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Found 16 cases where Vaccine is HPV2 and Patient Died and Submission Date on/before '2015-12-31'

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Table

   
AgeVaccine CountCountPercent
9-12 Years116.25%
total16.25%
12-17 Years1743.75%
total743.75%
17-44 Years1637.5%
total637.5%
Unknown116.25%
216.25%
total212.5%
TOTAL16100%

Case Details

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VAERS ID:363051 (history)  Vaccinated:2009-09-28
Age:14.0  Onset:2009-09-28, Days after vaccination: 0
Gender:Female  Submitted:2009-10-27, Days after onset: 29
Location:Foreign  Entered:2009-10-27
Life Threatening? No
Died? Yes
   Date died: 2009-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No known allergies. Was being treated for migraines with propranolol (unknown dose or presentation) but this has not been confirmed by patient''s GP or family.
Diagnostic Lab Data: UNK
CDC Split Type: B0595286A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA043BB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cardiac arrest, Circulatory collapse, Death, Malaise, Neoplasm malignant, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (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), Acute central respiratory depression (broad), Cardiomyopathy (broad), Malignant tumours (narrow), Hypersensitivity (narrow), Respiratory failure (broad)
Write-up: This case was reported by a physician and described the occurrence of death nos in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On the morning of the 28 September 2009 the patient received unspecified dose of CERVARIX (1 injection). On 28 September, within 30 minutes after vaccination with CERVARIX, the patient experienced a possible anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection. The patient had to be resuscitated by the paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient. The attempt was not successful and the patient was declared dead on 28 September 2009. It was unknown whether an autopsy was performed. Verbatim text: On the 28th September 2009 a public health consultant reported that a 14 year old female patient was administered a dose of CERVARIX ( Batch: AHPVA043BB, expiry: 09/2010) at school, in the morning of the 28th September 2009 as part of a school immunization program. The consultant reported that within 30 minutes after the administration of the CERVARIX the patient experienced what they believed was an anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection, she had to be resuscitated by paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient but it was not successful and the patient was declared dead. There was no further information available at the time of reporting. Follow-up information received via regulatory authority on 30 September 2009: The patient was taking CERVARIX for the prevention of premalignant cervical lesions and cervical cancer. The patient had no known allergies. She was being treated for migraines with propranolol (unknown dose or presentation) but his has not been confirmed by patient''s GP or family. The patient received her first dose of CERVARIX (Batch Number: A1-IPVA043BB) at 10:45 on Monday 28th September 2009 and following complaining of being unwell, had collapsed at approximately 12:00. Paramedics performed CPR on the patient but could not revive her and following further unsuccessful resuscitation attempts at the local acute trust Emergency Care Department, was pronounced dead. The patient died on 28 September 2009 from anaphylaxis. Follow-up information received on 8 October 2009: On 28 September 2009 the subject experienced circulatory collapse. The cause of death was unknown. Follow-up information received on 9 October 2009: Concurrent medications included lansoprazole and sumatriptan succinate. On the morning of the 28 September 2009 the subject received an unspecified dose of CERVARIX (1 injection, intramuscular). The reporter stated that it was not possible to confirm whether the subject was actually administered a dose of sumatriptan succinate prior to vaccination with CERVARIX. The regulatory authority reported that the subject ''received the vaccination, collapsed approximately 60 minutes later, VF, then asystolic arrest. No external signs of anaphylaxis.'' The cause of death was reported to be anaphylaxis. Follow-up information received on 16 October 2009: On an unknown date the subject experienced a malignant neoplasm. The outcome of the malignant neoplasm was fatal. The cause of death was reported to be malignant neoplasm. Post mortem results were pending.

VAERS ID:378500 (history)  Vaccinated:2009-10-14
Age:15.0  Onset:2009-10-15, Days after vaccination: 1
Gender:Female  Submitted:2010-01-27, Days after onset: 104
Location:Foreign  Entered:2010-01-27
Life Threatening? No
Died? Yes
   Date died: 2009-11-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Joint pain
Diagnostic Lab Data: UNK
CDC Split Type: B0628298A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA050AG1IMAR
Administered by: Other     Purchased by: Other
Symptoms: Death, General physical health deterioration, Headache, Impaired work ability, Loss of consciousness, Malaise, Pain in extremity, Pyrexia, Respiratory failure, Snake bite
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of respiratory failure in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included joints pain. Previous and/or concurrent vaccination included CERVARIX ;GlaxoSmithKline;intramuscular;unknown deltoid given on 9 September 2009. On 14 October 2009, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid). The subject was put under observation during 30 minutes after both vaccinations. No adverse event had occurred. On 15 October 2009, 1 day after vaccination with CERVARIX, the subject experienced a low grade fever and headache. She visited an homeopathy center where she was prescribed treatment with paracetamol, Liv 52 and RANTAC. The subject was advised to come back to the center for follow-up after 2 days of treatment. The events resolved and the subject restarted her daily chores. On 1st November 2009, the subject informed her parents that an insect has bitten her during the field work. She was not feeling well and complained about leg pain. Post noon, the subject didn''t go to work and rested at home. Overnight, her condition deteriorated. On the morning of the 2nd November 2009, an ambulance was called. The subject''s vital signs recorded at the time of shifting were poor. On the way to hospital, she became unconscious and her vital signs were not recordable. The cardio pulmonary resuscitation provided was unsuccessful. At hospital, she was declared dead due to a respiratory failure. Autopsy was rejected by the family. The physician considered the events were unrelated to vaccination with CERVARIX and so, no follow-up was necessary. The subject died on 2 November 2009 from a suspected snake bite. An autopsy was not performed.

