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Found 331 cases where Vaccine is HPV4 and Symptom is Death

Case Details

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VAERS ID: 792657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131812DEU008885

Write-up: This spontaneous report as received from an unspecified reporter, who found this case in a publish, refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot#, expiry unknown) for prophylaxis. It was reported by the Agency that on an unknown date, shortly after the vaccination, patient died due to unknown causes. It was unknown if an autopsy was performed or not. Causality assessment was not provided. This is one of the two reports received from the same reporter. Reported Cause(s) of Death: died.


VAERS ID: 793302 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Alopecia, Amnesia, Anxiety, Behaviour disorder, Coagulation test, Death, Decreased appetite, Depression, Encephalitis autoimmune, Fatigue, Gait disturbance, Gastrointestinal obstruction, Headache, Hot flush, Liver disorder, Loss of consciousness, Malaise, Mood altered, Multiple organ dysfunction syndrome, Myalgia, Nausea, Paraesthesia, Prothrombin time, Renal failure, Septic shock, Syncope, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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), Dementia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REPEVAX; TEMESTA
Current Illness: Anxiety; Obsessive-compulsive disorder (Stop Date: Continuing); Prophylactic vaccination; Trichotillomania
Preexisting Conditions: Medical History/Concurrent Conditions: Nervousness; Tonsillectomy; Comments: Medical history: Consultation on 28-Sep-05 : nervousness. Obsessive-compulsive disorder; major depressive disorder; tonsillectomy and adenoidectomy on 15-Jun-2010; psychiatric therapy since 2008; frequent nervous breakdown that began after the birth of her first child in 1986. No convulsion in her childhood but trichotillomania which would have started in 2005, anxiety, stress and somatization symptoms which would have started following a move. No known neonatal distress. According to the parents she had not experienced any psychomotor retardation. According to the parents, she was healthy and had no relevant medical history. She was active, joyful, enthusiastic and had many projects.
Allergies:
Diagnostic Lab Data: Test Date: 20100815; Test Name: Coagulation factor VII level; Test Result: 48 %; Test Date: 20100815; Test Name: Coagulation factor X level; Test Result: 48 %; Test Name: Prothrombin ratio; Result Unstructured Data: Lab result: 15Aug and 14Oct : below N 48 and 65 percent; Test Name: Prothrombin ratio; Result Unstructured Data: Lab result: 15Aug and 14Oct : below N 48 and 35 percent; Test Date: 20101014; Test Name: Prothrombin ratio; Test Result: 35 %
CDC Split Type: FR0095075131206USA03351

