chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pruritus, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female with no pertinent medical history, drug reactions or allergies who on 08-AUG-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot #659962/1740U). Secondary suspect vaccination was VARIVAX. On 08-AUG-2008, "about an hour after receiving GARADSIL," the patient developed an unspecified fever and then experienced facial itching that resolved within an hour after onset. The patient sought medical attention by phone call and did not seek treatment for the symptoms. On 09-AUG-2008 the patient recovered from the events. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Ultrasound uterus, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician assistant, for the Pregnancy Registry for GARDASIL, concerning a 24 year old black healthy female with a history of 6 pregnancies and 3 live births and a history of spontaneous abortion and stillbirth at 17 weeks for fetal anomalies who on 28-AUG-2008 was vaccinated with her first dose of GARASIL (Lot number 659964/1978U). There was no concomitant medication. The patient was pregnant. She had a menstrual period in Jun 2008 and then had vaginal bleeding on 28-AUG-2008 which was assumed to be a menstrual period. The patient sought medical attention and had been seen in the emergency room. The pregnancy test was performed there and the result was positive. On 04-SEP-2008, an ultrasound was performed for vaginal bleeding and the result showed as live intrauterine pregnancy at 6 weeks 3 days. The date of last menstrual period was unknown and the estimated delivery date was 26-APR-2009. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Genital herpes, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with an amoxicillin allergy and a history of genital herpes who on 19-DEC-2007 was intramuscularly vaccinated with the first 0.5 mL dose of GARADSIL (lot # 659439/1267U), on 11-MAR-2008 was intramuscularly vaccinated with the second 0.5 mL dose of GARDASIL (lot # 659182/1757U) and on 21-AUG-2008 was intramuscularly vaccinated with the third 0.5 mL dose of GARDASIL (lot # 66012/0229X). There was no concomitant medication. The patient developed a mild outbreak of her genital herpes about one day after being vaccinated with doses one and two of GARDASIL. About two weeks after her third dose of the series, the patient had a more severe outbreak that required treatment with VALTREX. The patient was seen in the office. At the time of reporting, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who at the beginning of September, on approximately 01-SEP-2008 was vaccinated with her first dose of GARDASIL. Four days after vaccination, on approximately 05-SEP-2008, the patient experienced tingling and numbness in all her extremities. The patient's tingling and numbness in all her extremities persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a grandmother concerning her 11 year old granddaughter who in July 2008, was vaccinated with GARDASIL. Concomitant therapy included "other vaccines" (unspecified). In July 2008 the patient experienced injection site pain, redness at injection site and swelling at injection site. Subsequently, "2 weeks after the vaccine was received," the patient recovered from injection site pain, redness at injection site and swelling at injection site. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness
Clinical narrative: Information has been received from a nurse concerning a female who on 07-JUL-2008 was vaccinated with a dose of GARDASIL, 0.5 mL, I.M. and experienced general weakness of extremities. The patient was referred to local emergency room. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a pharmacist concerning a female who on 14-JUL-2008 was vaccinated with GARASIL. The patient fainted 45 after receiving HPV vaccine. The patient was referred to the ER of a hospital. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site extravasation, Muscle spasms
Clinical narrative: Information has been received from a certified medical assistant concerning a female who on 15-AUG-2008 was vaccinated intramuscularly with a dose of GARDASIL (Lot # 660387/1967U) 0.5 mL. It was reported by the certified medical assistant that the patient had a muscle spasm as she was being vaccinated with GARDASIL. Most of the vaccine dose leaked back out of the injection site. An additional dose was then administered. On 15-AUG-2008 the patient recovered from muscle spasm. The patient sought medical attention: In office. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Dizziness, Eye injury, Fall
