chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed fever and experienced chills and achiness after receiving vaccination. On approximately 24-JUN-2008, "within the last ten days" the patient was seen by emergency room physician. The outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 25-OCT-2007 was vaccinated with the first dose of GARDASIL (lot no. 659435/1265U).  On 01-JUL-2008 the patient was vaccinated with the second dose of GARDASIL (lot no. 660387/1967U).  On the same day, the patient became pale and stiff after receiving the second dose.  The patient was also non responsive and the symptoms lasted for 30-45 seconds.  The patient was recovered.  The patient sought unspecified medical attention in office.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician assistant concerning her 26 year old female friend with diagnosed cervical papilloma viral infection who in May 2008, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  In approximately May 2008, "within the past two months" the patient developed genital warts.  The patient had had two outbreaks.  The outcome was unknown.  The patient contacted her physician to seek unspecified medical attention.  Follow-up information was received from the physician assistant stating that the patient was her personal friend and she did not see the patient in clinic.  Further information was unknown.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her daughter, an 18 year old female with no known pertinent medical history or drug reactions/allergies who on 22-AUG-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM. The patient developed a fever after receiving the first dose of GARDASIL. There was no concomitant medication. On 23-AUG-2007 the patient recovered from fever. On 25-OCT-2007 the patient was vaccinated with a second dose of GARDASIL 0.5 ml IM. On 26-FEB-2008 the patient was vaccinated with a third dose of GARDASIL 0.5 ml IM. It was noted that all doses were administered "in hip". The patient sought medical attention in the office at a later visit. Additional information has been requested. The patient's sister also had an adverse experiences with vaccination with GARDASIL (WAES# 0807USA01027).
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 year old female patient with no pertinent medical history and no allergies who on 01-JUL-2008 was vaccinated with the third dose of GARDASIL (lot# 660555/0279X).  Concomitant therapy included hormonal contraceptives (unspecified).  On 02-JUL-2008 the patient experienced headache, chills and nausea.  The patient's headache and chills and nausea persisted.  No symptoms were reported from the first and second doses.  The patient sought medical attention and called the physician's office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a teenager female who was vaccinated with the first dose of GARDASIL.  The patient experienced dizziness after vaccination.  Subsequently, the patient recovered from dizziness.  The patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 31 year old female who was vaccinated with GARDASIL. The patient experienced severe  nausea and vomiting for about a week. The physician would not administer any more doses to the patient. The patient recovered from severe nausea and vomiting. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Incorrect route of drug administration, Injection site mass
Clinical narrative: Information has been received from a physician concerning a female who in approximately May 2008, was vaccinated with GARDASIL SC instead of IM.  On approximately 02-JUN-2008 the patient experienced discomfort.  The patient experienced a bump under the skin at the injection site on approximately 02-JUL-2008.  The patient's bump at the injection site and discomfort persisted.  The patient sought medical attention and called the physician's office.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Eye irritation, Eye pain, Headache, Pyrexia
Clinical narrative: Information has been received from a nurse and a nurse practitioner concerning a 14 year old female patient with no pertinent medical history and no allergies who on 26-JUN-2008 was vaccinated with GARDASIL 0.5 ml IM in the deltoid.  There was no concomitant medication.  On 26-JUN-2008 evening or 1-2 days later, the patient experienced a mild fever that came and went, headaches, pressure on the head and eye and eye pain.  On 02-JUL-2008 the patient developed a barky cough.  The patient's mild fever that came and went and headaches and pressure on the head and eye and eye pain and barky cough persisted.  The patient sought medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a teenager female who was vaccinated with the first dose of GARDASIL. The patient experienced dizziness after vaccination. Subsequently, the patient recovered from dizziness. The patient sought medical attention.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a teenaged female who was vaccinated with the first dose of GARDASIL.  The patient experienced dizziness after vaccination.  Subsequently, the patient recovered from dizziness.  The patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently, the patient developed fever and experienced chills and achiness after receiving vaccination.  On approximately 24-JUN-2008, "within the last ten days" the patient was seen by emergency room physician.  The outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Inappropriate schedule of drug administration, Nausea
