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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: 378738 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-02
Onset:2009-08-01
   Days after vaccination:60
Submitted: 2010-01-28
   Days after onset:180
Entered: 2010-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA009DE / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Activities of daily living impaired, Amenorrhoea, Apathy, Aphasia, Blood follicle stimulating hormone increased, Blood luteinising hormone normal, Blood pH decreased, Blood prolactin normal, Blood testosterone decreased, Blood thyroid stimulating hormone normal, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, Electroencephalogram normal, Fatigue, Fear of pregnancy, Mean cell haemoglobin concentration normal, Mental disorder, Nuclear magnetic resonance imaging normal, Oestradiol normal, Pregnancy test negative, Premenstrual syndrome, Sleep disorder, Thyroxine free normal, Tri-iodothyronine free normal, Ultrasound scan normal, Urine analysis normal
SMQs:, Lactic acidosis (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), Respiratory failure (broad), Sexual dysfunction (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: Birth control
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Borrelia burgdorferi immunoglo, below 6U per ml, 25Nov2009; Borrelia burgdorferi immunoglo, below 1.0, 25Nov2009; Estradiol, 35pg per ml, 27Nov2009; Follicle stimulating hormone, 6.3IU per ml, 27Nov2009; Free T3, 3.7pg per ml, 25Nov2009; Free T4, 1.3mg per dl, 25Nov2009; Luteinising hormone normal, 5.8mIU per ml, 27Nov2009; MCHC, 32g per dl, 27Nov2009; Pregnancy test, negative, 19Nov2009; Prolactin, 4.6mcg per 1, 27Nov2009; Thyroid stimulating hormone, 2.65mcU per ml, 25Nov2009; EEG and MRT of cranium without pathological findings; Borrelia antibodies (IgG-Immunoblot), negative, 25 November 2009; Borrelia antibodies (IgM-Immunoblot), negative, 25 November 2009; gynecological without complaints, last menstrual period on 01 August 2009, cycles were irregular, menarche was in January 2009; gynaecological: tanner was 5, some androgynous hairiness; native: pH was 4, no infection; deoderlein flora degree of hormones 3-2; sonography: bladder filled, uterus existant, endometrium delicate, adnexe inconspicuous on both sides; mammae on both sides inconspicuous, axillae and areas of lymph free on both sides, tanner 5
CDC Split Type: D0066005A

Write-up: This case was reported by a physician and described the occurrence of premenstrual syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (Glaxosmithkline). On an unspecified date the subject received 2nd dose of CERVARIX (unknown route and application site). Approximately one month after vaccination with CERVARIX, the subject experienced premenstrual syndrome. At the time of reporting the outcome of the event was unspecified. Follow up information was received on 21 January 2010 from the reporting physician including physician''s report, report from a gynecologist and two laboratory test results. Previous vaccination included human papilloma type vaccine (Glaxosmithkline, intramuscular, left deltoid) given on 16 April 2009. Following vaccination included human papilloma vaccine (Glaxosmithkline, intramuscular, left deltoid) given on 6 November 2009. On 2 June 2009 the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). On holiday in August 2009, 2 months after vaccination with 2nd dose of CERVARIX, the subject firstly showed unusual psychic behaviour. Back at home the subject was increasingly apathetic, tired, did not talk, was constantly in bed, did not visit school and showed sleep disorder. The subject was admitted to psychiatric hospital. Because of cyclic appearance of the symptoms in relationship to menstrual period premenstrual syndrome was diagnosed. At the time of reporting the subject was treated ambulatory with psychiatric therapy and antidepressant. The physician considered that premenstrual syndrome was unlikely related to vaccination with CERVARIX. At the time of reporting on 13 January 2010 premenstrual syndrome was improved. On 19 November 2009 the subject went to see the gynecologist. The gynaecologist diagnosed secondary amenorrhea, psychic disorder and fear of pregnancy. The subject received contraceptive. The subject experienced 10-11 days psychosomatic dropouts and is gynaecologically free of complaints. The subject was treated with vitex agnus castus. Pregnancy test was negative. No further information will be available.


