chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Hypoaesthesia, Laboratory test, Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who in June 2008 (date discrepant), was vaccinated with the first dose of GARDASIL. On 07-DEC-2007 the patient vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. On 10-AUG-2008 the patient returned to the physician's office with numbness, tingling and weakness in her arms and fingers after receiving her third dose of GARDASIL. At the time of this report, the patient's symptoms persisted. The physician felt that the patient's condition was not a result of GARDASIL. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/15/2008. Initial and follow-up information has been received from a physician concerning a 21 year old female  with no related medical history who on 18-AUG-2008 was vaccinated into left deltoid with the first dose of GARDASIL. (Dose and site of administration not reported). (Lot # 60616/0570X). There was no illness at the time of vaccination. Concomitant therapy included birth control medication. At 1100 after shot was given patient started feeling dizzy and fainted. It lasted for couple of minutes.  The patient fainted after first dose within 2 minutes of receiving injection. No injury sustained. No hospitalization was required. It was unknown if the patient sought medical attention. No further information is available. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on 12-AUG-2008, was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X) for prevention of HPV. The physician reported that the patient fainted after receiving GARDASIL. The physician noted that the patient was already sweating and anxious prior to receiving the vaccine. At the time of the report, the patient had recovered. The patient sought medical attention by the physician. This is one of two reports received from the same source. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Headache, Myalgia, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with no medical history, no known allergies who in December 2007, was vaccinated with a third dose of GARDASIL (Lot # not reported). There was no concomitant medication. In May 2008, the patient experienced severe headaches, dizziness and muscle pain after receiving three doses of GARDASIL (dates of first and second dose were not reported). The patient's mother reported that the patient is in so much pain she is unable to lift her head off her pillow. An MRI and CAT scan were reported as normal. At the time of reporting the patient had not recovered. The patient sought medical attention at the office. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with a fear of needles who on 20-AUG-2008 was vaccinated with the third dose of GARDASIL 0.5mg, IM. Subsequently on 20-AUG-2008 the patient fainted and fell on her head. Subsequently, the patient recovered. The patient didn't seek medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008. Follow up information was received from the registered nurse on 23-DEC-2008: the patient was vaccinated with the third dose GARDASIL (Lot # 657617/0384U) intramuscularly in her right deltoid on 18-AUG-2008 at 10:50, and in the same day she received a dose of ADACEL (Lot # C2730AA) intramuscularly in her left deltoid at 10:46. It was reported that the patient was seated on exam table, talking post injection, did not complain, suddenly at 11:00 fell off left side of table, and landed on head, unconscious for approximately 3 to 4 minutes. No warning before fainting. At 11:10, the patient's blood pressure was 120/72 and she also had complaint of headache. The patient was examined by the physician. She was found to have full range of motion and had no parathesia. The patient had recovered at the time of this report. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient who toward the end of 2007 was vaccinated with the first dose of GARDASIL (Lot#not reported). There were no concomitant medication. The patient fainted within few minutes after her first dose. No injuries were sustained. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history, who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine, IM into her deltoid. There was no concomitant medication. The patient fainted immediately after receiving the first dose of GARDASIL. She did get her color back within a few seconds after fainting and recovered soon after. The patient sought medical attention at the office. There were no lab or diagnostic studies performed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropathy, Haematology test normal, Pain, X-ray normal
Clinical narrative: Information has been received from caller started her daughter concerning an 18 year old female with history of asthma who on 11-JUL-2008 was vaccinated with GARDASIL vaccine. Concomitant therapy included ALBUTEROL. On approximately 14-JUL-2008 the patient experienced arthritic symptoms and pain throughout her body shortly after receiving her initial dose of GARDASIL. The patient's arthritic symptoms and pain throughout her body persisted. Caller stated her daughter will not receive any future dose of GARDASIL. No further information is available.  2/23/09 MR received from Rheumatologist which include PCP recs as well.  Initially seen by PCP 7/18/08 & 8/1/08 with c/o joint pain x 2 months.  PE (+) for finger edema with decreased ROM and pain in toes. DX:  Synovitis and tenosynovitis. Referred to ortho. Pt reports knots around elbows, wrists, ankles, fingers and toes with morning stiffness. Referred to rheum.  OV 8/6/08. PE (+) fro swelling of digits and trace in hands. DX:  Polyarthargias.  Tenosynovitis. Tx with NSAIDs and steroids Labs:  ANA (-).  RF (-). anti-CCP (-). X-rays hands and feet WNL. Gliadin Ab (H) at 14.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing, Headache
