chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with a history of her first abnormal PAP Low Grade Squamous Intraepithelial Lesion (LGSIL) (18-MAR-2008) and cervical intraepithelial neoplasia (CIN 1) after colposcopy (02-MAY-2008), who on 14-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660393/0067X) IM and on 21-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 660553/0070X) IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The nurse practitioner reported that on 14-MAY-2008 and on 21-JUL-2008, the patient experienced itching, redness, swelling on left palm after received the first and second dose of HPV vaccine. On 15-MAY-2008, the patient was seen by her family physician who did not know patient had just received HPV vaccine and diagnosed patient with a cold sore and patient was treated with VALTREX 1gm for 1 dose. On 16-MAY-2008, the patient recovered from her first episode of itching, redness, swelling on left palm and swelling on left palm. On 21-JUL-2008, after the second dose of HPV vaccine, the patient developed itching, redness, and swelling of the left palm that evening. On 23-JUL-2008, antibody titers were done which showed IgM not detected IgG titer for Herpes simplex 1 was positive. On 26-JUL-2008, the patient recovered from her second episode of itching, redness, swelling on  left palm. The NP was unsure if she would give the patient the third dose of HPV vaccine. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nodule
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient who in March 2008, was vaccinated with the second dose of GARDASIL.  In May 2008, the patient called and told that she experienced knot on her upper right arm.  According to the nurse, it was documented in their file that second dose of GARDASIL was given on left arm of the patient.  At the time of the report, the patient was not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site reaction, Paraesthesia
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who on 16-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast). On 17-JUN-2008 the patient experienced shortness of breath and tingling in the arm were the vaccination had been given. The patient was then sent to the emergency room to be evaluated. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was vaccinated with the all three doses of GARDASIL vaccine (yeast). The patient reported that after receiving the third dose of GARDASIL vaccine (yeast) experienced decreased in energy level. The patient receive all three doses in anther physician's office, the reporting physician's office, the reporting physician in the case did not administer the of GARDASIL vaccine (yeast). The physician was performing blood tests. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 24-JUN-2008 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #660555/0279X). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 24-JUN-2008, after receiving the first dose GARDASIL vaccine (yeast), the patient fainted. On the same day the patient recovered from the same event. Unspecified medical attention was sought. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Herpes simplex serology positive, Pruritus, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient who in May 2008, was vaccinated with a first dose of GARDASIL vaccine (yeast) and approximately on 22-JUL-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). Concomitant medication was not reported. The nurse practitioner reported that the patient developed a red itchy area at the right wrist the evening she received GARDASIL vaccine (yeast). This occurred after both the first and second doses. Both doses were administered in the right arm. The saw her primary care physician after the first accident and he prescribed VALTREX for her and the symptoms resolved. After the second incident the patient saw the reporting nurse practitioner. No treatment was ordered. The nurse practitioner did perform a blood test for Herpes Simplex Virus 1 that was positive. The patient recovered on an unspecified date. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who was vaccinated with the first dose of GARSASIL vaccine (yeast) 0.5ml intramuscularly. The medical assistant reported that the patient fainted after receiving HPV vaccine. At the time of the report the patient had fully recovered. It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated IM with GARDASIL vaccine (yeast) 0.5 ml. The physician reported that a patient developed redness and swelling from the right side of her face to her wrist after she received GARDASIL vaccine (yeast). The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Muscular weakness, Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from the patient's mother concerning a 13 year old female with no known medical history and no known drug reactions/allergies, who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 24-JUL-2008, minutes after injection, the patient fainted and had sweating, tingling and heavy and weak limbs and had the same symptoms on 27-JUL-2008. Patient also reported feeling tired and her "feeling weird". The patient sought doctor medical attention. The patient was recovering from the adverse events. Additional information has been requested. 10/1/08 Reviewed PCP medical records of 7/12-9/23/2008. FINAL DX:Records reveal patient experienced usual state of good health on 7/12 when received Varivax, Menactra & TDaP.  Parent called PCP 7/14 w/local varicella  reaction of red, swollen, warm & indurated injection site.  RTC 7/24 for HPV #1.  Dizzy & fainted in office immediately after injection.  Observed & released.  Parent called office 7/29 after fainted again on 7/27 after having tingling in hands & cold sweat.  RTC 9/24 w/rash all over body, malaise, extreme fatigue, continued dizziness when standing, increased appetite, activities decreased, tingling hands, feeling hot, periods infrequent
