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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: 372888 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-09
Onset:2008-10-11
   Days after vaccination:2
Submitted: 2009-12-11
   Days after onset:426
Entered: 2009-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA021BA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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:
Current Illness: Unknown
Preexisting Conditions: Eczema
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0547712A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20341756) and described the occurrence of seizure in a 12-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included eczema in January 2001 following MMR vaccination on 06 July 2000. On 9 October 2008 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, batch AHPVA021BA, expiry March 2010). On 11 October 2008, approximately 2 days after vaccination with CERVARIX, the subject experienced seizure and status epilepticus. The subject was hospitalised. On 11 October 2008, the events were resolved. Verbatim Text : The patient experienced seizure and status epilepticus. She was in ITU for 3 nights and 5 nights in hospital. Follow-up information received 27 November 2008: The regulatory authority removed the event of seizure. They reported that the subject recovered after 6-8 hours. Follow-up information received 30 January 2009: A quality statement was subsequently received for the case stating ''The CERVARIX vaccine lot AHPVA021BA has been produced in compliance with the Good Manufacturing Practices and meets the requirements of our specifications. This lot has been checked by GSK Biologicals Quality Assurance and Quality Control according to our procedures.'' Follow-up information received on 01 December 2009: The regulatory authority reported that the status epilepticus was related to CERVARIX.


VAERS ID: 373944 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-17
Entered: 2009-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Disability, Muscular weakness, Rash pruritic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? 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: B0614178A

Write-up: This case was reported by a physician who is also the patient''s mother, and described the occurrence of muscle weakness of lower extremities in a 17-year-old female subject who was vaccinated with (CERVARIX, GlaxoSmithKline). On an unspecified date, the subject received 2nd dose of CERVARIX (intramuscular, injection site unknown, batch number not provided). 2 weeks after vaccination with CERVARIX, the subject experienced muscle weakness of lower extremities, patchy rash with pruritus on lower extremities and joint pain. The physician considered the events were disabling. At the time of reporting, weakness of lower extremities and joint pain are resolved, but patchy rash with pruritus on lower extremities was unresolved. The reporter did not want to give any other data.


VAERS ID: 374098 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-06
Onset:2009-11-08
   Days after vaccination:2
Submitted: 2009-12-18
   Days after onset:40
Entered: 2009-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactoid reaction, Arthralgia, Aspartate aminotransferase increased, Blood immunoglobulin E increased, Body temperature increased, C-reactive protein increased, Fatigue, Haemoglobin normal, Lip swelling, Mean cell volume decreased, Pyrexia, Streptococcus identification test positive, Streptococcal infection, Swelling face, Urticaria, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (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:
Allergies:
Diagnostic Lab Data: Aspartate aminotransferase, 10 Nov 2009, 400 - 800; Body temperature, 09 Nov 2009, 37.2; Body temperature 09 Nov 2009, 38; C-reactive protein, 10 Nov 2009, 37.1; Hemoglobin, 10 Nov 2009, 11.4; IgE 10 Nov 2009, 34; MCV, 10 Nov 2009, 76; White blood cell count, 10 Nov 2009, 12.3; A blood test on 10 November 2009 revealed "N? 10" and "group C beta hemolytic Streptococcus on swab".
CDC Split Type: B0604779A

