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From the 4/23/2021 release of VAERS data:

Found 380 cases where Vaccine is HPV4 and Patient Died



Case Details (Sorted by Submission Date)

This is page 8 out of 38

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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


VAERS ID: 850365 (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: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: BR0095075131911BRA011738

Write-up: a 9-year old girl that died after 11 days of the vaccination; manufacturer origin unknown; This spontaneous report was received from a physician via companies referring to a 9 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, route, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient died after 11 days of the vaccination. It was unknown if the autopsy was done. The causality assessment was not provided. The case is cross referenced to the case 1911BRA011806 due to receive from the same reporter.; Sender''s Comments: US-009507513-1911BRA011806:


VAERS ID: 864395 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Infertility, Premature menopause
SMQs:, Fertility disorders (narrow), Immune-mediated/autoimmune disorders (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: CH0095075132003CHE002445

Write-up: Gardasil has been associated with numerous deaths and over 8000 adverse reactions; 8000 adverse reactions; Gardasil is now said to adversely affect ovarian function; woman in question become infertile; This spontaneous report has been received from an unspecified reporter via a company representative from an online article referring to an unspecified number of patients of unknown age and gender. Information regarding the patient''s medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, numerous deaths were associated with vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). Over 8000 adverse reaction and unspecified number of dramatic side effects were were associated with vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). It was mentioned that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) affect ovarian function and that can cause female patients to experienced adverse events that had not been expected, in addition it was also stated that might be a connection between vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and a very severe premature ovarian failure which was further described as premature menopause where the ovaries stop working, no more oocytes mature and where the woman in question becomes infertile. According to the article, since 2006, 213 reports were published regarding amenorrhea and ovarian failure and that 88% of these were linked to vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). The outcome of death was reported as fatal. The outcome of adverse reaction, infertility and ovarian failure was unknown.


VAERS ID: 880476 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-05-18
Onset:2017-06-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2020-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. M037303 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Acute haemorrhagic leukoencephalitis, Agitation, Anaphylactic reaction, Anti-NMDA antibody, Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood creatinine, Blood electrolytes, Blood test, Blood urea, Brain stem syndrome, C-reactive protein, CSF pressure, Central nervous system injury, Cerebral hypoperfusion, Chest X-ray, Coma scale normal, Computerised tomogram head, Confusional state, Cyanosis, Death, Encephalitis, Endotracheal intubation, Full blood count, Fundoscopy, General physical health deterioration, Hypertension, Intensive care, Intracranial pressure increased, Lethargy, Magnetic resonance imaging brain abnormal, Malaise, Meningitis, Mydriasis, Oral herpes, Pallor, Pupil fixed, Pyrexia, Rash, Resuscitation, Seizure, Tachycardia, Tryptase, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypertension (narrow), Demyelination (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-08
   Days after onset: 734
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075132008AUS010299

Write-up: 4 days of history of unwell, fevers, vomiting and lethargy and pt appeared to have a cold sore on his left lower lip,Pt to be having what appears to be a seizure; Information was obtained on a request by the Company from the Agency via a public case detail reported by a physician concerning 12-year-old male patient. The patient''s concurrent conditions, medical history, concomitant medications were not reported. On 18-MAY-2017, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) via intramuscular route, lot no. M037303, expiration date was not reported, but upon internal validation established as 07-APR-2019 (dose, strength, indication and anatomical location were not reported). From 01-JUN-2017 (18 days after onset of therapy) to 04-JUN-2017, the patient was unwell for 4 days, with fevers, vomiting and lethargy. Patient''s family members also had similar symptoms. The patient appeared to have a cold sore on his left lower lip. On 04-JUN-2017 at 23:00, parents were alerted by patient''s sister that patient was making strange noises. The parents noted the patient to be having what appears to be a seizure. The patient turned blue and patient''s father performed cardiopulmonary resuscitation (CPR). The patient was taken to


