chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 16 female who tested negative for High Risk HPV on 06-Jan-2007. On 16-JAN-2007, the patient was IM vaccinated with her first dose of Gardasil (Lot # 653736/0868F). The patient received her second intramuscular dose of Gardasil (Lot # 653736/0014U) on 13-Mar-2007. The third dose of Gardasil (Lot # 653736/0014U) was IM administered on 08-May-2007. A fourth dose of Gardasil (Lot # 653736/0014U) is reported to have been given to the patient on 10-Jul-2007. Concomitant therapy included hormonal contraceptives (unspecified). On 15-JAN-2008 the patient tested positive for High Risk HPV. Subsequently, the patient is not recovered. The patient sought unspecified medical treatment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently on an unknown date the patient experienced syncope.  The outcome was not reported.  This is one of several reports from the same source.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 14-JAN-2008 was vaccinated with her first dose of Gardasil (lot # 654702/0011U).  Concomitant therapy included methylphenidate HC1 (CONCERTA) and clonidine HC1 (APO-CLONIDINE).  On 15-JAN-2008 the patient experienced low grade fever, dizziness, headache, nausea and stiffness in her right arm.  The vaccine was administered in her right arm.  She was instructed to take ibuprofen and apply ice.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information was received from a consumer in regards to an unknown number of patients who were vaccinated with Gardasil and experienced extreme pain at the injection site. Lot numbers and physician's information was not available. Additional information has been requested. 02/10/2010 In follow-up information received on 28-JAN-2008 the patient did not have an experience with the doctor.  Additional information has beenr equested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was intramuscularly vaccinated with her second dose of Gardasil (lot # 658560/1062U). Concomitant therapy included PERCOCET. About a month after the vaccine was administered, the patient sought unspecified medical treatment via an office visit for a painful lump at the injection site. The patient did not have any adverse reactions to the first dose. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a healthcare professional, who is the business manager at a pediatric facility, concerning a 13 year old male who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently, on an unknown date the patient experienced syncope.  The outcome was not reported.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a health professional concerning two female patients who were vaccinated intramuscularly with their third dose of Gardasil.  Within about two weeks, the patients experienced genital warts.  Both patients said they were not sexually active for about 5 months.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a consumer concerning her daughter, who on 17-JAN-2008 was vaccinated with her first dose of Gardasil. Patient is two days delayed with her period. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from an RN concerning a 16 year old white female student with no medical history who on the afternoon of 12-OCT-2007 was vaccinated IM with her second dose of Gardasil, lot #658560/1062U. On the afternoon of 14-OCT-2007 the patient developed lymphadenopathy, left axilla. No medical attention was required. Subsequently, the patient recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a 17 year old female who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently, on an unknown date the patient experienced syncope.  The outcome was not reported.  This is one of several reports from the same source.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a health professional concerning a 13 year old female with a history of nonspecific allergy to metals who was vaccinated with her first dose of Gardasil. Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced injection site reaction. The patient sought unspecified medical treatment during an office visit. Subsequently, the patient recovered from injection site reaction. Additional information has been requested. Information has been received from a healthcare professional concerning a 13 year old female with a history of nonspecific allergy to metals who on 18-OCT-2007 was vaccinated into the left deltoid with her first dose of HPV vaccine. On 19-OCT-2007 the patient developed an injection sit e rash, it was reported that the rash spread to the patient's extremities after on e month and resolved two months after the injection. The patient sought unspecified medical treatment during an office visit. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Full blood count normal, Presyncope, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning his sister, a 20 year old female with a history of dysmenorrhoea who on approximately 03-JAN-2008 was vaccinated with her first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  Twelve or thirteen days after vaccination, the patient experienced dizziness and almost passed out.  