chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Muscular weakness, Nausea, Pain in extremity, Premenstrual syndrome
Clinical narrative: Information has been received from an office manager concerning a 17 year old female with penicillin allergy and a history of tonsillectomy (1994) who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM and on 15-MAY-2008 was vaccinated with the second dose of GARDASIL vaccine 0.5 mL, IM.  The patient had not yet received the third dose.  Concomitant therapy included DEPO-PROVERA.  The office manager reported that in 2008, the patient experienced stomach pain, leg pain, back pain and her leg had been "sore" and limp.  The patient also had sleepy feeling.  The patient was also experienced increased incidence of headaches and she also had a thin white discharged in the vagina.  On 11-SEP-2008 the patient experienced green pink stool.  The patient felt nauseated after eating, she had no diarrhea and constipation.  As of 15-SEP-2008 the patient experienced green pink stool.  She had no diarrhea and constipation.  As of 15-SEP-2008 the patient had not recovered from the symptoms.  A vaginal specimen analysis was performed that were negative for vaginitis.  The patient sought medical attention by seeing the physician.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/14/2008. Follow-up information was received from a physician via medical record who reported that on 11-SEP-2008, the patient went to doctor's office complianing of vaginal discharge that she describe as burning, itchy, white, foul, smelling and thin. The doctor stated the patient had premenstrual dysmenorrhea. The duration in 5 days and was interfering with work and normal activities. It was reported that the patient was not going to take DEPRO-PROVERA anymore because she didn't like the way it makes her feel. It was also reported that the patient had an adenoidectomy in 1994. The patient had never had a PAP smear or a mammogram, she had no history of significant medical diseases. At the physical exam patient height: 64 inches, weight 105 pounds and blood pressure 103/60. The patient's pelvic exam was normal and she had no history of obstetrical or gynecological surgery. The patient denied previous exposure to STD. On 14-SEP-2008 the patient was having a lot of symptomatology. She was concerned it is for GARDASIL vaccine. On 16-SEP-2008 the patient's mother called the physician and stated that the primary care physician put the patient on prednisone and that did not work. The patient still had tingling in her legs. The patient was send to a Neurologist. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence, Vaginal discharge, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: Information has been received from an office manager concerning a 17 year old female with penicillin allergy and a history of tonsillectomy (1994) who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM and on 15-MAY-2008 was vaccinated with the second dose of GARDASIL vaccine 0.5 mL, IM.  The patient had not yet received the third dose.  Concomitant therapy included DEPO-PROVERA.  The office manager reported that in 2008, the patient experienced stomach pain, leg pain, back pain and her leg had been "sore" and limp.  The patient also had sleepy feeling.  The patient was also experienced increased incidence of headaches and she also had a thin white discharged in the vagina.  On 11-SEP-2008 the patient experienced green pink stool.  The patient felt nauseated after eating, she had no diarrhea and constipation.  As of 15-SEP-2008 the patient experienced green pink stool.  She had no diarrhea and constipation.  As of 15-SEP-2008 the patient had not recovered from the symptoms.  A vaginal specimen analysis was performed that were negative for vaginitis.  The patient sought medical attention by seeing the physician.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/14/2008. Follow-up information was received from a physician via medical record who reported that on 11-SEP-2008, the patient went to doctor's office complianing of vaginal discharge that she describe as burning, itchy, white, foul, smelling and thin. The doctor stated the patient had premenstrual dysmenorrhea. The duration in 5 days and was interfering with work and normal activities. It was reported that the patient was not going to take DEPRO-PROVERA anymore because she didn't like the way it makes her feel. It was also reported that the patient had an adenoidectomy in 1994. The patient had never had a PAP smear or a mammogram, she had no history of significant medical diseases. At the physical exam patient height: 64 inches, weight 105 pounds and blood pressure 103/60. The patient's pelvic exam was normal and she had no history of obstetrical or gynecological surgery. The patient denied previous exposure to STD. On 14-SEP-2008 the patient was having a lot of symptomatology. She was concerned it is for GARDASIL vaccine. On 16-SEP-2008 the patient's mother called the physician and stated that the primary care physician put the patient on prednisone and that did not work. The patient still had tingling in her legs. The patient was send to a Neurologist. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 24 year old female who in May 2008, was vaccinated with the third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently, after vaccination the patient experienced generalized urticaria.  As of 15-SEP-2008, generalized urticaria persisted.  The patient sought medical attention.  She was seen by the physician.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Information has been received from a physician concerning a 17 year old female with low blood pressure who on 11-MAR-2008, 12-MAY-2008 and 13-SEP-2008 was vaccinated with a first, second and third dose of GARDASIL.  