chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Gastroenteritis, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of rheumatoid arthritis who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 656372/0243U) (route and administrating site not reported), and a dose of MENACTRA vaccine (dip toxoid). On 21-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot# 657737/0522U) (route and administrating site not reported). On 05-DEC-2007 the patient had to see a rheumatologist for neck and hip pain. On 01-APR-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot# 659962/1740U) (route and administrating site not reported) and after that the patient experienced nausea and vomiting and was diagnosed with gastroenteritis. On 24-JUN-2008 the patient started experiencing abdominal pain and was referred to another physician who prescribed omeprazole (MSD) which did not help and switched to REGLAN. The patient sought unspecified medical attention. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 16 year old female with a history of rheumatoid arthritis who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL (lot# 656372/0243U) IM in her right deltoid, and a dose of MENACTRA. On 21-NOV-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 657737/0522U) IM in her left deltoid. On 05-DEC-2007 the patient had to see a rheumatologist for neck and hip pain. On 01-APR-2008 the patient was vaccinated with a third dose of GARDASIL (lot# 659962/1740U) IM in her left deltoid and after that the patient experienced nausea and vomiting and was diagnosed with gastroenteritis. On 24-JUN-2008 the patient started experiencing abdominal pain and was referred to another physician who prescribed omeprazole (MSD) which did not help and switched to REGLAN. The patient sought unspecified medical attention. Follow-up information was received. ON 08-JUL-2008 the patient experienced stomach pain. Her abdomen was soft and non-tender with positive bowel sounds. The patient was referred to a gastrointestinal doctor. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of rheumatoid arthritis who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 656372/0243U) (route and administrating site not reported), and a dose of MENACTRA vaccine (dip toxoid). On 21-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot# 657737/0522U) (route and administrating site not reported). On 05-DEC-2007 the patient had to see a rheumatologist for neck and hip pain. On 01-APR-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot# 659962/1740U) (route and administrating site not reported) and after that the patient experienced nausea and vomiting and was diagnosed with gastroenteritis. On 24-JUN-2008 the patient started experiencing abdominal pain and was referred to another physician who prescribed omeprazole (MSD) which did not help and switched to REGLAN. The patient sought unspecified medical attention. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 16 year old female with a history of rheumatoid arthritis who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL (lot# 656372/0243U) IM in her right deltoid, and a dose of MENACTRA. On 21-NOV-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 657737/0522U) IM in her left deltoid. On 05-DEC-2007 the patient had to see a rheumatologist for neck and hip pain. On 01-APR-2008 the patient was vaccinated with a third dose of GARDASIL (lot# 659962/1740U) IM in her left deltoid and after that the patient experienced nausea and vomiting and was diagnosed with gastroenteritis. On 24-JUN-2008 the patient started experiencing abdominal pain and was referred to another physician who prescribed omeprazole (MSD) which did not help and switched to REGLAN. The patient sought unspecified medical attention. Follow-up information was received. ON 08-JUL-2008 the patient experienced stomach pain. Her abdomen was soft and non-tender with positive bowel sounds. The patient was referred to a gastrointestinal doctor. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a health department coordinator concerning a female who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patient experienced tingling and numbness in the arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from tingling and numbness in the arm. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 13-FEB-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) 0.5 ml in her left deltoid (lot# 655327/1287U0. Concomitant therapy included CELEXA and minocycline. On approximately 16-FEB-2008 the patient experienced dizziness and was taken by ambulance to the emergency room. It was unspecified if the patient was admitted to the hospital or just treated and released by the emergency room. It was determined in the emergency room that the patient had a "probable allergic reaction" to GARDASIL vaccine (yeast), which also included a rash and hives. The patient was treated with BENADRYL. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on approximately 25-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast). After receiving GARDASIL vaccine (yeast), the patient left the office and went to work. It was reported that on approximately 25-JUN-2008 the patient was on her feet all night at work, had an alcoholic beverage after work and when she was going home that night she had felt dizzy. The dizziness had lasted until the morning and got better on her own. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 04-MAR-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot#655670/1459U). Concomitant therapy included hepatitis B virus vaccine (manufacture unknown). On 04-MAR-2008, after receiving GARDASIL, the patient fainted. EPIPEN was used to revive the patient. Subsequently, the patient recovered from the event.  The patient decided to discontinue the dosing schedule of GARDASIL. The reporting physician considered syncope to be an other important medical event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Pallor, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 03-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL vaccine (yeast) (lot number 659180/1758U) (injection site and route not reported). On the same day of vaccination the patient became pale, weak and vomited when she went to her car from the office. She did not faint or become dizzy. The patient was seen in the office. Subsequently, the patient recovered from the events. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Tuberculin test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 year old female who on 07-MAY-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot# 659964/1978U) and on 10-JUL-2008 was vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot# 660391/0063X). There was no concomitant medication. On 10-JUL-2008 the nurse reported that the patient was presenting with an abnormal tuberculosis test (TB).The nurse states that the TB test had a ring around the puncture. The TB test was conducted 2 days ago but the results were read today. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Nausea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a mother concerning her 17 year old daughter who with an allergy to "Zithromax", on 02-JUL-2008 was vaccinated with her third dose of GARDASIL vaccine (yeast) (Lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). The mother reported that the patient was always tired after receiving the first and second doses of GARDASIL vaccine (yeast) (Lot# not reported). On 02-JUL-2008 reported as "within a day or so" the patient experienced tiredness, nausea and chills. At the time of reporting, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008. Follow-up information was received from a certified medical assistant concerning a 17 year old female student with no drug allergies who on 02-Jul-2008 was vaccinated with the third dose of GARDASIL (Lot # 659182/1757U). On 02-Jul-2008 the patient experienced headaches, tiredness and nausea. The patient recovered from headache, tiredness and nausea after only two weeks. There was no illness at time of vaccination. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast) (Lot# not reported). The patient fainted 10 minutes after the first dose. It was reported that the patient hit her head "pretty hard" and stayed in the office until recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning to his 14 year old niece with peanut and other allergies as well (unspecified) who was vaccinated with GARDASIL.  Subsequently the patient experienced hives that last for weeks after vaccination. The patient was also given other unspecified vaccines at that time.  The patient was now recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient female who in July 2008 was vaccinated with GARDASIL vaccine (yeast) 0.5ml IM. The physician reported that the patient fainted "last week" in July 2008 after receiving GARDASIL vaccine (yeast). The patient sought medical attention, she was seen in the physician office. ("AE occurred in the office"). There was no product quality complaint. No lab diagnostics were performed. On unspecified date the patient recovered. Additional information has been requested. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Haematoma, Head injury, Immediate post-injection reaction
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 15 year old female who on 11-JUL-2008, was vaccinated with a third dose 0.5ml of GARDASIL (lot# 660393/0067X) intramuscularly in the left arm.  On 11-JUL-2008 the physician  reported the patient fainted approximately 3 minutes after receiving GARDASIL at the physician's office.  The patient hit her head.  The patient was also dizzy, nauseous and began vomiting.  The patient was sent to the emergency room.  On 11-JUL-2008 the patient was recovered.  Medical records were received.  A 15 year old female who was sent to the emergency room by her pediatrician's office for evaluation of a head injury, status post a brief syncopal event after receiving her third GARDASIL injection in the office. The patient stated she received a third GARDASIL injection in the office and approximately 30 seconds later, she had a witnessed syncopal event for a "couple of seconds".  Her mom and her sister were there, as well as the pediatrician staff.  The patient struck the back of her head on the floor below and since that time, vomited once and had been extremely dizzy and complained.  The patient denied any history of previous head injury or concussion.  There was no abrasion or laceration noted to the scalp.  The incident occurred approximately 30 minutes to 45 minutes prior to arrival in the emergency department.  A physical examination was performed and the vital signs were stable and the patient was afebrile.  The patient appeared nontoxic in no extremis.  The patient's head revealed a mild posterior scalp hematoma with tenderness to palpation in the occipital region.  A CT scan was performed of the head and was negative for acute pathology per the radiologist's interpretation.  The emergency room physician reported "given the fact that this did occur directly after an injection this might be vasovagal in nature".  