chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Skin burning sensation
Clinical narrative: Information has been received from a 27 year old female consumer with a history of yeast infection (after taking antibiotics) and allergic reaction to antibiotics telithromycin KETEK and levofloxacin LEVAQUIN, who on 12-MAR-2007 was vaccinated with a third dose of Gardasil. There was no concomitant medication. On 26-MAR-2007, the consumer developed a yeast infection two weeks later. It was reported that the consumer was initially treated with antibiotics (name not known) for treatment of what they thought was a urinary tract infection. She was then given fluconazole (DIFLUCAN) which did not resolve the yeast infection, and metronidazole (FLAGYL) which still has not resolved the yeast infection. It was reported that the consumer continues to experienced burning, itching and discomfort. Her symptoms have not changed in intensity. On 07-JUN-2007, a culture was taken that showed a yeast infection. It was reported that the consumer did not experience any difficulties after the last two vaccinations. At the time of this report, the consumer was reported to be recovering. It was reported that on 26-AUG-2006, the patient was vaccinated IM with a 0.5ml dose of Gardasil (Lot # 654540/0800F). No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7-16/2007. Information has been received from a 27 year old female consumer with a history of yeast infection (after taking antibiotics), endometriosis and allergic reaction to antibiotics KETEK and LEVAQUIN, who on 12-MAR-2007 was vaccinated into the left hip with a third dose of GARDASIL (Lot # 654540/0800F). There was no concomitant medication. About one week after the vaccination, the patient experienced severe itching, burning and pain. On 26-MAR-2007 two weeks later, the consumer developed a yeast infection. It was reported that the consumer was initially treated with antibiotics SEPTRA DS, MACRODANTIN for treatment of what they thought was a urinary tract infection. She was then given DIFLUCAN which did not resolve the yeast infection, and FLAGYL which still has not resolved the yeast infection. On 07-JUN-2007, a culture was taken that showed a yeast infection. It was reported that the consumer did not experience any difficulties after the last two vaccinations. It was reported that the symptoms lasted for two and a half months. Subsequently, the patient was recovering from yeast infection. It was reported that on 26-AUG-2006, the patient was vaccinated IM with a 0.5ml dose of GARDASIL (Lot # 654540/0800F). No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot number unknown). The registered nurse reported that after receiving the HPV the patient walked down the hall and fainted. The nurse was behind her and she fainted into the physician's arms. Medical attention was sought. The patient was placed on the chair and she was fine. At the time of reporting patient had recovered. Further information was not provided. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a registered nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number 655618/0186U) IM in the right deltoid. There was no concomitant medication used. On 21-APR-2007 the patient was vaccinated with a second dose of GARDASIL (lot # 655618/0186U) IM in the right deltoid. The registered nurse reported that after receiving the GARDASIL the patient walked down the hall and fainted. The nurse was behind her and she fainted into the physician's arms. Medical attention was sought. The patient was placed on the chair and she was fine. At the time of reporting patient had recovered. Further information was not provided. Follow-up information was received. The lot number and dates were updated. Within 5 minutes of injection as the patient rose to exit, the patient became lightheaded and complained of being dizzy. The mother was present. The patient required reclining position for 5 minutes. The patient stayed conscious and felt fine in 10 minutes. At the time of reporting the patient recovered on 21-APR-2007. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dysmenorrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a immunization coordinator concerning a female who was vaccinated with a first dose of Gardasil. Subsequently after the first dose the patient experienced abdominal cramping similar to menstrual cramps. Unspecified medical attention was sought. Subsequently, the patient recovered from the abdominal cramping similar to menstrual cramps. The patient was vaccinated with a second dose of Gardasil. Subsequently after the second dose the patient experienced abdominal cramping similar to menstrual cramps. Unspecified medical attention was sought. Subsequently, the patient recovered from the abdominal cramping similar to menstrual cramps. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial information has been received from an immunization coordinator concerning a 14 year old female who on 19-APR-2007, at 1:30 pm was vaccinated with a first dose of GARDASIL (lot # 653937/0637F). On 19-APR-2007 one hour after the first dose the patient experienced lower abdominal cramping similar to menstrual cramps. No treatment was required. Subsequently, the patient recovered from the lower abdominal cramping similar to menstrual cramps after 48 hours. On 14-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot # 657006/0188U). On 14-JUN-2007, one hour after vaccination after the second dose the patient experienced lower abdominal cramping similar to menstrual cramps. Subsequently, the patient recovered from the lower abdominal cramping similar to menstrual cramps after 48 hours. No treatment was required. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Labia enlarged, Local swelling
