chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a first and second dose of Gardasil (yeast). Subsequently the patient fainted 15 minutes after each vaccination. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician and a nurse practitioner concerning a 16 year old female with drug hypersensitivity to CECLOR who on 13-OCT-2006, at 15:00 was vaccinated, IM into the left arm with a first dose of GARDASIL (lot# 653978/0955F). The patient fainted 15 minutes after vaccination. On 13-Oct-2006, the patient recovered on her own with mild dizziness, oriented times 3. On 13-DEC-2006, at 15:30 the patient was vaccinated, IM into the right arm with a second dose of GARDASIL (lot# 654389/0961F). She again fainted 10 minutes after vaccination. On 13-DEC-2006, the patient recovered on her own, oriented time 3. There were no laboratory or diagnostic test performed. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a first and second dose of Gardasil (yeast). Subsequently the patient fainted 15 minutes after each vaccination. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician and a nurse practitioner concerning a 16 year old female with drug hypersensitivity to CECLOR who on 13-OCT-2006, at 15:00 was vaccinated, IM into the left arm with a first dose of GARDASIL (lot# 653978/0955F). The patient fainted 15 minutes after vaccination. On 13-Oct-2006, the patient recovered on her own with mild dizziness, oriented times 3. On 13-DEC-2006, at 15:30 the patient was vaccinated, IM into the right arm with a second dose of GARDASIL (lot# 654389/0961F). She again fainted 10 minutes after vaccination. On 13-DEC-2006, the patient recovered on her own, oriented time 3. There were no laboratory or diagnostic test performed. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with drug reactions/allergies to CECLOR and penicillin who on 13-OCT-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast), (lot#653978/0955F). Concomitant therapy included OVRAL. It was reported the patient fainted with the first vaccination. On 13-DEC-2006, the patient was vaccinated intramuscularly with the second 0.5 ml dose of Gardasil (yeast) (lot#65389/0961F). The patient lay down for 25 minutes after the vaccination to prevent fainting. It was reported that the patient fainted again while she walked out to the waiting room. The patient recovered on the same day. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with drug reactions/allergies to CECLOR and penicillin who on 13-OCT-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast), (lot#653978/0955F). Concomitant therapy included OVRAL. It was reported the patient fainted with the first vaccination. On 13-DEC-2006, the patient was vaccinated intramuscularly with the second 0.5 ml dose of Gardasil (yeast) (lot#65389/0961F). The patient lay down for 25 minutes after the vaccination to prevent fainting. It was reported that the patient fainted again while she walked out to the waiting room. The patient recovered on the same day. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female office employee in her office with drug reactions/allergies and pertinent medical history reported as unspecified who on an unspecified date was vaccinated with first dose of Gardasil (yeast) (lot# not reported) intramuscularly. Concomitant therapy was unspecified. On an unspecified date, the patient was vaccinated in the gluteal area and she experienced injection site pain. The patient sought medical attention. At the time of reporting, the outcome of the event was unspecified. No other information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Influenza like illness, Nausea, Pain, Stomach discomfort
Clinical narrative: Information has been received from a nurse practitioner concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who in approximately 2007 was vaccinated with second dose of Gardasil (yeast) (lot # not reported) 0.5 ml intramuscularly. Concomitant medication was unspecified. In approximately 2007, after the second dose of Gardasil (yeast), the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. Additional has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a nurse practitioner (NP) concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who on 24-OCT-2006 was vaccinated with first dose of GARDASIL vaccine (lot # not reported) 0.5 ml intramuscularly in the deltoid. Concomitant medications was unspecified. On 24-OCT-2006, the patient experienced body aches and nausea. The outcome of the events was not reported. In approximately 2006, the patient received second dose of GARDASIL vaccine (lot # not reported 0.5 ml IM. Subsequently, the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. No other information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 05-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil (yeast). Concomitant therapy included hormonal contraceptives (unspecified). The physician reported that the patient was extremely nervous about getting the shot. Later that evening, within 12 hours, the patient broke out in hives. The physician told the patient to go to the emergency room (ER). The patient went to the ER and was given BENADRYL for the hives. The physician reported that the patient was fine, but does not plan to give the patient anymore shots. There was no lot number provided. At the time of this report, it was noted that the patient was "fine after she had received BENADRYL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: Initial information has been received from a physician via a company representative and follow-up information has been received from the physician concerning a 14 year old female student who, on 20-NOV-2006, was vaccinated with a 0.5 ml dose of Gardasil (yeast) (lot# not reported). There was no concomitant medication. Subsequently, on approximately 22-NOV-2006 or 23-NOV-2006, the patient developed a bad acne breakout. The physician reported that the patient developed "giant pimples" the likes of which she'd not experienced previously. The patient was reported to have been using over the counter acne wash which had been working well up to this point. The patient was put on oral antibiotics and given a topical wash for the breakout, which occurred on her face, chest and back. The patient's acne breakout was continuing at the time of the report. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with allergic rhinitis who on 20-OCT-2006 was vaccinated intramuscularly in the morning with a first dose of Gardasil (yeast) (lot#653735/0688F). Illness at the time of vaccination included pharynigitis. Concomitant therapy included amoxicillin. In the evening of 05-NOV-2006, three weeks after vaccination, the patient developed shortness of breath. The patient had no history of asthma. Subsequently, on an unspecified date, the patient recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm, Cough
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with asthma and allergic eczema who on 10-NOV-2006 at 12:00PM, was vaccinated in the right arm intramuscularly with a first 0.5 ml dose of Gardasil (yeast) (lot#653978/0955F). Concomitant suspect vaccination included a dose of tetanus toxoidon 10-NOV-2004. Other concomitant therapy included albuterol and ZYRTEC. There was no illness at the time of vaccination. On 10-Nov-2006 the patient experienced bronchospasm 20 minutes after receiving Gardasil (yeast). It was also reported that the patient developed a cough but she did not vomit. The patient used her albuterol inhaler and then rested and was recovered on the same day, 10-NOV-2006. No vomiting and no other anaphylaxis type reaction was noted. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with asthma and no known allergies or adverse drug reactions reported. On 08-JAN-2007, the patient was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast) (lot#655165/1425F). Concomitant therapy included hormonal contraceptives (unspecified) and albuterol. On 09-JAN-2007, the patient developed a rash on her back and chest. The patient sought unspecified medical attention. The patient was being treated with BENADRYL. At the time of this report, the patient had not recovered from the event.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Malaise, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a penicillin allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated intramuscularly with one dose of Gardasil (Lot #654885/1424F). Concomitant therapy included Ortho Tri Cyclen. On 22-DEC-2006, the patient felt nauseous shortly after administration. The patient then fainted for approximately 10 seconds while she was at the office. The patient remained in the office until she felt "normal" again. The patient then went home where later she felt sick again. The patient went to the emergency room and was then released. It was reported that there were no laboratory diagnostics performed at the physician's office and it was unknown it any were performed in the emergency room. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no allergies or medical history who on 09-NOV-2006, was vaccinated with the first 0.5 L, dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot unspecified). Concomitant therapy included penicillin.  On 09-NOV-2006, at 1:30 P.M., the patient developed chills and fever of 102.7 degrees on 10-NOV-2006 at 7:00 P.M.  The patient did not seek medical attention.  The patient treated herself with acetaminophen (TYLENOL). The patient's symptoms lasted until noon on 11-NOV-2006.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reaction/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654885/1424F), injection, 0.5ml. Concomitant medication was not reported. ON 29-DEC-2006, the patient developed hives within hours of receiving the first dose of Gardasil. The physician reported that the hives became more generalized within 24 hours. On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued. Subsequently on an unspecified date, the patient recovered from hives. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a physician concering his daughter an 18 year old female with pertinent medical history and drug reactions/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of GARDASIL (lot #654885/1424F), injection, 0.5 mL.  Concomitant medication was not reported.  On 29-DEC-2006, the patient developed hives at the injection site within hours of receiving the first dose of GARDASIL.  The physician reported that "the hives became more generalized within 24 hours" and the patient "then developed hives on her trunk and knee the next day."  On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued.  Subsequently 48 hours after the vaccination, the patient recovered from hives.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea
Clinical narrative: Information has been received from a consumer through the pregnancy registry concerning a 15 year old daughter with pet allergies who on 08-JAN-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included prenatal medication (therapy unspecified) and erythromycin. On 08-JAN-2007, the patient was vaccinated with Gardasil and the patient was 14 weeks pregnant. The clinic administered the vaccine without confirming if her daughter was pregnant. The consumer stated that her daughter has experienced nausea since she received Gardasil. The physician did not administer the vaccine to the patient as she received the vaccination at a clinic. On 08-JAN-2007 therapy with Gardasil was discontinued. The outcome of the events was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Paraesthesia
