chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 12-DEC-2006 was vaccinated with 0.5 ml injection of Gardasil. In early March 2007, the patient passed out. The patient attributed the fainting to the Gardasil dose she received on 12-DEC-2006. Subsequently, the patient recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female who on 08-MAR-2007 was vaccinated with Gardasil. On 09-MAR-2007 the patient experienced redness, pain, swelling and rash at the injection site. The patient called the physicians office and was asked if she had trouble breathing. The patient reported no trouble breathing and was instructed to take BENADRYL. Then patient then called the physician's office back to report she had developed tightness in her chest. The tightness in her chest resolved with BENADRYL. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Information has been received from a dermatologist concerning her 20 year old "otherwise healthy" daughter with acne who on 08-MAR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included cephalexin (KEFLEX). On 10-MAR-2007, the patient developed a headache, "not feeling right", nausea, and fever. On 11-MAR-2007, the patient complained of generalized headache with "blurry vision" possibly attributed to the headache per the mother, chills, myalgias, and nausea. At the time of this report, the outcome was unknown. Additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Information has been received from a dermatologist concerning her 20 year old "otherwise healthy" daughter with acne who on 08-MAR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included cephalexin (KEFLEX). On 10-MAR-2007, the patient developed a headache, "not feeling right", nausea, and fever. On 11-MAR-2007, the patient complained of generalized headache with "blurry vision" possibly attributed to the headache per the mother, chills, myalgias, and nausea. At the time of this report, the outcome was unknown. Additional information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site scar
Clinical narrative: Information has been received from a health professional concerning a 26 year old female patient, who on 12-JAN-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot# 655617/1447F). Concomitant therapy included hormonal contraceptives (unspecified). On 12-JAN-2007 the patient developed "a 4mm dimple/scar on her arm." The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a physician and a Registered Nurse (R.N.) concerning a 19 year old female who on 05-MAR-2007 was vaccinated IM in her left deltoid with a first dose of Gardasil. Patient developed immediate swelling and erythema at the injection site. No other symptoms appeared. No prescription medication was provided. The patient recovered within the time she was in the office. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil (yeast). The patient immediately experienced numbness on one side of body. The patient's recovery status was unknown. Additional information has been requested. It was reported that another female experienced numbness on one side of the body immediately after receiving Gardasil (yeast) (WAES0703USA04280).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema multiforme, Rash generalised
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 16 year old female with no medical history or allergies, who on 08-MAR-2007 was vaccinated with a second dose of Gardasil. There was no concomitant medication. Two days after vaccination, the patient developed a rash all over her body. On 12-MAR-2007 the patient went to her primary care physician's office and was diagnosed with erythema multiforme. The patient was treated with a dose pack of methylprednisolone (MEDROL) and subsequently recovered. No product quality complaint was involved. Additional information has been requested.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a dose of Gardasil (yeast). Subsequently, the patient fainted 2 days after receiving the Gardasil vaccine. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Acne, Eye swelling
Clinical narrative: Information has been received from a nurse concerning her 12 year old daughter who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil. On the same day, the patient was concomitantly vaccinated with a dose of Varivax (MSD). Subsequently, the patient developed a swollen eye and acne. The patient sought unspecified medical attention. Subsequently, the patient recovered from swollen eye and acne. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a Dentist concerning a 20 year old female with a history of a drug allergy to cephalosporin who on 13-JAN-2007, at 5:00PM (previously reported as 03-JAN-2007) was vaccinated IM 0.5 ml first dose with Gardasil. There was no concomitant medication. On 27-FEB-2007 the patient experienced numbness hands and feet. Subsequently, the patient recovered form numbness hands and feet on 01-Mar-2007. The patient sought unspecified medical attention. In follow up information the reporter indicated that on 25-FEB-2007 in AM "my daughter called me from college reporting "numbness" of her right arm and slightly in her right foot." The patient was dropping her fork at dinner and being frightned and calling the reporter. The reporter was talking with her each day thereafter. On 10-MAR-2007 (previously reported as 01-MAR-2007) her symptoms never worsened and resolved with no therapy. Her second dose resulted in less symptoms lasting less than 2 weeks. On 25-MAY-2007 complete recovery was noted. