chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, she developed a little bit of redness and swelling.  On 07-AUG-2007 the patient was vaccinated with a second dose of Gardasil.  Immediately following the vaccination the patient began to swell from the elbow to the shoulder.  The patient felt nauseated and faint.  The patient was treated with BENADRYL.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. Initial and follow-up information has been received from a registered nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, she developed a little bit of a reddness and swelling. On 07-Aug-2007 the patient was vaccinated with a second dose of GARDASIL. Immediately following the vaccination the patient began to swell from the elbow to the shoulder. The patient felt nauseated and faint. The patient was treated with BENADRYL. The patient sought unspecified medical attention. At the time of the report, the patient was "doing wwell." No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin negative, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 year old female patient with no medical history and no known allergies who on 21-MAR-2007, was vaccinated IM into the left deltoid with a first 0.5ml dose of Gardasil (Lot# 658490/0802U). On 24-JUL-2007, the patient was vaccinated with a second dose of the vaccine. There was no concomitant medication. On 31-JUL-2007 one week later, the patient developed hives on her legs and arms. The patient was treated with over the counter BENADRYL. On 24-JUL-2007, a urine lab was taken and was negative for pregnancy. At the time of this report, the patient was recovering. It was reported that the patient was instructed to follow up with the doctor's office if any other symptoms arose, such as shortness of breath. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Eye disorder, Uveitis
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 25-JUN-2007 was vaccinated IM in her left deltoid with the first dose of Gardasil (Lot#655617/1447F).  Concomitant therapy included MENACTRA.  A few days later on approximately 27-JUN-2007 the patient experienced weakness in her left eye.  She went to an ophthalmologist who diagnosed her with uveitis.  She was treated with "high doses" (actual doses not reported) of unspecified oral steroid.  The physician reported that at the time of the report the patient was recovering from the event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a respiratory therapist concerning a 17 year old female patient with allergies who in June 2007, was vaccinated IM with a first 0.5ml dose of GARDASIL. Concomitant therapy included ZYRTEC. Within 24 hours after administration of the vaccine, the patient developed a widespread rash. Unspecified medical attention was sought. At the time of this report, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2001. Follow up information stated the patient was referred to an allergist and allergy tests were conducted. The allergist requested a sample of GARDASIL to test to see if the patient was allergic to the product. At the time of this report, the outcome of the allergy test was not known. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a dose of Gardasil.  Concomitant therapy included "multiple vaccinations" given on the same day.  Five minutes after receiving the vaccine, the patient experienced syncope.  Unspecified medical attention was sought.  Subsequently, the patient recovered quickly.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated IM with Gardasil (Lot # not provided). Subsequently on an unknown date the patient returned to the physician's office and reported that after her vaccination she experienced headache, nausea and dizziness. At the time of the report it was not known if the patient had recovered from these events. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated with a dose of Gardasil.  Concomitant therapy included two other vaccines (therapy unspecified) in the same day of vaccination.  The patient "fainted" after receiving the Gardasil.  Unspecified medical attention was sought by the patient.  The outcome was unknown.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an 18 year old female was vaccinated with a dose of Gardasil. Concomitant therapy included four other vaccines (therapy unspecified). The physician reported that the patient passed out after receiving the dose of Gardasil. Unspecified medical attention was sought by the patient. the outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Eclampsia