Clinical narrative: Information has been received from a physician's assistant concerning a female who on 08-JAN-2007 was vaccinated intramuscularly with a dose of Gardasil. Subsequently the patient passed out and experienced tingling sensation from her shoulder to her fingertips. It was reported that the patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced swollen lymph nodes on the same side as the injection two days after receiving the injection. The patient recovered from the swollen lymph nodes after the first injection with Gardasil. Two days after the second dose of Gardasil, the patient again experienced swollen lymph nodes on the same side as the injection. Clinical outcome related to the second occurrence of swollen lymph nodes in unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a female pharmacist who on 02-JAN-2007 was vaccinated with a second dose of Gardasil. On 02-JAN-2007, the patient experienced a strong stinging sensation during vaccination. After vaccination, her arm swelled and was very sore at the injection site. On 03-JAN-2007, the patient recovered. It was reported that the patient did not experience any of these symptoms with the first vaccination with Gardasil. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse and a physician via a company representative concerning an 18 year old female who on 27-DEC-2006 was vaccinated intramuscularly with one dose of GARDASIL (lot 653978/0955F). On 27-DEC-2006 the patient passed out after getting GARDASIL. The patient sought unspecified medical attention. It was not reported if the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse via a company representative concerning an 18 year old female student with no reported allergies who on 27-DEC-2006, at 9:30AM. was vaccinated intramuscularly into the left deltoid with a first dose of GARDASIL vaccine (Lot# 653978/0955F). There was no illness at the time of vaccination. Initial information indicated that on 27-DEC-2006 the patient passed out after getting GARDASIL vaccine. Follow-up information from the nurse clarified that the "patient felt faint after the injection but did not faint". The patient told the nurse that she had not eaten so they gave her some "coke" and after she sat for 15 minutes she felt better. The patient was reported as recovered on 27-DEC-2006. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Haemoglobin
Clinical narrative: Information has been received from a nurse practitioner concerning her daughter, a 20 year old female with possible human papilloma virus prior to May 2006 who had an abnormal Papanicolaou (PAP) smear and colposcopy, June 2006 who on 21-NOV2006 was vaccinated with a 0.5ml dose of Gardasil. Concomitant therapy included Yasmin. On 27-NOV-2006, the patient developed genital warts. The patient required laser surgery on 08-JAN-2007. Laboratory evaluation included hemoglobin. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning a 16 year old female patient with on pertinent medical history or drug reactions/allergies, who on 10-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml) (lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified date, the patient experienced severe cramping after her last menstruation which she had never experienced before. Unspecified medical attention was sought. The physician stated that no further doses of Gardasil will be given until further information was received. At the time of this report, the patient was recovering. No further information is expected. This is one of several report(s) received from the same source.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 14 year old female with no pertinent medical history who on 10-NOV-2006 was vaccinated IM with a first dose of Gardasil (lot #653937/0637F). There was no concomitant medication. On 12-NOV-2006 the patient developed "bad bruise". Unspecified medical attention was sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of Gardasil will be given until further information is received. Additional information has been requested. 5/14/10 Follow up: repored that medical attention was not sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of GARDASIL will be given until further information is received.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on 22-DEC-2006 was vaccinated with Gardasil (yeast) (lot number 653978/0955F). On 22-DEC-2006 the patient passed out after vaccination. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a registered nurse concerning a 20 year old female student with no reported allergies who, at 10:00AM on 22-DEC-2006, was vaccinated into the left deltoid with a first dose of GARDASIL (Lot# 653978/0955F).  There was no illness at the time of vaccination.  On 22-DEC-2006, after the vaccination, the patient felt faint and passed out for a short time.  The nurse reported that the patient was watched closely and felt fine after a while and then left the office, recovered the same day, 22-DEC-2006.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 08-Jan-2007 was vaccinated with Gardasil (yeast) (lot number 655165/1425F) 0.5 ml intramuscularly. On 10-JAN-2007 the patient experienced 102 degrees F fever, chills and body aches for "the past 10 hours". The patient's 102 degrees F fever and chills and body aches persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from an R.N. concerning a 19 year old female patient who on 09-JAN-2007 was vaccinated IM with a dose of GARDASIL (lot #653978/0955F) and felt dizzy and lightheaded. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007.  