Clinical narrative: Information has been received from a nurse, concerning her daughter who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # not reported). Ten minutes later, the patient experienced dizziness. When the patient stood up, she fell over and had a bruise on her eye. On an unknown date, the patient recovered. The patient sought medical attention with the nurse. There was no product quality complaint. Additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient, who one week ago (approximately 02-SEP-2008) was vaccinated with the second dose of GARASIL (Lot # not reported). One week ago (approximately 02-SEP-2008), the patient experienced urinary tract infection after receiving the second dose of GARDASIL. The patient sought medical attention, seen by the physician. There was no product quality complaint. Additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Diagnostic procedure, Hair growth abnormal
Clinical narrative: Information has been received from a nurse, concerning a 16 year old female patient with who on 06-AUG-2007 was vaccinated with the first dose of GARASIL IM. On 10-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #654540/1209U) and on 13-FEB-2008 was vaccinated with the third dose of GARASIL (Lot # 659055/1522U). Concomitant therapy included an unspecified birth control discontinued in May-2008. On 12-MAY-2008, the patient stated that she was having hair loss on her head only. At some point, she noticed that there was a little hair regrowth. She was seen by a dermatologist, who ordered a set of labs for her, they came back normal. As of 09-SEP-2008, the patient did not recovered. There was no product quality complaint. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient was lightheaded. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose of GARDASIL. After receiving GARDASIL, the patient was lightheaded. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient was lightheaded. The outcome of the patient was not reported. This one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose of GARDASIL.  After receiving GARDASIL, the patient was lightheaded.  The outcome of the patient was not reported.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning her daughter who on an unknown date was vaccinated with a first 0.5 mL dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient experienced fever, vomiting and muscle aches. Unspecified medical attention was sought. The outcome was unspecified. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Contusion, Loss of consciousness
Clinical narrative: Initial and follow-up information has been received from a physician and a registered nurse concerning an 9 year old female, also reported as 11 year old, with no relevant medical history or allergies, who on 04-SEP-2008 was vaccinated with dose of GARDASIL intramuscularly in the right deltoid. Concomitant therapy included MENACTRA and ADACEL (UF452AA) intramuscularly in the left deltoid. On 04-SEP-2008 3-5 minutes after the vaccination, the patient passed out at the front desk. The patient was unconscious for a few seconds. Her vital signs were stable. The patient bruised her chin and cheek. The patient was sent home with an icepack with her mother. It was unknown if the patient sought any medical attention. On 04-SEP-2008, the patient recovered from the events. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site inflammation, Injection site mass, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from an office staff at the doctor's office concerning an approximately 15 year old female who on 13-AUG-2008 was vaccinated with her third dose of GARDASIL (lot #659964/1978U).  On 10-SEP-2008 the patient came in the office with injection site inflammation with a lump at the site and swelling.  The patient had no adverse symptoms from the first and second dosed.  At the time of this report, the events persisted.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with sulfonamide allergy and no medical history reported, who on 03-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 660612/0229X), 0.5 mL, into the left deltoid. There was no concomitant medication. On 09-SEP-2008, the patient called the physician with complaint of hives on face. The patient was treated with over the counter oral BENADRYL. The patient's outcome was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no medical history, who on 17-MAY-2007 was vaccinated IM with a first dose of GARDASIL (655165/0137U), on 17-JUL-2007 was vaccinated with a second dose of GARDASIL (Lot # unknown), and on 19-DEC-2007 was vaccinated with a third dose of GARDASIL (Lot # 659441/1446U). Concomitant medication for birth control. The physician reported that the patient received all 3 doses of GARDASIL and recently had a PAP test done and it came positive for high risk HPV on 18-AUG-2008. The outcome of the patient was not reported. The patient did not seek for medical attention. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a Family nurse practitioner concerning a female who was vaccinated with GARDASIL (dose, therapy route and lot number not specified).  It was reported, after receiving GARDASIL, the patient's pap test came back for high risk of HPV.  