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From the 1/7/2022 release of VAERS data:

Found 1,514 cases where Vaccine is HPV2 and Serious

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Case Details

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VAERS ID: 375826 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-04
Onset:2009-12-09
   Days after vaccination:5
Submitted: 2010-01-04
   Days after onset:26
Entered: 2010-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Pyrexia, Rash, Urticaria, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: White blood cells, 20Dec2009, 16000; White blood cells, 22Dec2009, 10000
CDC Split Type: B0619817A

Write-up: This case was reported by a physician and described the occurrence of allergic urticaria in a 45 year old female subject who was vaccinated with CERVARIX (Glaxosmithkline). The patient was previously healthy with no allergic history. On 4 December 2009 the subject received a dose of CERVARIX (intramuscular, unknown site). On 9 December 2009, 5 days after vaccination with CERVARIX, the subject experienced allergic urticaria, generalized wheal and flare reaction, rash aggravated, fever and diarrhea. The subject was hospitalised. Relevant test results included white blood cells counts. The subject was treated with dexamethasone, prednisolone, chlorpheniramine maleate and norfloxacin. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with CERVARIX.


VAERS ID: 376307 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-14
Onset:2009-12-14
   Days after vaccination:0
Submitted: 2010-01-08
   Days after onset:25
Entered: 2010-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA058AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Feeling hot, Hyperventilation, Malaise, Muscle tightness, Paraesthesia, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DICLOFENAC; PARACETAMOL + codeine PO4; LEVONORGESTREL
Current Illness: Arrhythmogenic right ventricular DY; overweight
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0621919A

Write-up: This case was reported by the regulatory authority (#GB-MHRA-ADR 20546688) and described the occurrence of feeling unwell in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included arrhythmogenic right ventricular dysphlasia and being overweight. Previous vaccinations included the influenza virus vaccine (intramuscular) given on 12 December 2009 and PANDEMRIX given on an unknown date. Concurrent medications included VOLTAROL, Co-codamol, Levonelle-2. On 14 December 2009 the subject received a 0.5ml dose of CERVARIX (intramuscular, batch number AHPVA058AB) at 12:15pm. On 14 December 2009, within minutes of vaccination with CERVARIX, the subject experienced feeling unwell, feeling hot, dyspnea, an urticarial rash on the face and neck tightness. On the same day, 14 December 2009 the subject also experienced hyperventilation, paresthesia and facial rash. The subject was admitted to the Hospital where she was treated with Prednisolone. The subject was hospitalised and the regulatory authority reported that the events were life threatening. On 15 December 2009, the events were resolved and the subject was discharged from hospital. HPV vaccine given at school - 12:15 pm. Few minutes later felt unwell - hot, dyspnoea, rash to face, urticarial. Tightness in neck. Seen at GP surgery, given salbutamol nebuliser. Also hyperventialting, paraesthesia. Admitted to Accident and Emergency - treated with PREDNISOLONE, discharged next day.