The patient sought unspecified medical treatment by contacting her brother who is a physician.  The patient has been in and out of the emergency room because of the dizziness.  A CBC, CT scan, and urinalysis were performed and all were normal.  The patient received the vaccine from her pediatrician, so no further information is available.  The patient is still experiencing the severe dizziness.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Eye swelling, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 17-JAN-2008 was vaccinated with Gardasil. On 17-JAN-2008 the patient experienced swollen eyes. The patient experienced swollen eyes after receiving her second and third doses. No further information about the first dose was available. The patient sought unspecified medical attention. Subsequently, the patient recovered from swollen eyes. Additional information has been requested. Information has been received from a physican concerning a 21 year old female with a history of sulfonamide allergy who on 18-JAN-2008 was vaccinated with HPV vaccine (lot number reported as 046901 around 12:55 pm. At 1:10 pm on 18-JAN-2008 the patient experienced swollen, itchy eyes. The patient experienced swollen, itchy eyes after receiving her  second and third doses. Conflicting information was received during follow up from the physician regarding the date of vaccination and AE onset date. No further information about the first dose was available. The patient sought unspecified medical attention. The patient was given XYZAL and monitored in the office. The patient left at 1:45 pm in good condition. Subsequently, the patient recovered from swollen eyes. No further information was  available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash, Sinusitis
Clinical narrative: Information has been received from a health professional concerning a 27 year old female who on 28-MAR-2007 was IM vaccinated with her first dose of Gardasil (lot# 0210U). Concomitant therapy included FLONASE, LOESTRIN, and AMOXIBRON. On 14-Jan-2008 the patient received her second dose of Gardasil (Lot # 655327/1287U). On 15-JAN-2008 the patient experienced rash and some itching. Later the same day, the rash and itching spread to both thighs. On 15-Jan-2008 and 16-Jan-2008 the reaction was getting worse. On 18-Jan-2008 the patient sought unspecified medical treatment by contacting the physician's office. The patient was instructed to take Benadryl but the patient refused. The patient did not have any known reactions from the first dose. Additional information has been requested. Information has been received from a healthcare professional concerning a 27 year old female who on 28-MAR-2007 was IM vaccinated with her first dose of HPV vaccine (lot # 0210U). On 14-Jan-2008 the patient received her second dose of HPV vaccine (Lot # 655327/1287U). On 15-JAN-2008 the patient experienced rash and some itching. Later the same day, the rash and itching spread to both thighs. On 15-Jan-2008 and 16-Jan-2008 the reaction was getting worse. On 18-Jan-2008 the patient sought unspecified medical treatment by contacting the physician's office. The patient was instructed to take BENADRYL but the patient refused. The patient did not have any known reactions from the first dose. The patient recently finished taking AMOXICILLIN for a sinus infection. Additional informatio has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle tightness, Mydriasis, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with a history of fainting with vaccines in general who on 21-JAN-2008 was vaccinated with a third 0.5 mL dose of Gardasil (659437/1266U).  Subsequently, on 21-JAN-2008 the patient fainted when she stood up to leave the office.  The patients pupils were dilated, arms were held tight to chest, and she was non responsive.  EMS got called to the office.  Subsequently, on 21-JAN-2008, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a female (unknown age) with an unspecified history and allergies reported, who on an unspecified date was vaccinated with a 0.5 dose of Gardasil.  The lot number was not reported.  Subsequently, on an unknown date the patient experienced a knot at the injection site.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a vaccine coordinator concerning a 17 year old female with no pertinent medical history, who on 21-JAN-2008 was vaccinated with Gardasil and fainted.  It was noted that the patient has a history of fainting when given a shot.  The physician's assistant said that it did not meet the symptoms of a seizure.  Unspecified medical attention was sought.  Subsequently, the patient recovered from faint.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Diarrhoea, Drug exposure during pregnancy, Nausea, Urine analysis