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL. The patient has been getting dizzy "almost every single day" when she stands up, she sits down then this happens, and when the dizziness goes away her face feels flushed and she gets a headache. Prior to getting the vaccination, she would feel dizzy sometimes when she got out of bed in the morning shortly before her menstrual cycle. She will not be getting the rest of the series. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypomenorrhoea, Pregnancy test negative, Smear cervix normal
Clinical narrative: Information has been received from a pharmacist concerning that her 22 year old female pharmacy technician who on 19-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot# 0151X) 0.5ml, IM. The patient experienced extremely light periods ever since she was vaccinated. The patient's extremely light periods persisted. The pharmacist does not think her technician had contacted her physician regarding this. A pregnancy test was negative, PAP was normal. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 or more years old female patient who over one year ago was vaccinated with her first dose of GARDASIL. The same day post vaccination, the patient experienced headache, vomiting and abdominal pain. Subsequently, the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia, Nausea, Paraesthesia, Rash
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who on 19-AUG-2008 was vaccinated with the first dose of GARDASIL(lot# 660620/0571X) IM in the left deltoid. Concomitant therapy included MENINGOCOCCAL vaccine (unspecified) 4 weeks prior to GARDASIL, DROSPIRENONE(+) ethinyl estradiol (YASMIN), fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA D) and ALBUTEROL( inhaler). The same day, the patient experienced rash on both forearms. The next morning the patient experienced numbness and tingling in her extremities, shaking and lightheadedness that lasted 3 to 4 hours. The patient also experienced nausea for 48 hours on 21-AUG-2008, the temperature was normal. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who on 19-AUG-2008 was vaccinated with the first dose of GARDASIL(lot# 660620/0571X) IM in the left deltoid. Concomitant therapy included MENINGOCOCCAL vaccine (unspecified) 4 weeks prior to GARDASIL, DROSPIRENONE(+) ethinyl estradiol (YASMIN), fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA D) and ALBUTEROL( inhaler). The same day, the patient experienced rash on both forearms. The next morning the patient experienced numbness and tingling in her extremities, shaking and lightheadedness that lasted 3 to 4 hours. The patient also experienced nausea for 48 hours on 21-AUG-2008, the temperature was normal. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching, Syncope
Clinical narrative: Information has been received fro physician concerning a female patient between 14 and 16 year old who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL. After receiving the vaccine, the patient fainted and experienced twitching. The patient recovered. Medical attention was sought. This is one of two reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Angioedema
Clinical narrative: Information has been received from a healthcare worker from a physician's office concerning a 17 year old female with no medical history and allergic to SULFAMETHOXAZOLE (+) TRIMETHOPRIM (BACTRIM) who on 28-MAR-1996 was vaccinated with a first dose of VARICELLA (Lot# 660495/0431X) and experienced no adverse side effects. On 19-AUG-2008 the patient was vaccinated with a second dose of GARDASIL on the left arm and with a dose of FLUMIST. On 20-AUG-2008, an angioedema developed on her upper right arm where the VARICELLA was administered. At the time of reporting, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: Information has been received from a nurse concerning her 11 year old daughter who in approximately May 2008, was vaccinated with the first dose of GARDASIL. In approximately May 2008, the patient also received DTap-IPV. MENACTRA and medroxyprogesterone acetate (DEPO-PROVERA). About 7 to 10 days post vaccination, the patient experienced dizziness and fatigue. The patient was taken to the ER were unspecified test and studies were performed. The patient recovered. The nurse thought her daughter may have had the flu and did not attribute the event to the vaccine. No  further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyskinesia
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no drug reaction/allergies who on 13-MAY-2008 was vaccinated IM with the first dose of GARDASIL. There was no concomitant medication. On 13-MAY-2008, the patient experienced jerky movements in the upper torso. On an unspecified date. an electromyography was performed (no results provided). The patient sought unspecified medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested. 10/16/08-records received-neurology consult:Assessment-Suspect akathisia. presented for evaluation of abnormal movements described as muscular twitching occurring diffusely throughout her extremities. Twitching became more prominent after Gardasil injection several weeks ago. Normal neurological exam.  9/8/08-office visit for congenital pes planus. Twitching has not progressed, changed, worsened or gone away.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL. The patient fainted after receiving GARDASIL. No additional information. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Local swelling, Swelling face
