chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was vaccinated with her first dose of GARDASIL intramuscularly. There was no concomitant medication. The physician reported that the patient received her first dose of GARDASIL and had a pretty bad case of hives that took several weeks to clear up and two visits to the emergency room. The patient recovered and no further information was provided. Additional information has been requested. Additional informtion has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Mass
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with vision blurred and a history of sinusitis who on 15-NOV-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot # 658488/1264U).  Concomitant therapy included YAZ.  The nurse practitioner reported that the patient developed a swollen lower lip two hours after receiving the first dose of Gardasil vaccine.  The lip swelling resolved and the patient told the nurse practitioner that the lower lip developed a lump lasting for one month (exact duration for the swelling and subsequent lump was unspecified).  The patient did not inform the nurse practitioner of the adverse symptoms until the office visit for the second dose of Gardasil on 16-JAN-2008.  The nurse practitioner did not administer the second dose of Gardasil.  No other symptoms or treatments were reported.  The patient's status was reported as recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no medical history and no drug allergies, who on 02-JAN-2008 was vaccinated with a first dose of GARDASIL. Concomitant therapy included YAZ, used for acne and "bad periods." On 02-JAN-2008, immediately post vaccination the patient experienced severe pain and swelling at the injection site of her right arm. The patient experienced nausea and severe headaches. The patient felt tired and weak. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had recovered from the pain and swelling and was recovering from the rest of the symptoms. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Nausea
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no medical history and no drug allergies, who on 02-JAN-2008 was vaccinated with a first dose of GARDASIL. Concomitant therapy included YAZ, used for acne and "bad periods." On 02-JAN-2008, immediately post vaccination the patient experienced severe pain and swelling at the injection site of her right arm. The patient experienced nausea and severe headaches. The patient felt tired and weak. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had recovered from the pain and swelling and was recovering from the rest of the symptoms. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 655620/0171U).  There was no concomitant medication.  On 08-DEC-2007 the patient developed a "full body rash."  The patient reported that the rash was itchy.  No shortness of breath or difficulty breathing was reported.  The rash resolved within one week.  The patient recovered on 14-DEC-2007.  On 14-JAN-2008 the patient was seen in the office.  No laboratory diagnostics were performed.  No product quality complaint was involved.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Urticaria
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of foot infection and no known allergies who on 08-NOV-2007 was vaccinated with her first dose of GARDASIL intramuscularly. On 11-JAN-2008 the patient was vaccinated with her second dose of GARDASIL. Concomitant therapy included SEPTRA and oxaprozin. On 12-JAN-2008, 24 hours vaccination, the patient did not feel well and developed hives al over her body. The symptoms have continued since time of reporting. The patient started taking over the counter BENADRYL. No other information was available. Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a certified medical assistant and a registered nurse concerning a 21 year old female student with a recent foot infection and no known allergies, who on 08-NOV-2007 was vaccinated IM with her first dose of GARDASil. On 07-JAN-2008 the patient had taken SEPTRA for a foot infection. On 11-JAN-2008 the patient was vaccinated with her second dose of GARDASIL. Concomitant therapy included SEPTRA and oxaprozin. On 12-JAN-2008, 24 hours post vaccination, the patient did not feel well and developed hives on her back and her abdomen (previously reported as all over her body). It was reported by the nurse that the patient was also being treated for the foot infection at the time of the complaint of hives. It was also reported that the patient had eaten crab and shrimp on 12-JAN-2008. On 13-JAN-2008 the patient called the office and SEPTRA was discontinued. The patient started taking over the counter BENADRYL. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered from the hives on her back and abdomen on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pigmentation disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female with a history of a tonsillectomy who was vaccinated with her first dose and second dose intramuscularly in her left arm with Gardasil (dates not reported).  