.


VAERS ID: 646712 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-01
Onset:2010-10-01
   Days after vaccination:0
Submitted: 2016-08-05
   Days after onset:2135
Entered: 2016-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Coxsackie viral infection, Herpes virus infection, Lyme disease
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1608IRL003060

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) on 04-AUG-2016. This case was received from RA (Ref no. IE-HPRA-2016-027321) on 02-AUG-2016. Initial case was received from a consumer/other non-health professional which concerns a 13-year-old female adolescent patient received GARDASIL, (batch number unknown), dose 1 (route of administration: intramuscular) on 01-OCT-2010, GARDASIL, (batch number unknown), dose 2 (route of administration: intramuscular) on 01-OCT-2011. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient experienced Chronic Lyme''s Disease, Active Coxsackie Virus and Active Herpes Virus Type 1 on 01-OCT-2010. The reporter added that the patient cannot leave bed for days and can''t live life. Corrective treatment: None. The reporter added that the patient is struggling from day to day. The patient''s outcome was reported as Not Recovered/Not Resolved. The reporter assessed the causal relationship: between Lyme disease, Coxsackie viral infection, Herpes simplex type 1 and GARDASIL as Unknown.


VAERS ID: 673428 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-09
Entered: 2016-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1609COL004234

Write-up: Information has been detected in a television (TV) program concerning a female patient of unknown age. The patient was interviewed in the TV program. The patient''s concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiration date and dose were not reported), intramuscularly. The patient stated that after the vaccination (unspecified date), she could not walk normally, she had to use the walls to do it normally. The patient described that she could not feel her legs and hand numbness in the legs. During the interview, the patient was showed as wheelchair user. The outcome of the events was unknown at the time of this report. The reporter considered inability to walk normally and wheelchair user to be disability. This is one of several reports from the same reporter. Additional information is not expected as contact information is not reported.


VAERS ID: 673432 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-09
Entered: 2016-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Arthritis, Death, Epilepsy, Headache, Myalgia, Myocardial infarction
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1609VNM003100

Write-up: This solicited report was received from a social media researcher regarding an article about female patients who received HPV vaccine. The patient numbers were unknown. The patients'' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date/dates the patient/patients received GARDASIL (dosing details not specified). The article indicated that patients had dangerous side effects (myocardial infarction, headache, epilepsy, memory loss, arthritis, muscle ache and death) after receiving GARDASIL vaccine (the onset date was also reported as 07-JUL-2016). The article also indicated the that the vaccine''s effect was not verified and could increase the risk of getting cervical cancer. The action taken with GARDASIL due to the events was reported as unknown. The outcome of the events myocardial infarction, headache, epilepsy, memory loss, arthritis, increased risk of cervical cancer and muscle ache was unknown. The causal relationship between the events myocardial infarction, headache, epilepsy, memory loss, arthritis, muscle ache, increased risk of cervical cancer and death with GARDASIL was unknown. Events myocardial infarction, headache, epilepsy, memory loss, arthritis, muscle ache, increased risk of cervical cancer and death with were considered medically significant. The event myocardial infarction was considered life threatening. The events headache, epilepsy, myocardial infarction, memory loss, arthritis, muscle ache were considered to causing disability. Additional information is not expected as there was not consent for contact.