VAERS ID: 376317 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-10
Onset:2008-07-16
   Days after vaccination:6
Submitted: 2010-01-08
   Days after onset:541
Entered: 2010-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA008AD / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sensation in eye, Albumin CSF normal, Alpha 1 globulin normal, Alpha 2 globulin normal, Beta globulin normal, Blindness unilateral, Blood albumin normal, Blood immunoglobulin A, Blood immunoglobulin G normal, Blood immunoglobulin M, Borrelia burgdorferi serology negative, C-reactive protein normal, CSF cell count normal, CSF glucose normal, CSF immunoglobulin increased, CSF lactate normal, CSF lymphocyte count normal, CSF monocyte count, CSF oligoclonal band present, CSF protein normal, CSF white blood cell count negative, Conduction disorder, Immunoglobulins normal, Migraine, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination normal, Optic neuritis, Protein total normal, Somatosensory evoked potentials, Visual acuity reduced, Visual acuity tests abnormal, Visual evoked potentials abnormal, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Conduction defects (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypoglycaemia (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? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Familial risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Albumin, 07Aug2008, 4170mg/dl; Albumin CSF, 07Aug2008, 12.3mg/dl; Alpha 1 globulin, 07Aug2008, 3.9%; Alpha 2 globulin, 07Aug2008, 8.2%; Beta globulin, 07Aug2008, 11.1%; Borrelia burgdorferi immunoglo, 07Aug2008, negative; Borrelia burgdorferi immunoglo, 07Aug2008, negative; C-reactive protein, 07Aug2008, 0.2mg/dl; CSF IgG increased, 07Aug2008, 5.3mg/dl; CSF WBC, 07Aug2008, 4/ul; CSF cell count, Aug2008, 4 cells; CSF lactate, 07Aug2008, 13.2mg/dl; CSF monocyte count, 07Aug2008, 23%; CSF oligoclonal band present, Aug2008, positive; CSF oligoclonal band present, 07Aug2008, positive; Cerebrospinal fluid glucose, 07Aug2008, 54mg/dl; Cerebrospinal fluid lymphocyte, 07Aug2008, 76%; Cerebrospinal fluid protein, 07Aug2008, 30mg/dl; Eye exam normal, 28Jul2008, normal; Gamma globulin, 07Aug2008, 11.3%; IgA, 07Aug2008, 122mg/dl; IgG, 07Aug2008, 779mg/dl; NMR, 06Aug2008, abnormal; NMR, Oct2008, normal; Protein total, 07Aug2008, 7.8g/dl; Somatosensory evoked potential, normal; Visual acuity tests, 07Aug2008, 5-10%; Visual acuity tests, 13Aug2008, 75%; Visual acuity tests, 19Aug2008, 5%; Visual acuity tests, 15Sep2008, 30%; Examinations: Visual evoked potential: Complete conduction block, fitting into the diagnosis of optical nerve neuritis. Laboratory tests on 07 August 2008: Treponema pallidum hemagglutination test: negative. Cerebrospinal fluid IgA 0.11 mg/dl. Cerebrospinal fluid IgM 0.39 mg/dl. Cerebrospinal fluid Borrelia IgG and IgM negative. Cerebrospinal fluid plasma cell count 1%. Other cells in cerebrospinal fluid: solitary cells.
CDC Split Type: D0060193A

Write-up: This case was reported by a physician via a foreign regulatory authority (# DE-PEI-PEI2008021049) and described the occurrence of optic nerve neuritis, left, in a 20-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Family anamnesis included HPV associated severe cervical intraepithelial neoplasia/epithelial dysplasia of the mother. Previous vaccinations included the first and second doses of CERVARIX (GlaxoSmithKline), given on 27 December 2007 and 18 February 2008. On 10 July 2008 the subject received the third dose of CERVARIX (0.5 ml, unknown). Approximately six days post vaccination with CERVARIX, on 16 July 2008 or 17 July 2008, the subject experienced migraine-like headache and feeling of pressure behind left eyeball. Ophthalmological examinations, performed on 28 July 2008, were normal. The subject was treated with unspecified migraine medication prescribed by the family physician. Approximately 26 days post vaccination with CERVARIX, on 05 August 2008, the subject experienced nearly complete unilateral vision loss left. The subject was diagnosed with suspected optic neuritis left by an ophthalmologist. Optic neuritis left was confirmed by neurological examinations. This case was assessed as medically serious by GSK criteria. MRT of the cervical spine and the thoracic spine showed an inflammatory focus in the thoracic vertebra 1. CSF examination showed 4 cells and was positive for oligoclonal bands. The subject was treated with cortisone. Follow-up MRT, performed on an unknown date in October 2008, was normal. At the time of reporting, on 13 November 2008, examinations to exclude multiple sclerosis was not completed. At the time of reporting the final outcome of the events was unspecified. Follow-up information including a hospital report was received on 06 February 2009 from the foreign regulatory authority. At the time of the events the subject had no infection. The subject owns at home a healthy cat. The subject works in an office. Family anamnesis did not include autoimmune disorder except rheumatic disease of the grandmother at old age. Approximately two weeks post vaccination with CERVARIX, an unknown date end of July 2008, the subject experienced first signs of optic disorder, reported as spots before eyes. These spots before eyes were black and white similar to spots seen after having taken a picture with flashlight. At that time colours could still be seen well. Additionally the subject experienced headache at one side. The subject has taken unspecified migraine medication for headache. The subject was hospitalised for seven days from 07 August 2008 to 13 August 2008 for worsening of the events. In hospital optic neuritis left was diagnosed. On admission, visual acuity was 5-10 %. Internal examinations on admission were normal. Micturition and defecation were normal. Neurological examinations showed that convergence at the left eye was not possible. Visual evoked potential showed complete blockage of conduction which was in concordance with optic neuritis left. Somatic evoked potential was normal. CSF examination showed four cells and was positive for oligoclonal bands. MRT of neck and thoracic spine showed a focus of inflammation at the thoracic vertebra 1. The subject was treated with URBASON massive dose therapy at 1 g daily for five consecutive days. At the time of discharge from hospital, on 13 August 2008, visual acuity has improved substantially to 75 %. On 13 August 2008 the subject was discharged from hospital in improved general condition. According to additional information the visual acuity of the subject was improved about 50 % at the last ophthalmological examination, performed on an unknown date. On 17 March 2009 case D0058743A was identified as duplicate of case D0060193A. Case D0058743A was voided and all further information will be included in case D0060193A. Duplicate case D0058743A was initially received on 15 September 2009 by a physician via a sales representative. The subject has no underlying or concurrent medical conditions or other risk factors. The subject received no concomitant medication. On 10 July 2008 the subject received the third dose of CERVARIX (0.5 ml, intramuscular, right deltoid). Migraine-like headache improved after having taken the first dose of unspecified migraine medication on 30 July 2008. Approximately 20-21 days post vaccination with CERVARIX, since 30 or 31 July 2008, the subject experienced flickering of the left eye, followed by increasing vision loss of the left eye since 04 August 2008. Vision loss of the left eye worsened until visual acuity was as low as 5% on 19 August 2008. The subject was hospitalised for seven days from 07 August 2008 to 13 August 2008. The reporting physician considered that the events were disabling. In hospital the subject was diagnosed with optic nerve neuritis. The subject was seeing shades in the left eye, but colours could be identified well. There was a black and white flickering, similar to flashlights. CSF test showed four cells and positive oligoclonal bands. The subject was treated with URBASON high-dose therapy of 1 g over five days. Visual acuity improved a little bit. On 15 September 2008 visual acuity was 30%. In verbal follow-up information, received on 10 October 2008, the reporting physician stated that no cranial lesions could be found. Therefore the diagnosis was still optic nerve neuritis. Further examinations to exclude or confirm suspected multiple sclerosis were pending. According to follow-up information received on 4 January 2009 from the physician, approximately in November 2009 multiple sclerosis was diagnosed. No further information will be available.