Write-up: Due to narrative field size limitation, info submitted in previous version was revised in this FU. Case received from the Health Authorities on 15-Jun-2012 under the reference number TO20101212 and medically confirmed. Fup received from HAs on 28-Jun-2012, 04-Jul-2012. Fup received via a media press article (not medically confirmed information) on 19-Dec-2013, 3-Apr-2014 and 08-Apr-2014 on 25-Aug-2014. Fup information received via a legal source on 16-Dec-2014. A 17-year-old female patient had received the 3 doses of GARDASIL (batch numbers not reported) on 24-Oct-2008, 19-Dec-2008 and 24-Apr-2009 via IM route. The patient died on 20-Oct-2010. The patient had no history of convulsion. She had a medical history of obsessive-compulsive disorder, trichotillomania, major depressive disorder, and tonsillectomy in Jun-2010. It was reported that she was having a long-term treatment with Citalopram (SEROPRAM) since probably Feb-2009. The parents reported that before the vaccination, the patient was healthy and had no relevant medical history. She had been active, joyful, enthusiastic, with many projects. According to the parents, she experienced headache and abdominal pain on unspecified onset of time after receiving her first dose of GARDASIL on 24-Oct-2008. The patient''s parents reported that at the time it was not alarming for an adolescent, but symptoms became increasingly significant after second dose on 19-Dec-2008. She developed anxiety, hot flushes, paraesthesia in lower limbs, muscle pain, walking difficulties. On 18-Apr-2009, she presented with marked syncope preceded by lipothymic sensations and nausea. Emergency medical assistance was called injected her with magnesium.There was no recurrence of malaise. After the third dose of Gardasil on 24-Apr-2009, she still presented with intermittent symptoms, along with intense fatigue, fainting, mood changes and loss of appetite. EEG performed on 06-May-2009 was unremarkable, no specific elements of epileptic nature was found. The media press article stated that during the winter season before patient''s death, she had complained of being tired, with dark thoughts and formication in legs. She had no more energy and had increasing difficulties to climb stairs. Within the following months, she was suffering from intensified muscular pain and experienced malaise, hair loss and memory loss. In summertime, the patient had stayed prostrate and was unable to stand on her legs when she was admitted to hospital. She had additionally a "raging fever". The article also mentioned that the hospital neurologist was considering the relationship between the events and the vaccine as a hypothesis, but that there were no further elements allowing to confirm such a statement. The patient''s medical file had also established the vaccine imputability as possible, although it was considered doubtful by the Health Authorities. The patient''s health status abruptly worsened at the end of July 2010: loss of weight, loss of references, behavior disorders and memory lapses. The patient was hospitalized at the beginning of Aug-2010 in three successive hospitals. She was placed into induced coma from which she could not wake up due to irreversible convulsions. According to the HAs reports : she was hospitalized since 06-Aug-2010 due to major depressive disorder and catatonia. During hospitalization, on unspecified date between 06-Aug-2010 and 12-Aug-2010, she was given Lorazepam (Temesta) per os, 2 injections of Cyamemazine (Tercian) 50 Mg via intravenous route and one injection of Risperdone (Risperdal) via intravenous route. On 13-Aug-2010 she was hospitalized with clinical features of hyperthermia at 38,7 degree Celsius 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. EEG and brain MRI were normal. The following non drug-induced aetiologies were ruled out: EEG did not provide any evidence of 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 Aciclovir and Clonazepam was started and the patient was transferred to a neurology unit 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 Ceftriaxone and Levofloxacine 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 attempts of extubation failed. She still presented with neurovegetative dysautonomia. On 29-Aug-2010 tracheal aspiration showed P.aeruginosa therefore the patient was put on Imipenem/Cilastatine and Amikacine. On 02-Sep-2010 she experienced epilepticus status which regressed on Thiopental, as well as Phenobarbital and Levetiracetam. Hemodynamic status was stable. According to the physicians the only differential diagnosis was malignant catanonia, 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 Immunoglobulin Human Normal. On 21-Sep-2010, she experienced a convulsion treated by Fosphenytoine 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. On 17-Oct-2010, the patient experienced a septic shock (pyo). 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 the causal relationship between vaccination with GARDASIL and their daughter''s death by meningoencephalitis. Autopsy report from 22-Oct-2010: absence of spongiform encephalopathy. Quite diffuse astrocytic gliosis of the focal signal of the meningitis were noted. Elements suggesting meningoencephalitis. Time to onset of the event made it difficult to attribute a causal relationship to GARDASIL. On 29-Oct-2010, the conclusion of hospital report (intensive care) was provided : Malignant epilepticus status. 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.On 08-Jun-2012, a discussion with the neurologist in charge of the patient was reported: Autoimmune encephalitis was the central problem, the other manifestations being complications. The neurologist affirmed that the symptomatologylinked to the autoimmune encephalitis started before 06-Aug-2010, 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 (which, according to the parents started beginning of 2009) could be related to 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 patient''s medical history revealed no convulsion in her childhood but reported trichotillomania with onset 2005, anxiety, stress and somatization disorders triggered after moving home. Since 27-Feb-2009, psychiatric monitoring was initiated for frustrates depression, aggressivity and OCD (obsessive compulsive disorder) with trichollomania. Treatment with citalopram was prescribed. On 18-Apr-2009, the patient experienced loss of consciousness without clonic-like abnormal movements or vomiting. She gradually woke-up with tremors. The EEG on 06-May-2009 showed a discreetly unstable drawing but no specific elements of epilepsy. On 15-Jun-2010, amydalectomy and adenoidectomy were performed. On 16-Jul-2010, she received a dose of REPEVAX (batch number E0572). On 06-Aug-2010, she was hospitalized in psychiatric unit due to psychotic decompensation. Treatment with cyamemazine (Tercian) and risperidone (Risperdal) was introduced. On 12-Aug-2010, her condition worsened, she could not walk any longer, she was totally mute and she refused all food. On 13-Aug-2010, acyclovir (Zovirax) was introduced against herpetic meningoencephalitis. Cerebral CT-scan found no cerebral thrombophlebitis. Skull CAT ruled out thrombophlebitis but found right maxillary sinusitis. She experienced 2 episodes of tachycardia with clonies in upper limbs relieved by clonazepam (Rivotril). CSF showed 20 leucocytes /mm3, glycorachia at 1.78 g/l, proteinorachia at 0.27 g/l. Treatment with Zovirax was started. On 14-Aug-2010, she was hospitalized in neurology for neuroleptic malignant syndrome. She was still febrile. Neurological symptoms were unchanged and Dantrolen was started. On 15-Aug-2010, she experienced hypoxemia and acute respiratory distress and atelectasis of right lung. She was transferred in reanimation were she was conscious with open eyes but not responsive, with decreased of rigidity and absence of focalization signs, polpneic, decreased of right vesicular murmur and tachycardia. Treatment with recephin and tavanic with no improvement. She was intubated. Dantroelne was stopped. Full autoimmune work-up was performed with blood culture, tracheal aspirates, HIV and CMV serologies (negative), investigations of syphilis, Borrelia, leptospirosis and VZV. Autoimmune work-up was performed with investigations of ANCA, anti-DNA antibodies and antiphospholipid antibodies as well as normal C3-C4 assay complement and CH50. Tracheal aspiration was positive for Streptococcus viridans and Staphylococcus coagulase negative. Hemostatsis showed decreased value for Factor VII and X. On 16-Aug-2010, a new lumbar puncture found 18 nucleated elements with CSF protein level slightly decreased and CSF glucose normal. CSF analysis of 16-Aug-2010 were negative for mycological examination, toxoplasmosis and cryptococcal serologies, no