chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 26 year old female patient who on 05-FEB-2007 was vaccinated IM with a first dose of Gardasil lot #653736/0014U. On 09-APR-2007 the patient was vaccinated with a second dose of Gardasil. On 10-APR-2007 the patient developed rash at injection site which was "a little swollen and red, but nothing major." On 11-APR-2007, she was struck on the injection site and reported that the rash got "bigger," and was "two-three inches in diameter." The patient sought unspecified medical attention. The patient's outcome was unknown at the time of this report. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a health professional concerning a 26 year old female patient who on 05-FEB-2007 was vaccinated IM with a first dose of GARDASIL. On 09-APR-2007 the patient was vaccinated with a second dose of GARDASIL lot #653736/0014U. On 10-APR-2007 the patient developed rash at injection site which was "a little swollen and red, but nothing major". On 11-APR-2007, she was struck on the injection site and reported that the rash got "bigger" and was "two-three inches in diameter". The patient sought unspecified medical attention. The patient's outcome was unknown at the time of this report. In follow up it was reported that patient had flu at the time of the second injection was given and she was hit on arm the next day which was on 10-APR-2007 (previously reported as on 11-APR-2007). The outcome is unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with a first 0.5 ml dose of Gardasil concomitantly with a dose of MENACTRA. The day after vaccination, the patient experienced low grade fever and aching. Unspecified medical attention was sought. Subsequently, the patient recovered. On an unspecified date the patient was vaccinated with a second dose of Gardasil by itself and there was no reaction. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female student with no drug allergies, who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Chest discomfort, Neutrophil count, Pyrexia, Throat tightness
Clinical narrative: Information has been received from a physician concerning a 13 year old female who's family had been sick with a bacterial infection, including the patient's sister who was also vaccinated with Gardasil (WAES#0705USA01566) who was vaccinated on an unspecified date with her second dose of Gardasil intramuscularly. "Within about 18 hours after the vaccination," the patient experienced tightness in the chest and throat and a fever of 103 degrees. The physician did a follow-up chest X-ray and the patient was "fine." Other unspecified lab tests revealed a "shift in neutrophils" which led to the physician to believe this was a bacterial-related infection and not a result of Gardasil. The patient was treated with unspecified antibiotics and the condition resolved itself after treatment. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female with sulfonamide allergy and penicillin allergy who on 12-FEB-2007 was vaccinated IM with a first dose of Gardasil, lot #654702/0011U and in APR, 2007 received the second dose of Gardasil. Concomitant therapy included escitalopram oxalate (LEXAPRO) and TRI-NASAL (therapy unspecified). The patient reported a painful burning feeling at the injection site after both dose one and dose two. The patient also reported that the injection site was sore for about two weeks after the first injection. Patient sought unspecified medical attention. The patient was reported as recovering at the time of this report. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 25 year old female patient with a history of high fever after receiving the tetanus toxoid years ago who on 13-FEB-2007 was vaccinated IM in the Left arm with a first dose of Gardasil lot #655618/0186U. Years ago the patient developed swelling, redness and itching of left arm after the first injection and went to the Emergency Room (E.R.) and she was provided antibiotics. On an unspecified date, patient was vaccinated in Right arm with a second dose of Gardasil lot #657617/0384U. She developed swelling, redness and itching of right arm after the second injection and went to see her primary physician. The physician administered antibiotics and felt that event was Cellulitis without a cut causing the event. Patient had high fever after receiving the tetanus toxoid years ago. The patient recovered from the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Breast pain
Clinical narrative: Information has been received from a health professional concerning a 15 year old female who on 12-APR-2007 was vaccinated with Gardasil. Concomitant therapy included Depo-Provera Injection for birth control. On 13-APR-2007 after receiving her first dose of the vaccine, the patient experienced soreness in her breasts and weakness. It was reported that the patient received unspecified medical attention. No further information is available. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who was vaccinated in left arm with a second dose of Gardasil lot #657006/0188U. Concomitant therapy included Yasmin. On 06-APR-2007 about one hour later receiving the second injection she developed "red blotches" on her left arm (injection site arm) and chest. Unspecified medical attention was sought by the patient. The reaction resolved spontaneously about 4 hours later. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/14/07. Initial and follow up information has been received from a physician and a health care professional concerning a 16 year old female student who on 05-APR-2007, PM was vaccinated IM in the left arm deltoid with a second dose of GARDASIL lot #657006/0188U. Concomitant therapy included YASMIN. On 06-APR-2007 about one hour later receiving the second injection she developed "red blotches" on her left arm (injection site arm) and chest. Unspecified medical attention was sought by the patient. The outcome was recovered. Follow up information indicated that within an hour of getting the second injection patient had erythematous macular rash on chest which progressed to abdomen and left arm (where injection was given) over next three hours. The reaction resolved spontaneously about 4 hours later. No association of chest pain or shortness of breath. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning an 18 year old female patient who on 04-NOV-2007 was vaccinated in deltoid with a dose of Gardasil lot #656049/0187U. Concomitant therapy included Depo-Provera in the other arm. The patient developed hives about four hours after receiving Gardasil. Benadryl was ordered. The patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Viral infection
Clinical narrative: Information has been received from an office manager concerning a female in her late teens who was vaccinated with Gardasil. Subsequently, the patient received a dose of Gardasil and felt sick. The patient went to the emergency room. The reporter felt that felt sick was not related to therapy with Gardasil, but a viral infection. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 27 year old female patient who was vaccinated on 04-APR-2007 in to deltoid with a third dose of Gardasil lot #656049/0187U one week earlier than the recommended schedule. Concomitant therapy included prenatal vitamins (manufacturer unknown). After the third injection, the injection site area was "swollen, red and warm to touch". The size of the area was a 6 inch circumference. The patient sought unspecified medical attention. Her outcome was unknown at time of this report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a female child "older than 10 years" who was vaccinated with GARDASIL. Within 12-15 hours, the patient experienced nausea and vomiting. She recovered on an unspecified date.  This is one of two reports received from the same source. Additional information was not available.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Laryngitis, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil and on April 11 or 12, 2007, was vaccinated IM with a second dose of Gardasil. Four to five hours after receiving the second injection the patient developed "severe swollen glands, laryngitis, a sore throat and a mild fever of 99 degrees". The physician reported that the patient had a mild reaction after her first injection. The patient saw her Primary Care Physician (PCP) and was treated with Claritin and with other medications that were not specified. The patient's outcome was unknown at the time of this report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil and on April 11 or 12, 2007, was vaccinated IM with a second dose of Gardasil. Four to five hours after receiving the second injection the patient developed "severe swollen glands, laryngitis, a sore throat and a mild fever of 99 degrees". The physician reported that the patient had a mild reaction after her first injection. The patient saw her Primary Care Physician (PCP) and was treated with Claritin and with other medications that were not specified. The patient's outcome was unknown at the time of this report. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pustular
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 10 year old female patient, who was vaccinated with the first dose of Gardasil (date and dose not specified). "About 1 to 2 days later" the patient developed "a pustular rash on her hairline, face and abdomen. " The physician indicated that the patient recovered from the event (date not specified). The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning a 10 year old female patient, who was vaccinated with the first dose of GARDASIL (date and dose not specified). "About 1 to 2 days later" the patient developed a "strange rash", described as "a pustular rash on her hairline, face and abdomen". The physician indicated that the patient recovered from the event (date not specified). The patient sought unspecified medical attention. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Initial and follow up information has been received from a pharmacist, concerning a 16 year old female patient with no pertinent medical history, who on 13-APR-2007, approximately 9:30am, was vaccinated IM in the right deltoid, with the first dose, 0.5ml, of GARDASIL (Lot #654885/1424F). There was no concomitant medication. It was unknown if there was any illness at the time of vaccination. On 15-APR-2007 the patient developed a full body rash. The pharmacist described the rash as not itchy but red, and noted it was located on the patient's chest, legs, arms and back. Treatment included BENADRYL, with a MEDROL DOSE PAK also prescribed. At the time of this report, the pharmacist confirmed the patient was recovering from the rash. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. At the time of this report, the pharmacyst confirmed the patient had recovered (date an duration not specified). No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Fatigue, Pain, Pain, Throat irritation