Respectively, no concomitant medication was reported.  The physician mentioned that after the first dose on 11-MAR-2008 the patient passed out in the office.  No injuries were sustained and the patient was discharged home.   The physician reported that three hours after receiving the second dose on 12-MAY-2008 the patient passed out while driving and hit another vehicle.  No injuries were sustained.  The physician reported that there were no adverse effects after the third dose.  The outcome of the patient was not reported.  The patient sought medical attention:  in the office.  There was no product quality complaint.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female with an estimated age of 20 year old with cheese allergy who on 04-MAR-2008 was vaccinated with a dose of 0.5mL GARDASIL (lot# reported as 658219/0755U) intramuscularly in the deltoid.  Concomitant therapy included VALTREX.  After receiving GARDASIL, the patient developed a "fever of 106 F" and was hospitalized for an unspecified period on time.  The fever lasted two weeks and subsequently recovered.  The patient told the physician of the fever at an office visit on 19-Sep-2008.  No other symptoms or information about treatment reported.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician (also reported as medical assistant) concerning a 16 year old female with no known allergies or medical history, who on 28-JUL-2008 was vaccinated with a first, 0.5 mL dose of GARDASIL (LOT# 659964/1978U), intramuscular. There was no concomitant medication. Five or four days later the patient experienced joint pain. The patient is a golfer and indicated that her joints are so painful at the end of a golf game that she has to rest for the reminder of the time. At the time of the report, the patient had not recovered. She mentioned that she tried ice and BIO-FREE, but only ADVIL made it tolerable. The patient sought medical attention, she was seen. The patient's joint pain was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. The reporter states that the patient had "a tingling sensation in both her arms and hands" right after getting vaccination. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who in August 2007, was vaccinated with her first dose of GARDASIL and she received her second dose of GARDASIL in December 2007 at another office. Subsequently, the patient commented the second dose was more painful than the first. No specifics known as given at another practice. The patient sought medical attention at office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with sulfonamide allergy and no medical history reported who on 20-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660553/0070X), 0.5 mL, I.M. and on 17-SEP-2008 was vaccinated with the second dose of GARDASIL (Lot # 659184/0843X). Concomitant therapy included (OCELLA). After receiving her second dose, the patient fainted, fell and received a jagged laceration on her head about one inch in length. The patient was treated in an emergency room, where she received "7 sutures" to the laceration site. The patient was recovering from the events. The patient sought medical attention at the office. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who "two weeks ago" on approximately 04-SEP-2008 was vaccinated with her second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient has continuing pain in her arm. The physician reported that the patient has been able to continue to work. The patient did not experience any problems after the first dose (date of administration not known). The patient has been taking MOTRIN for the discomfort results were not known. The patient's pain in her arm persisted. The patient has an appointment to see the physician on 22-SEP-2008. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 02-JUL-2008 was vaccinated with GARDASIL vaccine (yeast) 0.5 mL intramuscularly in the deltoid. On 02-JUL-2008, the patient experienced "hive like area near the injection site" after receiving the dose of GARDASIL vaccine (yeast). The patient sought treatment for adverse symptoms with an unspecified family physician. The patient was prescribed BENADRYL and cortisone cream. The symptoms resolved in "about one week". No other symptoms or treatment reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an unspecified number of patients who had no adverse reactions reported with GARDASIL vaccine (yeast) (MSD) (LOT# was unspecified) except for some tingling at the injection site. The physician did not specify the number of patients who had tingling. It was not reported if the patients sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Electrocardiogram abnormal, Heart rate irregular, Paraesthesia, Syncope
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 10-SEP-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) 0.5 ml IM. On 10-SEP-2008, the patient was at the doctors office and after receiving the dose of GARDASIL vaccine (yeast), she had blood drawn and fainted. The patient reported to the physician that she felt tingling "down her side" after fainting. An EKG was performed in the office, which showed and irregular heart rate. The patient was evaluated in an emergency room, and then she recovered and was discharged to home. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Dizziness, Drug exposure during pregnancy, Musculoskeletal chest pain