In August 2007, she was vaccinated subcutaneously in her left arm with her third dose of Gardasil.  Subsequently, after each of the three doses the patient experienced "hypopigmentation" within a week or two after she received Gardasil.  "She said that in three separate areas of her left arm, there is a square-shaped area which is lighter in color than her normal skin color."  The patient's hypopigmentation persisted.  The patient sought unspecified medical attention.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL. Subsequently the patient experienced a rash on her arms, back and thighs shortly after being vaccinated. Her outcome was not reported. Additional information received 18-JAN-2008: The case concerned a patient who developed a pruritic rash below the injection site, also involving the opposite leg and back. The rash developed several days after vaccination and was not associated with any other complaints . This was not felt to be hypersensitivity reaction. The physician will discuss giving the second dose in the series with the patient and closely observe her. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Follow-up information indicated that the patient developed rash on left foream (vaccinated left deltoid) and rash on right leg and partial back. On 08-Nov-2007, the patient was vaccinated with her second dose of GARDASIL vaccine (lot# 659055/1522U) and no reaction was reported.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pain
Clinical narrative: Information has been received from a registered nurse concerning an unknown number of female patients who were vaccinated with a dose of Gardasil.  It was reported that the girls felt light headed afterwards.  It was also reported that it seemed quite painful to the girls.  At the time of this report, the patient's outcomes were unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 07-FEB-2007 was vaccinated with her first dose of Gardasil.  In August 2007 the patient was vaccinated with her third dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  Since the first dose in February 2007, the patient has experienced an irregular menstrual cycle.  The patient was placed on birth control pills to regulate her menstrual cycle, but it is still abnormal.  The patient's irregular menstrual cycle persisted.  The patient sought unspecified medical attention.  Additional information has been requested. 02/10/2010 The patient received two more doses of GARDASIL without side efftects. She was referred to a gynecologist.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Menstruation delayed
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a female patient (age not specified) who in September 2007, was vaccinated with a dose of GARDASIL (lot # not reported), and has since not had her period. Diagnostic laboratory testing was performed (test and results not specified). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Flushing, Head injury, Loss of consciousness, Syncope
Clinical narrative: Initial and follow-up information has been received from a physician and an other healthcare professional concerning an 18 year old female who on 14-JAN-2008 was vaccinated with a second 0.5 mL dose of Gardasil (659439/1267U). At 10:30, on 14-JAN-2008, the patient experienced fainting (she passed out and fell to the floor) and head injury (contusion). The patient reported that she felt flushed then doesn't know what happened. Post incident the patient was oriented and alert x3 and sustained a reddened area to left side of forehead (previously reported as head injury (contusion). Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint.  This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Dizziness
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who was treated for a stiff neck prior to vaccination. On an unknown date the patient was vaccinated with a second dose of GARDASIL. Subsequently, "a few hours" after, on an unknown date, the patient experienced disorientation and dizziness. The physician did not want to provide any further details about the adverse event at the time of the report. No product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Influenza like illness
