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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: 371043 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-05
Onset:2009-10-07
   Days after vaccination:2
Submitted: 2009-12-01
   Days after onset:55
Entered: 2009-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA048AK / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Fatigue, Vaginal lesion, Viral infection
SMQs:, Guillain-Barre syndrome (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: UNK
CDC Split Type: B0607467A

Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-ADR 20528862) and described the occurrence of viral infection in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 October 2009 the subject received a single dose of CERVARIX (.5 ml, intramuscular, batch: AHPVA048AK). On 7 October 2009, approximately 2 days after vaccination with CERVARIX, the subject experienced viral illness. The subject also had weakness, tiredness and lesions of vagina. The subject was hospitalised. At the time of reporting the subject was recovering after a couple of weeks but still under care of consultant. Verbatim Text: Reported by patients father, 2 days or so post vaccination, developed viral illness. Unknown origin, admitted to hospital, apparently had vaginal sores, weakness, tiredness, recovering after a couple of weeks but still under care of consultant.


VAERS ID: 371044 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-01
Onset:0000-00-00
Submitted: 2009-12-01
Entered: 2009-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Cholangitis, Transaminases increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Retroperitoneal fibrosis (narrow), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0607713A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of transaminases increased in a 22-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In March 2009, the subject received 1st dose of CERVARIX (intramuscular, unknown deltoid). Lot number not available. In 2009, within days of vaccination with CERVARIX, the subject experienced transaminases increased. The subject was hospitalised and primary cholangitis was diagnosed. The subject was treated with URSODIOL. On an unspecified date, the subject was discharged and continued her treatment. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with CERVARIX. The reporter stated that he has not seen the patient since. He saw her mother at some point and the mother reported that the patient is well and is still receiving the medication stated in the initial report. The reporter said that he will contact us when he has further information. No additional information has been received. The case has been closed.


VAERS ID: 371444 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-05-13
Onset:2008-07-09
   Days after vaccination:57
Submitted: 2009-12-03
   Days after onset:512
Entered: 2009-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Albumin urine present, Alpha 1 microglobulin urine, Arthralgia, Beta 2 microglobulin normal, Beta 2 microglobulin urine normal, Blood albumin decreased, Blood alkaline phosphatase normal, Blood calcium increased, Blood creatine increased, Blood glucose decreased, Blood parathyroid hormone normal, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Constipation, Creatine urine, Cystatin C, Decreased appetite, Fatigue, Glucose urine absent, Haematocrit normal, Haemoglobin increased, Joint swelling, Ocular hypertension, Platelet count normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Tubulointerstitial nephritis and uveitis syndrome, Urine protein/creatinine ratio decreased, Weight decreased, White blood cell count normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Chronic kidney disease (broad), Arthritis (broad), Proteinuria (narrow), Tubulointerstitial diseases (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Immune-mediated/autoimmune disorders (narrow)