Clinical narrative: Information has been received from a physician concerning a 23 year old female consumer with a history of migraine who on 26-SEP-2006 was vaccinated with a dose of Gardasil.  On 26-SEP-2006, it was found out that the patient became pregnant.  Gardasil therapy was discontinued.  On 20-JUN-2007, client gave birth to a full term live male healthy child.  Patient developed eclampsia post partum.  The patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow up information has been received for the Pregnancy Registry for GARDASIL vaccine from a physician concerning a 23 year old female house wife with anaemia and a history of migraine headaches, chickenpox and cervical dysplasia who on 26-SEP-2006 was vaccinated with a first dose of GARDASIL vaccine. Concomitant therapy included prenatal (vitamin uspecified), REGLAN and iron (unspecified). Subsequently, she became pregnant. On 29-SEP-2006 the patient experienced drug exposure during pregnancy. On 01-FEB-2007 an ultrasound was done for anatomy and fetus ratio was 0.89. On 22-JAN-2007 maternal serum alpha-fetoprotein test was done which had normal result. In 20-JUN-2007, the patient experienced post partum eclampcia and hemolysis elevated liver enzymes and low platelet count (HELLP) syndrome. Subsequently, the patient recovered from post partum eclampsia and HELLP syndrome. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Initial and follow-up information has been received from a nurse concerning several female patients who were vaccinated with doses of Gardasil. Subsequently the patients complained of burning as the Gardasil was being injected into their arms. The nurse reported that the burning has just recently been reported to her. On 27-AUG-2007 the nurse reported that she does not have the exact number of patients involved and that most patients complain about the injection. Unspecified medical attention was sought. At the time of the report the patients outcomes were unknown. 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: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 ml first dose of Gardasil. Subsequently the patient developed "swollen cherry sized lymph nodes on her right side of the body" where Gardasil was given. A complete blood count was performed, results not reported. Unspecified medical attention was sought. After six weeks the lymph nodes started to go down. At the time of the report the patient was recovering. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 ml first dose of GARDASIL. Subsequently the patient developed "swollen cherry sized lymph nodes on her right side of the body" where GARDASIL was given. A complete blood count was performed, results not reported. Unspecified medical attention was sought. After six weeks the lymph nodes started to go down. At the time of the report the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient fainted. unspecified medical attention was sought. The patient was fine after a little while, recovered and went home. The office manager reported that the office now lays down the patients while administering Gardasil and makes them stay there for at least 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced significant pain around the injection site which lasted for a week or longer after receiving the vaccine. Unspecified medical attention was sought. It was also reported that the same reaction occurred after the first dose of Gardasil. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Blood pressure abnormal, Injection site pain, Musculoskeletal stiffness, Syncope
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 21 year old female who on 04-JUN-2007 at 4:30 pm was vaccinated intramuscularly with a first dose of Gardasil (Lot#654702/0011U). After receiving her first dose she experienced severe pain at the injection site and stiffness in her left arm and neck. The patient treated herself with an unspecified hydrocortisone topical cream. On 09-JUN-2007 the patient had recovered from the event. On an unspecified date in approximately August, 2007 the patient received her second dose of Gardasil (Lot# not reported) IM and she fainted about 30 seconds later. The patient was observed for several hours. She was treated with hydration and elevation of her feet. Her blood pressure was 80/40 mm Hg after syncope and took several hours before returning to within normal range (actual measurement not reported). Subsequently the patient recovered from the event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 21 year old female who on 04-JUN-2007 at 4:30 pm was vaccinated intramuscularly with a first dose of Gardasil (Lot#654702/0011U). After receiving her first dose she experienced severe pain at the injection site and stiffness in her left arm and neck. The patient treated herself with an unspecified hydrocortisone topical cream. On 09-JUN-2007 the patient had recovered from the event. On an unspecified date in approximately August, 2007 the patient received her second dose of Gardasil (Lot# not reported) IM and she fainted about 30 seconds later. The patient was observed for several hours. She was treated with hydration and elevation of her feet. Her blood pressure was 80/40 mm Hg after syncope and took several hours before returning to within normal range (actual measurement not reported). Subsequently the patient recovered from the event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Blood pressure abnormal, Injection site pain, Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old female with a history of abnormal Papanicolaou smear in July 2007 who on 04-JUN-2007 was vaccinated IM with the first dose of Gardasil (Lot #654702/0011U).  