chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced erythema, edema and tenderness over that "took up her whole deltoid region". The reporter felt that erythema, edema and tenderness over that  took up her whole deltoid region were not related to therapy with GARDASIL. Per the reporter, the patient also had this experience with the first dose of GARDASIL. The patient will not receive the third dose. No further information was provided. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a nurse concerning a 16 week patient who on 09-JAN-2008 was vaccinated with the first dose of Rotateq.  The patient is not experiencing any known symptoms.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who on 11-DEC-2007 was vaccinated intramuscularly with a 0.5ml first dose of Gardasil.  Concomitant vaccinations included MENACTRA administered in the other arm.  On 11-DEC-2007 the patient experienced pain, redness, and swelling at the injection site.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Pain in extremity, Sleep disorder
Clinical narrative: Information has been received from a published newspaper article concerning an unspecified number of female patients (ages unknown), who on unspecified dates, were vaccinated with doses of GARDASIL. It was reported that the patients experienced short-lived pain and reacted with a "little more than a grimace." Some of the patients also reported that it was "uncomfortable driving with or sleeping on the injected arm for up to a day after getting the shot." At the time of the report, the outcome of the patients were unknown. No further information is avaiable
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pain
Clinical narrative: It was reported in an internet news article that an 18 year old female was vaccinated with Gardasil. In the article an infectious disease expert stated that "this vaccine stings a lot". The 18 year old college freshman consumer reported "it sure does". "She said other shots tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in". She further stated, "it burns". The consumer felt that the pain and burn was related to therapy with Gardasil. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female not pregnant and with no known medical history who on 22-SEP-2007 was vaccinated with the second 0.5 mL dose of Gardasil (lot # 659439/1267U).  There was no concomitant medication.  On 27-DEC-2007 the patient experienced hives and redness on her skin.  Subsequently, the patient recovered from hives and redness on her skin.  No laboratory diagnostic tests were performed.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a nurse practitioner concerning a 13 year old female not pregnant and with no known medical history who on 22-SEP-2007 was vaccinated with the second 0.5 mL dose of GARDASIL (lot # 658439/1267U). There was no concomitant medication. On 27-DEC-2007 the patient experienced hives and redness on her skin. subsequently, the patient recovered from hives and redness on her skin. No laboratory diagnostic testes were performed. Follow up information was received. The health care professional reported that the now 14 year old female patient with no medical conditions reported and no known drug allergies was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 659419/1267U). On 27-DEC-2007 the patient was vaccinated IM in the right arm with the second dose of GARDASIL (lot # 659039/1237U). Concomitant therapy included YAZ and BACTRIM. On 27-DEC-2007 the patient experinced hives and redness on her skin. On 28-DEC-2007 the patient experienced whelps all over her body that itched. The patient was treated with BENADRYL oral for a few days and rash subsided. No hospialization was required. It was reported that currently there are no problems. The patient recovered on an unspecified date. It was also reported that the patient had no reaction with the first injection of GARDASIL (lot # 659419/1267U). No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who was vaccinated with a dose of Gardasil. Subsequently, the patient fainted. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Antiphospholipid antibodies negative, Arthritis, Arthritis, Fatigue, Influenza like illness
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with the second dose of Gardasil. Subsequently the patient experienced arthritis-type symptoms and joint inflammation. Per the reporter, the patient "visited a rheumatologist and tests had been done, but all came back negative." The patient was a "long distance runner." No further information was provided and no lot number was given. Additional information received 09-JAN-2008: Per the reporter, the patient "a college student and long-distance runner - was vaccinated intramuscularly with the second dose of Gardasil on 12-OCT-2007. Approximately 24 hours after the dose she began to experience "flu-like symptoms, including feeling achy and tired." Then approximately 2 weeks after the dose, she began to experience joint swelling and inflammation. The patient was seen by a rheumatologist in December and so far all tests have been negative (lupus negative). The patient will again follow-up with the rheumatologist on 21-JAN-2008. Additional information has been requested. 02/10/2010 Follow up information was received on 13-Feb-2007 from the company representative reporting that the patient had a positive result for parvovirus and itwas believed that her joint symptoms were related to this diagnosis and not the vaccination with GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Pain