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 19 year old female with no drug reactions/allergeries who on 14-JUN-2007 was vaccinated intramuscularly into the right deltoid with the first dose of Gardasil (lot # 0211U). On 15-JUN-2007, the patient experienced "swelling in the groin area and the labia". The patient sought unspecified medical attention. The patient was advised to use miconazole nitrate (MONISTAT) and go to the emergency room if symptoms did not improve. The patient outcome was unknown at the time of the report. Follow-up information was received from the LVN. The patient was advised to take Benadryl.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician's assistant, for the Pregnancy Registry for Gardasil concerning a 21 year old white female with pelvic inflammatory disease and a history of gastrooesophageal reflux disease and penicillin allergy. On 04-DEC-2006 the patient was vaccinated with the first dose of Gardasil (Lot # 653736/0868F) 0.5 mL IM in the left arm and on 23-MAR-2007 with the second dose of Gardasil (Lot # 657006/0188U) 0.5 mL IM. Concomitant therapy included PREVACID and NESTABS FA TABLETS. The patient developed abdominal cramps on 23-APR-2007 and presented to the doctor's office. Medical attention was sought. Serum beta-human chorionic gonadotropin and urine beta-human chorionic gonadotropin tests were performed to confirm pregnancy. The patient was referred to a Ob/Gyn for follow-up care. No additional information was given. The date of the last menstrual period was 14-MAR-2007, the estimated conception date is 28-MAR-2007 and the estimated delivery date is 20-DEC-2007. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician's assistant for the Pregnancy Registry for GARDASIL concerning a 21 year old female with pelvic inflammatory disease and a history of gastrooesophageal reflux disease and penicillin allergy. On 04-DEC-2006 the patient was vaccinated with the first dose of GARDASIL (Lot # 663736/0868F) 0.5 mL IM in the left arm and on 23-MAR-2007 with the second dose of GARDASIL (Lot # 657006/0188U) 0.5 mL IM. Concomitant therapy included PREVACID and Nestabs FA tablets. The patient developed abdominal cramps on 23-APR-2007 and presented to the doctor's office. Medical attention has sought. Serum beta-human chorionic gonadotropin and urine beta-human chorionic gonadotropin tests were performed to confirm pregnancy. The patient was referred to a Ob/Gyn for follow-up care. The date of last menstrual period was 14-MAR-2007 the estimated conception date is 26-MAR-2007 and the estimated delivery date is 20-DEC-2007. No additional information was given. Follow-up information was received from a healthcare worker. The health care worker indicated that the patient delivered a normal healthy baby girl. Additional follow-up information was received. The baby was born on 16-DEC-2007 weighed 5 pounds and 12 ounces. The length was 19 1/2 inches and was 48 weeks from LMP. The head circumference was 12 1/2. The patient had a low fundal height and her pitocin was enhanced. On an unspecified date an ultrasound was performed. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 07-MAY-2007 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 21-MAY-2007, two weeks after getting the vaccination, the patient developed a "besicular" rash. The patient was seen by her physician again on 14-JUN-2007 and the rash had continued to spread. The course of treatment for the rash included PREDNISONE and ZYRTEC. The "besicular" rash persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Initial and follow-up information has been received from a physician concerning a 17 year old female with a history of psoriasis who on 07/MAY/2007 was vaccinated with the first 0.5 ml dose of GARDASIL.  On approximately 21-MAY-2007, two weeks after getting the vaccination, the patient developed a rash on her thighs, arms, abdomen and back which was macular in nature and itchy.  The patient was seen by her physician on 14-JUN-2007.  The course of treatment for the rash included PREDNISONE and ZYRTEC.  The rash lasted for more than three weeks after the patient was vaccinated with the first dose of GARDASIL.  At the time of the report, the patient had recovered.  There were no laboratory or diagnostic tests performed.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/14/2007. Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history or drug reactions/allergies who on 07-APR-2007 approximately was vaccinated with a first dose of Gardasil (lot # 656566/1511F) in the left arm IM. There was no concomitant therapy. Almost immediately after receiving Gardasil, the patient fainted. Medical attention was sought. The nurse practitioner had made the patient sit in the waiting room until she felt better. Patient seemed to have recovered momentarily after sitting in the waiting room. Further information was not provided. Follow-up information was received. The age, date of vaccination and lot number updated. It was reported that the patient fainted during immunization. The patient was assisted to the table. A blood pressure measurement was performed and the results were 103/70. The patient was given juice and rest. On 07-APR-2007 the patient recovered and discharged home. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a "high-grade" positive HPV on a PAP smear. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature normal, Headache