VAERS ID: 376478 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-21
Onset:2009-09-21
   Days after vaccination:0
Submitted: 2010-01-11
   Days after onset:112
Entered: 2010-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA058AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Anaphylactic reaction, Dizziness, Erythema, Fear, Flushing, Immediate post-injection reaction, Malaise, Skin discolouration, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Patient has no known allergies, and received all other primary immunisations with no adverse reactions. Currently in good health and not on any medication at present.
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0595542A

Write-up: This case was reported by a regulatory authority (GB-MHRA-ADR 20498626) and described the occurrence of anaphylaxis in a 14-year-old female subject who was vaccinated with CERVARIX. Patient has no known allergies, and received all other primary immunisations with no adverse reactions. Currently in good health and not on any medication at present. On 21 September 2009 the subject received unspecified dose of CERVARIX (intramuscular) at approximately 11:40am and experienced anaphylaxis-it was reported that immediately after vaccination the subject felt unwell although did not collapse. The subject complained of stomach cramps and dizziness. The subject was laid down and her legs were raised. The subject continued to feel unwell. The subjects colour changed at 12.35 and became flushed and complained of tightness in her throat. The subjects neck and throat area became red, and wheals appeared around this area. The subject she felt very frightened at that time. The subject was treated with adrenaline at 1:1000, 0.5mls (intramuscularly) at 12.35. The subjects condition improved quickly following administration of adrenaline and was assessed by paramedics prior to removal to hospital. The regulatory authority reported that the event was life threatening. At the time of reporting the event was resolved. Verbatim Text: Administered with CERVARIX at approximately 11.40 am. Immediately felt unwell although did not collapse. Complained of stomach cramps and dizziness. Was laid down and legs were raised. Continued to feel unwell. Colour changed at 12.35. Became flushed and complained of tightness in her throat. Neck and throat area became red, and wheals appeared around this area. Reported that she felt very frightened at that time. Adrenaline 1:1000, 0.5mls administered intramuscularly at 12.35. Condition improved quickly following administration of adrenaline and was assessed by paramedics prior to removal to hospital. No contraindications to vaccine were noted as school nurse had spoken to parent prior to immunisation to gain consent and information regarding their daughter''s general health, any current medication and any known allergies. Follow-up information received 6 January 2010: Patient began to feel unwell immediately post-immunisation. Symptoms escalated by 50 minutes post-immunisation. Recovery took place within 2-3 minutes of receiving adrenaline.