Write-up: This case was reported by a physician and described the occurrence of urticaria in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) for prophylaxis. Previous vaccination included CERVARIX; unknown given on an unspecified date. On 6 November 2009 the subject received 2nd dose of CERVARIX (1 injection). In November 2009, 36 hours after vaccination with CERVARIX, the subject experienced urticaria, lip swelling, swelling of face, pain in small joints, fever and tiredness. The subject was treated with STEROIDS. At the time of reporting the events were resolved. On the 16th November 2009 a doctor reported that a 17 year old female patient was administered the second dose of the CERVARIX vaccine on the 6th November 2009. The doctor reported that thirty-six hours after the vaccine had been administered the patient experienced severe urticaria, swelling of lips and face, aching of the small joints, fever and tiredness. Following this the patient was given STEROIDS. At the time of reporting all the patient''s symptoms had resolved and there was no further information available. Follow-up information received on 03 December 2009: On 08 November 2009, 2 days after vaccination with CERVARIX, the patient (ethnicity updated) experienced an anaphylactoid reaction (no circulatory collapse). The reporting physician considered the event potentially life threatening and probably related to vaccination with CERVARIX. Swelling was experienced, as previously reported. The patient was seen in the morning of 09 November 2009 and developed a fever (37.2) in the afternoon which increased in the evening (38). On 10 November 2009, blood test was carried out (diagnostic results updated) and group C beta hemolytic Streptococcus was detected on swab. The patient was treated with PENICILLIN V. The outcome of the events was resolved on 16 November 2009. The patient had no relevant medical history or concurrent illness and allergies. The vaccination course was "suspended until clarification received".


VAERS ID: 374108 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-05-16
Onset:2009-05-20
   Days after vaccination:4
Submitted: 2009-12-18
   Days after onset:212
Entered: 2009-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS ANPVA / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abscess, Aggression, Agitation, Anxiety, Arthropathy, Autoimmune disorder, Blood product transfusion, Blood test abnormal, Brain injury, Confusional state, Convulsion, Crying, Disorientation, Disturbance in attention, Dysgraphia, Dyspnoea, Electroencephalogram, Emotional disorder, Encephalitis, Epilepsy, Fatigue, Feeling hot, Groin abscess, Hallucination, auditory, Headache, Hyperhidrosis, Hypotension, Insomnia, Logorrhoea, Loss of consciousness, Lumbar puncture, Malaise, Mood disorder due to a general medical condition, Muscle spasms, Nuclear magnetic resonance imaging normal, Panic attack, Partial seizures, Pyrexia, Trichotillomania, Unresponsive to stimuli, Urinary incontinence, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: antibiotics; oral contraceptive; lorazepam; sedative; diazepam; valproate sodium; steroid; prednisolone
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NMR, 23May2009, normal; Contrast NMR was to be performed. On of the patient''s blood test came back showing something was attacking her immune system.
CDC Split Type: B0588743A

