chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with penicillin allergy and allergy to codeine who in March 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included YAZ. After receiving the first dose, she had itching and redness at the injection site and developed patches on her back and hips that were the size of a baseball and were purple on the outside and white on the inside, and her skin is very hard. The consumer reported that her daughter saw the physician at school for about two months and they could not figure out what it was so they had then sent her to a dermatologist, in which they did a biopsy and could not figure out what the patches were. In June 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). About two weeks later she had developed about eleven new patches on her breast, back, hips and other spots as well. The consumer reported that her daughter then came home from school and saw her own primary care physician who sent her to a dermatologist. The dermatologist as soon as she saw her daughter diagnosed her on site with localized morphea acleroderma, which is a build up of collagen that attacks the skin. The dermatologist also did a blood test, and first prescribed a topical steroid, name and manufacturer unspecified, which made some difference, but then was put up on prednisone for a month which had helped, and her daughter stated that "you can hardly see the patches but they are still there." The consumer also reported that "While taking prednisone, she lost about 5 pounds, even though she was eating normally, and she was having problems with her stomach and bladder. The patient has seen a physician about this and was tested for diabetes and bladder issues, but she did not have any and the physician feels it is from the prednisone. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the first dose of GARDASIL vaccine (yeast) IM in her arm. The patient experienced a rash after receiving the vaccination, but did not notify the nurse. The rash went away without treatment after 1 week and it was not known where on the patient's body occurred. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain
Clinical narrative: Information has been received from a physician, concerning a female patient who was vaccinated with the second dose of GARDASIL vaccine (yeast) and afterwards complained of pelvic pain. The physician thinks she may have been experiencing it prior to getting the second dose but he will have to check the charts. The patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in June 2008, about two months ago, was vaccinated with the first dose of GARDASIL vaccine (yeast). The patient experienced dizziness after vaccination. The patient sat down for a while and was given an "epi pen" just in case of an allergic reaction, but then recovered and was able to leave. The physician also reported that the patient has received the second dose of GARDASIL vaccine (yeast) and no adverse experienced occurred. The patient sought medical attention and saw physician. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician assistant concerning some patient which were vaccinated with GARDASIL vaccine (yeast). The physician assistant reported that some patients experienced injection-site pain after receiving GARDASIL vaccine (yeast). Follow up information was received from the physician assistant which reported that the patients felt "minimal to mild discomfort" while receiving GARDASIL vaccine (yeast). The physician assistant also reported that the "pain was significantly less than with the tetanus shot". He added that he does not have any patient information to provide since none of the patients returned with a problem. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with no allergies and no drug reactions, and a history of low blood sugar who on 07-AUG-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient had been experiencing nausea and fainting on 08-AUG-2008. The patient sought medical attention at the office. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no allergies/drug reactions and no pertinent medical history, who on 12-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658282/0929U) 0.5 mL, IM. On 15-APR-2008, the patient was vaccinated with the second dose of GARDSIL vaccine (yeast) (lot # 659964/1978U) 0.5 mL, IM. Concomitant therapy included MENACTRA. The patient experienced hives and itching after receiving the first and second dose of GARDASIL vaccine (yeast).  The patient sought medical attention: phone call. At time of reporting. the patient was recovered.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Information has been received from a consumer concerning her daughter, a 26 year old female with anxiety disorder and penicillin allergy who on 04-AUG-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included escitalopram oxalate (LEXAPRO). On 04-AUG-2008, several hours after received the first dose, the patient experienced heart palpitations. On 05-AUG-2008, the patient improved but experienced the onset of chills, diarrhea and nausea. The nausea improved, but on 07-AUG-2008, the patient began to have widespread body aches and a headache in addition to the continuing diarrhea. The patient contacted her physician's office by phone and was advised to call again if the symptoms persist. No therapy was prescribed. The patient improved from nausea. At the time of reporting, chills, diarrhea and widespread had not recovered. The reporter states the physician does not feel that patient's symptoms are related to GARDASIL vaccine.  Additional information is not expected as the consumer did not provide the physician's name
