chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 28 year old female patient with no drug reactions/allergies. The medical assistant reported that on 13-NOV-2009 the patient was hospitalized for anemia and had a blood transfusion. The patient was discharged from the hospital on an unknown date. On 16-NOV-2009 the patient went to the emergency room and complained of frequent headaches, nausea, vomiting and blurred vision. It was reported that the patient was not admitted to the hospital. It was also reported by the medical assistant on 17-NOV-2009 that the patient was vaccinated with a first dose of GARDASIL (Lot# 665547/1318Y). There was no concomitant medication and the patient did not receive any concomitant vaccinations when GARDASIL was administered. The physician reported that on 20-NOV-2009 the patient experienced general depression, was just feeling not right, crying, ache and dizziness. It was reported that the patient had dropped out of school because of what she was experiencing and had gone to the emergency room five times for the symptoms she was having. The physician also stated the patient was still experiencing the depression and had been put on Alprazolam (manufacturer unspecified). The medical assistant reported that on 26-NOV-2009 the patient went to the ER and complained of abdominal pain. The patient was not admitted to the hospital. On 01-DEC-2009 the patient had another physician's visit. The patient complained of abdominal pain, back pain, vomiting and headache. On 11-DEC-2009 the patient was seen by the physician. On 14-DEC-2009 the patient was seen by the physician and complained of headache, back pain and swollen glands. The patient was referred to an ENT specialist (name not reported). On 10-FEB-2010, the patient was seen by the physician. The patient complained of muscle aches, decreased ability to interact with other, decreased ability to concentrate, decreased energy and had no appetite. The physician advised the patient to have a Psychology evaluation. An ultrasound was ordered to rule out thyroid nodules and a TSH laboratory blood test was ordered. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test, Malaise, Pain, Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female without any drug reactions or allergies and with no pertinent medical history who on 01-DEC-2009 was vaccinated with the first dose of GARDASIL and then on 01-FEB-2010 was vaccinated with the second dose of GARDASIL. Concomitant therapy included birth control medication (name unspecified). On 02-FEB-2010 after receiving the second dose of GARDASIL, the patient broke out in hives, a macular papular rash that started on the back of her neck and went to the front of her body, the patient also experienced malaise and aches and pains. So the patient then called the nurse practitioner and told her the symptoms she was having and was told to take BENADRYL (manufacturer unspecified). The patient then went to the emergency room (ER) where they put her on MOTRIN (manufacturer unspecified) and hydroxyzine (manufacturer unspecified) and also ran blood work. At the ER, the ER physician asked the patient what might have caused this and the patient told the physician about getting GARDASIL. The ER physician then noticed that after receiving the first dose of GARDASIL on 01-DEC-2009 that she was in the ER with a much milder case of what she was experienced after the second dose of GARDASIL. The nurse practitioner reported that the patient followed up with her primary care office and OBGYN office and she was fine after reviewing blood work, but the patient did miss a day of school because of the experience. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female without any drug reactions or allergies and with no pertinent medical history who on 01-DEC-2009 was vaccinated with the first dose of GARDASIL and then on 01-FEB-2010 was vaccinated with the second dose of GARDASIL. Concomitant therapy included birth control medication (name unspecified). On 02-FEB-2010 after receiving the second dose of GARDASIL, the patient broke out in hives, a macular papular rash that started on the back of her neck and went to the front of her body, the patient also experienced malaise and aches and pains. So the patient then called the nurse practitioner and told her the symptoms she was having and was told to take BENADRYL (manufacturer unspecified). The patient then went to the emergency room (ER) where they put her on MOTRIN (manufacturer unspecified) and hydroxyzine (manufacturer unspecified) and also ran blood work. At the ER, the ER physician asked the patient what might have caused this and the patient told the physician about getting GARDASIL. The ER physician then noticed that after receiving the first dose of GARDASIL on 01-DEC-2009 that she was in the ER with a much milder case of what she was experienced after the second dose of GARDASIL. The nurse practitioner reported that the patient followed up with her primary care office and OBGYN office and she was fine after reviewing blood work, but the patient did miss a day of school because of the experience. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 27 year old female who was vaccinated with the third dose of GARDASIL (injection route). The physician reported that after receiving the third dose of GARDASIL, the patient developed rash. It was unspecified if the patient had sought medical attention. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts, Blister
