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Found 24 cases where Vaccine is HPV2 and Patient Died and Submission Date on/before '2015-12-31'

Case Details

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VAERS ID: 475457 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-20
Onset:2011-10-14
   Days after vaccination:147
Submitted: 2012-11-27
   Days after onset:410
Entered: 2012-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / UN
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Anomaly of external ear congenital, Biopsy, Death neonatal, Foetal exposure timing unspecified, Limb malformation, Multiple congenital abnormalities, Oligohydramnios, Premature baby, Skeletal dysplasia, Skin exfoliation, Skin oedema
SMQs:, Severe cutaneous adverse reactions (broad), Angioedema (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Iron salt; Indomethacin; Ampicillin trihydrate; Dinoprost trometamol; Intravenous fluids; Oxytocin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy, 17Oct2011, see lab text; Fetal heart rate, 13Oct2011, 161 per minute; Fetal heart rate, 13Oct2011, 151 per minute; Sonogram, 14Oct2011, see lab text 14 October 2011: She had a sonogram performed which showed: alive baby, dimorphic with the following findings: A) cephalic baby with a cephalic circumference that remembers the image of a strawberry, with a extremely thin bone table, with a mean gestational age of 26 weeks and with an important skin edema above the skull. At central nervous system as a single finding is observed a decreased differentiation of wrinkles. B) Heart exam: atrial rhythm 156 per minute (min), ventricular rhythm 143 min, arrhythmic, it seems to have a disorder due to an atrioventricular node block. Structurally is a heart of 4 chambers with AV and VA concordance, outflow tracts without obstructions and normal aortic arch are observed. C) seems to have a narrow chest with a circumpherence of 12 cm with levocardia. Diaphragm intact. No pleural or pericardic effusion. D) Important ascytic with intestine with echogenic internal areas, liver with echogenic areas or points, at the examination of the venous ductus is noted a "a" negative wave. Spinal cord closed without defects at lumbar or sacral levels. Kidneys of normal aspect. In upper as well as in lower limbs important macromelia. In distal as well as in proximal segments rizomelia and mesomelia. Is not possible the analysis of hands and face due to an important oligohydramnios. Diagnostic impression: 1) considering the findings of narrow chest and macromelia, with a convex forehead and a not oval skull the most probable diagnosis is a thanatophoric dysplasia, 2) severe oligohydramnios, 3) growth of 26 weeks by cephalic circumpherence, 4) abdominal circumpherence and longitudinal femoral are not valid. 17 October 2011: Biopsy 11-9099. Specimen: placental remains. Diagnosis: decidua. 17 October 2011: Biopsy 11-9134. Specimen: fetus. Diagnosis female fetus of approximately 21 weeks of gestational age, multiple external malformations, 400g, 26 cm, of macerated aspect, slough skin with low set ears, ogival palate, short limbs.
CDC Split Type: A0933003B