Clinical narrative: Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 25 year old female with allergy to Morphine who in approximately June was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot # not provided). On 02-SEP-2008 the patient received the second dose of GARDASIL vaccine (yeast) (lot # not provided) and soon afterward found out she was pregnant. Her LMP was approximately 07-AUG-2008. Expected date of delivery was 14-MAY-2009, The patient had no medical history. Concomitant therapy include Pindolol, vitamins (unspecified) and CELEXA (reportedly being discontinued). In early September 2008, the patient experienced stomach pain, abdominal pain, rib pain, nausea, dizziness and shakiness. Therapy with GARDASIL vaccine was discontinued. At the time of the report, the patient had not recovered from the adverse experiences. The patient did not seek medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pregnancy test, Tremor
Clinical narrative: Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 25 year old female with allergy to Morphine who in approximately June was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot # not provided). On 02-SEP-2008 the patient received the second dose of GARDASIL vaccine (yeast) (lot # not provided) and soon afterward found out she was pregnant. Her LMP was approximately 07-AUG-2008. Expected date of delivery was 14-MAY-2009, The patient had no medical history. Concomitant therapy include Pindolol, vitamins (unspecified) and CELEXA (reportedly being discontinued). In early September 2008, the patient experienced stomach pain, abdominal pain, rib pain, nausea, dizziness and shakiness. Therapy with GARDASIL vaccine was discontinued. At the time of the report, the patient had not recovered from the adverse experiences. The patient did not seek medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dyspepsia, Eating disorder, Gallbladder disorder, Intestinal functional disorder
Clinical narrative: Information has been received from a 19 year old female patient with allergy to codeine and no other medical history, who in August 2007, was vaccinated with GARDASIL 0.5mL. There was no concomitant therapy. On February 2008, the patient received the third dose of GARDASIL. After each shot her condition worsened. Since the beginning therapy, the patient experienced difficulty digesting food, loss of weight and energy, fever, problems with bowel movements, and at one time could not eat for 1.5 week. Her gall bladder is now not functioning and may have to be removed. The patient's mother, a registered nurse, stated that her daughter was sick almost most of summer especially with everything that contains fat. She was then eating a low fat diet. Ultrasound of the gallbladder was implemented and the results was negative for gall stones. At the time of report, the adverse events were ongoing. The patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Ultrasound scan normal, Vaccine positive rechallenge, Weight decreased
Clinical narrative: Information has been received from a 19 year old female patient with allergy to codeine and no other medical history, who in August 2007, was vaccinated with GARDASIL 0.5mL. There was no concomitant therapy. On February 2008, the patient received the third dose of GARDASIL. After each shot her condition worsened. Since the beginning therapy, the patient experienced difficulty digesting food, loss of weight and energy, fever, problems with bowel movements, and at one time could not eat for 1.5 week. Her gall bladder is now not functioning and may have to be removed. The patient's mother, a registered nurse, stated that her daughter was sick almost most of summer especially with everything that contains fat. She was then eating a low fat diet. Ultrasound of the gallbladder was implemented and the results was negative for gall stones. At the time of report, the adverse events were ongoing. The patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no pertinent medical history or drug reactions/allergies, who on 14-Aug-2008 was vaccinated with the first dose of GARDASIL (lot # 659655/1486U) I.M. into the right arm. Concomitant therapy included the first dose of MENACTRA (lot# 02560AA) IM into the left arm, the first dose of BOOSTRIX (lot# AC52B015AA) IM into the left arm, and the second dose of HAVRIX (lot# AHAVB245AA) IM into the right arm. After the patient was receiving HPV vaccine she waited in reception area for 10-15 minutes and with departure in hall and she vomited. No further information is available. It was reported that the patient's experience was considered non-serious. The original reporter was not provider. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, X-ray limb normal
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old white female with allergic reaction to CECLOR and clindamycin who on 17-Jan-2008 was vaccinated with a first dose of GARDASIL (lot# 659439/1267U) IM in her left deltoid. Other suspect therapy received on the same date included a first dose of VAQTA (lot# 569186/1258U) IM in her right deltoid. In January 2008, the patient experienced right knee pain, mostly anterior. On 25-Jul-2008 the patient was vaccinated with a second dose of GARDASIL (lot# 660553/0070X) IM in her left deltoid. Other suspect therapy received on the same date included a second dose of VAQTA (lot# 659186/1258U) IM in her right deltoid. Approximately 2 weeks after the vaccinations the patient experienced right knee pain, mostly anterior. On 08-Feb-2008 the patient was seen by an orthopedic and performed an X-ray with essentially normal result. As of 16-Sep-2008, the patient's right knee pain persisted without obtained knee injury. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lupus-like syndrome
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced lupus like reactions. No other information reported. This is one of several reports from the same source. Additional information requested.