VAERS ID: 378994 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-01
Onset:2009-09-01
   Days after vaccination:0
Submitted: 2010-02-01
   Days after onset:153
Entered: 2010-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Laboratory test normal, Myalgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Presyncope, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance ima, 09Oct2009, normal; 9/10/09: MRI brain + IAMS - normal
CDC Split Type: B0609764A

Write-up: This case was reported by a physician and described the occurrence of chronic fatigue in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of CERVARIX (1 injection, unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced chronic fatigue. At the time of reporting the outcome of the event was unknown. Verbatim text received: On the 30th November 2009 a hospital doctor reported that a female patient had developed chronic fatigue after the administration of CERVARIX (Unknown whether course had been completed). There was no further information available at the time of reporting. Follow-up information received on 25 January 2010 via the physician: This case was reported by a physician and described the occurrence of chronic fatigue in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The patient was previously fit and well. On an unknown date in September 2009, the subject received a single dose of CERVARIX (1 injection, intramuscular). Immediately after vaccination with CERVARIX, the subject experienced chronic fatigue, presyncope, myalgia, vertigo and headache. The physician considered the events were disabling. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with CERVARIX.


VAERS ID: 378998 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-11
Onset:2008-07-16
   Days after vaccination:5
Submitted: 2010-02-01
   Days after onset:565
Entered: 2010-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA014C1 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood amylase normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood fibrinogen normal, Blood glucose normal, Blood iron normal, Blood lactate dehydrogenase normal, Blood test normal, Blood urea normal, Electrocardiogram normal, Erythema, Henoch-Schonlein purpura, Mobility decreased, Oedema peripheral, Pain, Polymerase chain reaction, Protein total normal, Rash, Serum ferritin normal, Skin lesion, Urine analysis normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Activated partial thromboplast, 2008, Normal; Alanine aminotransferase, 2008, Normal; Amylase, 2008, Normal; Aspartate aminotransferase, 2008, Normal; Blood glucose, 2008, Normal; Blood test, 2008, Normal; Blood urea nitrogen, 2008, Normal; Creatine phosphokinase, 2008, Normal; Creatinine, 2008, Normal; Electrocardiogram, 2008, Normal; Fibrinogen, 2008, Normal; Iron, 2008, Normal; Lactate dehydrogenase, 2008, Normal; Polymerase chain reaction, 2008, Normal; Protein total, 2008, Normal; Prothrombin time, 2008, Normal; Serum ferritin, 2008, Normal; Urine analysis, 2008, Normal
CDC Split Type: B0537342A

Write-up: This case was reported by a physician and described the occurrence of Henoch-Schonlein purpura in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 11 July 2008, the subject received the 1st dose of CERVARIX (unknown route of administration, lot number not provided). On 16 July 2008, 5 days after vaccination with the 1st dose of CERVARIX, the subject experienced red patches at both lower limbs, followed by oedema at feet and ankles. The subject was hospitalised on 20 July 2008 and diagnosis of Henoch-Schonlein vasculitis was made. Results of laboratory tests were negative. The subject was discharged on 26 July 2008 in good clinical conditions. On 26 July 2008, the events were resolved. The vaccination course with CERVARIX was discontinued. The physician considered the events were possibly related to vaccination with CERVARIX. Further information has been requested but could not be obtained; this case has therefore been closed. Follow up information received on 25 January 2010: Case B0538387A has been identified as duplicate of this case and has therefore been voided. Case B0538387A was reported by a regulatory authority (# 89490). The subject had no relevant medical history and no concomitant medication. On 11 July 2008, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). On 16 July 2008, 5 days after vaccination with CERVARIX, the subject experienced vasculitic skin lesions on lower limbs, painful swelling of ankles. The subject was hospitalised on 20 July 2008 and Henoch-Schonlein purpura was diagnosed. The subject was discharged on 26 July 2008. On 14 August 2008, 34 days after vaccination with the 1st dose of CERVARIX, the subject experienced a relapse of Henoch-Schonlein Purpura. The subject was hospitalised. The laboratory tests performed during the hospitalisation showed normal blood tests, PT, APTT, fibrinogen, PCR, blood glucose, blood nitrogen, creatinine, iron, ferritin, CPK, LDH, AST, ALT, amylase, total protein, ECG. Urine analysis and pharyngeal swab culture were negative. The subject was treated with NUREFLEX. At the time of reporting, Henoch-Schonlein purpura was resolved with the following sequelae: bilateral painful swelling of ankle and decreased mobility. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. No additional information has been received, the case has been closed.