Clinical narrative: Information has been received from Merck pregnancy registry through a physician concerning a female who on approximately 15-JAN-2008 was vaccinated IM with the first dose of Gardasil. On approximately 15-JAN-2008 the patient experienced nausea, vomiting, lower abdominal pain and diarrhea. The patient received the second dose at an unspecified date while pregnant. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from Merck pregnancy registry through a physician concerning a female who on approximately 15-JAN-2008 was vaccinated IM with the first dose of Gardasil. On approximately 15-JAN-2008 the patient experienced nausea, vomiting, lower abdominal pain and diarrhea. The patient received the second dose at an unspecified date while pregnant. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a third dose of Gardasil.  Concomitant therapy included MENACTRA.  Subsequently the patient broke out in hives.  The physician stated that after each of the three doses the patient broke out in hives.  The reaction became worse each time.  Unknown medical attention was sought.  The patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Cardiac murmur, Electrocardiogram QT prolonged
Clinical narrative: Information has been received from a consumer, concerning his 12 year old daughter with no known allergies, who in June 2007, was vaccinated with the first dose of Gardasil (lot # not reported). Concomitant therapy included an unspecified beta blocker (indication not reported). Following the vaccination (date not specified), his daughter saw a cardiologist and had an electrocardiogram (EKG) result of an elongated QTC level of 494 (units not specified), with the potential for arrhythmia. In August 2007, his daughter was vaccinated with the second dose of Gardasil (lot # not reported). Following the second vaccination, her "LQTC" level was higher at 502 (date and units not specified). At the time of this report, the patient had not recovered. Additional information has been requested. Follow up information from the physician indicated that on 22-JUN-2007, the patient (a caucasian  student), with a heart murmur and a possible allergy to CEFZIL but otherwise well, was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 658094/0524U). Concomitant vaccine therapy, administered IM in the left arm at the visit, included the first dose of BOOSTRIX (lot #AC52B006BA). There was no illness at the time of vaccination. The physician stated that, "we noted a murmur at that visit which lead to a cardiac eval which lead to diagnosis for elongated QT." There was no immediate reaction noted. The diagnosis was confirmed on 18-JUL-2007, when the patient's QT, on a holter monitor, was between 0.46 and 0.54. The findings were reported to the physician by cardiology. Additional information has been requsted.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Swelling face
Clinical narrative: Information has been received from a health professional concerning an 18 year old female patient with no medical history who on 31-OCT-2007, was vaccinated into the right deltoid with a first dose of Gardasil (Lot# 0530U).  On 26-DEC-2007, the patient was vaccinated into the left deltoid with a second dose of Gardasil (Lot# 655154/1210U).  On 27-DEC-2007, the patient complained of her face being very swollen and itchy.  She was advised to take BENADRYL 50 mg PO and if it did not get any better to go to the emergency room.  No laboratory diagnostic tests were performed.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Wrong technique in drug usage process
Clinical narrative: Information has been received from a Nurse concerning a 16 year old female who on 16-FEB-2007 was vaccinated IM in the left deltoid with a 0.5 ml first dose of Gardasil (lot# 653735/0688F).  On 26-APR-2007 the patient received IM in the left gluteal muscle with a second dose (lot# 657006/0188U) and on 21-Aug-2007 received IM in the unspecified gluteal muscle with the third dose (lot# 657622/0388U).  The nurse mentioned that the patient experienced pain after receiving the first dose.  Medical attention was sought.  Subsequently the patient recovered from pain.  No product quality complaint was involved.  The nurse mentioned almost every patient (unspecified number) who received the vaccine complained of having pain for 2 or 3 days.  Attempts are being done to find more information about other patients.  Additional information has been requested. Information has been received from a nurse concerning a 16 year old female who on 16-FEB-2007 was vaccinated IM in the left deltoid with 0.5 ml first dose of HPV vaccine (lot # 653735/0688F). On 26-FEB-2007 the patient received IM in the left gluteal muscle with a second dose (lot # 657006/0188U) and on 21-AUG-2007 received IM in the unspecified gluteal muscle with the third dose (lot # 657522/0388U). The nurse mentioned that the patient experienced pain after receiving the first dose. Medical attention was sought. Subsequently the patient recovered from pain. No product quality complaint was involved. The nurse mentioned alsmost every patient (unspeciifed number) who received the vaccine complained of having pain for 2 or 3 days. Attempts are being done to find more information about the other patients. Follow-up information from the nurse indicated that there were approximately 300 patients who received the vaccination. She was not able to provide specific patient identifiers. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Laceration, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil via injection.  The physician reported that after the patient received the shot she fainted.  Because of the fall the patient had a cut and had to received 6 stitches.  No lot number was provided and no further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose and second of Gardasil.  Subsequently the patient fainted after the first injection.  Unspecified medical attention was sought by the patient.  Subsequently, the patient recovered.  It was reported that patient did not experience any adverse events after the second vaccination.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with Gardasil. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash macular, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL (lot# 658558/1061U). Subsequently the patient experienced macular type rash on her chest and stomach. the physician reported that this "rash had appeared after receiving both first and second doses". The physician also reported that the rash was non-pruritic. Unknown medical attention was sought. The patient recovered on an unknown date. No product quality complaint was involved. Additional information was involved.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Breast tenderness, Gynaecomastia
Clinical narrative: Information has been received from a consumer concerning her son with a history of migraine and no drug reaction or allergies, who on 21-AUG-2007 went to the doctor's office for physical and was vaccinated with first dose of Gardasil (lot # not provided). Consumer stated that the patient's breasts were tender and sticking out, but she thought that it was part of puberty. Unspecified medical attention was sought. No additional information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Presyncope
Clinical narrative: Information has been received from a consumer concerning her daughter who in approximately June 2007, was vaccinated with the first dose of GARDASIL. The patient received the third dose of GARDASIL on 15-JAN-2008. On 16-JAN-2008 the patient experienced pain around the injection site. The pain began escalating since then, and radiated down to her elbow. The mother did not know which arm the reaction occurred. The mother also reported that the patient almost fainted after receiving her first dose of GARDASIL. There were no reported reactions after receiving the second dose. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of syncope who on 18-JAN-2008 was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  On 18-JAN-2007 the patient "looked like she was going to faint."  Unspecified medical attention was sought.  On 18-JAN-2007, the patient recovered.  Additional information has been requested. Information has been received from a physician concerning a 20 year old female with a history of syncope who on 18-JAN-2008 was vaccinated with a first dose of HPV vaccine. On 18-JAN-2007 the patient "looked like she was going to faint." Unspecified medical attention was sought. On 18-JAN-2007, the patient recovered. Conflicitng information was received from a medical assistant. The medical assistant reported that an adverse event did not occur. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Migraine, Rash, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with a history of migraines and no known drug allergies who on 16-NOV-2007 was vaccinated with the first dose GARDASIL 0.5 mL IM (Lot # 0469U). Concomitant therapy included YASMIN. On 16-NOV-2007 shortly after she received the first dose, the patient developed a migraine. She received the second dose on 21-JAN-2008 (Lot # 655327/1287U). On the evening of 22-JAN-2008, the patient experienced an itchy rash on both arms, legs and trunk which was spreading up her neck by the morning of 23-JAN-2008. The nurse reported that the patient had recently been sitting in a hot tub with friends for a few hours a day. The rash was not evaluated by a health care professional but was reported by the patient to the office. The nurse indicated the rash was not thought to be hives or indicative of hypersensitivity. Th rash was treated with topical BENADRYL. As of 23-JAN-2008, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a registered nurse concerning an 18 year old female with a history of migraines and no known drug allergies who on 16-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot # 0469U).  