Unspecified medical attention was sought.  The outcome of the adverse event was not specified.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no allergies who on 28-FEB-2008 was vaccinated with the first dose of GARDASIL (LOT #659182/1757U). On 24-APR-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U). On the same day PAP smear test was performed. On 14-AUG-2008 the patient was vaccinated with the third dose of GARDASIL (lot # 660391/0063X). At the time she was informed of the results of the PAP smear test done on 24-APR-2008 which showed Low Grade Squamous Intraepithelial Lesion. There was no concomitant medication. The patient sought medical attention in the office. The patient was scheduled for follow-up and colposcopy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history or no drug allergies who on approximately 27-JUL-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot number was not known).  There was no concomitant medication.  On approximately 27-JUL-2008 the patient experienced pain in her arm around the site of injection.  The patient's pain in her arm around the site of injection persisted.  Medical attention was sought via telephone.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician, concerning a female patient who never was sexually active presented with positive Pap test with high risk of HPV after receiving all three doses of GARDASIL. The patient sought medical attention, she saw the physician. There was no product quality complaint. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient, who one week ago (approximately 02-SEP-2008) was vaccinated with the second dose of 0.5 mL GARDASIL (Lot # not reported). One week ago (approximately 02-SEP-2008), the patient experienced urinary tract infection after receiving the second dose of GARDASIL. The patient sought medical attention, seen by the physician. There was no product quality complaint. Additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 25 year old female with hypertension, type 2 diabetes mellitus and no known drug allergies, who on 26-AUG-2008, was vaccinated with her first dose of GARDASIL (Lot # 660557/0072X) 0.5 ml IM right deltoid. Concomitant therapy included AVAPRO, metformin and prenatal vitamins (unspecified). On 02-SEP-2008, the patient experienced generalized pruritus without a rash a week after receiving her first dose. The pruritus was worse on her hands and face. The patient called the physician. The patient was instructed to take BENADRYL. The patient's generalized pruritus persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Information has been received from a physician assistant concerning a female who was vaccinated the first dose of with GARDASIL and experienced numbness and weakness in one of her legs.  The patient sought medical attention.  The patient "got better".  The physician assistant indicated the patient would not be completing the vaccine series.  This is one of several reports from the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Infectious mononucleosis, Laboratory test, Splenomegaly
Clinical narrative: Information has been received from a consumer concerning her approximately 14 year old grandaughter with no pertinent medical history of drug reactions/allergies, who "about two years ago" in approximately 2006 received the three doses of GARDASIL 0.5 mL.  There was no concomitant medication.  The reporter stated that the patient either a month after receiving her first or third dose, experienced mononucleosis as well as an enlarged spleen.  Caller knew that patient received all three doses of the series, however it was unknown after which one the symptoms occurred.  Patient also experienced fatigue.  Last blood test was "about 6 months ago" in approximately March 2008.  The patient sought unspecified medical attention.  At time of report, the patient had not recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a dose of GARDASIL (lot # not available).  The reporter stated that the patient had not eaten prior to receiving the vaccination, and fainted for 3 minutes after receiving the shot.  The patient sought medical attention and saw the physician.  At time of report, the patient was recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis contact
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL (route, site and lot number not reported). Subsequently the patient experienced contact dermatitis from the GARDASIL band-aids. The skin affected was the shape of the band-aids. The patient came in the day after the band-aid was applied to report the reaction. There was no additional information at that time. Further information was received from the office manager. It was reported that "several girls" mentioned that the band aids "should not be used." The patient information was not recorded at the time, and therefore, the office had no way of knowing "who made the comments."
