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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: 382528 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-03
Onset:2010-02-12
   Days after vaccination:9
Submitted: 2010-03-12
   Days after onset:28
Entered: 2010-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sensation in eye, Alanine aminotransferase decreased, Antiphospholipid antibodies negative, Aphasia, Aspartate aminotransferase normal, Basophil count increased, Basophil percentage increased, Blood alkaline phosphatase, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea decreased, C-reactive protein increased, Cerebellar syndrome, Cerebral cyst, Cerebrovascular accident, Coagulation test normal, Creatinine urine decreased, Culture throat negative, Echocardiogram normal, Electroencephalogram normal, Eosinophil percentage increased, Extraocular muscle paresis, Eye pain, Haematocrit normal, Haemoglobin increased, Hemicephalalgia, Hemiparesis, Hyporeflexia, Inappropriate schedule of drug administration, Loss of consciousness, Lymphocyte percentage increased, Migraine with aura, Monocyte count decreased, Muscular weakness, Neutrophil count normal, Neutrophil percentage decreased, Nuclear magnetic resonance imaging, Oedema peripheral, Paraesthesia, Reading disorder, Red blood cell count normal, Rhinitis, Scan brain, Sensation of heaviness, Sensory disturbance, Staphylococcus test negative, Thyroid function test abnormal, Transient ischaemic attack, Treponema test negative, Ultrasound scan normal, Upper respiratory tract infection, Vertigo, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOVYNETTE
Current Illness: Rhythm disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, Feb2010, 0.58; Alkaline phosphatase, Feb2010, 0.86; Antiphospholipid antibodies, Feb2010, see text; Aspartate aminotransferase, Feb2010, 0.36; Basophil percentage, Feb2010, 1.4%; Basophils, Feb2010, 0.12; Brain computerized tomography, 12Feb2010, see text; C-reactive protein, Feb2010, 35.8; Chloride, Feb2010, 103; Coagulation test, Feb2010, see text; Creatinine urine, Feb2010, 74; Echocardiography, Feb2010, see text; Electroencephalogram, Feb2010, normal; Eosinophil percentage, Feb2010, 4.7%; Eosinophils, Feb2010, 0.39; Hematocrit, Feb2010, 0.387; Hemoglobin, Feb2010, 139; Lymphocyte percentage, Feb2010, 43%; Lymphocytes, Feb2010, 3.58; Monocyte percentage, Feb2010, 6.5%; Monocytes, Feb 2010, 0.54; Neutrophil percentage, Feb2010, 44.4%; Neutrophils, Feb2010, 3.7; Nuclear magnetic resonance ima, 13Feb2010, see text; Potassium, Feb2010, 4.13; Red blood cell count, Feb2010, 4.63; Serum glucose, Feb2010, 5.3; Sodium, Feb2010, 140.2; Staphylococcal identification, see text; Syphlis test, Feb2010, negative; Thyroid function test, Feb2010, see text; Ultrasound scan, 12Feb2010, see text; Urea, Feb2010, 3.13; White blood cell count, Feb2010, 8.34
CDC Split Type: B0636672A

