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Found 317 cases where Vaccine is HPV4 and Symptom is Death

Case Details

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VAERS ID: 424378 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-31
Entered: 2011-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA03486

Write-up: Case reported by a consumer and retrieved from a website by a healthcare professional (specialist) who transmitted to agency on 18-May-2011. This case was not medically confirmed. The consumer published an open letter about vaccination on the website, a citizen''s association. This open letter was addressed to an Agency. A 12-year-old female patient was vaccinated with a dose of GARDASIL ( lot and batch number not reported) on a recent date in. It was reported that the patient deceased 2 days after the vaccination. Medical history: It was reported that the patient was in excellent condition before the vaccination. Following to the reporter, the GP had told the parents that the vaccine was very safe but that, unfortunately, the patient had reacted to it. Until now, no other source confirmed the case. The healthcare professional (specialist) wrote to the consumer for more information. Other business partner included E2011-03076. No further information is available.


VAERS ID: 424381 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-02-15
Onset:2011-04-03
   Days after vaccination:47
Submitted: 2011-05-31
   Days after onset:58
Entered: 2011-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Death
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-04-07
   Days after onset: 4
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA03118

Write-up: Information has been received from a physician as part of the GARDASIL Access Program concerning a female who entered a HPV vaccine pilot project. On 15-FEB-2011 was vaccinated with 3rd dose of GARDASIL (lot # 666987/1016Z). The patient was admitted to hospital with abdominal pain and distension on 03-APR-2011. The patient died on hospital on 07-APR-2011. The cause of death was abdominal pain and abdominal distension. The reporting physician felt that abdominal pain (grade 5) and abdominal distension (grade 5) were not related to GARDASIL. Abdominal pain (grade 5) and abdominal distension (grade 5) were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.


VAERS ID: 437971 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-12
Entered: 2011-10-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA01164

Write-up: Information has been received from a physician (Local reference # ISR-015-OCT11) who stated that there was a publication approximately two months ago (approximately in August 2011) on a journal concerning 4 patients who were vaccinated with a dose of GARDASIL (dose, route, lot # were not specified). Subsequently, on an unspecified date the patients died (cause of death was unspecified). The physician stated that it was reported on the journal that GARDASIL was withdrawn from the market due to the 4 cases of death. The physician also reported that he also obtained information from a website. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.


VAERS ID: 441365 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-11-03
   Days after vaccination:9
Submitted: 2011-11-03
   Days after onset:365
Entered: 2011-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute leukaemia, Cerebral haemorrhage, Coma scale abnormal, Computerised tomogram abnormal, Death, Effusion, Haemoglobin decreased, Headache, Hypertension, Hypokinesia, Hypotension, Intensive care, Mydriasis, Pain in extremity, Platelet count decreased, Purpura, Somnolence, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-06
   Days after onset: 3
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Computed axial tomography, 04Nov10, Numerous effusions; WBC count, 04Nov10, 500000; WBC count, 04Nov10, 426000; hemoglobin, 04Nov10, 9.5; hemoglobin, 04Nov10, 7; platelet count, 04Nov10, 51000; platelet count, 04Nov10, 45000; Glasgow coma scale, 04Nov10, 13; Glasgow coma scale, 04Nov10, 8
CDC Split Type: WAES1110USA04403

Write-up: Case received from a physician on 24-OCT-2011 and medically confirmed. A 15-year-old female patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in the arm on 25-OCT-2010. On 03-NOV-2010, the patient was seen due to pain in calf and purpuric spots on both legs. The patient was not athletic and had been participating orienterring race the day before, and the physician thought it was a muscle strain. Blood count and differential white count was prescribed. On 04-NOV-2010, the patient experienced headaches and felt drowsy while being in classroom. Her mother picked her up and she remained at home. In the afternoon, her mother had difficulties waking her up. The patient was slow and had difficulties moving. EMU (Emergency Mobile Unit) was called and the patient was led to hospital on 04-NOV-2010. On admission diffuse hemorrhage cerebral and acute leukemia were discovered. White blood cells count was at 500 000. Hemoglobin was at 9, 5 and platelets at 51000. The patient was transferred to intensive care unit where her Glasgow coma scale quickly fell down from 13 to 8. Hemoglobin was at 7, platelets at 45000, white blood cells count at 426000. There was no adenopathy, no tumor. Liver and spleen were normal. CT scan showed numerous effusions. During the night, she experienced an episode of hypertension treated with EUPRESSYL and then hypotension and mydriasis. The patient died on 06-NOV-2010. To be noted that no clinical sign or symptom had been noticed prior to this episode. The patient used to be in good health and was not very often sick. She had received the first dose of GARDASIL via intramuscular route in the arm on 25-AUG-2010 which had been well tolerated. To be noted that the patient''s mother felt guilty and needed to "hold onto" something, including the vaccine. The hospital staff told her that there was no link between the vaccine and the events. Psychological follow-up was still ongoing. It was noteworthy that the general practitioner did not report any link with vaccination. Other business partner numbers included: E2011-06493. No further information is available.