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. initial and follow-up information has been received from a physician and a registered nurse concerning a 17 year old female who on 15-MAY-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On 15-MAY-2007 the patient experienced off and on headaches. The patient sought unspecified medical attention. On 17-MAY-2007, the patient recovered from off and on headaches. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 28 year old female who was vaccinated with the first dose of GARDASIL vaccine, on 07-MAY-2007. Two days after receiving the first injection, she experienced swelling in her lymph nodes (under her arm and in her neck). She sought unspecified medical attention. There were no diagnostic or laboratory tests performed. Subsequently the patient recovered. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL vaccine. She did not have any adverse reactions to the second dose. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 20 year old female who on 07-MAR-2007 was vaccinated intramuscularly with 0.5 ml dose of Gardasil. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). On 09-MAR-2007, the patient's right lymph node swelled to the size of a marble. She sought unspecified medical attention. The patient reported that she recovered 1 1/2 weeks after the swelling began. On an unspecified date, the patient was vaccinated intramuscularly with 0.5 ml of the second dose of Gardasil. Two days after the vaccination, the patient's left lymph node swelled to the size of a marble. The patient sought unspecified medical attention. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a kidney condition for which she is being treated who on an unspecified date was vaccinated with Gardasil (lot number unknown) injection. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). About an hour after being vaccinated with Gardasil the patient developed a rash all over her body. Medical attention was sought. The physician advised the patient to take diphenhydramine hydrochloride (BENADRYL) and to follow up with the office if the problem persisted. The patient has not contacted the office yet. The physician reported that it was not an anaphylactic type of reaction. No additional information is provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil. Subsequently the patient developed "swollen lymph nodes". Unspecified medical attention was sought. The outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a Nurse Practitioner (N.P.) concerning a 17 year old female student who on 18-JUN-2007 was vaccinated with a first dose of Gardasil. On 18-JUN-2007, after "her first injection the patient developed 3 1/2-4 centimeter red spot at injection site and it was swollen and itchy." The nurse practitioner then applied diphenhydramine hydrochloride (BENADRYL) and the patient was fine after that. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Stomach discomfort, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on 08-JUN-2007 "ten days ago", was vaccinated with a first dose of Gardasil. On 08-JUN-2007, the patient fainted after getting injection site Gardasil. The physician also reported that the patient felt dizzy and was sick to the stomach after the injection. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 year old female with no medical history or allergies, who on 27-FEB-2007 at 16:30 was vaccinated IM into the right arm with a first dose of GARDASIL vaccine (lot # 656372/0243U). About 5 minutes later the patient was on the floor because she had fainted and nauseous. It was reported that she sat for a few minutes and "felt fine" and was sent home. On 30-APR-2007 at 13:30, the patient was vaccinated IM into the left arm with a second dose of GARDASIL vaccine(lot# 657622/0388U). Immediately, the patient experienced the same symptoms and became nauseous and vomited. The patient did not faint. It was reported that afterward she was better. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. It was reported that the patient recovered in minutes. Additional information has been requested
