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Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient developed severe arm pain at the injection site. At the time of this report, the outcome of the event was unknown. No further details were provided. Additional information has been requested. 01/05/07: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician and a nurse concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced severe arm pain at the injection site. There was no redness and no swelling. The nurse reported that the pre-filled syringe "popped" when attempting to use it, causing the patient pain. The nurse then used another syringe which "worked fine". At the time of this report, the patient had not yet received her second vaccination. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a midwife registered nurse concerning a female with genital warts who "within the last few weeks" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included imiquimod (Aldara). Subsequently "within the last few weeks" the patient experienced "swelling in genital warts". At the time of the report the patient was recovering. Unspecified medical attention was sought. Other information has been requested. | ||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Information has been received from a registered nurse concerning a female who on 24 Oct 2006 was vaccinated with Gardisil (yeast) (Lot #654540/0800F). The nurse reported that on 24 Oct 2006 the pre-filled syringe of the vaccine malfunctioned and small amount sprayed out of the syring while she was withdrawing the syringe and the patient received an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt." Unspecified medical attention was sought. At the time of this report the patient''s outcome was unknown. Additional information has been requested. 01/05/2007 Information has been received from a registered nurse concerning a 18 year old female who at 12:30 on 24-OCT-2006 was vaccinated intramuscularly in the deltoid with GARDASIL (Lot#654540/0800F). The nurse reported that on 24-OCT-2006 the pre-filled syringe of the vaccine malfunctioned and a small amount sprayed out of the syringe while she was withdrawing the syringe and the patient received an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt". Unspecified medical attention was sought. At the time of this report the patient''s outcome was unnknown. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a triage nurse concerning a female (age unknown) with no other pertinent medical history reported. On approximately 17 Oct 2006, the patient was vaccinated with a 0.5mL dose of Gardisal (yeast). There were no concomitant medications reported. On an unspecified date, the patient contacted the nurse complaining about pain and swelling of the lymph nodes, in the groin area on her right side. Unspecified medical attention was sought. At the time of this report, the outcome of the events were unknown. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a female who was vaccinated IM with a 0.5ml first dose of Gardisal. Approximately 3 to 4 days after the vaccination, the patient experienced "myacitis", malaise and flu like symptoms and went to the emergency room. Subsequently, the patient recovered. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a health professional concerning a 17 year old female with no medical history or allergies, who on 20 Aug 2006 and 20 Oct 2006 was vaccinated IM with a first and second 0.5mL dose of Gardisal (yeast), respectively (first dose lot # 654540/0800F and second dose lot # 653736/0868F). There was no concomitant medication. On 20 Aug 2006, the patient experienced nausea and emesis. On 20 Oct 2006, the patient again experienced immediate nausea and vomiting. On 21 Oct 2006 the patient experienced low grade fever. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered from emesis. At the time of this report, the patient''s low grade fever persisted and the outcome of nausea was unknown. No product quality complaint was involved. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a Registered Nurse concerning an adult patient who was vaccinated with a dose of Gardisal. The patient complained of pain while being injected using the prefilled syringe. The nurse reported that another patient did not complain of pain when a "normal" syringe was used. The nurse suggested the pre-filled needles may be dull causing pain during injection. The patient''s out come was not reported. A product quality complaint was involved. No further information is available. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a nurse practitioner concerning a female who was vaccinated intramuscularly with a dose of Gardisil. The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." Unspecified medical attention was sought. At the time of the report, the patient''s outcome was unknown. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 12 year old female who on 11 Oct 2006 was vaccinated with the first dose of 0.5mL of Gardisil (Lot # 653937/0637F). On 21 Oct 2006, the patient developed a know on the arm with no rash and no redness. On 24 Oct 2006, the patient developed throbbing pain around the arm that the injection was administered. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 16 year old female patient who on 28 Aug 2006 was vaccinated with a first dose of Gardisil. On 28 Aug 2006 the patient experienced vomiting within four hours of receiving the vaccination. Outcome was not reported. On 25 Oct 2006, the patient was vaccinated with a second dose of Gardisil. On 25 Oct 2006 the patient experienced vomiting within four hours of receiving the vaccination. On 25 Oct 2006, the patient recovered from vomiting. Additional information has been requested. Initial and follow-up information has been received from a physician and a licensed practical nurse concerning a 16 year old female patient who on 28-AUG-2006 was vaccinated with a first dose of GARDASIL 0.5 ml IM. On 28-AUG-2006, the patient experienced vomiting within four hours of receivng the vaccination. The patient recovered on 28-AUG-2006. On 25-OCT-2006, the patient was vaccinated with a second dose of GARDASIL 0.5 ml IM. On 25-OCT-2006 the patient experienced vomiting within four hours of receiving the vaccination. The mother felt that the vomiting was flu related for the first dose, however the vomiting happened again after the second dose. The patient recovered on 25-OCT-2006. No additional information is expected. | ||||||||||||||||||||
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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=25&VAX[]=HPV2&VAX[]=HPV4&VAX[]=HPV9&VAX[]=HPVX&VAXTYPES=HPV&SUB_YEAR_HIGH=2017&SUB_MONTH_HIGH=10
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