VAERS ID: 376481 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-13
Onset:2009-01-20
   Days after vaccination:99
Submitted: 2010-01-11
   Days after onset:356
Entered: 2010-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA024BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Bladder catheterisation, Blood test normal, Intestinal functional disorder, Laboratory test normal, Neurogenic bladder, Ultrasound scan normal, Urinary retention
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Trimethoprim; Phenoxymethylpenicillin K
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, normal; Ultrasound scan, normal; All other investigations have been normal.
CDC Split Type: B0624096A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20378977) and described the occurrence of neuropathic bladder in a 13-year-old female subject who was vaccinated with CERVARIX. Concurrent medications included Penicillin. On 13 October 2008 and 1 December 2008 the subject received a dose of CERVARIX (intramuscular). On 20 January 2009, 99 days after vaccination on the 13th October 2009 with CERVARIX, the subject experienced neuropathic bladder and urinary retention. On unspecified dates the subject experienced bowel dysfunction and abdominal pain. The subject was hospitalised. Blood test and ultrasound were normal. At the time of reporting the events were unresolved. Neuropathic bladder urinary retention. Medically significant as is on intensive supportive care. Follow-up: Patient presented with inability to pass urine and inability to open her bowels normally, associated with abdominal pain. Currently, patient is being treated with intermittent catherisation to drain her bladder and laxatives. She remains a hospital inpatient. We feel that it is likely that there is a significant amount of psychological overlay to these symptoms but her mother knows of another girl, of a similar age, who had similar symptoms following HPV vaccination. Her mother is particularly concerned about the mercury levels in the vaccine.


VAERS ID: 377271 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-02-17
Onset:2009-02-17
   Days after vaccination:0
Submitted: 2010-01-18
   Days after onset:335
Entered: 2010-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

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

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, 0 days
   Extended hospital stay? No
Previous Vaccinations: Arm discomfort, diarrhoea~ ()~~0.00~Patient
Other Medications: MICROGYNON
Current Illness: Unknown
Preexisting Conditions: Stiff arm after first vaccine. Diarrhoea and vomiting after second vaccination.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0625173A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 20552375) and described the occurrence of diarrhea in a 17-year-old female subject who was vaccinated with CERVARIX. Previous vaccinations included CERVARIX given on the 1 September 2009 and 13 January 2009. Concurrent medications included MICROGYNON. On 17 February 2009 the subject received unspecified dose of CERVARIX (intramuscular). On 17 February 2009, 14 hours after vaccination with CERVARIX, the subject experienced diarrhea, vomiting and generalized pain. The subject was hospitalised. At the time of reporting the events were resolved. Verbatim Text: Third vaccine was given as symptoms of diarrhoea and vomiting considered probable coincidence at time of vaccine rather than cause. 14 hours after vaccine-diarrhoea and vomiting, general pain ''everywhere'', bed bound next few days required hospital admission and rehydration. Recovered after a few days.


VAERS ID: 377906 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-01
Onset:2009-10-22
   Days after vaccination:51
Submitted: 2010-01-22
   Days after onset:92
Entered: 2010-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Cold sweat, Dizziness, Feeling cold, Feeling hot, Flushing, Headache, Hyperventilation, Immediate post-injection reaction
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (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, 0 days
   Extended hospital stay? No
Previous Vaccinations: Dizzy~Vaccine not specified (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0627338A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 20553254), via a physician, and described the occurrence of frontal headache in a 13-year-old female subject who was vaccinated with CERVARIX. On 01 September 2009 the subject received 1st dose of CERVARIX. On 22 October 2009, the subject received 2nd dose of CERVARIX (0.5 ml, intramuscular). On 22 October 2009, immediately after vaccination with 2nd dose of CERVARIX, the subject experienced dizziness and hyperventilation. The subject complained of frontal headache, feeling hot, shivering, cold, clamminess and facial flushing. The subject was hospitalised. On 22 October 2009, the events were resolved some hours later. Verbatim Text: Immediately post vaccination the patient felt dizzy and began to hyperventilate. Complaining of feeling hot and severe left frontal headache. Shivery, cold and clammy with a flushed face. Pulse 84 and steady, alert and oriented. An ambulance took her to A&E where she recovered some hours later.


VAERS ID: 378327 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-25
Onset:2008-10-02
   Days after vaccination:7
Submitted: 2010-01-26
   Days after onset:481
Entered: 2010-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Conjunctivitis allergic
SMQs:, Conjunctival disorders (narrow), Hypersensitivity (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: UNK
CDC Split Type: D0066154A

Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of allergic conjunctivitis in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 September 2008 the subject received 1st dose of CERVARIX (unknown route and application site). On 2 October 2008, 7 days after vaccination with CERVARIX, the subject experienced allergic conjunctivitis on the left eye. The subject was hospitalised. Examination by a rheumatologist showed no reasons. Possible myositis was diagnosed. On 23 October 2008 the subject received 2nd dose of CERVARIX (unknown route and application site). At the time of reporting, on 20 January 2010, the outcome of the events was unspecified. Further information was requested.