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Chlamydia identification test negative, Smear cervix normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on an unspecified date was vaccinated with a first dose Gardasil (lot number unknown). Subsequently the patient developed genital warts. At the time of reporting it is unknown if the patient has recovered. Additional information was unavailable. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL vaccine. Subsequently the patient experienced sore throat and fever after the first and second dose. No medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no drug reactions or allergies with hypertension and asthma who on 13-APR-2007 was vaccinated intramuscularly into the left deltoid muscle with the first dose of Gardasil, (Lot # 656050/0245U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN LO), fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA-D), hydrochlorothiazide (manufacturer unknown), albuterol, bupropion HCl (WELLBUTRIN), atomoxetine hydrochloride (STRATTERA) and venlafaxine HCl (EFFEXOR). On 13-APR-2007 the patient developed hives after receiving her first dose of Gardasil. The hives were mostly on her vaccinated arm. The patient sought unspecified medical attention. The hives disappeared the next day, 14-APR-2007. No further information was available. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. In follow-up it was reported that the patient was a female with an allergy to cat hair, asthma and hypertension, who reported an annual gynecology exam with no significant problems. It was reported the patient received the GARDASIL in the left deltoid muscle on 13-APR-2007 at 10:00 a.m. It was reported that on 13-Apr-2007, the patient experienced hives on the left arm in the afternoon of the day of injection and went into the evening. The hives were "stnowen" on 14-APR-2007. It was reported the patient recovered on 14-APR-2007. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 year old female who on approximately 18-JUN-2007 was vaccinated IM with a third 0.5 ml dose of Gardasil (lot# 657868/0523U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On 18-JUN-2007, the patient experienced redness and a rash at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 18-JUN-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female who on 24-APR-2007 and on approximately 18-JUN-2007 was IM vaccinated with a first and second 0.5 ml dose of Gardasil (lot# 657868/0523U), respectively. Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). On 18-JUN-2007,the patient experienced redness and a rash at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 18-JUN-2007, the patient recovered. It was reported that there were no problems after she received the first dose. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been released from a physician, via a company representative, concerning a 26 year old female patient, who on 18-JUN-2007 was vaccinated with the second of Gardasil (Lot #657736/0389U). On 18-JUN-2007, two hours after the vaccine was administered, the patient experienced ongoing numbness and tingling in her legs. At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a certified medical assistant concerning a 26 year old female with no medical history or allergies, who on 18-JUN-2007 was vaccinated intramuscularly into the right arm with a 0.5mL second dose of Gardasil (lot#657736/0389U). Subsequently, on 18-JUN-2007 the patient experienced numbness and tingling in both legs. The patient called the office on 19-JUN-2007 and stated that the symptoms had not resolved. She stated that it's "a weird kind of sensation." The patient had a follow up appointment. She is able to walk and is at work. No lab or diagnostic studies were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with Gardasil. After receiving Gardasil, the patient passed out, hit her head on the tablet resulting in a concussion. Therapy with Gardasil was discontinued. As of 19-JUN-2007, the patient had improved after stopping therapy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated on an unknown day with a third dose of Gardasil. The patient fainted after her third injection. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea, Pain
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who on 15-JUN-2007, was vaccinated IM with a first dose of Gardasil. A few minutes later the patient started sweating profusely and became nauseous. The patient also complained that the injection hurt when she was getting it. No medical attention was sought. No laboratory diagnostic studies were performed. Within 5 minutes, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 24 year old female with stress, human papilloma 5B and cervical intraepithelial neoplasic I  who on 05-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (lot # 657617/0384U). Concomitant therapy included sertraline HCl (ZOLOFT) and amoxicillin. On 18-JUN-2007, the patient developed a red rash on her chest and back. The patient sought unspecified medical attention. No other symptoms were noted. At the time of the report, the patient was recovering. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. One week later, the patient developed a yeast infection and she sought unspecified medical attention. Subsequently she recovered from the yeast infection. On an unspecified date, the patient was vaccinated with the second dose of Gardasil and developed a yeast infection one week later. She sought unspecified medical attention and subsequently recovered. On an unspecified date, the patient was vaccinated with the third dose of Gardasil. With the third dose, the physician gave the patient unspecified medication along with the dose and no yeast infection occurred. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who was vaccinated with Gardasil. Subsequently, the patient experienced "stinging pain at the injection site". The patient sought unspecified medical attention. She recovered on an unspecified date. 