Concomitant therapy included YASMIN.  On 04-JUN-2007 the patient experienced severe pain in her arm, unable to turn her head and troubled sleeping.  The pain lasted about 5 to 7 days.  The patient treated herself with ADVIL and did not have any other symptoms.  Medical attention was sought.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old female with a history of abnormal Papanicolaou smear in July 2007 who on 04-JUN-2007 was vaccinated IM with the first dose of Gardasil (Lot #654702/0011U).  Concomitant therapy included YASMIN.  On 04-JUN-2007 the patient experienced severe pain in her arm, unable to turn her head and troubled sleeping.  The pain lasted about 5 to 7 days.  The patient treated herself with ADVIL and did not have any other symptoms.  Medical attention was sought.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on 04-AUG-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The day after vaccination the patient experienced rash all over her body. The morning after the vaccination the patient was "itchy on her back". The patient's mother looked at her back and noticed "huge welts" along the patient's back, neck and up to her scalp. They were also located on her thighs. The patient had been taking Benadryl for her symptoms. The patient's symptoms are improving but not completely resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Heart rate decreased, Hypotension, Immediate post-injection reaction, Local reaction
Clinical narrative: Information has been received from a physician concerning a female with asthma and IgG who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced itchy local reaction. The patient received the second dose (physician believes on 06-Jul-2007) and experienced and immediate headache that was pounding and migraine like, hypotension, vomiting and a pulse in the 50s. Both doses were given by the patient's pediatrician so the reporting physician did not have any further information. Subsequently the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Pruritus, Vomiting
Clinical narrative: Information has been received from a physician concerning a female with asthma and IgG who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced itchy local reaction. The patient received the second dose (physician believes on 06-Jul-2007) and experienced and immediate headache that was pounding and migraine like, hypotension, vomiting and a pulse in the 50s. Both doses were given by the patient's pediatrician so the reporting physician did not have any further information. Subsequently the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a pharmacist concerning an 18 year old female who on 06-AUG-2007 was vaccinated with a first dose of Gardasil.  On 06-AUG-2007 the patient experienced syncope shortly after the dose was administered.  Subsequently, the patient recovered from syncope.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Head injury, Limb injury, Syncope, X-ray limb
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 02-AUG-2007 was vaccinated with Gardasil.  Concomitant therapy included meningococcal vaccine (unspecified) and VARIVAX.  On 02-AUG-2007 the patient fainted and hit her head and arm.  Medical attention was sought.  The patient was evaluated with an X-ray of her arm.  The patient recovered.  No other information was available.  The nurse also reported that their office had 4 other patients who had fainted after receiving a dose of Gardasil.  No details were available on those patients.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 06-AUG-2007 was vaccinated with a dose of Gardasil.  Concomitant therapy included MENACTRA and VARIVAX.  The patient experienced syncope after vaccination.  Within the 15 minutes of observation after vaccination the patient got dizzy.  Medical attention was sought.  Symptoms had resolved.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Cryotherapy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an approximately 21 year old female who in June 2007, was vaccinated IM with Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  Two days after receiving the first dose of Gardasil, the patient developed groin warts.  There is no known history of these warts.  The patient came back in about a month later and was given the second dose of Gardasil.  A few days after receiving the second dose, the patient had a huge outbreak of warts.  The patient was treated with cryotherapy.  The patient did not notify the physician of the warts until the second outbreak occurred.  Medical attention was sought.  The patient's outcome was not reported.