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site nodule
Clinical narrative: Information has been received from a emergency medical technician and a patient's mother concerning an 18 year old female with KEFLEX allergy who on 24-SEP-2007 (previously reported as "6 months ago") was vaccinated with the first dose of GARDASIL (lot# 658558/1061U). On 13-FEB-2008, she was vaccinated with a second dose of GARDASIL (lot # 659439/1267U). On 19-AUG-2008 (previously reported as "week of 11-AUG-2008") the patient was vaccinated with a third dose of GARDASIL (lot #660612/0229X), 0.5, I.M. Shortly, after receiving her third dose, on 19-AUG-2008, the patient experienced a 30 mm nodule at the injection site (previously reported as a lump at the injection site, the size of a "half dollar"). The patient sought medical attention calling the practice. The nodule persisted for 7-10 days, then resolved. The nodule returned at the same area in September 2008. At the time of reporting, the patient had not recovered from the nodule at the injection site. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL Lot # was not available. Per nurse, the patient fainted after receiving the first dose of GARDASIL. The same day the patient recovered from fainted. The patient was seen by the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a registered pharmacist concerning a college student female who on an unspecified date was vaccinated with the first dose of GARDASIL and experienced a big lump at the injection site (50-60 millimeter in diameter). The pharmacist also mentioned that there was no shortness of breath and the lump resolved in 2 weeks. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female with penicillin allergy and no pertinent medical history who on an unknown date, was vaccinated with the first dose of GARDASIL 0.5 mL, IM. The patient did not experience any difficulties. On 09-SEP-2008, the patient was vaccinated with the second dose of GARDASIL 0.5 mL, IM. There was no concomitant medication. On 10-SEP-2008, the patient experienced over all body rash. The patient's over all body rash persisted. No laboratory tests were performed. The patient was seen in the physician's office (not further specified). The patient sought medical attention by a doctor's office visit. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 11-SEP-2008 was vaccinated with GARDASIL (lot no. and route of administration were not reported). On 11-SEP-2008, the patient fainted after receiving GARDASIL at the doctors office. The physician reported that the patient had not eaten any meals prior to vaccination. As of 11-sep-2008, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood count, Chlamydia identification test, Computerised tomogram, Gram stain
Clinical narrative: Information has been received from a consumer concerning her daughter, an 18 year old female patient with a history of "asthma as a child," who on 06-MAR-2007 was vaccinated with the first dose of GARDASIL (lot #, route and injection site not reported). According to the consumer, on 07-MAR-2007 her daughter had "terrible pain and abdominal cramping" after receiving her first dose of GARASIL. The patient contacted doctor and went to the emergency room on 08-MAR-2007 (reported as 08-MAR-2008). CT scan of pelvis and abdomen, wet smear, urinalysis, blood count, Gram smear, gonorrhea and Chlamydia tests were performed without results reported. It was reported that the patient was not hospitalized. The patient was placed on unspecified therapy and the event improved. At the time of the report, the patient was recovering from the event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Smear cervix, Smear test, Urine analysis
Clinical narrative: Information has been received from a consumer concerning her daughter, an 18 year old female patient with a history of "asthma as a child," who on 06-MAR-2007 was vaccinated with the first dose of GARDASIL (lot #, route and injection site not reported). According to the consumer, on 07-MAR-2007 her daughter had "terrible pain and abdominal cramping" after receiving her first dose of GARASIL. The patient contacted doctor and went to the emergency room on 08-MAR-2007 (reported as 08-MAR-2008). CT scan of pelvis and abdomen, wet smear, urinalysis, blood count, Gram smear, gonorrhea and Chlamydia tests were performed without results reported. It was reported that the patient was not hospitalized. The patient was placed on unspecified therapy and the event improved. At the time of the report, the patient was recovering from the event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site inflammation, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a medical assistant and a health care worker concerning an approximately 15 year old female patient who on 01-AUG-2007 was vaccinated with the first dose of GARDASIL (lot #656050/0245U). On 05-OCT-2007, was vaccinated with the second dose of GARDASIL (lot #657006/0188U), and on 13-AUG-2008, was vaccinated with the third dose GARDASIL (lot 659964/1978U), all doses intramuscularly into her left arm. About three weeks after receiving the third dose of GARDASIL, on approximately 03-SEP-2008, the patient experienced injection site inflammation with a lump at the site and swelling. There was no adverse symptoms from the first or second doses. On 10-SEP-2008, the patient was seen at the physician's office. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Injection site vesicles, Nausea
