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Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Information has been received from a nurse practioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional has been requested. 01/05/2007 Information has been received from a nurse practitioner concerning a 22 year old female patient who on 06-SEP-2006 at 14:00 was vaccinated with the first dose of GARDASIL (Lot# 653650/0640F). Subsequently, the patient fainted 30 minutes post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink(soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested. | ||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Information has been received from a 28 year old female patient with epilepsy, asthma and an allergy to carbamazepine (TEGRETOL) who on 18-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO), lorazepam, "lomectol," zolpidem tartrate (AMBIEN), and fluticasone propionate (FLOVENT). The patient stated that since her vaccination she has been experiencing dizzy, tired, has headaches and felt nauseous. No medical attention was sought. As of the report date the patient has not recovered. Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning the patient with a seizure disorder who on 18-SEP-2006 at 9:50 a.m. received her second dose of GARDASIL, lot # 653937/0637F, in the left deltoid. The physician reported that the patient complained of right lower quadrant pain and mild nausea after receiving the vaccine. A pelvic sonogram was performed to rule out ovarian cyst. The patient had not yet recovered. Additional information is not expected. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a licensed practical nurse concerning a female patient with sulfonamide allergy who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced a fever for four days. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. This is a follow-up to report (s). Information has been received from a physician concerning his 19 year old daughter with a sulfonamide allergy and no other pertinent medical history reported. In August 2006, the patient was vaccinated with the first dose of GARDASIL by another health care professional. Concomitant therapy included EFFEXOR. In approximately August 2006, "about 4 days after being vaccinated", the patient developed a primary herpetic gingivostomatitis on her lips. The patient sought unspecified medical attention. All symptoms had resolved. At the time of this report. The patient had recovered from the event (date 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 17 year old female with no history of varicella virus vaccine live vaccination and an unknown history of varicella, who on 11-SEP-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The physician reported that on 12-SEP-2006 "the next day, the patient developed a low grade fever and a vesicular rash on her neck and shoulders of about 15-20 lesions." The patient was treated with acetaminophen (TYLENOL). All of her symptoms resolved within 3-4 days (approximately 15-SEP-2006). Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. 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 medical assistant concerning a 25 year old female with connective tissue disorder, thrombocytopenia, depression and allergy to ZITHROMAX who on 20-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) IM in the deltoid described as "pre-filled syringe one time." Concomitant therapy included escitalopram oxalate (LEXAPRO) and methylphenidate HCl (RITALIN). On 21-SEP-2006 the patient experienced fever of 100 degrees F. The patient sought unspecified medical attention. The patient''s fever of 100 degrees F. persisted. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a nurse practitioner concerning a female who on 18-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced injection site reaction. The patient sought unspecified medical attention. Injection site reaction persists. Additional information has been requested. | ||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered. | ||||||||||||||||||||
Administered by: Private Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 21 year old female who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient developed "swelling feet" for an unspecified amount of time after receiving the injection. At the time of this report the patient was recovering. 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 14 year old female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient experienced burning and pain at the injection site. Unspecified medical attention was sought. It was unknown at the time of the report if the patient had recovered. Additional information has been requested. | ||||||||||||||||||||
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