Clinical narrative: Information has been received from a nurse (patient's mother) concerning her daughter (age unspecified) with a history of asthma who was vaccinated intramuscularly with a first dose of Gardasil.  Concomitant therapy included "birth control pill" hormonal contraceptives (unspecified) and inhaler for asthma (therapy unspecified).  Subsequently, on an unknown date the patient had an asthma attack and also experienced flu like symptoms.  The patient had her inhaler with her and used it to stop the adverse event.  Subsequently, on an unknown date the patient recovered.  It was reported that the therapy was discontinued.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Dizziness, Epistaxis, Nausea, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 17-DEC-2007 was vaccinated with her second dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE USP). On 17-DEC-2007 the patient experienced dizziness, nausea, nose bleeding and fainted. The patient sought unspecified medical treatment. Subsequently, the patient recovered from dizziness, nausea, nose bleeding and fainting on the same day. The patient did not have an adverse event with the first dose. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Local swelling, Lymphadenopathy, Swelling face
Clinical narrative: Information has been received from a 38 year old female with a history of swollen glands every 4-8 years who on 12-DEC-2007 was vaccinated intramuscularly in the buttocks with her first dose of Gardasil (lot # unspecified).  There was no concomitant medication.  On 12-DEC-2007 the patient experienced swollen glands on her face and neck.  The patient reported that she was treated with antibiotics for her symptoms.  Subsequently, the patient recovered from swollen glands on face and neck.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning his daughter who "last week" was vaccinated with her second dose of Gardasil (lot # unspecified).  There was no concomitant medication.  Subsequently the physician reported that his daughter received the vaccination and fainted.  The shot was given by another physician at a pediatric office.  Subsequently, the patient recovered on the same day as the shot.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Tooth injury
Clinical narrative: Information has been received from a company representative concerning 3 females who were vaccinated with a dose of GARDASIL. It was reported that after receiving a dose (unspecified whether first, second or third dose) the patients fainted. It was reported that one of the patients broke her tooth when she fell. The patient's status was reported as recovered. Attempts are being made to obtain identifiable information about the individual patients. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration, Papilloma viral infection, Smear cervix
Clinical narrative: Information has been received from a 38 year old female with a history of uterine fibroids who on 31-OCT-2006 was vaccinated with the third dose of GARDASIL. The patient reported that on 27-DEC-2007 after receiving the third dose of the vaccine, she had a PAP test and HPV test done. The results of the PAP test came back negative for lesions and malignant and the test for HPV came back positive for high intermediate HPV. the consumer reported that her PAP test previous to getting the vaccine has always come back negative. The patient's status was not reported. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of near fainting who on 15-JAN-2008 was vaccinated with the third dose of GARDASIL. Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified (+) tetanus toxoid. On 15-JAN-2008 the patient experienced symptoms of fainting: everything went blank, she got sweaty and had to lie down and vomited. Subsequently, the patient recovered from fainting. The patient sought unspecified medical attention. The patient has a history of fainting while giving blood. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 15-JAN-2008 was vaccinated with the first dose of GARDASIL and experienced hives on the face and neck. As of 16-JAN-2008, the patient was recovering. Follow-up information was received from the physician's assistant who reported that the rash was probably due to exposure to something else and not related to GARDASIL.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a female who in January 2008, was vaccinated with GARDASIL. Subsequently, the patient experienced a rash. The patient sought unspecified medical attention. Additional information has been requested. 07/08/08 Additional information received 19-MAR-2008: The nurse states, "I don't remember the students name. If she comes in again I will fill out the (B) form". Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL. The physisican reported that the patient was HPV negative before the patient was vaccinated with HPV vaccine. The patient subsequently became HPV positive. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal ulceration
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil.  It was unknown which dose in the series she received.  Subsequently the patient experienced vaginal ulcers.  Unspecified medical attention was sought.  The outcome of the event was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who in 2007 was vaccinated with the first dose of GARDASIL. Per the reporter, the patient fainted after receiving the first dose of GARDASIL. The patient sought unspecified medical attention. Subsequently, the patient recovered from having fainted. No further informtion was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with Gardasil.  Concomitant therapy included tetanus toxoid in the same arm.  The patient developed a blister at the injection site.  The patient's sister also received the first dose of Gardasil and had the same adverse event (WAES #0801USA01424).  Subsequently, the patient recovered.  No further information was provided regarding this adverse experience.  This is one of several reports from the same source.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Smear cervix abnormal