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 21 year old female with no pertinent medical history, drug reactions/allergies and no illness at the time of vaccination who on 07-MAY-2007 (also reported as June 2007), was vaccinated IM in the deltoid with a first dose of GARDASIL (lot# 654272/0319U) in the evening. Concomitant therapy included hormonal contraceptives (unspecified). Two days (also reported on an unspecified date in May 2007) after receiving the first dose of GARDASIL, the patient developed groin warts (also reported as vulvar warts). There is no known history of these warts. The patient came back in about a month later (also reported as 09-JUL-2007) was given the second dose of GARDASIL (657868/0523U) IM. A few days after receiving the second dose, the patient had a worse outbreak of warts. The patient was treated with cryotherapy. The patient did not notify the physician of the warts until the second outbreak occurred. Medical attention was sought. The patient's outcome was not reported. In August 2007, the patient had recovered within 2 weeks post treatment. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced fever and aches.  The patient's outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Sunburn
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the third dose of GARDASIL.  Subsequently the patient experienced swelling at the injection site about the size of a silver dollar.  There was no redness or itching.  The patient reported getting sunburn shortly after receiving the vaccination, after which the swelling appeared.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. There was increased redness and pain after a week. The patient reported getting sunburn shortly after receiving the vaccination, after which the swelling appeared. The patient denied a fever or streaking. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 16-JAN-2007 was vaccinated with the first dose of Gardasil.  The patient received the second dose on 13-MAR-2007 and the third dose on 06-AUG-2007.  On 06-AUG-2007, after receiving the third injection of Gardasil, the patient passed out for about 10 seconds.  The patient recovered the same day.  The patient did not experience the same event after the first two doses.  Medical attention was sought.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 04-JUN-2007 was vaccinated with the first dose of Gardasil (lot # 653736/0868F) injection.  There was no concomitant medication.  On 04-JUN-2007, the patient experienced a vasovagal reaction.  After receiving the vaccination, the patient sat for a while, and then when she got up, the patient started to get pale and light headed.  The patient laid down, was given fluids, and had her blood pressure taken.  After that the patient was fine and was able to leave.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 15 year old female who on 22-June-2007, was vaccinated in the right deltoid with a first dose of Gardasil (Lot #0211U), concomitantly with BOOSTRIX.  On 22-JUN-2007 the patient fainted.  It was reported that the patient came out of the room and stated "grandma" and went down on the floor.  The patient was treated with something to eat and drink for 1/2 hour.  It was reported that the patient had nothing to eat or drink since the night before.  On 22-JUN-2007 the patient recovered.  Medical attention was sought.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female who was vaccinated with Gardasil.  Concomitant therapy included MENACTRA, BOOSTRIX and YASMIN.  On 02-AUG-2007 the patient fainted.  Medical attention was sought.  The patient recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a medical assistant concerning her patients who were vaccinated with a dose of GARDASIL.  Subsequently the patients experienced pain.  The patient recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a female (age unknown) with a history of negative Pap test, who was vaccinated with a first dose of Gardasil.  Subsequently, the patient's Pap test was positive for HPV.  Prior to the vaccination the patient's Pap test was negative for HPV.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Fall, Head injury, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 06-AUG-2007 was vaccinated IM with a first dose of Gardasil (lot # "0929U").  Immediately after the vaccination the patient fainted and "fell off the exam table and hit her head and in doing so bruised her knees."  The patient was "out" for a long time.  On 06-AUG-2007 the patient recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 30-JUL-2007 was vaccinated with a first dose of Gardasil.  On 02-AUG-2007 the patient experienced swollen eye and welts developed all over her body.  Medical attention was sought.  The patient recovered from swollen eye and welts developed all over her body.  Additional information has requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced flu like symptoms and nausea.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 21 year old female student with an allergy to sulfa, who on 03-Aug-2007 was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (Lot # 0469U). On 06-Aug-2007 the patient experienced flu like symptoms, nausea, a severe headach, malaise, swollen glands, and a fever. The patient sought unspecified medical attention. A strip screen was performed (results unknown). On 10-Aug-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with acne and no known drug allergies and a history of spinal meningitis at 6 months old who on 06-AUG-2007 was vaccinated with a second dose of Gardasil.  