Write-up: This female subject was enrolled in the study sponsored by the National Cancer Institute (NCI). On 20 May 2011, the subject received the 1st dose of CERVARIX and ENGERIX B in her right deltoid. The serious adverse event described below was not experienced by a study subject but her offspring. The study subject or mother was exposed to CERVARIX and ENGERIX B before conception. The mother took concomitant medications iron, folic acid, PROSTIN, oxytocin, iron, indomethacin, IV fluids, folic acid and ampicillin during her pregnancy. The mother had the following relevant medical conditions: SAE of therapeutic miscarriage (see case A0933003A for more details). On 14 October 2011, five months after the mother (subject) took the 1st dose of CERVARIX and the 1st dose of ENGERIX B, the subject''s fetus was diagnosed with multiple congenital malformations. The event was a congenital anomaly, clinically significant (or requiring intervention) and resulted in a fatal outcome. Due to the multiple congenital anomalies elective termination of pregnancy was decided on 17 October 2011. The investigator reported the multiple congenital malformations as possibly related to CERVARIX and ENGERIX B given the short time that elapsed between the last done of the vaccine and the last menstrual period (LMP). Investigator comments: Last menstrual period (LMP): 23 May 2011, total of seven pregnancies, five deliveries and one previous miscarriage. The subject (mother) used oral contraception before becoming pregnant. She only attended one prenatal care appointment. On 16 November 2011, the subject reported by phone that on 14 October 2011 she was hospitalized due to threatened preterm delivery (see serious adverse event number 60411). On 17 October 2011, when she was 21 weeks of gestational age she had induced a vaginal delivery and she gave birth to a preterm female newborn, weight 400 grams, length 23.5 centimeters, Apgar score unknown, who died some minutes after delivery. The medical chart will be reviewed as soon as possible. Diagnosis: prematurity. Investigator comments received on 22 November 2012: To follow up the serious adverse event 60446, with diagnosis of prematurity, on 21 November 2012 the medical chart was reviewed in a local hospital and the following was found: 13 October 20121: Referred from a primary care center to the emergency room (ER): gestational age: 20 weeks, with history of abundant vaginal bleeding. Physical examination: Normal BP, without fever, pelvic exam: 1 cm of dilation, vaginal bleeding (negative), hydrorrhea (positive), fetal heart rate: 161 per minute (min), fetal movements (positive). Diagnostic impression: threatened miscarriage. At the ER: delayed miscarriage. Pelvic exam: 1 cm of dilation, mild vaginal bleeding, fetal heart rate: 151 min. Plan: admission, ward routine, Indomethacin. Diagnosis of admission: delayed threatened miscarriage. 14 October 2011: She had a sonogram performed which showed: alive baby, dimorphic with the following findings: A) cephalic baby with a cephalic circumference that remembers the image of a strawberry, with a extremely this bone table, with a mean gestational age of weeks and with an important skin edema above the skull. At central nervous system as a single finding is observed a decreased differentiation of wrinkles. B) Heart exam: atrial rhythm 156 min, ventricular rhythm 143 min, arrhythmic, it seems to have a disorder due to an atrioventricular node block. Structurally is a heart of 4 chambers with AV and VA concordance, outflow tracts without obstructions and normal aortic arch are observed. C) seems to have a narrow chest with a circumference of 12 cm with levocardia. Diaphragm intact. No pleural or pericardic effusion. D) Important ascytis with intestine with echogenic internal areas, liver with echogenic areas or points, at the examination of the venous ductus is noted "a" negative wave. Spinal cord closed without defects at lumbar or sacral levels. Kidneys of normal aspect. In upper as well as in lower limbs important macromelia. In distal as well as in proximal segments rizomelia and mesomelia. Is not possible the analysis of hands and face due to an important oligohydramnios. Diagnostic impression: 1) considering the findings of narrow chest and macromelia, with a convex forehead and a not oval skull the most probable diagnosis is a thanatophoric dysplasia, 2) severe oligohydramnios, 3) growth of 26 weeks by cephalic circumference, 4) abdominal circumference and longitudinal femoral are not valid. Plan: the progress is explained to the patient, sterile clothe, lab tests. 15 October 2011: Is indicated: temperature measurement curve, ampicillin. 16 October 2011: Informed consent for therapeutic miscarriage is completed. Plan: PROSTIN gel, IV solution and oxytocin. 17 October 2011: She underwent dilation and curettage and biopsy. Pre and post surgical diagnosis: incomplete miscarriage. Plan: post surgical protocol, diclofenac, cephalothin, ampicillin, schedule for bilateral tubal occlusion by request of the patient, transfuse PRBC. On 18 October 2011, 19 October 2011 and 20 October 2011 hospitalized due to bilateral tubal occlusion. Diagnosis of discharge: delayed miscarriage, multiple fetal malformations, premature rupture of membranes, satisfied parity. Diagnosis: female fetus of approximately 21 weeks of gestational age, multiple external malformations, 400 grams (g), 26 centimeters (cm), of macerated aspect, slough skin with low set ears, ogival palate, short limbs. Given the information obtained the onset date and the diagnosis change. Considering that the diagnosis of the event changes to multiple malformations in the participant''s daughter and given the short time elapsed between the vaccination and the LMP we decided to change the relation with the vaccine as "possibly related". Diagnosis: multiple congenital multiple malformations in the participant''s daughter.