VAERS ID: 378500 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-14
Onset:2009-10-15
   Days after vaccination:1
Submitted: 2010-01-27
   Days after onset:104
Entered: 2010-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA050AG / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Headache, Impaired work ability, Loss of consciousness, Malaise, Pain in extremity, Pyrexia, Respiratory failure, Snake bite
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-02
   Days after onset: 18
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: Joint pain
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0628298A

Write-up: This case was reported by a physician and described the occurrence of respiratory failure in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included joints pain. Previous and/or concurrent vaccination included CERVARIX ;GlaxoSmithKline;intramuscular;unknown deltoid given on 9 September 2009. On 14 October 2009, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid). The subject was put under observation during 30 minutes after both vaccinations. No adverse event had occurred. On 15 October 2009, 1 day after vaccination with CERVARIX, the subject experienced a low grade fever and headache. She visited an homeopathy center where she was prescribed treatment with paracetamol, Liv 52 and RANTAC. The subject was advised to come back to the center for follow-up after 2 days of treatment. The events resolved and the subject restarted her daily chores. On 1st November 2009, the subject informed her parents that an insect has bitten her during the field work. She was not feeling well and complained about leg pain. Post noon, the subject didn''t go to work and rested at home. Overnight, her condition deteriorated. On the morning of the 2nd November 2009, an ambulance was called. The subject''s vital signs recorded at the time of shifting were poor. On the way to hospital, she became unconscious and her vital signs were not recordable. The cardio pulmonary resuscitation provided was unsuccessful. At hospital, she was declared dead due to a respiratory failure. Autopsy was rejected by the family. The physician considered the events were unrelated to vaccination with CERVARIX and so, no follow-up was necessary. The subject died on 2 November 2009 from a suspected snake bite. An autopsy was not performed.


VAERS ID: 378501 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-05
Onset:2009-11-15
   Days after vaccination:10
Submitted: 2010-01-27
   Days after onset:73
Entered: 2010-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA042AH / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin A normal, C-reactive protein increased, Culture urine negative, Electrophoresis, Haematocrit normal, Haematuria, Haemoglobin normal, IgA nephropathy, Lymphocyte count increased, Protein urine present, Red blood cell count decreased, Red blood cell sedimentation rate increased, Ultrasound kidney normal, Urinary sediment present, Urine analysis abnormal
SMQs:, Acute renal failure (broad), Haematopoietic erythropenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: C-reactive protein, 18Nov2009, 1.1MG/DL; Electrophoresis, 18Nov2009, see text; Erythrocyte sedimentation rate, 18Nov2009, 60; Hematocrit, 18Nov2009, 32.8; Hemoglobin, 18Nov2009, 10.9; IgA, 18Nov2009, 335; IgA, 01Dec2009, 333; Lymphocytes, 18Nov2009, 18.4; Protein urine, 01Dec2009, positive +; Protein urine, 01Dec2009, positive +; Red blood cell count, 18Nov2009, 3750; Renal artery ultrasound, 18Nov2009, normal; Urinary sediment present, see text; Urine analysis, 18Nov2009, see text; Urine analysis, 01Dec2009, see text; Urine culture, 18Nov2009, negative
CDC Split Type: B0628834A

Write-up: This case was reported by a regulatory authority (110105) and described the occurrence of Berger''s disease in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 November 2009, the subject received an unspecified dose of CERVARIX (intramuscular, administration site unknown). On 15 November 2009, 10 days after vaccination with CERVARIX, the subject experienced Berger''s disease and hematuria. The subject was hospitalised. Tests results: 18 November 2009: Erythrocyte Sedimentation rate: 60, IgA: 335, Pharynx tampon: negative for streptococcus and stafilococcus aureus, urine culture: negative, electrophoresis: alpha 2=12.7- beta 1= 6.9- gamma=12.2, beta 2=6, red blood cells: 3750, hemoglobin: 10.9, hematocrit: 32.8, lymphocytes: 18.4, hematuria: positive ++++, urine protein: positive +++, renal ultrasonography: normal, urinary sediment: red blood cells present, c-reactive protein: 1.1 MG/DL. 01 December 2009: IgA: 333, hematuria: positive++++, urine protein: positive +. At the time of reporting, the events were improved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.


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