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from the patient's mother concerning a 13 year old female with no known medical history and no known drug reactions/allergies, who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 24-JUL-2008, minutes after injection, the patient fainted and had sweating, tingling and heavy and weak limbs and had the same symptoms on 27-JUL-2008. Patient also reported feeling tired and her "feeling weird". The patient sought doctor medical attention. The patient was recovering from the adverse events. Additional information has been requested. 10/1/08 Reviewed PCP medical records of 7/12-9/23/2008. FINAL DX:Records reveal patient experienced usual state of good health on 7/12 when received Varivax, Menactra & TDaP.  Parent called PCP 7/14 w/local varicella  reaction of red, swollen, warm & indurated injection site.  RTC 7/24 for HPV #1.  Dizzy & fainted in office immediately after injection.  Observed & released.  Parent called office 7/29 after fainted again on 7/27 after having tingling in hands & cold sweat.  RTC 9/24 w/rash all over body, malaise, extreme fatigue, continued dizziness when standing, increased appetite, activities decreased, tingling hands, feeling hot, periods infrequent
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 15-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 mL, injection. On approximately 15-JUL-2008, the patient fainted after getting second dose of GARDASIL vaccine (yeast). It was unknown when patient was administered with first dose. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from fainted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Conflicting information was received in follow-up from the physician concerning a patient who only received one dose of GARDASIL and had no documented adverse reaction.  To date, the patient had not received a second dose.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Musculoskeletal pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a mother concerning her daughter, with no pertinent medical history and no drug reaction/allergies, who on 04-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5mL IM, and on 03-APR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) 0.5mL IM. There was no concomitant medication. The mother stated that each time her daughter was given GARDASIL vaccine (yeast), she had pain in the back of her shoulder of the arm she got the shot in and it "went down her arm" and she had menstrual cramps. Each time the AE started the day she got the vaccination and she recovered after 2 days. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Facial bones fracture, Fall, Syncope
Clinical narrative: Information has been received from a nurse concerning a 22 year old female with no known drug allergies and no pertinent medical history, who on 18-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660557/0072X) 0.5 mL, IM into her right deltoid. There was no concomitant therapy. The patient was sitting on the exam table and after GARDASIL vaccine (yeast) was administered, she fainted and fell forward onto the floor and broke her nose. She was taken to the emergency room (ER) but was admitted. The patient told the nurse she is not afraid of needles, injections or blood being drawn, but never had an experience like this. At the time of reporting, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Palpitations, Syncope
Clinical narrative: Information has been received from a registered nurse reporting that she heard of a patient that experienced lightheadedness, palpitations and fainting after receiving GARDASIL vaccine (yeast). The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning about 5 patients who on unspecified dates, were vaccinated with GARDASIL vaccine (yeast) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Subsequently, the patients experienced syncope and saw the physician. The outcome of the event was not reported. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Scan with contrast normal
Clinical narrative: Information has been received from a pharmacist concerning a 12 year old female with graves' disease and no known allergies, who on 05-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml intramuscularly. On 06-NOV-2007 and on 08-MAR-2008 was vaccinated with a second and a third dose of GARDASIL vaccine (yeast) respectively. There was no concomitant medication prior to vaccination with GARDASIL vaccine (yeast). The pharmacist mentioned that the patient had experienced headaches since the first dose of GARDASIL vaccine (yeast). She had already completed the series. The headaches had persisted since September 2007, the degrees of the pain changed from dull to severe pain, but had never fully resolved. The patient had been seen by a neurologist. Scans of her head were performed and all results were negative. The pharmacist mentioned that the neurologist believed that the headaches are "tension headaches". The patient had been on several medications and pain medications without relief. Her endocrinologist took her off all the medications and prescribed her a muscle relaxer at bed time. This also did not seem to provide the patient with relief. The patient sought medical attention. She contacted the pharmacist. There was no product quality complaint. Additional information has been requested. 