chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Papilloma viral infection
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female with human papilloma virus who on an unspecified date, was vaccinated with a dose of GARDASIL and her human papilloma virus had gotten worse. At the time of reporting, the outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a friend of the family concerning an 18 year old female with orthostatic hypertension who was vaccinated intramuscularly with the 0.5ml dose of GARDASIL. Subsequently the patient experienced black outs. The patient's outcome was unknown. Unspecified medical attention was sought. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Malaise, No reaction on previous exposure to drug, Pallor
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL and was well tolerated. On an unspecified date was vaccinated with the second dose of GARDASIL. After receiving the second dose, the patient felt ill, pale, fever, felt faint and possibly vomited. Her symptoms began immediately after the second dose. Subsequently, within 48 hours the patient recovered from pale, fever, felt faint, possibly vomited and felt ill. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL and was well tolerated. On an unspecified date was vaccinated with the second dose of GARDASIL. After receiving the second dose, the patient felt ill, pale, fever, felt faint and possibly vomited. Her symptoms began immediately after the second dose. Subsequently, within 48 hours the patient recovered from pale, fever, felt faint, possibly vomited and felt ill. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a registered nurse. On 16-AUG-2008, the mother called the office and reported that her daughter a 19 year old female patient who on 15-AUG-2008, was vaccinated with the first dose of GARDASIL (Lot # 660612/0229X) 0.5ml, IM into the upper arm. On 16-AUG-2008, within 24 hours of receiving the first dose the patient experienced swollen lip. The mother has not called the office back at the time of the report, and the patient is assumed to be recovering. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 9/15/2008. Additional information was received from the nurse. The patient was fine. No additional information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 11.5 year old female who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 08-JUN-2008, "within a few days after getting her first dose", the patient experienced her first cycle. The patient has had a 4 menstrual periods since receiving GARDASIL. The menses were irregular but were not excessively heavy. The outcome was unknown. The patient was seen and sought unspecified medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female who on approximately 06-AUG-2008 was by vaccinated with the first dose of GARDASIL. Concomitant therapy included "other vaccines" (therapy unspecified). On approximately 06-AUG-2008, the patient fainted and her blood pressure drop after vaccination with GARDASIL and other vaccines gave at the same time. The patient sought medical attention. On an unspecified date the patient recovered. This is one of two reports from the same source. Additional information has been requested. The doctor going to call and ambulance for one the girls (unspecified).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Furuncle, Radiation exposure during pregnancy
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter who on 11-JUN-2008 was vaccinated with the first dose of GARDISIL and VARIVAX. At the time of vaccination, the patient was probably 6 weeks pregnant (LMP approx. 30-APR-2008, EDD 4 FEB-2009). In approximately July 2008, the patient had x-ray done at the dentist's office. Also, about a week ago, the patient had "two boils". The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Information has been received form a receptionist concerning a female who was vaccinated with GARDASIL. The patient expressed that the vaccine really hurt. It burned all the way down her arm. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash generalised, Urticaria
Clinical narrative: Information has been received form a pharmacist concerning his 21 year old daughter with no known allergies/ reactions who in early June 2008, was vaccinated with the first dose of GARDASIL. On 13-AUG-2008, the patient was vaccinated with the second dose of GARDASIL. Concomitant therapy included YASMIN. On 13-AUG-2008, after the second dose was given, the patient experienced rashes and hives throughout the body (from the trunk to elbow and shoulder of both arms). There were occasional hives and rashes on the front of the hips also. The pharmacist has been treating his daughter with BENADRYL and an unspecified topical steroid. The patient did not have a reaction after receiving the first dose of GARDASIL. The patient sought medical attention with the pharmacist. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Malaise
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a fourth dose of GARDASIL vaccine because of an unknown vaccination history for the patient, when the fourth dose was given. the day after the fourth dose was given; the patient stated that she felt sick. The patient sought medical attention. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: Information has been received form a physician concerning a patient who was vaccinated with a dose of GARDASIL vaccine. Subsequently the patient experienced increase in anxiety after vaccine administration. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a medical assistant concerning a female who in October 2007, was vaccinated with the first dose of GARDASIL, after receiving the first dose the patient developed a severe case of mononucleosis. The provided did not have treatment information because the patient received the vaccine and treatment for mononucleosis at a college health center. The patient fully recovered by an unspecified date and on 19-AUG-2008 received the second dose of GARDASIL. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 9/15/2008. Follow-up information was received. The patient received the vaccination of GARDASIL at her college. The patient came to office requesting her second injection. The office did not have any information regarding the vaccination and her illness. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope, Vertigo