VAERS ID: 457993 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2009-04-18
   Days after vaccination:138
Submitted: 2012-06-22
   Days after onset:1161
Entered: 2012-06-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test negative, Aspiration tracheal abnormal, Atelectasis, Autoantibody negative, Autonomic nervous system imbalance, Autopsy, Bacterial test negative, Blood potassium increased, Blood triglycerides increased, Borrelia test negative, C-reactive protein increased, CSF glucose, CSF protein, CSF white blood cell count increased, Cardiac failure, Catatonia, Central nervous system lesion, Clonus, Computerised tomogram head abnormal, Condition aggravated, Convulsion, Cytolytic hepatitis, Cytomegalovirus test negative, Death, Dizziness, Electroencephalogram normal, Encephalitis, Encephalitis autoimmune, Endotracheal intubation, Gastrointestinal obstruction, Gliosis, HIV antibody negative, Hepatocellular injury, Hyperkalaemia, Hyperthermia, Hypertonia, Hypertriglyceridaemia, Immunosuppression, Inflammation, Intensive care, Major depression, Malaise, Mechanical ventilation, Meningitis, Multi-organ failure, Mutism, Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pseudomonas infection, Pseudomonas test positive, Renal failure acute, Respiratory distress, Rhabdomyolysis, Septic shock, Sinusitis, Status epilepticus, Treatment failure, Treponema test negative, Varicella virus test negative, Viral test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dyslipidaemia (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Parkinson-like events (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
   Days after onset: 550
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: TEMESTA
Current Illness: Obsessive-compulsive disorder; Trichotillomania; Major depression
Preexisting Conditions: Tonsillectomy
Allergies:
Diagnostic Lab Data: electroencephalography, 12May09, normal; brain radionuclear scan, ??Aug10, no cerebral thrombophlebitis, sinusitis; electroencephalography, 16Aug10, normal, no epileptic activity; magnetic resonance imaging, 16Aug10, normal; diagnostic laboratory test, 29Aug10, Aspiration tracheal P.aeroginosa; autopsy, 22Oct10, Result for brain autopsy: astrocytal gliosis; autopsy, 22Oct10, Result for brain: subacute inflammatory lesions; diagnostic laboratory test, Leptospirosis negative; diagnostic laboratory test, Syphilis test negative; diagnostic laboratory test, autoantibody test negative.; body temp, 13Aug10, 38.7 C; serum C-reactive protein, 13Aug10, 100 mg/l; serum creatine kinase, 13Aug10, 2400 IU/l; CSF glucose, ??Aug10, 1.78 g/l; CSF white cell count, ??Aug10, 20 /mm3, normal; cerebrospinal fluid total protein test, ??Aug10, 0.27 g/l; serum potassium, 08Oct10, hyperkaliemia; serum triglyceride, End Sep-Beg Oct-2010: hypertriglyceridemia; serum varicella zoster virus antibody, virus test negative; Cytomegalovirus culture, negative; serum HIV-1 p24 antibody test, negative; serum antiadrenal antibody test, workup negative; serum Borrelia burgdorferi antibody test, negative
CDC Split Type: WAES1206USA03351