Follow up information has been received concerning the 20 year old female student who on 09-JAN-2007 at 9:30 a.m. was vaccinated IM in left deltoid with her first dose of GARDASIL, lot #653978/0955P.  After the first injection, the patient felt faint.  On 06-MAR-2007 at 10:00 a.m. The patient was vaccinated IM in left deltoid with her second dose of GARDASIL, lot #655619/1427P.  After the second injection, the patient did faint.  She went out approximately 5 minutes, came to and then felt fine.  The patient stated she "does this for all injections, even eye drops".  She was reported as recovered on 08-MAR-2007.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 08-JAN-2007 was vaccinated IM with a dose of Gardasil (yeast). It was noted that the patient fainted during the administration of the vaccine, the patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil (yeast). Subsequently the patient fainted. Unspecified 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.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with no medical history or allergies, who on 04-JAN-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 04-JAN-2007 the patient felt dizzy and had a sensation of hands being pressed down on her head. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The symptoms lasted about 15 to 20 minutes and then resolved. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of Gardasil (yeast). After receiving the vaccine, the patient fainted. Unspecified 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.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Nuclear magnetic resonance imaging, Pain in extremity, Radiculitis brachial
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with the first dose of Gardasil (yeast). Subsequent following vaccination, the patient experiences extreme pain in the arm and inflammation. The patient underwent physical therapy and was diagnosed as having brachial neuritis. It was not specified if the series of Gardasil (yeast) would be completed. At the time of this report, the patient was recovering from the brachial neuritis. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an aspirin allergy who on 04-OCT-2006 at 16:00 and 11-DEC-2006 at 14:30 was vaccinated IM into the right deltoid with a first and second dose of Gardasil (first dose lot #653736/0689F, second dose lot #654510/0962F). Concomitant therapy given on 04-OCT-2006 and 11-DEC-2006 included a dose of Havrix. Three days after the first dose, the patient vomited for 2 days and was out of school. Three days after the second dose the patient threw up a lot more for 2 days and was out of school. The nurse was concerned about this patient and considered her condition to be disabling since she missed  school for two days after each dose. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. No product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with no pertinent medical history and no known allergies who on 21-DEC-2006 was vaccinated into the right arm with a 0.5 ml first dose of Gardasil (yeast) (lot#654389/0961F). Concomitant therapy included unspecified over the counter vitamin supplements. Subsequently the patient experienced severe deep pain in her right shoulder. Unspecified medical attention was sought and there was no treatment given. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 year old female with diabetes and eczema who on approximately 07-JAN-2007 was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) concomitantly with a dose of an unspecified vaccine. On approximately 07-JAN-2007, later in the night, the patient developed hives all over her body, mostly on her legs.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: HIV test false positive
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no medical history or allergies, who on 14-AUG-2006 on 02-NOV-2006 was vaccinated IM with a first and second 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  There was no concomitant medication. In December 2006, the patient had a false positive HIV result.  It was noted that the physician stated that the patient had no risk factors for HIV.  Unspecified 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.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the felt faint post vaccination. The patient sought unspecified medical attention. At the time of this report, it was unknown if the patient had recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the patient felt faint post vaccination. The patient sought unspecified medical attention.  At the time of this report, it was unknown if the patient had recovered from the event.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 12-DEC-2006 was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain down her arm one month after receiving her second dose.  The patient's pain down her arm persisted.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 12-JAN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml intramuscularly.  The patient fainted when she got outside in the parking lot of the physician's office (also reported as within 10 minutes). The patient was brought back into the physician's office and "let rest for a while".  The physician checked the patient's blood pressure (no details provided). The physician noted that the patient is "fine now".  Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Fluid retention, Weight increased