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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Albumin, 13 Aug2008, 31.2MG/L; Albumin, 06Nov208, 7.4MG/L; Alkaline phosphatase, 13Aug2008, 73U/L, 80, 210; Alpha 1 microglobulin urine, 13Aug2008, 42.7MG/L, 8; Alpha 1 microglobulin urine, 06Nov2008, 5.2MG/L, 8; Blood Creatine, 21Jul2008, 120UMOL/L, 45, 90; Blood Creatine, 28Jul2008, 129UMOL/L, 45, 90; Blood Creatine, 31Jul2008, 143UMOL/L, 45, 90; Blood Creatine, 04Aug2008, 150UMOL/L, 45, 90; Blood Erythrocyte, 28Jul2008, 3, 72E12/L, 3, 90, 5, 20; Blood Erythrocyte sedimentatio, 21Jul2008, 107MM/H, below 15; Blood Erythrocyte sedimentatio, 23Jul2008, 99MM/H, below 15; Blood Erythrocyte sedimentatio, 13Aug2008, 70MM/H, 0, 15; Blood Erythrocyte sedimentatio, 11Sep2008, 20MM/H, below 15; Blood Erythrocyte sedimentatio, 06Nov2008, 10MM/H, 0, 15; Blood Erythrocyte sedimentatio, 01Jun2008, 7MM/H, below 20; Blood Hematocrit, 28Jul2008, 0, 32, 0, 35,0, 48; Blood Hematocrit, 01Jun2008, 0, 40, 0, 35,0, 48; Blood Hemoglobin, 28Jul2008, 106G/L, 118, 148; Blood Hemoglobin, 01Jun2009, 133G/L, 117, 155; Blood Platelet count, 01Jun2009, 200E9/L, 150, 360; Blood Red blood cell count, 01Jun2009, 4, 57E12/L, 5, 20; Blood White blood cell count, 01Jun2009, 5, 7E9/L, 3, 4, 8, 2; Creatine, 13Aug2008, 93uMOL/L, 93uMOL/L, 45, 90, Creatine, 06Nov2008, 74uMOL/L, 45, 90; Cystatin C, 06Nov2008, 0.91MG/L, 0, 1.20; Erythrocyte sedimentation rate, 13Aug2008, 70MM/H, 0,15; Erythrocyte sedimentation rate, 11Sep2008, 20mm/h; Erythrocyte sedimentation rate, 06Nov2008, 10MM/H,0,15; Parathyroid hormone, 06Nov2008, 2.5PMOL/L, 1.6,6.9; Plasma Alkaline phosphatase, 13Aug2008, 73U/L, 80, 210; Plasma C-reactive protein, 21Jul2008, 87MG/L, below 5,0; Plasma C-reaction protein, 23Jul2008, 57MG/L, below 5,0; Plasma C-reaction protein, 01Jun2009, 0,8MG/L, below 5,0; Plasma Calcium, 31Jul2008, 2,53MMOL/L, 2,15, 2,51; Plasma Creatine, 23Jul2008, 124UMOL/L, 45, 90; Plasma Creatine, 13Aug2008, 93uMOL/L, 45,90; Plasma Creatine, 06Nov2008, 74uMOL/L, 45, 90; Plasma Creatine, 01Jun2009, 84UMOL/L, 50, 90; Plasma Cystatine C, 13Aug2008, 1,58MG/L, 0, 20; Plasma Cystatine C, 06Nov2008, 0,9MG/L, 0, 1,20; Plasma Potassium, 01Jun2009, 3,8MMOL/L, 3,3 4,8; Plasma Sodium, 01Jun2009, 142MMOL/L, 135,146; Plasma Urea, 28Jul2008, 6, 3MMOL/L, 2,7, 6,0; Plasma Urea, 31Jul2008, 6,9MMOL/L, 2,7,6,0; Plasma Urea, 01Jun2009, 7,2MMOL/L, 2,6, 6,4; Urine Albumin, 13Aug,2008, 31,2MG/L, NA; Urine Albumin, 06Nov2008, 7,4MG/L, NA; Urine Alfal microglobulin, 06Nov2008, below5, 2MG/L, below8MG/; Urine Alfal microglobulin, 13Aug2008, 42,7MG/L, below8MG/; Urine B2Microglobulin, 01Jun2009, below2UG/L, below 250; Urine Creatine, 01Jun2009, 13MMOL/L; Urine Glucose, 01Jun2009, 0,1G/l, below0,1; Urine Protein, 01Jun2009, 0,11G/L, below0,1; fPlasma parathyreoidhormone, 06Nov2008, 2,4 PMOL/L, 1,6, 6,9
CDC Split Type: R0000665A