Clinical narrative: Information has been received form a licensed practical nurse (L.P.N.) concerning a 17 year old female with no pertinent medical history or no known drug allergies who on 20-SEP-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 657868/0523U), on 04-JAN-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 659439/1267U) and on 20-JUN-2008 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL ( lot # 660393/0067X). Concomitant therapy included BENZACLIN, SUMYCIN, MENACTRA (20-JUN-2008). On 20-SEP-2007 the patient experienced syncope. The patient had also experienced intermittent vertigo and nausea since May 2008. The patient's syncope and intermittent vertigo and nausea persisted. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Colonoscopy normal, Tooth discolouration, Weight decreased
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 21 year old female with significant mitral regurgitation and an allergy to VERSED and a history of miscarriage (at age 18), gallbladder surgery and appendicectomy (in 2000) who on 02-AUG-2007, 30-OCT-2007 and 19-FEB-2008 was vaccinated intramuscularly with 0.5 ml first, second and third dose of GARDASIL (lot #658556/1060U, 659437/1266U and 659653/1448U), respectively. Concomitant therapy included NUVARING and VALTREX. On 30-OCT-2007 and the patient weighed 144 lbs. "After her third dose", the patient stated that she lost 25 pounds after receiving GARDASIL. Colonoscopy was performed and the result indicated negative. The nurse did not have the current weight of the patient. The nurse also mentioned that recently she observed that the patient's teeth were brown and white which resembled someone who had anorexia or bulimia. The patient initially called her primary care physician and was told to contact the nurse's office. At the time of this report, the events persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a series of three doses of GARDASIL. The patient developed cramps after her first two doses of GARDASIL. Subsequently, the patient recovered from cramps. She did not have cramps (type unknown) after the third dose of GARDASIL. Medical attention was sought in the physician's office.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 18 year old female who on an unspecified date, was vaccinated with the second dose of GARDASIL and for a couple days after that the patient was experiencing a fever of 103 degrees. At the time of reporting, the outcome was unknown. No product quality complaint was involved. This is one of several reports received form the same source. Additional information has been requested. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Myalgia, Pyrexia, Smear cervix
Clinical narrative: Information has been received from a physician concerning a 17 year old female with PENICILLIN allergy and no other pertinent medical history who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (lot# 660389/1968U).  There was no concomitant medication.  Subsequently the patient experienced myalgas and fever that lasted for three days after  receiving the first dose.  STD panel routine PAP were performed.  On an unspecified date, the patient recovered from myalgas and fever.  The patient sought medical attention seen by the practice.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with asthma and no known drug allergies/reactions who on an unspecified date was vaccinated with the first dose GARADSIL and on 14-AUG-2008 was vaccinated with the second dose of GARDASIL (Lot No. 659184/0843X).  Concomitant therapy included SEASONIQUE.  On 14-AUG-2008 the patient developed dizziness and nausea immediately after administration and throughout the evening.  Patient has not responded back to the office's attempt to follow-up.  Patient sought medical attention, at the office.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a physician concerning a 22 year old female with history of fainting when receiving needles and no drug reaction/allergies who on an unspecified date was vaccinated with the first dose of GARDASIL and on 15-AUG-2008 was vaccinated with the second dose of GARDASIL (Lot no. 0250X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 15-AUG-2008m the patient passed out the needle was injected. When the patient became alert she complained of nausea and lightheadedness. The patient did receive GARDASIL. At the time of the reporting the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Stomatitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female who on unspecified dates, was vaccinated with the three doses of GARDASIL intramuscularly.  The patient reported that she developed mouth sores after receiving each of the three doses of GARDASIL vaccine.  The patient had also injection site pain.  The patient recovered on an unspecified date.  Unspecified medical attention was sought.  There was no product quality complaint. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with rheumatoid arthritis and no known drug reactions/allergies and a history of passing out who on 14-AUG-2008 was vaccinated intramuscularly in left arm with the 0.5ml first dose of GARDASIL. The patient also was vaccinated in her right arm with a dose of MENACTRA. Concomitant therapy included nabumetone (RELAFEN) and ranitidine HCL (ZANTAC). The patient passed out after administration of the vaccine while in the office. On the same day, the patient recovered. Medical attention was sought in the physician's office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia, Joint instability, Musculoskeletal pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with no medical history and no known allergies, who on 25-OCT-2007 was vaccinated with a first dose of GARDASIL (lot and site unspecified).  On 10-JAN-2008 was vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL (lot # 658560/1062U) and on 09-MAY-2008 was vaccinated intramuscularly into the left deltoid with a third dose of GARDASIL (lot # 659962/1740U).  Concomitant therapy included DEPO-PROVERA.  The patient reported that she developed shoulder and knee pain with numbness in her feet with an onset in April 2008.  