Clinical narrative: Information has been received from a 25-year-old female pharmacy technician who reported that on 10-SEP-2008, she received the second dose of GARDASIL (lot # not reported) 0.5 mL via intramuscular route in her left deltoid. Concomitant medication included ORTHO-CYCLEN. According to the reporter, on 11-SEP-2008 she developed two "fluid filled blisters on either side of the site of injection" after the second dose of vaccination. The patient also experienced nausea and diarrhea. She sought unspecified medical attention. At the time of reporting, the patient had not recovered from the events. The patient's received her first dose of GARDASIL on 03-JUN-2008. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 18-year-old female patient who on 15-AUG-2008 received the second dose of 0.5 mL GARDASIL (lot number, route and injection site not reported). On on 15-AUG-2008, after the vaccination the patient experienced a rash on one side of her body. She sought unspecified medical attention by calling the practice. On 15-AUG-2008 the patient recovered from the event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her daughter a 19 year old female who on 04-OCT-2006 was vaccinated with the first dose of GARDASIL. In December 2006, the patient was vaccinated with a second dose of GARDASIL. In April 2007, she was vaccinated with a third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient received an abnormal pap smear. The abnormal cells were diagnosed as HPV. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from HPV. The patient's physician plans to retest in 3 months. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a female with no medical history and no know allergies who on approximately 29-AUG-2008 was vaccinated with a second dose of GARDASIL. There was no concomitant medication. The certified medical assistant reported that the patient developed swelling after injection on approximately 29-AUG-2008 and a hard knot days later around the injection site. It was reported that the patient exercised regularly and noticed that the knot at the muscle area was noticeable when she flexed her arm. At the time of reporting the patient had not recovered. Patient sought medical attention: was seen. There was no product quality complain. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female with penicillin allergy and sulfonamide allergy and history of tachycardia who on 18-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, IM. Concomitant therapy included metoprolol. Since 19-AUG-2008, the patient experienced fever, nausea, vomiting, chills, dizziness and fatigue. On 09-SEP-2008, the patient sought medical attention calling to the office because her symptoms had not resolved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female with penicillin allergy and sulfonamide allergy and history of tachycardia who on 18-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, IM. Concomitant therapy included metoprolol. Since 19-AUG-2008, the patient experienced fever, nausea, vomiting, chills, dizziness and fatigue. On 09-SEP-2008, the patient sought medical attention calling to the office because her symptoms had not resolved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a mother and a certified medical assistant concerning the development of a rash by a twin sister following vaccination. A 18 year old female who on 20-JUN-2008, was vaccinated with the first dose of GARDASIL. On 19-AUG-2008, was vaccinated with the second dose of GARDASIL. On 20-JUN-2008, the patient experienced rash after the first vaccination, but development or resolution was not available at the time of the report. The patient reported on 25-AUG-2008, that she developed a rash that started 10 days prior (4 days prior to the second vaccination). On 15-AUG-2008, the patient experienced 10 point erythematous rash all over her torso. At the time of reporting, the outcome was unknown. Her rash was described as similar to her twin sister's (WAES0809USA02661). Additional information has been requested. This one of several reports received from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blepharospasm, Vitamin B12 absorption test