Sex: F
Vaccine: HPV4
Symptoms: Lupus-like syndrome
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced lupus like reactions. No other information reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Oedema peripheral
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under freedom of information Act. A patient with no pertinent medical history or allergies who on 28-AUG-2008, was vaccinated with GARDASIL (lot# 659441/1446U) IM into the right arm and MENACTRA (lot# U2621AA) IM, into the left arm. There was no concomitant medication. On 28-AUG-2008 the patient complained of feet swelling, about double sizes after receiving the vaccine. The patient's mother stated that the patient had no pain in her feet. It was reported that her feet started swelling about 45 minutes after receiving the vaccines and the swelling went away 90 minutes. She denied another problem. No laboratory tests were performed. The original reporting source was not provided. The VAERS ID # is 324371-1. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a mother concerning her 22 year old female daughter with colitis and allergies to Ceclor, who on 20-SEP-2008 was vaccinated with the second dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) and ASACOL. The mother reported that her daughter developed a fever, nausea, vomiting and a rash on her chest about 8 hours after receiving her second dose of GARDASIL. The patient sought medical attention by a phone call. At the time of report the patient had not recovered. Additional information has been expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Drug administered at inappropriate site, Injection site haematoma, Injection site necrosis, Injection site scar
Clinical narrative: Information has been received from the mother patient concerning a 16 year old female with a knee operation who in "Fall 2007" approximately in September 2007, was vaccinated with her first dose of GARDASIL 0.5mL in her hip, closer to the waist than the thigh. Concomitant therapy included hormonal contraceptives (unspecified). About two weeks after the first shot, at the injection site she developed a scar that is indented and bruised, and the physician said it was dead tissue. She had her second and third dose of HPV vaccine(yeast) in the same spot so that it would not scar her arm too. She had also experienced joint pain. The patient's adverse experience persisted. The patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient who on 12-AUG-2008 was vaccinated with her first dose of GARDASIL from her school. Lot number not available at this time. A few days ago, she experienced symptoms of Bell's palsy with paralysis of her face. She phoned the doctor and will be seen in the office this week. As of 22-SEP-2008, the patient had not recovered. There was no product quality complaint. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site induration
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 11-SEP-2008 was vaccinated with GARDASIL was administered subcutaneous instead of intramuscular into the right upper arm. On an unspecified date, the patient experienced knot at injection site post vaccination. In September 2008 the patient recovered from knot at injection site post vaccination. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Fatigue, Malaise
Clinical narrative: Information has been received from a physician concerning a female who on 17-Jun-2008 was vaccinated intramuscularly with the second dose of GARDASIL (lot# 659180/1758U). Her first dose was on 31-Mar-2008. The patient has no concomitant conditions and medical history. She has no drug reactions or allergies either. Subsequently the patient experienced shortness of breath, dyspnea, malaise and fatigue. The patient has been several times at an urgent care center. She was last seen by physician on 04-Sep-2008 and the physician wrote in her notes "symptoms resolving, possible GARDASIL reaction". At this appointment the patient stated that she is experiencing transient dizziness that last for 1 minute. At the time of the report the patient had not recovered. No additional information is available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no medical history who on 19-Sep-2008 was vaccinated with second dose of GARDASIL (Lot number reported as 0152X). The patient received her first dose of GARDASIL in JUL (year unspecified). On 22-Sep-2008 the patient experienced rash. No lab diagnostics studies were performed for the patient. It was unspecified if the patient received any concomitant therapy. However, the patient did not experience any rash after the 1st dose. The physician told the patient to take BENADRYL for the rash. The patient informed the physician that once the BENADRYL wears off the rash come back. The patient did not recover from the rash. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL was given. Subsequently the patient did not have menstrual period 4 months after GARDASIL was given. The patient sought medical attention. Additional information has been requested. This is one of two reports received from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who was intramuscularly vaccinated with a dose of GARDASIL (MSD) on 04-FEB-2208. Concomitant vaccination on 04-SEP-2008 included MENACTRA (manufacture unspecified) in the same arm at the same time. Approximately on 19-SEP-2008 ("about 3 days ago") the patient experienced blisters around the injection site after she received GARDASIL (MSD) and MENACTRA (manufacture unspecified). On 22-Sep-2008, the patient was schedule to come into the physician's office for a check-up. The patient was recovering at the time of report. No