Clinical narrative: Information has been received from a 33 year old male consumer with "multiple sclerosis" and a history of genital warts, and no allergies who "a couple of years ago" was vaccinated with 0.5 ml dose of GARDASIL three times. Concomitant therapy included insulin and "medicine for multiple sclerosis". "With in the last 2 weeks" on approximately 09-FEB-2010 the consumer experienced a genital wart. There was not laboratory studies performed. When asked if the adverse event improved and about his present status, the consumer stated that his doctor froze the genital warts on 22-FEB-2010 and on 23-FEB-2010 there was a blister where the wart was. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no medical history or allergies who in September 2007, was vaccinated with 0.5 ml dose of GARDASIL (lot # 658560/1062U). There was no concomitant medication. In September 2007, the patient experienced sore arm. It resolved in a few days in September 2007. On 23-FEB-2010 the patient would received second dose of GARDASIL. There were no laboratory studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Lymphadenopathy
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 year old female with no known drug allergies and pertinent medical history who on 30-DEC-2009 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 662518/0087Y). Concomitant therapy included LOESTRIN FE. It was reported that the patient developed swollen lymph nodes in her neck after administration of GARDASIL. The patient stated that she could notice them in the mirror. The patient did not have any other symptoms. The patient sought medical attention via telephone. No lab test was performed. On 04-JAN-2010 the patient recovered from swollen lymph nodes. Follow up information has been received from a licensed practical nurse concerning a 22 year old female patient with no known drug allergy and no illness at time of vaccination who in the afternoon of 30-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 662518/0087Y) in her right deltoid. On 01-JAN-2010 (previously reported as 02-JAN-2010), the patient awoke to find her neck swollen. The patient's lymph nodes in her neck were enlarged. The patient phoned to the doctor on call. Since the patient had no other adverse reactions, she was advised to monitor. The patient stated that 2 days later the lymph nodes returned to normal. On 03-JAN-2010 (previously reported as 04-JAN-2010) the patient recovered. In the morning of 23-FEB-2010 the patient was vaccinated with the second dose of GARDASIL (lot # 663559/1178Y) in her left deltoid. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Migraine, Vaccination complication, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 17 year old female patient, who on unknown dates was vaccinated with the three doses of GARDASIL (route and lot numbers not provided). It was unknown if there was concomitant therapies. The Nurse stated that the patient experienced vomiting and headache after each dose. On an unknown date, the patient went to a health center where she was initially diagnosed with "abdominal migraines", but later diagnosed as "having a reaction to GARDASIL. At the time of reporting, the patient outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning a female patient who in November 2009, was vaccinated with her third dose of GARDASIL. It was reported that in November 2009, the day after vaccination and continuing to 03-MAR-2010, the patient stated that her arm was stiff and that she had intermittent excruciating pain in her left deltoid, up high. At the time of the report the patient had not recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a doctor's licensed practical nurse concerning a 50 year old female patient who was post menopausal and had never had children and with a history of breast cancer who on 21-MAY-2010 was vaccinated with the first 0.5mL dose of GARDASIL. Concomitant therapy included TAMIFEN. On 28-MAY-2010 the patient called the office stating she had vaginal bleeding. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The doctor would discuss ultrasound testing with the patient. At the time of the report, the patient's outcome was unspecified. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a "12 or 13 year old male patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The patient received therapy a dose of dose of diphtheria toxoid and pertussis acellular vaccine (unspecified and tetanus toxoid and a dose of MENACTRA on the same visit. On an unspecified date the patient experienced rash. Unspecified medical attention was sought. The patient was given 3 days of prednisone and it cleared. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (lot number not reported).  It was reported that the patient experienced redness and swelling at the injection site when she received the vaccine.  It was unknown which dose in the series the patient received when she experienced the adverse event.  It was unknown if medical attention was sought.  The outcome of the patient was not reported.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with anxiety who on 24-MAY-2010 was vaccinated with the first dose of GARDASIL (lot number not reported). The patient past out shortly after the vaccination. The patient's condition improved on therapy. No medical attention was sought. On 24-MAY-2010, the patient recovered.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date, the patient experienced genital warts. The patient sought unspecified medical attention. At this time of reporting, the patient's outcome was unknown. This is the first of two reports from same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient who on 01-APR-2010 was vaccinated IM with a first dose of GARDASIL (lot # 665768/1377Y) in her left deltoid. Five minutes after injection, the patient experienced metallic taste in her mouth, which lasted 12 hours. The patient did not report this side effect until 20-MAY-2010, prior to her second dose of GARDASIL vaccine. The physician recommended to proceed with a second injection of GARDASIL. The patient did not seek medical attention. On 02-APR-2010, upon awakening, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Skin disorder, Swelling