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a consumer concerning her daughter, a 26 year old female with anxiety disorder and penicillin allergy who on 04-AUG-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included escitalopram oxalate (LEXAPRO). On 04-AUG-2008, several hours after received the first dose, the patient experienced heart palpitations. On 05-AUG-2008, the patient improved but experienced the onset of chills, diarrhea and nausea. The nausea improved, but on 07-AUG-2008, the patient began to have widespread body aches and a headache in addition to the continuing diarrhea. The patient contacted her physician's office by phone and was advised to call again if the symptoms persist. No therapy was prescribed. The patient improved from nausea. At the time of reporting, chills, diarrhea and widespread had not recovered. The reporter states the physician does not feel that patient's symptoms are related to GARDASIL vaccine.  Additional information is not expected as the consumer did not provide the physician's name
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Chills, Nausea, Pyrexia, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter, a 23 year old female with no known drug allergies and no pertinent medical history reported, who on unspecified dates was vaccinated with the first and second doses of GARDASIL. In the summer of 2007, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included PROZAC. On an unspecified date, the patient experienced fainted after receive the first dose of GARDASIL, for the second and third doses she was lying down while receiving it and she was fine. After receiving the third dose, the patient started experiencing nausea, vomiting, low grade fever and chills that come an go ever since. The patient sought unspecified medical attention. Blood work came back normal. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning her daughter, a 23 year old female with no known drug allergies and no pertinent medical history reported, who on unspecified dates was vaccinated with the first and second doses of GARDASIL. In the summer of 2007, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included PROZAC. On an unspecified date, the patient experienced fainted after receive the first dose of GARDASIL, for the second and third doses she was lying down while receiving it and she was fine. After receiving the third dose, the patient started experiencing nausea, vomiting, low grade fever and chills that come an go ever since. The patient sought unspecified medical attention. Blood work came back normal. At the time of reporting, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with the third dose of GARDASIL. Subsequently the patient experienced mononucleosis. the patient sought unspecified medical attention. No further information is available
Sex: U
Vaccine: HPV4
Symptoms: Medication error
Clinical narrative: Information has been received form a registered nurse concerning an unknown number of patients who were vaccinated with GARDASIL (lot number not reported). The nurse reported that the patients received GARDASIL (lot number not reported) that had been stored at 33 degrees F for 12 hours. No adverse effects reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia oral, Throat irritation
Clinical narrative: Information has been received from a certified nurse midwife concerning a 22 year old white female with an allergy to CECLOR (causes rash) who on 29-JUL-2008 was vaccinated with the first dose of GARDASIL. The patient was sitting in the office for observation as recommended. Approximately ten minutes after the injection, she noticed numbness in her tongue and an "itchy" feeling in her throat, that became more noticeable over the next five minutes. She never had progression or symptoms behind these and never experienced shortness of breath or inability to speak. She was given 60 mg of Allegra suspension (sample) and monitored for approximately one hour. Her symptoms totally resolved within 40 minutes after receiving Allegra. She was given x420/2.5 mg x 7 to take at home nightly. Concomitant therapy included hormonal contraceptives (unspecified). No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysmenorrhoea, Menorrhagia
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated with GARDASIL (dose, therapy route, lot number not reported). The patient received GARDASIL and experienced dizziness and a profuse/painful menstruation. The patient reported feeling dizzy the day following vaccination with GARDASIL. It was unknown which dose of GARDASIL was administered. The patient also reported a profuse and painful menstruation following the dose of GARDASIL. The patient normally did not have profuse and painful menstruation and felt it was related to the dose of GARDASIL. On 11-AUG-2008 the patient sought medical attention by an office visit. Subsequently the patient recovered from the dizziness and a profuse/painful menstruation. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive, Vaginitis gardnerella
Clinical narrative: Information has been received form the pregnancy registry for GARDASIL from a 20 year old female patient, with no known pertinent medical history and no drug reactions/allergies, who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL (Lot # 655604/0052X). There was no concomitant therapy. The health care worker reported that on 04-AUG-2008, the patient had a positive pregnancy test. The patient sought medical attention at physician's office. The last menstrual period was on 06-JUL-2008. Estimated date of delivery approximately 12-APR-2009. At the time of the report the pregnancy was normal. Follow up information was received from a health care worker which reported that the patient had a medical history of genital condyloma, who on 14-JUL-2008, was vaccinated with the first dose of GARDASIL (Lot # 9725103). The health care worker reported that the last menstrual period was on 05-JUL-2008. Estimated date of delivery approximately 10-APR-2009. On 16-JUL-2008, the patient was treated with metrogel and vaginal gel at bedtime for gardnerella vaginalis. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a female who in April 2008, was vaccinated with her second dose of GARDASIL (Lot number not reported). The patient developed the "wart like rashes" on her body 4 months after the second dose (in Aug 2008). the patient sought unspecified medical attention ant the "wart like rashes" persisted. This one of the several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dyspnoea, Local swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with no pertinent medical history and no known drug reactions/allergies who on 06-AUG-2008 was vaccinated with a dose of GARDASIL and a dose of VARIVAX (Merck). there was no concomitant medication. On 09-AUG-2008 the patient experienced a swollen feeling in her neck and difficulty breathing. Subsequently the patient recovered from swollen feeling in her neck and difficulty breathing. At the time of the nurse report. The patient's medical chart was not available. The patient sought medical attention at the emergency room. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Headache, Inappropriate schedule of drug administration, Nausea, Pain