Clinical narrative: Information has bee received from a 25 year old female patient with no pertinent medical history and concomitant medication who in approximately 2006 "at an unspecified time about 2 1/2 years ago by another provider was vaccinated with the first and second dose of GARDASIL. On 01-JUL-2008 the patient received the third dose of GARDASIL (frequency, therapy route and Lot# unspecified). On 03-JUL-2008, the patient developed tightness in her chest and a feeling of nausea two days after she received the third dose of GARDASIL on 01-JUL-2008. The patient has not sought treatment for the symptoms. The patient's adverse events persisted. No other symptoms or treatment reported. No other information provided. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter who on an unspecified date was vaccinated with a dose of GARDASIL.  On the same day, the patient was vaccinated with a dose of VARIVAX in the same arm.  Subsequently, the patient experienced swelling at the injection site, fever and lethargy.  Subsequently, the patient recovered.  The patient's mother called the physician to seek unspecified medical attention.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase, Blood lactate dehydrogenase, Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 28 year old female with no medical history or drug allergies who on 28-JAN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 659439/1267U) and on 07-APR-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 658558/1061U).  There was no concomitant medication.  On 07-APR-2008 the patient experienced pain at the injection site.  The patient had constant soreness and pain without redness or bruise.  The patient got worse when she moved her arm over her head.  At the time of this report, the patient's pain at the injection site persisted.  The patient was seen by the physician.  The patient did not have any symptoms when she received her first dose of GARDASIL (lot  # 659439/1267U).  No product quality complaint was involved.  Additional information has been requested.  Additional information was received from a registered nurse who administered the second dose of vaccine for the patient. According to the reporter, the patient had intermittent pain in the left arm for several months after the injection on 07-APR-2008. Erythema or edema was not reported. Laboratory test were performed (CPK, LDH, xray) but no results were reported. On an unspecified date, the patient recovered from the event. It was stated "The patient chose to continue series of requested third dose in left arm".  No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Pain in extremity, X-ray
Clinical narrative: Information has been received from a physician concerning a 28 year old female with no medical history or drug allergies who on 28-JAN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 659439/1267U) and on 07-APR-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 658558/1061U).  There was no concomitant medication.  On 07-APR-2008 the patient experienced pain at the injection site.  The patient had constant soreness and pain without redness or bruise.  The patient got worse when she moved her arm over her head.  At the time of this report, the patient's pain at the injection site persisted.  The patient was seen by the physician.  The patient did not have any symptoms when she received her first dose of GARDASIL (lot  # 659439/1267U).  No product quality complaint was involved.  Additional information has been requested.  Additional information was received from a registered nurse who administered the second dose of vaccine for the patient. According to the reporter, the patient had intermittent pain in the left arm for several months after the injection on 07-APR-2008. Erythema or edema was not reported. Laboratory test were performed (CPK, LDH, xray) but no results were reported. On an unspecified date, the patient recovered from the event. It was stated "The patient chose to continue series of requested third dose in left arm".  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the third dose of GARDASIL. The patient experienced tingling and numbness at midnight the same day of the vaccination. The patient went to the emergency room and was "discharged" several hours later. Unspecified tests were performed at the emergency room (results not reported). The patient sought unspecified medical attention by phone call. The patient did not have any problems with the first and second doses of GARDASIL. On an unknown date the patient recovered from tingling and numbness. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Lymphadenopathy, Myalgia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL (lot number was not provided). On 02-JUL-2008 the patient developed sore muscles all over, swollen lymph nodes underarm and a small patch of herpes zoster on her back. At the time of this report, the outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia of pregnancy, Drug exposure during pregnancy, Induced labour, Pre-eclampsia, Pregnancy induced hypertension
Clinical narrative: Information has been received through the Merck pregnancy registry from a licensed practical nurse at an OB/GYN office concerning a 13 year old female with asthma, sickle cell trait, cardiac murmur and no known allergies who in March 2008, was vaccinated with the third dose of GARDASIL at her primary health care provider's office.  The dates of the previous 2 doses of GARDASIL were unknown.  The patient was pregnant.  On 03-JUL-2008 the patient was seen in the office for her first obstetric visit.  The patient's last menstrual period was unknown.  Ultrasound confirmed the estimated delivery date is 24-AUG-2008.  Based on this, the patient's last menstrual period was estimated to be 15-NOV-2007.  The patient was anemic in the pregnancy.