Clinical narrative: Information has been received from a medical assistant concerning a 38 year old female with edema who on 07-DEC-2006 "between 9 a.m. and 5 p.m." was vaccinated IM, into the right deltoid, with a 0.5 ml first dose of GARDASIL vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 08-Dec-2006 the patient "gained 13 pounds of water weight". Medical attention was sought and the patient was treated with unspecified diuretics. On approximately 29-Dec-2006, the patient recovered from "gained 13 pounds of water weight".  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. On 29-DEC-2006, the patient recovered from weight gain and edema. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on 19-SEP-2006 was vaccinated intramuscularly (IM) with a first 0.5 ml dose of GARDASIL vaccine. Subsequently the patient experienced pain at the injection site. Unspecified medical attention was sought. It was reported that the patient did not return to complete the schedule.  Additional information has been requested.  This is in follow-up to report (s) previously received on 2/14/2007. On 14-DEC-2006, the patient was vaccinated with IM GARDASIL vaccine (lot # 654389/0961F) in the right deltoid. On 14-DEC-2006, the patient experienced pain in her arm, difficulty moving and lifting arm. The patient reported recovery from difficulty moving and lifting arm on 28-DEC-2006. The patient reported recovery from arm pain on 14-JAN-2007. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Dizziness
Clinical narrative: Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of Gardasil (yeast) (lot#653938/0954F). The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of GARDASIL (lot # 653938/0954F). Follow up information reported that the vaccination was administered by the IM route. The initial report of being vaccinated SC was charted incorrectly. The patient's chart was corrected by the nurse who gave the injection. The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. No further information was available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arteriogram carotid, Dizziness, Echocardiogram, Loss of consciousness, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on 28-DEC-2006 was vaccinated with Gardasil (yeast) (lot# not reported) injection. Concomitant therapy unspecified. On 01-Jan-2007, the patient passed out. Medical attention was sought. The patient later reported that she was experiencing light headedness and tingling in her hands and feet on 02-JAN-2007. The patient was referred to a cardiologist. The patient had a carotid ultrasound and echocardiogram performed on 05-JAN-2007 and 11-JAN-2007, respectively (results not reported). At the time of reporting, the tingling in her hands and feet persisted. No further information was available at the time of reporting. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated, intramuscularly with the first, 0.5 ml dose of Gardasil. The patient concomitantly received Menactra and Dtap. The patient complained that her subsequent menstrual period was "much more painful than usual" with severe menstrual cramping. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site anaesthesia, Injection site pain, Paraesthesia, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from  registered nurse concerning a 11 year old female who on 11-OCT-2006 at 15:30, was vaccinated with the first dose of Gardasil (yeast) (lot number 654540/0800F) intramuscularly in the left deltoid.  Concomitant vaccinations included hepatitis A vaccine (inactive) (MSD) (lot number 652809/1008F) intramuscularly in the right deltoid, meningococcal ACYW conj vaccine (MENACTRA) (lot number U2002AC) intramusculary in the right deltoid and (ADACEL) (lot number C2455AA) intramuscularly in the left deltoid.  On 11-OCT-206 the patient stated that her arm tingled and felt numb at the injection site (arm not specified). Tingling and numbness lasted one hour. After that the patient stated the arm was just sore at the injection site. On 27-DEC-2006 was vaccinated with the second dose of Gardasil vaccine (yeast). On 27-DEC-2006 the patient again experienced arm tingled at injection site, but it "just lasted a few minutes".  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on approximately 16-Nov-2006, "about two months ago," was vaccinated with a 0.5 ml dose of GARDASIL vaccine. On approximately 16-Nov-2006, the patient developed swelling of the arm (unspecified) after the injection and experienced pain "in her whole arm." The patient sought unspecified medical attention. The patient's arm pain persisted. although, the outcome of the patient's arm swelling was unknown. Additional information has been requested.  This is in follow-up to report (s) previously received on 2/14/2007. Additional information received from the registered nurse indicated that the patient was vaccinated at another physician's office and provided no additional information. No additional informatin is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Injection site swelling, Tenderness
Clinical narrative: Information has been received from an R.N. concerning a 22 year old female patient with an allergy to codeine who on 11-NOV-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast); and according to the nurse, developed severe swelling on the injection site arm after the first dose.  The patient received the first vaccination at another office and no information was available on where the first vaccination was administered or the physician involved in the first vaccination. On 16-JAN-2007 the patient was seen in the office. She was breast feeding, and was reported to have been breast feeding when the first vaccination was administered. The patient reported that she had developed an egg shaped swelling at the injection site on the left upper arm that lasted for more than one week after the first vaccination. No timeline on the development of the swelling in relation to the vaccination was available.  The arm was still bruised and tender 2 months after the first vaccination. The second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) has not been administered. At the time of the report, the patient was recovering.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Local swelling, Oedema peripheral