Clinical narrative: Information has been received from a physician's assistant concerning a 26 year old female with no pertinent medical history who was vaccinated with a 0.5 ml second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient developed a swollen face, neck and lips. Eight days after the vaccination, the patient went to an emergency room, she was given an unspecified antibiotic and was released from the emergency room. At the time of this report, the outcomes were unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no pertinent medical history or allergies who on 11-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# 660389/1968U). There was no concomitant medication. On 11-MAR-2008 after the patient received the vaccine, she felt very funny. No laboratory diagnostics studies were performed. She sat for 10 minutes, was ok and went home. Unspecified medical attention was sought. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on an unspecified date was vaccinated with a dose of GARDASIL. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a sore arm for three to four days. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. The patient was diagnosed with human papilloma virus shortly after receiving a dose of GARDASIL. It was not known as to type of HPV or what dose of GARDASIL was administered. The patient's HPV persisted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. On the same office visit as vaccination, the patient had syncope after getting GARDASIL. In the office that day, the patient recovered from syncope. The patient saw the doctor and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Nephrotic syndrome
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of nephrotic syndrome who on 11-JAN-2007, 16-MAR-2007 and 02-AUG-2007, was vaccinated intramuscularly with the first, second and third 0.5 ml doses, respectively, of GARDASIL (Lot # of the first dose 654702/0011U, Lot # of the second dose 656049/0187U). Concomitant therapy included LOESTRIN 24 PE and KENALOG. "2 months after the third dose", on approximately 02-OCT-2007, the patient experienced an exacerbation of nephrotic syndrome. The outcome of the patient was not reported. The patient did not seek medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with allergic reaction to Tdap (the patient was starting into space and constantly crying) and a history of shingles (onset when she was five years old) who "about three weeks ago", on approximately 24-JUL-2008, was vaccinated with a first dose of GARDASIL. "About 6 weeks ago", on approximately 03-JUL-2008, the patient had a neurological episode where she losing her vision, muscle spasms and had severe headaches. It was reported that the patient was seen by a neurologist who did blood work, spinal tap and at first they thought she was having a brain amorism, and then they ruled that out with everything else and diagnosed her with having a full blown migraine episode. The reporter stated that the patient was hospitalized for a short time for blood patches because her spinal fluid was leaking for three days, and she was having severe spinal headaches. It was reported that at hospital the patient was given VICODIN and other medications, which were unspecified. The reporter stated that it took her sometime for the headaches to go away. But "about three weeks later", on approximately 24-JUL-2008, the patient went to her pediatrician and was given a dose of GARDASIL. After the vaccination, the patient was "still having mild headaches", but the patient had been given medication, which the name and manufacturer was unspecified, to treat her migraines. It was reported that the patient needed hospitalization or prolonged hospitalized. At the time of the report, the patient was recovering from the event. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female who was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently the patient experienced a near fainting episode. The patient recovered from near fainting episode after 5 - 10 minutes. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a nurse concerning a friend of a friend's 13 year old daughter who was vaccinated with a dose of HPV rL1 11 16 18 VLP vaccine (yeast). On an unspecified date the patient developed "Guillain Barre". The outcome of the patient was not reported. The patient was seen by the physician. Upon internal review, "Guillain Barre" was determined to be an other important  medical event. Additional information has been requested. 11/17/08-records received from Clinic-2/12/08-seen for C/O sore throat and fever. Rhinorhea and nasal congestion, belly pain, headache, fatigue and not eating as much. DX: Strep pharyngitis. Received HPV vaccine. Office visit 7/16/08-C/O muscle weakness times 1 month in arms and legs getting worse over last month. 7/30/08- DX infect polyneuritis. 8/1/08-suture removal from back of head. Headaches times 1 week.7/16/08-C/O knee and thigh pain and weakness times 6 weeks becoming worse some weakness in arms times 1 month. 7/16/08-Seen for Guillain Barre syndrome diagnosed 3 weeks ago and hospitalized. 