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL (lot no. 0250X) (route not reported). Concomitant therapy included birth control pills (unspecified), lithium (unspecified), SYNTHROID and CECLOR. On 03-JUL-2008, two days after vaccination the patient experienced eye twitching. The patient was testing for Lyme disease, thyroid dysfunction, vitamin B12 deficiency and the patient had a magnetic resonance imaging (MRI) done to rule out an aneurysm. No diagnosis was given. The patient sought medical attention by calling the physician. Additional information has been requested.  11/06/2008  Records received from OBGYN. Exam 7/1/08 with normal PE. Pt will not be getting 2nd HPV vax due to developing an eye twitch 2 days s/p 1st vax on 7/1/08. Has seen PMD, Neuro and endocrine with no dx.  12/19/2008 MR received from PCP beginning 7/18/-12/2/2008. Initially seen 7/18/08 with c/o of feeling unwell and intermittent eye twitch, lid lag and torso twitches. Seen in ER and dx: sinusitis-tx-abx. PE (+) for ptosis and R eye lateral and upward deviation, RUE and R upper eyelid weakness. Concern for MS or MG.  DX: Palsy, parial 3rd nerve.  Muscle fasculations. Referred to neuro who felt either sinusitis or psychiatric etiology.  Returned 8/11/08 with c/o throbbing head pain/pressure on R side of head. Assessment:  Muscle fasiculations.  H/A etiology unclear. Ophth exam (=) for ptosis but no ocular componant to h/a. Seen in referral  for 1 mon hx of eye twitching and muscular fatigue on exertion.   ROS (+) for 18# wt loss, eye twitching, hip soreness, acne, hair loss and abnormal bruising.  PE (+) for R eye lag. DX: Hypothyroidism.  Muscle fasciculations. OV 9/19/08 in f/u. Dx: Infection, viral. Rx: Doxycycline. Flu vax 12/2/08. F/u for ER visit for SOB/sore throat. DX: Strep throat.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia, Epistaxis, Parosmia
Clinical narrative: Information has been received from a 23 year old female with penicillin, metals, FLOXIN and bromafid allergy, who on 29-FEB-2008, was vaccinated with the first dose of GARDASIL (lot no. 655327/1287U) 0.5 mL, IM. On 12-MAY-2008, was vaccinated with second dose of GARDASIL (lot no. 0152X) 0.5 mL, IM and on 12-SEP-2008 was vaccinated with the third dose of GARDASIL (lot no.660557/0072X) 0.5 mL, IM. The nurse reported that the patient experienced a metallic taste and smell of ammonia after each vaccine. The patient had nose bleed 2 hours after vaccination with first and second dose of GARDASIL that lasted for a few minutes. The nurse reported that no treatment was required. No laboratory tests were performed. The patient sought medical attention at the doctor's office. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 22-year-old female patient who on 11-SEP-2008 received the first dose of 0.5 mL GARDASIL (lot number and injection site not reported) via intramuscular route. On an unknown date after the vaccination, the patient developed a rash on her abdomen. No itching was noted. She sought unspecified medical attention through phone call. At the time of reporting, the patient was recovering from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis contact
Clinical narrative: Information has been received from a physician concerning two patients who were vaccinated with GARDASIL (route, site and lot number not reported). Subsequently the patients experienced contact dermatitis from the GARDASIL band-aids. The skin affected was the shape of the band-aids. There was no additional information at that time. Further information was received from the office manager. It was reported that "several girls" mentioned that the band aids "should not be used." The patient information was not recorded at the time, and therefore, the office had no way of knowing "who made the comments."
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal infection
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 14-AUG-2008 was vaccinated with the third dose of GARDASIL. On approximately 15-AUG-2008 the patient developed a "strep infection" and was placed on steroids. The patient recovered without incidence. The patient sought medical attention at the office. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a certified nurse midwife concerning her daughter's friend a 26 year old female with no pertinent medical history reported who on unspecified dates was vaccinated with the first and second doses of GARDASIL. After 2 doses of GARDASIL, the patient experienced an atypical squamous cells of undetermined significance. A PAPANICOLAOU test was performed which was positive for HPV. The friend's physician has recommended a cervical biopsy. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Blood test, Chest X-ray, Cough, Joint swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with penicillin allergy and drug hypersensitivity to CECLOR who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included MENACTRA. "A couple weeks ago" the patient developed swollen ankles, rash on her legs and arms and night time fevers after her first dose of GARDASIL. Her ankles were swollen to the size of grapefruit. She also had an unproductive cough for 2 weeks and general malaise. The patient was seen in the office. At the time of reporting a chest X-ray and a blood tests were performed but results were pending. At the time of reporting the patient had not recovered from swollen ankles, rash on her legs and arms and night time fevers. Additional information has been requested.  