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up telephone information was received which reported that on 23-APR-2007, the patient received the first dose of GARDASIL, on 25-JUN-2007 received the second dose and on 29-OCT-2007 the third dose of GARDASIL. The patient conceived around 16-NOV-2007. The patient was induced on approximately 11-Aug-2008 at 37 weeks, 4 days for PIH (pregnancy-induced hypertension) /Pre-eclampsia-like symptoms. The baby was a little over 5 lbs, she couldn't remember exactly. She saw the baby last week, who was fine and well and has been given up for adoption to a relative of an office staff member. According to the nurse, the patient, seems to be doing well too. She had no further information to report. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry from a licensed practical nurse at an OB/GYN office concerning a 13 year old female with asthma, sickle cell trait, cardiac murmur and no known allergies who in March 2008, was vaccinated with the third dose of GARDASIL at her primary health care provider's office.  The dates of the previous 2 doses of GARDASIL were unknown.  The patient was pregnant.  On 03-JUL-2008 the patient was seen in the office for her first obstetric visit.  The patient's last menstrual period was unknown.  Ultrasound confirmed the estimated delivery date is 24-AUG-2008.  Based on this, the patient's last menstrual period was estimated to be 15-NOV-2007.  The patient was anemic in the pregnancy.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up telephone information was received which reported that on 23-APR-2007, the patient received the first dose of GARDASIL, on 25-JUN-2007 received the second dose and on 29-OCT-2007 the third dose of GARDASIL. The patient conceived around 16-NOV-2007. The patient was induced on approximately 11-Aug-2008 at 37 weeks, 4 days for PIH (pregnancy-induced hypertension) /Pre-eclampsia-like symptoms. The baby was a little over 5 lbs, she couldn't remember exactly. She saw the baby last week, who was fine and well and has been given up for adoption to a relative of an office staff member. According to the nurse, the patient, seems to be doing well too. She had no further information to report. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Genital haemorrhage, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry for GARDASIL from a physician (also reported as medical assistant) concerning an 18 year old female with no pertinent medical history and no history of drug reactions or allergies who on 11-JUN-2008 was vaccinated with GARDASIL (dose unspecified). Concomitant therapy included birth control pills (unspecified). Subsequently, the patient reported a positive home urine pregnancy test. The patient's last menstrual period was the last week in May 2008 (dates unspecified). However, the patient had menstrual spotting from 24-JUn-2008 to 25-JUN-2008. No other adverse symptoms or treatment reported. The reporter is the patient's gynecologist and the patient received the GARDASIL elsewhere. The estimated delivery date is 02-MAR-2009. The patient sought medical attention with a telephone call. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL IM (lot # not reported). On 16-JUL-2008 the patient fainted almost immediately after receiving vaccine. The patient took a little longer to come out of it than what they have seen in the past. Subsequently, the patient recovered from fainted immediately after receiving vaccine. The patient sought medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who on 01-JUL-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot # 660391/0063X). Concomitant therapy included hormonal contraceptives (unspecified). The patient developed a swollen, 2 cm, right, axillary lymph node, on the same side that she was vaccinated with her first dose of GARDASIL. She was referred to have an ultra sound of the area. At time of reporting, patient was not recovered. Unspecified medical attention was sought through a call to the office. Additional information has been requested. 9/23/08-records received for DOS 7/8/08-C/O lump under arm status post Gardasil. Right axilla small nodule questionable cyst. This is in follow-up to report(s) previously submitted on 8/14/2008, 1/7/2009.  Follow-up information has been received from a health professional who reported that the patient without a pertinent medical history on 11-SEP-2008, the patient received the second dose of GARDASIL (lot n. 660618/0572X) and on 20-JAN-2009, the patient received the third dose of GARDASIL (lot n. 661766/0652X), 0.5 mL intramuscularly.  Concomitant therapy included YASMIN (previously reported as hormonal contraceptives (unspecified).  The healthcare worker reported that the patient experienced a rash on her left leg, from her hip to her knee, after receiving the second dose of GARDASIL on 12-SEP-2008.  The patient was seen by the practice.  No labs were performed.  At time of reporting the patient recovered on an unspecified date.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old female who was vaccinated IM with a dose of GARDASIL. Concomitant therapy included tetanus toxoid (manufacturer unknown) received within the same visit. Unspecified medical attention was sought. Patient recovered on an unspecified date, swelling healed on its own with ice. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided) and fainted. It was reported that the patient recovered and went to an on site Pharmacy, where she had fainted for a second time. Unspecified medical attention was sought. At the time of this report the patient recovered from her experiences. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Swelling face
