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From the 11/26/2021 release of VAERS data:

Found 1,511 cases where Vaccine is HPV2 and Serious

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Case Details

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VAERS ID: 363102 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:2008-11-20
   Days after vaccination:19
Submitted: 2009-10-27
   Days after onset:340
Entered: 2009-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Audiogram abnormal, Brain stem auditory evoked response, Dizziness, Electroencephalogram normal, Fall, Headache, Hypoacusis, Hypoaesthesia, Hypoaesthesia facial, Loss of consciousness, Lumbar puncture normal, Neurological symptom, Nuclear magnetic resonance imaging normal, Sensory disturbance, Serology normal, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Audiometry, Abnormal; Electroencephalogram, Dec2008, Normal; Lumbar puncture, Dec2008, Normal; Nuclear magnetic resonance ima, Dec2008, Normal; serology NOS, Dec2008, Normal
CDC Split Type: B0582537A

Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). This case is one of 3 cases from the same reporter. All the subjects lived in the same village. On an unspecified date, the subject received unspecified dose of CERVARIX (unknown route and injection site), lot number not provided. On an unspecified time after vaccination with CERVARIX, the subject experienced hypoacusis unilateral. After an audiometry test, it was confirmed that the subject didn''t hear. The physician thought the event was simulated. The subject was hospitalised to undergo different tests. After a auditive evoqued potential test it was concluded that it could be something subjective. At the time of reporting the event was resolved. Follow-up received on 7 July 2009: The subject was hospitalised in the neurology unit due to neurological symptoms. Unilateral hypoacusis was not experienced. Follow-up received on 31 August 2009: In November 2008, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). On 20 November 2008, less than one month after vaccination with CERVARIX, the subject experienced loss of consciousness with non convulsive tremors of upper and lower limbs with good recovery. But since that moment, the subject developed numbness on the face and on the right side of body. These episodes recurred event at 4 times until 27 November 2008, when the subject visited the emergency room in hospital due to dizziness with falling to the right side and sensation of walking around things and oppressive occipital headache. The subject was hospitalised for 7 days to perform various tests in the neurology unit and was discharged on 3 December 2008, after having a favourable evolution and normality in the nuclear magnetic resonance imaging and electroencephalogram. The events repeated in several occasions in the following months. Additional tests performed didn''t show pathological findings (serology, lumbar puncture, Nuclear magnetic resonance imaging and electroencephalogram). At the time of reporting the events were resolved. Follow-up received on 20 October 2009: This case has been identified as a duplicate of case B0559674A. It has therefore been voided.


VAERS ID: 363691 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-13
Onset:2008-11-20
   Days after vaccination:7
Submitted: 2009-10-29
   Days after onset:342
Entered: 2009-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA015CM / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aldolase normal, Anxiety, Asthenia, Blood creatine phosphokinase normal, Blood heavy metal increased, Blood test normal, Borrelia burgdorferi serology negative, Chest X-ray, Convulsion, Crying, Dissociation, Dizziness, Dyskinesia, Electrocardiogram normal, Electroencephalogram normal, Fall, Gait disturbance, Headache, Hemiparesis, Hypoaesthesia, Hypoaesthesia facial, Laboratory test normal, Loss of consciousness, Lumbar puncture normal, Neurological examination abnormal, Nuclear magnetic resonance imaging normal, Opisthotonus, Paraesthesia, Retching, Sensorimotor disorder, Sensory disturbance, Sensory loss, Sleep study normal, Syncope, Tremor, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Dystonia (narrow), Parkinson-like events (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 (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Aldolase, 2009, normal; Blood test, 2008, normal; Blood test, 21Nov2008, unknown; Blood tests, 26Nov2008, normal; Blood test, 2009, normal; Borrelia burgdorferi serology, 2009, negative; Chemistry normal, 2008, see text; Chemistry normal, 2009, see text; Chest X-ray, 21Nov2008, unknown; Creatine phosphokinase, 2009, normal; Electrocardiogram, 22Nov2008, normal; Electroencephalogram, 22Nov2008, normal; Electroencephalogram, 26Nov2008, normal; Lumbar puncture, 2009, normal; Neurological examination, 2009, abnormal; Neurological examination, 2009, see text; Nuclear magnetic resonance ima, 26Nov2008, normal; Nuclear magnetic resonance ima, 2009, normal; Sleep study, 2009, normal
CDC Split Type: B0559674A