VAERS ID: 379779 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-09
Onset:2009-11-19
   Days after vaccination:10
Submitted: 2010-02-08
   Days after onset:81
Entered: 2010-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA056BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Blood electrolytes normal, Blood urea normal, Full blood count normal, Headache, Liver function test normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity, Red blood cell sedimentation rate normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: No allergies, no relevant previous medical history.
Allergies:
Diagnostic Lab Data: Blood electrolytes, normal; Erythrocyte sedimentation rate, normal; Full blood count, normal; Liver function tests, normal; Nuclear magnetic resonance imaging, normal; Urea, normal
CDC Split Type: B0629813A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 20558902) and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 9 November 2009 the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular, batch number AHPVA056BA). On 19 November 2009, 10 days after vaccination with CERVARIX, the subject experienced headache, back pain and muscle weakness in the lower limbs. The subject was hospitalised three times. MRI scans to the head and spine as well as blood tests were all normal. At the time of reporting the events were improved but the subject still had occasional pain in the left leg. MHRA Verbatim Text: CERVARIX administered, symptoms started 10 days later and has required x3 admissions to hospital. The consultant in charge has stated that if the symptoms were associated with the vaccine then she would consider the reaction to be serious but if unrelated to be not serious. The patient has been investigated with MRI scans to head and spine (normal) and blood tests including FBC, U+E, LFT and ESR which were all normal. Is recovering but still has occasional pain in left leg.


VAERS ID: 379897 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-17
Onset:2009-11-01
   Days after vaccination:45
Submitted: 2010-02-09
   Days after onset:100
Entered: 2010-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA049AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aplastic anaemia, Biopsy bone marrow, Blood product transfusion dependent, Contusion, Laboratory test, Neutropenia, Neutrophil count decreased, Sepsis
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oral contraceptive
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Bone marrow examination, 01Dec2009, anemia; Neutrophils, below 2.0
CDC Split Type: B0629812A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 20559011) and described the occurrence of aplastic anemia in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medications included the oral contraceptive. On 17 September 2009 and 23 October 2009 the subject received unspecified doses of CERVARIX (intramuscular, batch numbers AHPVA049AA and AHPVA048AK). On 1 November 2009, after vaccination with CERVARIX, the subject experienced severe aplastic anemia. The onset of the event was not very clear cut, easy bruising was noticed initially. The subject was also severely neutropenic and at risk of life threatening sepsis. The subject was hospitalised and the regulatory authority reported that the events were life threatening. Diagnosis was confirmed by bone marrow assessment and additional full screening. At the time of reporting the events were unresolved. The subject was transfusion dependent and will undergo either a bone marrow transplant or immunotherapy. Verbatim Text: The onset of the very severe aplastic anaemia is not clear cut-easy bruising noticed at first. The diagnosis was confirmed by bone marrow assessment and additional full screening as per guidelines for aplastic anaemia. No cause has been identified for the aplastic anaemia. Patient is transfusion dependent (blood and platelets) and will undergo either bone marrow transplant or immunotherapy (both prolonged hospitalisation with associated morbidity/mortality). Patient is severely neutropaenic and at risk of life threatening sepsis. Remains very severe and undergoing tissue typing for bone marrow transplant.


VAERS ID: 379968 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-26
Onset:2010-01-26
   Days after vaccination:0
Submitted: 2010-02-10
   Days after onset:15
Entered: 2010-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA062AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Rash
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Patient was given first vaccination of the HPV Programme on the 9/12/09.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0631095A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20561806) and described the occurrence of rash in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The patient was given first vaccination of HPV on 9 December 2009. On 26 January 2010 the subject received a single dose of CERVARIX (.5 ml, intramuscular, batch number: AHPVA062AA). On the same day, at an unspecified time after vaccination with CERVARIX, the subject developed a rash and had difficulty breathing. The subject was taken to the Accident and emergency department. The regulatory authority reported that the events were life threatening. Appropriate first aid was given by school (adrenalin and oxygen). At the time of reporting the events were improved. Patient was taken to Accident and Emergency (A&E) department after vaccination with rash and breathing difficulties, appropriate first aid given by school (adrenalin and oxygen).