further adverse event information reported. The patient called the doctor to seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a vaccine nurse who noticed that children that are on attention deficit disorder (ADD) or attention deficit/hyperactivity disorder (ADHD) medication or with psychological needs experience syncope more often after receiving GARDASIL (lot# not provided). The patients sought unspecified medical attention. Follow-up information was received from the nurse. She said that the office had 3 or 4 patients faint after receiving GARDASIL. When they looked into it the patients were all on ADHD medicine of Psych medicine. The office decided to lay all the patients down after they received the vaccine to hopefully prevent the syncope. None of the patients were hospitalized. She did not have any patient identifiers because all of this happened over a year ago. Since they started laying patients down after the vaccinations over a year ago they have had no problems. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 08-SEP-2008 was vaccinated with a first dose of GARDASIL (lot # 0152X).  Concomitant therapy included ZOVIA.  On 15-SEP-2008 the patient experienced a rash on her face.  The patient did not seek medical attention but was told to take BENADRYL for the rash.  There was no lab test.  No further information was provided.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Iris hypopigmentation
Clinical narrative: Information has been received from a optometrist concerning a female patient who in November 2007, was vaccinated with her first dose of GARDASIL, 0.5mL, IM. In January 2008, was vaccinated with her second dose of GARDASIL in May 2008, was vaccinated with her third dose of GARDASIL in November 2007. Since receiving the vaccine the patient experienced a depigmentation of the lower half of the iris of the right eye which has been progressive with each. A gonioscopy was performed which results normal. The patient had not recovered. The patient sought medical attention at the physician's office. The timing of the depigmentation was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gonioscopy normal, Iris hypopigmentation
Clinical narrative: Information has been received from a optometrist concerning a female patient who in November 2007, was vaccinated with her first dose of GARDASIL, 0.5mL, IM. In January 2008, was vaccinated with her second dose of GARDASIL in May 2008, was vaccinated with her third dose of GARDASIL in November 2007. Since receiving the vaccine the patient experienced a depigmentation of the lower half of the iris of the right eye which has been progressive with each. A gonioscopy was performed which results normal. The patient had not recovered. The patient sought medical attention at the physician's office. The timing of the depigmentation was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning many patients that were vaccinated on unspecified dates with an unknown dose of GARDASIL and experienced sore arm after vaccination. Attempts are being made to obtain identifying information to distinguish the individual patients. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL vaccine (yeast). The patient developed dizziness after vaccination. On an unspecified date 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: Skin papilloma
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL vaccine (yeast). The patient developed warts on hands after vaccination. The outcome of the patient was unknown. This is one of several reports from the same source. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Hypertension
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/14/2008. Information has been received from a public school registered nurse concerning a 11 year old female who on 03-SEP-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) (unspecified whether the injection was the first or a subsequent injection in the series). After receiving GARDASIL vaccine (yeast), the patient developed hypertension (152/82) and "about a week after receiving GARDASIL vaccine (yeast)", the patient developed headaches. The hypertension was discovered as the reporter monitored the patient's blood pressure after a complaint of headache. No other symptoms or treatment were reported. On an unknown date, an unspecified blood work was performed (results not provided). The patient's status at the time of the report was not recovered. The patient sought medical attention at the office. In follow-up, the nurse reported that the vaccine involved in this report was VARIVAX (Merck) and not GARDASIL. This report was previously sent on 14-OCT-2008. This report was previously sent on 14-OCT-2008. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Paraesthesia, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 26 year old female who was vaccinated the first 0.5ml dose of GARDASIL vaccine (yeast) (MSD) on 17-JUL-2008. On 15-SEP-2008 the patient was vaccinated the second 0.5 ml dose of GARDASIL vaccine (yeast( (MSD) in the left arm. The patient took oral contraceptive (unspecified). A few hours later on 15-SEP-2008, the patient had a headache and blurry vision. The patient laid down and later woke up the tingling of right hand. The tingling resolved in 15 minutes. No treatment required. At time of report, the patient recovered on an unspecified date. The patient sought medical attention by phone. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Generalised erythema, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL vaccine (yeast). The physician reported that the patient received the HPV vaccine and experienced red, itchy welts head to foot. At the time of the report the patient had not recovered. The patient sought medical attention by phone. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Leukocytoclastic vasculitis, Petechiae