3/27/09 Received PCP vaccine & medical records of 12/21/2006-2/26/2009. FINAL DX: none provided Records reveal paitent experienced general good health on 7/28/08 & also received MCV4 same day.  Ongoing psych counseling for eating disorder.  RTC 9/11/08 for rash, fever, cough x 2 wk, bilateral ankle swelling w/pain x 4 days, eczema flareup & fatigue.  RTC 1/12/09 w/intermittent abdominal pain.  Dx w/UTI & tx w/antibiotics.  RTC 2/26/09 w/migraine HA x 4 days w/phonophobia, photophobia, N/V & had missed school.  Tx w/meds. This is in follow-up to report (s) previously submitted on 10/14/2008. Follow up information was received on 23-Dec-2008, patient weights 141 pounds and is 5 feet 11 inches tall. GARDASIL (lot # 660551/0070X) was received on the left deltoid at 3:00 pm. On 07-Sep-2008 patietn experienced fatigue, ankle pain, swelling and joint arthralgias. Follow-up information received on 18-Feb-2009 from a liscensed practical nurse who reported that it was determined by the doctor that the patient's symptoms were not related to GARDASIL but rather were a result of other medical condition. GARDASIL is not considered to be suspect. No futher information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with penicillin allergy and drug hypersensitivity to CECLOR who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included MENACTRA. "A couple weeks ago" the patient developed swollen ankles, rash on her legs and arms and night time fevers after her first dose of GARDASIL. Her ankles were swollen to the size of grapefruit. She also had an unproductive cough for 2 weeks and general malaise. The patient was seen in the office. At the time of reporting a chest X-ray and a blood tests were performed but results were pending. At the time of reporting the patient had not recovered from swollen ankles, rash on her legs and arms and night time fevers. Additional information has been requested.  3/27/09 Received PCP vaccine & medical records of 12/21/2006-2/26/2009. FINAL DX: none provided Records reveal paitent experienced general good health on 7/28/08 & also received MCV4 same day.  Ongoing psych counseling for eating disorder.  RTC 9/11/08 for rash, fever, cough x 2 wk, bilateral ankle swelling w/pain x 4 days, eczema flareup & fatigue.  RTC 1/12/09 w/intermittent abdominal pain.  Dx w/UTI & tx w/antibiotics.  RTC 2/26/09 w/migraine HA x 4 days w/phonophobia, photophobia, N/V & had missed school.  Tx w/meds. This is in follow-up to report (s) previously submitted on 10/14/2008. Follow up information was received on 23-Dec-2008, patient weights 141 pounds and is 5 feet 11 inches tall. GARDASIL (lot # 660551/0070X) was received on the left deltoid at 3:00 pm. On 07-Sep-2008 patietn experienced fatigue, ankle pain, swelling and joint arthralgias. Follow-up information received on 18-Feb-2009 from a liscensed practical nurse who reported that it was determined by the doctor that the patient's symptoms were not related to GARDASIL but rather were a result of other medical condition. GARDASIL is not considered to be suspect. No futher information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test abnormal, Headache, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a nurse and office manager for the pregnancy registry for GARDASIL a 27 year old Caucasian female who on 28-SEP-2006 was vaccinated with the first dose of GARDASIL. On 31-OCT-2006, the patient was vaccinated with a second dose of GARDASIL. On 06-MAR-2008, she was vaccinated with a third dose of GARDASIL. Concomitant therapy included a first influenza virus vaccine (unspecified) on 23-JAN-2006 and a second dose on 17-OCT-2007 and vitamins (prenatal vitamins). In September 2007, approximately 6 months after the third dose the patient became pregnant. When she was 15 weeks pregnant she experienced headaches and in the 18th week of pregnancy she was diagnosed with venous sinus thrombosis. The patient's family history and genetic relation of blood disorder that out after delivery. Since then, the patient has had a live birth female who was healthy and was born at 39 weeks from the LMP on 26-APR-2008 with a weight of 7 pounds and 1 oz and the length was 21.5 inches (LMP = approximately 26_JUL-2007, EDD - approximately 03-MAY-2008). Additional information is not expected. 3/10/09-records received for DOS 12/7-12/8/07-DC DX: Venous sinus thrombosis. Presented with C/O headaches at time 18 weeks pregnant.  Office note 11/19/07 seen for evaluation of worsening headaches. During course of first trimester of pregnancy had increasing and severity of chronic headaches which began at age 8 or 9. Throbbing pain and sensationof nasal congestion. Assessment:mirgraine headaches. Office visit 2/14/08-follow up visit after hospitalization. Assessment:right cerebral transverse sinus thrombosis. 3/12/09-office records received office visit 6/20/07-annual exam WNL- 7/30/06-C?o fatigue and discharge, vagninitis. 9/28/06-1st Gardasil vaccine Lot #0955F, left deltoid. 10/31/06-2nd Gardasil vaccine received. 1/19/07-C/O feelings of anxiety, chest pain, shaking. 3/6/07-3rd Gardasil vaccine given Lot #0146U.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Genital lesion