11/26/08-records received for DOS 7/23-7/25/08-DC DX: Subacute demyelinating polyneuropathy. Presented with 2 month history of progressive bilateral extremity weakness worse in lower than upper extremities. First noted bilateral knee pain 2 months ago progressed in ascending manner. Difficulty climbing stairs, falling a lot. Few days before onset of knee pain had a URI with rhinorrhea and productive cough lasted 3 days. Received Gardasil in February. Treated with IVIG.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no pertinent medical history and no allergies who on 12-MAY-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. On 04-AUG-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM (lot # 660391/0063X). Concomitant therapy included YASMIN. Approximately on 11-AUG-2008, one week after receiving her second dose, the patient experienced bruise on the injection site. The bruise seemed to spread down to her bicep. She has no fever and no redness. She has full range of motion. She had no problem with her first dose. The patient was noted to be recovering. The patient sought medical attention and saw the nurse practitioner. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no allergies who in approximately August 2008, was vaccinated with the third dose of GARDASIL 0.5 ml IM. There was no concomitant medication. On 12-AUG-2008 the patient experienced fever after receiving the third dose. On 13-AUG-2008 the patient recovered from fever. The patient sought medical attention seen by the physician. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who in July 2008, was vaccinated with the third dose of GARDASIL. In July 2008, the patient passed out 1-5 minutes after her 3rd dose. Subsequently, the patient recovered immediately after gaining consciousness. The patient sought medical attention and saw nurse. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with GARDASIL. The registered nurse reported that the patient had a syncopal episode. This is one of two reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Condition aggravated
Clinical narrative: Information has been received from a physician concerning a 13 year old female with asthma who was vaccinated with GARDASIL. The patient experienced an asthma attack 24 hours after receiving the vaccine. Subsequently, the patient recovered. The asthma attack was considered to be immediately life-threatening. There were not lab diagnostic studies performed No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Staphylococcal infection
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 14 year old female who was vaccinated with her third dose of GARDASIL. On an unspecified date, the patient developed a staph infection on her face. She sought unspecified medical attention. The patient's staph infection persisted. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Information has been received from a physician concerning a 23 year old white female who on 13-AUG-2008 was vaccinated with the first dose of GARDASIL (lot no. 0250X). On 13-AUG-2008, after the vaccination, the patient felt lightheaded and left the treated room and fainted. The patient fell to the floor. The patient was not injured. Patient was un-injured. Subsequently the patient recovered fine and wanted to continue the series of GARDASIL. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with her first dose of GARDASIL. Subsequently, within two weeks the patient experienced a mid-cycle, very heavy menstrual period and then had another period two weeks later when she would normally have her period. No additional issues or concerns and periods went back to normal, but they had "discounted" further doses of GARDASIL until they were more comfortable with the vaccine. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient who had unspecified "issues with injections" and no known allergies, who on an unknown date was vaccinated with 0.5 mL GARDASIL IM. The patient experienced fainted after receiving the dose of GARDASIL. The patient recovered on an unknown date. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL. Subsequently the patient broke out in warts all over her feet. At the time of reporting, the outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Nausea
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter who on 01-AUG-2008 was vaccinated with the second dose of GARDASIL. Concomitant therapy included an unspecified birth control medication. On approximately 01-AUG-2008 the patient experienced nausea and bone pain for about 2 weeks. The nurse noted that the only new factor between the first dose and the second dose was an initiation of an unspecified birth control medication. The patient recovered without any intervention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with her first dose of GARDASIL.  In January 2008, she was vaccinated with her second dose of GARDASIL and reported pain, nausea, fever and vomiting.  Subsequently, on an unspecified date, the patient recovered from pain, nausea, fever and vomiting.  The reporter also indicated the patient's sister had the same symptoms after receiving GARDASIL.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia burgdorferi serology negative, Full blood count normal, Infectious mononucleosis, Uveitis