Concomitant therapy included ACCUTANE.  It was reported that RETIN-A, AMOXIL and a topical medication for acne were discontinued when ACCUTANE was started.  On 06-AUG-2007 the patient experienced generalized itching and hives over most of her body.  The patient sought unspecified medical attention.  It was noted that on 04-JUN-2007 the patient received her first dose of Gardasil  (Lot # 657868/0523U) and MENACTRA with no reaction noted.  No laboratory diagnostic studies were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning teenaged patients (gender not specified), who were vaccinated on unknown dates, with a dose of Gardasil (lot # not reported).  The CMA reported that the "every young teenager" that had the vaccine administered complained that the medicine burned (no further details provided).  At the time of this report, it was unknown if the patients recovered.  The CMA reported an additional female patient experienced the "medicine burned" when vaccinated with Gardasil (lot # not reported) (WAES #0708USA00619).  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) with a history of mononucleosis who in June 2007, was vaccinated with a first dose of Gardasil.  Subsequently, between the first and second dose of Gardasil (second dose yet to be given) the patient developed mononucleosis.  It was also reported that there "no adverse symptoms."  The patient sought unspecified medical attention.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who, on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (Lot # unavailable). Subsequently, on an unspecified date the patient experienced fatigue after receiving Gardasil. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Diabetes mellitus
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a 12 year old female patient, who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot # 655205/1426F).  There was no concomitant medication.  Subsequently the patient developed diabetes, sometime "after 03-APR-2007."  At the time of this report, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a healthcare professional (immunization coordinator), via a company representative, concerning a 20 year old female patient, who on 03-APR-2007 was vaccinated with the second dose of Gardasil (Lot # not provided).  On 03-AUG-2007, while the vaccine was being administered, the patient experienced tingling and numbness.  On 07-AUG-2007, the patient reported that the pain had increased at the injection site and she was now having difficulty lifting her arm.  She was instructed to take ADVIL three times daily for the pain, to apply ice or heat to the arm, and to come for a visit if there was no improvement.  At the time of this report, the patient had not recovered from the events.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diabetes mellitus
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who was vaccinated with a dose of Gardasil (Lot # 654741/1208F).  Concomitant therapy included FLOXIN, amoxicillin and albuterol.  Subsequently the patient developed diabetes.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nasal congestion, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who was vaccinated with a dose of Gardasil.  Subsequently, the patient developed a fever of 102-103 that was unable to be broken.  The patient also had a stuffy nose.  The fever lasted 3-5 days.  At the time of the report the patient's outcome of stuffy nose was unknown.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history who on 09-JAN-2007 was vaccinated in the hip area with a first dose of Gardasil.  On an unspecified date the patient was vaccinated in the hip area with a second dose of Gardasil.  On approximately 12-JUL-2007 the patient was vaccinated intramuscularly in the arm with 0.5 ml third dose of Gardasil (658094/0524U).  There were no concomitant medication.  On approximately 12-JUL-2007 the patient developed, "tenderness and swelling that formed a hard knot at the injection site".  On 10-AUG-2007 the nurse reported that that patient still had the "knot" in her arm, swelling, and pain.  The patient had been on steroids but there was still no improvement.  There were no laboratory or diagnostic tests performed.  At the time of the report the patient had recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with a history of insect bite allergy who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (lot # unknown) IM.  On 18-JUL-2007 the same night as the vaccination the patient developed a fever.  On 20-JUL-2007 "about 2 days after vaccination", the patient went swimming and broke out into a "rash with hives".  Medical attention was sought.  The patient went to her physician where they believed the event was related to ant bites and treated the patient with steroids (therapy unspecified).  After the treatment was completed there was a reoccurrence of hives.  The outcome of the fever was not reported and patient's rash with hives persisted.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL.  Concomitant therapy included NUVARING.  