Clinical narrative: Information has been received from a 19 year old female patient with no pertinent medical history or allergies who on in the end of July, approximately 31-JUL-2008 who completed the 3 dose series and was vaccinated with GARDASIL (dose and route not reported). Concomitant therapy included birth control (unspecified). A couple of weeks ago in approximately September 2008, the patient experienced a little bump on the genital area that had not gone away, she has not experienced itching or pain. The patient stated she had had the same boyfriend for eight months. The vaccine was administered in one state and she is now in school in another state and the patient had no physician. As of 15-Sep-2008, the patient had not recovered. No laboratory test was performed. The patient did not seek medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood test normal
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who had no pertinent medical history or allergies who in November 2007, was vaccinated with the first dose of GARDASIL and in May 2008, was vaccinated with the second dose of GARDASIL .  Concomitant therapy included ALLEGRA.  In June 2008, the mother reported that her daughter started losing her hair, where her hair was thinning and she had bald spots on the front of her head and in other specific areas.  The mother's patient also reported that the patient had seen her physician and was diagnosed with alopecia.  It was reported that the physician did full blood work which were negative.  The mother stated that her daughter looked like a man balding with hair plugs.  It was reported that physician gave her a medicated shampoo, just in case of fungus on her scalp, which she was almost finished and she was starting to see some regrowth, but her hair was still thin.  The mother also reported that in November 2007 the patient had stopped therapy with fexofenadine hydrochloride when she received her first dose of GARDASIL.  The patient was also received routine vaccines (names and manufactures unspecified), before going back to school.  The HPV vaccine series was discontinued (last dose May 2008).  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Diagnostic procedure, Dysmenorrhoea, Faeces discoloured
Clinical narrative: Information has been received from an office manager concerning a 17 year old female with penicillin allergy and a history of tonsillectomy (1994) who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM and on 15-MAY-2008 was vaccinated with the second dose of GARDASIL vaccine 0.5 mL, IM.  The patient had not yet received the third dose.  Concomitant therapy included DEPO-PROVERA.  The office manager reported that in 2008, the patient experienced stomach pain, leg pain, back pain and her leg had been "sore" and limp.  The patient also had sleepy feeling.  The patient was also experienced increased incidence of headaches and she also had a thin white discharged in the vagina.  On 11-SEP-2008 the patient experienced green pink stool.  The patient felt nauseated after eating, she had no diarrhea and constipation.  As of 15-SEP-2008 the patient experienced green pink stool.  She had no diarrhea and constipation.  As of 15-SEP-2008 the patient had not recovered from the symptoms.  A vaginal specimen analysis was performed that were negative for vaginitis.  The patient sought medical attention by seeing the physician.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/14/2008. Follow-up information was received from a physician via medical record who reported that on 11-SEP-2008, the patient went to doctor's office complianing of vaginal discharge that she describe as burning, itchy, white, foul, smelling and thin. The doctor stated the patient had premenstrual dysmenorrhea. The duration in 5 days and was interfering with work and normal activities. It was reported that the patient was not going to take DEPRO-PROVERA anymore because she didn't like the way it makes her feel. It was also reported that the patient had an adenoidectomy in 1994. The patient had never had a PAP smear or a mammogram, she had no history of significant medical diseases. At the physical exam patient height: 64 inches, weight 105 pounds and blood pressure 103/60. The patient's pelvic exam was normal and she had no history of obstetrical or gynecological surgery. The patient denied previous exposure to STD. On 14-SEP-2008 the patient was having a lot of symptomatology. She was concerned it is for GARDASIL vaccine. On 16-SEP-2008 the patient's mother called the physician and stated that the primary care physician put the patient on prednisone and that did not work. The patient still had tingling in her legs. The patient was send to a Neurologist. Additional information has been requested.