Clinical narrative: Information has been received from a Registered Nurse concerning a 25 year old female who on 15-JAN-2008 was vaccinated IM with the first dose of Gardasil (Lot #659653/01448U).  Concomitant therapy included YASMIN.  The patient experienced dizziness on the afternoon of the injection (15-JAN-2008) and on the morning of 16-JAN-2008 and 17-JAN-2008.  The patient's outcome was not reported.  The patient had an abnormal PAP test (results not reported).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Yellow skin
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced pain in her abdomen and turned yellow for two weeks. The patient's outcome was not reported. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Chills, Nausea, Urinary tract disorder
Clinical narrative: Information has been received from a physisican concerning 2 patients (ages and gender unknown), who, on unspecified dates, were vaccinated with doses of GARDASIL. Subsequently, the patients experienced urinary tract problems, then later experienced chills and nausea. At the time of the report, the outcomes of the patients were unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Vaginal haemorrhage
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old female who on 26-OCT-2007 was vaccinated with her first dose of Gardasil (lot number: 658488/0930U).  On 04-JAN-2008 she was vaccinated with her second dose of Gardasil (lot number: 657868/0523U).  On approximately 10-JAN-2008, "1 week ago" the patient experienced cramps and vaginal bleeding.  The patient's cramps and vaginal bleeding persisted.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a physician concerning an 18 year old female with an allergy to chloral hydrate capsule and a history of migraine and attention deficit/hyperactivity order who on 05-SEP-2007 (lot number:0724U/657756) and 09-NOV-2007 was vaccinated with her first and second d dose of GARDASIL (lot number: 0530U) and her third dose on 16-JAN-2008. Concomitant therapy included sumatriptan (IMITREX (sumatriptan)) and ADDERALL TABLETS. On 17-JAN-2008 the patient experienced incorrect schedule and pain at injection site. The patient's incorrect schedule and pain at injection site persisted. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with first dose of Gardasil and became lightheaded.  Unspecified medical attention was sought.  Subsequently, the patient recovered from lightheadedness.  This is one of several reports received from the same source.  Additional information has been requested. 07/08/08 Follow-up information indicated request for no further contact. No additional information available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Dizziness, Haematology test, Hypotension, Nausea
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of lightheadedness and low blood pressure (February 2007) who on 10-JAN-2008 was vaccinated with the first dose of Gardasil.  Concomitant therapy included methacycline.  On 10-JAN-2008 the patient experienced lightheadedness, tunnel vision, cold sweats, nausea, lowered blood pressure, a swollen tongue and her throat started to close roughly 2 minutes after receiving Gardasil.  Subsequently, the patient recovered from lightheadedness, tunnel vision, cold sweats, nausea, low blood pressure, swollen tongue and closing throat.  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swollen tongue, Throat tightness, Tunnel vision
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of lightheadedness and low blood pressure (February 2007) who on 10-JAN-2008 was vaccinated with the first dose of Gardasil.  Concomitant therapy included methacycline.  On 10-JAN-2008 the patient experienced lightheadedness, tunnel vision, cold sweats, nausea, lowered blood pressure, a swollen tongue and her throat started to close roughly 2 minutes after receiving Gardasil.  Subsequently, the patient recovered from lightheadedness, tunnel vision, cold sweats, nausea, low blood pressure, swollen tongue and closing throat.  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood pressure decreased, Dizziness, Ear discomfort, Injection site irritation