Clinical narrative: Information has been received regarding a case in litigation. A 39 year old female with no known allergies reported that on an unspecified date she was vaccinated with the second dose of GARDASIL. After receiving the second dose she broke out in a rash. In June 2007, the patient was vaccinated with the third dose of GARDASIL. After receiving the third dose, she broke out in a rash again and it was much worse. Also after the third dose, she started having recurring urinary track infection, nausea and headache. And she also reported she was having diarrhea and pains. At the time of this report, the patient's symptoms persisted. She sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.  1/23/09 Reviewed ER medical records of 5/24/2007. FINAL DX: Urinary anomaly Records reveal pt experienced frequency, pressure & rgency x 2 days.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urinary tract infection
Clinical narrative: Information has been received regarding a case in litigation. A 39 year old female with no known allergies reported that on an unspecified date she was vaccinated with the second dose of GARDASIL. After receiving the second dose she broke out in a rash. In June 2007, the patient was vaccinated with the third dose of GARDASIL. After receiving the third dose, she broke out in a rash again and it was much worse. Also after the third dose, she started having recurring urinary track infection, nausea and headache. And she also reported she was having diarrhea and pains. At the time of this report, the patient's symptoms persisted. She sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.  1/23/09 Reviewed ER medical records of 5/24/2007. FINAL DX: Urinary anomaly Records reveal pt experienced frequency, pressure & rgency x 2 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Device leakage, Pain in extremity, Underdose
Clinical narrative: Information has been received from registered nurse (R.N.) concerning a 17 year old female who on 11-AUG-2008 was vaccinated with a dose of GARDASIL. On 11-AUG-2008, when administering GARDASIL, a small account of GARDASIL leaked out from the hub. The nurse reported that the patient had no problems other than reporting a "sore arm". The outcome of the patient was not reported. additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling cold, Headache, Influenza like illness, Presyncope
Clinical narrative: Information has been receiving from a physician's office manager and her co-worker concerning a 26 year old white female positive for high risk papilloma viral infection and no known allergies who on 11-JUN-2008 at approximately 12:00PM was vaccinated in her left deltoid with the first dose of GARDASIL (LOT# 660393/0067X). Concomitant therapy included DEPO-PROVERA. After the vaccination, the patient sat for about 10-15 minutes in the waiting room to make sure that she did not have an reaction to the injection. the patient "was absolutely fine" when she left the physician's office. About 1/2 hour after leaving the office, she went to pick up her kids and she started to experience flu-like symptoms. she felt to then cold. She got a headache and felt dizzy. She almost fainted and almost had a wreck in her car on her way home. She got home and slept for 4 hours. when she woke up, she took some aspirin and drank tea to help her feel better. She did not feel better until the next day. The patient did not seek medical treatment at a hospital or from any other doctor for these symptoms, nor did she call the physician's office. The other vaccines within a month before or after getting GARDASIL. No tests were ordered by any doctor or medical facility to try to determine her ailment at this time. On 08-AUG-2008, the patient called the physician's office. She wanted to cancel her scheduled appointment for her second vaccination. additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physicians concerning a 16 year old female who in approximately May 2008, about two and a half months ago, was vaccinated with the first dose of GARDASIL. The patient experienced dizziness after vaccination. The patient sat down for a while and was given an "epi pen" just in case of an allergic reaction, but then recovered and was able to leave. The physician also reported that the patient has received the second dose of GARDASIL and no adverse experienced occurred. The patient sought medical attention and saw physician. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Urinary tract infection
Clinical narrative: Information has been received regarding a case in litigation. A female consumer reported that her 14 year old daughter who on an unspecified dates were vaccinated with three doses of GARDASIL. The patient's mother reported that the patient started having stomach pains since then. It was also reported that the patient was having continually urinary track infection, diarrhea and pains. At the time of this report, the patient's symptoms persisted. She sought unspecified medical attention. this is one of several reports received from the same source. Additional information has been requested. 11/24/08-records received-10/31/07-presented with C/O social issues. Now in adoptive home. 4/14/08-C/O sore throat, mild nasal discharge. Upper viral infection. 8/6/08-seen for school exam.