Write-up: This case was reported by a regulatory authority (#GB-MHRA-ADR 20472224) and described the occurrence of seizure in a 18-year-old female subject who was vaccinated with CERVARIX. On 16 May 2009 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 20 May 2009, 4 days after vaccination with CERVARIX, the subject experienced seizure, and encephalitis and on an unknown date the patient experienced emotional reaction and abscess. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. At the time of reporting the events were improved. Mother reported seizure and encephalitis - needed in-patient care in neurology ward then transferred to psychiatric hospital. Was in hospital for 8 weeks. Now under home care team. She also developed an abscess in the groin sometime between the 1st and 2nd dose of the CERVARIX vaccine. Father said she started to get ''emotional'' after the 1st dose of CERVARIX vaccine. Information received from the patient''s mother (not verified from a healthcare professional) as per duplicate case B0592998A: This case was reported by a consumer (patient''s mother) and described the occurrence of seizure in a female subject of unspecified age who was vaccinated with CERVARIX, (GlaxoSmithKline). On 15 November 2008 at 10:00, 24 January 2009 and 16 May 2009 the subject received 1st dose, 2nd and 3rd dose of CERVARIX. After approximately one week after the 1st vaccine the subject was very emotional. One week after the 2nd vaccine the subject had an argument with her sister including verbal disagreement and the occasional slap and punch. After the 3rd vaccination the subject was said to be feeling agitated. She was rambling and no one could make sense if what she was saying. She complained of a headache and was given ibuprofen. The subject had a panic attack (she had difficulty breathing). After seeing a GP, he said that she was suffering with mild anxiety and he prescribed her with mild anti depressants. He put this down to sleep depravation as the subject had not been able to sleep. It was reported that the she experienced seizure a few days after her 3rd vaccination and over the following weeks. The patient exhibited emotional behaviour (punching, screaming), also aggressive and abusive behaviour. the mother reported that the daughter had no recollection of such behaviour. On one occasion when she had the seizure the subject stopped breathing and was unconscious and unresponsive. The paramedics who attended to her stated that she low blood pressure, when the subject came to she was disoriented and she vomited. The mother had observed vacant expressions on her daughter which she later learned were partial seizures. The patient was admitted into hospital and transferred to several units. On 23 May 2009 the subject had an MRI scan, nothing abnormal was found. She also had a lumber puncture done. On other occasions when the subject had a seizure she would wet herself. She had a high temperature, a cannular was fitted and iv anti viral drugs were started. It was also reported that the subject had experienced brain damage and encephalitis. On 26 May 2009 she had an EEG. The subjects would hear voices. On other occasions when the subjects had a seizure she would wet herself and on another occasion she was dribbling onto the pillow. She was hot and sweating she was crying and showing confusion. The doctor said the subject was very poorly, moody and found it hard to concentrate. On 12 June 2009 the subject was given haloperidol to sedate her and she slept for most of the afternoons. She then started to have muscle spasms in her face and hands and was told it was one of the side effects off the haloperidol. She was then given procyclidine to counteract this problem because the subject was struggling to close here mouth. The subject would pull out her hair, was upset, and not sleeping. Whilst in hospital she wondered around, it was reported that the subject had gone missing twice off the ward during the early hours of the morning. On Tuesday 28th July the doctor changed her epilepsy table to EPILIM, she was weaned her off the carbamazepine. he gave her a course of steroids and said that one of the blood results had come back and was showing that something was still attacking her, something to do with the autoimmune system. On one occasion she gave herself the wrong medication. She did not feel well and was tired and anxious. At the time of reporting the outcome of these events was unknown. GSK case number B0588743A is a duplicate of B052998A. All future correspondence will be submitted to B0588743A.


VAERS ID: 374509 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2008-12-01
   Days after vaccination:0
Submitted: 2009-12-21
   Days after onset:385
Entered: 2009-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Diplopia, Disability, IVth nerve paralysis, Influenza like illness
SMQs:, Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune 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: There is no relevant past medical history.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0615056A

Write-up: This case was reported by a physician via a foreign regulatory authority (# GB-MHRA-ADR 20405655) and described the occurrence of influenza like illness in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccinations included the 2 single doses of CERVARIX received on 22 October 2008 and 26 November 2008. On an unspecified date in December 2008 the subject received a single dose of CERVARIX (1 injection, subcutaneous). On an unknown date in December 2008, approximately 2 days after vaccination with CERVARIX, the subject experienced influenza like illness, ivth nerve palsy and double vision. An MR scan has been arranged to see if there is any evidence of demyelination. The regulatory authority reported that the events were disabling. At the time of reporting the events, influenza like illness, ivth nerve palsy had improved and double vision had resolved. Verbatim Text: The patient experienced a flu-like illness and bilateral 4th nerve palsies. Follow-up: With respect to further developments, the patient had a second dose of HPV vaccine following which she developed flu like symptoms but no change in her symptoms of double vision which have largely resolved. An MR scan has been arranged to see if there is any evidence of demyelination. She has had no treatment at present.


VAERS ID: 374857 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-27
Onset:2009-11-27
   Days after vaccination:0
Submitted: 2009-12-23
   Days after onset:26
Entered: 2009-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Hyperventilation, Pharyngeal oedema, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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? 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: B0617000A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20539942) and described the occurrence of throat swelling in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 November 2009 the subject received a single dose of CERVARIX (.5 ml, intramuscular). On the same day later, at an unspecified time after vaccination with CERVARIX, the subject experienced throat and tongue swelling, difficulty breathing and hyperventilation. The regulatory authority reported that the events were life threatening. The subject was treated with ADRENALINE 0.5mls given IM (intramuscularly). At the time of reporting the events were improved. Patient described throat/tongue swelling and difficulty breathing. Hyperventilated at time. Medically significant: ADRENALINE 0.5mls given IM (intramuscularly).