VAERS ID: 487130 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-01
Onset:0000-00-00
Submitted: 2013-03-18
Entered: 2013-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0875158A

Write-up: This case was reported by a physician and described the occurrence of suicide in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). In September 2011, the subject received an unspecified dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject committed suicide. The suicide was accomplished. It was unknown whether an autopsy was performed. No further information could be obtained. Case was closed.


VAERS ID: 489011 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-06
Onset:2013-04-06
   Days after vaccination:0
Submitted: 2013-04-11
   Days after onset:5
Entered: 2013-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA173AE / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute pulmonary oedema, Blood pressure abnormal, Cardiac arrest, Cyanosis, Death, Electrocardiogram abnormal, Mechanical ventilation, Mydriasis, Peripheral coldness, Respiratory arrest, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
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: Blood pressure, 06Apr2013, 100/60; Blood pressure, 06Apr2013, 0; Body temperature, 06Apr2013, 36.5deg.C; Electrocardiogram, 06Apr2013, Flatten; Heart rate, 06Apr2013, 0
CDC Split Type: B0882178A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of death due to acute pulmonary edema in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline) given in 6 March 2013 and which was uneventfully. The subject had no concurrent illness, allergies or relevant medical history. On 6 April 2013, at 9 - 10:00AM, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, left arm). She stayed in the medical center for 30 minutes before making her way home. No reaction was observed during this period. On 6 April 2013, in the afternoon, less than one day after vaccination with CERVARIX, the subject was found as breathless. On the same day, at 17:20, the subject was brought to a 1st hospital for emergency and was hospitalised with cardiac arrest and breathless. The subject had cardiopulmonary resuscitation and face mask ventilation. The subject did not recover and was transferred to a 2nd hospital with cyanosis, cold hands and legs, nul blood pressure and heard beep, mydriasis, body temperature of 36.5 deg.C and flatten ECG. The subject was treated with NaCl and adrenaline. The emergency cares were stopped after 45 minutes by lack of any signal of recovery. The subject finally died due to acute pulmonary edema.


VAERS ID: 495540 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-05-02
Onset:2012-09-25
   Days after vaccination:2338
Submitted: 2013-06-28
   Days after onset:276
Entered: 2013-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS VX17027 / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject was enrolled in Vaccine Trial and received 3 doses of CERVARIX. Following closeout from CVT in 12/17/2010, patient continued in Extended Follow-up Study (since 8/1/2011). At study visit on 6/21/2013, parents-in-law of patient reported she passed away at home on 9/25/2012. Patient has hx of severe dilated cardiomyopathy starting in 2008, and suffered severe respiratory illnesses and a stroke in 2010 and 2011, respectively. Cause of death was believed to be related to her underlying heart condition and not related to vaccination.


VAERS ID: 506585 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-30
Onset:0000-00-00
Submitted: 2013-10-07
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143CA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy bone abnormal, Death, Imaging procedure, Osteosarcoma, Pain, Surgery, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Biopsy, 22Nov2011, osteosarcoma; Imaging procedure, 21Nov2011, osteosarcoma
CDC Split Type: B0927643A

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of osteosarcoma in a 14-year-old female patient subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject was previously healthy. Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular) given on 29 July 2011. On 30 August 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site). In 2011, less than one year after vaccination with CERVARIX, the subject presented with marked swelling and pain. The following evening the pain subsided and the subject did not visit the hospital. In early October 2011, the subject was aware of the pain at the tumor site. On 21 November 2011, diagnostic imaging revealed osteosarcoma, which had developed within the past several months. On 22 November 2011, biopsy was performed. On 29 November 2011, diagnosis was confirmed. On 5 December 2011, the subject was admitted to hospital and was treated with cytotoxic agent (Unknown cancer therapy drug) and underwent a surgery. The physician considered the event was unrelated to vaccination with CERVARIX. It was considered that the causal relationship between the vaccine and the onset of osteosarcoma had not been medically confirmed. The subject died from osteosarcoma. It was unknown whether an autopsy was performed.