The pain and numbness were described as  "off and on".  The pain was described as worsening with increased intensity and frequency.  On 11-AUG-2008 the pain was described as becoming more constant.  The patient saw an orthopedic physician and her primary care physician.  The orthopedic physician diagnosed the pain as "joint instability"  and no treatment was given.  The nurse noted that the patient started exercising in April 2008.  At the time of reporting the patient had not recovered.  The patient sought for medical attention: office call.  There was no product quality complaint.  Additional information has been requested.  12/19/2008 Patient does not recall having ortho consult & no f/u done w/PCP.  Has recovered completely w/o residual.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from two medical assistants concerning a 17 year old female who in July 2007, was vaccinated with the first dose of GARDASIL. In November 2007, the patient was vaccinated with the second dose of GARDASIL. In April 2008, the patient was vaccinated with the third dose of GARDASIL. The medical assistants reported that the patient came back to the office in July 2008 for her annual checkup and had "abnormal pap atypical squamous cells of undetermined significance". The patient also had a colposcopy. The outcome was unknown. The patient saw the physician to seek unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Syncope
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with sulfonamide allergy who on 12-AUG-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included varicella virus vaccine live (manufacturer unknown) and Hepatitis A vaccine (inactive) (manufacturer unknown). The mother reported that her daughter fainted after receiving the first dose of GARDASIL. Blood pressure test was performed for half an hour after the experience, (results not provided). The mother also reported that her daughter currently had redness and hardness at the injection site about 4 inches big. At the time of report, the daughter had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of urinary tract infection who on 07-MAY-2008, was vaccinated with the third dose of GARDASIL. The dates of administration for the first and second dose was not known. There was no concomitant medication. The physician reported that on 21-MAY-2008, after the administration of all three doses of GARDASIL, the patient developed about 25 facial common flat warts and 15 warts on the back of her hands. The patient was initially examined by a dermatologist who prescribed acne cream the first visit. The dermatologist began treatment for warts after the second examination. At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose, Loss of consciousness
Clinical narrative: Information has been received from a health professional, concerning a 17 year old female patient who on 15-AUG-2008 was vaccinated with 0.5 mL dose of GARDISIL IM. On 15-AUG-2008, the patient "passed out as she was walking out of the room". On the same date, the patient recovered. Glucose test was performed and the result was not provided. The patient did seek medical attention. There was no product quality complaint. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient who in February 2008, was vaccinated with the first dose of GARDASIL. In May 2008, was vaccinated with the second dose of GARDASIL. In February 2008, since the first dose was given the patient experienced rash. In May, 2008, after the second dose was given the patient's rash got worse. The patient's rash persisted. The patient spoke to the physician for medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of GARDASIL and fainted. Subsequently the patient recovered. The patient since, has received her second and third dose and did not have any more fainting episodes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash pustular, Rash vesicular
Clinical narrative: Information has been received from a physician assistant concerning a female who on 05-Aug-2008 was vaccinated with the first dose of GARDASIL in the right deltoid. In 2008, the patient developed a rash on both her upper and lower extremities. The rash was pus filled blisters that were greater on the left arm. The rash resolved on its own. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history and no history of drug reactions or allergies who on 30-JUL-2007 was vaccinated with the first dose of GARDISIL (lot#: 657621/0387U) 0.5ml IM into the right arm. There was no concomitant medication. Subsequently the patient experienced severe vomiting, headache and abdominal pain. Subsequently, the patient recovered from severe vomiting, headache and abdominal pain. The patient sought medical attention with a physician office visit. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 female who on an unspecified date was vaccinated with the first dose of GARDISIL. On an unspecified date was vaccinated with the second dose of GARDISIL. The patient experienced fever and syncope after the first and second dose. The first incident was not as severe as the second. Subsequently, on an unspecified date, the patient recovered from fever and syncope. The patient sought medical attention at physician's office. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TDAP
Symptoms: Cough, Dizziness, Headache, Heart rate increased, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no medical history, who in July 2008, was vaccinated with a first dose of GARDASIL 0.5 ml, hepatitis A vaccine (manufacturer unknown), Tdap (unspecified) (manufacturer unknown) and meningococcal vaccine (manufacturer unknown). The consumer reported that her daughter developed symptoms after receiving her first and only dose of GARDASIL. She had fever for 3 days and it went up as high as 102.5 F degrees. She had also experienced severe headache, cough, runny nose, fast heart rate, sore arm and dizziness several hours after the vaccination. The patient recovered from all of the symptoms after 3 days, except the sore arm at the injection site which had lasted a week. The patient sough medical attention: The patient's mother called the office. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TDAP