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated IM into the gluteus with a second dose of Gardasil (yeast). It was reported that the patient was vaccinated into the gluteus because her arm was sore for 3 months after the first dose of the vaccine. 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: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a health professional concerning a 24 year old female with a penicillin allergy who on 03-MAR-2007 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot#654702/0011U). Concomitant therapy included CYCLESSA. On 04-MAR-2007 post vaccination the patient started spotting, menstrual cycle. It was reported that the patient is not pregnant. At the time of this report the spotting, menstrual cycle persisted. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up information received from a health professional stated that the dose of GARDASIL was from Lot # 654510/0962F, not lot # 654702/0011U as perviously reported. It was also reported that the patient recovered from the event on 15-Mar-2007. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female who on 12-JAN-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. On 12-MAR-2007, the patient was vaccinated with the second dose of Gardasil. Subsequently, on an unspecified date, the patient missed her menstrual cycle after receiving her first dose of Gardasil. Subsequently in February, the patient's menstrual cycle returned to normal and the patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a female who on 05-MAR-2007 was vaccinated with a dose of Gardasil (yeast) (lot # 654747/1208F). In March 2007, "a few days after receiving the shot" the patient experienced headache, dizziness, stiff neck and shoulders. Unspecified medical attention was sought. The patient's headache, dizziness, stiff neck and shoulders persisted. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 08-MAR-2007 was vaccinated with a 0.5 mL dose of Gardasil. On 10-MAR-2007, the patient experienced excessive vaginal bleeding and her period was a week early after receiving Gardasil. 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: Blood human chorionic gonadotropin negative, Menstruation irregular, Pregnancy test negative, Smear cervix normal
Clinical narrative: Information has been received from a healthcare worker concerning a 24 year old female who on 12-MAR-2007 was vaccinated IM 0.5ml first dose of Gardasil (lot# 655617/1447F). Concomitant therapy included DEPO-PROVERA lasted administered 12-Feb-2007. On 12-MAR-2007 the patient experienced induced period 2 hours after receiving Gardasil. Her previous period was 12-Feb-2007 so the nurse believes Depo is not working properly. The patient had the following lab diagnostics studies performed: Pap smear was normal and pregnancy test was negative. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a healthcare worker concerning a 24 year old female with no medical history or allergies, who on 12-MAR-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot# 655617/1447F). Concomitant therapy given the same day included DEPO-PROVERA last administered 12-Feb-2007. There was no illness at the time of vaccination. On 12-MAR-2007 the patient developed an induced period 2 hours after receiving GARDASIL. Her previous period was 12-Feb-2007 so the nurse believes DEPO was not working properly. The patient had the following lab diagnostics studies performed: Pap smear was normal and pregnancy test was negative. The patient sought unspecified medical attention. At the time of this report, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a first dose of Gardasil (lot# not reported). Subsequently, the patient experienced pain while receiving the injection. The nurse indicated that it seemed as if the needle was "too big for girls with small arms and it almost feels as if the needle is hitting the bone in the child  patients". The nurse said that they have to switch to a 5/8 inch needle when administering the vaccine to patients. Unspecified medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with first dose of Gardasil (yeast) (lot # not reported) injection. Subsequently, the patient experienced nausea and diarrhea. Medical attention was sought. On an unspecified date, the patient recovered from nausea and diarrhea. No further information was available at the time of reporting. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 year old female (ptreviously reported as 15 year old) with no illness at the time of vaccination and no pre-existing illness or allergies who on 02-MAR-2007 (previously reported as 09-MAR-2007) was vaccinated with first dose of Gardasil (lot# 657006/0188U). 0.5 ml once IM in the left deltoid at 5:15 PM.   On 02-MAR-2007, after receiving the injection, the patient fainted and fell from the chair where she was sitting. Medical attention was sought. However, she regained consciousness after five minutes. She went home after the recovery. No further information was available at the time of reporting. Additional information has been requested.  Additional infromation was received from a licensed vocational nurse. On 02-MAR-2007, at 5:15 PM after receiving the vaccination the patient stated that she felt lightheaded and fell forward and laid her head on the nurses shoulder. The patient then briefly had a "seizure like" motion of her head. The nurse laid her back on the table. The patient quickly resumed normal fucntion and stated she felt fine. The physician stated vasovagal episode.  