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with the second dose of Gardasil. Subsequently the patient experienced arthritis-type symptoms and joint inflammation. Per the reporter, the patient "visited a rheumatologist and tests had been done, but all came back negative." The patient was a "long distance runner." No further information was provided and no lot number was given. Additional information received 09-JAN-2008: Per the reporter, the patient "a college student and long-distance runner - was vaccinated intramuscularly with the second dose of Gardasil on 12-OCT-2007. Approximately 24 hours after the dose she began to experience "flu-like symptoms, including feeling achy and tired." Then approximately 2 weeks after the dose, she began to experience joint swelling and inflammation. The patient was seen by a rheumatologist in December and so far all tests have been negative (lupus negative). The patient will again follow-up with the rheumatologist on 21-JAN-2008. Additional information has been requested. 02/10/2010 Follow up information was received on 13-Feb-2007 from the company representative reporting that the patient had a positive result for parvovirus and itwas believed that her joint symptoms were related to this diagnosis and not the vaccination with GARDASIL. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RV5
Symptoms: Dyspnoea, Gastroenteritis viral, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 week female who on 16-NOV-2007 was vaccinated with the second of ROTATEQ. Concomitant therapy included DTap-Hib (OMPC) (manufacturer unknown), poliovirus vaccine and pneumococcal vaccine (unspecified). On 19-NOV-2007 or 20-NOV-2007, the patient experienced vomiting episode and right after vomiting shortness of breath. The patient was sent to the emergency room and was informed that she had a stomach virus. Patient was stop breast feeding afterwards. Subsequently, the patient recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Full blood count normal, Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no drug reaction/allergies who in November 2007, was vaccinated IN in the hip with the first 0.5 mL Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 28-DEC-2007, the patient was vaccinated IM in the hip with the second 0.5 mL Gardasil.  On unspecified date after each vaccination, the patient developed enlarged lymph nodes in the groin.  A complete blood count with results within normal limits was performed.  The patient's status was not reported.  There was no product quality complaint involved.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who on 04-DEC_2007 was vaccinated with the first dose of Gardasil. On approximately 04-JAN-2008 the patient experienced extreme pain on the deltoid area. As of 04-JAN-2007, the patient was recovering from extreme pain on the deltoid area. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Influenza, Muscle spasms
Clinical narrative: Information has been received from a 24 year old female with no pertinent medical history and no known allergies who on 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM.  Concomitant therapy included a tetanus shot in the opposite arm.  On 31-DEC-2007 the patient felt nauseous and had a pain in her arm.  On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in.  Unspecified medical attention was sought.  As of 04-JAN-2008, the patient's arm was "kind of tingly and numb" and she reported she was recovering.  Additional information has been requested. 04/07/2008 Information has been received from a 24 year old female (117 lbs.. 53 in.) with chronic perennial allergic rhinitis who on 31-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot #659055/1522U) 0.5 mL IM. Concomitant therapy included a tetanus shot in the opposite arm. On 31-DEC-2007 the patient felt nauseous and had a pain in her arm. On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in. Unspecified medical attention was sought. As of 04-JAN-2008, the patient's arm was "kind of tingly and numb" and she reported she was recovering. Follow-up information received from the physician reported that the patient reported arm pain, nausea, chills and sweats on 02-JAN-2008. The patient's outcome was not reported. No further information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 24 year old female with no pertinent medical history and no known allergies who on 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM.  Concomitant therapy included a tetanus shot in the opposite arm.  On 31-DEC-2007 the patient felt nauseous and had a pain in her arm.  On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in.  Unspecified medical attention was sought.  As of 04-JAN-2008, the patient's arm was "kind of tingly and numb" and she reported she was recovering.  Additional information has been requested. 04/07/2008 Information has been received from a 24 year old female (117 lbs.. 53 in.) with chronic perennial allergic rhinitis who on 31-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot #659055/1522U) 0.5 mL IM. Concomitant therapy included a tetanus shot in the opposite arm. On 31-DEC-2007 the patient felt nauseous and had a pain in her arm. On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in. Unspecified medical attention was sought. As of 04-JAN-2008, the patient's arm was "kind of tingly and numb" and she reported she was recovering. Follow-up information received from the physician reported that the patient reported arm pain, nausea, chills and sweats on 02-JAN-2008. The patient's outcome was not reported. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Deep vein thrombosis, Drug exposure during pregnancy, Incorrect route of drug administration, Injection site pain, Thrombosis