Clinical narrative: Information has been received from a female patient concerning herself who on 26-APR-2010 was given 3 series of GARDASIL. It was reported that she noticed it was a little swollen and she stated she rubbed her arm to work it and since then she has noticed it was marked-hand and stretched her skin. She stated that she went to doctor's office on 20-MAY-2010. At the time of the report the outcome of the patient was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injury
Clinical narrative: An online magazine reported that the mother of a patient said that her daughter was vaccinated with a dose of GARDASIL. It was reported that the patient was adversely injured from GARDASIL. This is one of several reports received from the same source. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vomiting
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient who on 23-DEC-2009 was vaccinated with the first dose of GARDASIL (lot# 0669Y). It was reported that the patient might have been pregnant when she was given the first dose of GARDASIL. No other doses had been given to the patient. The nurse stated the patient had no adverse reactions but did go to the Emergency Room for vomiting in February 2010. The patient was not admitted to hospital. At the time of the report, the patient's status was unknown. The patient's last menstrual period was 13-DEC-2009. The estimated delivery date was 19-SEP-2010. Additional information has been requested. The patient went to Emergency Room at medical center.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a practice manager concerning a 12 year old female patient who on 16-MAR-2010 was vaccinated with one dose of GARDASIL (Lot # 663559/1178Y). The practice manager reported that the patient experienced edema of the extremities. At the time of this report, the patient had not recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Erythema, Headache, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on approximately 29-DEC-2009 was vaccinated with the second dose of GARDASIL. On 29-DEC-2009 the patient experienced weakness, redness on her face, swelling, pain at injection site, headache and nausea. No lot number is provided. On an unspecified date the patient recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on approximately 29-DEC-2009 was vaccinated with the second dose of GARDASIL. On 29-DEC-2009 the patient experienced weakness, redness on her face, swelling, pain at injection site, headache and nausea. No lot number is provided. On an unspecified date the patient recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with an unspecified dose of GARDASIL (lot number or expiration date not provided). In "2009" the patient had fainting when getting the vaccine. No medical attention was sought. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received concerning a 31 year old female with no pertinent medical history and no known allergies who on 06-MAR-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 655503/0012U, expired date 13-JUN-2009).  On 30-JUN-2007 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 658094/0524U, expired date 28-FEB-2010).  On 05-MAY-2008 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number 659964/1978U, expired date 29-AUG-2010).  Concomitant therapy included "nasal spray" (unspecified), occasional antimicrobial (unspecified) as needed and NUVARING.  On 20-MAY-2010 the patient had a Papanicolaou test (PAP) that indicated "HPV high risk detected".  The patient had previous PAP test in which HPV was not detected.  The dates of the PAP tests were:  27-SEP-2007, 05-MAY-2008, 03-JAN-2009 and 23-JUL-2009.  Medical attention was sought via office visit.  The outcome of the patient was not reported.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a medical assistant concerning a current 20 year old female patient who on 28-MAY-2008 at the age of 18 year old was vaccinated with the first dose of GARDASIL, on 25-NOV-2008 was vaccinated with the second dose of GARDASIL and on 16-MAR-2009 was vaccinated with the third dose of GARDASIL. Concomitant therapy included occasional antibiotic for sore throat. The medical assistant reported that on an unspecified date, the patient tested positive for HPV post vaccination with GARDASIL. The medical assistant reported the patient was HPV negative before getting vaccinated with GARDASIL; the patient had never tested positive before. The patient sought unspecified medical attention. At the time of the report, the event persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date, the patient experienced genital warts. The patient sought unspecified medical attention. At this time of reporting, the patient's outcome was unknown. This is the second of two reports from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a 22 year old female patient with no known allergies/drug reactions, who in the fall of 2007, was vaccinated with the first and second dose of GARDASIL (Lot # not provided) and early 2008, the patient was vaccinated with the third dose of GARDASIL (Lot # not provided). It was reported that the patient received her papsmear test results on 27-MAY-2010 and she tested positive for HPV serotypes 16 and 18. At the time of this report, the patient's status was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder, Throat tightness