No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: False positive tuberculosis test, Tuberculin test negative, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil (lot# not reported). The patient was given the vaccine on the same day as a Tuberculosis test which was positive. Since the patient had an initial positive TB test, a second more through TB test was given in which blood was drawn and the results were negative. No other information was provided. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report previously submitted on 4/13/2007. Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL (lot# not reported) on 9-Feb-2007. The patient was given the vaccine on the same days as a Tuberculosis test (lot# C 2008AA) intradermal in the left arm which was positive. Since the patient had an initial positive (TB interferon). TB test (14mm), a second more thorough TB test was given in which blood was drawn and the results were negative. No other information was provided. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. She was due for her second dose of Gardasil on 13-MAR-2007. Subsequently, she developed a urinary tract infection. Unspecified medical attention was sought. Urinary tract infection persisted. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Dysgeusia, Throat tightness
Clinical narrative: Information has been received from a 23 year old female with pertinent medical history and drug reactions/allergies not reported who on 12-MAR-2007 was vaccinated with Gardasil, 0.5 ml, once. Concomitant medication was not reported. Subsequently, on an unspecified date, the patient experienced a feeling of her throat closing 5 minutes after receiving Gardasil. One hour after the vaccination, the patient "felt like she was having an asthmatic attack with a metallic taste in her mouth" . The patient called the physician's office and was advised to go to the local emergency room. The outcome and causality of the event  was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Influenza like illness, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 22 year old female who in October 2006, was vaccinated with the first dose of Gardasil. There was no concomitant medication. In December 2006, the patient was vaccinated with the second dose of Gardasil. The patient experienced injection site pain. Five days later, she experienced flu like symptoms and unsteadiness. Subsequently, the patient recovered from injection site pain. The flu like symptoms resolved after 7 days. The patient's unsteadiness lasted for 14 days. No lab testing was performed. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female, with no pertinent medical history or drug reactions/allergies who on 12-MAR-207 was vaccinated with Gardasil (lot# 654741/0013U). Concomitant therapy included Ortho-Tri-Cyclen. Two hours later, on 12-MAR-2007, the patient experienced nausea and vomiting. The patient self treated with Compazine. The vomiting resolved but as of 14-Mar-2007 the nausea continued. No lab testing was performed. Additional information has been requested. The registered nurse reported that 3 other patients' experiences after Gardasil administration (WAES 0703USA02859, WAES 0703USA02797, WAES703USA02840). Initial and follow up information has been received. There was no illness at the time of vaccination.  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation & Research and was released.
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received a physician concerning a female who was vaccinated with her first dose of Gardasil. Subsequently, "2 days later" the patient experienced pruritic and maculopapular rash. Unspecified medical attention was sought. The patient recovered from pruritic and maculopapular rash. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female, with no medical history or history of drug reactions/allergies who on 12-MAR-2007 was vaccinated with 0.5 ml intramuscular Gardasil (lot# 654741/0013U). Concomitant therapy included Alesse. Subsequently the patient experienced nausea and vomiting. Patient outcome was unknown. No lab testing was performed. Additional information has been requested. The registered nurse reported that 3 other patients' experiences after Gardasil administration (WAES 0703USA02859, WAES 0703USA02797, WAES0703USA02815). This is in follow-up to report (s) previously submittedon 4/13/2007. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biological Evaluation & Research, and was released.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Anxiety, Condition aggravated, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female with acne who on 25-SEP-2006 was first vaccinated IM with 0.5 ml of Gardasil (lot# 654741/0013U). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 25-SEP-2006 the patient experienced increased acne. On 25-NOV-2006, the patient received her second dose of Gardasil. Her acne became progressively worse. On 12-MAR-2007, the patient was vaccinated with the third dose of Gardasil. On 12-MAR-2007, she experienced severe anxiety. It was noted that the patient's acne was related to Gardasil. No treatment or lab testing was provided. Subsequently, the patient had not recovered from increased acne. The patient's severe anxiety resolved in 24 hours. Additional information has been requested. The registered nurse reported that 3 other patients' experiences after Gardasil administration (WAES 0703USA02840, WAES 0703USA02797, WAES0703USA02815).