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated with the three dose series of GARDASIL (lot # 657868/0523U), 658556/1060U, 659439/1267U, respectively), was completed on 08-JAN-2008. In April of 2008, the patient experienced uveitis and was treated with prednisone. The symptoms continued to the time of the report, 22-AUG-2008. No other information was available. Additional information has been requested. Follow-up information was received via medical records. The patient was vaccinated with a first dose of GARDASIL on 15-JUN-2007 (lot # 657868/0523U), a second dose on 24-AUG-2007 (lot # 658556/1060U) and a third on 15-JUN-2008 (lot # 659439/1267U) respectively in the left arm. At the time of diagnosis with uveitis the patient was on KARIVA. The patient was also diagnosed with mononucleosis prior to uveitis. On 03-APR-2008 the patient had a lyme IgG/IgM Ab test performed and was negative. the patient also had a complete blood test performed and the results were normal. The patient recovered on an unspecified date but received 2 weeks of prednisone and intrancular steroid injection. On 14-JUL-2008 the patient had an evaluation at the eye center. The patient was started on KENALOG daily and was off prednisone with recurrent headache behind both eyes, photophobia, redness, no vision changes and chronic "flickering" right eye. The patient also had decreased optic disc edema. The patient was doing well and follow-up was in 2 months. Previous vaccinations included MENACTRA and DTAP on 15-JUN-2007. The reporting physician felt that uveitis was an other medical event. Additional informatio is not expected. Medical records are available upon request.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who on 03-JUL-2008 was vaccinated with the first 0.5mL dose of GARDASIL (Lot # 0250X) IM into the right deltoid. After receiving the first dose of GARDASIL, the patient experienced rash behind one of the ears. The patient sought medical attention, spoke to the physician. At the time of the reporting, the outcome of the patient was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis
Clinical narrative: Information has been received from a nurse concerning her daughter, who on an unspecified date was vaccinated with a dose of GARDASIL, 0.5 mL, I.M., and developed blood clots. The patient sought medical attention. Additional information has been requested.  6/18/09 Medical records received 7/30/07 to 12/23/08. Assessment: Tinea corporus, bilateral macromastia, superficial phlebitis R and L lower extremity - thrombus, subluxation of left patella Patient presents with injured foot. Heavy painful menses. Lower back, shoulder, and neck pain. Obese. Itchy rash on arm, erythematous plaque. laceration of finger. Bilateral large pendulus breasts. Nonproductive cough. Bilateral breast reduction surgery. Delayed healing of surgical site. Bilateral leg pain. Bruise on leg. Scraped knee. Fell and injured knee. Reduction of patellar dislocation. MEDS:   PMH.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a female patient between 14 and 16 year old who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL. After receiving the vaccine, the patient experienced vomiting. The patient recovered. Medical attention was sought. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a consumer concerning a female patient who on unspecified dates, was vaccinated with GARDASIL. The consumer reported that she was speaking with another mother who stated her daughter was experiencing terrible headaches since receiving GARDASIL. Outcome was not reported. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who on 02-JUL-2008, was vaccinated with her third dose of GARDASIL. Soon after receiving her third dose, the patient experienced nausea, fatigue, headaches and dizziness. The patient sought medical attention at pediatrician's office and unspecified blood work was performed. Her symptoms persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 12 year old female who on 30-JUL-2007, was vaccinated with her first dose of GARDASIL. On 27-SEP-2007, she was vaccinated with her second dose of GARDASIL. On 27-DEC-2007, she was vaccinated with her third dose of GARDASIL. At a recent wellness visit, the patient told the nurse practitioner, that she had had some hair loss on her scalp, following each dose. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Menstruation irregular
Clinical narrative: Information has been received from a consumer concerning a female who was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. A consumer reported that her step daughter has experienced headaches, that have been pretty intense, since her third dose of GARDASIL. He also stated there was an interruption in her menstrual cycle. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No additional AE information was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 16 year old female with asthma and no drug allergies who in March 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and in June 2008, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient experienced menstrual cramping after the first and second dose of GARDASIL. Cramping was more severe after second dose. The reporter was undecided as to whether to receive final dose of GARDASIL. On an unspecified date, the patient recovered. The patient was not experiencing any menstrual cramping at the time of reporting. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mononucleosis syndrome