VAERS ID: 530376 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-01-02
Submitted: 2014-05-07
   Days after onset:489
Entered: 2014-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-13
   Days after onset: 130
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: B0990813A

Write-up: This case was reported by a consumer (subject''s relative) via a regulatory authority (ES-AGEMED-805461241) and described the occurrence of acute disseminated encephalomyelitis in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In 2012, the subject received unspecified dose of CERVARIX (unknown route, injection site and batch number). On 2 January 2013, less than one year after vaccination with CERVARIX, the subject experienced acute disseminated encephalomyelitis. The subject was hospitalised and the regulatory authority reported that the event was disabling. On 13 May 2013, the subject died die to acute disseminated encephalomyelitis. It was unknown whether an autopsy was performed. The regulatory authority reported that the event was unlikely to be related to vaccination with CERVARIX.


VAERS ID: 535577 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-06
Onset:2012-01-21
   Days after vaccination:290
Submitted: 2014-07-01
   Days after onset:891
Entered: 2014-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA076EB / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Back pain, Biopsy cervix abnormal, Blood test, Cervical dysplasia, Cytology abnormal, Death, Exposure during pregnancy, Fatigue, Malaise, Metastasis, Papilloma viral infection, Smear cervix normal
SMQs:, Retroperitoneal fibrosis (broad), Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-21
   Days after onset: 0
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: Cervical uterine dysplasia
Allergies:
Diagnostic Lab Data: Blood test, Dec2011, Not provided; Cervical biopsy, 21Mar2011, See text; Cervical cytology, 11Mar2011, Positive for hig; Cytology, 17Jan2011, Low grade sqamou; Cytology, 20Oct2011, See text; Laboratory test, Jan2014, Metastasis of un; On 21 March 2011, the cervical biopsy was performed which showed low grade squamous intraepithelial lesion with morphological changes related to Human Papilloma virus, Uterine cervical dysplasia; On 29 October 2011, cytology showed no malignant cells and cervical smear without dysplastic lesion
CDC Split Type: B1006932A

Write-up: This retrospective pregnancy case was reported by a consumer via a regulatory authority (# ES-AGEMED-205169340) and described the occurrence of metastasis in a 29-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 17 January 2011, cytology was performed which showed low grade squamous lesion (mild dysplasia). On 11 March 2011, a test to detect the papillomavirus in the cervical secretion was performed and the result was positive to high grade Human Papilloma virus (unknown the serotype of HPV) and a biopsy was recommended. On 21 March 2011, the cervical biopsy was performed which showed Low Grade Squamous Intraepithelial Lesion with morphological changes related to Human Papilloma virus (uterine cervical dysplasia). On 6 April 2011, the subject received 1st dose of CERVARIX, (.5 ml, intramuscular, unknown site of injection). In April 2011, less than a month after vaccination with CERVARIX, the subject experienced malaise, asthenia, fatigue and back pain. On 14 June 2011, the subject received 2nd dose of CERVARIX, (.5 ml, intramuscular, unknown site of injection). On 20 October 2011, the subject received 3rd dose of CERVARIX, (.5 mol, intramuscular, unknown site of injection). On the same day, after the administration of the 3rd dose of the vaccine, a new cytology was performed. On 2 November 2011, the results showed no malignant cells and cervical smear without dysplastic lesion. On 14 November 2011, the subject visited the gynaecologist where it was confirmed that the subject was pregnant from 1 month. The subject was pregnant at the time of 3rd vaccination with CERVARIX, leading to vaccine exposure during pregnancy. She went to the physician every week since November. The subject took paracetamol. No more tests were performed to determine the subject''s bad health conditions. In December 2011, the gynaecologist requested a new blood test due to the pregnancy. The pain was more intense. When the subject went to pick up the test results, the gynaecologist told that the subject had to go to the hospital. On 2 January 2012, the subject was hospitalized. On 21 January 2012, (19 days later) the subject died (while she was pregnant). During those 19, days several test were performed and the physicians told the family that she had metastasis of an unknown cause. It was unknown whether an autopsy was performed or not. The regulatory authority considered that metastasis, malaise, asthenia, fatigue and back pain were unlikely related to vaccination with CERVARIX.