Write-up: The subject was enrolled in the prophylactic study which is open or single blind according to communities. On 15 April 2008 and on 13 May 2008, the subject received the 1st and 2nd dose of CERVARIX, IM deltoid. On 09 July 2008, 57 days after the 2nd dose of CERVARIX, this 15 year-old subject developed tubulointerstitial nephritis and uveitis syndrome. The subject was hospitalized and the event was clinically significant (or requiring intervention). The subject was treated with PREDNISONE, OMEPRAZOLE, DEXAMETHASONE, HYOSCINE and DORZOLMAIDE/ TIMOLOL ophthalmic solution. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the tubulointerstitial nephritis and uveitis syndrome may have been caused by CERVARIX. Subsequent study vaccine administration was discontinued. The subject received investigational vaccine I and II on 15 April 2008 and 13 May 2008. One and a half month later the subject developed fever approx 38 Celsius degrees that lasted for a month. She had no symptoms of respiratory-infections, no abnormal pain, no headache. She had tiredness, loss of appetite, weight loss of 4 kilos in a month. No urticaria. No arthralgia except of right knee pain when lying with knees flexed. One month of constipation symptoms. She was first examined in hospital (report missing) and then in the hospital. She was admitted to the hospital for kidney biopsy. The subject was free of findings when examined on 23 July 2008 by a pediatrician. Lab tests were normal except for ESR (erythrocyte sedimentation rate), CRP (c-reactive protein), Creatine, urea and glycosuria. Rheumatoid disease, diabetes, tularemia, epidemic nephropathy, Borrelia, EBV (Epstein-Barr Virus) - kampylo and Yersinia - infections were excluded. Culture of urine and faces were normal. An ultrasound of the abdomen and kidneys were normal. Chest and sinus x-rays were normal. Because of ongoing fever and lab test findings TINU was suspected. An Opthamologist was consulted and acute iritis was found in both eyes on 05 August 2008. Topical medication was started. She was referred to the hospital for a kidney biopsy on 07 August 2008 (hospital stay 06-08 August 2008). The biopsy finding was some improvement in lab finding. The subject was still in good condition but she had pain and some swelling in the knees. The iritis was followed and got better. At visit on 11 September 2008, no changes in findings or symptoms but the lab tests were normal except for ESR 20mm/h. There is a probability that the subject got the TINU-syndrome because of the vaccination, so she did not receive third vaccine. Follow-up controls had been arranged in hospital. On a control visit 06 November 2008 the subject was in good medical condition. PREDNISOLON medication was stopped on 14 November 2008. On 30 December 2008, the iritis activated again and topical medication was started for 8 weeks and a follow-up control was arranged. A kidney function test made on 15 January 2009 (GFR-test=glomerular filtration rate) showed a slightly lowered kidney function (79ml/min/1.73m2, normal range 75-134 ml/min/ 1.73m2) but other blood tests showing kidney function were normal. The GFR-test will be repeated after half a year. On a follow-up contact on 16 January 2009 the iritis was improved. The topical medication was diminished and stopped on 24 February 2009. On 24 February 2009 the iritis had improved but there was a bit hypertension in both eyes. Dexa-drops were discontinued but drops for ocular hypertension continued until 03 March 2009. The eye pressure were normal on 20 March 2009. A pediatrician follow-up control on 01 June 2009; the subject was in good condition except for common allergic symptoms. Status was normal. On 28 August 2009 she went to an ophthalmologist because of symptoms of iritis. There was a mild iritis in both eyes and topical medication was started. On a follow-up control on 22 September 2009 the condition had improved and medication discontinued (subject had stopped the medication 5 days earlier).


VAERS ID: 371591 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-02
Onset:2009-03-03
   Days after vaccination:1
Submitted: 2009-12-04
   Days after onset:276
Entered: 2009-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Balance disorder, Blood count normal, Blood electrolytes normal, Blood pressure abnormal, Blood test normal, Blood urea normal, Dizziness, Electrocardiogram normal, Headache, Hypotension, Liver function test normal, Neck pain, Syncope, Thyroid function test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: Asthma; Fit, well, sporty young girl.
Allergies:
Diagnostic Lab Data: Blood count, 01April2009, normal; Blood test, normal; Electrocardiogram, normal; Liver function test, 01April2009, normal; Thyroid function test, 01April2009; Urea, 01April2009, normal; Blood electrolytes, normal
CDC Split Type: B0570579A

Write-up: This case was reported by a regulatory authority (GB-MHRA-ADR 20413061) and described the occurrence of dizziness in a 18 year old female subject who was vaccinated with CERVARIX. The subject''s medical history included asthma. On 02 March 2009 the subject received unspecified dose of CERVARIX (.5ml, intramuscular). On 03 March 2009, at an unspecified time after vaccination with CERVARIX, the subject experienced dizziness, blood pressure abnormal, headache, syncope and low blood pressure. The subject was hospitalised. At the time of reporting the events were unresolved. Verbatim text: 24 hours after injection patient attended local Accident and Emergency. Patient experienced a collapse episode, followed by headache and dizziness. Had short stay in Accident and Emergency due to low blood pressure. Follow-up information received on 26 November 2009: The subject complained about a headache that was persisted since the vaccine. 24 hours later, after vaccination with CERVARIX, she had a syncopal episode and went into A&E. The subject was told that her blood pressure was very low. Her ECG was normal. She was kept in the hospital for observation for a few hours and then was discharged home. Since then, the subject reported that she was not well. She had a persistent headache and dizziness. She was generally well and active, but she was not able to do anything in school. The subject was feeling of light-headed and her legs were unsteady. The subject was complaining of neck pain. There was no associated fever, nausea or vomiting. The subject was further treated with paracetamol, CODEINE and ibuprofen tablets and the headaches slowly resolved around the first week of April. During this time, her thyroid function test, full blood count, urea, blood electrolytes and liver function tests were within normal limits. At the time of reporting the events dizziness, headache and syncope were resolved. The outcome of low blood pressure and neck pain was unknown. MHRA verbatim text: Follow-up: Patient had the vaccination HPV CERVARIX. She went into A&E the next day and was seen in Clinic on 8 days later when she complained about headache which has persisted since the vaccine. 24 hours later, after the HPV vaccination, she had a syncopal episode and went into A & E. She was told that her blood pressure was very low. Her ECG was normal. She was kept in for observation for a few hours and then was discharged home. Since then, she says she was not well. She had a persistent headache and dizziness. She is generally well and active. She was not able to do anything in school and she feels since then she has been light-headed and her legs have been unsteady. She has been complaining of neck pain. There is no associated fever, nausea or vomiting. She was further treated with paracetamol, CODEINE, and ibuprofen tablets and the headaches slowly resolved around the first week of April. During this time, her thyroid function test, full blood count, urea and electrolytes and liver function tests were within normal limits.