VAERS ID: 380066 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-01
Onset:2009-10-04
   Days after vaccination:3
Submitted: 2010-02-11
   Days after onset:130
Entered: 2010-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Pulmonary artery thrombosis, Thrombophlebitis
SMQs:, Interstitial lung disease (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Heparin; detralex; (aesculus + diosmin + bioflavonoids); warfarin sodium; calcium channel blocker; birth control
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0631714A

Write-up: This case was reported by a physician and described the occurrence of pulmonary artery thrombosis in a 23-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medications included Heparin, Detralex, Warfarin, Calcium channel blocker and Birth control (Contraceptive). After the 1st dose the subject was smooth. On 1 October 2009 the subject received 2nd dose of CERVARIX (unknown), lot number not provided. On 4 October 2009, 3 days after vaccination with CERVARIX, the subject experienced pulmonary artery thromboembolism (both a pulmonalis), acute thrombophlebitis of left leg and shock lung. The subject was hospitalised for 16 days and the physician considered the events were life threatening. On 19 October 2009, the events were resolved. The subject refused to get the 3rd dose. The physician considered the events were almost certainly related to vaccination with CERVARIX.


VAERS ID: 380070 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-11
Entered: 2010-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Arthralgia, Burning sensation, Depression, Fatigue, Feeling hot, Hyperhidrosis, Hypoaesthesia, Vaccine positive rechallenge
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Hypoglycaemia (broad), Sexual dysfunction (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: B0630287A

Write-up: This case was reported by a consumer via a GSK employee and described the occurrence of burning sensation in a 32-year-old female subject who was vaccinated with CERVARIX. A physician or other health care professional has not verified this report. On an unspecified date, the subject received 1st dose of CERVARIX (unknown route and injection site), lot number not provided. At an unspecified time after vaccination with CERVARIX, the subject experienced burning sensation, hot sweats and joint pain. The events resolved. After the next vaccination with CERVARIX the events recurred. One month after vaccination with the 1st dose of CERVARIX, the subject received the 2nd dose of CERVARIX (unknown route and injection site), lot number not provided. At an unspecified time after vaccination with 2nd dose of CERVARIX, the previous events recurred with in addition anxiety. The subject was hospitalised. At the time of reporting, the subject had depression, fatigue and numbness in arms. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 380530 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-18
Onset:2010-01-18
   Days after vaccination:0
Submitted: 2010-02-16
   Days after onset:29
Entered: 2010-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA079CA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: B0632785A

Write-up: This case was reported by a physician and described the occurrence of injection site pain in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 18 January 2010, the subject received 1st dose of CERVARIX (intramuscular, left deltoid). On 18 January 2010, 2 hours after vaccination with CERVARIX, the subject experienced injection site pain and injected limb mobility decreased. She could not get her arm up. The physician considered the events were disabling and clinically significant (or requiring intervention). On 25 January 2010, the mobility of her arm was half resolved. On 1 February 2010, the decreased mobility remained in the morning. The subject was referred to an orthopedist. At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with CERVARIX. No further information can be obtained; additional information will be sent in a proactive way. The case has been closed.


VAERS ID: 380881 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-01
Onset:0000-00-00
Submitted: 2010-02-19
Entered: 2010-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA060DC / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Local reaction, Oedema peripheral, Pain, Paraesthesia, Skin discolouration
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0633634A

Write-up: This case was reported by a physician and described the occurrence of local reaction after vaccination in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 February 2010, the subject received 1st dose of CERVARIX (intramuscular, unknown limb). In February 2010, 16 hours after vaccination with CERVARIX, the subject experienced limb edema with painful movement, tingling in fingers and skin discoloration with the skin of limb colored to violet. The subject was hospitalised for 2 days. At hospital, the subject was under observation and the diagnosis of local reaction after vaccination was made. The subject was treated with symptomatic therapy. The events were resolved after 24 hours and the subject was discharged from hospital. At the time of reporting the subject had fully recovered.


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