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 on 18-JUN-2007 was vaccinated intramuscularly with the second dose of Gardasil (lot # 655618/0186U). On 18-JUN-2007, ten minutes after receiving the vaccination, the patient became "light-headed". It was reported that after the physician gave her water and she sat down for a while, she felt fine. The patient recovered after "a few minutes". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who was vaccinated (date unspecified), with the second dose of Gardasil. The patient indicated that the shot "was very painful," and the physician reported that her arm was "still hurting" two weeks later. At the time of this report, the patient had not recovered from the arm pain. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) was vaccinated with a dose of Gardasil. Subsequently, after receiving the vaccination the patient fainted. The patient sought unspecified medical attention. At the time of the report, the patient had recovered on unspecified therapy. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning "many patients" who were vaccinated with a dose of Gardasil. Subsequently, the patients reported that the vaccination was painful. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Headache, Inappropriate schedule of drug administration, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who on 17-APR-2007 was vaccinated with a first dose of Gardasil (lot#656051/0224U). Concomitant suspect vaccinations received on 17-APR-2007 included Varivax and Vaqta (manufacturer unknown). Other concomitant therapy included DTaP (unspecified) (+) tetanus toxoid. Subsequently, after being vaccinated with a first dose of Gardasil (lot#656051/0224U) the patient fainted a few minutes after administration. It was also reported that when the patient was vaccinated with a second dose of Gardasil (lot#657868/0523U), 15 minutes later the patient experienced light headedness, nausea, and a headache. The physician reported that "the patient got well" on the same day that she received the first and second dose. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 year old female with Asthma, Allergic Rhinitis, and no drug allergies, who on 08-SEP-2006 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included ZYRTEC and ADVAIR. About 48 hours after vaccination on approximately 10-SEP-2006 the patient experienced hives mainly on her face and neck. She was treated with BENADRYL and ZYRTEC. In approximately November 2006, a test dose was given intradermally which resulted in a positive allergic reaction. The second dose of Gardasil was not administered due to the patient's suspected allergy to the vaccine. The patient sought unspecified medical attention. No lab diagnostic studies were performed. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female, who did not eat anything and was very anxious before the vaccine, who on 19-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. The patient fainted immediately following the injection. Unspecified medical attention was sought. there were no laboratory or diagnostic tests performed. At the time of the report the patient was recovering. The physician reported that the patient will continue the series of vaccines. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: DTAP, HPV4, MEN
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Inappropriate schedule of drug administration, Pallor
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 18-JUN-2007 was vaccinated with a 0.5ml first dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified) and DTaP (+) tetanus toxoid. On 18-JUN-2007 the patient became pale, woozy and began sweating. The patients blood pressure measurement was low. She laid down and had some orange juice and crackers. On 18-JUN-2007, the patient recovered from becoming pale, woozy and sweating, and low blood pressure Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female with chronic vaginitis who on 17-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 57736/0389U). There was no concomitant medication. On 19-MAY-2007 the patient developed a rash on her interior and posterior trunk and a little bit on her arms. The rash was described as kind of flat and raised, and was itchy and red. The patient went to the urgent care emergency room and was administered steroids which helped the rash. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with a history of colitis who on 16-ARPR-2007 was vaccinated IM with the first dose of Gardasil (lot # 657621/0387U). On 19-JUN-2007 was vaccinated IM with the second dose of Gardasil (lot # 0211U). Concomitant therapy included FEMCON FE. Immediately after the second dose the patient experienced "extreme lightheadedness and dizziness". Unspecified medical attention was sought. The registered nurse reported the symptoms lasted "within 10 minutes or so". On 19-JUN-2007, the patient recovered from "extreme lightheadedness and dizziness". There were no laboratory or diagnostic tests performed. It was reported that the patient did not experience any symptoms after receipt of the first dose. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Initial and follow-up information has been received from a registered nurse concerning a 26 year old female with a history of colitis who on 16-APR-2007 was vaccinated IM with the first dose of GARDASIL (lot # 657621/0387U).  