Clinical narrative: Information has been received from a registered nurse concerning her 14 year old niece with no pertinent medical history and no allergies or drug reactions, who on 29-MAY-2008 was vaccinated with the second dose of HPV 4L1 6 11 18 VLP vaccine (yeast). There was no concomitant medication. The nurse reported that in "mid June 2008", her niece experienced a generalized, "petechial-type rash". The above was diagnosed by a dermatologist as leukocytoclastic vasculitis. At the time of the report the patient had not recovered. Additional information has been requested. 11/5/08-records received-note of 9/23/08-Left leg superficial perivascular infiltrate of lymphocytes with erythrocyte extravasation consistent with progressive pigmentary purpura. No neutrophilic infiltrate or fibrinoid degeneration of vessels is identified to suggest a true vasculitis. Allergic contact dermatitis. 10/27/08-cancelled follow up appointment.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a female patient who on unknown dates, was vaccinated with the first and second dose of GARDASIL vaccine (yeast). The nurse reported that the patient experienced fever and dizziness after each dose of GARDASIL vaccine. The nurse would follow-up with medical services to see if she would give the patient her third dose. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL vaccine (yeast) and fainted, but was caught before she fell. It was unknown if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician concerning an approximately 20 year old female patient who on an unspecified date, was vaccinated with the second dose of GARDASIL vaccine (yeast). The physician reported that the patient had an unspecified systemic reaction after receiving GARDASIL vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from an office manager concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast). It was reported that on an unspecified date some time ago (also reported as some weeks ago) the patient passed out while standing at the check out after her first dose. The patient recovered. There were no emergency procedures; she was not injured and no pregnant. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 23 year old female who in May 2008, was vaccinated with GARDASIL vaccine (yeast), 0.5 mL intramuscularly. Three days after receiving vaccination, the patient developed abdominal pain. The physician ran some laboratory tests but the results were negative. On an unspecified date, the patient recovered from abdominal pain. The patient sought physician's medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Rash, Urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a 16 year old female who on 16-SEP-2008 was vaccinated with a dose of GARDASIL (lot # 660618/0572X) into the left deltoid.  On 17-SEP-2008 the patient developed a rash on her groin and hives over the rest of her body.  She also reported swollen lymph nodes in her left axillary area.  She was treated topical steroids and antibiotics.  No other information was available.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated IM with GARDASIL  vaccine (yeast). Subsequently the patient developed irregular menstrual periods after GARDASIL vaccine (yeast) was given. The patient sought medical attention. Additional information has been requested. This is one of two reports received from the same source.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood test
Clinical narrative: Information has been received from a consumer concerning his 12 year old daughter with no pertinent medical history, allergies or drug reactions who in April 2008, was vaccinated with the second dose GARDASIL vaccine (yeast) 0.5 ml (lot no. not reported). There was no concomitant medication. On an unknown date, the patient developed a bald spot on her head. Therapy with human papillomavirus vaccine was discontinued. The patient's bald spot on head persisted. In Jun 2008 a blood work was done (results not reported). The patient sought unspecified medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter a 17 year old female with no known drug allergies/reactions and no pertinent medical history reported who on unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). On 18-AUG-2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) and experienced soreness at the injection site after receiving the vaccine. On 23-SEP-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) 0.5 mL intramuscularly, and the patient's mother stated that the doctor's nurse accidentally administered the fourth dose. On 23-SEP-2008, soreness at the injection site reappeared after the 4th dose of GARDASIL vaccine (yeast). The patient sought unspecified medical attention. The patient recovered from soreness at the injection site on 23-SEP-2008. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry from a nurse who reported that on approximately 19-SEP-2008, a 2 week old old infant was born with an unspecified weakness to a mother who received the first dose of GARDASIL vaccine (yeast) about a year ago, approximately in September 2007. There was no concomitant medication. The patient is now receiving physical therapy. The patient sought medical attention with an office visit. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history and no allergies or drug reactions who on 23-JUL-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 ml, intramuscularly. Concomitant therapy included YAZ. On 24-SEP-2008, the patient was vaccinated with the second dose of HPV vaccine (lot# 661044/0548X), 0.5 ml intramuscularly. The nurse practitioner reported that the patient developed intermittent nausea 1 and a 1/2 hours after receiving her second dose. The nausea was mild and intermittent, and had not caused emesis. At the time of the report, the patient had not recovered. The patient sought medical attention by phone. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Visual impairment