10/1/08 Reviewed PCP medical records of 8/11-9/2/08. FINAL DX: Records reveal patient experienced chronic HAs.   10/17/08-records received for DOS 2/5-10/6/08-follow-up visits for Grave's disease diagnosed 1/8/07. Visit on 2/5/08-headache waxes and wanes began in early September 2007-occurring daily ever since. Visit on 5/6/08- C/O feeling tired and malaise worse in morning. Intermittent headache per another physician they are tension headaches. Intermittent tremor. Brittle nails. Visit 10/6/08-Continues with headaches for last 13 months. No longer feeling tired or malaise.  11/6/08-records received-DOS 1/2/08-C/O continued headaches since 11/7/07-CT scan of head and sinuses normal. Some sensitivity to light. 1st Gardasil received 9/8/07-lot#1061U. 2nd dose 11/6/07-lot#1267U. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. The nurse stated the patient described her headache as centrally located pushing out towards ears. She also experienced some dizziness. In follow up information the nurse provided the lot numbers for GARDASIL: first dose (658558/1061U), second dose (659439/1267U) and third dose (659964/1978U). The patient sought medical attention: She contacted the pharmacist. There was no product quality complaint. Follow up information was received from a pharmacist concerning a 12 year old female with grave's disease. The patient experienced persistent and chronic headache since first week of September 2007. The AE required ER/DR visit. At the time of reporting the patient had not recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Apgar score normal, Drug exposure during pregnancy, Hypertension, Pre-eclampsia
Clinical narrative: Information has been received from a licensed practical nurse (LPN), for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning a 15 year old female with no drug allergies and no previous pregnancies who on 25-JUL-2007 was the first dose of vaccinated with GARDASIL vaccine (yeast) (lot # 658490/0802U) and on 27-OCT-2007 was the second dose of vaccinated with GARDASIL vaccine (yeast) (lot # 658282/1263U). At week 37 of pregnancy, the patient developed slight hypertension. The patient delivered a healthy baby on 28-JUN-2008. At the time of this report, the outcome of slight hypertension was unknown. The patient was seen in office. No product quality complaint was involved. Additional information has been requested. Follow-up information was received on 27-OCT-2008 from a physician who reported that the patient with a history of gastritis and her estimated conception date was 20-OCT-2007 and LMP was 06-OCT-2007 who on 28-JUN-2008 (weeks form LMP 38), delivered a normal female baby. Weight 7lbs4oz and Apgar score 8/8.  On 30-JAN-2008 serum alpha-fetaprotein test negative and on 18-APR-2008 ultrasound was normal. There was no congenital anomaly. Labor was induced at 38 weeks secondary to pre-eclampsia, 3+ protein in urine, underwent C-section after vaginal bleeding occurred during labor. The patient was also noted to ahve questionable partial placental abruption. Pre-eclampsia in mother during pregnancy with patient. Outcome was satisfactory. Upon internal reveiw, vaginal bleeding during labor which required a C section was determined to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Premature separation of placenta, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Information has been received from a licensed practical nurse (LPN), for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning a 15 year old female with no drug allergies and no previous pregnancies who on 25-JUL-2007 was the first dose of vaccinated with GARDASIL vaccine (yeast) (lot # 658490/0802U) and on 27-OCT-2007 was the second dose of vaccinated with GARDASIL vaccine (yeast) (lot # 658282/1263U). At week 37 of pregnancy, the patient developed slight hypertension. The patient delivered a healthy baby on 28-JUN-2008. At the time of this report, the outcome of slight hypertension was unknown. The patient was seen in office. No product quality complaint was involved. Additional information has been requested. Follow-up information was received on 27-OCT-2008 from a physician who reported that the patient with a history of gastritis and her estimated conception date was 20-OCT-2007 and LMP was 06-OCT-2007 who on 28-JUN-2008 (weeks form LMP 38), delivered a normal female baby. Weight 7lbs4oz and Apgar score 8/8.  On 30-JAN-2008 serum alpha-fetaprotein test negative and on 18-APR-2008 ultrasound was normal. There was no congenital anomaly. Labor was induced at 38 weeks secondary to pre-eclampsia, 3+ protein in urine, underwent C-section after vaginal bleeding occurred during labor. The patient was also noted to ahve questionable partial placental abruption. Pre-eclampsia in mother during pregnancy with patient. Outcome was satisfactory. Upon internal reveiw, vaginal bleeding during labor which required a C section was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a patient's parents concerning an adolescent female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (route and administration site not reported). Subsequently the patient experienced arthralgia. The patient sought unspecified medical attention. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a parent concerning her 19 year old daughter with sulfonamide allergy who in November 2006, was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast) (lot # not reported). There was no concomitant medication. The parent reported that since March 2007, her daughter has been experiencing severe hip pain after the second dose of GARDASIL vaccine (yeast) 0.5 mg. On an unspecified date she underwent an MRI (results not reported). At the time of the report, the patient had not recovered. The parent reported that her daughter has received all three GARDASIL vaccines (yeast), and that therapy was stopped in January 2007. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (lot # not reported). Subsequently the patient had an abnormal pap after receiving GARDASIL vaccine (yeast). The patient was seen in the physician's office. No other information was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Liver function test abnormal
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 17 year old female who was vaccinated with GARDASIL vaccine (yeast), In approximately March 2008, "about 5 months ago", the patient's liver specific protein profile was 2.5 times above normal after she received the first dose. It was noted that the latter profile was a liver profile lab report. Liver specific protein profiles also remained at same level after the second dose as well. Recently liver specific protein profiles were closed to normal. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Epstein-Barr virus antibody negative, Fatigue, Full blood count normal, Metabolic function test normal
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with an allergy to BIAXIN who in June 2007 was vaccinated IM with a first dose of 0.5 mL GARDASIL vaccine (yeast) (lot # 655503/0012U), in August 2007 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # 658282/0929U), and in December 2007, was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U). There was no concomitant medication. It was reported that the patient experienced weight loss, fever, fatigue, and bulging veins. The patient has had a 20 pound weight loss between March 2008 and May 2008. The patient sought medical attention by phone and office visit. The patient was in the office on 05-MAY-2008 because of a "fever for the past 2 days and off and on diarrhea in February and March 2008. "Laboratory diagnostic studies performed were complete metabolic panel, CBC, sed rate, mono spot, EBV titers, thyroid, and urinalysis. All tests were normal except one of the tests showed patient had "MONO" in the past. Subsequently, the patient recovered on an unknown date. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Thyroid function test normal, Urine analysis normal, Vein disorder
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with an allergy to BIAXIN who in June 2007 was vaccinated IM with a first dose of 0.5 mL GARDASIL vaccine (yeast) (lot # 655503/0012U), in August 2007 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # 658282/0929U), and in December 2007, was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U). There was no concomitant medication. It was reported that the patient experienced weight loss, fever, fatigue, and bulging veins. The patient has had a 20 pound weight loss between March 2008 and May 2008. The patient sought medical attention by phone and office visit. The patient was in the office on 05-MAY-2008 because of a "fever for the past 2 days and off and on diarrhea in February and March 2008. "Laboratory diagnostic studies performed were complete metabolic panel, CBC, sed rate, mono spot, EBV titers, thyroid, and urinalysis. All tests were normal except one of the tests showed patient had "MONO" in the past. Subsequently, the patient recovered on an unknown date. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with an allergy to BIAXIN who in June 2007 was vaccinated IM with a first dose of 0.5 mL GARDASIL vaccine (yeast) (lot # 655503/0012U), in August 2007 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # 658282/0929U), and in December 2007, was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U). There was no concomitant medication. It was reported that the patient experienced weight loss, fever, fatigue, and bulging veins. The patient has had a 20 pound weight loss between March 2008 and May 2008. The patient sought medical attention by phone and office visit. The patient was in the office on 05-MAY-2008 because of a "fever for the past 2 days and off and on diarrhea in February and March 2008. "Laboratory diagnostic studies performed were complete metabolic panel, CBC, sed rate, mono spot, EBV titers, thyroid, and urinalysis. All tests were normal except one of the tests showed patient had "MONO" in the past. Subsequently, the patient recovered on an unknown date. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Muscular weakness, Musculoskeletal pain, Neck mass