On 19-JUN-2007 was vaccinated IM with the second dose of GARDASIL (lot # 0212U).  Concomitant therapy included FEMCON FE.  Immediately after the second the patient experienced "extreme lightheadedness and dizziness".  Unspecified medical attention was sought.  The registered nurse reported the symptoms lasted "within 10 minutes or so".  On 19-JUN-2007, the patient recovered from "extreme lightheadedness and dizziness".  There were no laboratory or diagnostic tests performed.  It was reported that the patient did not experience any symptoms after receipt of the first dose.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Body temperature increased, Lip blister, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a office assistant concerning a 23 year old female with drug hypersensitivity to aspirin who on 11-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657868/0523U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) Norethindrone acetate (LOESTRIN 24 FE). On 11-JUN-2007 in the evening, the patient experienced fever 100-101F, stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips. Unspecified medical attention was sought. The patient's fever 100-101F and stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation, Swelling
Clinical narrative: Information has been received from a office assistant concerning a 23 year old female with drug hypersensitivity to aspirin who on 11-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657868/0523U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) Norethindrone acetate (LOESTRIN 24 FE). On 11-JUN-2007 in the evening, the patient experienced fever 100-101F, stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips. Unspecified medical attention was sought. The patient's fever 100-101F and stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 year old female, with no pertinent medical history, who on 20-APR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 0210U). On 18-JUN-2007 was vaccinated IM into the right deltoid with a 0.5 ml second dose of Gardasil (lot # 0210U). There was no concomitant medication. On 15-JUN-2007 at 3:00 pm, (previously reported as later that evening), the patient experienced dizziness and nausea. Unspecified medical attention was sought. The patient's dizziness and nausea persisted. The certified medical assistant reported that the patient did not experience any difficulties with the 20-APR-2007 first dose. Additional information has been requested.  Additional infromation is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a mother concerning her daughter who on unspecified dates was vaccinated with first and second doses of Gardasil. Her daughter only took 2 doses of the vaccine and had to stop. Subsequently, it was reported that the patient's body had rejected the vaccine. Unspecified medical attention was sought. The patient was seen by a neurologist. The patient's outcome was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 18-JUN-2007 was vaccinated with Gardasil. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, tuberculin purified protein derivative and MENACTRA. On 18-JUN-2007 the patient experienced syncope. Subsequently, the patient recovered from syncope. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 18-JUN-2007 was vaccinated IM with Gardasil and fainted after receiving the injection. 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 who on 19-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # 655618/0186U) and immediately fainted. It was reported that the patient "came back on her own" 15 seconds later. Concomitant therapy included hepatitis A virus vaccine (unspecified). The patient sought unspecified medical attention. It was also reported that the patient was menstruating at the time. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Information has been received concerning a "below 20" year old female (age estimated) who on an unspecified date was vaccinated with Gardasil (Lot number unknown). Concomitant medication was not reported. On an unspecified date the patient experienced burning, redness and a little bit of pain at the injection site after receiving a dose of Gardasil. At the time of reporting, the outcome causality were not reported. No further information was available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Cyst, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old female or older who in approximately May 2007, was vaccinated with Gardasil (lot number unknown) 0.5 mL IM. In approximately May 2007, the patient complained of pain in the arm where she received the injection for over a month. Medical attention was sought. An MRI was performed on an unspecified date and the results showed a "8mm fluid sac". It was reported that it was not known if the fluid sac was the injection site. At the time of reporting the patient has not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse in an OB/GYN office concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On an unspecified date the patient experienced headaches that lasted for 30 days unspecified. Medical attention was sought. The nurse reported that when the patient called into the OB/GYN office, there were no documents stating that the patient had received the Gardasil and that the last patient visit was August 2006. The nurse believed that the patient may have received the vaccination for her primary care physician. The nurse was unsure the patient had received the vaccine in their OB/GYN office. At the time of reporting, it was unknown if the patient had recovered. Additional information has been requested available. Further information is not available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Metrorrhagia