Write-up: This case was reported by a consumer and described the occurrence of functional disease in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 November 2008 the subject received 1st dose of CERVARIX (intramuscular). On 20 November 2008, 7 days after vaccination with CERVARIX, the subject experienced dizziness, headache, and faint with spasmodic movements of arms and legs. The subject was having a test at school therefore her physician told that the event might be caused by the effort made in the test. On 21 November 2008 the subject was at school and around 11 am she had the same events including faint, arm and leg movements (non episode was accompanied by loss of sphincter). Besides she also had numbness at the right side of her body, less strength and sensitivity. The same day around 45 minutes later she had another episode with the same characteristics. Her faint lasted around 5 minutes and arms and legs movements around 3-4 minutes. The subject could not walk alone because the loss of strength of her right side. Around 7 pm the subject went to the emergency room where blood test and chest X-ray were performed. The subject was also seen by a neurologist and a cardiologist. On 22 November 2008 the subject was discharged. The same day the subject experienced the same episodes. She went back to the emergency room where an electroencephalogram and a electrocardiogram were performed. Both tests were normal. The subject stayed in observation for 1 day. On 23 November 2008 the subject was discharged. On 26 November 2008 the subject was seen by a cardiologist who observed less sensitivity on the right side. Therefore the cardiologist and neurologist decided to send her to the emergency room. Relevant test included Magnetic Resonance Imaging, electroencephalogram and blood test. All of them were normal. On 03 December 2008 the physician stated that this maybe caused by the vaccine as an inflammatory adverse event. The subject was treated with TEGRETOL. The report stated that the subject had syncopal attack possibly secondary to HPV vaccine. On 29 January 2009 the subject experienced the same events at school. She was brought to the emergency room and she was admitted to hospital. During her hospitalization the magnetic resonance, sleep test and lumbar puncture were done. All of them with negative results. On 11 February 2009 the subject was discharged. It seemed that the subject was recovering her strength and sensitivity of her right side. On 16 February 2009 the subject experienced a new episode including headache, faint, dry heaves, arm and leg movements. She was brought again to the emergency room. The diagnosis was not clear; it was also considered that all these episodes were caused by nerves. A psychiatrist has also seen the subject and he thought that the girl could not cause all these episodes. The subject was hospitalized for 17 days. At the time of reporting the events were unresolved. In the follow up received on 17 February 2009 it was mentioned that TEGRETOL treatment was withdrawn at the end of January. The subject did not receive any other treatment since then. The subject''s mother stated that according to the physicians who had seen her daughter, they said that could be a functional disease which is not related to vaccination since the symptoms appeared one week after. A neurologist appointment was planned. Follow up received on 27 February 2009 from the physician. The neurologist stated that the adverse events were functional seizures which neither are not related to CERVARIX vaccine at all. The subject was admitted to hospital twice and the physicians performed an exhaustive study to discard any organic origin and all of them were negative. No further information was available; therefore this case has been closed. Follow up received on 23 March 2009 from the foreign regulatory authorities (ES-AGEMED-224767332). Approximately 2 weeks a prior symptom, the subject was vaccinated with CERVARIX. On 20 November 2009 the patient started having dizziness with falling to the right side and sensation of turn round things with occipital cephalea. Since then she presented 4 episodes of loss of consciousness without bitten the tongue or relaxation of the sphincter but with tremors on upper and lower limbs. She refers sensation of numbness of the face and right hemybody. In the neurological exploration she presents paresis (4/5) of right hemi body, right hemi hypoesthesia (nonciceptive and deep). On 27/11/2008 the subject was admitted in hospital. Relevant test included normal biochemistry, blood analysis as well as coagulation analysis. The nuclear magnetic resonance (with or without contrast) showed no parenchymatous