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of lightheadedness and low blood pressure (February 2007) who on 10-JAN-2008 was vaccinated with the first dose of Gardasil.  Concomitant therapy included methacycline.  On 10-JAN-2008 the patient experienced lightheadedness, tunnel vision, cold sweats, nausea, lowered blood pressure, a swollen tongue and her throat started to close roughly 2 minutes after receiving Gardasil.  Subsequently, the patient recovered from lightheadedness, tunnel vision, cold sweats, nausea, low blood pressure, swollen tongue and closing throat.  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of lightheadedness and low blood pressure (February 2007) who on 10-JAN-2008 was vaccinated with the first dose of Gardasil.  Concomitant therapy included methacycline.  On 10-JAN-2008 the patient experienced lightheadedness, tunnel vision, cold sweats, nausea, lowered blood pressure, a swollen tongue and her throat started to close roughly 2 minutes after receiving Gardasil.  Subsequently, the patient recovered from lightheadedness, tunnel vision, cold sweats, nausea, low blood pressure, swollen tongue and closing throat.  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Dizziness, Haematology test, Hypotension, Nausea
Clinical narrative: Information has been received from a health professional concerning a 20 year old white female with no pertinent medical history or drug reactions/allergies and no illness at the time of vaccination who on 10-JAN-2008 was vaccinated with a first dose of Gardasil (lot# 659439/1267U) IM into the right deltoid at 11 AM.  There was no concomitant medication.  On 10-JAN-2008 at 11:10 AM the patient experienced swelling of tongue and throat, stomach pain, burning at the injection site, feeling dizzy, ears were burning and had a drop in blood pressure.  The patient was given a 50 mg (diphenhydramine hc1) BENADRYL IM into the left deltoid at 11:20 AM.  All adverse reactions were stopped by 11:50 AM.  The patient was released to go home at 1PM.  The patient stated she slept until 3 PM and awoke feeling great.  At the time of reporting the patient had recovered.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swollen tongue, Throat tightness, Tunnel vision
Clinical narrative: Information has been received from a health professional concerning a 20 year old white female with no pertinent medical history or drug reactions/allergies and no illness at the time of vaccination who on 10-JAN-2008 was vaccinated with a first dose of Gardasil (lot# 659439/1267U) IM into the right deltoid at 11 AM.  There was no concomitant medication.  On 10-JAN-2008 at 11:10 AM the patient experienced swelling of tongue and throat, stomach pain, burning at the injection site, feeling dizzy, ears were burning and had a drop in blood pressure.  The patient was given a 50 mg (diphenhydramine hc1) BENADRYL IM into the left deltoid at 11:20 AM.  All adverse reactions were stopped by 11:50 AM.  The patient was released to go home at 1PM.  The patient stated she slept until 3 PM and awoke feeling great.  At the time of reporting the patient had recovered.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood pressure decreased, Dizziness, Ear discomfort, Injection site irritation
Clinical narrative: Information has been received from a health professional concerning a 20 year old white female with no pertinent medical history or drug reactions/allergies and no illness at the time of vaccination who on 10-JAN-2008 was vaccinated with a first dose of Gardasil (lot# 659439/1267U) IM into the right deltoid at 11 AM.  There was no concomitant medication.  On 10-JAN-2008 at 11:10 AM the patient experienced swelling of tongue and throat, stomach pain, burning at the injection site, feeling dizzy, ears were burning and had a drop in blood pressure.  The patient was given a 50 mg (diphenhydramine hc1) BENADRYL IM into the left deltoid at 11:20 AM.  All adverse reactions were stopped by 11:50 AM.  The patient was released to go home at 1PM.  The patient stated she slept until 3 PM and awoke feeling great.  At the time of reporting the patient had recovered.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Information has been received from a health professional concerning a 20 year old white female with no pertinent medical history or drug reactions/allergies and no illness at the time of vaccination who on 10-JAN-2008 was vaccinated with a first dose of Gardasil (lot# 659439/1267U) IM into the right deltoid at 11 AM.  There was no concomitant medication.  On 10-JAN-2008 at 11:10 AM the patient experienced swelling of tongue and throat, stomach pain, burning at the injection site, feeling dizzy, ears were burning and had a drop in blood pressure.  The patient was given a 50 mg (diphenhydramine hc1) BENADRYL IM into the left deltoid at 11:20 AM.  All adverse reactions were stopped by 11:50 AM.  The patient was released to go home at 1PM.  The patient stated she slept until 3 PM and awoke feeling great.  At the time of reporting the patient had recovered.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Oedema mouth, Pharyngeal oedema