On 16-JUL-2007 the patient experienced arm "full of pain".  There was no redness or itching.  The patient's arm "just hurts really badly."  Unspecified medical attention was sought.  The patient's arm "full of pain" persisted.  Additional information has been requested. This is in follow-up information has been received from a registered nurse and a health care professional concerning a 21 year old female with no medical history, who on 16-JUL-2007 was vaccinated IM in the right deltoin with a first dose of GARDASIL vaccine (previously reported as lot # 657868/0523U). Concomitant therapy included NUVARING. On 16-JUL-2007 the patient experienced arm "full of pain". There was no redness or itching. The patients arm "just hurts really badly." On 08-AUG-2007 the patient's mother called the office and reported that the patient complained of a sore arm for two weeks and denied redness of lump. The office prescribed ice and ADVIL. The patient recovered on an unspecified date. On 16-SEP-2007 the patient received the second dose of GARDASIL without incidents. The patient was advised to call office. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Injected limb mobility decreased, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with allergy to metals who on 30-JUL-2007 was vaccinated IM with a dose of Gardasil (lot # 657737/0522U).  Concomitant therapy included ZOLOFT and hormonal contraceptives (unspecified).  Within 12 hours of the vaccination, the patient experienced arm pain in the arm she was vaccinated in .  The nurse practitioner reported that over the next 8 days the pain was progressively worse and the arm pain and spread up to her shoulder.  She had difficulty lifting her arm and difficulty lifting her infant child.  On 07-AUG-2007 the patient was seen in the clinic.  The patient had a fever of 99 degrees, swelling and warmth around the injection site.  The patient was treated tin antimicrobial (unspecified) and ibuprofen.  On 09-AUG-2007 the patient recovered from the warmth around the injection site and all other symptoms had persisted.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with allergy to metals who on 30-JUL-2007 was vaccinated IM with a dose of Gardasil (lot # 657737/0522U).  Concomitant therapy included ZOLOFT and hormonal contraceptives (unspecified).  Within 12 hours of the vaccination, the patient experienced arm pain in the arm she was vaccinated in .  The nurse practitioner reported that over the next 8 days the pain was progressively worse and the arm pain and spread up to her shoulder.  She had difficulty lifting her arm and difficulty lifting her infant child.  On 07-AUG-2007 the patient was seen in the clinic.  The patient had a fever of 99 degrees, swelling and warmth around the injection site.  The patient was treated tin antimicrobial (unspecified) and ibuprofen.  On 09-AUG-2007 the patient recovered from the warmth around the injection site and all other symptoms had persisted.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on 08-AUG-2007 was vaccinated IM with a first dose of Gardasil.  Concomitant therapy included Vaqta (MSD), Varivax (MSD), MENACTRA, and Tdap.  On 08-AUG-2007 the patient experienced "dizziness".  Subsequently, the patient recovered from dizziness on 08-AUG-2007.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately 2006, about a year ago, was vaccinated IM with a first dose of Gardasil. In approximately 2006, about a year ago, the patient fainted in the office. No medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who on an unknown date was vaccinated with a dose, 0.5ml, of Gardasil (Lot # not provided).  After the vaccination, the patient experienced "dizziness for only a moment."  At the time of this report, the patient had recovered from the event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 01-AUG-2007 "about a week ago", was vaccinated IM with a dose of Gardasil.  It was reported that other vaccinations were given within the same visit but specifics were unknown.  About a week ago, the patient fainted in the office.  No medical attention was sought.  Before leaving the office, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician, concerning a female patient (born in 1989), who on 18-JUL-2007 was vaccinated with a dose of Gardasil (lot # not reported).  On 19-JUL-2007, she went swimming, and "developed bumps on her body and a rash," and also a fever (date of onset not specified).  Treatment for the rash involved unspecified steroids, and the rash resolved; however, the rash returned after the steroids were stopped.  The steroid treatment was restarted.  At the time of this report, the outcome of the fever was unknown, and the outcome of rash was not recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning his 19 year old daughter with no medical history or allergies who in February 2007, was vaccinated IM with a first 0.5ml dose of Gardasil.  On 06-AUG-2007, the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified) and on 02-AUG-2007, an allergy shot was given.  