focal lesions in supra or infratentorial level on the white substance level or on the encephalic trunk. No focal lesions that will highlight with the contrast administration. Two small retention cysts are showed on the left maxillary and frontal sinus with probable relation with the inflammatory pathology. Serological test for Q fever was negative. Analysis of the cerebrospinal fluid showed transparent liquid, 3 blood cells and 1 leukocyte otherwise the rest was normal. Electroencephalogram performed with privation of normal sleeping. X-ray was normal with Para nasal sinus. The subject''s evolution was favorable, she remained asymptomatic during the hospitalization and she recovered mobility and sensibility on her limbs. On 03 December 2008 she was discharged with the diagnosis of "loss of consciousness" episode together with neurological disorders in probable relationship with seizures. Neurological data that justified those episodes were not found. The subject was treated with TRILEPTAL (oxcarbazepine) data that justified those episodes were not found. The subject was treated with TRILEPTAL (oxcarbazepine) 150mg/12h. On 21January 2009 the subject underwent a medical control. After the normality on the tests the subject''s treatment on the antiepileptic was decreased. The subject was re hospitalized from 30 January 2009 till 11 February 2009 presenting the same symptoms with loss of strength and paresthesis in the right side. The neurological exploration showed 4/5 of right hemiparesia, right hemi hypoesthesia that respected the face. The subject required help to walk as she had a paretic walking in both knees. Other relevant test included normal biochemistry, blood analysis and coagulation. Antibodies, CPK, Aldolase tests and hormonal studies were pending. Serological tests for: fever Q, LUES, mononucleosis, brucella, borrelia and HIV negative. Venous gasometry without alteration on the acid-base balance, lactic acid normal, negative culture of LCR. Oligoclonal band in cerebrospinal fluid and IGG secretion on cerebrospinal fluid was pending. The analysis of the cerebrospinal fluid showed transparent liquid, 3 blood cells and 1 leukocyte test were normal. Nuclear magnetic resonance of cranium with contrast, perfusion study and epilepsy protocol showed no alterations. Electroencephalogram with privation of normal sleep, electroencephalogram sinusal rhythm with good frequency showed no signs of acute ischemia. On 03 February 09 she had anarchia and triparesia (paraparesis and paresis of the right upper limb) that was resolved after 10 minutes. Due to lack of collaboration of the subject who showed great anxiety, crying and opistotone position a lumbar puncture could not be performed. Then after the subject was sedated and then the lumbar puncture was performed. The diagnosis included "Episode of disconnection of the environment and sensitive-motor dysfunction and of the language of cause not subsidiary that seemed to be functional. According to the responsibly health professional from the laboratory the symptomatology of the patient was not related with the vaccine. After all complementary tests done any organic cause could be found. The possibility of a functional base let think to an alternative cause to the vaccination with CERVARIX. The authorities considered the events were unlikely related to vaccination with CERVARIX. After several attempts no further information could be obtained. Therefore on 14 July 2009 this case has been closed. Follow up received on 19 October 2009: The subject also presented sensory loss which started on 20 November 2008. The subject''s father went to a TV program and reported as follow: He started that her daughter''s health was seriously aggravated after vaccination with CERVARIX. She had the leg and the right arm paralyzed and she suffered from facial paralysis. The problems started 2 days after vaccination. The subject was initially admitted to hospital where, after carrying out all kind of test during the 19 days, she was hospitalized. They found high levels of arsenic, aluminum and copper in blood. The problems were aggravated therefore she was treated in hospitals in different areas. Currently she was hospitalized with facial paralysis and cannot move her leg and right arm. Neuralgia was considered as an early diagnosis and as a possible cause of her health problems. Sometimes she should take even a wheelchair. Follow up received on 20 October 2009 from the neurologist. The physician stated that he saw the girl in July and the subject''s father took him a blood and urine test where levels of heavy metals (including arsenic) were observed. The physician asked a new test which was pending.