Write-up: This case was reported by a physician source (company contact) and described the occurrence of migraine aura in a 29-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). No family history of stroke. No concurrent of previous illness or allergies. Concurrent medications included NOVYNETTE (since 2008) for 1 and a half year before starting the 1st event. On 3 February 2010 the subject received 1st dose of CERVARIX (unknown). On 12 February 2010, 9 days after vaccination with CERVARIX, the subject experienced stroke with hemiparesis of right side of body, ocular weakness, unable to read, unable to speak and headache (left side of head). She was brought to the emergency room and she was treated with infusions and injections (unspecified); within an hour the symptoms resolved. She was hospitalized the same day until 19 February 2010. She was prescribed with ANOPYRIN and AGAPURIN. On 23 February 2010 she experienced a 2nd stroke with the same symptoms on the opposite site of the body and with vertigo and loss of consciousness. Since the she presented prickling of various parts of the body every day. In hospital the subject was diagnosed with chronic rhinitis and she was treated with unspecified medication. NOVYNETTE intake was discontinued at hospital. At the time of reporting the events were unresolved. Follow up received on 03 March 2010 including the hospital report: Subject''s family history included negative thrombotic family history, IM or CVE in the young age, grandfather died in the older age of lung cancer. Subject''s medical history included a healthy woman. She had no previous hospitalization, no traumas, and no surgery. On 03 February she was vaccinated against HPV, she was 2 years using HA-NOVYNETTE for rhythm disorders. She had negative allergic history of drugs, chemicals and food. On 12 February 2010 the subject was urgently admitted at hospital from 12 February 2010 till 19 February 2010. She started feeling pain and pressure behind the left eye that was transformed into uncertain feeling in the right eye; this condition lasted 5 minutes and subsequently she developed paresthesia of the right half of face and right upper extremity; right upper extremity became to be weighty and weak; she had a transient and very short paresthesia of RLE and the right half of trunk. She could not speak at that time, she could hear and understand what her brother told her, but she was not able to answer to him. She could not read neither understands a written text. This condition lasted 5 minutes according to the patient but maybe up to 20 minutes according to her brother and afterwards faded away spontaneously. She had no stability disorders, she reported no nausea. She was exanimated at central admission department with suspected ischemic TIA, laboratory results were in limits. Patient was not sick; she had no fever or infection. She denied any injury. At admission she showed tonus asymmetry and tendoperiosteal reflexes to the disadvantage of right-sided extremities, mild dysmetria of the right, acral edematous infiltration on RUE. Relevant test included brain computerized tomography showing no recent, focal and expansive changes of intracranium, no bleeding, no shift of middle structures. Size of the external and internal liquor spaces is adequate. No hyperdense ACM, aa. vertebrales, a. basilaris. Pyramids airy and without any destructive changes, internal ear canals not widened. Shadows of left maxillary cavity extended to ethmoids with the blood admixture-most probably as the manifestation of acute sinusitis. Conclusion: No recent expansive changes of intracranium. Sinusitis max. I.sin., ethmoidalis acuta. Additional lab test revealed FW 6/20 AST 0.26; 0.36, ALT: 0.45, 0.58, ALP: 0.86, GMT: 0.36, Minerals: Na: 139.4; 140.2 K: 4.06; 4.13, Cl: 103, Serum: GLU: 5.3; 5.2, Creatinin Urea: CREA: 74; 69, UREA: 3.13, Immunological examination: C-reactive protein: 3.73; 5.2; 35.8, Thyroidal diagnostics: FT4e: 15.8, TSHe: 0.42, Blood count: white blood cell count: 8.34; 4.32, neutrophils: 3.7; 2.29, lymphocytes: 3.58; 1.7, monocytes: 0.54; 0.26, eosinophils: 0.39; 0.08, basophils: 0.12; 0, Neutrophils percentage: 44.4; 53, Lymphocytes percentage: 43; 39.3, Monocytes percentage: 6.5; 6, Eosinophils percentage: 4.7; 1.8, Basophils percentage: 1.4; 0, Red blood cell count: 4.63; 4.32, hemoglobine: 139; 131, hematocrite: 0.387; 0.365, mean corpuscular volume: 83.4; 84.5, MCH: 30; 30.2, MCHC: 359; 358, RDW: 11.2; 11.1, PLT: 276; 204, PDW: 15.9; 14.8, MPV: 8; 8.1, Coagulation analyse showed PT percentage: 102.9; 110.1, INR: 0.97; 0.92, APTT: 26.9; 29, APTR: 0.8; 0.88, TT: 17.1, FBG: 2.6; 2.9, DD: 60; 116, AIII: 85.6, TRK: 204, Syphilis: TPPA: negative, RRR: negative; without functional group: B12: 151, KLIS: 12.6, HCYp: 11.93, ASLO: 62.8, RNFE: negative. The evaluation showed. Haemocoagulation parameters