Clinical narrative: Information has been received from a medical assistant, via a company representative, concerning a 15 year old female patient who had felt ill 2 weeks prior to the vaccination, who on 26-MAR-2007 was vaccinated with the first dose, 0.5ml, of Gardasil. On 30-MAR-2007 ("end of March 2007"), the patient had a low grade temperature (not specified) for one day, had body aches, throat irritation, and felt run down for a few days. The reporter confirmed that on 30-MAR-2007, the patient had recovered from all of the events.No further information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Fungal infection, Human papilloma virus test positive, Pruritus, Skin irritation
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 21 year old female patient with penicillin allergy who on 02-MAR-2007 was vaccinated IM with a first dose of Gardasil. The NP reported that the patient had genital warts after receiving the Gardasil. On 19-MAR-2007 she first had itching and irritation. On 21-MAR-2007 she was examined and had both bacterial vaginosis and yeast infection. On 19-MAR-2007 she was treated with Diflucan and on 21-MAR-2007 she was treated with Flagyl. On 16-APR-2007 the genital warts were visually confirmed during the examination. The patient had tested positive for serum human papillomavirus prior to the vaccination. The patient's genital wart was persisting. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal candidiasis, Vaginitis bacterial
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 21 year old female patient with penicillin allergy who on 02-MAR-2007 was vaccinated IM with a first dose of Gardasil. The NP reported that the patient had genital warts after receiving the Gardasil. On 19-MAR-2007 she first had itching and irritation. On 21-MAR-2007 she was examined and had both bacterial vaginosis and yeast infection. On 19-MAR-2007 she was treated with Diflucan and on 21-MAR-2007 she was treated with Flagyl. On 16-APR-2007 the genital warts were visually confirmed during the examination. The patient had tested positive for serum human papillomavirus prior to the vaccination. The patient's genital wart was persisting. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a physician's assistant (PA), concerning a 21 year old female patient, who on 20-FEB-2007 was vaccinated with the first dose of Gardasil (Lot #653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified). On 20-FEB-2007, following the vaccination, the patient experienced itching from head to toe for 3-4 days, but no rash was present. Treatment involved Benadryl. On approximately 24-FEB-2007 (after "3-4 days"), the patient recovered. The PA felt that the itching was "from the vaccination" and related to therapy with Gardasil. Additional information has been requested. Follow up information confirmed that the patient was vaccinated with the second dose of GARDASIL (date not specified), with no problems reported. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on approximately 09-APR-2007 was vaccinated with Gardasil. In April 2007, the patient experienced a crescent shaped burn-like area, over a small hematoma about 1 centimeter in diameter at the injection site. No pain was noted. It was reported that the patient sought unspecified medical attention. It was also reported that the patient is recovering at this time. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a LPN concerning her 14 year old daughter who was vaccinated with Gardasil. There was no concomitant medication. Subsequently, the patient experienced nausea. The patient sought unspecified medical attention. Addition information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Antepartum haemorrhage, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received via the Merck pregnancy registry, from a nurse practitioner (NP), concerning a 22 year old female patient, who on 09-OCT-2006 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #653735/0688F), and on 09-DEC-2006 was vaccinated with the second dose, 0.5ml, IM, of Gardasil (Lot #654389/0961F). There was no concomitant medication. The NP reported that the patient is now pregnant; the date of the LMP was 14-DEC-2006, with an estimated date of delivery on 20-Sep-2007. A blood test confirmed the pregnancy. The NP reported that the patient had developed "some bleeding during pregnancy." The patient sought unspecified medical attention. Additional information has been requested. 07/08/2008 Initial and follow up information has been received via the Merck pregnancy registry, from a nurse practitioner (NP) and a nurse, concerning a 22 year old female patient, who on 09-OCT-2006 was vaccinated with the first dose, 0.5ml, IM, of GARDASIL (Lot #653735/0688F), and on 09-DEC-2006 was vaccinated with the second dose, 0.5ml, IM, of GARDASIL (Lot #654389/0961F). There was no concomitant medication. The NP reported that the patient is now pregnant; the date of the LMP/date of gestation was "14-DEC-2006", with an estimated date of delivery on 03-AUG-2007 (previously reported as 20-SEP-2007). A blood test confirmed the pregnancy. The NP reported that the patient had developed "some bleeding during pregnancy". On 20-JUL-2007, the patient gave birth "to a normal healthy baby" (gender not specified), birth weight 7 lb 5 oz, 20 1/2 inches long. No further details were provided. The patient sought unspecified medical attention. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with hypersensitivity who on 29-Jan-2007 was vaccinated with a first dose of Gardasil (lot# 654741/1208F). Concomitant therapy included cough, cold, and flu therapies (unspecified). On 29-JAN-2007 the patient experienced dizziness and nausea and sought unspecified medical attention. Subsequently, the patient recovered from the dizziness and nausea within a few hours of vaccinations. The patient was subsequently vaccinated with her second dose of Gardasil on 16-APR-2007. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a 16 year old female patient, who in April 2007, was vaccinated with a dose of Gardasil. Concomitant therapy included Menactra and Vaqta. The nurse practitioner stated that the patient "fainted after she received the Gardasil vaccination. " The "patient was given liquids to drink and something to eat, and she was fine." Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Initial follow up information has been received. There was no illness at the time of vaccination. The nurse practioner stated that as the patient walked from the exam room at 8:35, she felt lightheaded, passed out and fell and hit her right occipital area. The NP stated that the patient had not eaten that morning, and was given juice and a banana. The patient left the office after about 10 minutes, and recovered on the same day, 10-Mar-2007. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a physician, concerning a 12 year old female patient who on 10-APR-2007, was vaccinated with the first dose,  0.5ml, IM, of Gardasil (Lot #656051/0244U). There was no concomitant medication. The physician reported that the patient developed pruritus at the injection site within minutes of the vaccine administration. Treatment included Benadryl. At the time of this report, the physician confirmed that the patient had recovered (date not specified). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary mass
Clinical narrative: Information has been received from a physician's assistant (PA), concerning a 25 year old female patient with asthma and acne, who on 12-APR-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5ml, of Gardasil (Lot #657621/0387U). Concomitant therapy included Nuvaring, Accutane and albuterol. On 13-APR-2007 the patient developed a lump in her left axilla, though the PA there was no swelling or redness present. Treatment consisted of warm soaks and Motrin. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Though an office visit was not required. The PA informed the patient that if the condition persisted for more than 2 weeks, a fefferal to a surgion would be ordered. At the time of this report (08-May-2007), the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 25 year old female patient who on 16-APR-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Strattera. On 16-APR-2007 the patient experienced dizziness and headache. The headache was resolved when patient awoke the next day. The patient's dizziness persisted. Unspecified medical attention was sought. The patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who was vaccinated with a dose of Gardasil. The patient experienced joint pain after getting the injection. Unspecified medical attention was sought. Patient's outcome was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information by telephone has been received from a physician concerning a 19 year old female patient who was vaccinated with a first and second dose of GARDASIL. The patient experienced joint pain after getting her second injection. Follow up information from the physician indicated that the patient had a positive ANA and an increased sed rate and he was trying to rule out the possibility of lupus. The physician requested additional information about GARDASIL and lupus and whether or not the patient should receive her third injection. On 30-APR-2007 the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Laboratory test, Urticaria, Vomiting, Weight decreased
Clinical narrative: Information has been received from the mother of a 14 year old female with no pertinent medical history or drug reactions/allergies, who on 18-JAN-2007 was vaccinated with Gardasil (0.5 ml). There was no concomitant medication. On 19-JAN-2007 the patient experienced hives, vomiting, dizziness and weight loss. At the time of this report, the patient's hives, vomiting, dizziness and weight loss persisted. Unspecified medical attention was sought and it was reported that the patient underwent blood tests (results not provided). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Flushing