VAERS ID: 363697 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-21
Onset:2009-09-21
   Days after vaccination:0
Submitted: 2009-10-29
   Days after onset:38
Entered: 2009-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0598949A

Write-up: This case was reported by the foreign regulatory authority (#GB-MHRAADR20510269) and described the occurrence of anaphylactic shock in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 21 September 2009 the subject received an unspecified dose of CERVARIX (1 ml, intramuscular). On 21 September 2009, the same day as vaccination with CERVARIX, the subject experienced anaphylactic shock. The regulatory authority reported that the event was life threatening. At the time of reporting the event was improved. Agency Verbatim Text: Patient experienced anaphylactic shock.


VAERS ID: 364044 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-17
Onset:2009-08-15
   Days after vaccination:59
Submitted: 2009-10-30
   Days after onset:76
Entered: 2009-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA023EC / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF test abnormal, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CSF test, Sep2009, GSB
CDC Split Type: B0597575A

Write-up: This case was reported by a regulatory authority (104325) and described the occurrence of Guillain-Barre Syndrome in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 17 June 2009 the subject received 3rd dose of CERVARIX (intramuscular). On 15 August 2009, 59 days after vaccination with CERVARIX, the subject experienced Guillain-Barre Syndrome. The subject was hospitalised. Relevant test results included liquor examination which was performed on September 2009. At the time of reporting the outcome of the event was unspecified. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. In the follow up received on 28 October 2009 it was confirmed that the case was a duplicated case of B0595939A, therefore it has been voided.


VAERS ID: 364045 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-07
Onset:2009-10-07
   Days after vaccination:0
Submitted: 2009-10-30
   Days after onset:23
Entered: 2009-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA058BF / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0596965A

Write-up: This case was reported by a pharmacist and described the occurrence of a fit (unspecified) in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 7 October 2009, the subject received the 1st dose of CERVARIX (1 injection). On 7 October 2009, 1 hour after vaccination with CERVARIX, the subject experienced a fit (unspecified) and involuntary jerking. The subject was hospitalised and the pharmacist did not specify the relationship between the events and CERVARIX. At the time of reporting the outcome of the events were unspecified. Verbatim text: On 07 October 2009, a pharmacist reported that a 13-year-old female patient received her first dose of CERVARIX vaccine on 07 Oct 2009, one hour post vaccination the patient experienced involuntary uncontrollable jerking which got progressively worse but the patient did not loss consciousness. It was also reported that the patient experienced fitting. The patient was hospitalised as a result of the fitting and jerking. The pharmacist did not have any additional information at the time of reporting. Follow-up information received on 22 October 2009: The subject was hospitalised for one night only. No action was taken with CERVARIX. On 7 October 2009 the events resolved. The reporter considered that the events were possibly related to vaccination with CERVARIX.


VAERS ID: 364048 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-07
Onset:0000-00-00
Submitted: 2009-10-30
Entered: 2009-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA053BG / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood product transfusion, CSF test normal, Clonus, Hypoaesthesia, Lumbar puncture normal, Myelitis transverse, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Peroneal nerve palsy, Sensation of heaviness, Sensory level abnormal, Skin warm
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Mycophenolate mofetil
Current Illness: Anemia; Lupus erythematous; Malar rash; Polyarthritis; Proteinuria
Preexisting Conditions: Fever; Flare of skin; Growth hormone; Herpes zoster; Nephritis; Neuropsychiatric lupus; Pneumonia; Rash on skin; Toxic shock syndrome; Transient ischemic attack
Allergies:
Diagnostic Lab Data: CSF test, 06May2009, see text; Lumbar puncture, 05May2009, see text; Nuclear magnetic resonance ima, May2009, see text; Nuclear magnetic resonance ima, 05May2009, see text; Sensory level, 05May2009, T9
CDC Split Type: B0577139A