VAERS ID: 371714 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-08
Onset:2008-07-08
   Days after vaccination:0
Submitted: 2009-12-04
   Days after onset:514
Entered: 2009-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA019A43 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Immediate post-injection reaction, Malaise, Myalgia, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0602754A

Write-up: This case was reported by a regulatory authority (# 105252 # 105261) and described the occurrence of colic in a 11-year-old female subject who was vaccinated with Cervarix (GlaxoSmithKline). On July 8 2008, the subject received 2nd dose of Cervarix (intramuscular, unknown injection site). On 8 July 2008, immediately after vaccination with Cervarix, the subject experienced colic. On 16 December 2008, 5 months after vaccination, she had vertigo, malaise and myalgia. The subject was hospitalised. On 23 December 2008, the event was resolved. The regulatory authority reported that colic was possibly related to vaccination with Cervarix. This case has been identified as duplicate of case of B0601400A.


VAERS ID: 371719 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-26
Onset:2009-11-26
   Days after vaccination:0
Submitted: 2009-12-04
   Days after onset:8
Entered: 2009-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Rash morbilliform
SMQs:, Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: UNK
CDC Split Type: B0608630A

Write-up: This case was reported by a healthcare professional and described the occurrence of arthralgia in a 41-year-old female subject who was vaccinated with Cervarix (GlaxoSmithKline). On 26 November 2009 the subject received 1st dose of Cervarix (intramuscular, unknown deltoid) lot number not provided. On 26 November 2009, 1 hour after vaccination with Cervarix, the subject experienced arthralgia and rash (measles-like rash) that worsened each hour. On 27 November 2009 the subject was hospitalized as she could not stand the symptoms. No diagnosis has been yet established. At the time of reporting the events were worse. The healthcare professional considered the events were possibly related to vaccination with Cervarix.


VAERS ID: 372001 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-21
Onset:2009-09-23
   Days after vaccination:2
Submitted: 2009-12-07
   Days after onset:75
Entered: 2009-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Aphonia, Blood immunoglobulin A, Blood immunoglobulin A normal, Blood immunoglobulin G, Blood immunoglobulin M, Blood immunoglobulin M normal, Eosinophil count decreased, Fatigue, Full blood count normal, Laboratory test normal, Liver function test normal, Mononucleosis heterophile test negative, Oropharyngeal pain, Thyroid function test normal
SMQs:, Haematopoietic leukopenia (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No alcohol or tobacco use.
Allergies:
Diagnostic Lab Data: Eosinophils, 0.26; FBC, 08Oct2009, NAD; FBC, 12Nov2009, NAD; IgA, 12Nov2009, NAD; IgG, 12Nov2009, NAD; IgM, 12Nov2009, NAD; Liver function test, 12Nov2009, NAD; Mononucleosis heterophile test, 08Oct2009, NAD; Mononucleosis heterophile test, 12Nov2009, NAD; TFTs, 12Nov2009, NAD; On 12 October 2009 the subject had a camera inserted in to the nasal passage to check the voice box. The test had shown that the larynges and vocal function were perfect.
CDC Split Type: B0598600A

