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Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: death was unconvincingly blamed on Gardasil; This spontaneous report was received from a physician via social media and refers to a 19 year old female patient. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. 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)(GARDASIL 9) (dose, dose number, route, vaccination site, lot# and expiration date were not reported), for prophylaxis. On an unknown date, the patient died (death). The cause of death was not reported and it was unknown if an autopsy was performed. The reporter considered the patient''s death to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) as he stated that the patient''s death was unconvincingly blamed on the vaccine. | ||||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: died; Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) (dates were not reported). Subsequently the patients died, the cause of death was unknown. This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients. Additional information has been requested. This is an amended report: HCP confirmed has been changed to no for regulatory consumer. Company Causality Assessment: Episode Profile: Medically Confirmed: N | ||||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: girl dies hours after getting HPV vaccine; This spontaneous report as received from a journalist refers to a female patient of unknown age. No information regarding the 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) (lot number, expiration date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, hours after getting HPV vaccine, the patient died. It was unknown if an autopsy was performed. The relatedness between the patient''s death and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported. | ||||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: HPV vaccine used for hands warts; This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 50 year old male patient. The patient''s pertinent medical history included therapy with liquid nitrogen, curettage and topical fluoracil (reported as 5-FU). The patient''s current conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported). The authors informed that on an unspecified date, the patient died due to natural causes. A copy of the published article is attached as further documentation of the patient''s experience. This is one of several reports received from the same literature. Sender''s Comments: US-009507513-1912USA001729: | ||||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: HPV vaccine used for hands warts; Literature Report:. This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 50 year old male patient. The patient''s pertinent medical history included therapy with liquid nitrogen, curettage and topical fluoracil (reported as 5-FU). The patient''s current conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported). The patient''s immune status was reported as none. The patient was followed up for treatment for 2 months. The authors informed that on an unspecified date, the patient died due to natural causes. A copy of the published article is attached as further documentation of the patient''s experience. This is one of several reports received from the same literature. Follow-up information was received via telephone call on 02-APR-2020. A request was made for patient identifiers, events experienced and causal relationships.; Sender''s Comments: US-009507513-1912USA001729: | ||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a gynecologist concerning a 19 year old female with no previous medical history reported, who on 19-SEP-2007 was vaccinated (route and site not reported) with the 1st dose of Gardasil (Batch# NF37120, lot#1475F). On the morning of 12-OCT-2007, the patient was found dead in her bed. One week prior to death the female suffered from diarrhea, treatment without antibiotics. The patient also developed light sensitivity. The evening before the patient died she was out with a girlfriend until 3:00 am in the morning. The reporting physician excluded any drug misuse, as she knew the female as a sportive young woman. Contraception was stopped 3 months before vaccination. No reason for the death was detected in autopsy. The only finding in the autopsy was mild bronchitis and mucus. The reporting physician excluded any connection between vaccination and death. Other business partners numbers include E2007-08849(0). Additional information is not expected. | ||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a health professional concerning a 42 year old female who on 12 Apr 2008 was vaccinated with GARDASIL. Prior to the vaccination, the patient was reported looking weak and lost weight. On 14 Apr 2008, the patient returned to the clinic and complained of abdominal pain and bleeding. The patient was treated with painkillers for abdominal pain and advised to return if pain persists. The patient never came back. The second dose was due on 12 Jun 2008 but the patient did not turn up. On 14 Jun 2008, the clinic was informed that the patient had died. The cause of death was unknown. The reporter felt that abdominal pain, bleeding and death were not related to therapy with GARDASIL. No further information is available. | ||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a physician concerning a 20 year old female with no relevant medical history reported who was vaccinated with a first dose of GARDASIL on an unspecified date. Subsequently, exact onset not reported, the patient felt unwell. About 6 weeks post vaccination, she experienced pulmonary embolism with fatal outcome. An autopsy is scheduled. Other business partner numbers included: E2008-05832. Additional information has been requested. | ||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a general practitioner concerning an 18 year old female with pollen allergy, allergic asthma and who was overweight, with a family history of the mother having multiple sclerosis, who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL, lot # not reported, which was well tolerated. It was reported that the second dose of GARDASIL, lot # not reported, was given intramuscularly (IM) to the right deltoid on 21-APR-2008. Concomitant therapy included SERETIDE, albuterol, NASACORT and KESTINE. There was no contraceptive use. On 16-JUL-2008 the patient experienced sudden brutal cephalgia and then she suffered from a pain evocating an aneurysm during rupture. The patient suddenly died in spite of resuscitation technique performed by the agency which evoked a ruptured aneurysm. An autopsy was on-going and the results would be provided. As to the reporter there may not be any link between adverse effect and vaccination. The reported cause of death by the ageny was ruptured cerebral aneurysm, but it had not been confirmed yet by the results of the autopsy which were still pending. Additional information has been requested. Other business partner numbers include E2008-11575. | ||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a health authority (reference # PEI2009000661) concerning a 15 year old female who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL, lot #1427U (batch #NH15200) IM into the left upper arm. No information regarding toleration was given. On 29-DEC-2008, the patient was vaccinated with a second dose of GARDASIL, lot #1316U (batch #NH45640) IM into the left upper arm. On 30-DEC-2008 the patient died. According to the preliminary report, the autopsy showed no acute or chronic organic disease. The possibility of carbon monoxide intoxication was not yet ruled out. Investigation by public prosecution is ongoing. Lot checks have been requested. Other business partner numbers included: E2009-00404. Additional information has been requested. | ||||||||||||||||||||
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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=17&SYMPTOMS[]=Death_%2810011906%29&VAX[]=HPV4
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