within normal limits, this time without activation of IVZ. It was recommend to complete differential diagnosis of thrombophilia including DNAn diagnostics and to exclude the using of contraception. Thorax PA performed on 12 February 2010 showed without recent and focal changes in lungs, adequate hilar structure, domed diaphragm, angles free, heart of adequate size and shape PND Rtg: sinusitis maxilaris bilat. - more to the left, frontally adequately developed, airy. ORL examination showed deviation septi nasi ad. I.dx, rhinosinusitis chronica vs vasomotoric. It was recommended. Immunoallergological examination. Ultrasonography of afferent brain vessels showed B image: well visible courses and intervals of ACC, ACE and ACI bilat. No stenotic changes. Aa. vertabrales-I.dx (0.32 cm), AV I.sin (0.29 cm). Doppler average flow rates in all examined vessels including vertebral bed. Z: Asymmetry a. vertebrales, hypoplasia on the edge (vs within limits of physiological variation), otherwise normal finding. Antiphospholip. autoAb: ACLG: 1.45, ACLM: 1.17, APTG: 1.92, APTM: 2.16, B2GG: 1.94, B2GM: 1.87, Undefined class: GanglioGM1 IgG negat., GanglioGD1b IgG negat., GanglioGQ1b IgG negat., GanglioGM1 IgM negat., GanglioGD1b IgM negat., GanglioGQ1b IgM negat. Nasal swab: Finding: Staphylococcus sp. - coagulase negative. Transthoraxic echocardiography: Routine image of heart suggests against organic malformation. If the suspected embolisation of CNS persists, it would be recommendable to add the TEE examination. Electroencephalogram: Basic activity in the record over the posterior quadrants is represented by symmetrical, adequately configuration alpha rhythm with the frequency of approximately 11.5 Hz, ampl. 20 - 30 uV, without any side asymmetry. Rz well expressed, the flat beta-alpha activity prevails over right quadrants, non-rhythmic, HV and FS intervals did not change the record. Conclusion: Normal finding. Brain magnetic resonance imaging performed on 13 February 2010 showed, tra tse T2, tra Flair, tra tse T1, DVO, 3D TOF, 2D PC sinuses, after contrast medium 3D T1 f1. In the brain tissue supratentorially and infratentorially without any focal changes. Signal intensity of the white and grey matter was adequate. In DWI no manifestations of acute ischemic changes in the brain - no restriction of brain proton diffusion. Venous sinuses without any pathological signal, in 2D PC flow signal recorded with no manifestations of thrombosis. Postcontrastly in 3D F1 T1 sequention with homogenous lumen opacification of venous sinuses, no thrombosis. In 3D TOF adequate flow signal in brain arteries recorded, with no vascular malformation, without any more pronounced segmental stenosis and with present developmental hypoplasia of the left vertebral artery that was thinner. Postcontrastly without any pathological enhancement in intracranium. Oval 12 x 8 mm cyst in the pineal area. Ventricular system and subarachnoidal spaces have the adequate size and configuration. No shifts of middle line structures. CC junction is spacious, free. Pyramids without disturbance of airiness of pneumatic system. In the maxillary cavities and ethmoidal cellules parietal irregularly thickened mucosa almost with obliteration of ethmoidal cellules and in the left maxillary cavity centrally pathological content with hypointensive signal in T2VO and Flair, with hyperintensive signal in T1VO - staining in blood, with inflammatory changes. Conclusion: Without any acute ischaemic changes in the brain, without any manifestations of expansion in the intracranium. No evidence of venous thrombosis. No vascular malformation by MRAg. Sinusitis maxillaris, ethmoidalis. According to the reporter and in the absence of other risk factors in ischemic cerebrovascular event /the only potential risk factor was the use of hormonal contraceptives. The subject was treated with Saline solution + LUCETAM + AGAPURIN, Saline solution + Magnesium + MESOCAIN, FRAXIPARINE 0.3 mL, ANOPYRIN 100 mg, AMOXIKLAV, AGAPURIN. The subject was released to the outpatient care in stabilised condition with the following recommendation: antimicrobial therapy for the patient due to the infection of upper respiratory tract with the mild increase of inflammatory parameters, discontinuing the hormonal contraception; AMOXICLAV 625 mg every 12 hours up to 10 days, AGAPURIN ret 2 x 1 tbl, 1 tbl of ANOPYRIN 100 mg in the morning; adequate hydration; control visit in the ORL and immunological outpatient department and checking of inflammatory parameters in the district after the last dose of antimicrobial therapy. Add the complex eye examination (eye ground, perimeter, IOP). At the time of reporting the results of DNA thrombophilic condition examination were not yet available. The subject was diagnosed with complicated migraine with aura. Sinusitis maxillaris and ethmoidalis chronica, vs vasomotorica.