Concomitant therapy included YASMIN.  On 16-NOV-2007 shortly after  she received the first dose, the patient developed a migraine. She received the second dose on 21-JAN-2009 (Lot # 655327/1287U).  On the evening of 22-JAN-2009, the patient experienced an itchy rash on both arms, legs and trunk which was spreading up her neck by the morning of 23-JAN-2009 and to the entire body later.  On an unspecified date the patient had headache.  The nurse reported that the patient had recently been sitting in a hot tub with friends for a few hours a day.  The patient called back later that day to admit that the rash may have been due to chemicals in the water versus the second dose of GARDASIL.  The rash was not evaluated by a health care professional but was reported by the patient to the office.  The nurse indicated the rash was not thought to be hives or indicative of hypersensitivity.  The rash was treated with topical BENADRYL.  On an unspecified date the patient had recovered.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Metrorrhagia, Thyroid function test normal
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female with no pertinent medical history or drug reactions/allergies on 22-AUG-2007 was vaccinated with a first dose of Gardasil (lot#655617/1447F) IM. There was no concomitant medications. In August 2007 the patient experienced cessation of menstruation. Medical attention was sought. The patient was seen by the physician's assistant in December 2007 and still did not start menstruating. In January 2008, the patient had "some spotting". On an unspecified date the patient had a thyroid function test performed and was negative. At the time of reporting the patient had not recovered. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Feeling cold, Feeling hot, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician and a healthcare professional concerning a 14 year old female who on approximately 01-JAN-2008 was vaccinated with a second dose of Gardasil (659439/1267U).  On approximately 01-JAN-2008 following vaccination the patient experienced fainting.  Unspecified medical attention was sought.  Outcome unknown.  There was no product quality complaint.  This is one of several reports received from the same source.  Additional information has been requested. Initial and follow-up information has been received froma physician and a healthcare profesional concerning a 14 year old female who on 27-DEC-2007 was vaccinated with a third dose of HPV vaccine. (659439/1267U). At 12:15 on 27-DEC-2007 following vaccination the patient experienced fainting. In follow-up it was reported that she passed out as she was walking out the exam door. She was aware that she was fainting because she felt hot, cold, then fell to the floor. Post incident she was oriented x3 and stated "didn't know why she fainted." Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint. This is one of several reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness, Pallor
Clinical narrative: Information has been received from a physician and a healthcare professional concerning a 16 year old female who on approximately 15-JAN-2008 was vaccinated with a first dose of Gardasil (659439/1267U).  On approximately 15-JAN-2008 following vaccination the patient became pale and woozy, and had to lay down.  Unspecified medical attention was sought.  Outcome unknown.  There was no product quality complaint.  This is one of several reports received from the same source.  Additional information has been requested. Initial and follow-up informatin has been received from a physician and a healthcare professional concerning a 16 year old female who on 21-JAN-2008 was vaccinated with a first dose of HPV vaccine (659439/1267U). At 15:15, on 21-JAN-2008 following vaccination the patient became pale and woozy, and had to lay down. In follow-up it was reported that the patient became lightheaded and dizzy. The patient was plasced on the exam table. The vital sign were stable. Patient remained in room for 30 minutes. Unspecified medical attention was sought. The patient left the office feeling fine. There was no product quality complaint. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Head deformity