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from the mother of a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced pain. The mother reported that her daughter will receive the third vaccination "late". Additional information has been requested. It was also reported that another daughter was vaccinated with Gardasil and experienced pain (WAES 0703USA03939).
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia
Clinical narrative: Information has been received from a health professional who was a 28 year old female with migraine who on 06-FEB-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant therapy included zolmitriptan (ZOMIG) and vitamins (unspecified). On 07-FEB-2007, the patient experienced sweet taste on the surface of tongue the day after vaccination (within 24 hours) which did not last very long. Subsequently, the patient recovered from sweet taste on the surface of tongue. Sweet taste on surface of tongue was considered to be non-serious. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Information has been received from a Registered Nurse concerning a 20 year old female with tourette's disorder who on 12-MAR-2007 was vaccinated IM 0.5 ml first dose with Gardasil (yeast) (lot # 654741/0013U). Concomitant therapy included clonidine HC1 (CATAPRES), sertraline HC1 (ZOLOFT) and ethinyl estradiol/norethindrone acetate (MICROGESTIN). On 12-MAR-2007 the patient experienced nausea, vomiting and diarrhea 2 hours after receiving Gardasil (yeast). The physician prescribed ondansetron hydrochloride (ZOFRAN) and loperamide hydrochloride (IMODIUM). The nurse is requesting a lot check. The patient sought unspecified medical attention. No lab diagnostics were performed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a registered nurse concerning a 20 year old female with Tourette's disorder and no known drug allergies, who on 12-MAR-2007 was vaccinated IM 0.5ml, with the first dose of GARDASIL (lot# 654741/0013U). Concomitant therapy included CATAPRES, ZOLOFT and MICROGESTIN. There was no illness at the time of vaccination. On 12-MAR-2007 the patient experienced nausea, vomiting and diarrhea 2 hours after receiving GARDASIL. The physician prescribed ZOFRAN and IMODIUM. The nurse is requesting a lot check. The patient sought unspecified medical attention. No Lab diagnostics were performed. Follow up information fromthe nurse confirmed that the patient had recovered from the nausea, vomiting and diarrhea. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standard of the health regulatory agency, and was released. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a registered nurse concerning a 25 year old female police officer (151 lb, 62 inches), with no pertinent medical history, who on 12-MAR-2007 was vaccinated with a dose of GARDASIL (lot # 656049/0187U), left upper arm, in the morning. Concomitant therapy included hormonal contraceptives (YAZ). On 12-MAR-2007, in the afternoon or evening, the patient experienced severe itching in legs, feet, calves and hands. Unspecified medical attention was sought. After four days, on 15-MAR-2007, the patient recovered from the severe itching in calves, feet and hands. No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 03-OCT-2006 at 12:30 and on 18-DEC-2006 at 18:00 was vaccinated into the right and left deltoid with a first and second dose of Gardasil, respectively. On 08-FEB-2007, the patient developed genital warts. No sexual activity was reported. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Food poisoning
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced food poisoning. It was reported that the patient was one week later for her second dose because she was recovering from food poisoning. No symptoms or problems were noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 17 year old female who was vaccinated with a second dose of Gardasil five week after vaccination with the first dose. Subsequently, the patient developed a "bruise" at the injection site. The patient sought unspecified medical attention. The outcome of the patient's injection site bruising was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no known drug allergies who in February 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. In February 2007, "shortly after" vaccination, the patient developed fever, chills and flu-like symptoms. The patient was treated with acetaminophen (TYLENOL). On an unspecified date, the patient recovered from the fever, chills and flu-like symptoms. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007. Follow-up information was received from the registered nurse stating that they had no additional information on the case.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Skin lesion, Skin papilloma