Clinical narrative: Information has been received from a physician concerning a female patient with aspirin allergy who on 17-APR-2007 was vaccinated with a first dose of Gardasil. On 17-APR-2007 the patient developed facial flushing with red cheeks and ears after receiving the injection. The patient was administered Benadryl and her symptoms resolved within 10 minutes. The patient was fully recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a healthcare worker concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 19-FEB-2007 was vaccinated intramuscularly with GARDASIL. There was no concomitant medication. On 19-FEB-2007, with a few hours of receiving the vaccine, the patient developed hives. Unspecified medical attention was sought, and the patient took BENADRYL for the symptoms. The hives subsequently resolved. Additional information has been requested. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil (date and dose not provided). Subsequently at an unspecified time, the patient had a Pap smear that tested positive for HPV 6 and HPV 11. It was also reported that the patient experienced a break out of genital warts not long after vaccination with HPV. It was reported that the patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 22 year old female, with no known drug allergies, who on 07-NOV-2006 was vaccinated with IM with a dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included VALTREX. Subsequently on an unspecified date, the patient had a PAP smear that tested positive for HPV 6 and HPV 11. On 16-NOV-2006 the patient developed break out of genital warts. It was reported that the patient sought unspecified medical attention. The patient's break out of genital warts persisted. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Lymphadenopathy
Clinical narrative: Information has been received from a physician's assistant concerning a 13 year old female with seasonal allergy who in March 2007, was vaccinated IM with the first 0.5 mL dose of Gardasil. The physician's assistant reported that within 21 days of vaccination the patient developed bilateral axillary lymph node swelling. Multiple nodes were noted bilaterally. The patient was treated with Zithromax for three days. Unspecified laboratory tests were obtained; all reported as normal. The patient recovered within 1-2 weeks of Zithromax therapy. It was reported that the opposite side of vaccination resolved first, "in several days," then the side of vaccination resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with the first and second doses of Gardasil. The consumer reported that a week after the second vaccination, her daughter's pap test came back HPV positive. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician's nurse concerning her 14 year old daughter who on 14-SEP-2006 was vaccinated with the first dose Gardasil (lot #653735/0688F). Concomitant therapy included Fluzone. On 09-NOV-2006, the patient received the second dose of Gardasil (lot653735/0688F). On 21-MAR-2007, the patient received the third dose of Gardasil (lot #655503/0012U). The nurse reported that after her daughter received all three injections, she experienced a high fever of 103-104 degrees fahrenheit. The fever resolved each time after about one day. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) which borderline mental retardation who on an  unspecified date was vaccinated with a first dose of Gardasil. On an unspecified date, the patient was vaccinated with a second dose of Gardasil (lot # not reported) 0.5 ml injection. In December 2006, the patient experienced an interruption of her menstrual cycle after receiving the second dose of vaccine. The patient sought medical attention. At the time of reporting, the patient had not recovered. No further information was provided at the time of reporting. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician, concerning a 25 year old female patient who on 13-FEB-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #655503/0012U). There was no concomitant medication. The physician reported that "shortly after her first dose of Gardasil," the patient experienced nausea and vomiting. At the time of this report, the physician confirmed that the patient had recovered (date not specified). The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a female "teenager" (exact age unspecified) who in March 2007, was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil. Shortly after administration of the vaccine, the patient fainted. It was noted that the patient received allergy shots often and had never fainted prior to this event. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The patient recovered the same day and did not have to go to the emergency room. No product quality complaint was noted. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a licensed practical nurse concerning a 25 year old female with allergies to amoxicillin and BIAXIN who on 27-MAR-2007 at approximately 08:30 was vaccinated intramuscularly into the right deltoid with a first 0.5 mL dose of GARDASIL (Lot #656051/0244U). Shortly after administration of the vaccine (approximately 08:45), the patient fainted (also reported as "while at the check out window, the patient passed out"). The patient never lost consciousness and was immediately alert and oriented (x3) and neuro was grossly intact. The patient was clammy and pallor and was given a granola bar and orange juice. The patient reported feeling better after resting for 10 minutes. The patient's blood pressure was 120/70. It was noted that the patient received allergy shots often and had never fainted prior to this event. The patient recovered the same day and did not have to go to the emergency room. The patient left the office in good condition. No product quality complaint was noted. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007.  