VAERS ID:382971 (history)  Vaccinated:2009-10-09
Age:10.0  Onset:2009-10-29, Days after vaccination: 20
Gender:Female  Submitted:2010-03-18, Days after onset: 140
Location:Foreign  Entered:2010-03-18
Life Threatening? No
Died? Yes
   Date died: 2009-10-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA050AG1IMLA
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)
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:393523 (history)  Vaccinated:2008-11-07
Age:12.0  Onset:2008-11-28, Days after vaccination: 21
Gender:Female  Submitted:2010-07-23, Days after onset: 601
Location:Foreign  Entered:2010-07-23
Life Threatening? No
Died? Yes
   Date died: 2008-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body height, 02Dec2008, 172cm; Respiratory rate, 28Nov2008, 60 (at admission); Weight, 02Dec2008, 59kg; 02 Dec 2008: Bacterial test B haemolytic strep group B. 02 Dec 2008: Viral test. Nasal swab: respiratory syncytical virus.
CDC Split Type: B0554054A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA021AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Ascites, Autopsy, Bronchopneumonia, Cardiac arrest, Cough, Death, Dyspnoea, Endotracheal intubation, Generalised oedema, Hypotension, Inflammation, Lower respiratory tract infection, Mechanical ventilation, Mediastinitis, Necrosis, Oedema, Pleural effusion, Pleurisy, Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Skin oedema, Speech disorder, Streptococcal sepsis, Streptococcus test positive, Tachycardia, Tachypnoea, Tracheitis, Upper respiratory tract infection, Upper respiratory tract inflammation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the Medicines and Healthcare products Regulatory Agency (GB-MHRA-ADR 20357549) and described the occurrence of streptococcal septicemia in a 12-year-old female subject who was vaccinated with CERVARIX. Previous vaccinations included 1st dose CERVARIX given 07 October 2008, smallpox vaccine 1996 and November 2000, Meningococcal c vaccine 22 November 2000, MMR vaccine 22 November 2000, Diphtheria toxoid 1996 and November 2000, Hib vaccine 1996 and November 2000, bacillus clostridium tetani 1996 and November 2000, whooping cough vaccine 1996 and November 2000 and poliomyelitis vaccine 1996 and November 2000. On 7 November 2008 the subject received unspecified second dose of CERVARIX (.5 ml, intramuscular, batch AHPVA021AA). At an unspecified time after vaccination with CERVARIX, the subject experienced streptococcal septicemia. The subject died on 30 November 2008 from streptococcal septicemia. It was unknown whether an autopsy was performed. MHRA Verbatim Text: Patient died 3 weeks following 2nd HPV Vaccination. Reported to have died due to Streptococcal A Septicemia. Still awaiting coroners verdict. Follow-up information received on 14 July 2010 from the MHRA: The patient had a cough for one week and then developed fever for three days. Patient was admitted to hospital three weeks after CERVARIX vaccination when the cough got worse and they developed difficulty breathing. On admission the respiratory rate was 60 per minute and they were distressed. They became so distressed they were unable to speak. The patient was transferred to the high dependency unit. On 28 November 2008 the patient then became tachycardic and a chest infection was diagnosed and the patient was taken to the theatre and intubated and ventilated. The patient crashed an hour later and had arrests characterized by very severe hypotension. The patient became asystolic. Despite all efforts the decision that further attempts were futile was made and the patient died on 28 November 2008. The cause of death was streptococcal septicemia. The coroner states that there is no doubt death was due to a group A streptococcal septicaemia. There was active inflammation of the upper respiratory tracts, the mediastinum, and focally the lungs. Group A streptococcus was cultured from multiple sites both at post-mortem and during the short terminal illness. It was noted that a respiratory syncytial virus was identified from the nose swab. According to the coroner it was probable that an upper respiratory tract infection was the portal of the devastating bacterial infection that caused death and it was possible that the respiratory syncytial virus was significant here. Post mortem results: A post mortem was carried out and there was found to be a considerable degree of generalized subcutaneous oedema. Both pleural cavities contained approximately 150mls of turbid yellow fluid. The lungs were found to have a necrotizing pleuritis with some extension of acute inflammation into the pulmonary parenchyma that is immediately adjacent to the pleural surface, though extensive pneumonia is not identified. Some inflammation and oedema extends into the pulmonary interstitium in the areas close to the pleural and mediastinal surface of the lungs. Some areas of bronchopneumonia are identified. The pericardial cavity contains approximately 50ml of clear liquid and the peritoneal cavity contains approximately 250-300ml of clear yellow fluid. The trachea shows evidence of an acute tracheitis with mediastinitis of the upper mediastinum. The larynx shows evidence of an upper respiratory tract infection. The thymus shows marked oedema, and the presence of scattered inflammatory cells.