Sex: F
Vaccine: HPVX
Symptoms: Rash macular
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL injection. The physician reported that a patient received GARDASIL and five days later developed blotches on her back. Patient was referred to dermatologist. The outcome was not reported. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Presyncope, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 06-AUG-2008 was vaccinated with the first dose of GARDASIL {0.5 ml, left arm, lot number not reported} via IM route, and VARIVAX (MSD) (dose, route not reported) and hepatitis A virus vaccine (unspecified0 (manufacturer not known) ( dose, route not reported) received in the right arm. Immediately following the injections the patient's left arm became numb and she felt dizzy and "almost passed out." The patient was observed for 10 minutes in the office and recovered fully and was discharged home. The nurse mentioned that the physician believed this to be a syncopal episode. No lab diagnostics studies was performed. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with no pertinent medical history or drug allergy who on 04-JUN-2008 was vaccinated with the first dose of GARDASIL {0.5 ml, lot number not reported} via IM route. There was no concomitant medication. The patient had had diarrhea since her first GARDASIL shot on 04-JUN-2008. She did receive her second GARDASIL shot on 04-AUG-2008. The consumer could not provide the lot numbers. No lab diagnostic test was performed. The patient sought unspecified medial attention. The patient's diarrhea was not improved or recovered as of 12-AUG-2008. Additional information has been requested.  12/3/08 Per parent pt has not sought medical tx for diarrhea, only informed provider.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Subsequently the patient experienced fatigue. The patient's fatigue persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis, Scar, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female with environmental allergy and penicillin allergy who in June 2008, was vaccinated with the first dose of GARDASIL 0.5 ml IM. ON approximately 29-JUL-2008, about 2 weeks ago, the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM. Concomitant therapy included ZYRTEC as needed. The patient experienced dermatitis on her extremities after each of the 2 doses. The patient was treated with oral steroids. The patient has some scarring on her wrists from the dermatitis. the patient sought medical attention in an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Psoriasis
Clinical narrative: Information has been received from a physician concerning a female with no known allergies or pertinent medical history who was vaccinated IM with the third dose of GARDASIL vaccine. The physician reported that a patient developed psoriasis after she received her third dose of GARDASIL. No lab diagnostics were performed. Unspecified medical attention was sought. there was no product quality complaint. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning an unknown number of patients, who on an unknown date were vaccinated with GARDASIL. The nurse practitioner reported that 99% of her patients who were administered GARDASIL complained of pain at the time of injection. No patient specific information was available. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with GARDASIL. Concomitant therapy included hepatitis A virus vaccine (manufactured unspecified) and MENACTRA. The registered nurse reported that the patient did not pass out, because the patient was squeezing her hand, but the mother thought that the patient passed out. This is one of the reports from the same source additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Dysmenorrhoea, Haematocrit decreased, Menorrhagia, Von Willebrand's factor antigen normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with GARDASIL, 0.5 ml, intramuscular route. The physician reported that the patient developed painful menses after a vaccination with GARDASIL. The patient sought medical attention at physician's office. At the time of the report the patient had not recovered. Follow-up information has been received from the physician who reported that the patient with no drug allergies who in September 2007 received the first dose of GARDISIL. In September 2007, the patient developed right lower quardrant pain and heavy mense and had since started on oral contracptive pills with continued mild right lower quadrant pain. Laboratories test were performed. In December 2007, a whole blood hematocrit was 39.7, in April 2008 was 23.6 and was Willebrand factor antigen test was negative, and in June 2008 whole blood hematocrit was 39.3. At the time of reporting, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Aggression, Laboratory test abnormal, Ovarian cyst
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL, lot number was not provided. A week later the patient developed atypical aggressive behavior. The patient did have some tests (unspecified) done and was diagnosed with having an ovarian cyst but that since has resolved. The patient sought unspecified medical attention. the patient will not receive the second and third dose of GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain in extremity, Pregnancy test positive