VAERS ID: 673618 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-13
Entered: 2016-09-13
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, Antinuclear antibody positive, Appendicectomy, Asthenia, Autoimmune thyroiditis, Blood thyroid stimulating hormone abnormal, Brain stem auditory evoked response normal, Cognitive disorder, Condition aggravated, Electromyogram normal, Electroneuromyography, Epilepsy, Facial pain, Fatigue, Gait disturbance, Headache, Hypotension, Immunology test abnormal, Malaise, Myofascitis, Nuclear magnetic resonance imaging normal, Paraesthesia, Positron emission tomogram abnormal, Pyelonephritis, Renal colic, Renal failure, Renal pain, Romberg test positive, Sensory loss, Sleep disorder, Somatosensory evoked potentials, Ultrasound Doppler abnormal, Visual evoked potentials normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2013, Nephrolithiasis; 2013, Pyelonephritis; Renal failure; Appendicectomy
Diagnostic Lab Data: Ultrasound Doppler Cervical (US) (05-MAR-2013): thoracobrachial outlet syndrome bilateral but predominant on left side. Nuclear magnetic resonance imaging (MRI) (27-MAR-2013): normal. Blood test (03-NOV-2014): antinuclear antibodies positive (Hep 2 and immunofluorescence test positive). Electromyogram (04-NOV-2014): unremarkable including evoked potentials (auditory, visual, somatosensory, laser, electroneuromyography). Positron Emission Tomogram (PET/CT) scan (date unknown): hypometabolism predominant in corpus amygdaloid and hippocampus and to a lesser extent sylvian area (frontal, postero inferior and upper temporo areas) and cerebellum. Blood thyroid stimulating hormone (TSH) (date unknown): abnormal. Clinical examination (date unknown)
CDC Split Type: WAES1609FRA005181

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # FR-1577272925-2016008947) on 09-SEP-2016, as a part of business agreement. Case received from a other health professional via Agency under the ref number PC20160517 on 05-Sep-2016. This case was reported in the context of data collection in the RCND. A 16-year-old (also reported as 18-year-old) female patient received GARDASIL (Lot Unk, Dose 1) via intramuscular route on 12-Jul-2009 and GARDASIL (lot Unk, Dose 2) via intramuscular route in 2010. Other suspect products included: REVAXIS (Lot Unk) on 09-Mar-2010; ENGERIX-B (batch number 1704B9, Dose 1) administered via intramuscular route on 18-Jan-1996; ENGERIX-B (batch number 1704B9, Dose 2) administered via intramuscular route on 15-Feb-1996; ENGERIX-B (batch number 1704B9, Dose 3) administered via intramuscular route on 18-Jul-1996; INFANRIX (batch number unknown) on 21-Dec-2004; INFANRIX (batch number unknown) on 19-May-1999. In 2009 she had received a first dose of GARDASIL and one year later a booster dose. In 2010, onset of first episodes of asthenia that lasted 3 weeks and associated to hypotension (systolic value at 8). In 2010, aggravation of health status with fatigue, kidney pain and diagnosis of thyroiditis Hashimoto with abnormal TSH. Levothyrox was initiated. In 2013, malaise with suspicion of epileptic fit. From 3Nov2014 to 5Nov2014 she had been hospitalised. She had difficulties in walking needing to rest every 10 min, feeling of tingling of the forearm and loss of sensation in hands, fits of pain starting in occipital area and irradiating towards face. She presented also sleeping disorders and cognitive disorder. The patient was admitted to hospital on 03-Nov-2014. Medical history of kidney stone that aggravated into pyelonephritis in 2013 and associated to renal colic with medical care. Slight renal insufficiency and appendectomy. Additional investigations included: Ultrasound Doppler Cervical U/S showed thoracobrachial outlet syndrome bilateral but predominant on left side on 05-Mar-2013; Nuclear Magnetic Resonance Imaging normal on 27-Mar-2013; blood Test Antinuclear antibodies positive (Hep 2 and immunofluorescence test positive on 03-Nov-2014; Electromyogram Unremarkable including evoked potentials (auditory, visual, somatosensory, laser, electroneuromyography) on 04-Nov-2014; Positron Emission Tomogram Hypometabolism predominant in corpus amygdaloid and hippocampus, and to a lesser extent sylvian area (frontal, postero inferior and upper temporo areas) and cerebellum on an unknown date; Blood Thyroid Stimulating Hormone abnormal on an unknown date. At clinical examination, outstretched arms were maintained for 5 sec and associated to right myoclonia, slowed sensitivity to finger-nose test, constant contraction of tibialis anterior tendon, positive Romberg test (positive YF), loss of epicritic sensitivity of the lower limbs extremities, proprioception of the thumb modified, heel/knee normal with open eyes and abnormal with closed eyes, no hypotonia, cranial nerve normal. Conclusion provided in Agency report was that the patient presented with myofasciitis macrophagic and that since 2013 she was forced to stop studying. The patient''s outcome with regard to events myofasciitis macrophagic and Hashimoto thyroiditis was reported as Not recovered/not resolved. The outcome of other reported events was unknown.