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient who in April 2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot # not provided) and on 17-Jun-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # not provided). After the second dose the patient developed left arm weakness, pain at the back of the shoulder, swollen glands and a lump on the neck. At the time of reporting, the patient sought medical attention at the office on 07-Jul-2008 for these symptoms. The patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 07-JUL-2008 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL vaccine (yeast) (Lot # r660555/0279X). No information was provided related to the first and second dose of GARDASIL vaccine (yeast). On 07-JUL-2008 the patient began to feel faint about 15 minutes after the injection. The patient was brought back in the office, given some juice and laid down until she was feeling better. The patient sought unspecified medical attention. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow up information was received from a nurse practitioner concerning a 22 year old female patient with no known allergies, who on 31-DEC-2007, 03-MAR-2008 and 07-JUL-2008 was vaccinated in the deltoid with a first, second and third dose of GARDASIL respectively. (Lot # reported as "9670402" for dose 1 or 2). The nurse practitioner reported that on 07-JUL-2008, the patient was feeling faint after injection, but did not faint. Blood pressure was 120/60. The patient was pale in color. The patient was alert and responsive, within 10 minutes the event was over. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a female who in April 2008, was vaccinated with her second dose of GARDASIL vaccine (yeast) (lot# unknown, route and site not reported). Subsequently the patient experienced bumps on her hips. The patient had heard the news media about all the adverse events experienced with GARDASIL vaccine and called the doctor's office to report the bumps on her hips.. The patient's bumps on her hips persisted. No other information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated on an unspecified on an unspecified date with a dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently on an unspecified date the patient experienced pain at the injection site and swelling of the arm. The patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 08-JUL-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL vaccine (yeast) (lot# 660555/0279X). On 08-JUL-2008 the patient fainted almost immediately after receiving her first dose, The nurse reported that they gave the patient some juice and had her lie down until th symptoms resolved. It was noted that the patient had not eaten much prior to receiving the vaccine. The patient sought unspecified medical attention on an unspecified date and the patient's outcome was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Weight increased
Clinical narrative: Information has been received from a physician concerning a female who in approximately July 2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# not reported) and she was late getting her menstrual cycle. Subsequently the patient also gained 30 pounds since getting the vaccine. The patient sought medical attention since getting the vaccine. The patient sought medical attention on an unspecified date with an office visit, The patient's outcome was not reported. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 13 year old female who on 17-MAY-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 655619/1427F). On 17-JUL-2007 the patient was vaccinated intramuscularly in the left arm with her second dose of GARDASIL (lot# 656050/0245U) and she was late getting her menstrual cycle. Subsequently the patient also gained about 30 pounds since getting the vaccine. The patient's BMI before 1st vaccine was 26 and BMI after the 2nd vaccine is 30. The patient sought medical attention on an unspecified date with an office visit. The patient's outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with a first dose of GARDASIL vaccine (yeast) (date not reported). On 11-APR-2008 the patient was vaccinated with a second dose 0.5 ml dose GARDASIL vaccine (yeast). On 08-JUN-2008, for the past month, the patient has experienced right foot pain and parasthesia. At the time of the report the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a consumer who on 05-MAY-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot number not reported) and experienced flu like symptoms. Consumer declined to provide any additional information. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who on approximately 04-JUN-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot number not reported) and broke out in hives on an unspecified date. Healthcare worker also states when the patient goes in a cold pool, she breaks out in hives. Patient sought unspecified medical attention by calling physician's office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a physician assistant concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot # not provided). Subsequently the patient developed a small lump on the arm of the injection site. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician assistant concerning a female patient who was vaccinated with a dose of GARDASIL (lot # not provided). Subsequently, the patient developed swelling at injection site and a small lump on the arm of the injection site, 1 cm round, hard nodule that cleared spontaneously within 1-2 weeks. This was considered to be a local vaccine reaction. No fever and no erythema were experienced. The patient sought unspecified medical attention. The patient recovered. No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Peroneal nerve palsy