Initial and follow-up information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female student with no pertinent medical history or drug reactions/allergies who on 17-APR-2007 at approximately 3:55 PM was vaccinated IM in left deltoid with a first dose of Gardasil (lot # 0378U not valid). Concomitant therapy included ZYRTEC. On 17-APR-2007 at approximately 4:00 the patient fainted in her chair soon after the administration of her first injection. She recovered quickly after she was placed on the floor and her legs were elevated. This is one of three reports from the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no known drug reactions/allergies who was vaccinated with Gardasil. Subsequently, the patient experienced dizziness, nauseous, starting to faint throughout the evening and pale. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from dizziness, nauseous, starting to faint throughout the evening and turned pale. The product quality complaint unit was not involved. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event, Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced an unspecified adverse experience. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse in a physician's office concerning a female patient in her "late teens" with no drug reactions/allergies and with a history of anxiety problems who was vaccinated with Gardasil. Subsequently the patient fainted after receiving Gardasil. No lab tests were performed. The patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a registered nurse concerning "about 35" female patients who were vaccinated with 0.5 ml of Gardasil and who experienced burning at the injection site. The patients sought unspecified medical attention. Therapy with Gardasil was discontinued. 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.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a 24 year old female who on an unspecified date, was vaccinated with her first dose of Gardasil. Subsequently the patient experienced rash that went up from her arm to her shoulders. On 12-APR-2007 was vaccinated with her second dose of Gardasil. On 12-APR-2007 the patient experienced rash that went up from her arm to her shoulders. Subsequently, the patient recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody increased, Arthralgia, C-reactive protein increased, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Initial and follow up information has been received from a physician concerning an 18 year old female patient, with a suspected strep infection on 27-MAR-2007 ("two weeks prior"), who on 09-APR-2007 was vaccinated with the third dose of Gardasil (route and dose not specified). The physician reported that after receiving Gardasil, the patient experienced arthralgia (date not specified). The physician reported that the following diagnostic testing had been performed (dates not specified), antistreptolysin (ASO), elevated, C-reactive protein (CCRP), elevated antinuclear antibodies test (ANA), minimally elevated; erythrocyte sedimentation rate, negative, rheumatoid factor, negative; and testing for Lyme disease, result pending. Patient outcome was unknown, as the physician was unable to contact the patient. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test positive
Clinical narrative: Initial and follow up information has been received from a physician concerning an 18 year old female patient, with a suspected strep infection on 27-MAR-2007 ("two weeks prior"), who on 09-APR-2007 was vaccinated with the third dose of Gardasil (route and dose not specified). The physician reported that after receiving Gardasil, the patient experienced arthralgia (date not specified). The physician reported that the following diagnostic testing had been performed (dates not specified), antistreptolysin (ASO), elevated, C-reactive protein (CCRP), elevated antinuclear antibodies test (ANA), minimally elevated; erythrocyte sedimentation rate, negative, rheumatoid factor, negative; and testing for Lyme disease, result pending. Patient outcome was unknown, as the physician was unable to contact the patient. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a pharmacist concerning her daughter, a 14 year old female with an amoxicillin allergy who on 06-FEB-2007 was vaccinated with Gardasil. Concomitant therapy included hepatitis B virus vaccine (unspecified) in the other arm. On 06-FEB-2007, at the time of administration, the patient experienced severe pain. The patient sought unspecified medical attention. On 07-FEB-20074, after a day, the patient recovered from severe pain. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a nurse, concerning a female patient who was vaccinated with the first dose, 0.5ml, Gardasil (date unspecified). Subsequently the patient experienced bruising at the injection site. At the time of this report, the nurse confirmed that the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female (age unspecified) who on 18-APR-2007 was vaccinated with a first dose of Gardasil. Subsequently, on an unspecified date, the patient experienced nausea and vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. This is in follow-up to report (s) previously submitted on 5/14/2007; 7/6/2007. Follow up information received from the physician stated that on an unspecified date the patient received the second dose GARDASUK (Lot # not reported). The physician stated that the patient did not have any problems with the second vaccination. Additional information has been requested. Initial and follow up information has been received from a physician concerning a 16 year old female who at 13:00 on 18-APR-2007 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 654702/0011U). Subsequently, at 13:30 that same day the patient experienced nausea and vomiting. The patient sought