Write-up: This case was reported by a professor and described the occurrence of transverse myelitis in a female of 24 year-old who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included systemic lupus erythematous. On an unspecified date, the subject received unspecified dose of CERVARIX (unknown route and injection site). On an unspecified time after vaccination with CERVARIX, the subject experienced a neurological problem. At the time of reporting, the outcome of the event was unspecified. Follow up has been asked but since no further information was provided, the case has been closed. Follow up received on 14 September 2009: this case has been upgraded to serious. Subject''s medical history included transient ischemic attack. On 09 March 2009 the subject received the 1st dose of CERVARIX (intramuscular, unknown deltoid). On 07 April 2009 she received the 2nd dose of CERVARIX (intramuscular, unknown deltoid). Since late April 2009 the subject complained of abnormal sensation, (heavy and temperature increased) over left lower limb from thigh to shin followed by weakness and numbness. On 05 May 2009 the subject was hospitalized for further investigation. On admission the subject''s lower limb power proximal was 4 (right), 4 (left) and distal 4 (right) and 4 (left). Left side body sensory level up to T9 and all reflexes were 2+. Pilateral down going plantar reflexes. Other relevant test done the same day included abnormal magnetic resonance imaging lumbar spine showing intra-medullar high T2 signal in cord from T7 to T8 which in view of subject''s history most likely represented transverse myelitis from SLE. This involved right side and central part of cord. No cord expansion and no serpiginous vessel within cord or spinal canal. On 06 May 2009 lumbar puncture showed cerebral spinal fluid clear, no organism (no fungi isolated, no gram stain seen, AFB culture no growth), total protein normal. Cycology showed very rare lymphocytes present. The subject was treated with intravenous methylprednisolone 600 mg given from 07 May 2009 to 09 May 2009. On 11 May 2009 the subject received intravenous cyclophosphamide. On 12 May 2009 she received immunoglobulin to 13 May 2009. On 14 May 2009 the subject was discharged. The subject''s lower limb power improved, proximal 4 (right). 5 (left), distal 5 (right), 5 (left). On 20 May 2009 the subject was rehospitalized due to deteriorating lower limb neurology. The subject presented right foot drop. Relevant test included for right side power: hip flexion 0/5, knee extension 2/5, ankle dorsiflexion/ big toe dorsiflexion 0/5, ankle plantarflexion 2/5, up going plantar on right foot associated with right ankle clonus. For left side power: power was normal and sensory level was up to T9. Magnetic resonance imaging CTL spine revealed no evidence or cord compression. Increase of T2W abnormal signal intensity of the spinal cord as intramedullary high T2 signal in the cord was extended from T5 to T9 (previously only T7 and T8 involvement). The subject was seen by a neurologist who suggested plasmapheresis in total 5 courses were given. The subject presented a mild improvement of lower limb neurology after treatment. For right side power: hip flexion up to 3/5, hip extension 4+/5, knee flexion 0/5, knee extension 3/5, ankle DF 0/3 ankle PF 3/5. Toe flexion and extension 0/5. Left side power was normal and sensory level still around T8-T9. On 07 June 2009 the subject was discharged. Follow up received on 23 October 2009: Subject''s medical history included in 1994 to systemic lupus erythematosus (SLE), presented with malar rash, polyarthritis, anaemia, pyrexia of unknown origin, positive antinuclear antibody and anti-ds DNA. She was treated with ASPIRIN, PREDNISOLONE and CHOLORQUINE. She has on and of cutaneous flare and chloroquine was switched to hydroxychloroquine in August 1995, and AZATHIOPRINE was added after a flare up in 1996. She was found to have growth failure in 1999 and received growth hormone injection from June 99 till May 2002. Other complications included herpes zoster in May 2000 resolved after intravenous (IV) ACYCLOVIR. In May 2001, she was admitted for skin rash and shock (? Toxic shock syndrome) requiring fluid resuscitation and intensive care. Blood culture was negative. All medications were stopped since Sept 2003. She had cutaneous flare in Feb 2004, PREDNISOLONE, HCQ and AZATHIOPRINE were resumed. In May 2005, she was admitted for pneumonia and neuropsychiatric lupus with transient ischemic attack and nephritis with increase proteinuria up to 1.4g/day. PREDNISOLONE was increased and mycophenolate mofetil was started since July 2005. Her condition remained stable since then although anti-ds DNA all along been elevated and complements were depressed. In September 2009 the subject''s motor function remained as follow: Hip flexion (right 5, left 5); knee extension (right 5, left 5); ankle dorsiflexion (right 2, left 5); big toe dorsiflexion (right 4, left 5); ankle planter-flexion (right 5, left 5). In October 16, 2009 she has completed 6 months of IVCY. Left leg sensation was diminished up to L2 level. Left knee jerk was absent. The patient was able to walk on a quadruped. The subject''s history of TIA might suggest she was prone to SLE related neuropsychiatry manifestation.