This was discussed with the patient and her mother and no further diagnostic work-up was indicated at the time.  The patient was discharged home with symptomatic supportive treatment and PMD follow-up in the next 48 hours for reevaluation.  Aftercare instructions were given on vasovagal syncope, head injury with wake-up and the patient was instructed to take TYLENOL when needed for pain, ice to the head for discomfort as needed, rest, activity as tolerated.  Diagnosis was status post GARDASIL injection, vasovagal syncope and closed head injury.  On 11-JUL-2208 the patient was considered recovered.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope, Tenderness, Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 15 year old female who on 11-JUL-2008, was vaccinated with a third dose 0.5ml of GARDASIL (lot# 660393/0067X) intramuscularly in the left arm.  On 11-JUL-2008 the physician  reported the patient fainted approximately 3 minutes after receiving GARDASIL at the physician's office.  The patient hit her head.  The patient was also dizzy, nauseous and began vomiting.  The patient was sent to the emergency room.  On 11-JUL-2008 the patient was recovered.  Medical records were received.  A 15 year old female who was sent to the emergency room by her pediatrician's office for evaluation of a head injury, status post a brief syncopal event after receiving her third GARDASIL injection in the office. The patient stated she received a third GARDASIL injection in the office and approximately 30 seconds later, she had a witnessed syncopal event for a "couple of seconds".  Her mom and her sister were there, as well as the pediatrician staff.  The patient struck the back of her head on the floor below and since that time, vomited once and had been extremely dizzy and complained.  The patient denied any history of previous head injury or concussion.  There was no abrasion or laceration noted to the scalp.  The incident occurred approximately 30 minutes to 45 minutes prior to arrival in the emergency department.  A physical examination was performed and the vital signs were stable and the patient was afebrile.  The patient appeared nontoxic in no extremis.  The patient's head revealed a mild posterior scalp hematoma with tenderness to palpation in the occipital region.  A CT scan was performed of the head and was negative for acute pathology per the radiologist's interpretation.  The emergency room physician reported "given the fact that this did occur directly after an injection this might be vasovagal in nature".  This was discussed with the patient and her mother and no further diagnostic work-up was indicated at the time.  The patient was discharged home with symptomatic supportive treatment and PMD follow-up in the next 48 hours for reevaluation.  Aftercare instructions were given on vasovagal syncope, head injury with wake-up and the patient was instructed to take TYLENOL when needed for pain, ice to the head for discomfort as needed, rest, activity as tolerated.  Diagnosis was status post GARDASIL injection, vasovagal syncope and closed head injury.  On 11-JUL-2208 the patient was considered recovered.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Suture insertion, Syncope, Wound
Clinical narrative: Information has been received from a registered nurse, a physician and a certified medical; assistant concerning a 15 year old female who in July 2007, was vaccinated intramuscularly with a first dose, of GARDASIL vaccine (yeast) (lot # not reported). On 10-JUL-2008 the patient received meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) first; then she received a second dose of GARDASIL vaccine (yeast) 0.5mL intramuscularly (lot # 659964/1978U), and lastly she received varicella virus vaccine live (VARIVAX) (MSD). The patient fainted after the injections. The patient was talking when she passed out, fell and hit her chin on the side of the exam table. She required 8 stitches that were completed in the physician's office. The patient returned to the office in about 1-2 hours and the physician stated "she was fine and smiling". The registered nurse considered stitches in chin to be an other important medial event but the physician and the medical assistant did not consider it to be an other important medical event. No additional information was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a office administrator concerning her daughter, a 20 year old female who on an unknown date, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # not available). The patient experienced dizziness and nausea the same day after receiving GARDASIL vaccine (yeast). The patient did not seek medical attention. Patient recovered the following day. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who on an unknown date was vaccinated with the first dose of GARDASIL vaccine (yeast) and on 08-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 mL, IM. On 08-JUL-2008, the patient fainted after receiving the second dose of GARDASIL vaccine (yeast). On 08-JUL-2008, the patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from the mother of a 12 year old female patient, who on 07-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 10-JUL-2008, the patient received the second dose of GARDASIL vaccine (yeast). The consumer reported that about three minutes after receiving the second dose of GARDASIL vaccine (yeast), her daughter felt nauseous and fainted. About 15 minutes later she came to and went    home. The consumer reported that when her daughter got home she laid down for about an hour and she was doing better. The consumer also reported that her daughter did eat breakfast that morning before getting GARDASIL vaccine (yeast). The patient sought unspecified medical attention. At the time of the report the patient was recovering. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a mother concerning her 21 year old daughter who on unknown dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). The patient's mother reported that her daughter gained 20 pounds after her 1st and 2nd doses of GARDASIL vaccine (yeast). It is unknown if the patient sought medical attention. Caller did not have time to fill out an AE report and will call back. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow up information was received from a medical assistant. On 21-MAR-2008, the female patient, was vaccinated in the physician's office at 11:38 am, wtih the first dose of GARDASIL (Lot  # : 655327/1287U) intramuscularly, into the left deltoid. The patient weight was 120.6 Lb. On 23-MAY-2008, the patient was vaccinated in the physician's office at 10:50 am, with the second dose of GARDASIL (Lot # 0152X) intramuscularly, into the left deltoid. The patient's weight was 127.2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 or 13 year old female who was vaccinated with GARDASIL vaccine (yeast). At the same time, the patient was vaccinated with hepatitis A virus vaccine inactivated (manufacturer unknown) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) as GARDASIL vaccine (yeast). The physician reported that the patient had a fainted from a dose of GARDASIL vaccine (yeast). The patient was fine in a few seconds. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with GARDASIL vaccine (yeast). The patient's mother reported that her daughter. Subsequently she experienced shortness of breath, rapid heart beat, dizziness and headaches. Outcome was not reported. Additional information is not expedited.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a female who in approximately July 2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (659182/1757U) and she was late getting her menstrual cycle. The patient's outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash papular, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 22 year old female patient with penicillin, amoxicillin and erythromycin allergies who on 26-JUN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot # 660553/0070X), 0.5 mL, IM. On 30-JUN-2008, the patient developed "red welts" on her abdominal and trunk area. On 10-JUL-2008, the patient had dry, small raised, red bumps on her abdominal area and upper back. The patient was recovering from "red welts" on her abdominal and trunk area and dry, small raised, red bumps on her abdominal area and upper back. The patient sought medical attention at the physician's office. Additional information has been requested. Follow up information was received from a registered nurse concerning a 22-year-old femal with ESS/ampicillin and Penicillin allergies who on 26-Jun-2008 was vaccinated with a first dose of GARDASIL (lot# 660553/0070X), intramuscular into the left deltoid. The patient called ad stated that 4 days after GARDASIL (lot# 660553/0070x), on 10-JUN-2008 (also reported as 09=JUL2008) she felt hot and hada red rash. She saw similar reaction to penicillin. At the time of reporting the patient recovered. There were no laboratory/diagnostic test performed. There was no illness at the time of vaccination. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 659180/1758U, route and site of administration not reported) and on 11-APR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U, route and site of administration not reported). The physician reported that the patient had numbness in her top right foot, headaches and severe abdominal pain with her first and second doses of GARDASIL vaccine (yeast). She will not receive dose 3. She reported this to the physician on 08-JUL-2008 after her mom saw "news reports of GARDASIL vaccine (yeast) problems." No additional AE information reported. At the time of the report, it was unknown if the patient had recovered from the numbness in her top right foot, headaches and severe abdominal pain. The patient sought medical attention, was seen by physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated on an unspecified date with a dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently on an unspecified date the patient experienced pain at the injection site and swelling of the arm. The patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history, drug reactions or allergies who in a late afternoon of May 2008, was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The next morning after the vaccination, the patient felt dizzy and faint like. On the same day the patient recovered. The patient sought medical attention by contacting office. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 year old white, 119 pound, 65 inch, female with pertinent medical history reported as none, with no illness at time of vaccination, except complaints of hunger, who on 03-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660389/1968U), 0.5 ml. It was reported that immediately when the needle was withdrawn the patient passed out. She was caught by the physician,  her feet were elevated, cool compresses were applied, and smelling salts were used. The event lasted 15-30 seconds. After a "T & R" popsicle she was observed for 20 minutes and had no further sequelae. The patient was reported as recovered on 03-JUL-2008. This is one of two patients from the same source. No additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). The patient fainted. It was reported that the patient recovered with no problems. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Gaze palsy, Head injury, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with a history of vasovagal reaction who on 11-JUL-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). On 11-JUL-2008 "within the last hour" the patient fell down and hit her head at the front of the office. The patient was vomiting and her eyes rolled back. The patient was sent to emergency room. It was unknown if the patient had any problems with the first dose or the second dose of GARDASIL vaccine (yeast). The patient's outcome was unknown. Patient sought medical attention in the office and emergency room. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate decreased, Muscular weakness, Myalgia, Paraesthesia, Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 14-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 16-OCT-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) and on 19-FEB-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). Between the second dose and the third dose, the patient had a decrease in pulse, fainting spells, hives, tingling in her fingers, and aches and weakness in her muscles. A "whole workup" was done and no result was provided. The patient's symptoms persisted. The patient sought medical attention in the physician's office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 14-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 16-OCT-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) and on 19-FEB-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). Between the second dose and the third dose, the patient had a decrease in pulse, fainting spells, hives, tingling in her fingers, and aches and weakness in her muscles. A "whole workup" was done and no result was provided. The patient's symptoms persisted. The patient sought medical attention in the physician's office. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a consumer concerning her daughter with a history of attention deficit/hyperactivity disorder and no drug reactions/allergies who in July 2007 and in January 2008, was vaccinated with first and third doses, respectively, of GARDASIL vaccine (yeast) (lot#s unspecified). Concomitant therapy included CONCERTA. Date and lot # of the second dose was unspecified. It was reported that in October 2007, (three months after the firse dose), the patient developed warts on her hands and fingers. It was also reported that the warts were treated and disappeared, but returned four times worse in March 2008. Unspecified medical attention was sought. At the time of this report, the patient's warts persisted. Additional information has been requested. Follow up the patient didn't seek medical attention. At the time of this report, the patient's warts persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test, Lymph node pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 13-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot not reported). Subsequently the patient experienced tenderness near her inguinal lymph nodes. On 14-JUL-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot not reported). On an unspecified date, the patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a practice manager concerning a 20 year old female who on approximately 07-JUL-2008 (reported as "last week") was vaccinated intramuscularly with first 0.5 ml dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that the patient has been experiencing nausea and vomiting and that the symptoms lasted through the weekend and up to and including today, 14-Jul-2008. Unspecified medical attention was sought. It was reported that the physician will be prescribing a suppository (unspecified brand) for her symptoms. No other details. At the time of this report the patient's nausea and vomiting persisted. No other details available. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow-up information was received on 14-AUG-2008 from the practice manager. On 10-JUL-2008, at 8:30 a.m., the 20 year old female student with allergies to penicillin and codeine was vaccinated in the left arm with a first dose of GARDASIL (Lot #0152X). On 10-JUL-2008, following vaccination with GARDASIL, the patient experienced nausea and vomiting which lasted 4 days. "On day 4" (13-JUL-2008), the patient was treated with phenergan suppositories and recovered from the events. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated with first and second doses, respectively, of GARDASIL vaccine (yeast) (lot#s not reported). Nurse reported that the patient fainted shortly after receiving her second dose of GARDASIL vaccine (yeast). Nurse reported that she gave the patient something to drink and then the patient "was fine". It was also reported that the patient had not eaten anything for several hours prior to her office visit. Unspecified medical attention was sought. No further information was provided. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Stress, Weight decreased, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from consumer, a 19 year old pregnant female, and her aunt, for the Pregnancy Registry for GARDASIL vaccine (yeast), who on 12-JUN-2008 was vaccinated (route unknown) "by accident" with the first 0.5 mL dose of GARDASIL vaccine (yeast) (Lot # unknown). No medical history and or drug reaction/allergies were reported. It was reported that the patient was supposed to receive an unknown vaccine for "negative blood". The patients LMP was reported as "18-MAR-2008". The aunt reported that the patient has lost ten pounds since the vaccination, probably due to stress. The aunt also reported that the patient is taking prenatal vitamins (unspecified). This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Bruxism, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Initial and followup information has been received from a nurse practitioner concerning a 23 year old female with an allergy to CECLOR and no illness at the time of vaccination who on 26-JUN-2008 was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) (lot# 660393/0067X). On 28-JUN-2008 the patient experienced restlessness, tiredness, shortness of breath, migraines, wrist soreness, teeth grinding, hot face, ankle soreness and knee soreness, edgyness, skin breakouts, and body hurts. The patient was treated with ibuprofen and referred to her physician. The outcome was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling jittery, Migraine, Restlessness
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Initial and followup information has been received from a nurse practitioner concerning a 23 year old female with an allergy to CECLOR and no illness at the time of vaccination who on 26-JUN-2008 was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) (lot# 660393/0067X). On 28-JUN-2008 the patient experienced restlessness, tiredness, shortness of breath, migraines, wrist soreness, teeth grinding, hot face, ankle soreness and knee soreness, edgyness, skin breakouts, and body hurts. The patient was treated with ibuprofen and referred to her physician. The outcome was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 23 year old female who on 18-JUN-2008 was vaccinated with the thirds dose of GARDASIL vaccine (yeast) (lot not reported). Concomitant therapy included hormonal contraceptives (unspecified). "A month after vaccination" the patient experienced pain and swelling at the injection site. The patient's pain and swelling at the injection site persisted. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site erythema, Urticaria
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 09-JUL-2008 was vaccinated with the first 0.5 mL dose of GARDASIL vaccine (yeast) (lot not reported). "Soon after receiving the second dose of the vaccine the patient experienced injection site red welt and ongoing headache that will not go away. The patient's injection site red welt and ongoing headache that will not go away persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, Dysarthria, Extensor plantar response, Hyperreflexia, Speech disorder
Clinical narrative: Information has been received from a physician concerning an 18 year old female with histiocytosis X and severe scoliosis and a history of iron deficiency secondary to dysfunctional uterine bleeding who in August 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On an unspecified date, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). In March 2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). About the time she started the vaccination, the patient was very ataxic. At the time of reporting, the patient's speech was slurred and slow, and was hyper reflexic with present Babinskis bilaterally. The patient was seen by a neurologist, but had no diagnosis. The patient had scheduled for second opinion neurologist. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning an 18 year old female with histiocytosis X and severe scoliosis and a history of iron deficiency secondary to dysfunctional uterine bleeding who in September 2007, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). On an unspeciifed date, the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). In March 2008, the patient was vaccinated with a third 0.5 ml dose of GARDASIL (lot number, injection site and route not reported). About the time she started the vaccination, the patient was very ataxic. At the time of reporting, the patient's speech was slurred and slow, and was hyper reflexic with present Babinskis bilaterally. The patient was seen by a neurologist, but had no diagnosis. The patient had scheduled for second opinion neurologist. At the time of this report, the patient's events persisted. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Antibody test normal, Asthenia, Blood test normal, Cataplexy, Hypersomnia
Clinical narrative: Information has been received from a physician concerning a 12 year old white female patient who in June 2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). In June 2008, the patient shortly (within days) began to have decrease energy and had several episodes of cataplexy. Her energy continued to decline. Sleeping longer and longer, her blood work was normal (including Lyme) and finally the patient was sent to a neurologist who specializes in sleep disorders, he immediately suspected narcolepsy and it was confirmed on a sleep study-polysomnogram. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Narcolepsy, Sleep study abnormal
Clinical narrative: Information has been received from a physician concerning a 12 year old white female patient who in June 2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). In June 2008, the patient shortly (within days) began to have decrease energy and had several episodes of cataplexy. Her energy continued to decline. Sleeping longer and longer, her blood work was normal (including Lyme) and finally the patient was sent to a neurologist who specializes in sleep disorders, he immediately suspected narcolepsy and it was confirmed on a sleep study-polysomnogram. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, Peripheral motor neuropathy