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with an allergy to Zithromax who on 17-JAN-2007 was vaccinated IM with a 0.5 mL of the first dose of Gardasil. Concomitant therapy included acetaminophen/codeine phosphate (TYLENOL WITH CODEINE) and albuterol. On 24-MAR-2007 the patient was vaccinated with the second dose of Gardasil and is now pregnant. Her LMP is 13-APR-2007. On 18-JUN-2007 the patient experienced light spotting and stomach cramps. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning 3 females who were vaccinated with the first dose of Gardasil (Lot # 656372/0243U). Subsequently the patients experienced metal taste in their mouths five minutes after receiving the vaccine. Medical attention was sought. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no pertinent medical history and seasonal allergies who on 04-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # "0524U") 0.5 mL IM. Concomitant therapy included YASMIN and CLARITIN. The physician reported that after receiving the Gardasil the patient experienced a syncope episode for 45 seconds. Medical attention was sought. The patient was back to normal within 2 minutes. The doctor feels the patient was not accustomed to receiving injections. At the time of reporting the patient recovered. No additional information at this this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Follow-up information was received the adverse event was a brief syncope episode and no treatment was necessary.  Further information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a consumer concerning his niece who on 18-JUN-2007 was vaccinated with the first dose of Gardasil. On 19-JUN-2007, the patient experienced severe abdominal cramping "in the stomach area." The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report previously submitted on 07/16/2007 Initial and follow-up information has been received from a healthcare professional and a consumer concerning a 15 year old female who on 18-JUN-2007 was vaccinated in the left deltoid with the first dose of GARDASIL (lot #657868/0523U). On 19-JUN-2007, 24 hours post-vaccination, the patient experienced severe abdominal cramping in the stomach area, it was reported that the patient experienced the severe abdominal cramping on day two of her menstrual cycle. The patient sought unspecified medical attention. Subsequently, the patient recovered. No additional information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Initial and follow-up information has been received from a physician and a healthcare professional concerning a 14 year old female who on 24-APR-2007, at 15:30, was vaccinated in her left arm with the third dose of GARDASIL vaccine (lot #4657617/0384U). Subsequently, during the evening after vaccination, on 24-APR-2007, at 2:00, the patient developed a half-dollar, raised welt at the injection site. The patient sought unspecified medical attention. It was reported that the welt lasted for two days. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007.   On 25-APR-2007, the following day, the patient was recovered. No additional information is expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Disorientation, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with Gardasil. It was reported that the patient sat in the room for 10 minutes after receiving the vaccination and when she went to stand up she fainted. They took her to the waiting room to sit for a bit and when she went to stand up and leave she fainted again. The patient sought unspecified medical attention. No other information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 11 year old (previously reported as a 16 year old) female student, with no pertinent medical history, who on 12-JUN-2007 at 13:30 was vaccinated IM in the right deltoid with a first dose of GARDASIL (lot # 657868/0523U). Concomitantly with a second subcutaneously in the left arm of VARIVAX (lot # 657449/0597U), a first dose IM in the left deltoid with of BOOSTRIX (lot # AC52B011CA), a first dose IM in the left deltoid of HAVRIX (lot # AHAVB162D9), and a first dose IM in the right deltoid of meningococcal vaccine (unspecified) (lot # U1968AA). On 12-JUN-2007 at 13:35 the patient went to get up and became disoriented, developed pallor and was syncopal for a few seconds. (Previously reported as the patient sat in the room for 10 minutes.) It was reported that the patient awoke and unaware of what happened. Her total heartbeat count was reported as 78 and the blood pressure measurement was 92/60. The patient waited 15 minutes, then went to leave and was syncopal again for 3 seconds. She waited 30 minutes and then ambulated fine. On 12-JUN-2007, the patient recovered from being disoriented, pallor and fainting. Additional information is not expected.