Write-up: This case was reported by a consumer (patient''s father) and described the occurrence of voice loss in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 21 September 2009 the subject received the 1st dose of CERVARIX (1 injection). On 23 September 2009, 2 days after vaccination with CERVARIX, the subject experienced total voice loss and a sore throat and had not been able to speak since. The subject was diagnosed with possible severe viral laryngitis and was recommended to wait 4 to 5 days for it to clear up after which the events had not abated and therefore the subject was treated with antibiotics, which did not have any effect. On 12 October 2009 the subject had a camera inserted in the nasal passage to check the voice box. The test had shown that the larynges and vocal function were perfect. On 15 October 2009 the voice loss and sore throat improved with the subject being able to speak a little but just in a tiny whisper. The outcome of the possible laryngitis was unknown. Verbatim text received: On the 19th October 2009 a member of the public reported that his 14 years old daughter was administered the first dose of CERVARIX vaccine (Batch and expiry not available) on Monday the 21st September 2009. The father reported that his daughter had woken up on Wednesday 23rd September 2009 with a total loss of her voice and sore throat. The girl had not been able to speak since, the father reported. The young girl had gone to her general practitioner who had diagnosed a possible viral severe laryngitis and had not prescribed anything and recommended to wait 4 to 5 days to clear up. The symptoms had not cleared up, so the patient was prescribed some antibiotics that had not done any effect. The father of the patient reported that on Monday 12th October 2009 the general practitioner had made an emergency appointment with the ear, nose and throat specialist who had inserted a camera via nasal passage to check the patient''s function of voice box. The test had shown that larynges and vocal functions were perfect. The father explained that on Thursday 15th October 2009 his daughter had been able to speak a little bit but just a tiny whisper. The patient was healthy and was not taking any other medication at the time of reporting. There was no further information available at the time of reporting. Follow up information received on 06 November 2009: The subject also experienced severe fatigue. The subject had received CERVARIX as part of school immunisation. Follow-up information received on 27 November 2009 from a physician: The subject did not use any alcohol or tobacco. All tests performed were negative. The reporter considered that the events were serious and disabling. At the time of reporting the events were unresolved.


VAERS ID: 372254 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-02
Onset:2009-11-05
   Days after vaccination:3
Submitted: 2009-12-08
   Days after onset:33
Entered: 2009-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Mobility decreased, Physiotherapy, Sensory disturbance, Urinary retention
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Tendinopathies and ligament disorders (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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0609790A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20531102) and described the occurrence of urinary retention in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 2 November 2009 the subject received unspecified dose of CERVARIX (intramuscular). On 5 November 2009, at an unspecified time after vaccination with CERVARIX, the subject experienced urinary retention. The subject was hospitalised. On contacting the hospital, it was specified the subject was transferred to another hospital with some slight altered sensation and mobility. The subject was discharged from the hospital on an unknown date. The subject was still having physiotherapy. The subject''s consultant who treated her considered the events were not associated with CERVARIX. The subject was keen to complete programme. On 16 November 2009, the urinary retention was resolved. Weakness was resolved on an unknown date. The outcome of the events abnormal physical sensation and decreased mobility was unknown. Verbatim Text: Patient given CERVARIX vaccination with no problems at this time. Informed that patient admitted to hospital suffering with urinary retention. On contacting the hospital, it was specified that patient was transferred to another hospital with some slight altered sensation and mobility. Nurse informed us that investigations had been carried out, and that patient was discharged. Still having physiotherapy. Patient stated that consultant who treated her advised it would not be associated with vaccine, and she is still keen to complete programme.


VAERS ID: 372327 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-24
Onset:0000-00-00
Submitted: 2009-12-09
Entered: 2009-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0610140A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20534137) and described the occurrence of convulsion in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included influenza virus vaccine given on an unspecified date. On 24 September 2009 the subject received a single dose of CERVARIX (.5ml, intramuscular). Approximately 10 days after vaccination with CERVARIX, the subject experienced convulsion. The subject was hospitalised. At the time of reporting the event was resolved. The subject was well and back at school. Verbatim Text : Patient had CERVARIX, then a couple of days later had flu vaccine. Then sometime later (about 10 days) suffered convulsion. Was admitted to hospital and is still undergoing investigation. But is well and back at school.


VAERS ID: 372659 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-10
Entered: 2009-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0610446A

Write-up: Encephalitis; This case was reported by the UK regulatory authority (#GB-MHRA-ADR 205321122) and described the occurrence of encephalitis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of Cervarix (intramuscular). At an unspecified time after vaccination with Cervarix, the subject experienced encephalitis. At the time of reporting the event was resolved with the following sequelae. N-methyl-D-aspartate receptor (NMDAR) encephalitis.


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