Clinical narrative: Information has been received from a licensed practical nurse concerning an 11 year old female with acne who on 17-NOV-2006 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot# 654741/0013U). On 02-FEB-2007 the patient received a second dose of GARDASIL. Concomitant therapy included adaplalene (DIFFERIN). Two weeks after receiving the second dose, the patient developed wart-like lesions on her hands. It was reported that the physician arranged a dermatologist consult for the patient. No diagnostic laboratory studies were involved. 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 4/13/2007.  Information has been received from an advanced practice registered nurse concerning an 11 year old female with acne on 17-NOV-2006 was vaccinated IM with a first dose 0.5 ml of GARDASIL vaccine (lo#654741/0013U). On 02-FEB-2007 the patient was vaccinated IM, in the left arm with a second dose of 0.5 ml of GARDASIL vaccine (lot #653978/0955F0. Concomitant threrapy included DIFFERIN. Two weeks after receiving the second dose, the patient developed 12-13 warts on her hands. It was reported that the physician arranged a dermatologist consult for the patient. No diagnostic laboratory studies were involved. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse a female who on an unspecified date was vaccinated with Gardasil (0.5 ml) (lot # 655503/0012U). It was reported that several days following vaccination the patient experienced a sharp, shooting pain at the injection site. Unspecified medical attention was sought. No further details were provided. At the time of this report, the patient had not recovered. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a nurse a 26 year old female with no pertinent medical history who on 28-FEB-2007 was vaccinated, into the left deltoid, with a first dose of GARDASIL (0.5 ml) (lot # 655503/0012U). On 28-FEB-2007, the patient experienced a sharp, shooting pain at the injection site. The patient called the physician's office on 14-MAR-2007 at 14:00. It was reported that the pain "comes and goes" and the pain is "worse than the injection". Subsequently, the patient recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 14-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml) (lot # 656049/0187U). Concomitant therapy included Adderall tablets. On approximately 15-MAR-2007, the patient experienced headache and abdominal pain. Unspecified medical attention was sought, At the time of this report, the outcome of the events was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Immediately after the vaccine was administered, the patient felt dizzy and three hours later, the patient experienced abdominal pain. The patient also experienced headache. The dizziness subsided after 30 minutes, and subsequently, the patient recovered from the abdominal pain. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient passed out after receiving the vaccination. The patient recovered. 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 medical assistant concerning a female who on approximately 05-MAR-2007 was vaccinated with the first dose of Gardasil. On approximately 05-MAR-2007 the patient fainted in the waiting room 10 minutes after vaccination. The patient was recovering. The patient will discontinue further series of the vaccine. Additional information has been requested. This is in follow-up to report (s) previously submittedon 4/13/2007.  No Further information expected. It was reported that another female fainted after GARDASIL vaccination (WAES 0403USA04745).
Sex: F
Vaccine: HPV4
Symptoms: Headache, Myalgia
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, on an unspecified date, the patient experienced myalgia and headaches. It was noted that the reporting physician was not the patient's physician. At the time of this report, the outcome was unknown. No product quality complaint was involved. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female who on 12-JAN-2007 was vaccinated with a first dose of Gardasil and a second dose on 12-MAR-2007. The patient's mother reported to the nurse her daughter did not get a period in January 2007 but she in February 2007 and she is not pregnant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a  registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported that bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 07-MAR-2007 was vaccinated with the first dose of 0.5ml of Gardasil IM. During the same visit, the patient was vaccinated with hepatitis A vaccine (inactive) (duration and dose not reported). The patient returned to the office 4 hours after her appointment complaining of dizziness. The patient was monitored for 1 hour. During that time, the patient recovered from dizziness and was sent home. No lab testing was performed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007.  In follow-up, it was reported there were no further details to provide.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from a health professional, via a company representative, concerning a female patient who was vaccinated with a dose, 0.5 ml of Gardasil (date not specified). It was reported that the patient "developed auto immune disease soon after the injection." The patient sought unspecified medical attention. No further information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from the mother of a 21 year old female with sulfonamide allergy who in December 2006, was vaccinated with 0.5 ml Gardasil IM and fainted afterward. There was no concomitant medication. Subsequently, the patient recovered. Unspecified lab testing was performed. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old  female patient who on 15-MAR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included traxodone HC1 and citalopram. On 15-MAR-2007 the patient experienced generalized hives. Treatment included diphenhydramine HC1 (BENADRYL), and at the time of the report the patient was reported to be recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning her 14 year old daughter with no reported medical history who in February 2007, was vaccinated with the first dose of Gardasil intramuscularly. There was no concomitant medications. The patient felt woozy and fainted approximately 5 minutes after receiving the vaccine. Subsequently, the patient recovered from the events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no reported medical history who on 09-MAR-2007 was vaccinated with Gardasil intramuscularly. There was no concomitant medication. On 09-MAR-2007 the patient experienced a pale face. Subsequently, the patient recovered from pale face. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil. Subsequently the patient fainted after being administered the vaccine. As of 16-MAR-2007 the patient was recovering. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoventilation, Inappropriate schedule of drug administration, Somnolence
Clinical narrative: Information has been received from a registered nurse concerning a 49 year old female with penicillin allergy, sulfa allergy, ciprofloxacin hydrochloride (Cipro) allergy, erythromycin (E-Mycin) allergy and hypothyroidism who on 15-MAR-2007 was vaccinated with Gardasil, IM. Concomitant therapy included Levaothyroxine Na (SYNTHROID), vitamin B (unspecified) and valacyclovir HC1 (VALTREX). On 15-MAR-2007, after receiving the first dose of Gardasil, the patient became drowsy and had trouble taking a deep breath. The patient was not in distress. No treatment was provided. The patient called the physician back on 16-MAR-2007 and reported she was still having trouble taking a deep breath. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil. Subsequently the patient passed out 4 days after vaccination. Patient outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a female who a month ago, on approximately 16-FEB-2007, was vaccinated with 0.5 ml Gardasil. When the patient received Gardasil therapy her arm got sore for over a month. As of 16-MAR-2007 the patient had not recovered, and the patient rejected to have a second dose of Gardasil. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site pain, Nausea, Wrong technique in drug usage process
Clinical narrative: Information has been received from a physician at an university student health facility concerning a 22 year old female with a penicillin and amoxicillin allergies and no pertinent medical history who had no problems with her first dose of Gardasil and was vaccinated at a private physician's office with the second dose on 09-MAR-2007 of Gardasil. Concomitant therapy included unspecified hormonal contraceptives. On 09-MAR-2007 the patient experienced burning sensation in arm in which she was vaccinated as well as nausea. The patient stated that she was vaccinated high in her arm possibly in the joint space which caused her immediate discomfort. She thought the needle hit her joint. The patient sought unspecified medical attention. As of 19-MAR-2007 the patient continued to have pain in the arm and shoulder which she thought was due to the injection technique. The patient took ibuprofen which helped the pain. The patient planned to see someone in the sports-medicine department for further assessment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose abnormal, Condition aggravated
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) with diabetes who on approximately 12-MAR-2007, "last week", was vaccinated with Gardasil. Concomitant therapy included insulin. On approximately 12-MAR-2007, the patient experienced blood sugar out of control for 48 hours after receiving Gardasil. The patient sought unspecified medical attention. On approximately 14-MAR-2007, the patient from blood sugar out of control. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient with allergies to codeine (unspecified) and Benadryl and a history of an atypical Papanicolaou smear but negative for human papilloma virus (HPV), who on 04-JAN-2007 was vaccinated, IM, with the first dose of Gardasil and on 08-MAR-2007 was vaccinated, IM, with the second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 08-MAR-2007, the patient's pap smear results were received as "positive for HPV," and the second dose had already been administered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician, via company representative, concerning a patient who was vaccinated with a dose, 0.5ml, IM, of Gardasil (date not specified). Subsequently the patient "had a reaction to Gardasil." The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Underdose