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 17-MAY-2010 was vaccinated with a second dose of GARDASIL (Lot number not provided). The nurse reported that about 15-20 minutes after receiving the vaccine the patient felt like her throat was tightening and had trouble speaking. The nurse practitioner reported that the patient contacted the office on 18-MAY about experience and came in the office. At the office the patient was given BENADRYL (manufacturer unspecified) and since the patient had not gotten worse. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 28 year old female patient who on 14-FEB-2010 was vaccinated with a first dose of GARDASIL (Lot # not provided). Concomitant therapy included a dose of HAVRIX and a dose of diphtheria toxoid and pertussis acellular vaccine (unspecified) and tetanus toxoid (manufacturer unknown).  It was reported that the patient developed a rash after receiving GARDASIL. On an unspecified date the patient had recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female patient with obesity and no drug reactions or allergies who on 15-MAR-2010 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number 663559/1178Y, expiration date 11-NOV-2011) IM. On 17-MAY-2010 the patient was vaccinated with a 0.5 ml second dose of GARDASIL (Lot number 665768/1377Y, expiration date 29-JUN-2012) IM. The nurse reported that the patient developed swelling of her throat 15-30 minutes after receiving her second dose of GARDASIL. The patient was treated with BENADRYL. The patient reported that she felt there was still some swelling on the left side of her throat on 18-MAY-2010. No laboratory tests were performed. At the time of the report the patient was recovering. The patient sought medical attention by an office visit. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Tension
Clinical narrative: Information has been received from a nurse concerning a 19 year old female patient with allergic to erythromycin who on 19-MAY-2010 was vaccinated with a third 0.5 ml dose of GARDASIL (lot number 665768/1377Y) IM in the ventrogluteal area. Concomitant therapy included MICROGESTIN. The patient tensed up during administration and might not have received the full dose because some of the vaccine came out. The patient also felt light headed but the patient did not eat on the day and took a vitamin on an empty stomach. The patient mentioned GARDASIL injection previously "hurt her" and that was the reason why she did not want to get the vaccine at the recommended administration areas. It was unknown the area the patient received the previous dose or which dose, whether it was the first or second dose. No lab studies performed. On an unspecified date, the patient had recovered. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Retching, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 17 year old male with irritable bowel and asthma and no drug allergies who on 18-MAY-2010 at 5:00 PM was vaccinated intramuscularly into left deltoid with a dose of GARDASIL (Lot # 0670Y). Concomitant therapy included CYMBALTA. On 19-MAY-2010 at 03:00 AM the patient experienced vomiting and dry heaves. There was no lab diagnostics performed. Unspecified medical attention was sought. He had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pyrexia, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with no drug allergies or pertinent medical history who on 10-MAY-2010 was vaccinated with the first dose of GARDASIL (Lot number 663454/0672Y, expiration date 19-SEP-2011) IM. There was no concomitant medication. The nurse reported that in the evening of 10-MAY-2010 the patient developed stomach cramping, diarrhea, fever of 100.5 degrees F and chills. The patient was seen in the emergency room and was told it was a viral infection. The patient was given BENTYL and was told to take ibuprofen for the fever. On an unspecified date the patient recovered.  Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a male consumer who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number not provided). When the patient got home he experienced dizziness and fainted. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Hyperventilation, Nausea, Throat tightness, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL in another office. Concomitant therapy included YAZ and SOLODYN. It was reported that 5-7 minutes later "her throat closed, she hyperventilated and had nausea and vomiting". The physician stated that the patient became anxious during this whole process. It was reported that this lasted 20 minutes after which the patient resolved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an "about 22 year old" female who on an unspecified date was vaccinated with all three doses of GARDASIL at another physician's office. It was reported that the patient did not receive them in the correct time frame. The physician reported that after receiving GARDASIL the patient had a PAP test done and her PAP smear came back abnormal. The patient sought unspecified medical attention. At the time of the report the outcome of the patient was not reported. Additional information has been requested.