VAERS ID: 382969 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-01
Onset:0000-00-00
Submitted: 2010-03-18
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Dysphagia, Dyspnoea, Quadriplegia
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: B0639600A

Write-up: This case was reported by a regulatory authority and described the occurrence of tetraparesis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In February 2010, the subject received unspecified dose of CERVARIX (unknown route of administration, unknown injection site, lot number not provided). In 2010, less than one year after vaccination with CERVARIX, the subject experienced tetraparesis, dyspnea and problems with deglutition. The subject was hospitalised. At the time of reporting the events were improved.


VAERS ID: 382971 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-09
Onset:2009-10-29
   Days after vaccination:20
Submitted: 2010-03-18
   Days after onset:140
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA050AG / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Basophil percentage decreased, Blood smear test abnormal, Death, Eosinophil percentage, Haemoglobin decreased, Headache, Lymphocyte percentage, Malaria, Monocyte percentage decreased, Neutrophil percentage increased, Pyrexia, White blood cell count increased
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-30
   Days after onset: 1
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: Basophils, 30Oct2009, 0%; Blood smear test, 30Oct2009, Positive; Eosinophils, 30Oct2009, 1%; Hemoglobin, 30Oct2009, 4g/dl; Lymphocytes, 30Oct2009, 28%; Monocytes, 30Oct2009, 0%; Neutrophils, 30Oct2009, 71%; White blood cell count, 30Oct2009, 46200/mm3
CDC Split Type: B0639818A

Write-up: This case was reported by a healthcare professional and described the occurrence of malaria in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; left deltoid given on 2 September 2009. On 9 October 2009, the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). No adverse event was reported during the observation period of 30 minutes after each dose of CERVARIX. The subject migrated to another village with her parents. She was in good condition and doing well. On 29 October 2009, 1 month after vaccination with the 2nd dose of CERVARIX, the subject experienced severe headache and fever. She visited a private local clinic for treatment as an outdoor patient. The subject was given an injection of an unspecified drug in the right upper arm by the physician. Malaria was suspected and a blood test was prescribed. Unspecified medication was also provided by the physician. On 30 October 2009, the subject was brought to the hospital in critical condition. The laboratory test on blood showed low hemoglobin level 4g/dl which is only 27.58% of a normal level, white blood cells 46200/mm3 with 71% neutrophils, 28% lymphocytes, 1% eosinophils, 0% monocytes and 0% basophils. The thin and thick blood smear analysis revealed many rings of trophozoites and schizont of plasmodium Vivax. The diagnosis of malaria was made. The subject was sent to the community health center where a treatment was started. Around 1 hour later, the subject was declared dead. The subject died on 30 October 2009 from malaria. An autopsy was not performed.


VAERS ID: 382975 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-26
Onset:2009-10-26
   Days after vaccination:0
Submitted: 2010-03-18
   Days after onset:143
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA020BF / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular 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:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: B0640328A

Write-up: This case was reported by a regulatory authority (# ES-AGEMED-414994443) and described the occurrence of muscle weakness in a 14 year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 October 2009, the subject received 2nd dose of CERVARIX (administration site and route unknown). On 26 October 2009, less than one day after vaccination with CERVARIX, the subject experienced muscle weakness, headache and dizziness. The regulatory authority reported that the events were disabling. The patient was sent to the Emergency Room. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.


VAERS ID: 383382 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-02
Onset:2010-03-02
   Days after vaccination:0
Submitted: 2010-03-23
   Days after onset:20
Entered: 2010-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA011BP / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Electroneurography, Local reaction, Mobility decreased, Neuropathy peripheral, Oedema, Pain, Paraesthesia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, 06Mar2010, normal; Electroneurography, 06Mar2010, normal
CDC Split Type: B0641008A

Write-up: This case was reported by a regulatory authority (#113465) and described the occurrence of neuropathy in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 2 March 2010, the subject received an unspecified dose of CERVARIX (intramuscular, administration site unknown). On 2 March 2010, 6 hours after vaccination with CERVARIX, the subject experienced pain, paresthesia, edema and impaired arm mobility (impaired at left arm). The diagnosis was local reaction with neuropathy. The subject was hospitalised from 6 to 12 March 2010. The subject was treated with Bentelan, lasonil, Prednisone, Zithromax, Augmentin and Tachipirina. Blood tests and elelctroneurography were normal. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.


VAERS ID: 383764 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-23
Onset:2009-11-23
   Days after vaccination:0
Submitted: 2010-03-29
   Days after onset:125
Entered: 2010-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA057BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0641837A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20588782) and described the occurrence of swelling of face in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 November 2009 the subject received a single dose of CERVARIX (intramuscular, batch number: AHPVA057BA). On the same day, at an unspecified time after vaccination with CERVARIX, the subject experienced swelling of face and was feeling unwell. The regulatory authority reported that the events were life threatening. At the time of reporting the events were resolved.