DNA toxoplasma gondii and no CMV, EBV, HSV1, HSV2, VZV and enterovirus. On 16-Aug-2010, repeat EEG showed no signs of epilepsy or encephalitis but irregularity of the track was found and monitored. On 18-Aug-2010, sedation was stopped and patient was extubated. But persistent catatonia and neck stiffness with no Babinski sign but opposition movements on mobilization. On 19-Aug-2010, she was intubated again for inhalation pneumopathy with "white" left lung. Fibroscopy was normal. Brain MRI on 19-Aug-2010 was normal. On 20-Aug-2010, she presented with extra-pyramidal deterioration syndrome. That day, she was given piperacilline, tazobactam (Tazocilline) until 22-Aug-2010 for viridens 105 streptoccocus pneumonia and for coagulase staphylococcus negative at 105 found in the tracheal aspirates. CSF was negative. Blood culture was negative. She had no fever. On 26-Aug-2010, no fever and she was off antibiotics. On 26-Aug-2010, she experienced tonic-clonic seizures and persistent neurovegetative dysautonomia. Despite sedation, she ended up in a generalized convulsive epilepticus state resistent to benzodiazepines. She was put on fosphenytoine (Prodilantin) with enhanced sedation, then on levetiracetam (Keppra) clinically for sedation seizures. On 02-Sept-2010, she was found in epilepticus state regressing under high doses of thiopental-sodium (Pentothal). After Pentothal was discontinued, no more signs of status epilepticus but presence of spike and waves discharges. On 02-Sept-2010, tracheal aspirates from 29-Aug-2010 showed Pseudomonas aeruginosa and lack of Acinotobacter leading to stopping antibiotherapy on 31-Aug-2010 with imipenem cilastatine (Tienam) and amikacine (Amiklin) both at day 3 substituted by ceftazidine (Fortum) on 01-Sept-2010. Lyme disease in CSF, direct examination and HIV serology were negative. The patient was apyretic. Repeat EEG on 02-Sep-2010 found no convulsive activity. On 07-Sep-2010, she was tracheotomized to allow respiratory weaning. On 09-Sep-2010, despite treatment with levetiracetam (Keppra), phenobarbital (Gardenal) and lorazepam (Temesta) for catatonia, the patient experienced clinical clonic episodes after each lifting of sedation confirmed by EEG. Hypothesis of autoimmune limbic encephalitis was discussed. Treatment with Tegeline 2 g/kg for 5 days was started on 09-Sep-2010 with clinical reassessment. On 09-Sep-2010, she was apyretic after 7 days treatment with Fortum for pseudomonas aeruginosa in tracheal aspirates. Partial fits observed on EEG on 13-Sep-2010. On 16-Sep-2010, Pseudomonas aeruginosa found in tracheal aspirates on 06-Sep-2010 and enterococcus faecium was marked in urine test of 10-Sep-2010. Since 16-Sep-2010, these bacteria were treated with meropenem trihydrate (Meronem) and linezolide (Zyvoxid), central venous line was removed and urinary catheter changed. Daily EEGs showed a discontinuation of status epilepticus, persistent track of diffuse brain-damage, presence of some epileptic seizures depending on the day and lack of reactivity. Prodilantin treatment was reintroduced on 21-Sep-2010 due to new seizures. MRI scan on 21-Sep-2010 was normal. On 21-Sep-2010, she was transferred to intensive care. On arrival in ICU, she was intubated, sedated, hemodynamics was stable, she was put on assisted ventilation in low Fi02, without obvious abnormality at physical examination and she was apyretic. She did not convulse clinically. Progression in intensive care: from a neurological standpoint, she was in status epilepticus resistent to Keppra, Hypnovel, Prodilantin and Gardenal. Reintroduction of Pentothal was decided and seizures stopped after bolus treatment, then intravenous infusion through syringe driver. On 27-Sep-2010, she was placed in barbiturate coma 1g/h to avoid seizures or paroxysm on EEG. With lower doses of barbiturates, periodic bursts were found on EEG due to persistence of encephalitic-like brain-damage. Unfortunately, on 29-Sep-2010 her status worsened with cystolitic hepatitis, hepatocellular insufficiency, lactic acidosis and hyperkalemic and acute renal failure (complicated by cardiac conduction disorders). On 30-Sep-2010, investigations of CSF, HIV, CMV, EVB, HSV1, HSV2, VZV, Herpes virus 6, enterovirus, polyomavirus and bacteriology were negative. The immunological exploration in CSF and serum showed negative antiGAD65. Laboratory tests showed hypertriglyceridemia. On 04-Oct-2010, high dose corticotherapy was initiated with Solumedrol bolus 1g/30 min for 3 days. A new course of human normal immunoglobulins (Tegeline) was considered but not possible due to continued hemofiltration for acute renal insufficiency. A ketogenic diet was initiated on 06-Oct-2010. Bolus of solumedrol was initiated again on 9-Oct-2010 (500 mg/30 min) repeated 3 days. On 17-Oct-2010, while the patient was under 350mg/h of Pentothal, EEG showed again a low veiled recording, overloaded by diffuse spikes either isolated or in short bursts. Treatment with Zonegran was advised. There was no obvious favorable neurological outcome. From hemodynamic, renal and infectious respiratory standpoint, the patient promptly presented with septic shock with acute respiratory distress syndrome and presence of Pseudomonas aeruginosa resistant to imipenem in tracheal aspirates. An extended spectrum beta lactamase (ESBL) was found in tracheal aspirates and vaginal secretions. A thoracic, abdominal and pelvic injected CAT-scan did not find evidence of deep focus. Ketogenic diet initiated was complicated by hepatic and renal intolerance with hepatocellular insufficiency, acute anuric and hyperkalemic renal insufficiency (with cardiac repercussions) requiring continuous hemofiltration (PRISMAFLEX) on 08-Oct-2010. After diet was discontinued hepatic cytolysis and prothrombin time regressed but the patient did not recover effective renal function, she was still anuric. She experienced gastrointestinal obstruction. On 17-Oct-2010, the patient''s condition deteriorated with a right pneumonia. She was febrile under Prisma. Tracheal aspirates were positive to multiresistant Pseudomonas aeruginosa. Blood culture was positive to enterococcus faecium. She had severe diarrhoea. Antibiotherapy was adjusted. The outcome was not favorable with new acute respiratory distress syndrome followed by septic shock. On 19-Oct-2010, the patient was found to have multi-organ failure. On 20-Oct-2010, arterial PH was 6.87under Prisma, intensive reanimation was initiated (protective ventilation, catecholamines, Prisma, anti-infection treatment). Patient died in the evening. In conclusion: malignant epileptic seizure, autoimmune limbis encephalitis evoked, initial psychiatric symptoms, induced barbituric coma, early failure of ketogenic diet (hepatic intolerance), strong immunosuppression induced by barbiturates and corticotherapy, sceptic shock with initial pulmonary and digestive trigger, acute respiratory distress syndrome, multi-organ failure. Immu?nological and bacterial lab sample did not provide diagnosis orientation. Autopsy report showed no lesions suggestive of negative anti-PrP immunohistochemistry (Spibio, 12F10, 1/200th) and negative Western Blot. She was diagnosed with malignant neuroleptic syndrome associated with sepsis and meningitis. The patient had presented with a malaise following severe alcohol intoxication. This info was not reported by the general practitioner who provided medical assistance to the patient that day. Follow up information has been received from Sanofi Pasteur MSD on 20-FEB-2015.FU on 17-Feb-2015 from lawyer: Cerebral biopsy on 22-OCT-2010: Analysis of 26 samples on left cerebral hemisphere. Western Blot test for prion protein on right cerebral hemisphere negative on 10-FEB-2011. Creutzfeldt-Jakob disease ruled out, absence of spongiform encephalopathy, data in favor of meningoencephalitis diagnosis. Immunohistochemistry confirms diagnosis of meningitis associated with diffuse microgliosis, presence of B and T cells on leptomeningeal area. No toxicological titration on brain sample during the autopsy. FU received from Sanofi Pasteur MSD on 11-SEP-2015. FU on 8-Sep-15 from lawyer: Consultation on 28-Sep-05: nervousness. F/U information has been received from the patient''s parents via reposted online article. It was reported that the patient was mown down by the GARDASIL and that the vaccine killed their daughter. It has been determined that case #FR-009507513-1812FRA003087 is a duplicate of case #FR-009507513-1206USA03351. Therefore, case # FR-009507513-1812FRA003087 is being deleted from our files and the cases are consolidated into case #FR-009507513-1206USA03351.; Reported Cause(s) of Death: Meningoencephalitis; Neuroleptic malignant syndrome; Sepsis; Autopsy-determined Cause(s) of Death: Meningoencephalitis; Neuroleptic malignant syndrome; Sepsis