Clinical narrative: Information has been received from a physician assistant concerning hi daughter, a 13 year old female, who was administered her second dose of vaccination with GARDASIL vaccine (yeast) IM> Subsequently the patient experienced vision problems. The patient received a computed axial tomography (CAT) scan, and results were found to be normal. Subsequently, the patient recovered from vision problems. The physician assistant felt that vision problems are not related to therapy with GARDASIL vaccine (yeast). No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Fall, Mouth injury, Suture insertion, Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient with no medical history who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (LOT# 659653/1448U) 0.5 ml intramuscular into the left arm. There was no concomitant medication. After receiving the injection the patient fainted and fell face first onto the the floor and was unresponsive for three minutes. Subsequently 911 notified and transported the patient to the hospital. The patient underwent a CT scan of the skull (no result was provided) and received 7 stitches to the upper lip. No other laboratory tests were performed. There were no other symptoms or treatment reported. Then the patient was released from the emergency room. At the time of this report, the patient's father reported that the patient was at home and feeling better. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient with no medical history who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (LOT# 659653/1448U) 0.5 ml intramuscular into the left arm. There was no concomitant medication. After receiving the injection the patient fainted and fell face first onto the the floor and was unresponsive for three minutes. Subsequently 911 notified and transported the patient to the hospital. The patient underwent a CT scan of the skull (no result was provided) and received 7 stitches to the upper lip. No other laboratory tests were performed. There were no other symptoms or treatment reported. Then the patient was released from the emergency room. At the time of this report, the patient's father reported that the patient was at home and feeling better. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 13 year old female patient with no medical history who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (LOT# 660557/0072X) 0.5 ml intramuscular into the left deltoid. There was no concomitant medication. Subsequently the patient fainted as she stood up after receiving GARDASIL vaccine (yeast). The fall was braced and the patient lowered to the floor without injury. The patient was monitored for 20 minutes and released to home with the patient's mother. No other laboratory tests were performed. At the time of this report, it was unknown if the adverse event was ongoing. 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: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient fainted. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no illness at time of vaccination who on 12-MAY-2008 was vaccinated with her third dose of GARDASIL vaccine (yeast) (therapy route, dose and Lot # unspecified). There was no concomitant medication. No lab diagnostics studies were performed for the patient. A couple of months after the vaccination, the patient experienced Bells Palsy. The patient sought medical attention in the emergency room but not admitted to the hospital. Subsequently, the patient recovered from Bells Palsy (recovered date unknown). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Computerised tomogram normal, Convulsion, Fall, Head injury, Hypotension
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 17-SEP-2007 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM, on 24-SEP-2008 was vaccinated with second dose of GARDASIL vaccine (lot no. 660618/0572X) 0.5 ml, IM. Concomitant therapy included MENACTRA and FLUMIST. On 24-SEP-2008. 5 minutes after vaccination, the patient passed out and fell to the floor hitting the head. The nurse also reported that the patient "had what looked like a little seizure", the patient was hypotensive. The patient was transferred to the emergency room. The head computed axial tomography performed was negative (head normal). The patient was not admitted in the hospital. The patient recovered and was discharged home. The emergency room diagnosis was syncope. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 17-SEP-2007 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM, on 24-SEP-2008 was vaccinated with second dose of GARDASIL vaccine (lot no. 660618/0572X) 0.5 ml, IM. Concomitant therapy included MENACTRA and FLUMIST. On 24-SEP-2008. 5 minutes after vaccination, the patient passed out and fell to the floor hitting the head. The nurse also reported that the patient "had what looked like a little seizure", the patient was hypotensive. The patient was transferred to the emergency room. The head computed axial tomography performed was negative (head normal). The patient was not admitted in the hospital. The patient recovered and was discharged home. The emergency room diagnosis was syncope. Additional information has been requested.