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASSIL vaccine (yeast). Subsequently the patient experienced drop foot. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional disorder, Insomnia, Syncope
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter who on approximately 09-MAY-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# not reported). On approximately 09-JUN-2008 the patient experienced a fainting spell 1 month after receiving the vaccine. The mother feels this was due to lack of sleep and also looking at pictures of burn victims in health class. Subsequently, the patient recovered from the fainting spell. No additional information is expected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Hypoaesthesia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 31 year old female with a history of 3 cervical disk problems in her neck and who gets sick with pain medications who on 26-MAR-2007 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast) (lot# not reported). On 21-MAY-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL vaccine (yeast) (lot# not reported). On 20-NOV-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL vaccine (yeast) (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). Some time after her third dose of GARDASIL vaccine (yeast) the patient was not able to feel her arm for an hour. She was able to lift the arm. Following this incident the nurse mentioned that the patient had two similar episodes that lasted for a much shorter time where her arm felt funny.  It was not known if the incidences occurred in the injection site arm or not. The patient has been referred to a neurologist for evaluation. The patient sought unspecified medical attention by calling the office on an unspecified date. The patient is recovering from her arm being numb and feeling funny. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Initial and follow up information has been received from a nurse practitioner (NP) concerning an 17 year old white female student with no known drug allergies who was vaccinated with a first and a second dose of GARDASIL vaccine (yeast). Subsequently, the patient experienced nausea and vomiting respectively. There was no illness at the time of vaccination. Twenty four to forty eight hours after vaccine, the patient recovered from nausea and vomiting. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patient developed hives. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular, Skin discolouration
Clinical narrative: Information has been received from a 22 year old female with allergic reaction to erythromycin who on 07-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number was not available). Concomitant therapy included hormonal contraceptives (unspecified). On 08-JUL-2008 the patient experienced a rash of brown spots on her hands and arms. The patient's a rash of brown spots on her hands and arm persisted. Medical attention was sought via physician and nurse. No product quality complaint was involved. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female with anxiety disorder and a history of papanicolaou smear abnormal and positive for HPV that resolved with no treatment and no drug allergies who in June 2008, was vaccinated with the third dose of GARDASIL vaccine (yeast). Concomitant therapy included PROZAC. On 18-JUN-2008, the patient had a Papanicolaou (PAP) that was positive for HPV. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who in May 2008, was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient passed out within 5 minutes of receiving the first dose of GARDASIL vaccine (yeast) at the office. She was sent by ambulance to the hospital and was diagnosed with vasovagal. The patient recovered on the same day. This is one of several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Pregnancy test negative
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with no pertinent medical history or history of drug reactions or allergies who in May 2008, was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL vaccine (yeast) (lot no 660389/1968U). Concomitant therapy included LOESTRIN. The nurse reported that the patient was having amenorrhea. The patient's last menstrual period was April 2008. The patient took a few home pregnancy tests and was not pregnant. At the time of this report, the patient's amenorrhea persisted. The patient contacted the office to seek unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female who on 20-MAY-2008 was vaccinated with a 0.5 ml dose of GARDASIL vaccine (yeast) IM into the deltoid (lot number not reported). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced pain and discomfort of the vaccinated arm. The patient was seen in the physician's office. The patient's pain and discomfort of the vaccinated arm persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2008. Information has been received from a registered nurse concerning a female who on 20-MAY-2008 was vaccinated with a 0.5 ml dose of GARDASIL IM into the deltoid (lot number not reported). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced pain and discomfort of the vaccinated arm. The patient was seen in the physician's office. The patient's pain and discomfortof the vaccinated arm persisted. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis C positive