VAERS ID: 813968 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. R006069 / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: Anaphylactic shock, Asthenia, Chest pain, Chills, Death, Dizziness, Encephalitis allergic, Haemolytic anaemia, Headache, Hypersensitivity, Hyperuricaemia, Intensive care, Nausea, Pyrexia, Vomiting
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131905CHN004395

Write-up: anaphylactic shock / headache, dizziness, chills, fever, accompanied with general asthenia, chest pain, nausea and vomiting; allergical encephalitis; hemolytic anemia; hyperuricemia; the patient died / unknown cause of death; This spontaneous report was received from the regulatory authority and refers to a 23-year-old female patient. The patient''s concurrent conditions and concomitant medications were not provided. The patient did not have a history of allergy. On unknown dates, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot # R006069, expiration date not reported but upon internal validation established as 27-SEP-2020) and had no adverse event. On 19-APR-2019, the patient was vaccinated with the third dose using the same lot number of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, for prophylaxis (strength, dosage schedule and route of administration were not provided). On the same day, 9 hours after vaccination, the patient had headache, dizziness, chills, fever, accompanied with general asthenia, chest pain, nausea and vomiting. It was specified that the patient experienced allergy after injecting with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The patient was hospitalized because of anaphylactic shock and she was transferred to ICU on 21-APR-2019 at 02:00. The admission diagnosis were anaphylactic shock, hemolytic anemia and hyperuricemia. On 22-APR-2019, the hospital organized an experts consultation and then, the patient took an improvement of the disease, and was transferred to common ward (general sickroom) on 24-APR-2019. On 30-APR-2019, the patient''s disease exacerbated, and the patient was transferred to ICU of a second hospital. On 04-MAY-2019, the patient was transferred back to the first hospital, critically ill with mortality risk. The discharge diagnoses included: allergical encephalitis, hemolytic anemia and hyperuricemia. At this time of the report, the outcome was reported as not recovered. On 07-MAY-2019, the relatives gave up the treatment because of no improvement of the disease, the patient was under critical condition and vital signs were extremely unstable. On 11-MAY-2019 at 21:00, the patient died due to unknown reasons and an autopsy had not been conducted. The reporter considered encephalitis allergic to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL); however, no assessment was provided for the patient''s death, anaphylactic shock, hemolytic anemia and hyperuricemia. It was reported that the relatives submitted "vaccine abnormal response" survey application and requested compensation as soon as possible. Additional information has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 815213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-11
Onset:2019-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. R028276 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death, Dizziness, Endotracheal intubation, Feeling cold, Injection site pain, Muscular weakness, Peripheral coldness, Sensory loss, Shock, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), 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) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131905CHN007162