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated IM with a dose of GARDASIL. Subsequently the patient "came down with some syndrome", may have been Guillain-Barre syndrome. Medical attention was sought and the patient recovered. The consumer noted in this report was not one of the physician's patients. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to identify the existence of a patient. Additional information has been requested.  3/10/08 Per FDA contact-DX: Bell's Palsy not GBS. Confirmed. Infrmation has been recieve from a physician concerning a 14 year old female who was vaccinated IM with a dose of HPV vaccine. Subsequently the patient "came down with some syndrome", may have been Guillain-Barre Syndorme. Medical attention was sought and the patient recovered. The consumer noted in this report was not one of the physician's patients. Additional information was obtained for the patient by telephone call froma physician.l The physician informed that patient was his niece and she developed Bells Palsy. He put on his wife who provided that patient was 16 year old. She did not believe that there were any other vaccines given with HPV vaccine. The patient had no pertinent medical history and no known allergies. She was treated at the hospital and seen by a neurologist. The Bell's Palsy "slowly resovled". When asked if it was disbaling the physician;s wife responded "it was disfiguring the side of her face drooped. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Laboratory test, Oedema peripheral, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning her 12 year old granddaughter who in February 2007, was vaccinated with a first dose of Gardasil (lot# unknown) injection.  In April 2007, the patient was vaccinated with a second dose of Gardasil injection and experienced dizziness.  Medical attention was sought.  The patient recovered from dizziness.  In August 2007 the patient was vaccinated with a third dose of Gardasil injection.  Approximately one week after receiving the third dose of Gardasil the patient had broken out in hives all over the body and since then the patient had developed rashes all over her body, hands were turning blue and swelling had occurred.  The patient was given (diphenhydramine hc1) BENADRYL and (montelukast sodium) SINGULAIR (MSD) to help with these symptoms, but they have not subsided.  The nurse reported that the patient had gone to the emergency room on 22-JAN-2008 and was placed on prednisone (manufacturer unspecified).  The nurse was not sure if the patient was admitted to the hospital.  The nurse reported that the patient had many unspecified diagnostic tests.  There was no further AE experience.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning her 12 year old granddaughter who in February 2007, was vaccinated with a first dose of Gardasil (lot# unknown) injection.  In April 2007, the patient was vaccinated with a second dose of Gardasil injection and experienced dizziness.  Medical attention was sought.  The patient recovered from dizziness.  In August 2007 the patient was vaccinated with a third dose of Gardasil injection.  Approximately one week after receiving the third dose of Gardasil the patient had broken out in hives all over the body and since then the patient had developed rashes all over her body, hands were turning blue and swelling had occurred.  The patient was given (diphenhydramine hc1) BENADRYL and (montelukast sodium) SINGULAIR (MSD) to help with these symptoms, but they have not subsided.  The nurse reported that the patient had gone to the emergency room on 22-JAN-2008 and was placed on prednisone (manufacturer unspecified).  The nurse was not sure if the patient was admitted to the hospital.  The nurse reported that the patient had many unspecified diagnostic tests.  There was no further AE experience.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no medical history who approximately 26-DEC-2007, approximately 2 to 4 weeks ago, was vaccinated IM with a first dose of GARDASIL. On approximately 26-DEC-2007, the patient fainted and lost consciousness for a few seconds. No laboratory diagnostic studies were performed. Within a few minutes the patient was reported as fine. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash
Clinical narrative: Information has been received from a Physician's Assistant concerning a female patient who in approximately November 2007, was vaccinated with her first dose of GARDASIL. After receiving her first dose, the patient experienced itching all over body for about a week. Medical attention was sought and the patient recovered. In January 2008 the patient received her 2nd dose of GARDASIL, and no reaction occurred. Additional information has been requested. 02/12/2010 Follow-up indicated that the office was unsure if the patient actually had a reaction to the vaccine. The patient did develop a rash but was still vaccinated with the second dose with no problems. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with allergic reactions to bees who on 21-JAN-2008, was vaccinated IM with a first dose of Gardasil.  On approximately 22-JAN-2008, within 24 to 48 hours of being vaccinated, the patient experienced hives on both arms.  Unspecified medical attention was sought.  The nurse practitioner recommended that the patient take BENADRYL.  It was reported, after the patient took the BENADRYL, her symptoms resolved.  No product quality complaint was involved.  