VAERS ID: 364075 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-01-14
Onset:0000-00-00
Submitted: 2009-10-30
Entered: 2009-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA015CJ / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abnormal faeces, Activated partial thromboplastin time normal, Alanine aminotransferase normal, Antithrombin III, Back pain, Benign intracranial hypertension, Blood calcium normal, Blood chloride normal, Blood count normal, Blood creatinine normal, Blood fibrinogen, Blood glucose normal, Blood potassium normal, Blood sodium normal, C-reactive protein, C-reactive protein normal, CSF cell count normal, CSF culture negative, CSF lactate normal, CSF protein normal, Coagulation factor level normal, Computerised tomogram normal, Dizziness, Dyspnoea, Ear congestion, Ethanol gelation test negative, Fall, Fibrin D dimer normal, Gastritis, General physical health deterioration, Headache, Hyperventilation, Intracranial pressure increased, Laboratory test, Nuclear magnetic resonance imaging normal, Paraesthesia, Post lumbar puncture syndrome, Prothrombin time normal, Sensory loss, Sunburn, Syncope, Urine analysis normal, Viral infection, Vision blurred, Visual impairment, Vomiting
SMQs:, Torsade de pointes/QT prolongation (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), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic results (Hospitalization from 25 April 2008 to 29 April 2008): urine status: normal, no leucocyturia; blood count: normal for red and white blood count; clinical chemistry: normal sodium, potassium, calcium, chloride, glucose, creatinin, GPT and CRP; coagulation: normal Quick''s test and partial thromboplastin time, fibrinogen, antithrombin III; monomere negative, d-dimere; Liquor diagnostic: liquor pressure 17 cm H2O, no nucleated cells, normal lactate, liquor glucose and liquor protein; microbiology: liquor: no growth; magnetic resonance tomography: age-corresponding mrt of neurocranium. no signs of intracranial pressure, no sinus or brain vein thrombosis, orbita without pathological findings; consultation of eye specialist on 25 April 2008: vein congestion on both sides; consultation of eye specialist on 28 April 2008: normal, no signs of congestion
CDC Split Type: D0063196A