Clinical narrative: Information has been received from a pharmacist concerning an 18 year old female who on 10-NOV-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included CHEMET. The patient has been receiving CHEMET for mercury poisoning and was to complete a 2 year course of treatment. The patient had been taking CHEMET four times per day for several months without problem. On 11-NOV-2007 the patient experienced lip swelling, mouth swelling and throat swelling. The patient contacted her physician by phone and was suggested to stop the CHEMET. The patient discontinued the CHEMET and the symptoms resolved without treatment. After 3 weeks, the patient restarted taking CHEMET and the lip, mouth, and throat swelling returned the next day. The patient has discontinued CHEMET and has fully recovered. The patient will not receive further doses of Gardasil. No further information is available. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Skin laceration
Clinical narrative: Information has been received from a physician concerning approximately 14 year old female who on unspecified date was vaccinated with the first dose of Gardasil and passed out, and needed stitches on her nose, because the bridge of her glasses cut her nose.  Subsequently, the patient recovered.  This is one of several reports received from the same source.  Additional information has been requested. 07/08/08 Follow-up information indicated request for no further contact. No additional information available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who on 30-OCT-2007 was vaccinated intramuscularly with her 1st dose of Gardasil (lot # 659435/1265U).  Concomitant therapy included YAZ.  It was reported that the patient experienced pain at the injection site.  The patient's pain at the injection site persisted.  No further information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 07-DEC-2007 was vaccinated IM with the first dose of Gardasil (lot# 659437/1266U). Concomitant therapy included LOESTRIN. On 07-DEC-2007 the patient experienced pain at the injection site. Medical attention was sought. As of 21-DEC-2007 the patient's pain at the injection site persisted. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008.  Initial information has been received from a physician concerning a 15 year old female student patient who on 07-DEC-2007 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot# 659437/1266U).  Concomitant therapy included LOESTRIN.  On 07-DEC-2007 the patient experienced pain at the injection site.  Medical attention was sought.  As of 21-DEC-2007 the patient's pain at the injection site persisted.  No quality complaint was involved.  Follow-up information received from the registered nurse indicated that the patient had pain at the injection site for 2 weeks.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with an allergy to penicillin, who on 14-JAN-2008 was vaccinated with the second dose of Gardasil (lot# 655154/1210U). Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours the patient developed fever of 102F, headache, nausea, dizziness, muscle aches and low back pain. Treatment oral Benadryl every 4 hours for 48 hours. The patient was recovering, but still had some dizziness, low back pain and is tired. The patient did not experience any adverse effects after her first vaccination. Medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a health professional concerning a 21 year old female with an allergy to PENICILLIN, who on 14-JAN-2008 was vaccinated with the second dose of GARDASIL (lot# 655154/1210U).  Concomitant therapy included hormonal contraceptives (unspecified).  Three days after the vaccination the patient developed body aches, low back pain "hurts all over", fever, and dizziness.  Treatment oral BENADRYL over 4 hours for 4 hours.  The patient recovered from dizziness, low back pain, body aches, hurts all over and fever.  Initial report indicated that patient had headache and nausea and the outcome was unknown.  The patient did not experience any adverse effects after her first vaccination.  Medical attention was sought.  No product quality  compliant was involved.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with an allergy to penicillin, who on 14-JAN-2008 was vaccinated with the second dose of Gardasil (lot# 655154/1210U). Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours the patient developed fever of 102F, headache, nausea, dizziness, muscle aches and low back pain. Treatment oral Benadryl every 4 hours for 48 hours. The patient was recovering, but still had some dizziness, low back pain and is tired. The patient did not experience any adverse effects after her first vaccination. Medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a health professional concerning a 21 year old female with an allergy to PENICILLIN, who on 14-JAN-2008 was vaccinated with the second dose of GARDASIL (lot# 655154/1210U).  Concomitant therapy included hormonal contraceptives (unspecified).  Three days after the vaccination the patient developed body aches, low back pain "hurts all over", fever, and dizziness.  Treatment oral BENADRYL over 4 hours for 4 hours.  The patient recovered from dizziness, low back pain, body aches, hurts all over and fever.  Initial report indicated that patient had headache and nausea and the outcome was unknown.  The patient did not experience any adverse effects after her first vaccination.  Medical attention was sought.  No product quality  compliant was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date was vaccinated with Gardasil and experienced nausea after the 3rd dose. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Haematology test, Lymphadenopathy, Lymphoid tissue hyperplasia