VAERS ID: 375288 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-30
Onset:2009-08-26
   Days after vaccination:118
Submitted: 2009-12-29
   Days after onset:125
Entered: 2009-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-thyroid antibody positive, Antinuclear antibody positive, Blood immunoglobulin G increased, Blood immunoglobulin M increased, Blood product transfusion, Blood test normal, Blood thyroid stimulating hormone decreased, C-reactive protein decreased, Complement factor C3, Complement factor C4, Ecchymosis, Fundoscopy, HIV test negative, Haemoglobin normal, Haemorrhage, Idiopathic thrombocytopenic purpura, Liver function test normal, Petechiae, Platelet count decreased, Protein total, Purpura, Rash, Renal function test normal, Serum ferritin normal, Skin lesion, Thyroxine free normal, Tri-iodothyronine free normal, Ultrasound abdomen normal, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness: Dysphagia (solids and liquids); lumbar fossa pain; pain in area of crista iliaca; submaxillary lymph node; thorax skin rash
Preexisting Conditions: Adenoidectomy; recurring throat infections
Allergies:
Diagnostic Lab Data: Anti-thyroid antibody, 26Aug2009, 81IU / ml; Antinuclear antibody, 24Sep2009, < 1/80; Blood test, 17Nov2009, normal; C-reactive protein, 26Aug2009, 0mg / l; Complement factor C3, 26 Aug 2009, normal; Complement factor C4, 26Aug2009, normal; Free T3, 26Aug2009, normal; Free T4, 26Aug2009, normal; Fundi examination, 26Aug2009, normal; HIV test, 26Aug2009, negative; Hemoglobin, 26Aug2009, 13.4g / dl; Immunoglobulin G, 26Aug2009, 20g / l; Immunoglobulin M, 26Aug2009, increase; Liver function test, 26Aug2009, normal; Platelet count, 26Aug2009, 2G / l; Platelet count, 27Aug2009, 5G/L; Platelet count, 28Aug2009, 4G/L; Platelet count, 29Aug2009, 4G/L; Platelet count, 30Aug2009, 42G/L; Platelet count, 01Sep2009, 102G / l; Platelet count, 04Sep2009, 301G/L; Platelet count, 08Sep2009, 488G/L; Platelet count, 10Sep2009, 465G/L; Platelet count, 17Sep2009, 296G /l ; Platelet count, 24Sep2009, 287G / l; Platelet count, 01Oct2009, 278G / l; Platelet count, 17Nov2009, 294G / l; Protein, 26Aug2009, see lab text; Renal function test, 26Aug2009, normal; Thyroid stimulating hormone, 26Aug2009, 0.270mIU / l; Ultrasound abdomen, 26Aug2009, normal; White blood cells, 26Aug2009, 7660; 26 August 2009, ferritin 71.5 ng / ml. No mononucleosis cells. No schizocytes. anti-thyroid peroxidase antibody: normal. Positive anti-thyroid antibody=thyroglobulin like.
CDC Split Type: B0616965A