VAERS ID:451701 (history)  Vaccinated:2011-03-25
Age:30.0  Onset:2011-06-05, Days after vaccination: 72
Gender:Female  Submitted:2012-03-12, Days after onset: 281
Location:Foreign  Entered:2012-03-14, Days after submission: 2
Life Threatening? No
Died? Yes
   Date died: 2011-12-24
   Days after onset: 202
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA102AB1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Exploratory operation, Hepatic mass, Hepatic neoplasm malignant non-resectable, Jaundice, Laboratory test, Laparotomy, Nausea, Palliative care, Pruritus generalised, Terminal state, Ultrasound abdomen abnormal, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Malignant tumours (narrow), Liver malignant tumours (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer.

VAERS ID:451703 (history)  Vaccinated:2005-02-16
Age:28.0  Onset:2010-06-03, Days after vaccination: 1933
Gender:Female  Submitted:2012-03-12, Days after onset: 648
Location:Foreign  Entered:2012-03-14, Days after submission: 2
Life Threatening? No
Died? Yes
   Date died: 2011-10-23
   Days after onset: 507
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSVX107872UNLA
Administered by: Other     Purchased by: Other
Symptoms: Chemotherapy, Colitis, Hysterectomy, Mass excision, Metastasis, Ovarian cancer stage III, Ovarian disorder, Pelvic discomfort, Pelvic pain, Stomach mass, Ultrasound ovary abnormal
SMQs:, Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Malignant tumours (narrow), Ovarian malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad), Noninfectious diarrhoea (broad)
Write-up: Between June-August 2010, subject started with pain/discomfort in pelvic region. She consulted her local primary care center and was diagnosed and treated for colitis. After symptomology progressively worsened she was given a sonogram (8/25/2010) that showed "shadows on ovaries". Following readmission (8/30/2010), surgeons on 9/1/2010 removed a mass apparently started in the stomach; they told subject''s sister it was invasive cancer. Hospital admission and multiple chemotherapy courses took place in 9/2010 and 10/2010, then total hysterectomy (1/28/2011) and more chemo (5/2011). On 6/22/2011 she was admitted with diagnosis of ovarian cancer stage III C. Was taking Hyoscine, methadone, and bisacodyl as necessary.

VAERS ID:456608 (history)  Vaccinated:2011-08-18
Age:13.0  Onset:2011-09-01, Days after vaccination: 14
Gender:Female  Submitted:2012-05-31, Days after onset: 273
Location:Foreign  Entered:2012-05-31
Life Threatening? No
Died? Yes
   Date died: 2011-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic rhinitis; Congenital heart disease
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0804493A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Completed suicide, Death, Musculoskeletal stiffness
SMQs:, Suicide/self-injury (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of suicide in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis and congenital heart disease. Concurrent medications included MUCODYNE, ALLEGRA and ONON. On 18 August 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On an unspecified date, as the subject had muscle stiffness, Kakkonto 2.5g twice a day for 3 days and LOXONIN for 6 doses were prescribed. On 1 September 2011, 14 days after vaccination with CERVARIX, the subject committed suicide. The subject died on 1 September 2011 from accomplished suicide. It was unknown whether an autopsy was performed.

VAERS ID:467780 (history)  Vaccinated:2005-11-01
Age:31.0  Onset:2010-01-15, Days after vaccination: 1536
Gender:Female  Submitted:2012-10-04, Days after onset: 992
Location:Foreign  Entered:2012-10-05, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2012-07-12
   Days after onset: 908
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Biopsy stomach abnormal, Chemotherapy, Gastrectomy, Gastric cancer, Metastases to ovary, Radiotherapy
SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Malignant tumours (narrow)
Write-up: In 11/2009, subject reported onset of severe epigastralgia and was examined and biopsied on 01/15/2010. After receiving Dx of gastric cancer, had complete gastrectomy on 2/9/2010 and 45 day hospital stay. Was also hospitalized in 4/2010 for chemotherapy and radiotherapy, and discharged on 5/26/2010. Followed up with specialist, chemotherapy, and metoclopramide daily. Mother reported subject received Dx of ovarian metastasis in 4/2011, and additional chemotherapy was not successful.

VAERS ID:475457 (history)  Vaccinated:2011-05-20
Age:  Onset:2011-10-14, Days after vaccination: 147
Gender:Female  Submitted:2012-11-27, Days after onset: 410
Location:Foreign  Entered:2012-11-27
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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
CDC Split Type: A0933003B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0UNRA
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNRA
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)
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.

VAERS ID:487130 (history)  Vaccinated:2011-09-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-03-18
Location:Foreign  Entered:2013-03-18
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0875158A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)
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.

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