Write-up: lower limb weakness; whole body cold; dizziness; sensory loss of lower limb; sudden death; she experienced shock; coma; coldness of lower extremities; injection site pain without red swelling; This spontaneous report as received from a regulatory authority refers to an adult, currently 37-years-old female patient. No information regarding the patient''s pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 11-MAY-2019, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # R028276, expiration date 22-FEB-2021 (dose, frequency and route of administration were not provided) for prophylaxis. On 11-MAY-2019, reported as on the night of the vaccination, the patient experienced injection site pain without red swelling and coldness of lower extremities. On 12-MAY-2019 (reported as on the next day), around 17:00, the patient had lower limb weakness, dizziness, whole body cold and clear consciousness. She was sent to the hospital''s emergency department, where she had clear consciousness and lost sensory of lower limb. When the doctor took her a physical examination, she experienced shock and coma, then she was given an intubation, adrenaline hydrochloride injection, dopamine (reported as domamine) hydrochloride injection, a continuous infusion of sodium chloride through a syringe pump and sodium bicarbonate injection by intravenous drip for rescue. On 12-MAY-2019, at 19:00, the rescue was invalid and the patient died. The cause of death was reported as sudden death. It was unknown if the autopsy was performed. The outcome of the events of injection site pain, coldness of lower extremities, lower limb weakness, dizziness, whole body cold, sensory loss of lower limb, shock and coma was unknown. The relatedness between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided. Upon internal review, the events of shock and coma were determined to be medically significant.; Reported Cause(s) of Death: sudden death