Clinical narrative: Information has been received from a consumer, concerning her 20 year old daughter with a sulfonamide allergy and drug hypersensitivity to cephalosporin, who was vaccinated with the first and second dose of Gardasil (date and lot # not reported). Concomitant therapy included YASMIN. In December 2007 ("about four weeks ago"), her daughter developed swollen glands on both sides of her groin area. Diagnostic blood tests were obtained (specific test and results not provided). At the time of this report, the outcome of the event was unknown. Additional information has been requested. 02/10/2010 On 06-FEB-2008, a computed tomography (CT) scan of the abdomen and pelvis revealed subpleural reticular change in the left lower lobe of the liver, which was at the upper limits of normal, and several borderline enlarged bilateral inguinal lymph nodes, which were nonspecific. ON 07-FEB-2008, the pathology report for a left femoral lymph node exision, indicated on lymph node with reactive, lymphoid hyperplasia. Also on 07-FEB-2007, a flow cytometry immunophenotypic report indicated "no immuniphenotypic abnormalities detected." At the time of this report, the outcome fo the events was unknown.  Additional information has been requested. All available medical records will be provided upon request.
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse, via a company representative, concerning a female patient (age not reported), who in November 2007, was vaccinated with a dose, 0.5 ml, of Gardasil (lot # not reported). In December 2007, one month after vaccination, the patient developed shingles. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dry skin, Rash macular, Skin warm, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who was vaccinated with all 3 doses of Gardasil. On 05-JAN-2008, after the second dose, the patient experienced mild hives and blotches. After receiving the third dose, the patient had huge red blotches on her face that became dry and warm to the touch. As of 18-JAN-2008, the patient was recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient, who on 17-JAN-2008 was vaccinated orally with the first dose of Gardasil. On 17-JAN-2008 the patient experienced lymphadenopathy and a fever. Medical attention was sought. The patient's lymphadenopathy and fever persisted. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site scab, No reaction on previous exposure to drug, Scab
Clinical narrative: Information has been received from a consumer concerning herself with a history of infectious mononucleosis two years ago and seasonal allergies who on 21-NOV-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included LOESTRIN. On 10-JAN-2008 the patient was vaccinated with her second dose of Gardasil. After receiving the second dose in January 2008, the patient experienced scab at the injection site and scabs on her torso. The patient's scab at the injection site and scabs on her torso persisted. She indicated she did not have any adverse events after the first dose. The patient gives permission to contact her physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a health professional concerning herself who reports that every time she administered the Gardasil vaccine to a patient her lips swelled.  No other information was available and the physician can not be contacted.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Dizziness, Dyspnoea, Electrocardiogram normal, Haemoglobin decreased
Clinical narrative: Information has been received from a physician concerning a 19 year old female with anaemia who on 02-JAN-2008 was intramuscularly vaccinated with her first dose of Gardasil (lot # 659437/1266U).  On 13-JAN-2008 the patient experienced syncope.  She went to the ER and was found to be slightly anemic.  On 19-JAN-2008 the patient had an office visit and experienced shortness of breath and generally did not feel well.  Subsequently, the patient recovered from syncope but not from the shortness of breath.  Additional information has been requested. 