Age: 0.27
Sex: M
Vaccine: HPV4
Symptoms: Infantile spitting up, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 weeks old male patient who on 13-MAY-2010 was vaccinated by mistake with a dose of GARDASIL (lot # 663558/0819Y) 0.5mL, intramuscularly. Concomitant therapy included poliovirus vaccine and hepatitis B virus vaccine (unspecified) (manufacturer unknown). The mother of the patient stated that he was "spitting up a lot" a day or two days after getting the vaccine. Therapy with human papillomavirus vaccine was discontinued. The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Flushing, Immediate post-injection reaction, Rash, Tremor
Clinical narrative: Information has been received from a nurse practitioner, concerning a 11 year old female patient, who in December 2009, was vaccinated with the first dose of GARDASIL (dose and route not provided) (lot number 665547/1318Y). Other vaccines administered the same day included ADACEL, which was given right before the GARDASIL dose was given. In December 2009, immediately after the first dose of GARDASIL was given, the patient was flushed, had a rash on her face and neck and was shaking. The nurse practitioner reported that these symptoms lasted for 15 minutes and then resolved. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 18 year old female patient with a family history of cervical cancer who on 27-JUL-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot number 654885/1424F). On 03-OCT-2007, the patient was vaccinated with a 0.5 ml second dose of GARDASIL (lot number 654885/1424F). On 05-FEB-2008, the patient was vaccinated with a 0.5 ml third dose of GARDASIL (lot number 654885/1424F). Nurse reported that the patient had a PAP Smear test done in 2009 and the result came negative. Approximately on 13-MAY-2010, the patient had another PAP Smear and the result came in as positive HPV and Cervical Intraepithelial Neoplasia II (CIN 2). The patient sought for unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Drug exposure during pregnancy, Dysuria, Laboratory test, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry of GARDASIL, concerning a female patient with abnormal period (end of March 2010 and beginning of April 2010) who on 01-DEC-2009 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number 661841/0653X, expiration date 25-FEB-2011) IM. On 27-APR-2010 the patient was vaccinated with a 0.5 ml second dose of GARDASIL (Lot number 665607/1332Y, expiration date 25-JUN-2012) IM. There was no concomitant medication. The nurse reported that the patient was given the second dose of GARDASIL and then had a pregnancy urine test that was positive on 06-MAY-2010. The nurse reported that the patient went to a clinic with complaints of pain with urination (onset date was 22-APR-2010) and intermittent left lower quadrant pain. A routine pregnancy urine test was done according to guidelines at the clinic (patient did not know her last menstrual period). The patient's exam was within normal limits. Laboratory tests performed included tests for sexually transmitted disease (STDs) with no results provided. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain
Clinical narrative: Information has been received from a physician concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 mL dose of GARDASIL (route and lot number not reported). Physician said the patient experienced chest pain after receiving GARDASIL injection. She went to her primary doctor and had many tests but "everything was fine". It was unknown which dose of the vaccine she received. Subsequently, on an unknown date, the patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Salmonellosis
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the first 0.5ml dose of GARDASIL. "A week after the vaccination, the patient developed a fever and nausea". The patient was taken to the emergency room. At this time of reporting, the patient's status was unknown. The ER doctor informed the patient that he believed it was more of a flu thing rather than a reaction to GARDASIL. Follow up information received from a nurse practitioner followed up with the patient and it turned out that her symptoms were not related to GARDASIL. She ended up having salmonella. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no known pertinent medical history or drug reactions/allergies who on approximately 13-APR-2010 was vaccinated with a first dose of GARDASIL (lot # not provided). There was no concomitant medication. The physician stated that on the same day of vaccination, the patient developed axillary lymphadenopathy. On an unspecified date, a complete blood cell count was performed with normal results. The patient sought unspecified medical attention. On an unspecified date, the patient had recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dry skin, Erythema, Eyelid oedema, Hypersensitivity, Injection site rash