Write-up: Case received from the Health Authorities on 15-JUN-2012 under the reference number T020101212 and medically confirmed. A 17-year-old female patient had received the three doses of GARDASIL (batch numbers not reported) in December 2008, January 2009 and April 2009. The route of vaccine administration reported as transdermal is to be clarified with HA. She had a medical history of obsessive-compulsive disorder, trichotillomania, major depressive disorder, and had undergone tonsillectomy in June 2010. It was reported that she was having a long-term treatment with SEROPRAM 10 mg per os. She was hospitalized since 06-AUG-2010 due to major depressive disorder and catatonia. During hospitalization, on an unspecified date between 06-AUG-2010 and 12-AUG-2010, she was given TEMESTA per os, 2 injections of TERCIAN 50 mg via intravenous route and one injection of RISPERDAL via intravenous route. On 13-AUG-2010 she was hospitalized with clinical features of hyperthermia at 38.7 C associated with mutism and generalized hypertonia with neurovegetative dysautonomia. Biological work-up on 13-AUG-2010 showed inflammatory syndrome with CRP at 100 mg/l and rhabdomyolysis with CPK at 2400 IU/l. On 16-AUG-2010 SEG and brain MRI were normal. The following non drug-induced aetiologies were ruled out: EEG did not enable to evidence any evident epileptic activity. Brain CT scan showed no cerebral thrombophlebitis but right maxillary sinusitis was present. Lumbar puncture showed CSF white cell count at 20/mm3, CSF glucose at 1.78 g/l and CSF protein at 0.27 g/l. Infectious work-up were negative for Cytomegalovirus, HIV, varicella, Lyme disease, Leptospirosis and syphilis. Autoimmune workup was negative. Further to lumbar puncture results a treatment with ZOVIRAX and RIVOTRIL was started and the patient was transferred to neurology department where she was given Dantrolene on 14-AUG-2010, ZOVIRAX was maintained. On 15-AUG-2010 at 4.00 am the patient experienced acute respiratory distress on right lung atelectasis. She was intubated, ventilated, sedated and treatments with ROCEPHIN and TAVANIC were initiated. These treatments failed. Dantrolene was also stopped then started again on 16-AUG-2010. On 26-AUG-2010 the patient was still intubated and sedated as the attempts of extubation failed. Neurovegatative dysautonomia was still present. On 29-AUG-2010 tracheal aspiration showed p.aeruginosa therefore the patient was put on TIENAM and AMIKLIN. On 02-SEP-2010 she experienced epilepticus status which regressed on PENTHOTAL, as well as GARDENAL and KEPPRA. Her hemodynamic status was stable. According to the physicians the only differential diagnosis was malignant catalonia, which was very rare. On 09-SEP-2010, the patient experienced clonism after each lifting of sedation despite treatment with TEMESTA, GARDENAL and KEPPRA. Autoimmune limbic encephalitis was treated with TEGELINE. On 21-SEP-2010, she experienced a convulsion treated by PRODILANTIN and PENTHOTAL. It was followed by ketogenic diet causing hepatic cytolysis, acute renal insufficiency, cardiac insufficiency and hypertriglyceridemia. On 04-OCT-2010, corticotherapy was initiated. On 08-OCT-2010, ketogenic diet was poorly tolerated, causing hepatocellular insufficiency, acute renal insufficiency, hyperkalemia and gastrointestinal obstruction. Continued hemofiltration enabled to improve prothrombin level and hepatic function. On 17-OCT-2010, the patient experienced a septic shock. On 19-OCT-2010, she was found to have multi-organ failure. The patient died on 20-OCT-2010. The patient''s parents sent a letter to the Health Authorities questioning a causal relationship between vaccination with GARDASIL and their daughter''s death linked with meningoencephalitis. The general practitioner was contacted. The patient had received the 3 doses of GARDASIL in December 2008, January 2009 and April 2009. On 18-APR-2009, the patient presented with malaise preceded by lipothymic sensations and nausea. Emergency medical assistance service was called and the patient received an injection of magnesium. There was no recurrence. The patient had no history of convulsion. EEG performed on 12-MAY-2009 was unremarkable. Citalopram 0.5 dosage form per day was introduced at the end of Feb. On 11-OCT-2010, the conclusion of hospital report (intensive care) was provided: Malignant epilepticus status. Encephalitis limbic autoimmune suggested. Early failure of ketogenic diet. Significant immune suppression induced by barbiturates and corticotherapy. Septic shock with pulmonary and digestive starting point. Acute respiratory distress. Multi-organ failure. Brain autopsy was suggested and accepted by the parents. Autopsy report on 22-OCT-2010: absence of spongiform encephalopathy. Quite diffuse astrocytic gliosis of the focal signal of the meningitis were noted. Elements suggesting meningoencephalitis. Lesions showed subacute inflammatory pathology mainly meningeal associated to tissue context. Time to onset of the event made it difficult to attribute a causal relationship to GARDASIL. On 08-JUN-2012, a discussion with the neurologist who had followed the patient was reported: Autoimmune encephalitis was the central problem, the other manifestations being complications. The neurologist affirmed that the symptomatology linked to the autoimmune encephalitis started before 06-AUG-2010, and this already for the symptomatologies at the end of July 2010 and beginning of August. It seemed at least possible that the symptoms which sneakily appeared over the previous months (and according to the parents starting on beginning of 2009) could be related to the autoimmune encephalitis. Upon medical review, the company judged relevant to code the adverse events respiratory distress, septic shock, renal insufficiency, cardiac insufficiency, hepatic cytolysis, right lung atelectasis, pseudomonas aeruginosa infection, status epilepticus, gastrointestinal obstruction, malaise, nausea and lipothymic sensations which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and RISPERDAL and TERICAN as possible" (C2 S2 12) according to the foreign method of assessment. The Health Authorities assessed the causal relationship between the reported reactions and SEROPRAM and vaccination with GARDASIL as doubtful (C1 S1 11) according to the foreign method of assessment. Other business partner numbers include E2012-03912. No further information is available.