Clinical narrative: Information has been received from a RN concerning a 13 year old female patient who on 15-Jan-2007 was vaccinated IM with a dose of Gardasil, lot #6536978/0955F. Several hours later, the patient experienced pain and swelling at injection site and extending into her hand. There were no other symptoms noted. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. 5/14/10 Follow up information has been received from a physician concerning the female student with no medical history who on 15-JAN-2007 was vaccinated IM in right deltoid with her first dose of GARDASIL, lot #653978/0955F. 24 hours later the patient presented with complaints of numbness and swollen thumb at the arm where shot was given. The physician stated "No reaction at the site of injection. Also itching." The patient recovered from numbness and swollen thumb at the arm where shot was given and itching. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. 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 patient who on an unspecified date was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 27-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of Gardasil (lot #654885/1424F). There was no concomitant medication. On 24-DEC-2006, the patient developed a rash up and down both arms. The patient's rash was treated with Benadryl. Subsequently, after three days, the patient recovered from the rash. It was reported that the event did not require an emergency room/doctor visit. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report. the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with dose (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a 24 year old female with an unremarkable medical history and no known allergies or adverse drug reactions reported. In November 2006, the patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of Gardasil. concomitant therapy included influenza virus vaccine (unspecified) and hormonal contraceptives (unspecified). In November 2006, right after she received her first injection of Gardasil, the patient vomited and the passed out. The patient developed burning at injection site. The patient sought unspecified medical attention. It was reported that the patient was alright after about 20 minutes after the injection. The patient plans to receive her second shot on 17-JAN-2007. In November 2006, the same day that the first dose of the vaccine was administered, the patient had recovered from the events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female with high blood pressure and an allergy to sulfa. On 08-Jan-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of Gardasil (lot #655619/1427F). Concomitant therapy included Micronor. On 10-JAN-2007, the patient developed intermittent hives. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Initial an dfollow up information has been received from a physicia's assistant and a 26 year old female with a drug hypersensitivity to tetracycline, prochlorperazine maleate (COMPAZINE) and doxycycline and no other pertinent medical history reported. On 15-JAN-2007, at 8:03 AM, the patient was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL vaccine (Lot# 655165/1425F). Concomitant therapy included a "steroid shot" and unspecified hormonal contraceptives. On 15-JAN-2007, the patient developed a terrible rash.  The patient sought unspecified medical attention.  At the time of this report, the patient had not recovered from the event.  Additional information has been requested.  This is in follow-up to report previously received on 2/14/2007. There were no illnesses noted at the time of vaccination. That same day, the patient developed a terrible rash. On 16-JAN-2007, the patient went to the emergency room and was treated with unspecified steroids. On 17-JAN-2007, the patient followed up with the physician assistant and there was no significant rash noted at the time. At the time of this report, the patient had recovered fromthe event (date unknown). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed partner nurse concerning her 20 year old white daughter student with pertinent medical history and drug reactions/allergies reported as unspecified who on 01-NOV-2006 was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0702F) IM left arm at 1500 hours.  On approximately 17-JAN-2007, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported).  Following each dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient experienced a metallic taste.  The metallic taste was more pronounced after the first dose. The patient sought medical attention.  Subsequently, the patient recovered. No other information was available at the time of reporting.   Additional information was received from the licensed practical nurse.  The patient complained of strong "metal" taste at the back of her tongue immediately after the first injection. This odd taste sensation lasted somewhere between 30 and 60 seconds and then slowly disappeared after 2 to 3 minutes.   No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Syncope
Clinical narrative: Information has been received from a physician concerning several females who on unspecified dates were vaccinated with Gardasil 0.5 ml by injection. Subsequently, several patients fainted after receiving Gardasil and several patients experienced pain and swelling at the injection site. Medical attention was sought. The outcome of the events was unspecified. No additional information is available.