Clinical narrative: Information has been received from a female with allergies who on unspecified dates was vaccinated with two doses of GARDASIL (lot # not reported).  The consumer reported that "I'm having a fever and some swelling around the face but I think it maybe just my allergies".  The consumer also reported that "I will have my third dose of GARDASIL next week".  No further information was provided.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient female who in July 2008 was vaccinated with GARDASIL vaccine 0.5 mL IM. The physician reported that the patient fainted "last week" in July 2008 after receiving GARDASIL vaccine. The patient sought medical attention; she was seen in the physician office. ("AE occurred in the office"). There was no product quality complaint. No lab diagnostics were performed. On unspecified date the patient recovered. Additional information has been requested. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who was vaccinated with the third dose of GARDASIL vaccine 0.5 mL (Lot # 660393/0067X). The nurse reported that they kept the patient for approximately 10-15 minutes after administration and then on her way out, as she was passing the receptionist desk; she passed out and bumped her head. When she come to; she vomited. She was take to the ER, but the physician's office had not heard any follow up on her condition as of the time of the report. Additional information has been requested. This is one of several reports from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Thrombosis
Clinical narrative: Information has been received from a female concerning her 17 year old granddaughter who on unspecified dates was vaccinated with the complete series of GARDASIL.  About 7 months ago (in approximately 2008), the patient started to experience blood clots and severe pain on the lower part of her stomach on both sides and still hasn't recovered.  The patient was not hospitalized.  It was unspecified if the patient sought medical attention.  This is one of three reports from the same source.  (WAES: 0807USA03323 and 0807USA03552).  Additional information has been requested. 10/30/08-records received-on 1/30/08-received 3rd Gardasil injection. Depoprovera given. 3/5/08-C/O continuous bleeding on Depo, has been getting Depo for 3 years but just started bleeding everyday in the last two month. 3/28/08-C/O nausea, difficulty eating, low abdominal cramping heavy bleeding but no clots. Started birth control early March. 4/25/08-RLQ pain radiating to rectal area bleeding after intercourse. Now on Orhto EVRA patch and continues with Depoprovera. 6/19/08-Menometrorrhagia. Patient requests a D&C. 7/15/08-Post D&C now C/O pelvic pain and heavy bleeding. Polyp removed. 7/18/08-passed large clot and bleeding heavy again. Declines depo provera and mirena.
Sex: F
Vaccine: HPV4
Symptoms: Lactose intolerance
Clinical narrative: Information has been received from a nurse practitioner concerning one of three girls in the same family who "a few months ago" in 2008, were vaccinated with GARDASIL.  Subsequently the patient became lactose intolerant after receiving GARDASIL.  It was not specified whether the patient sought medical attention.  The patient's lactose intolerance persisted.  Additional information has been received from the nurse who called to confirm the information.  She will complete the form and send it back to Merck.  Follow up information was received which reported that the three girls in the same family became lactose intolerant after receiving GARDASIL.  This is one of several reports from the same source.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Cyst, Endometriosis, Thrombosis
Clinical narrative: Information has been received from a female concerning her 17 year old granddaughter who on unspecified dates was vaccinated with the complete series of GARDASIL. "Six months ago" (in approximately February 2008), the patient experienced severe pain on the lower part of her stomach. The patient was diagnosed of endometriosis and cyst that needed to be dissolved. The patient was not admitted to hospital but was brought to emergency room three times. The patient was still having big blood clots. This is one of three reports from the same source (WAES: 0807USA03323 and 0807USA3551). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lactose intolerance
Clinical narrative: Information has been received from a nurse practitioner concerning one of three girls in the same family who "a few months ago" in 2008, were vaccinated with GARDASIL.  Subsequently, the patient became lactose intolerant after receiving GARDASIL. It was not specified whether the patient sought medical attention.  The patient's lactose intolerance persisted.  Additional information has been requested.  This is one of several reports from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Gaze palsy, Pallor, Syncope, Tremor
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 20 year old female with no medical history or drug allergies who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included NUVARING.  Subsequently the patient felt weird, the patient then became pale and fainted.  The reporter stated that the patient's eyes rolled back, she was unresponsive and her arms and legs were shaking. The patient was sent to the emergency room but it was unknown what the patient was diagnosed with.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 20 year old female with no medical history or drug allergies who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included NUVARING.  Subsequently the patient felt weird, the patient then became pale and fainted.  The reporter stated that the patient's eyes rolled back, she was unresponsive and her arms and legs were shaking. The patient was sent to the emergency room but it was unknown what the patient was diagnosed with.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Eye infection, Herpes simplex, Keratitis, Scar, Uveitis