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no medical history, who in July 2008, was vaccinated with a first dose of GARDASIL 0.5 ml, hepatitis A vaccine (manufacturer unknown), Tdap (unspecified) (manufacturer unknown) and meningococcal vaccine (manufacturer unknown). The consumer reported that her daughter developed symptoms after receiving her first and only dose of GARDASIL. She had fever for 3 days and it went up as high as 102.5 F degrees. She had also experienced severe headache, cough, runny nose, fast heart rate, sore arm and dizziness several hours after the vaccination. The patient recovered from all of the symptoms after 3 days, except the sore arm at the injection site which had lasted a week. The patient sough medical attention: The patient's mother called the office. There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no known allergies who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot number not provided). On an unspecified date the patient received the third dose of GARDASIL and experienced syncope. The patient recovered on an unspecified date. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 16 year old female with no medical history and no known allergies, who in January 2008, was vaccinated with a dose of GARDASIL. Concomitant therapy included PAMELOR 25 mg. She reported she was experiencing headaches after receiving her first and second dose of GARDASIL. The headache occurred above both eyes. Laboratory/diagnostic tests performed: CAT scan: Results not provided. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  10/10/08 Reviewed PCP medical records of 12/29/06-8/14/08. FINAL DX: Records reveal patient experienced usual state of good health on day of HPV vaccines, HPV #1 on 2/11/08 & HPV #2 on 4/19/08.  RTC 5/6/08 w/intermittent HA, dizziness & blurred vision since 3/08 & worsening after HPV #2.  Exam revealed nasal congestion & boggy turbinates, tx w/allergy meds w/ no improvement in s/s.  Tx w/antibiotics unsuccesful & referred to neuro.  Neuro consult included.  Tx w/meds.  No further records available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site haematoma, Injection site mass
Clinical narrative: Information has been received from a 25 year old female with no medical history and no known allergies who on 12-AUG-2008 was vaccinated with a dose of GARDASIL. There was no concomitant medication. On 13-AUG-2008 the patient experienced a bruise on the same are where she received GARDASIL. Also, a white bump developed at the injection site. No lab/diagnostic tests were performed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Oral herpes, Vaccine positive rechallenge
Clinical narrative: Information has been received from an office receptionist concerning a female cousin with a history of cold sores who on an unspecified dates was vaccinated with the first and second dose of GARDASIL. After each doses the patient experienced cold sores that were larger and clustered, more intense outbreaks than ever before. At the time of the reporting the outcome of the patient was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on unspecified dates was vaccinated with the first and second dose of GARDASIL. After receiving the first dose her arm was numb for a couple of hours, and after receiving her second dose her arm was even more numb. The patient sought unspecified medical attention. At the time of the reporting, the patient had recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-AUG-2008 was vaccinated with the first dose of GARDISIL (Lot No. 659184/0843X). After receiving the first dose, the patient experienced dizziness and vomiting at the physician's office. At the time of the reporting, the patient had recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL and on 01-AUG-2008 was vaccinated with the second dose of GARDASIL. After receiving her second dose the patient's arm was very sore, when her shirt touches it, it was very painful. The patient sought unspecified medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Chest discomfort, Skin warm
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 11 year old patient, with no pertinent medical history and no drug reactions/allergies, who on 16-AUG-2008 was vaccinated IM with the first 0.5mL dose of GARDASIL. Secondary therapy included the second dose of VARIVAX (Merck) (MSD). Other concomitant vaccinations included MENACTRA and Tdap. No concomitant medication was included. On 16-AUG-2008 the patient experienced warmth on the same arm as that of GARDASIL and this warmth traveled to her chest. The patient sought unspecified medical attention (was seen). At the time of the reporting, the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. Concomitant therapy included 2 other injections (therapy unspecified), prior to having GARDASIL. After receiving the first dose, the patient went stiff and then fainted for about 20 seconds. Lot number was not provided. The patient sought unspecified medical attention. At the time of the reporting the outcome of the patient was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer, concerning her 25 year old female daughter with a history of malaria, who in October 2007 was vaccinated with the first dose of GARDASIL. Concomitant medication included ORTHO TRI - CYCLEN. The patient fainted after getting the first dose of GARDASIL. The patient recovered on an unknown date. The patient has not received the second and third dose yet. The patient sought unspecified medical attention. There was no product quality complaint. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Syncope
Clinical narrative: Information has been received from a physician, concerning a female patient, who in July 2008 was vaccinated with 0.5ml GARDASIL IM. A few minutes post vaccination, the patient got very pale and fainted. While the patient was still unconsciousness her body jerked several times, and then she regained consciousness. The patient was fully recovered on an unknown date. The patient sought medical attention in the office. There was no product quality complaint. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a unspecified nurse concerning her 21 year old niece who on an unspecified date was vaccinated with a dose of GARDASIL and was seriously ill in the intensive care unit. An unspecified physician at the hospital said the patient was seriously ill due to GARDASIL. The niece was under the care of the infectious disease service in intensive care unit. The nurse did not provide any further information on herself or her niece's case. At the time of the reporting, the patient hads not recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Immediate post-injection reaction, Mouth injury, Syncope