Clinical narrative: Information has been received from a 18 year old female with allergy to dust and mold who on 22-MAY-2008 was vaccinated with the first dose of GARDASIL and with the second dose of GARDASIL on 11-JUL-2008. There was no concomitant medication. On 07-AUG-2008 (last Thursday) the patient found out she was pregnant. On 12-JUL-2008 the patient experienced arm soreness which subsided on 13-JUL-2008 and went away on 14-JUL-2008. Therapy with human papilloma virus vaccine was discontinued. Her last menstrual period was approximately on 30-JUN-2008. On 07-AUG-2008, was performed a pregnancy test resulting positive. Estimated date of delivery approximately on 06-APR-2009. The patient sought medical attention by seeing a doctor. Additional information is not available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient with a history of seizures up until 8 years old, who on 16-JUL-2008 was vaccinate with the first dose of GARDASIL (lot # 660557/0072X). Concomitant therapy included DEPO-PROVERA two days before GARDASIL. On 16-JUL-2008, the patient experienced fainting 15 minutes later after vaccination. The patient hit her head when she fainted. The patient recovered on an unspecified date. Th patient sought medical attention. There was no product quality complaint. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Eye burns, Medical device complication, Paranasal sinus discomfort
Clinical narrative: Information has been received from a medical assistant concerning a female medical assistant. On 12-AUG-2008 the medical assistant was preparing to attach a needle to prefilled GARDASIL syringe (Lot # 0250X) when the vaccine splashed into her left eye. She was going administer the injection, so before she attached the needle, she was trying to take off the gray colored syringe tip cap, when the plunger popped out through the back end and the vaccine splashed into her eyes. The safety device did not activate. The needle was not attached. The syringe was empty and there in no vaccine left. the syringe was the first one on the right side of the tray, when they took it out for use. There was no damage to the package or the tray. The medical assistant has been administered GARASIL vaccine for a long time. When the vaccine splashed into her left eye, she immediately flushed her eye. The eye was irrigated but still "Burns a little." There was no redness or pain. There was slight burning sensation and irritation in her sinuses. No visual problems are noted. At the time or the report the patient had not recovered. Information has been received from a medical assistant regarding GARDASIL in a prefilled syringe (lot number: 0250X). It was reported that the plunger of the vaccine prefilled syringe "came out the wrong way" as the tip cap was being removed. SR Number: 1-3088949518. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Skin hyperpigmentation
Clinical narrative: Information has been received from a physician concerning an approximately 23 year old female with history of hyper pigmentation, who on 01-JUL-2008 was vaccinated with the second dose of GARDASIL. The physician reported that the patient developed hyper pigmentation on her skin where the vaccine was given. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 29-APR-2008 was vaccinated with the first dose of GARDASIL (lot # 557622/0388U). On 29-APR-2008 the patient developed a localized rash at the injection site. As of 06-MAY-2008, the rash spread over the body and still persisted. The patient sought unspecified medical attention. Additional information has been requested
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Nausea, Syncope, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with no pertinent medical history and no drug reactions or allergies, who on 11-OCT-2006 was vaccinated with the first dose of GARDASIL 0.5 mL IM. On 05-APR-2007, the patient was vaccinated with second dose of GARDASIL 0.5 mL IM. On 08-JUN-2007, the patient received the third dose of GARDASIL 0.5 mL IM. On 23-JUL-2008, the patient received a fourth dose of GARDASIL (lot # 658558/1061U) 0.5 mL IM. Concomitant therapy included DEPO-PROVERA on 23-JUL-2008. Two weeks ago (approximately 29-JUL-2008), the patient developed the following symptoms: fainting, dizziness, nausea and vomiting. The patient sought medical attention and was seen by the nurse practitioner. No labs diagnostics studies were performed. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Drug hypersensitivity, Pruritus, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with penicillin allergy who on unspecified dates was vaccinated with the first and second doses of GARDASIL. In October 2007, was vaccinated with a third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). In October 2007, the day after administration of her third dose, the patient developed pruritic urticaria in different areas of her body every day. An skin biopsy was performed on 21-JUL-2008 and the results showed urticarial lesion due to systemic antigen including drug. She has been treated with steroid dose packs, antihistamine and KENALOG INJECTIONS. She has been also examined by an allergist but the information is not available. At time reporting, the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Information has been received form an healthcare worker (also reported as an office administrator) concerning a 25 year old female patient who in May 2008, was vaccinated with the third dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. On a date reported, the patient was seen by an orthopedic surgeon for pain at the shoulders and knees and numbness in ankles and feet. The orthopedic surgeon was unable to find the cause and referred the patient to another orthopedic surgeon. As of 12-AUG-2008 the patient's symptoms persisted. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 25 year old white female who on 01-MAY-2008, at 11:30 AM, was vaccinated with a first dose of GARDASIL (Lot # 654272/0073X), intramuscularly into the first deltoid. It was reported that on 01-MAY-2008 (reported as 11:30 AM), patient had not eaten and within minutes, she a fainting episode. Patient was given juice and cookies and responded favorably. The patient recovered. Subsequent injection, on 01-JUL-2008 went without problems. It was not specified if there was illness at the time of vaccination. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from the mother concerning her daughter who a couple of weeks ago was vaccinated with the first dose of GARDASIL. On an unknown date, the patient experienced leg pain associated with joint pain for about two weeks. This was just reported to the doctor. The pain has resolved and the parent doesn't want the daughter to receive the second or third dose. Patient was not given other medications and not involved in heavy exercise. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Skin papilloma
Clinical narrative: Information has been received from a registered nurse concerning the daughter of a physician who was vaccinated an unknown dose of GARDASIL (Lot number not reported). After the vaccination the patient developed the "wart like rashes" on her body. It was unknown if the patient sought medical attention. The patient's "wart like rashes" persisted. This is one of the several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning her 22 year old daughter with CECLOR allergy who on 11-AUG-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On 12-AUG-2008 the patient developed fever of 100 degrees F and headache. The patient's fever persisted and was still present at the time of the report. The headache was not a complaint at the time of the report. The patient was treated with acetaminophen. The patient did not seek medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Injection site pain
Clinical narrative: Information has been received concerning a 10 year old female who within the last month (in July 2008), was vaccinated with the first dose of GARDASIL (Lot No. not reported). The patient complained that the injection was very painful and she cried. She was given 4 other injections after that. They gave her ice and elma after. The outcome of the adverse events was not reported. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 21 year old female with no pertinent medical history or drug reactions or allergies who in February 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 658563/1063U). There was no concomitant medication. In approximately March 2008, "about 1 month after the first dose", the patient was not feeling well. The CMA thought she was referring to flu-like symptoms. Subsequently, on an unspecified date the patient recovered from not feeling well and flu-like symptoms. The patient did not seek medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on approximately 30-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included "other vaccines" (therapy unspecified). On approximately 30-JUL-2008, the patient fainted and her blood pressure drop after vaccination with GARDASIL and other vaccines gave at the same time. The patient sought medical attention. On an unspecified date the patient recovered. This is one of two reports from the same source. Additional information has been requested. The doctor was going to call an ambulance for one of the girls (unspecified).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Fatigue, Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions or allergies who on 09-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. On 18-JUL- 2008 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot no. 0250X). There was no concomitant medication. The patient experienced almost identical symptoms after receiving the first and second dose. The patient developed enlarged lymph nodes with fatigue and lower abdominal pain within 24 hours of the vaccinations. The symptoms disappeared within 36 to 72 hours after the vaccination in both cases. The patient called the physician to seek unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female with a history of "passing out" while having her blood drawn in the past who on 13-AUG-2008 was vaccinated with the first dose of GARDASIL. After receiving the first dose, the patient "passed out". No injuries noted. The outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her friend, an 18 year old female with no pertinent medical history and no history of drug reactions or allergies who in April 2008, was vaccinated with the second dose of GARDASIL 0.5ml and VAQTA . Soon after the vaccination the patient experienced a stiff neck, pain in her legs, arms and stomach. The patient may or may not be pregnant but if she was, she would only be approximately 5 days. The patient also received her second dose of GARDASIL later than the recommend 2 months after the first dose (specific time was not provided). The patient's adverse events persisted. The patient didn't seek medical attention. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac flutter, Dizziness