VAERS ID: 464985 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-23
Onset:2012-09-08
   Days after vaccination:16
Submitted: 2012-09-13
   Days after onset:5
Entered: 2012-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G007396 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Cardiac arrest, Cardio-respiratory arrest, Condition aggravated, Death, Dyspnoea, Electroencephalogram abnormal, Endotracheal intubation, Headache, Hypoxic-ischaemic encephalopathy, Intensive care, Loss of consciousness, Nervous system disorder, Neurological decompensation, Nuclear magnetic resonance imaging abnormal, Resuscitation, Scan abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-08
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209ESP005292

Write-up: Case received from a healthcare professional, a physician who is a member of the Advisory Board of Vaccination on 10-SEP-2012. A 13 year-old female patient, with a medical history of poorly controlled asthma, had received the second dose of a GARDASIL, batch number not reported, route and site not reported) date not reported. The patient was vaccinated according to the healthcare centre vaccination schedule. It was reported that 12 hours after vaccine administration (exact date not reported), the patient presented with severe asthma. The patient was taken to the hospital where she presented cardio-pulmonary arrest, the patient was transferred to the paediatrician ICU ward of another hospital, where she died. It was reported that the patient had received the first dose of GARDASIL (date of administration not reported), after vaccination the patient''s asthma aggravated. According to the reporter (he was not the physician who treated the patient directly) this case of death was not related to vaccine administration. No further information was reported. Additional information received on 11-SEP-2012, from a healthcare professional, an ICU ward physician who treated the patient: A 13-year-old female patient, born 03-JUL-1999, with a medical history of poorly controlled asthma and allergy to pollen, had received the second dose of GARDASIL, batch number not reported, route and site not reported) on 23-AUG-2012. Previous to vaccine administration and according to the family, the patient presented a mild dyspnea, which she frequently had. According to the reporter, 12 hours after vaccine administration, on 23-AUG-2012, the patient presented with a severe difficulty in breathing and headache. On 23-AUG-2012 at 20:20 hrs, the patient arrived at the healthcare center. The patient was unable to breathe, she vomited once (cessation date 23-AUG-2012) and then she lost consciousness. The patient was transferred to the hospital. She arrived 23 minutes later with asystolia. Cardiac arrest. Cardiopulmonary resuscitation was performed during 12 minutes. The patient was intubated, 3 doses of adrenaline were administered. 17 minutes after they were able to reanimate her. Bronchodilators, Ketamine and Bicarbonate were administered. The patient was transferred in a mobile paediatric intensive care unit to the hospital''s paediatric criteria care unit. MRI and scanners were performed. Neurological lesions were detected. The patient was diagnosed with severe neurological status deterioration and an almost flat encephalogram. On 08-SEP-2012 the patient died. Cause of death was ischemic encephalopathy. The family referred that after the patient had received the first dose of GARDASIL the patient had a mild-moderate asthmatic crisis. According to the reporter, who contacted the patient''s paediatrician, the patient received the first dose of GARDASIL on 27-JUL-2012, route and site not reported, batch number not reported. On 31-JUL-2012 the patient went to the healthcare center to report to her paediatrician that she had presented an asthmatic crisis (date not reported) after vaccination and she had been treated in the hospital. According to the physician who treated the patient in the ICU there is possible relationship between events and vaccination. Further information is expected. Additional information received on 12-SEP-2012, from the physician''s pediatrician: The patient received the first dose of GARDASIL (batch number G007396, route and site not reported) on 23-JUL-2012 (this date is different to the one reported by the ICU pediatrician but it is the one included in the clinical record of the patient at her healthcare centre). According to the pediatrician the patient went to the hospital on the 29-JUL-2012 due to a severe asthmatic crisis where she was treated and controlled. The reporter don''t know if the patient was admitted to hospital or treated at the emergency room. No further information on this episode was reported. On 31-JUL-2012 the patient attended his office to report the episode. At that time the patient was well. On 23-AUG-2012 the patient was administered the second dose of GARDASIL (batch number G007396, route and site not reported). According to the clinical record of the patient she had history of allergic asthma, not controlled because she did not follow the recommended treatment (prophylaxis with SYMBICORT), allergy to acaridae. The patient had frequent moderate exacerbations and previous episodes of bronchitis since year 2010, which is the date since the pediatrician had patient history. The patient had history of intrauterine growth retardation and short stature. According to the pediatrician opinion relationship of adverse events and vaccination is unknown. No further information is reported.