Write-up: This case was reported by a physician, via sales representative, and described the occurrence of chronic back pain in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 14 January 2008 the subject received 1st dose of CERVARIX (unknown route and and injection site). 6 weeks after vaccination with CERVARIX, the subject experienced sunburn and fell during skiing. 3 months later, on 11 April 2008, the subject consulted the physician because of dizziness, abdominal pain, breathing disturbance and vision disturbance. The subject was examined in hospital without pathological findings. Lumbar puncture was performed. 1.5 years after vaccination with CERVARIX the subject was treated psychologically. At the time reporting the outcome of the events was unspecified. The physician considered the events were unrelated to vaccination with CERVARIX, but stated that the parents held the vaccination responsible for the events. Follow up information was received on 22 October 2009 including the physician''s report and hospital reports. Physician''s report: On 14 January 2008 the subject received 1st dose of CERVARIX (intramuscular, left deltoid). 5 weeks later the subject experienced sunburn during skiing. On 11 April 2008 the subject experienced headache, dizziness and blurred vision that was seen as a viral infection. In the course of the following 2 weeks, the subject experienced persistent severe vomiting, headache and feeling of breathlessness. On 25 April 2008 the subject was hospitalized. The case was upgraded to serious. On 29 April 2008 the subject experienced severe back pain after lumbar puncture. Since this time back pain reappeared in irregular intervals and stayed without association organ-pathological findings (chronic back pain). Meanwhile appeared disturbance of sensation in the area of foot and face suspended spontaneously. The subject was treated psychologically. At the time of reporting vaccination with CERVARIX was not continued. According to the treating physician the events were unlikely related to vaccination with CERVARIX. Hospital report (hospitalization from 25 April 2008 to 29 April 2008) Diagnosis: In hospital signs of intracranial pressure, unclear vomiting, headache, suspected infectious viral gastritis and reaction after lumbar puncture were diagnosed. Differential diagnosis was pseudotumor cerebri. Anamnesis: 14 days before admission to hospital the subject experienced one thin stool together with vomiting. Within the last 14 days before admission the subject experienced recurrent vomiting, especially at night. In this context the subject showed syncope for several times without losing consciousness. During day the subject vomited some time and during night regularly 4 to 5 times. At the time of admission the subject showed thin stool once again. There was no fever, no dizziness and no permanent headache. The subject was healthy before. Menarche appeared one year ago. Diagnostic findings: The subject showed reduced general health. Neurology: intracranial nerve status was properly, pupils isocor, light reaction prompt on both sides and there was no meningismus. Assessment and course: The subject was admitted to hospital because of intracranial pressure signs, with vomiting at night and headache for a period of 14 days. The eye specialist diagnosed congestion in both eyes. A mrt diagnostic showed no evidence to expansion of signs of intracranial pressure. A sinus vein thrombosis could be excluded. On 28 April 2008 lumbar puncture was performed because of severe headache and nausea. Normal intracranial pressure was found and no nuclear cells were detectable. Headache improved after letting of liquor. In the course the events improved. The subject was discharged from hospital on 29 April 2008 with mild lumbar pain after puncture. The hospital physician considered a possibly viral gastritis. Increased intracranial pressure at for example pseudotumor cerebri could be not excluded. Hospital report (hospitalization from 29 April 2009 to 02 May 2009) Diagnosis: In hospital, lumbalgia, dizziness and paresthesia at hyperventilation were diagnosed. Anamnesis: The subject was admitted to hospital because of severe back pain lasting for three days. The subject was treated with ibuprofen, paracetamol and consultation with psychiatrist (Psychotherapy). The events improved during hospitalization. According to a hospital report from 05 June 2009 the subject was completely free of complaints for three weeks after discharge from last stationary hospitalization. From 03 June to 05 June 2008 the subject was hospitalized again because of lumbalgia and headache. Both events improved during hospitalization. No further information will be available.


VAERS ID: 364512 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-16
Onset:2009-09-16
   Days after vaccination:0
Submitted: 2009-11-02
   Days after onset:47
Entered: 2009-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyskinesia
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin
Current Illness: Unknown
Preexisting Conditions: Patient on other medication.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0599542A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20510993) and described the occurrence of orofacial dyskinesia in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medications included vitamin supplements and the subject was reported to be on other medication. On 16 September 2009 the subject received an unspecified dose of CERVARIX (intramuscular). On 16 September 2009, the same day as vaccination with CERVARIX, the subject experienced orofacial dyskinesia. The subject was hospitalised. At the time of reporting the event was unresolved. Verbatim Text : Orofacial dyskinesia.