Clinical narrative: Information has been received from a physician office manager concerning an 18 year old female with mitral valve prolapse and polycystic ovarian syndrome, a history of kidney stone and no history of drug reactions or allergies who on 30-JAN-2008 was vaccinated with the first dose GARDASIL (lot#: 654535/0950F) 0.5ml IM and on 31-MAR-2008 was vaccinated with the second dose of GARDASIL (lot#: 659962/1740U). Concomitant therapy included hydrochlorothiazide, Mg oxide, pyridoxine, ZOLOFT, YAZ and polycitric K crystals. In mid May 2008 the patient experienced dizziness and heart flutter. Subsequently, the patient recovered from dizziness and heart flutter. The patient sought medical attention with a telephone call. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 23 year old female with no pertinent medical history and no known drug allergies who on 02-NOV-2007, 17-JAN-2008 and 16-MAY-2007, was vaccinated intramuscularly with her first, second and third 0.5 ml doses, respectively, of GARDASIL (Lot # of the first dose 659435/1265U, Lot # of the second dose of 558282/1263U, Lot # of the third dose 658490/0802U). There was no concomitant medication. On 16-MAY-2008, after receiving the third dose GARDASIL, the patient became warm and sweaty. She fainted and was unconscious for 45 seconds. The patient had only eaten fruit prior to administration of GARDASIL. Subsequently, on 16-MAY-2008 the patient recovered from the events. The adverse events happened during office visit. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 20 year old female with no medical history or no known drug allergies who on 12-AUG-2008 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # 658490/0802U). There was no concomitant medication. On 12-AUG-2008 the patient experienced syncope after administration of GARDASIL. The patient became warm and sweaty. She fainted and was unconscious for 45 seconds. The patient had only eaten fruit prior to administration of GARDASIL. Subsequently, on 16-MAY-2008 the patient recovered from the events. The adverse events happened during office visit. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse concerning a12 year old female with no allergies who in 2007 was vaccinated with GARDASIL (lot # not reported). In September 2007, 11 months ago, the patient experienced headaches. The patient's headaches persisted. The patient sought medical attention seen by the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 24-JUn-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. Concomitant therapy included HAVRIX and ADACEL. On 24-JUn-2008 the patient experienced lethargic for about 24 hours after vaccination. Subsequently, the patient recovered from lethargic for about hours. The patient sought medical attention and called office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history and no allergies who on 08-JUL-2007 was vaccinated with the first dose of GARDASIL 0.5 ml IM (lot # 660387/1967U). Concomitant therapy included NUVARING (birth control) and Ibuprofen as needed. The patient developed rash over her back 3-5 days after vaccination. The patient's mother called the office since the rash has persisted and she was referred to dermatologist. According to the patient's mother the rash looks like "blotches over the back like a sun burn. There is no itch and it is not raised." The patient was noted to be recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's nurse concerning a female who "about one year ago", in approximately August 2007, was vaccinated intramuscularly with 0.5 ml dose of GARDASIL. In approximately August 2007, after receiving GARDASIL, the patient fainted. Subsequently, the patient recovered an later completed the GARDASIL series with no other symptoms noted. The patient was seen in office. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Nausea, Palpitations, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old female, who on 06-FEB-2008 was vaccinated with the first dose of GARDASIL (lot# 654488/1264U). On 07-APR-2008, the patient was vaccinated with the second dose of GARDASIL (lot# 659655/1486U). After receiving the first and second dose of GARDASIL, the patient experienced dizziness, nausea and heart palpitations. The patient also experienced fever after the second dose. The patient's symptoms started the same vaccination days. The AE symptoms began in the physician's office and unspecified medical attention was sought. Follow-up information was received which reported that the patient recovered from dizziness, nausea, heart palpitations, chills and fever the same date that the adverse events started. The patient also experienced a Fever on 06-FEB-2008. Also, chills and fever were reported in one occasion all day long. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 17 year old female, who on 06-FEB-2008 was vaccinated with the first dose of GARDASIL (lot# 654488/1264U). On 07-APR-2008, the patient was vaccinated with the second dose of GARDASIL (lot# 659655/1486U). After receiving the first and second dose of GARDASIL, the patient experienced dizziness, nausea and heart palpitations. The patient also experienced fever after the second dose. The patient's symptoms started the same vaccination days. The AE symptoms began in the physician's office and unspecified medical attention was sought. Follow-up information was received which reported that the patient recovered from dizziness, nausea, heart palpitations, chills and fever the same date that the adverse events started. The patient also experienced a Fever on 06-FEB-2008. Also, chills and fever were reported in one occasion all day long. No further information is available.