Write-up: This case was reported by a foreign regulatory authority (BS20090649, BS09B0269) and described the occurrence of idiopathic thrombocytopenic purpura in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s past medical history included recurrent throat infection with adenoidectomy during childhood. Concurrent medical conditions included dysphagia (to solids and liquids) and two bilateral submaxillary lymph nodes, which occurred eight days before her admission; a rhinopharingitis was suggested but at admission there was no infectious syndrome. Concurrent medications included DAFALGAN as required. There was no other medication. On 22 February 2008, on 16 February 2009 and on 30 April 2009, the subject received three doses of CERVARIX (batch, intramuscular and site unknown). On 26 August 2009, more than three months after the third dose of CERVARIX, the subject presented with ecchymosis, petechiae and purpura on legs with upward spread, leading to hospitalization the same day. At auscultation, leg, thorax, arm and endo-buccal purpuric lesions were present. Lab tests revealed thrombopenia at 2 G/L, an increased anti-thyroid antibody levels at 81 IU / ml (thyroglobulin like), an increased immunoglobulin G level at 20 g/ L and high level of immunoglobulin M. The subject was diagnosed with idiopathic thrombocytopenic purpura. On 27 August 2009, platelet count was 5 G/L. On 28 August 2009, platelet count was 4 G/L. Treatment with prednisolone at 60 mg daily was given and normal immunoglobulin at 40 g on 27 and 29 August 2009. On 29 August 2009, the subject was feeling better. Since then, new hemorrhagic episodes or functional complaint did not recur. Platelet count was at 4 G/L. On 30 August 2009, platelet count was at 42 G/L. On 01 September 2009, cutaneous lesions were stabilized. Platelets level was at 102 G/L. The subject was discharged from hospital with the following treatment: CORTANCYL at 60 mg daily for six days and then at reduced doses the following days. On 08 September 2009, platelet count was at 488 G/L. On 10 September 2009, dose of prednisolone was reduced to 40 mg daily and then dose had to be reduced of 10 mg every week. Platelet count was at 465 G/L. On 17 September 2009, platelet count was at 296 G/L. On an unspecified date, idiopathic thrombocytopenic purpura resolved without sequelae and treatment with prednisolone was discontinued. In end of September 2009, the subject would have had a non pruritic skin rash on right hemithorax which resolved in three days. She also experienced pain in bilateral crista iliaca which increased at palpation (incidental events). Lab tests were normal on 01 October 2009, including platelet count at 278 G/L. On 19 October 2009, the subject received a fourth dose of CERVARIX (batch, intramuscular and site unknown) by her general practitioner (extra dose administered). Idiopathic thrombocytopenic purpura did not recur (negative rechallenge). On 12 November 2009, the subject presented with slight lumbar fossa discomfort at palpation (incidental event). On 17 November 2009, lab tests were normal. Platelet count was at 294 G/L. The agency considered the events as life threatening. According to the method of assessment, the causal relationship of idiopathic thrombocytopenic purpura with CERVARIX was "unlikely".


VAERS ID: 375300 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-09
Onset:2009-09-10
   Days after vaccination:1
Submitted: 2009-12-29
   Days after onset:110
Entered: 2009-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA042BB / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cytomegalovirus test positive, Epstein-Barr virus test positive, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Subject was fit and well. No past medical or drug history.
Allergies:
Diagnostic Lab Data: Cytomegalovirus test, Positive; EPSTEIN-BARR virus test, Positive
CDC Split Type: B0617626A

Write-up: This case was reported by the foreign regulatory authority (GB-Medicines and Healthcare products Regulatory Agency # GB-MHRA-ADR 20517860) and described the occurrence of Guillain Barre Syndrome in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject was positive for cytomegalovirus (CMV) and Epstein-Barr virus (EBV) titres. On 9 September 2009 the subject received a single dose of CERVARIX (AHPVA042BB). On 10 September 2009, at an unspecified time after vaccination with CERVARIX, the subject developed Guillain Barre (GB) Syndrome. The subject was hospitalized and the regulatory authority reported that the event was disabling and life threatening. It was reported that Guillain Barre Syndrome was possibly due to infection with one of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) or both. At the time of reporting the event was unresolved. MHRA Verbatim Text: Patient developed Guillain-Barre (GB) syndrome. Follow-up information: Subsequently I have cytomegalovirus (CMV) and Epstein-Barr virus (EBV) titres which are both positive but not strongly positive. They were taken 6-7 weeks after presentation with GB. It is possible that her GB was due to infection with one of these viruses (or both).