Clinical narrative: Information has been received from a physician's assistant concerning a 21 year old female patient who on 15-APR-2010 was vaccinated with the first dose of GARDASIL. On 15-APR-2010 the patient had an allergic reaction.  She got a rash around injection site. The patient had a red rash on the neck and arms. Also it was red and really dry around the eyes. She also had swelling in the upper eyelid. The patient sought unspecified medical attention. She was given a "MEDRAL" pack. At the time of the report, the patient was recovering. On 30-APR-2010, therapy with GARDASIL was discontinued. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a physician's assistant concerning a 21 year old female patient who on 15-APR-2010 was vaccinated with the first dose of GARDASIL. On 15-APR-2010 the patient had an allergic reaction.  She got a rash around injection site. The patient had a red rash on the neck and arms. Also it was red and really dry around the eyes. She also had swelling in the upper eyelid. The patient sought unspecified medical attention. She was given a "MEDRAL" pack. At the time of the report, the patient was recovering. On 30-APR-2010, therapy with GARDASIL was discontinued. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with high risk HPV who within last two years was vaccinated with 0.5mL IM third dose of GARDASIL (lot # not reported). The nurse reported that the patient "had a PAP test done at age of 19" and " it came back high risk HPV". The physician then suggested to the patient to have LEEP procedure done and the patient refused and decided to get GARDASIL. The patient was tested after GARDASIL and came back high risk HPV; however it was worse than previously and will have to have a procedure done (unspecified what kind). The patient sought unspecified medical attention. At the time on the report on 13-MAY-2010 the patient had not recovered from high risk HPV. Additional information has been requested. P
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old male who was vaccinated with a dose of GARDASIL. Concomitant medication included 2 other unspecified vaccines. It was reported that on 13-MAY-2010 "the patient had fainted after the vaccination. The patient recovered on 13-MAY-2010 and went home." The patient received unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a healthcare provider concerning a 13 year old female with no drug allergies, who was vaccinated with a series of GARDASIL. The last dose was given about one and a half years ago. "3 months ago" (on approximately 14-FEB-2010) the patient had been losing hair. It was unknown if the patient sought medical attention. At the time of the reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Fatigue, Gingivitis, Headache, Hypersomnia
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with asthma, who on 10-MAY-2010 was vaccinated with "three doses of series" of GARDASIL. Concomitant therapy included montelukast sodium (MSD) and corticosteroids (unspecified). The nurse practitioner reported that "the patient received the first dose of GARDASIL and had an unspecified side effect. Then the patient received the second dose of GARDASIL, the date was unspecified, and after receiving the second dose the patient experienced a headache, fatigue and arm pain. Then on 10-MAY-2010 the patient received the third dose of GARDASIL and after receiving the third dose the patient had an irritated mouth, lips were infected, five inflamed taste buds, inflamed gums and it hurts to eat. Also the patient was sleeping a lot and had lost nine pounds between 10-MAY-2010 to 14-MAY-2010. The patient then saw a dentist who gave her amoxicillin for two days and then on 14-MAY-2010 the patient saw the nurse practitioner and the patient was diagnosed with Aphthous ulcer and it also said on her chart toxicity from vaccine. The nurse practitioner put the patient on VALTREX and viscous lidocaine and was told to finish the amoxicillin." The patient had not recovered at time of reporting. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lip infection, Pain in extremity, Stomatitis, Weight decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with asthma, who on 10-MAY-2010 was vaccinated with "three doses of series" of GARDASIL. Concomitant therapy included montelukast sodium (MSD) and corticosteroids (unspecified). The nurse practitioner reported that "the patient received the first dose of GARDASIL and had an unspecified side effect. Then the patient received the second dose of GARDASIL, the date was unspecified, and after receiving the second dose the patient experienced a headache, fatigue and arm pain. Then on 10-MAY-2010 the patient received the third dose of GARDASIL and after receiving the third dose the patient had an irritated mouth, lips were infected, five inflamed taste buds, inflamed gums and it hurts to eat. Also the patient was sleeping a lot and had lost nine pounds between 10-MAY-2010 to 14-MAY-2010. The patient then saw a dentist who gave her amoxicillin for two days and then on 14-MAY-2010 the patient saw the nurse practitioner and the patient was diagnosed with Aphthous ulcer and it also said on her chart toxicity from vaccine. The nurse practitioner put the patient on VALTREX and viscous lidocaine and was told to finish the amoxicillin." The patient had not recovered at time of reporting. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Unevaluable event
Clinical narrative: Information has been received from a 25 year old female medical assistant concerning herself who in December 2008, was vaccinated with a dose of GARDASIL. In May 2009, the patient experienced an abnormal PAP. It was not known if the patient received all three doses of GARDASIL. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning one of their health care provider's 11 year old daughter who on an unspecified date, was vaccinated with the first dose of GARDASIL (lot# not reported). Subsequently, the patient developed a high fever after the first dose of GARDASIL. It was reported that the patient had received the second dose of GARDASIL (lot# not reported). At the time of this report, the patient's outcome was not reported. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Expired drug administered