VAERS ID: 364862 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-17
Onset:2009-09-18
   Days after vaccination:1
Submitted: 2009-11-03
   Days after onset:46
Entered: 2009-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Full blood count normal, Immunisation reaction, Laboratory test normal, Myalgia, Red blood cell sedimentation rate normal
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Usually well child, with no significant past medical history.
Allergies:
Diagnostic Lab Data: Erythrocyte sedimentation rate, 13Oct2009, normal; Full blood count, 13Oct2009, normal; 13/10/2009 - Biochemical Screen: all normal.
CDC Split Type: B0599532A

Write-up: This case was reported by a foreign regulatory agency (Agency # GB-MHRA-ADA 20511133) and described the occurrence of an immunization reaction in a 15-year-old female subject who was vaccinated with CERVARIX, GlaxoSmithKline. On 17 September 2009 the subject received an unspecified dose of CERVARIX (intramuscular). On 18 September 2009, within 24 hours of vaccination with CERVARIX, the subject experienced an immunization reaction, myalgia and fatigue. The regulatory agency reported that the events were disabling. On 13 October 2009 the subject had a normal erythrocyte sedimentation rate, full blood count and biochemical screen. At the time of reporting the events were unresolved. Verbatim Text: Onset of myalgia and fatigue within 24 hours of first dose of CERVARIX.


VAERS ID: 364863 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-01
Onset:0000-00-00
Submitted: 2009-11-03
Entered: 2009-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Blood immunoglobulin E increased, Demyelinating polyneuropathy, Eosinophil count increased, Eosinophilia, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies abnormal, Somatoform disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Eosinophil count, 01Oct2009, mild; Immunoglobulin E, 01Oct2009, raised; Nerve conduction studies, 01Apr2009, see text; Nerve conduction studies: consistent with a sensory-motor demyelinating peripheral neuropathy (Guillain-Barre).
CDC Split Type: B0599534A

Write-up: This case was reported by a foreign regulatory authority (Regulatory Agency # GB-MHRA-ADR 20511717) and described the occurrence of Guillain Barre syndrome in a 13-year-old female subject who was vaccinated with Cervarix (Glaxosmithkline). Previous vaccination included the first two doses of Cervarix. On 1 April 2009 the subject received the 3rd dose of Cervarix (intramuscular). In April 2009, one week after vaccination with Cervarix, the subject experienced Guillain Barre syndrome, eosinophilia and increased immunoglobulin E. The reporter stated ''the subject had proximal muscle weakness; query myopathy query systemic Lupus Erythematosus. The subject had considerable limb girdle weakness and was arreflexic. Nerve conduction studies were consistent with a sensory-motor demyelinating peripheral neuropathy (Guillain Barre). The subject was considered psycogenic.'' The regulatory authority reported that the events were disabling. At the time of reporting the Guillain Barre syndrome and eosinophilia were unresolved. The outcome of the increased immunoglobulin E was unknown. This patient was referred for a 6 months history of proximal muscle weakness: query myopathy query Systemic Lupus Erythematosus. She had considerable limb girdle weakness and was arreflexic. Nerve conduction studies were consistent with a sensory-motor demyelinating peripheral neuropathy (Guillain-Barre). This patient was considered psycogenic". With further questioning it transpired that the onset had been one week after the third dose of Cervical cancer vaccine. Abnormal results were a mild eosinophilia and a highly raised IgE. I am very concerned about this adverse reaction as this vaccine has the same oil adjuvant used in the Pandremix vaccine to be issued next week to several million people.


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