About 1 hour after receiving her third dose of the vaccine, the patient experienced nausea, vomiting, arthralgia and myalgia.  It was reported that the patient stated this dose was administered higher on her arm than the last two doses and it hurt a lot more than the other doses.  She did not have any other symptoms.  Unspecified medical attention was sought.  The patient was treated with an anti-emetic medication and TYLENOL or ibuprofen for the pain.  No laboratory diagnostic studies were performed.  On 07-AUG-2007, the physician spoke to the patient and it was reported that she was doing slightly better.  No product quality complaint was involved.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient with an allergy to VICODIN which caused tachycardia who on approximately 08-JUL-2007 "about 1 month ago", was vaccinated with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). "Two days after the vaccination", the patient experienced an exacerbation of her psoriasis. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician, concerning a 25 year old female patient, with no history of a reaction when vaccinated with the first dose of Gardasil, who on 07-AUG-2007 was vaccinated IM in the right arm, with the second dose, 0.5ml, of Gardasil (Lot #658219/0680U).  There was no concomitant medication.  On 08-AUG-2007, the patient reported she had been experiencing nausea.  At the time of this report, the patient had not recovered from the event.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning an approximately 14 year old ("14 or 15" years), female patient, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not provided), and subsequently fainted. At the time of this report, the patient had recovered from the event (date and duration not specified). The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Pharyngolaryngeal pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a physician and a healthcare professional (HCP), via a company representative, concerning a 16 year old female student, with no pertinent medical history and no known allergies, who on 19-JUL-2007 was vaccinated IM, with the first dose of GARDASIL (Lot # 658100/0525U).  Other unspecified vaccinations were given on the same day. On 19-JUL-2007, following the vaccination, the patient reported she felt dizzy and had throat pain.  Subsequently, the patient recovered from the events (date and duration not specified).  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female who was vaccinated with a 0.5 ml first dose of Gardasil. Subsequently the patient developed "a little rash on the opposite arm (not the injection site arm)". Subsequently the patient recovered. On an unspecified date, the patient was vaccinated with the second dose of Gardasil. The physician assistant reported that the patient did not have a reaction after the second dose of Gardasil. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Fall, Head injury, Heart rate, Loss of consciousness
Clinical narrative: Initial and follow up information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 20-JUL-2007, at 11:35 AM was vaccinated IM in to left deltoid with the first dose of Gardasil lot # 658094/0524U. On 20-JUL-2007, following the vaccination, the patient experienced syncope, as she "fainted and hit her head." In follow up it was reported that the patient left room to check out and passed out hitting head on floor. The physician and several people heard the sound. The physician immediately ran to assess patient. Cool wash rag applied to patient's forehead and blood pressure was checked which was stable. On 20-JUL-2007, at 11:40 AM blood pressure was 120/82 and heart rate was 78. At 11:45 B/P was 118/76 and pulse was 72. at 11:50 AM the B/P was 120/74 and pulse was 76. The physician evaluated patient's head. At the time of this report, she had recovered from the events (duration and date not specified). Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial and follow up information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 20-JUL-2007, at 11:35 AM was vaccinated IM in to left deltoid with the first dose of Gardasil lot # 658094/0524U. On 20-JUL-2007, following the vaccination, the patient experienced syncope, as she "fainted and hit her head." In follow up it was reported that the patient left room to check out and passed out hitting head on floor. The physician and several people heard the sound. The physician immediately ran to assess patient. Cool wash rag applied to patient's forehead and blood pressure was checked which was stable. On 20-JUL-2007, at 11:40 AM blood pressure was 120/82 and heart rate was 78. At 11:45 B/P was 118/76 and pulse was 72. at 11:50 AM the B/P was 120/74 and pulse was 76. The physician evaluated patient's head. At the time of this report, she had recovered from the events (duration and date not specified). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil.  A few minutes after vaccination the patient felt dizzy and nauseous.  Unspecified medical attention was sought.  On 08-AUG-2007, the patient recovered.  No further information is available.