VAERS ID: 673957 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-19
Entered: 2016-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chronic fatigue syndrome, Feeling abnormal
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1609GBR008167

Write-up: Information has been received from Sanofi Pasteur MSD (reference # GB-1577272925-2016009232) on 16-SEP-2016. Case received from a consumer/other non-health professional by MHRA (Ref No. GB-MHRA-ADR 2365952) on 12-Sep-2016. A 12-year-old female adolescent patient received GARDASIL (batch number unknown, expiry date not reported) via parenteral route on an unknown date. The patient experienced Chronic fatigue syndrome on an unknown date. The patient''s outcome was reported as Not Recovered/Not Resolved. Debilitating. Seek Advice Details: nearly all listed sides effect happened after each of the 3 injections, as well as being ill for a period of 6 years (on going) which was diagnosed as Chronic Fatigue.


VAERS ID: 674014 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2016-08-23
Onset:2016-08-26
   Days after vaccination:3
Submitted: 2016-09-23
   Days after onset:28
Entered: 2016-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Burning sensation, Headache, Hypoaesthesia, Multiple sclerosis, Musculoskeletal stiffness, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: On an unknown date blood test was conducted, results were normal.
CDC Split Type: WAES1609GBR010334

Write-up: Information has been received from SPMSD (MFR number 2016009379) on 21-SEP-2016. This case was received from MHRA (GB-MHRA-ADR 23643100) on 16-Sep-2-16. Initial case received from a consumer/other non-health professional which concerns a 25-year-old female patient (weight: 53.45 kg) received GARDASIL (batch number unknown) via parenteral route on 23-Aug-2016. The patient experienced headache day after vaccine followed by M.S. like symptoms. Numbness and pain in extremities, burning in arms, stiff neck on 26-Aug-2016 3 days post administration. Additional investigations included Blood test normal n/a on an unknown date. The patient''s outcome was reported as Not Recovered/Not Resolved. Headache day after vaccine followed by multiple sclerosis (MS) like symptoms. Numbness and pain in extremities, burning in arms, stiff neck Seek Advice Details: I am a very active and healthy person so when I started showing symptoms I saw my GP. All my blood work came back normal. I do not have any family history of auto immune diseases or chronic illnesses.


VAERS ID: 655529 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-14
Onset:0000-00-00
Submitted: 2016-09-27
Entered: 2016-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Chills, Fatigue, Fibromyalgia, Haemorrhage, Headache, Hypermobility syndrome, Increased tendency to bruise, Injection site bruising, Injection site pain, Injection site swelling, Lymphadenopathy, Menstrual disorder, Muscle disorder, Myalgia, Nausea, Paraesthesia, Pyrexia, Rash, Sensory disturbance, Skin striae, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Body temperature measurement (unknown date): pyrexia
CDC Split Type: WAES1609IRL012492

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number IE-1577272925-2016009610) on 26-SEP-2016. This case was received from the agency on 21-SEP-2016 under the reference number IR-HPRA-2016-028844. Initial report was received by the agency on 07-SEP-2016, from a member of the public (patient''s mother) which concerns a 12 year old female patient who experienced injection site swelling, headache, pyrexia, nausea, lymphadenopathy, muscular disorder, skin striae, rash, hypermobility syndrome, syncope, injection site pain, injection site bruising and fibromyalgia following vaccination with GARDASIL. Concomitant medications: none. Medical history/concurrent conditions: none. The patient was vaccinated with 3 doses of GARDASIL (dose 1 on 13-SEP-2010 (batch/lot no. NM11420), dose 2 on 17-NOV-2010 (batch no. NM46680) and dose 3 on 14-MAR-2011 (batch no. NM3113). The patient collapsed after dose 1 and was sent home from school. She also became quite ill after each subsequent dose. She experienced pain, swelling and bruising at injection site, headaches, fever, nausea, swollen glands, muscle weakness, tingling/abnormal sensations in arms and legs, vomiting, joint pain, aching muscles, chronic fatigue, chills, bleeding and bruising easily, issues with menstrual cycle, stretch marks, skin rash and hypermobility. The patient has been seen by a number of consultants for different symptoms, has been hospitalized on a number of occasions and is currently waiting to be seen by more specialists. At present she has been diagnosed with fibromyalgia and has told by a rheumatologist and a number of physiotherapists that she is hypermobile. The reporter indicated that no diagnosis has been made to cover all of her symptoms. At the time of reporting the patient''s symptoms were persisting.