VAERS ID: 882193 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-02-21
Onset:2020-08-28
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2020-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. R023497 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Chest discomfort, Death, Dengue virus test negative, Dizziness, Fall, Illness, Loss of consciousness, Malaise, Nausea, Pallor, Resuscitation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-08-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: GARDASIL SYRINGE (DEVICE)
Current Illness: Fever (High fever 39 degree Celsius); Illness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200829; Test Name: dengue fever; Test Result: Negative
CDC Split Type: TH0095075132008THA015004

Write-up: first dose of Gardasil on 21-FEB-2020, second dose on 28-AUG-2020; Physician tried to do CPR but could not help. The daugther died at 02:00am/ Patient''s father informed that she may die of hear failure; fell down; became unconscious.; It was believed that she may allergic to vaccine; she got pale on mouth and face; came back home and got sick; she had vomiting; chest tightness; Dizziness; Nausea; This spontaneous report was received from a consumer via company representative thru social media regarding a female patient who would be 11-year-old at the reporting time. The patient''s concurrent conditions include fever of 40 Celsius degrees and illness. There was no information about patient''s concomitant medications or pertinent medical history. On 21-FEB-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, anatomical location, lot number and expiration date were not reported) as vaccination against cervical cancer. On 28-AUG-2020 (reported as last Friday), the patient went to school and had fever if 39 Celsius degrees and illness. The patient''s teacher asked her to sleep for rest until around 14:00 hours. At that time, the patient was in a queue where the health worker provided her the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot number R023497, expiration date not reported but upon internal validation established as 08-JAN-2021 (dose, route and anatomical location were not reported) as vaccination against cervical cancer. Until the evening, her uncle picked up her from school and went back home as usual. This patient stayed with uncle and grandmother due to parent were working. Around 16:00 hours, the patient''s mother picked up her to come back home at a different district. On 28-AUG-2020, the patient complained that she had nausea, dizziness and chest tightness (chest discomfort). The mother thought that this was normal sickness, so she gave to the patient an unspecified medicine and some rest. Mother had asked for her daughter''s symptom and the patient told that she was getting better. On 29-AUG-2020 (reported as Saturday), the patient went to school as normal until 8.00 hours; the patient was very sick (malaise), she got pale on mouth and face (pallor) and the teacher took the patient back home. Then, the patient was referred to see the physician at the hospital. After physician interviewed the patient''s history, the patient informed that the school had provided vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the temperature was high around 39 Celsius. Then, a blood test for testing dengue fever was performed but the result was negative. Therefore, the physician prescribed unspecified medicine and the patient came back for rest at home. While resting at home, the patient had continuous vomiting and chest tightness. her parents took care of her and asked her for symptoms until midnight of 29-AUG-2020, the patient had heavy vomiting and vomited in the bathroom. The parents called her many times, but the patient did not reply. Therefore, when the parents opened the door and they saw that the patient felt down (fall) and became unconscious (loss of consciousness). They took the patient to the hospital. The physician tried a cardiopulmonary resuscitation (CPR) but could not help. The patient died on 30-AUG-2020 at 02:00 hours. The patient''s father stated that she might have died of heart failure. It was reported that an autopsy was performed, however the results were not provided. It was also reported that it was believed that the patient could be allergic to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (allergy to vaccine). At the time of the report, the outcome of loss of consciousness, vomiting, malaise, pallor, allergy to vaccine, nausea, dizziness, fall and chest discomfort was unknown. The event of allergy to vaccine was related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). The relatedness between the events of cardiac failure, loss of consciousness, vomiting, malaise, pallor, nausea, dizziness, fall and chest discomfort and therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported. Upon internal review, cardiac failure and loss of consciousness were determined to be medically significant event. combinationproductreport: Yes; brandname: GARDASIL SYRINGE (DEVICE); commondevicename: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R023497; expirationdate: 08-JAN-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Reported Cause(s) of Death: heart failure


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