VAERS ID: 375516 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-20
Onset:2009-11-20
   Days after vaccination:0
Submitted: 2009-12-30
   Days after onset:40
Entered: 2009-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Balance disorder, Dizziness, Headache, Inner ear disorder, Lethargy
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Inhaler
Current Illness: Unknown
Preexisting Conditions: Asthma. Fit and normally well. No allergies.
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: B0618419A

Write-up: This case was reported by the regulatory authority (GB-MHRA-ADR 20543385) and described the occurrence of dizziness in a 16 year old female subject who was vaccinated with CERVARIX (Glaxosmithkline). The subject''s medical history included asthma. On 20 November 2009 the subject received a single dose of CERVARIX (.5 ml, intramuscular). Within 24 hours after vaccination with CERVARIX, the subject felt dizzy, weak, lethargy and had a headache. The subject''s balance was also affected. lethargy. Impression of labyrinthine dysfunction. There was no respiratory infection. The subject was hospitalised and kept in for 24 hours. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. Within 24 hours patient felt dizzy, weak lethargy and had a headache. Balance was affected. Impression of labyrinthine dysfunction. No respiratory infection, patient was referred to hospital and kept in for 24 hours.


VAERS ID: 375818 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-02-07
Onset:2009-06-08
   Days after vaccination:121
Submitted: 2010-01-04
   Days after onset:210
Entered: 2010-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Autoantibody negative, Blood folate decreased, Blood test abnormal, Crohn's disease, Decreased appetite, Frequent bowel movements, Haematochezia, Impaired work ability, Inflammation, Malaise, Pain, Serum ferritin decreased, Tenderness, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), 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: Loose Stools
Allergies:
Diagnostic Lab Data: Anti TTG is negative. Bloods done earlier show raised inflammatory markers with low ferritin and folate. General examination was unremarkable but with some tenderness in the right iliac fossa.
CDC Split Type: B0621753A

Write-up: This case was reported by the foreign regulatory authority GB-MHRA-ADR 20468604 and described the occurrence of abdominal pain in a 18-year-old female subject who was vaccinated with CERVARIX vaccine. The subject''s medical history included loose stools. On 7 February 2009 the subject received a single dose of CERVARIX (intramuscular). Approximately 4 months after vaccination with CERVARIX, on 8 June 2009, the subject experienced abdominal pain, increased bowel frequency and inflammatory reaction. The subject had problems with her bowels with loose stools triggered by meat with no mucous but occasional blood. The subject had lot a lot of weight in the past few months - about 1.5 stone and her appetite was not good. Blood tests done earlier show raised inflammatory markers with low ferritin and folate. Anti TTG was negative. The subject was off work due to the problem. She was on codeine at present which controlled her pain. She did not have nocturnal symptoms and generally she was feeling unwell. General examination was unremarkable but with some tenderness but with some tenderness in the right iliac fossa. The regulatory authority reported that the events were disabling. Assessment - her symptoms coincide with CROHN''S disease but given the iron and folate deficiency it would be best to do an OGD and D2 biopsies to rule out coelic disease. Abdominal pain, bowel frequency and raised inflammatory markers. Patient is being investigated for irritable bowel syndrome. The patient has been having problems with her bowels with loose stools triggered by meat with no mucous but occasional blood. The patient has lost a lot of weight in the past few months - about 1.5 stone and her appetite is not good. Bloods done earlier show raised inflammatory markers with low ferritin and folate. Anti TTG is negative. The patient has been off work due to the problems. She is on codeine at present time which controls her pain. She does not have nocturnal symptoms and generally feels unwell. General examination was unremarkable but with some tenderness in the right iliac fossa. Assessment - her symptoms coincide with Crohn''s disease but given the iron and folate deficiency it would be best to do and OGD and D2 biopsies to rule out coelic disease.


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