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced pain when receiving the vaccine and subsequent doses were given in the buttocks. Medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested. 03/25/2010 The patient's date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the nubmer of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient's pregnancy was unknown. Follow-up information was received from the nurse practioner. The patient was administerd GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknwon.  Follow up information was received from the physician's office via phone. THe patient's name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failed to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 10-JUN-2007 the patient was given nitrofurantoin (MACROBID) 100mg BID for 7 days for UTI, enoxaparin sodim (LOVENOX)1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site anaesthesia, Injection site pain, Sleep disorder
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no known allergies and no reported medical history who in December 2007, was vaccinated with her second dose of 0.5 ml GARDASIL intramuscularly. There was no concomitant medication. The patient experienced pain in her arm at the injection site. The patient couldn't sleep following the injection due to the numbness and tenderness in her arm. The patient experienced the conditions after the first and second dose of GARDASIL. The second was given in DEC-2007. There was no lot number provided. No additional information was provided. This is one several reports received from the same source. Additional information has been requested. 02/10/2010 Follow up information was received from the physician. It was reported that it's been approimately 6 months and the patient still gets sharp pains on the area that she received the shots. The pain usually lasts for about 2-3 minutes, but they occur often, 2-3 times per day. The patient has recovered from the soreness, tenderness, redness and numbness, the outcoome of sharp pain the in the arm is unknown.  This is one of several reports received from the same source. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Nausea
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no medical history and no known allergies who on 21-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (Lot #659441/1446U). There was no concomitant medication. On 23-DEC-2007 the patient's mother called the nurse practitioner and reported that her daughter woke up that morning with pain over her left eye and nausea. No laboratory diagnostic studies were performed. On 27-DEC-2007, the patient's mother called again and stated that the symptoms had resolved. No product quality complaint was involved. Additional information has been requested. 02/12/2010 Follow up information from the registred nurse indicated that the patient had received a second dose of GARDASIL on 10-MAR-2008 and experienced no adverse symptoms. No product quality compliant was involved.  Additonal information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with no medical history who in December 2007, was vaccinated with a 0.5 ml first dose GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On the day the shot was given, the patient experienced severe nausea and diarrhea for four days. No diagnostic laboratory studies were performed. The patient did not seek medical attention. About 5 days after receiving the shot, the patient recovered. No PQC was involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 2-month-old female with no medical history or allergies who on 11-JAN-2008 was vaccinated PO with a dose of ROTATEQ (Lot #658383/1389U). There was no concomitant therapy. The CMA reported that on 11-JAN-2008 the patient vomited right after the dose of  ROTATEQ was given. The patient was seen in the office and no other symptoms were noted. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested. Follow-upinformation received 06/18/2008 the patient projectile vomited right after the dose of rotavirus was given on 11-JAN-2008. No additional information is expected.
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: Information has been received from a health professional concerning a female infant who was vaccinated with a dose of ROTATEQ. Subsequently the patient spit up. No product quality complaint was involved. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a physician concerning a 26 day old child who on 15-JAN-2008 was vaccinated with a first dose of ROTATEQ. The physician reported that the patient was not experiencing any known symptoms. There was no product quality complaint. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a physician concerning a female who at approximately 8 weeks of age. On 08-NOV-2007, was vaccinated with a first dose of ROTATEQ. The patient was vaccinated with a second dose of ROTATEQ on 03 JAN 2008, followed by a third dose on 16 JAN 2008. The physician noted that there were no problems reported. There was no product quality complaint. Additional information is not expected.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 36 week old patient who was vaccinated PO with dose three of ROTATEQ. No symptoms were noted. There was no product quality complaint. Additional informtion has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning an approximately 6 month old patient who on 17-JAN-2008 was vaccinated at the physician's office with the second dose of ROTATEQ 4 months after the first dose (at 2 months of age) to complete the series. No adverse experience was related to this event. There was no product quality complaint. No further information is available.