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 17-MAR-2007 was vaccinated with a dose of Gardasil, lot #655619/1427F. The nurse reported that she noticed that the syringe was leaking, and she couldn't quantify how much vaccine was received. She added that several minutes after the injection, the patient felt a bit faint, but recovered with no specific intervention. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with no pertinent medical history and no drug reactions or allergies who on 17-MAR-2007 was vaccinated IM into the left deltoid with Gardasil (Lot #655619/1427F). The nurse reported the patient was administered an incomplete dose of Gardasil and soon after fainted. The nurse also reported that while she was administering the patient's first dose of Gardasil she experienced some resistance in the plunger of the syringe. Before finishing the injection, some of the vaccine leaked out around the injection site. When the patient was informed of the problem and possibly of another injection she fainted. The patient fainted 3-5 minutes after the vaccine was administered. On 17-MAR-2007, she recovered quickly. The patient's vital signs were taken and she was monitored for twenty minutes. The office received an e-mail from the patient's father one hour after she left the office which stated that she had fully recovered. There were no laboratory diagnostic studies performed. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No additional information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Information has been received from a 24 year old female registered nurse with no drug reactions/allergies and no reported medical history who on 01-FEB-2007 was vaccinated with the first dose of GARDASIL intramuscularly. Concomitant therapy included ORTHO TRI-CYCLEN LO. On 27-FEB-2007 the patient had a complete blood count with differential and her white blood cell count was low. Another CBC with differential was taken on 19-MAR-2007 (results pending). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a registered nurse and a 24 year old female registered nurse with no drug reactions/allergies and reported medical history who on 01-FEB-2007 at 9:15 am, was vaccinated IM in the right deltoid muscle witha first dose of GARDASIL vaccine (lot # 654702/0011U). Concomitant therapy included ORTHO-TRI-CYCLEN LO). On 27-FEB-2007 the patient had a complete blood count with differential and her white blood cell count 3.6. On 15-MAR-2007 and her white blood cell count 3.5. On 27-MAR-2007 her white blood cell count 4.3. On 27-MAR-2007, the patient recovered from low white cell count. Patient stated she had a virus at the time of the first lab draw of 27-FEB-2007. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a female who on 04-MAR-2007 was vaccinated with Gardasil. On 09-MAR-2007 the patient presented with an abnormal papanicolaou (PAP) test. Unspecified medical attention was sought. Patient outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007. Follow-up information was received from the physician, who reported the patient was lost to follow up. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Fatigue, Rash, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 12-MAR-2007 was vaccinated with Gardasil (Lot 653736/0014U). On 13-MAR-2007 the patient experienced a rash on her chest, back and face. On 14-MAR-2007, the patient experienced fatigue. On that same day, the patient went to see her pediatrician who placed her on therapy with hydrocortisone (manufacturer unknown) and BENADRYL. The patient did not improve and hydrocortisone and felt to be ineffective (WAES#0703USA04721). On 16-MAR-2007, the patient experienced vomiting and diarrhea. The patient's rash, fatigue, vomiting and diarrhea persisted. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperaesthesia, Injection site anaesthesia, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a registered nurse, via a company representative, concerning the nurse's daughter, a 22 year old female patient, who on 19-JAN-2007 was vaccinated with the first dose, 0.5ml, IM, of GARDASIL (Lot# 654540/0800F). There was no concomitant medication. On 19-JAN-2007, beginning at 2:00pm, the patient "experienced numbness and tenderness around the injection site." The nurse reported that her daughter had a painful deltoid for eight weeks and that sometimes the pain woke her daughter up at night and continued for a month, and indicated that "contact with the area was extremely painful. There was no swelling or erythema." On 19-FEB-2007 (previously reported as 18-FEB-2007), the patient had recovered from the numbness and tenderness, and the second dose of GARDASIL was then administered without any problems. The patient sought unspecified medical attention. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Underdose
Clinical narrative: Information has been received from a pharmacist concerning her daughter, a female "in her early 20's," who in January 2007, was vaccinated with the second dose, 0.5ml, IM, of Gardasil. The pharmacist reported she did not think her daughter received the full 0.5ml dose, and stated there was "some of the suspension remaining" in the vial. In additional, the pharmacist reported her daughter developed a sore arm, which she believed was "from the nurse's administration technique and not from the product." The patient sought unspecified medical attention. No further information is available.