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with GARDASIL. The patient came down with mono within one month of getting the vaccine. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, C-reactive protein increased, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who in spring of 2007, was vaccinated with a first dose of GARDASIL (lot number ,injection site and route not reported). About two weeks after the vaccination, the patient developed intermittent fevers. The physician also reported that the patient completed the series of GARDASIL (the vaccine was given on a 0, 2, 6 month schedule) without any pattern of injection-related fever or associated symptoms. The patient has had three episodes of unexplained fever as high as 103-104 degrees F with no other localizing signs since her first dose. These episodes lasted up to several weeks and then resolved spontaneously. Medical work-up was negative except for a markedly elevated C-reactive protein. At the time of this report, the patient's event persisted. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a pharmacist concerning an approximately 10 year old female with no pertinent medical history who was vaccinated with the first and second dose of GARDASIL, 0.5 ml (dates, therapy route and lot number not reported). There was no concomitant medication. The patient experienced joint pain after getting first and second dose of GARDASIL. No lab diagnostics studies was performed. The patient sought unspecified medical attention. The outcome of the adverse events were not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, FLU3, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Colonoscopy, Endoscopy, Fatigue
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with a history of dysmenorrhoea and attention deficit/hyperactivity disorder and no drug reactions/allergies who on 24-SEP-2007 was vaccinated with the first 0.5mL dose of GARDASIL (Lot No. 658560/1062U) IM and on 03-DEC-2007 was vaccinated IM with the second dose 0.5 mL dose of GARDASIL (Lot No. 659437/1266U). She has not yet received the third dose. Concomitant therapy included Tdap (unspecified) , influenza virus vaccine (unspecified) and MENACTRA. In October 2007 de patient experienced abdominal pain and fatigue. She was examined with endoscopy and colonoscopy. In October 2007, she was diagnosed with, the possible inflammatory bowel disease. The patient sought medical attention was seen by a physician. At the time of the reporting, the patient had not recovered Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 14-AUG-2007 was vaccinated with the first dose of GARDASIL. Immediately after receiving GARDASIL the patient vomited. Also, for six months thereafter, the patient periodically experienced dizziness, nausea and vomiting. The patient sought unspecified medical attention. At the time of the reporting, the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eye disorder, Vision blurred
Clinical narrative: Information has been received from a registered nurse concerning a female who on 25-AUG-2008 morning was vaccinated intramuscularly with her second dose of GARDASIL. (Dose, site of administration and lot number not reported). Couple hours later the patient called the office back and said she had pulsating in her right eye and was unable to focus. The patient went to the emergency room and was still there. The outcome of the patient was known. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 24 years old female who was vaccinated with the first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient developed a rash around the site of injection the day after receiving GARDASIL. Also, the patient developed a generalized rash two weeks after vaccination. At the time of the report, the patient had not recovered. The patient sought medical attention via telephone. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with her first dose of GARDASIL. In January 2008, she was vaccinated with her second dose of GARDASIL and pain, nausea, fever and vomiting. Subsequently, on an unspecified date, the patient recovered from pain, nausea, fever and vomiting. The reporter also indicated the patient's sister developed the same symptoms after receiving GARDASIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dysmenorrhoea, Menstrual disorder, Muscle spasms, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old female who in April-2008 was vaccinated with GARDASIL (unknown if this was the 1st or 2nd dose) and 01-JUN-2006, was vaccinated with the third dose of GARDASIL. The patient was the entire GARDASIL series. The mother reported that her daughter received the last dose of GARDASIL and her menstrual cramps have changed. It was about 15 days apart and a change in color; also she experienced severe cramps and pain in her legs. Her daughter cried over the severe menstrual cramps. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Headache, Lethargy, Malaise, Pain
Clinical narrative: Information has been received from a receptionist and a physician's assistant, concerning a female who was vaccinated with the first dose of GARDASIL. After the first dose, the patient's body was achy and wasn't generally feeling well. Approximately 3 hours after the second dose of GARDASIL, she had difficulty with breathing. She also experienced, lethargy, aches and headaches. The patient sought unspecified medical attention. The patient outcome was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: CSF test normal, Computerised tomogram normal, Facial palsy, Hypoaesthesia, Lumbar puncture