VAERS ID: 471789 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-26
Entered: 2012-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES1210HKG011628

Write-up: This spontaneous report as received from a consumer, who learnt from a radio channel of fatal cases after GARDASIL vaccination (121USA012211) and (2 fatal cases, this case) and (3 fatal cases, 1210USA012210). The reporter himself experienced serious adverse events (1210HKG011385). This report refers to three patients of unknown age. The patients were vaccinated with GARDASIL (date and route of administration not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients died. No details for death are available. The relatedness for death is unknown for GARDASIL. Additional information has been requested.


VAERS ID: 477609 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-11
Entered: 2012-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES1212CAN002771

Write-up: This unconfirmed spontaneous report as received from a nurse, who obtained the information from the internet, refers to 47 patients of unknown age. The patients were vaccinated with GARDASIL on unknown dates. No other co-suspects and no concomitant medications were reported. The nurse mentioned 47 deaths as a result of patients getting GARDASIL. No treatment information was reported. The outcome of she mentioned 47 deaths as a result of patients getting GARDASIL was reported as fatal. No details for death are available. The relatedness for she mentioned 47 deaths as a result of patients getting GARDASIL is unknown for GARDASIL. Additional information is not expected.


VAERS ID: 478227 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-25
Onset:2012-12-01
   Days after vaccination:6
Submitted: 2012-12-17
   Days after onset:16
Entered: 2012-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Oedema peripheral, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-17
   Days after onset: 16
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: WAES1212NPL005349

Write-up: This spontaneous report as received from a physician via a business partner refers to a female patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (lot number, dose, route, and strength were not reported). on 25-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. Following the vaccination on that evening, on 25-NOV-2012, the patient had little bit of swollen hand. She did not come to her class the next day, but a day after that, she had been moving around and attending her classes. But on 29-NOV-2012, her body was swollen and she died on 01-DEC-2012. The outcome of swollen hand and swollen body was unknown. The patient''s death was confirmed, her parents did not file any complain and the physician was told that it was not in relation with the vaccine administration. Based on the written field report the physician got from the local program coordinator, the death was not caused by vaccination. Additional information is not expected.


VAERS ID: 479323 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-26
Entered: 2012-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212GBR009750

Write-up: This invalid case (multiple unknown patients) a hearsay report was received from a consumer on 12-DEC-2012. This case is not medically confirmed. Up to 200 girls received injections of GARDASIL (batch number not reported), route and site not reported, on an unreported date. The reporter stated that the girls were killed outright and that tens of thousands of others were injured. The outcome of the injured girls was not reported.


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