unspecified medical attention. It was reported that on 20-APR-2007 that patient had recovered from the events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Adnexa uteri pain, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 26 year old female daughter who on 14-NOV-2006 was vaccinated with the first dose of Gardasil, injection, 0.5 ml. Concomitant therapy included Ortho Tri-Cyclen. On 15-NOV-2006 the following day after receiving the first dose of Gardasil, the patient experienced nausea, vomiting and severe ovary aches. On 12-DEC-2006, the second dose of Gardasil, the patient experienced nausea, vomiting and severe ovary aches. The third dose of Gardasil was received on 13-APR-2007. On 14-APR-2007, the patient experienced nausea, vomiting and the patient has recovered from the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil. On 09-APR-2007 the patient experienced a tickly feeling in her throat for about 24 hours after receiving the vaccine. She needed to clear her throat constantly. It was reported that the subject unspecified medical attention. Subsequently, the patient recovered from tickly feeling in her throat. This is one of two reports that was received from the same source for a sibling. No further details were provided. Additional information is not available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning three female patients who were vaccinated with Gardasil. Subsequently the patients passed out after receiving the vaccine. Subsequently, the patients recovered from passing out. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 13-FEB-2007 was vaccinated with the first dose of Menactra. The physician reported that the patient experienced aching in her body and neck after receiving the first dose. The patient subsequently recovered. The patient had since received the second dose of Gardasil and did not experience the symptoms again. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 13 year old female with a history of eczema who in April 2007, was vaccinated with Gardasil. In April 2007, within 24 hours later after receiving the vaccine, the patient experienced a rash behind her knee. It was reported that the patient sought unspecified medical attention. No further information was provided. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 17 year old female with a history of eczema who on 28-MAR-2007 at 10:45 am was vaccinated intramuscularly into the left deltoid with the first dose of the GARDASIL (Lot # 657006/0188U). On approximately 03-APR-2007, within 24 hours after receiving the vaccine (also reported as one week after vaccination), the patient developed an eczema-like rash behind her knee. It was reported that the patient sought unspecified medical attention. There were no laboratory or diagnostic tests performed. The patient recovered on an unspecified date. This is a consolidation of two reports. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Presyncope, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown) who on 19-APR-2007 was vaccinated with a first dose of Gardasil. After receiving the Gardasil, the patient "almost fainted". The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19-APR-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a nurse practitioner concerning a 17 year old female who on 19-APR-2007 at 10:59 was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (Lot #654741/0013U). After receiving the GARDASIL (also reported as 10:30), the patient "almost fainted" and had a vasovagal response. There was no loss of consciousness. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19-APR-2007, the patient recovered as the symptoms only lasted a few minutes. No product quality complaint was involved. No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a registered nurse, concerning a 21 year old female student with asthma, polycystic ovaries and migraines, who on 18-DEC-2006 was vaccinated IM in the gluteal area, with the second dose, 0.5ml, of Gardasil (Lot #654540/1161F). Concomitant therapy included Yasmin, Zomig, Imitrex tablets and albuterol inhaler. The nurse reported that the patient complained of pain at the injection site. At the time of this report, the nurse confirmed that the patient had recovered (date unspecified). The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Computerised tomogram normal, Dyspnoea, Electrocardiogram normal, Muscle spasms
Clinical narrative: Information has been received from an office receptionist concerning a 20 year old female patient with family history of heart disease, allergic reaction to antibiotics, who on 02-FEB-2007 was vaccinated IM with a first dose of Gardasil lot #654741/0013U. Concomitant therapy included Ortho Tri-Cyclean Lo. On 02-FEB-2007 the patient developed arm soreness but otherwise felt fine. On 16-APR-2007, the patient was vaccinated IM with the second dose of Gardasil lot #657621/0387U. Within one to one and half hours after the second injection patient developed muscle spasm in chest area which radiated from left chest to center. She described pain as sharp intermittent and took her breath away. On 18-APR-2007 she took Advil for something else (not specified) and it helped pain a little but was not relieved. The physician instructed patient to go the emergency room (ER). Patient was planning to go to the ER on 19-APR-2007. At the time of this report the patient had not recovered. Additional information has been requested.