VAERS ID: 383923 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-31
Entered: 2010-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Genital herpes, Poor quality drug administered, Vaginal infection, Vulvovaginal mycotic infection, Vulvovaginal pruritus
SMQs:, Medication errors (broad), Opportunistic infections (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0066982A

Write-up: This case was reported by a consumer''s mother and described the occurrence of female genital warts in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject was virginal. On an unspecified date the subject received unspecified dose of CERVARIX (unknown route and application site). 24 hours after vaccination with CERVARIX, the subject experienced itching in vaginal area and detected little lobes at labium. Afterwards, vaginal bacterial infection was diagnosed by gynaecologist, later additionally a vulvovaginal mycotic infection. After three weeks of unsuccessful treatment, the subject was hospitalised for 5 days. In hospital the subject was treated against female genital warts and genital herpes. The consumer''s mother reported, that physician supposed vaccination damage. At the time of reporting, the events had not improved, for eight months.


VAERS ID: 383926 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-02
Onset:2010-03-02
   Days after vaccination:0
Submitted: 2010-03-31
   Days after onset:28
Entered: 2010-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Electromyogram normal, Injected limb mobility decreased, Laboratory test normal, Oedema peripheral, Pain in extremity, Paresis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (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: Electromyogram, 07Mar2010, normal; Laboratory test, 07Mar2010, negative
CDC Split Type: B0643671A

Write-up: This case was reported by a physician and described the occurrence of left arm paresis in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 2 March 2010, the subject received an unspecified dose of CERVARIX (route unknown, left arm, batch number not provided). On 2 March 2010, less than one day after vaccination with CERVARIX, the subject experienced left arm paresis, pain in left arm, edema left arm and injected limb mobility decreased. The subject was hospitalised on 7 March 2010. Lab tests were negative, electromyogram was normal. The subject was treated with cortisone and antibiotics. At the time of reporting, left arm paresis was unresolved, oedema was resolved. The outcome of the other events were unspecified. As no additional information could be obtained, the case has been closed on 31 March 2010.


VAERS ID: 384026 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-15
Onset:2009-09-15
   Days after vaccination:0
Submitted: 2010-04-01
   Days after onset:198
Entered: 2010-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA025BB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Paraesthesia oral, Pruritus, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), 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: B0643283A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20594272) and described the occurrence of itchy skin in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 15 September 2009 the subject received a single dose of CERVARIX (.5, intramuscular, AHPVA025BB). On the same day, at an unspecified time after vaccination with CERVARIX, the subject experienced itchy skin, hive, tingling of lip, itchy throat and was unwell. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved.


VAERS ID: 384028 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-05
Onset:2009-03-08
   Days after vaccination:3
Submitted: 2010-04-01
   Days after onset:388
Entered: 2010-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA059BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Confusional state, Convulsion, Dizziness, Headache, Migraine with aura, Speech disorder, Urinary incontinence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: dizziness; headache; speech disorder
Preexisting Conditions: Brain damage from car accident
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0565153A

Write-up: This case was reported by a regulatory authority (# NL-LRB-85240) and described the occurrence of migraine with aura in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included non-congenital brain damage. Concomitant medication was not reported. On 5 March 2009, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. On 8 March 2009, 3 days after vaccination with CERVARIX, the subject experienced convulsion, speech disorder, dizziness and headache. The subject was hospitalised. The subject was treated with paracetamol. At the time of reporting the events were improved. Follow up information received on 28 July 2009: Lot number was provided. The subject was hospitalised on 8 March 2009. The regulatory authority considered the events were unlikely to be related to vaccination with CERVARIX. Follow up information received on 30 July 2009: The non-congenital brain damage was due to car accident. The subject experienced headache on the day of vaccination and 3 days later, dizziness and afebrile convulsion. She was hospitalised due to headache, confusion and urinary incontinence in bed (once). At the time of reporting, the events were resolved. Follow up information received on 25 March 2010: Concurrent medical conditions included 2 similar episodes of dizziness, headache and speech disorder the year before. The final diagnosis was migraine with aura. At the time of reporting the events were unresolved. No further information could be obtained from the regulatory authority; therefore the case has been closed.


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