Sex: U
Vaccine: RV5, UNK
Symptoms: Culture stool, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with three doses of ROTATEQ. The physician stated that the patient experienced mild diarrhea after receiving the first and second doses of ROTATEQ. Third dose of ROTATEQ was administered with "other vaccines" who was still experiencing mild diarrhea at the time of vaccination. The patient sought medical attention through an office visit. A stool sample was performed. The patient was not recovered at the time of this report. There was no product quality complaint. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced diarrhea. The patient sought unspecified medical attention. The outcome was unknown. It was noted that the dates of the first and second doses were unspecified. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nervousness, Palpitations
Clinical narrative: Information has been received from a nurse concerning a 25 year old female with no medical history or drug allergies who on 26-DEC-2007 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot *659441/1446U). There was no concomitant medication. The patient called the office and reported that on 26-DEC-2007 she felt shaky, lightheaded and like her heart was racing. The symptoms lasted several days and the patient went to the emergency room. The ER stated that her vital signs were all normal and the patient was sent home. No other laboratory diagnostic studies were performed. On 31-DEC-2007, the patient recovered. No PQC was involved. Additional information has been requested. 02/12/2010 Follow up was received from a nurse practioner who reported that she hasn't had any patient's with adverse experiences.  Additional informations has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 25 year old female patient, who on 10-DEC-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot # nor reported). There was no concomitant medication. On the same day, the patient developed a lump at the injection site. At then time of this report, the outcome of the event was unknown. The patient sought out unspecified medical attention. Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a physician, concerning a 25 year old female patient, an office manager, with a penicillin allergy, who on 10-DEC-2007, at 5:10 pm, was vaccinated in the right deltoid muscle with the first dose, 0.5 ml, of GARDASIL (lot # 657868/0523U). There was no concomitant medication. There was no illness at the time of vaccination. At 11:00 that night, the patient had developed a slight lump at the injection site, that "was a little tender". After approximately 2 weeks, the symptoms had resolved. The patient intended to pursue the second vaccination with GARDASIL. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 12-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# 655154/1210U) IM. On an unspecified date the patient experienced "pain in her arm ever since her first vaccination". It was reported that when the patient visited the office to receive her second dose, this is when the patient informed the physician of the problems she was having from her first dose of GARDASIL. At the time of reporting the patient had not recovered. On 03-JAN-2008, the patient was vaccinated with her second dose of GARDASIL. No further information has been provided.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Biopsy, Rash generalised, Wrong technique in drug usage process
Clinical narrative: Information has been received from a female nurse who on 13-FEB-2007 vaccinated herself with a first dose of GARDASIL into the buttocks. On approximately 20-FEB-2007 the patient developed a bad rash which were "raised bumps on her arms, legs, her trunk and everywhere else besides her face." She went to a dermatologist who took a biopsy of the bumps and told her it was an auto immune response to the vaccine. In April 2007, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue
Clinical narrative: Information has been received from a health professional concerning a 23 year old female patient who in November 2007, 2 months ago, was vaccinated with a second dose of Gardasil.  In November 2007, a few hours after the second dose was given, the patient felt weak and tired.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 22 year old white female with a history of mild asthma who on 28-DEC-2007 was vaccinated with a second dose of Gardasil (lot# 658563/1063U) IM in the left deltoid.  There was no concomitant medication.  On 30-DEC-2007 the patient noted itching at the site.  On 02-JAN-2008, the patient noted pain with movement of the left arm and swelling.  The patient called the office on 03-JAN-2008.  The patient was seen the same day and there was no redness.  The patient had a 2-3 cm subcutaneous mass at the injection site.  Medical attention was sought.  The patient was treated with diphenhydramine hcl (BENADRYL) and warm soaks.  No further information was provided.  The patient recovered on 14-JAN-2008.  It was recommended that there was no third injection to be administered.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Erythema, Lymphomatoid papulosis, Neurological examination, Neurological symptom