VAERS ID: 655778 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-03-01
Submitted: 2016-09-28
   Days after onset:210
Entered: 2016-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aspiration bone marrow, Face injury, Guillain-Barre syndrome, Intensive care, Mood altered, Paralysis, Systemic lupus erythematosus
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (narrow), Dementia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1609CHL012416

Write-up: This spontaneous report was received from a patient''s mother via social media refers to her 14 year old daughter. There was no information about the patient''s concurrent conditions, concomitant therapies and medical history provided. The patient''s mother stated that, before the events, her daughter was a normal and healthy child. On an unknown date, the patient was vaccinated with a dose of GARDASIL intramuscularly (dose, lot # and expiration date were not reported). On an unknown date in March 206, after vaccination with GARDASIL, the patient experienced paralysis which began in her limbs and, as reported due to gravity, was hospitalized in intensive care unit (ICU) within 3 hours of reaching the hospital. Approximately in 2016, the patient underwent 4 bone marrow aspirates Guillain Barre and Lupus were suspected. The last 3 tests had results reported as altered (details not specified). At the time of the report (reported as currently), the patient presented face damage due to aggressive paralysis and her decreased mood. At the time of this report the outcome of the events was unknown and the patient was undiagnosed. Relatedness between the events and GARDASIL was not reported. The events of Guillain Barre and Lupus were determined to be medically significant and disabling. Additional information has been requested.


VAERS ID: 674624 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-11
Entered: 2016-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Hypersensitivity, Migraine, Muscle spasms, Strabismus
SMQs:, Angioedema (broad), Dystonia (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1609CHL000956

Write-up: This spontaneous report was received from the patient''s mother via social media concerning her female daughter of unknown age. The patient''s concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL strength reported as: 0.5 ml, via intramuscularly route (lot, expiry date, dosage schedule, and anatomical location were not specified). Other suspect and concomitant medication were not reported. On an unknown date, the patient presented allergy and migraine. Also on an unknown date, patient experienced unspecified adverse event. The outcome of adverse event, migraine and hypersensitivity were unknown at the time of reporting. The relatedness between the events with GARDASIL were not reported. The unspecified adverse event was considered serious by the reporter due to disability caused. Follow up information has been received from the patient''s mother via social media on 03-OCT-2016, who reported that on an unspecified date, the patient also experienced strabismus in the left eye, cephalea and muscles cramps. The patient had been treated with biomedicine and it was observed a recovering in strabismus, cephalea and muscles cramps events. The reporter considered that strabismus, cephalea and muscles cramps were related to GARDASIL. The strabismus was considered serious by the reporter due to disability caused. Additional information is not expected as there were no contact details provided. Patient details, event information and narrative were updated.


VAERS ID: 674654 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-24
Onset:0000-00-00
Submitted: 2016-10-11
Entered: 2016-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007883 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Feeling abnormal, Headache, Lyme disease, Migraine, Pharyngeal ulceration, Sinusitis
SMQs:, Agranulocytosis (broad), Systemic lupus erythematosus (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Constipation; Asthma; Varicella
Diagnostic Lab Data:
CDC Split Type: WAES1610IRL002927

