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| Table |
 |   | ||
| Age | Event Outcome | Count | Percent |
| 9-12 Years | Death | 1 | 3.13% |
| total | 1 | 3.13% | |
| 12-17 Years | Death | 11 | 34.38% |
| Permanent Disability | 1 | 3.13% | |
| Emergency Room | 1 | 3.13% | |
| Hospitalized | 3 | 9.38% | |
| total | 16 | 50% | |
| 17-44 Years | Death | 6 | 18.75% |
| Emergency Room | 1 | 3.13% | |
| Hospitalized | 3 | 9.38% | |
| total | 10 | 31.25% | |
| Unknown | Death | 14 | 43.75% |
| Permanent Disability | 3 | 9.38% | |
| Emergency Room | 1 | 3.13% | |
| Emergency Doctor/Room | 2 | 6.25% | |
| Hospitalized | 2 | 6.25% | |
| Life Threatening | 2 | 6.25% | |
| total | 24 | 75% | |
| TOTAL | † 51 | † 159.38% | |
| † Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 32 (the number of cases found), and the Total Percentage is greater than 100. | |||
| Case Details |
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? Yes Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 879 patients experienced disability (from an unspecified adverse event), 99 patients died, 5352 patients did not recover (from an unspecified adverse event), 500 patients had abnormal papsmear, 202 patients experienced cervical dysplasia, 57 patients experienced cervix carcinoma, 502 patients had adverse event which was life threatening, 9545 patients had to visit emergency room (from an unspecified adverse event), 2717 patients were hospitalized and 218 patients extended the hospital stay (from an unspecified adverse event), 3625 experienced serious adverse events (from an unspecified medically significant adverse event), 25636 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)", abnormal papsmear, cervical dysplasia, cervix carcinoma, "adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. Upon internal review, the events cervix carcinoma was determined to be medically significant. This is one of the multiple reports from the same reporter. | ||||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? Yes Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The patients current condition include prophylaxis. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 9 patients experienced disability (from an unspecified adverse event), 8 patients died, 124 patients did not recover (from an unspecified adverse event), 16 patients had adverse event which was life threatening, 354 patients had to visit emergency room (from an unspecified adverse event), 65 patients were hospitalized, 5 patients extended the hospital stay (from an unspecified adverse event), 80 patients experienced serious adverse events (from an unspecified medically significant adverse event), 1169 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)","adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. This is one of the multiple reports from the same reporter. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No 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. | ||||||||||||||||||||
Link To This Search Result:
https://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&GROUP2=CAT&EVENTS=ON&VAX=HPV2&DIED=Yes&SUB_YEAR_HIGH=2017&SUB_MONTH_HIGH=05
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