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who in January 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified) with her second dose of GARDASIL. The mother is reporting that her daughter received all 3 doses of GARDASIL (on schedule) an developed neurological symptoms. Medical attention was sought. She does not remember when the symptoms began. Initially the daughter's left toes became swollen, red and tingly which lasted for 2 to 3 days. On 07-JUN-2007, the patient woke up with a tingly sensation of her left leg from her knee to her ankle. There was also a pimple-like bump on her leg which she thought was a spider bite. Since that day her leg has worsened. If the daughter gets generalized goosebumps on her body, they do not appear on that area of her leg. The patient cannot feel hot or cold sensations of that area and she cannot wear flip-flops because her toes cannot hold onto them. The bump was diagnosed as lymphomatoid papulosis. On 09-JAN-2008, the patient will also be going to a neurological center. At the time of reporting the patient had not recovered. No other details were given. On an unspecified date 3 magnetic resonance imaging test and a neurological examination was also performed. Additional information has been requested.  10/31/08 Reviewed dermatology, heme/onc & neuro clinic records of 12/12/07-7/14/2008. FINAL DX: LyP, lymphomotoid papulosis & cutaneous mononeuropathy LLE. Records reveal patient experienced skin lesions/eruptions since 6/2007 w/left LE swelling, numbness, pain, burning sensation, poor appetite & intermittent diplopia on meds w/15# weight loss.  Tx w/steroids w/o improvement then methotrexate which did provide relief but when tapered off, lesions recurred.  Exam in 12/07 revealed chickenpox-like skin lesions, papular & crusted. Biopsy done.  Began UVB phototherapy.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Oedema peripheral, Paraesthesia, Rash, Sensory disturbance
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who in January 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified) with her second dose of GARDASIL. The mother is reporting that her daughter received all 3 doses of GARDASIL (on schedule) an developed neurological symptoms. Medical attention was sought. She does not remember when the symptoms began. Initially the daughter's left toes became swollen, red and tingly which lasted for 2 to 3 days. On 07-JUN-2007, the patient woke up with a tingly sensation of her left leg from her knee to her ankle. There was also a pimple-like bump on her leg which she thought was a spider bite. Since that day her leg has worsened. If the daughter gets generalized goosebumps on her body, they do not appear on that area of her leg. The patient cannot feel hot or cold sensations of that area and she cannot wear flip-flops because her toes cannot hold onto them. The bump was diagnosed as lymphomatoid papulosis. On 09-JAN-2008, the patient will also be going to a neurological center. At the time of reporting the patient had not recovered. No other details were given. On an unspecified date 3 magnetic resonance imaging test and a neurological examination was also performed. Additional information has been requested.  10/31/08 Reviewed dermatology, heme/onc & neuro clinic records of 12/12/07-7/14/2008. FINAL DX: LyP, lymphomotoid papulosis & cutaneous mononeuropathy LLE. Records reveal patient experienced skin lesions/eruptions since 6/2007 w/left LE swelling, numbness, pain, burning sensation, poor appetite & intermittent diplopia on meds w/15# weight loss.  Tx w/steroids w/o improvement then methotrexate which did provide relief but when tapered off, lesions recurred.  Exam in 12/07 revealed chickenpox-like skin lesions, papular & crusted. Biopsy done.  Began UVB phototherapy.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Blood test, Computerised tomogram, Diagnostic procedure, Gait disturbance
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who in January 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified) with her second dose of GARDASIL. The mother is reporting that her daughter received all 3 doses of GARDASIL (on schedule) an developed neurological symptoms. Medical attention was sought. She does not remember when the symptoms began. Initially the daughter's left toes became swollen, red and tingly which lasted for 2 to 3 days. On 07-JUN-2007, the patient woke up with a tingly sensation of her left leg from her knee to her ankle. There was also a pimple-like bump on her leg which she thought was a spider bite. Since that day her leg has worsened. If the daughter gets generalized goosebumps on her body, they do not appear on that area of her leg. The patient cannot feel hot or cold sensations of that area and she cannot wear flip-flops because her toes cannot hold onto them. The bump was diagnosed as lymphomatoid papulosis. On 09-JAN-2008, the patient will also be going to a neurological center. At the time of reporting the patient had not recovered. No other details were given. On an unspecified date 3 magnetic resonance imaging test and a neurological examination was also performed. Additional information has been requested.  10/31/08 Reviewed dermatology, heme/onc & neuro clinic records of 12/12/07-7/14/2008. FINAL DX: LyP, lymphomotoid papulosis & cutaneous mononeuropathy LLE. Records reveal patient experienced skin lesions/eruptions since 6/2007 w/left LE swelling, numbness, pain, burning sensation, poor appetite & intermittent diplopia on meds w/15# weight loss.  Tx w/steroids w/o improvement then methotrexate which did provide relief but when tapered off, lesions recurred.  Exam in 12/07 revealed chickenpox-like skin lesions, papular & crusted. Biopsy done.  Began UVB phototherapy.