Clinical narrative: Information has been received from a consumer concerning her daughter a 21 year old female with penicillin allergy and sulfonamide allergy and no other medical history who in May 2008, was vaccinated with a first dose of GARDASIL. Concomitant therapy included a birth control medicine (name not provided). One week after receiving GARDASIL, the patient developed a bad eye infection in her left eye. The patient's vision with this eye had become worse and had a scar on this eye. Unspecified medical attention was sought. The patient was noted to be recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information was received form a physician which reorted the patient with amoxicillin allergy developed herpes simplex virus keratitis on 20-MAY-2008. At last on 11-JUL-2008, there was no known of aquried infection. Decreased vision was surveyed. Tapering medications was given. There was no known illness at the time of vaccination. The outcome of herpes simplex virus keratitis was not reported. Follow-up information was received from a primary physician reported that on 13-MAY-2008, the patient was vaccinated intramusculary with a first dose of GARDASIL into left arm (lot# 660387/1967U). On 20-MAY-2008, the patient developed keratitis and uveitis. Vision 20/100; herpes was not definitely diagnosed, but patient placed on one and a half weeks treatment of VALTREX. Conditions were not disabling or life threatening. On 11-JUL-2008 (after VALTREX was complete), the patient was seen by ophthalmologist (corneal specialist), whose consult note stated "compromised secondary to scarring", but reported vision as 20/20. The patient was seen again by physician on 22-JUL-2008, the patient doing fine (recovered). At next visit, the patient would have blood work done to check for herpes. The physician said there was absolutely no connected between the patient's eye disorder and GARDASIL use. This report no longer meets the criteria for expedited submission to the FDA. The AE term was changed from herpetic keratitis to keratitis and uveitis and was considered non serious. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Visual acuity reduced
Clinical narrative: Information has been received from a consumer concerning her daughter a 21 year old female with penicillin allergy and sulfonamide allergy and no other medical history who in May 2008, was vaccinated with a first dose of GARDASIL. Concomitant therapy included a birth control medicine (name not provided). One week after receiving GARDASIL, the patient developed a bad eye infection in her left eye. The patient's vision with this eye had become worse and had a scar on this eye. Unspecified medical attention was sought. The patient was noted to be recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information was received form a physician which reorted the patient with amoxicillin allergy developed herpes simplex virus keratitis on 20-MAY-2008. At last on 11-JUL-2008, there was no known of aquried infection. Decreased vision was surveyed. Tapering medications was given. There was no known illness at the time of vaccination. The outcome of herpes simplex virus keratitis was not reported. Follow-up information was received from a primary physician reported that on 13-MAY-2008, the patient was vaccinated intramusculary with a first dose of GARDASIL into left arm (lot# 660387/1967U). On 20-MAY-2008, the patient developed keratitis and uveitis. Vision 20/100; herpes was not definitely diagnosed, but patient placed on one and a half weeks treatment of VALTREX. Conditions were not disabling or life threatening. On 11-JUL-2008 (after VALTREX was complete), the patient was seen by ophthalmologist (corneal specialist), whose consult note stated "compromised secondary to scarring", but reported vision as 20/20. The patient was seen again by physician on 22-JUL-2008, the patient doing fine (recovered). At next visit, the patient would have blood work done to check for herpes. The physician said there was absolutely no connected between the patient's eye disorder and GARDASIL use. This report no longer meets the criteria for expedited submission to the FDA. The AE term was changed from herpetic keratitis to keratitis and uveitis and was considered non serious. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Angioedema, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who was vaccinated with the second dose of GARDASIL.  Subsequently the patient developed angioendemic urticaria.  At the time of this report, the outcome was unknown.  No product quality complaint was unknown.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Feeling abnormal
Clinical narrative: Information has been received from a healthcare worker concerning a 23 year old female who on unspecified dates, was vaccinated with three doses of GARDASIL.  After the first dose, the patient felt strange.  After the second dose, the patient felt weird.  After the third dose, the patient was curled up in a ball.  Subsequently on an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram ambulatory, Full blood count normal, Palpitations
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 14 year old daughter with adverse drug reaction to pertussis vaccine (caused muscle rigidity) who on 26-JUN-2008 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. Concomitant therapy included unspecified birth control medication. On 07-JUL-2008 the patient started to experience intermittent episodes of heart palpitations. The episodes of palpitation lasted from several minutes to a few hours and resolved without treatment. On 12-JUL-2008 the patient was evaluated in a local emergency room. A complete blood count was normal. A 24 hours Holter monitoring was performed (results pending). At the time of the report, the patient was still experiencing 1-2 episodes of heart palpitations per day. Additional information has been requested.   This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up information was received on 18-AUG-2008 from a R.N. indicating that they knew nothing about this report.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Hypoaesthesia, Rash