VAERS ID: 827739 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-31
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: CO0095075131908COL001519

Write-up: On the day before the reporting time, she died. They attribute the reaction to the vaccine; the complications that caused her death; This spontaneous report was received from an unspecified reporter, via a company representative, referring to a 14 year old female patient. The patient''s pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. Approximately in 2014 (reported as "at the age of 9-year-old"), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient had an unspecified reaction which "they" attributed to the vaccine; the complications that caused her death (vaccination complication). She died on 31-JUL-2019 (reported as "on the day before the reporting time"). It was unknown if an autopsy was performed. The reporter considered vaccination complication to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).; Reported Cause(s) of Death: They attribute the reaction to the vaccinate; the complicalions that caused her death


VAERS ID: 837420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiopulmonary failure, Death
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL000718

Write-up: CARDIORESPIRATORY FAILURE; This spontaneous report as received from a regulatory authority refers to a female patient (age reported as 16 (units not provided). No information on patient''s concurrent conditions, medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose reported as 4 (lot#, expiration date, route of administration were not provided) for prophylaxis. On an unknown date, the patient experienced cardiorespiratory failure. The outcome of the event was reported as fatal. The patient died on an unknown date, it was unknown if an autopsy was performed. The relatedness between the event and the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.; Reported Cause(s) of Death: CARDIORESPIRATORY FAILURE


VAERS ID: 845185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131910NZL016991

Write-up: Gardasil kills three girls; This is a social media spontaneous report which has been received from a freelance research and writer, who wrote and article concerning to a female patient of unknown age. The patient''s medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose, frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The reporter stated that, on an unknown date, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) killed the patient (death). In addition, it was unknown if an autopsy was performed. The causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the patient''s death was reported as related. This is one of several cases provided by the same reporter.; Sender''s Comments: NZ-009507513-1911NZL000272: NZ-009507513-1911NZL000270: NZ-009507513-1911NZL000271:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 845186 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131911NZL000271

Write-up: Gardasil kills three girls; This is a social media spontaneous report which has been received from a freelance research and writer, who wrote and article concerning to a female patient of unknown age. The patient''s medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose, frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The reporter stated that, on an unknown date, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) killed the patient (death). In addition, it was unknown if an autopsy was performed. The causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the patient''s death was reported as related. This is one of several cases provided by the same reporter.; Sender''s Comments: NZ-009507513-1910NZL016991: NZ-009507513-1911NZL000272: NZ-009507513-1911NZL000270:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 845187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131911NZL000272

Write-up: Gardasil kills three girls; This spontaneous information has been received from a freelance research and writer, who wrote and article concerning to a female patient of unknown age. The patient''s medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose, frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The reporter stated that, on an unknown date, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) killed the patient (death). The causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the patient''s death was reported as related. This is one of several cases provided by the same reporter.; Sender''s Comments: NZ-009507513-1910NZL016991: NZ-009507513-1911NZL000271: NZ-009507513-1911NZL000270: NZ-009507513-1911NZL000271: NZ-009507513-1911NZL000270:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 848661 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Glioblastoma, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131911AUS007603

Write-up: Glioblastoma; pyrexia; Information has been received from a regulatory authority freedom of Information Act, on 07-NOV-2019 (Agency reference# AU-TGA-0000468362) referring to a 11 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, frequency, route, lot # and expiration date were not reported) and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX) for prophylaxis. On an unknown date, the patient experienced glioblastoma and pyrexia. The outcome of the events was reported as death. It was unknown if an autopsy was performed. The causality assessment between the events and suspect vaccines was not reported. Upon internal review, glioblastoma was determined to be medically significant.; Reported Cause(s) of Death: Glioblastoma; pyrexia


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