Additional information has been requested. Information has been received from a nurse practitioner concerning a 22 year old female patient with allergic reactions to bees and a questionable allergy to "ncodan" who on 21-JAN-2008, was vaccinated IM into the left deltoid with a furst dose of HPV vaccine (lot # 654539/0742U). On approximately 22-JAN-2008, within 24 to 48 hours of being vaccinated, the patient experienced hives on both arms. Unspecified medical attention was sought. No laboratory diagnositc studies were performed. The nurse practitioner recommended that the patient take BENADRYL. It was reported, after the patient took the BENADRYL, her symptoms resolved. No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Blood pressure decreased, Dizziness, Injection site irritation, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 21 (also reported as 22 years) year old female, with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions, who on 10-SEP-2007 at 3:15 p.m., was vaccinated into the left deltoid muscle with the first dose of Gardasil, (Lot # 658560/1062U).  On 10-SEP-2007, at 3:15 p.m., the patient stated that as the vaccine was being injected, her arm felt like it was on fire.  When she stood up she felt dizzy and passed out.  Her blood pressure dropped to 100/72 mmHg from 126/71 mm/Hg.  When she recovered after a minute she complained of nausea and feeling faint.  The next day the patient stated that she had hives around the injection site, on lower arms, hands and neck.  She also stated she had cold symptoms.  It was reported that the patient recovered 3 days after the injection.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nasopharyngitis, Nausea, Presyncope, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 21 (also reported as 22 years) year old female, with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions, who on 10-SEP-2007 at 3:15 p.m., was vaccinated into the left deltoid muscle with the first dose of Gardasil, (Lot # 658560/1062U).  On 10-SEP-2007, at 3:15 p.m., the patient stated that as the vaccine was being injected, her arm felt like it was on fire.  When she stood up she felt dizzy and passed out.  Her blood pressure dropped to 100/72 mmHg from 126/71 mm/Hg.  When she recovered after a minute she complained of nausea and feeling faint.  The next day the patient stated that she had hives around the injection site, on lower arms, hands and neck.  She also stated she had cold symptoms.  It was reported that the patient recovered 3 days after the injection.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Medical Assistant concerning a female patient who was vaccinated with her 3rd dose of Gardasil and developed redness at the injection site.  Her outcome was unknown.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 19 year old black female with no pertinent medical history who on 09-MAY-2007 was vaccinated into the deltoid with a first dose of GARDASIL (lot #656051/0244U) Concomitant therapy included ORTHO EVRA. On 16-MAY-2007 the patient experienced urticaria. The patient required 2 emergency room visits. The patient was treated with SOLU-MEDROL, prednisone and BENADRYL. Subsequently, the patient recovered from urticaria. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Palmar erythema
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 23-JAN-2008 was vaccinated with her first dose of Gardasil (655327/1287U) in her right deltoid.  On 23-JAN-2008 the patient experienced swelling and erythema of her right palm, wrist, and forearm.  The patient sought unspecified medical treatment by contacting the nurse.  The patient was instructed to apply ice, elevate her arm and to take Benadryl.  Additional information has been requested. Follow-up received 04/16/2008. The swelling and erythema extended 3 inches up her forearm. The nurse advised to see an ER doctor if the symptoms increased or changed. Follow up information obtained thru a telephone call on 24-JAN-2008 to the patient's mother includes a decrease in symptoms. The mother declined a physician appointment for evaluation. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of attention deficit disorder who on 16-APR-2007 was vaccinated with her first dose of GARDASIL. The patient received her second dose of GARDASIL on 14-Jun-2007. On 19-Oct-2007, the patient received her third dose of GARDASIL. On 03-DEC-2007 the patient had a routine PAP test which was low grade positive for HPV. The patient sought unspecified medical treatment with an office visit. Subsequently the patient has not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed practical nurse regarding her 16 year old daughter who, on an unspecified date, was vaccinated with her first dose of GARDASIL. Subsequently, "within a couple weeks", the patient developed plantar's warts on her foot. The patient had the wart treated and it resided. On an unspecified date, the patient was vaccinated with her second dose of GARDASIL. Subsequently, the patient developed plantar's warts again on the same foot. The patient had the wart treated again, and again it resided. On an unspecified date, the patient was vaccinated with her third dose of GARDASIL. The patient did not developed plantar's wart or have any other symptoms after receiving her third dose of GARDASIL. The reported stated that the patient received all three doses of GARDASIL according to the dosing schedule. As of the date of this report, the plantar's wart have not returned and the patient is "doing fine now". Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: Information has been received from a 20 year old female medical assistance with a history of live birth who on 01-MAR-2007 was vaccinated with her first dose of GARDASIL. On an unspecified date, the patient was vaccinated with her second dose of GARDASIL. On 25-SEP-2007, the patient was vaccinated with her third dose of GARDASIL. On 21-NOV-2007 the patient found out she had a cyst on the ovary. The patient reported that she is getting the cyst removed. No further information was expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot #658560/1062U). Concomitant therapy included vitamins (unspecified). On the evening of 19-NOV-2007 the patient experienced itching at injection site. The patient self-medicated with over-the-counter BENADRYL which provided good relief of the symptoms. Subsequently, the patient recovered from itching at injection site. On 21-NOV-2007, the patient was vaccinated with the influenza virus vaccine (unspecified). On 22-JAN-2008, patient reported the adverse symptoms during an office visit. Additional information has been requested. Information has been received from a registered nurse concerning a 22 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the left deltoid with her first dose of HPV vaccine (lot # 658560/1062U). On the evening of 19-NOV-2007 the patient experienced itching at injection site. The patient self-medicated with over-the-counter BENADRYL which provided good relief of the symptoms. Subsequently, the patient recovered from itching at injection site. On 21-NOV-2007, the patient was vaccinated withthe influenza virus vaccine (unspecified). On 27-JAN-2008, patient reported the adverse symptoms during an office visit.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, No reaction on previous exposure to drug, Visual disturbance, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 07-DEC-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified) and meningococcal vaccine (unspecified). On 21-JAN-2008 was vaccinated with the second dose of GARDASIL. On 21-JAN-2008, two hours post vaccination the patient experienced nausea, vomiting and headache. On approximately 23-JAN-2008, two days post vaccination the patient experienced problems with vision in her right eye. The patient did not have AE after receiving the first dose of GARDASIL. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a company representative via a nurse concerning a 16 year old female who on 18-JAN-2008 was vaccinated with a first dose of GARDASIL (lot# unknown) injection in the deltoid area. On 18-JAN-2008 the patient fainted after receiving her dose of GARDASIL. Medical attention was sought. Subsequently, the patient recovered from fainting approximately 20 minutes. No further information was available. Additional information has been requested. This is one of two reports.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse concerning a "teenage" female who on 22-JAN-2008 was vaccinated with her first dose of Gardasil.  Subsequently the patient experienced dizziness, nausea and vomiting.  No other information was available.  The patient sought unspecified medical attention.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Information has been received from the mother concerning her 15 year old daughter with no previous medical history or any known drug allergies, who in approximately November 2007, was vaccinated IM with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  The day after the vaccination, the patient experienced generalised rash.  Unknown medical attention was sought.  After 3 weeks of vaccination the patient recovered from generalised rash.  The mother decided to discontinue the dosing schedule.  No product quality complaint was involved.  Additional information has been requested. Information and follow up information has been received froma mother and the physician concerning her 15 year old daighter who had right shoulder pain at the time of the vaccination, who on 05-DEC-2007, was vaccinated IM in the left arm with 0.5 ml first dose of HPV vaccine (lot # 657868/05230). On 05-DEC-2007 the patient developed a full body rash from head to toe, papular rash which was mildly pruritic. The rash lasted at least 9 days. The patient recovered from a papular rash on 15-DEC-2007. The patient was seen in the office on 15-DEC-2007 and started oral steroids. Antihistamines did not improve the symptoms. The mother decided to discontinue the dosing schedule. No product quality complaint was involved.