02/10/2010 In follow up report from the doctor's office and medical record it was indicated that patient had diagnosis of sycope/near syncope on admission to ER. It occured while she was standing after taking a shower. She became nausous, dizzy and then she passed out. She had no prior history of similar problems. Her discharge diagnoses from teh mergency room was syncope vasovagal. In the emergency room laboratroy result revealed her hemoglobin was 10.9 which was low. Her blood pressure meausrment was 110/60, heart reate was 77, repiration was 10 and oral temperature as 97.3 F. She had no pain and pulse oximety was 100% in room air. Head computed axial tomographyic of brain showed no caute intracranial abnormality. Electrcardiogram showed normal sinus rhythm and was sent to her physician. All other laboratory results were within normal range. No other information was avaiable.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Loss of consciousness, Malaise, Nausea, Presyncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with anaemia who on 02-JAN-2008 was intramuscularly vaccinated with her first dose of Gardasil (lot # 659437/1266U).  On 13-JAN-2008 the patient experienced syncope.  She went to the ER and was found to be slightly anemic.  On 19-JAN-2008 the patient had an office visit and experienced shortness of breath and generally did not feel well.  Subsequently, the patient recovered from syncope but not from the shortness of breath.  Additional information has been requested. 02/10/2010 In follow up report from the doctor's office and medical record it was indicated that patient had diagnosis of sycope/near syncope on admission to ER. It occured while she was standing after taking a shower. She became nausous, dizzy and then she passed out. She had no prior history of similar problems. Her discharge diagnoses from teh mergency room was syncope vasovagal. In the emergency room laboratroy result revealed her hemoglobin was 10.9 which was low. Her blood pressure meausrment was 110/60, heart reate was 77, repiration was 10 and oral temperature as 97.3 F. She had no pain and pulse oximety was 100% in room air. Head computed axial tomographyic of brain showed no caute intracranial abnormality. Electrcardiogram showed normal sinus rhythm and was sent to her physician. All other laboratory results were within normal range. No other information was avaiable.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with anaemia who on 02-JAN-2008 was intramuscularly vaccinated with her first dose of Gardasil (lot # 659437/1266U).  On 13-JAN-2008 the patient experienced syncope.  She went to the ER and was found to be slightly anemic.  On 19-JAN-2008 the patient had an office visit and experienced shortness of breath and generally did not feel well.  Subsequently, the patient recovered from syncope but not from the shortness of breath.  Additional information has been requested. 02/10/2010 In follow up report from the doctor's office and medical record it was indicated that patient had diagnosis of sycope/near syncope on admission to ER. It occured while she was standing after taking a shower. She became nausous, dizzy and then she passed out. She had no prior history of similar problems. Her discharge diagnoses from teh mergency room was syncope vasovagal. In the emergency room laboratroy result revealed her hemoglobin was 10.9 which was low. Her blood pressure meausrment was 110/60, heart reate was 77, repiration was 10 and oral temperature as 97.3 F. She had no pain and pulse oximety was 100% in room air. Head computed axial tomographyic of brain showed no caute intracranial abnormality. Electrcardiogram showed normal sinus rhythm and was sent to her physician. All other laboratory results were within normal range. No other information was avaiable.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Inappropriate schedule of drug administration, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 17 year old female, with no pertinent medical history or drug reactions/allergies, who on 18-JAN-2008 was vaccinated with Gardasil (lot # "0972U"). The patient received her second dose of Gardasil (lot # 659653/1448U) on 17-JAN-2008, which resulted in an inappropriate schedule of vaccine administered. Concomitant therapy included hormonal contraceptives (unspecified). On 18-JAN-2008 the patient experienced fatigue and lymphadenopathy in the left supraclavicular area. The patient's fatigue and lymphadenopathy persisted. The patient was examined by the physician on 21-JAN-2008 and the lymphedematous area remained the same although the patient was less fatigued. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 18 year old female patient, who was vaccinated with the first dose of Gardasil (date, dosing details and lot # not reported), and subsequently "came down with genital warts."  The patient completed the second and third dose of the vaccination series.  At the time of this report, the outcome of the event was unknown.  The reporting physician did not feel that the genital warts were related to therapy with Gardasil.  Additional information has been requested.