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Lymphomatoid papulosis, Nerve injury, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who in January 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified) with her second dose of GARDASIL. The mother is reporting that her daughter received all 3 doses of GARDASIL (on schedule) an developed neurological symptoms. Medical attention was sought. She does not remember when the symptoms began. Initially the daughter's left toes became swollen, red and tingly which lasted for 2 to 3 days. On 07-JUN-2007, the patient woke up with a tingly sensation of her left leg from her knee to her ankle. There was also a pimple-like bump on her leg which she thought was a spider bite. Since that day her leg has worsened. If the daughter gets generalized goosebumps on her body, they do not appear on that area of her leg. The patient cannot feel hot or cold sensations of that area and she cannot wear flip-flops because her toes cannot hold onto them. The bump was diagnosed as lymphomatoid papulosis. On 09-JAN-2008, the patient will also be going to a neurological center. At the time of reporting the patient had not recovered. No other details were given. On an unspecified date 3 magnetic resonance imaging test and a neurological examination was also performed. Additional information has been requested.  10/31/08 Reviewed dermatology, heme/onc & neuro clinic records of 12/12/07-7/14/2008. FINAL DX: LyP, lymphomotoid papulosis & cutaneous mononeuropathy LLE. Records reveal patient experienced skin lesions/eruptions since 6/2007 w/left LE swelling, numbness, pain, burning sensation, poor appetite & intermittent diplopia on meds w/15# weight loss.  Tx w/steroids w/o improvement then methotrexate which did provide relief but when tapered off, lesions recurred.  Exam in 12/07 revealed chickenpox-like skin lesions, papular & crusted. Biopsy done.  Began UVB phototherapy.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Skin lesion
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who in January 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified) with her second dose of GARDASIL. The mother is reporting that her daughter received all 3 doses of GARDASIL (on schedule) an developed neurological symptoms. Medical attention was sought. She does not remember when the symptoms began. Initially the daughter's left toes became swollen, red and tingly which lasted for 2 to 3 days. On 07-JUN-2007, the patient woke up with a tingly sensation of her left leg from her knee to her ankle. There was also a pimple-like bump on her leg which she thought was a spider bite. Since that day her leg has worsened. If the daughter gets generalized goosebumps on her body, they do not appear on that area of her leg. The patient cannot feel hot or cold sensations of that area and she cannot wear flip-flops because her toes cannot hold onto them. The bump was diagnosed as lymphomatoid papulosis. On 09-JAN-2008, the patient will also be going to a neurological center. At the time of reporting the patient had not recovered. No other details were given. On an unspecified date 3 magnetic resonance imaging test and a neurological examination was also performed. Additional information has been requested.  10/31/08 Reviewed dermatology, heme/onc & neuro clinic records of 12/12/07-7/14/2008. FINAL DX: LyP, lymphomotoid papulosis & cutaneous mononeuropathy LLE. Records reveal patient experienced skin lesions/eruptions since 6/2007 w/left LE swelling, numbness, pain, burning sensation, poor appetite & intermittent diplopia on meds w/15# weight loss.  Tx w/steroids w/o improvement then methotrexate which did provide relief but when tapered off, lesions recurred.  Exam in 12/07 revealed chickenpox-like skin lesions, papular & crusted. Biopsy done.  Began UVB phototherapy.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 13-14 year old daughter who approximately 2 months ago, November 2007 (exact date not reported), was vaccinated (route and site not reported) with the second 0.5ml dose of Gardasil (lot# not reported).  On 02-JAN-2008 the patient developed a rash on "her leg and on her shoulders".  The patient did receive unspecified medical attention.  Per the patient's mother, the patient has not recovered.  No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old white female with no allergies, who, on 28-DEC-2007 at 15:30 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (Lot# 658219/0755U).  On 25-DEC-2007 at 15:30 the patient had fainted in the office and became alert within seconds after laying down.  The patient was monitored for 15 to 20 minutes in the office.  It was reported that the patient was fine when she left the office with her parent.  No ill effects were noted.  The patient recovered on 28-DEC-2007.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Sleep disorder