VAERS ID: 574665 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-04
Onset:2014-12-07
   Days after vaccination:3
Submitted: 2015-02-05
   Days after onset:60
Entered: 2015-02-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Death, Resuscitation
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-07
   Days after onset: 0
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: No other medications
Current Illness: Foster care
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2015GSK013930

Write-up: This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 13-year-old female patient who received CERVARIX. Concurrent medical conditions included foster care. Concomitant products included DTPa-IPV. On 4th December 2014, the patient received CERVARIX (unknown) .5 ml. On 7th December 2014, 3 days after receiving CERVARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and collapse circulatory (serious criteria death and GSK medically significant). The patient was treated with non-drug therapy (Cardiopulmonary Resuscitation). On an unknown date, the outcome of the unknown cause of death and collapse circulatory were fatal. The patient died on 7th December 2014. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and collapse circulatory to be related to CERVARIX. Additional information was provided: The subject was living with a foster family (foster care). On 4 November 2014 the subject was vaccinated with an unspecified BOOSTRIX Polio (GSK) or REPEVAX (Sanofi Pasteur MSD). On 4 December 2014 the subject received an unknown dose of CERVARIX. On 7 December 2014, while the subject performed at a Christmas market, the subject collapsed. Immediately cardiopulmonary resuscitation (CPR) was performed by two physicians who visited the Christmas market. An emergency physician was called and the subject was hospitalised. Despite of another course of cardiopulmonary resuscitation (CPR) in the hospital the subject had to be declared dead. At the moment the cause of death was unknown. The deceased subject was transferred to an institute of forensic medicine. It was unknown whether an autopsy has been performed.


VAERS ID: 582013 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-10
Entered: 2015-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Non-Hodgkin's lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK079785

Write-up: This case was reported by a non-health professional via other and described the occurrence of lymphoblastic lymphoma in a 12-year-old female patient who received CERVARIX. On an unknown date, the patient received the 2nd dose of CERVARIX. On an unknown date, several weeks after receiving CERVARIX, the patient experienced lymphoblastic lymphoma (serious criteria death and GSK medically significant). In January 2011, the outcome of the lymphoblastic lymphoma was fatal. The patient died in January 2011. The reported cause of death was lymphoblastic lymphoma. It was unknown if the reporter considered the lymphoblastic lymphoma to be related to CERVARIX. Additional details were provided as follows: This case was reported in a newspaper article. According to patient''s parents, the patient became unwell within weeks of receiving the second dose of CERVARIX. A year later, in January 2011, the patient died of lymphoblastic lymphoma (a rare form of leukaemia). Parents believed that she died as a result of the HPV vaccine. According to medicines agency, there was no indication that the vaccine was the cause. This is 1 of 4 cases reported from the same newspaper article.


VAERS ID: 582096 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-12
Entered: 2015-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Non-Hodgkin's lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK079782

Write-up: This case was reported by a non-health professional via other and described the occurrence of lymphoblastic lymphoma in a 13-year-old female patient who received CERVARIX. Concomitant products included CERVARIX. On an unknown date, the patient received the 2nd dose of CERVARIX. On an unknown date, several week after receiving CERVARIX, the patient experienced lymphoblastic lymphoma (serious criteria and GSK medically significant). In January 2011, the outcome of the lymphoblastic lymphoma was fatal. The patient died in 2011. The reported cause of death was lymphoblastic lymphoma. It was unknown if the reporter considered the lymphoblastic lymphoma to be related to CERVARIX. Additional details were provided as follows: This case was reported in a newspaper article. According to patient''s parents, the patient became unwell within weeks of receiving the second dose of CERVARIX. A year later, in January 2011, the patient died of a rare form of leukaemia known as lymphoblastic lymphoma. The parents believed that she died as a result of the HPV vaccine since she rarely fell ill before the vaccination. According to medicines agency, there was no indication that the vaccine was the cause. This is 1 of 4 cases reported from the same newspaper article.


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