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced progressive ataxia and motor neuropathy. At the time of this report, the outcome was unknown. The reporter felt that progressive ataxia and motor neuropathy were plausibly related to therapy with GARDASIL vaccine (yeast). This is one of several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, Peripheral motor neuropathy
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). Shortly after receiving GARDASIL vaccine (yeast) the patient experienced progressive ataxia and motor neuropath. It was reported that the patient was being worked up right now for progressive ataxia and motor neuropathy. One of the pediatric rheumatologists  who had been heavily involved did believe there was a very plausible link. This is one of two reports received from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 10 or 11 year old female who in June 2008, was vaccinated with a first dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number and injection site not reported). Immediately after administration, the patient experienced vomiting. Subsequently, the patient recovered from vomiting. The patient did not seek any medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Bronchitis, Epstein-Barr virus antibody positive, Haematology test normal, Immunology test normal
Clinical narrative: Information has been received from a registered office nurse manager and a consumer concerning her 12 year old daughter who on 19-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660387/1967U) intramuscularly in her right deltoid. The patient's mother reported that her medical doctor noted she was in good physical condition at the time the vaccine was administered. She also reported that the patient's vaccine site was extremely tender and sore for a complete week after she received the vaccination. Within a few days of receiving the vaccine, in February 2008, the patient began complaining of persistent stomach cramps and nausea. The nurse office manager reported that the patient developed stomach cramps and nausea after the vaccination. According to the nurse, the patient was treated as the physician's office as follows: on 07-MAR-2008 for a diagnosis of bronchitis (treatment unspecified) on 23-APR-2008, for symptoms of a left ankle sprain (treatment unspecified), on 15-MAY-2008 for symptoms of stomachache. On 16-MAY-2008, an ultrasound of the liver, kidney, pelvis and spleen were performed and the results were within the normal range. On 23-MAY-2008, upper gastrointestinal air contrast, hematology test, routine immunology test, blood chemistry test were performed and the results reported to be within the normal range except for serum Epstein-Barr virus antibody test positive for EBV IgG, EBV IgM and EBV nuclear antigen. Results suggested recovery or reactivation. The provider will recommend a gastrointestinal consult. No other symptoms or treatment noted. The patient's mother reported that the patient's stomach cramps and nausea continued until the time of this report despite a series of medical testing. The outcome of the patient's bronchitis, L ankle sprain and positive mononucleosis test was unknown. The patient sought medical attention.. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Joint sprain, Laboratory test normal, Mononucleosis heterophile test positive, Nausea
Clinical narrative: Information has been received from a registered office nurse manager and a consumer concerning her 12 year old daughter who on 19-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660387/1967U) intramuscularly in her right deltoid. The patient's mother reported that her medical doctor noted she was in good physical condition at the time the vaccine was administered. She also reported that the patient's vaccine site was extremely tender and sore for a complete week after she received the vaccination. Within a few days of receiving the vaccine, in February 2008, the patient began complaining of persistent stomach cramps and nausea. The nurse office manager reported that the patient developed stomach cramps and nausea after the vaccination. According to the nurse, the patient was treated as the physician's office as follows: on 07-MAR-2008 for a diagnosis of bronchitis (treatment unspecified) on 23-APR-2008, for symptoms of a left ankle sprain (treatment unspecified), on 15-MAY-2008 for symptoms of stomachache. On 16-MAY-2008, an ultrasound of the liver, kidney, pelvis and spleen were performed and the results were within the normal range. On 23-MAY-2008, upper gastrointestinal air contrast, hematology test, routine immunology test, blood chemistry test were performed and the results reported to be within the normal range except for serum Epstein-Barr virus antibody test positive for EBV IgG, EBV IgM and EBV nuclear antigen. Results suggested recovery or reactivation. The provider will recommend a gastrointestinal consult. No other symptoms or treatment noted. The patient's mother reported that the patient's stomach cramps and nausea continued until the time of this report despite a series of medical testing. The outcome of the patient's bronchitis, L ankle sprain and positive mononucleosis test was unknown. The patient sought medical attention.. Additional information has been requested.