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female with no known allergies and asthma who on 15-NOV--2007 was vaccinated with Gardasil (Lot #657617/0384U) intramuscularly in the left arm. Concomitant therapy included ALLEGRA. The patient was seen by the physician on 04-DEC-2007 because she developed pain in the left shoulder. The patient said that it hurt to lay on her side when sleeping and described it as can be "pinching". No further information is available because the patient has not been seen for a follow up. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 03-JAN-2008 was vaccinated with her second dose of Gardasil and within an hour after the vaccination she developed a headache.  Concomitant medications included oral contraceptives.  The nurse also reported that the patient had a similar reaction following her first dose of Gardasil.  No other information was provided.  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 registered nurse concerning a 19 year old female with no preexisting illness who on 24-SEP-2007 was vaccinated with her first dose of GARDASIL (Lot #658558/1061U) intramuscularly in the left arm and on 03-JAN-2008 was vaccinated with her second dose of GARDASIL intramuscularly in the right arm. The nurse reported that after the first dose the patient had a slight headache on an unspecified date. On 03-JAN-2008, 30 minutes to one hour after the second dose, the patient reported a headache. The patient did not require any follow up and recovered on an unspecified date. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on 07-JAN-2008 was vaccinated with her first dose of 0.5 ml Gardasil intramuscularly.  The patient fainted after she was given the vaccine.  No other information was available.  As of 07-JAN-2008 the patient recovered from her experience.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a licensed practical nurse concerning a 19 year old white female who on 07-JAN-2008 was vaccinated with her first dose of GARDASIL (Lot #655439/1257U) intramuscularly in the left arm at 10:00 am. There was no concomitant medication. The patient fainted after she was given the vaccine. No other information was available. As of 07-JAN-2008 the patient recovered from her experience. Follow up information has been received from the licensed practical nurse on 28-FEB-2008. It was reported that on 07-JAN-2008 at 10:00 am the patient fainted and hit her head and hurt  her neck. The patient was evaluated and neck and skull x-rays were performed. Both skull and cervical spine x-rays were negative. The patient was watched for about an hour and released to her mother. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 04-JAN-2008 was vaccinated with her third dose of 0.5 ml of GARDASIL (Lot #659055/1522U) intramuscularly. There was no concomitant medication. Subsequently the patient developed myalgia. The patient received the vaccine in the right deltoid and has developed the myalgia on the entire left side of her body. The patient received her first dose of GARDASIL on 21-JUN-2007 and her dose on 06-AUG-2007. The patient's outcome was not reported. No further information is available. Additional information has been received.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain, Ultrasound scan
Clinical narrative: Information has been received from the Merck Pregnancy Registry for Gardasil from a consumer concerning her 24 year old daughter with no pertinent medical history or drug reactions/allergies who in August 2007 "about 5 months ago" was vaccinated with Gardasil (lot# unknown) 0.5 mL injection.  There was no concomitant medication.  In July 2007, "about 6 months ago" the patient experienced pain during her pregnancy.  No further information was provided.  Medical attention was sought.  On unspecified dates ultrasounds were performed.  The outcome was not reported.  The patient's date of last menstrual period was 01-JUL-2007 "about 6 months along" and the estimated date of delivery is 06-APR-2008.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with Gardasil (lot# unknown) injection. Subsequently the patient experienced heavy vaginal bleeding after the first dose of Gardasil. Medical attention was sought. The patient experienced this for 10 to 12 days and it only stopped when (estrogens, conjugated) PREMARIN (manufacturer unknown) was administered. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from heavy vaginal bleeding on an unspecified date. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Myalgia, Nausea
Clinical narrative: Information has been received from a female patient's father who states that in August 2007, his daughter was vaccinated with the first dose GARDASIL. In October 2007 the patient was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced joint pain, muscle pain, headache and nausea. The patient's joint pain, muscle pain, headache and nausea were ongoing. The physician was contacted, but did not know if the latter events were related to GARDASIL. The caller declined to provide any additional information. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a patient who on 20-DEC-2007 was vaccinated with her third dose GARDASIL (lot# unspecified). On 20-DEC-2007 the patient experienced persistent pain at the injection site of the right deltoid. The patient experiences pain at the injection site only when the right arm is raised to shoulder level. The patient's pain at the injection site of the right deltoid persisted. No treatment has been initiated. The reporter felt that persistent pain at the injection site of the right deltoid muscle was not related to therapy with GARDASIL. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a physician concerning a 25 year old female with a history of obesity who on 25-OCT-2007 was vaccinated intramuscularly in the left arm with the first dose of Gardasil (657621/0387U).  Concomitant therapy included NUVARING.  On 25-OCT-2007 the patient experienced a rash on both arms immediately after vaccination and the rash has now spread to the legs.  The patient's rashes on both arms that has spread to legs persisted.  The patient sought unspecified medical attention in the physician's office.  There were no other details.  Additional information has been requested.