Clinical narrative: Information has been received from a health professional concerning a 16 year old female patient with a history of absence seizure free for 2 years-off divalproex sodium (DEPAKOTE for 2 years) who on 25-JUN-2008 at 10:00 am was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot #658222/0927U).  On 25-JUN-2008 the patient went to bed and woke up four times that evening complaining of numbness in the left arm and weakness.  She developed a rash on both arms from wrist to elbows the next day on 26-JUN-2008.  The numbness and weakness resolved the next morning.  At the time of reporting, the outcome of the rash on both arms from wrist to elbows was unknown.  It was not specified if there was an illness at the time of vaccination.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who on 11-JUL-2008 was vaccinated with the first dose of GARDASIL.  Subsequently the patient developed an injection site reaction.  The patient developed arm soreness and injection site reaction.  The patient developed arm soreness and hardened raised area the size of a walnut (also reported as a "hard lump") at the injection site. At the time of the report, the patient was recovering from the symptoms. The vaccine was provided at the patient's primary care physician's office, not at this clinic. No further information is available.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0807USA04078 is a duplicate of WAES # 0807USA04026. Therefore, WAES # 0807USA04078 is being dleted from our files and the reportd consolidated into WAES # 0807USA04026.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female with unknown allergies who 11-JUL-2008 was vaccinated with a first dose of GARDASIL (lot# not reported). Within "24 to 36 hours," the mother of the patient called, because the patient developed rashes on her tongue and on her forearm. The patient was seen by a physician. No further information was available. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner reported that "a month or two after receiving a dose of GARDASIL" the patient had developed warts on her face, which were predominately on her lips.  No lab diagnostics were performed.  The nurse practitioner did not know if the patient is going to receive any more doses of GARDASIL because she had not heard back from the patient as of yet.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow up information has been received from a physician assistant who reported that the patient presented at the walk in clinic for an unrelated complaint.  Mentioned that she had received GARDASIL injection from another clinic approximately 1 month ago and now had a large wart on face on upper lip (0.5 cm flat wart was seen on right upper lip).  No prior history of warts of any kind.  Adverse event following prior vaccination was reported as:  patient wart on upper lip, onset age 16 with GARDASIL, dose in series, 3.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Pruritus, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 26-APR-2008 and 15-JUL-2008 was vaccinated with a first and second doses of GARDASIL, respectively.  On the same day of vaccinations were administered, the patient developed swollen lips and "itchy hands".  The patient was seen by a physician.  The outcomes were not reported.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Blood immunoglobulin A increased, Fatigue, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 20 year old female with allergic reaction to doxycycline, who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL.  On 14-DEC-2007, the patient was vaccined with the second dose of GARDASIL IM.  There was no concomitant medication.  In December 2007, the patient developed an allergy to gluten.  On 24-DEC-2007, the patient developed hives that resolved on its own.  She had seen a hematologist/oncologist, endocrinologist, and Gastroenterologist.  The physician mentioned that the specialist were not able to determine a cause for the gluten allergy.  The patient had significant abdominal pain, upset stomach, weakness and fatigue.  She had a 10-15 weight loss.  In October 2007, she weighed 115 lbs and on March 18 2008, she weighed 101 lbs.  Testing for Celiac disease were negative.  Immunoglobulin A (IgA) was low positive in March, 2008.  Repeated testing for Celiac disease in March 2008 was negative.  Subsequently, the patient recovered from the adverse events.  The patient sought medical attention.  Additional information has been requested. 10/07/08-records received-Yasmin OCP. Placed on gluten free diet now feels great and has energy, and gaining weight. 10/7/07 first Gardasil vaccination given. Right ear pain and weight loss.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Stomach discomfort, Urticaria, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 20 year old female with allergic reaction to doxycycline, who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL.  On 14-DEC-2007, the patient was vaccined with the second dose of GARDASIL IM.  There was no concomitant medication.  In December 2007, the patient developed an allergy to gluten.  On 24-DEC-2007, the patient developed hives that resolved on its own.  She had seen a hematologist/oncologist, endocrinologist, and Gastroenterologist.  