Clinical narrative: Information has been received from a clinical director/ registered nurse, concerning a 25 year old female patient, who on 11-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5mL IM, the second dose of GARDASIL (Lot #658094/0524U) on 13-AUG-2007 and the third dose of GARDASIL (Lot #659439/1267U) on 02-JAN-2008. The patient experienced facial paralysis and numbness and tingling of the hands and feet one and a half months (approximately in July 2007) after get the first dose of GARDASIL. The patient had been seen by the primary care physician and a neurologist for the symptoms. All laboratories and diagnostic studies came back negative (computed tomography scan, spinal tap and magnetic resonance imaging) for cause and GARDASIL is now the primary suspect. At the time of reporting the patient did not recovered. There was no product quality complaint. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Information has been received from a clinical director/ registered nurse, concerning a 25 year old female patient, who on 11-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5mL IM, the second dose of GARDASIL (Lot #658094/0524U) on 13-AUG-2007 and the third dose of GARDASIL (Lot #659439/1267U) on 02-JAN-2008. The patient experienced facial paralysis and numbness and tingling of the hands and feet one and a half months (approximately in July 2007) after get the first dose of GARDASIL. The patient had been seen by the primary care physician and a neurologist for the symptoms. All laboratories and diagnostic studies came back negative (computed tomography scan, spinal tap and magnetic resonance imaging) for cause and GARDASIL is now the primary suspect. At the time of reporting the patient did not recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who in approximately May 2008, was vaccinated with a dose of GARDASIL (route and administration site not reported). Shortly after the vaccination, the patient fainted in the waiting room. Subsequently, the patient recovered from fainting. There was no injury associated with the fainting episode. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with a dose of GARDASIL 0.5 ml IM. Subsequently the patient experienced joint pain. The patient's joint pain persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician assistant, concerning a patient who received a dose of GARDASIL. The patient had a reaction after receiving GARDASIL. The physician assistant refused elaborate on the nature of the reaction. There was no product quality complaint. Additional information is not available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site anaesthesia, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no relevant medical history or allergies who on 12-APR-2007 was vaccinated with a first dose of GARDASIL (lot number 1926F) (injection site and route not reported). On 12-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot number 655324/0089U) (injection site and route not reported). On 12-OCT-2007 the patient was vaccinated with a third dose of GARDASIL (lot number 658222/0927U) (injection site and route not reported). On 16-JUL-2008, the patient was vaccinated with a fourth 0.5 ml dose of GARDASIL (lot number 0063A) intramuscularly (injection site not reported). Secondary suspect therapy included a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). On 17-JUL-2008 the patient experienced numbness, soreness and pain at the injection site. There is no redness or induration. The patient went to see the physician. The patient's events persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a physician concerning a 16 year old female with no pertinent medical history and no history of drug reactions or allergies who no 06-MAY-2008 was vaccinated with the first dose of GARDASIL. On 08-JUL-2008 the patient had her last menstrual period. On 18-AUG-2008 the patient was vaccinated with the second dose of GARDASIL (lot#: ). On 26-AUG-2008 the patient was seen in the physician's office due to nausea. Urine pregnancy test result was positive. The patient was pregnant at 7 weeks gestation. The estimated delivery date is 15-APR-2009. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Drug exposure during pregnancy, Loss of consciousness, Ultrasound scan
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no relevant medical history or allergies who in February 2008, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). On 15-JUN-2008 the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). There was no concomitant medication. According to the reporter, the patient became sexually active on "April 2008". And the patient's mother was not sure if the clinical conducted a pregnancy test prior to giving the second dose of vaccine. On 15-JUN-2008 the patient passed out and was brought to emergency room and on that day, pregnancy was confirmed after blood and urine was taken for tests. The patient was not admitted to the hospital. The patient's mother noted that the patient was fine at time of this report and her due date was on 28-JAN-2009. At time of this report, the patient was 19 weeks pregnancy. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no relevant medical history or allergies who in February 2008, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). On 15-JUN-2008 the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). There was no concomitant medication. According to the reporter, the patient became sexually active on "April 2008". And the patient's mother was not sure if the clinical conducted a pregnancy test prior to giving the second dose of vaccine. On 15-JUN-2008 the patient passed out and was brought to emergency room and on that day, pregnancy was confirmed after blood and urine was taken for tests. The patient was not admitted to the hospital. The patient's mother noted that the patient was fine at time of this report and her due date was on 28-JAN-2009. At time of this report, the patient was 19 weeks pregnancy. Additional information has been requested.