Clinical narrative: Information has been received from a nurse concerning a 12 year old female patient with none drug allergies who on 09-MAR-2010 was vaccinated IM with the first dose 0.5 ml of GARDASIL (lot number not available). On 12-MAY-2010 the patient was vaccinated IM with the second dose of GARDASIL (lot number 661954/0075Y, expiration 15-MAR-2010). Within 10 minutes of receiving the second dose, the patient experienced dizziness. The following morning (13-MAY-2010) the patient had diarrhea. The patient was treated with clear liquid diet. Unspecified medical attention was sought. No lab studies were performed. On an unknown date, the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a billing clerk who work in the office concerning a 16 year old female with no drug allergies, who was vaccinated with a series of GARDASIL. The last dose was given about one and a half years ago. "3 months ago" (on approximately 14-FEB-2010) the patient had been losing hair. It was unknown if the patient sought medical attention. At the time of the reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Disorientation, Heart rate decreased, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 15 year old female patient who on 30-APR-2010, was vaccinated IM in the left deltoid with the third dose of GARDASIL (Lot No. 665607/1333Y) at 14:30 PM. It was reported that the patient was nervous before vaccine administration. The patient was sitting up during administration and the patient "passed out" and lost consciousness for 10-15 seconds. The patient was observed for 10-15 minutes. The patient's blood pressure reading during the loss of consciousness was 78/50 with a pulse rate of 60. The patient was alert but slightly disoriented immediately.. The patient was placed supine, and orange juice was given. ON the same date, the patient recovered from the event. By the time the patient left the office, the blood pressure reading was 96/70 with a pulse rate of 80. The patient was discharged with mother in stable condition. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning the physician's 15 year old niece with a history of seizure disorder who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. It was reported that the patient "got very ill". The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Therapy with human papillomavirus vaccine was discontinued. 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 on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. There was no concomitant medication. Sometimes last week (approximately 10-MAY-2010), the patient fainted. The patient did not seek medical attention. At the time of the report, the patient recovered from fainted. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash, Scar
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with a history of pertussis vaccine (unspecified) reaction/allergy, who on 28-DEC-2009 was vaccinated with the first dose of GARDASIL (No lot number provided) and on 30-APR-2010 was vaccinated with the second dose of GARDASIL (lot # 662304/1013Y). The nurse stated that the patient received the second dose of the vaccine and experienced redness in her hands and stomach. She also reported that the patient experienced the rash on 02-MAY-2010. Nurse stated that the patient was started on steroids on 05-MAY-2010. At the time of the report, the patient had not recovered from the redness in her hands and stomach and rash. The patient sought medical attention through a nurse's office visit. Follow up information has been received from the consumer who reported that the rash was getting more severe and darker. The patient was also developing significant scarring. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 17-MAR-2009, 15-MAY-2009 and 30-DEC-2009 was vaccinated with a first, second and third dose of GARDASIL (Lot # 661841/0653X, expiration date: 25-FEB-2011, Lot # 661841/0653X, expiration date: 25-FEB-2011 and Lot # 663558/0819Y, expiration date: 10-OCT-2011, respectively). The physician reported that the patient on 20-FEB-2010 started to experiencing recurrent syncope after receiving 3 doses of GARDASIL. The patient was examined by a cardiologist who prescribed FLORINEF. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who in 2007 at the age of 16 years completed the vaccination with the series of GARDASIL (Lot number not provided). The physician reported that currently the patient had and abnormal (papanicolaou) PAP test, positive for 13 types of high risk HPV including types 16 and 18; and positive for 5 types of low risk HPV including types 6 and 11. At the time of the report the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information ha been requested.
Sex: F
Vaccine: HPV4
Symptoms: Clumsiness, Concussion, Disorientation, Fall, Head injury
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number not provided). The mother reported that after receiving the dose of GARDASIL the patient had been clumsy and disoriented. The mother reported that sometime last week (on approximately 10-MAY-2010) while the patient was ice skating she fell and hit her head, had a concussion and injured her jaw. The patient did go to the emergency room. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injury
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number not provided). The mother reported that after receiving the dose of GARDASIL the patient had been clumsy and disoriented. The mother reported that sometime last week (on approximately 10-MAY-2010) while the patient was ice skating she fell and hit her head, had a concussion and injured her jaw. The patient did go to the emergency room. At the time of the report the patient's outcome was unknown. No further information is available.