The physician mentioned that the specialist were not able to determine a cause for the gluten allergy.  The patient had significant abdominal pain, upset stomach, weakness and fatigue.  She had a 10-15 weight loss.  In October 2007, she weighed 115 lbs and on March 18 2008, she weighed 101 lbs.  Testing for Celiac disease were negative.  Immunoglobulin A (IgA) was low positive in March, 2008.  Repeated testing for Celiac disease in March 2008 was negative.  Subsequently, the patient recovered from the adverse events.  The patient sought medical attention.  Additional information has been requested. 10/07/08-records received-Yasmin OCP. Placed on gluten free diet now feels great and has energy, and gaining weight. 10/7/07 first Gardasil vaccination given. Right ear pain and weight loss.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Rash erythematous, Rash papular, Skin warm
Clinical narrative: Information has been received from a physician concerning a 11 year old female with a history of blood in urine -cause unknown who on 30-JUN-2008 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL in her arm (not specified). There was no concomitant medication. On 30-JUn-2008, within one minute of vaccination, the patient developed a red, raised and warm rash on her left arm, and spread to her face, trunk and other limbs in physician's office. No laboratory diagnostics studies were performed. The patient was treated with BENADRYL. On 30-JUN-2008 the patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 12-13 year old female who on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently the patient developed an indentation at the injection site growing from quarter size to a half dollar size.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient, an office staff member, who in approximately 2007 was vaccinated with the first and second dose of GARDASIL. The nurse practitioner reported that the patient was in the office on 17-JUL-2008 for the 3rd dose of GARDASIL. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Malaise, Paraesthesia, Syncope
Clinical narrative: Information has been received from a pharmacist concerning her 12 year old daughter with no pertinent medical history or allergies who on 21-JUL-2008 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL in her left upper arm.  There was no concomitant medication.  A few minutes after vaccination, the patient experienced faint.  No laboratory diagnostics studies were performed.  The patient recovered while in the office.  Since returning home from the office, the patient had complained of malaise and tingling of the left arm "from shoulder to fingertips".  There was no problem with movement of the arm.  At the time of report, the patient's malaise and tingling of the left arm persisted.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL.  Subsequently the patient developed vaginal bleeding.  The number of vaccinations was not known.  The timing of the incident or whether it was resolved was not known.  No additional information is available.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Information has been received from a nurse concerning a female in her 20's who on 11-JUL-2008 was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced a "hard lump", a size of a walnut at the injection site. The patient was not vaccinated in the reporter's office. The patient sought medical attention by contacting the nurse. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL.  After receiving GARDASIL the patient passed out, her lips went blue and she was very pale.  The physician reported that the patient had passed out for about two to three minutes and then she was fine and left the office.  The physician was unsure if the patient was going to receive any additional doses of GARDASIL because of the fainting.  The patient sought physician's medical attention.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 8/14/2008. Follow-up information was received on 26-AUG-2008 from the physician concerning a 16 year old female student who at 3:00 p.m. of 26-JUN-2008 was vaccinated in the left arm with a first dose of GARDASIL (Lot #656050/0245U). There was no illness at time of vaccination. The patient was at the office for a well-visit. Concomitant therapy included TUBERSOL (Lot #C2908AA), HAVRIX (Lot #AHAVB234BA) and MENACTRA (Lot #U2621AA). At 4:00 p.m. of 26-JUN-2008 the patient fainted. Her lips turned blue and she was very pale. On 27-JUN-2008 the patient recovered from the events. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: Information has been received from a physician assistant concerning his niece who was vaccinated with GARDASIL.  Subsequently the patient experienced depression.  It was unspecified if the patient sought medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL (dose and route not reported) and experienced "more than syncope", but passed out for several minutes. The patient was sent for computed axial tomography (CAT) scans (no results provided); she seemed to recover completely. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Palpitations
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who in July 2008, was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly into the deltoid (lot number not reported).  It was unspecified if this was the patient's first dose or a subsequent dose.  Subsequently, also reported as about a week ago, the patient experienced heart palpitations and chest pain.  The patient's mother called the office and the reporter instructed the patient to go to the emergency room.  It was reported that the office had checked with the hospital but it did not appear that the patient went to the emergency room.  Additional information has been requested.