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (case report number IE-1577272925-2016009960) on 06-OCT-2016. This report was received from the HPRA on 03-Oct-2016 under reference number IE-HPRA-2016-027889. Case received from a consumer/other health professional on 15-Sep-2016. A 15-year-old female adolescent patient received the first dose of GARDASIL (batch number H013137) via intravenous route on 16-Sep-2013; the second dose of GARDASIL (batch number H019633 was received on 18-Nov-2013 and of GARDASIL batch number J007883 third dose on 24-Mar-2014. The patient experienced throat ulcers, headaches, migraine, sinusitis, brain fog, joint pain and Lyme disease on an unknown date. The patient was admitted to hospital on an unspecified date. The patient had a medical history of constipation, asthma and varicella. The patient''s outcome was reported as Not Recovered/Not Resolved. The reporter assessed the causal relationship: -between throat ulcer and GARDASIL as unknown -between headache and GARDASIL as unknown - between migraine and GARDASIL as unknown -between sinusitis and GARDASIL as unknown - between foggy feeling in head and GARDASIL as unknown -between joint pain and GARDASIL as unknown - between Lyme disease and GARDASIL as unknown.


VAERS ID: 674998 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-12
Entered: 2016-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Bedridden, Chronic fatigue syndrome, Coeliac disease, Cognitive disorder, Postural orthostatic tachycardia syndrome, Sensory disturbance
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1610GBR004260

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control no. GB-1577272925-2016010090) on 11-OCT-2016. This report was received from the agency on 06-Oct-2016 under reference number GB-MHRA-ADR 23667457. Case received from a consumer/other non health professional concerning a 13-year-old female adolescent patient who received GARDASIL, batch number unknown via parenteral route on an unknown date. The patient experienced chronic fatigue syndrome, postural orthostatic tachycardia syndrome, allergic asthma, coeliac disease, cognitive disorder (patient could not read or watch television), sensory disturbance (extreme sensitivity to sense stimuli) and bedridden on an unknown date. The patient was admitted to hospital on an unspecified date. The outcome of chronic fatigue syndrome was recovered/resolved with sequelae, postural orthostatic tachycardia syndrome, allergic asthma, coeliac disease was not recovered/not resolved, cognitive disorder, sensory disturbance and bedridden was unknown. The patient patient''s overall outcome was reported as unknown.


VAERS ID: 675188 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2010-12-13
Onset:2016-10-05
   Days after vaccination:2123
Submitted: 2016-10-21
   Days after onset:16
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthropathy, Asthenia, Ear pain, Fibromyalgia, Lymphadenopathy, Pyrexia, Sleep disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1610IRL011075

Write-up: Information has been received from business partner sanofi Pasteur MSD on 20-OCT-2016. This case was received from the HPRA on 14-Oct-2016 under reference number IE-HPRA-2016-028106 Initial report was received by the HPRA on 02/Oct.2016 from a member of the public (MOP) (patient herself) which concerns a 13 year old female patient who experienced asthenia, abdominal pain upper, lymphadenopathy, pyrexia, arthropathy, ear pain, fibromyalgia and sleep disorder following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient was vaccinated with dose 1 of GARDASIL on 05/Oct/2010 (batch no. NN01990 exp 05/2012) and dose 2 on 13/Dec/2010 (batch no. NN33040 exp 01/2013). Post vaccination the patient experienced weakness that day and was resolved, then severe stomach pain after a coupe of weeks, developed swollen glands and high temperatures. The reporter indicated that she has since developed a lot of joint problems and ear pains. The reporter indicated that she has all the symptoms of fibromyalgia however blood results are inconclusive. The patient cannot also go the full day without a sleep and has chronic sleep problems. Corrective treatment: Unspecified help with joints, swollen glands and sleep. At the time of reporting the patient''s symptoms were ongoing.


VAERS ID: 675213 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1610JPN011013

Write-up: Information has been received from an unspecified reporter via social media concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unspecified date, the patient received GARDASIL (lot#, expire date, dose and route unknown). On an unknown date, the patient became permanently disabled. The relationship between the event and the vaccine was unknown. The outcome was unknown. Upon internal review, disability was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter.


VAERS ID: 675403 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-10
Onset:2015-09-01
   Days after vaccination:568
Submitted: 2016-10-26
   Days after onset:421
Entered: 2016-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Autoimmune hepatitis, Biopsy site unspecified normal, Blood test normal, Cold sweat,