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 14 year old female patient with no previous medical history reported, who on 30-JUN-2008 was vaccinated with 0.5 mL first dose of GARDASIL (Lot #660553/0070x) IM. There was no concomitant medication. On 30-JUN-2008, the patient fainted immediately following the vaccination. The patient did sustain a cut to her lip from the fall when her face hit the stool. The patient was observed in the office and was discharged home with her parent and was considered recovered on 30-JUN-2008. There was no product quality complaint. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Alanine aminotransferase increased, Alopecia, Aphthous stomatitis, Aspartate aminotransferase increased, Blood alkaline phosphatase increased
Clinical narrative: Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician's office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood bilirubin increased, Blood thyroid stimulating hormone decreased, Contusion, Globulins increased, Granulocyte count increased
Clinical narrative: Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician's office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hyperhidrosis, Liver function test abnormal, Malaise, Mean cell volume decreased, Neutrophil count decreased
Clinical narrative: Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician's office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Protein total increased, Red blood cell count increased, Red cell distribution width increased, Syncope
Clinical narrative: Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician's office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tremor, Vomiting
Clinical narrative: Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician's office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Lip swelling, Lymphadenopathy, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history and no allergies who on 11-AUG-2008 was vaccinated with the first dose of GARDASIL IM 0.5 ml (lot # not reported). There was no concomitant medication. On 15-AUG-2008 the patient experienced swelling of her lips, unilateral facial swelling and swollen glands after administration of her first dose. On 19-AUG-2008 the throat culture result indicated negative. The patient's swelling of her lips and unilateral facial swelling and swollen glands persisted. The patient sought medical attention in the office visit. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Gaze palsy, Presyncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 11 year old female who on approximately 11-AUG-2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA and Tdap. While getting the shot the patient's mother had her arms around her for support. After the patient had received the dose of GARDASIL, the patient's eyes rolled back and she started to slide down. The nurse practitioner stated that this seemed like a fainting motion but the patient was conscious the whole time. Subsequently, the patient recovered. The patient was seen by physician to seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with a history of syncope (similar response) with other injections who on 19-AUG-2008 was vaccinated intramuscularly with the with the first 0.5 ml dose of GARDASIL. On 19-AUG-2008 the patient experienced syncope. Subsequently, the patient recovered on the same day. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Pruritus generalised, Rash, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter, a 23 year old female with no known pertinent medical history or drug reactions/allergies, who in approximately June 2008, was vaccinated with a first dose of GARDASIL 0.5 ml. Concomitant therapy included hormonal contraceptives (unspecified). Soon after receiving her first dose of GARDASIL the patient experienced some minor itchiness. In approximately August 2008, the patient was vaccinated with a second dose of GARDASIL 0.5 ml. The patient experienced severe itchiness over most of her body, rash and hives. The patient was prescribed ZYRTEC, which was a big help. The patient would be seeing an allergist in the near future. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a healthcare worker concerning a female who was vaccinated with a first dose of GARDASIL. Subsequently the patient developed severe headaches. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a certified nurse midwife concerning a female who was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL. Subsequently the patient developed Bell's palsy. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008.  Follow up information was received from the C.N.M. who indicated that the patient was not her patient.  The patient just briefly discussed with her and the vaccine was given by someone else.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a first dose of GARDASIL. Shortly after receiving the first dose of GARDASIL the patient experienced lightheadedness. Subsequently, the patient recovered from lightheadedness. The adverse event occurred at office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Laboratory test normal
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with asthma who on an unspecified date was vaccinated with a first dose of GARDASIL. "5 days after vaccination", the patient experienced faintness, shortness of breath and chest tightening in the morning. She went to the Emergency room and was given an unspecified inhaler but it did not relieve her symptoms. She had some labs done, which came back negative. The emergency physician believed that this could be a late response from GARDASIL. The patient was sent home and recovered next day. Additional information has been requested.