Clinical narrative: Information has been received from a patient's mother concerning a 22 year old female patient with no pertinent medical history and no allergies who in approximately May 2008, was vaccinated with the second dose of GARDASIL vaccine (yeast) 0.5ml IM. There was no concomitant medication. In May 2008, the patient tested hepatitis C positive two weeks after receiving her second dose. The patient sought medical attention, Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who was vaccinated with GARDASIL vaccine (yeast) 0.5ml IM. Concomitant therapy included hormonal contraceptives (unspecified). The patient developed dizziness since vaccination. The patient had completed the series (dates of vaccination not known at this time). It was not clear at what point in the series that the dizziness began, "but it has been a while". The patient sought medical attention in office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Asthenia, Inappropriate schedule of drug administration, Pallor
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 07-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658282/0929U) 0.5ml IM at the same office visit. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, MENACTRA vaccine (dip toxoid) and varicella virus vaccine live (MSD). On 07-FEB-2008  the patient experienced pale and weak. Therapy with human papillomavirus vaccine was discontinued. The patient's mother took her to the emergency room. On an unspecified date the patient recovered from pale and weak. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Cold sweat, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: Information has been received from a certified registered nurse practitioner concerning a 22 year old white female with an allergy to amoxicillin, azithromycin (Zpack) and seasonal allergies and no known illness at time of vaccination who on /1968U), IM, left 09-JUL-2008 at 11:00 AM was vaccinated with first dose of GARDASIL vaccine (yeast) (Lot# 660389/1968U) (Dose not reported). Concomitant therapy included YASMIN. On 09-JUL-2008, the patient received her first dose of GARDASIL vaccine (yeast) and at 11:10 AM she became "light headed, hot, felt funny, stomach ache, cool, pale, clammy skin, faint pulse". The nurse could not get her blood pressure and the office had to call 911 to send her to hospital via squad. Approximately 1 hour later on the same day, the patient called the office back and said she was feeling fine and was released from hospital and that it was a Vaso Vagal reaction. The patient recovered from the Vaso Vagal reaction. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Pulse pressure decreased, Syncope vasovagal
Clinical narrative: Information has been received from a certified registered nurse practitioner concerning a 22 year old white female with an allergy to amoxicillin, azithromycin (Zpack) and seasonal allergies and no known illness at time of vaccination who on /1968U), IM, left 09-JUL-2008 at 11:00 AM was vaccinated with first dose of GARDASIL vaccine (yeast) (Lot# 660389/1968U) (Dose not reported). Concomitant therapy included YASMIN. On 09-JUL-2008, the patient received her first dose of GARDASIL vaccine (yeast) and at 11:10 AM she became "light headed, hot, felt funny, stomach ache, cool, pale, clammy skin, faint pulse". The nurse could not get her blood pressure and the office had to call 911 to send her to hospital via squad. Approximately 1 hour later on the same day, the patient called the office back and said she was feeling fine and was released from hospital and that it was a Vaso Vagal reaction. The patient recovered from the Vaso Vagal reaction. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female who on approximately 25-JUN-2008, also reported as within the past two weeks, was vaccinated with a first dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number and injection site not reported). Subsequently the patient developed hives that she gets off and on. Unspecified medical attention was sought. The patient's hives persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). A couple days after vaccination the patient fainted. Unspecified medical attention was sought. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin, Oral contraception, Skin papilloma
Clinical narrative: Information has been received from a consumer concerning her daughter, a 25 year old female with no known drug reactions/allergies and a history of migraine who in 2007 was vaccinated with a total of three 0.5 ml doses of GARDASIL vaccine (yeast) (exact time of each dose not reported). Concomitant therapy included birth control pills. In 2008, a "couple months ago" the patient experienced wart like growths on her fingers. Biopsy was done and no result was provided. The patient's wart like growths persisted. Unspecified medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Diarrhoea, Gastroenteritis viral, Headache, Nausea, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a nurse concerning her daughter, a 17 year old female patient who at 3:00 pm on 18-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot# 660553/0070X) IM in her left deltoid. Other suspect therapy at 3:00 pm on 18-JUN-2008 included a second dose of VARIVAX (Merck) (lot# 660084/0333X) SQ in her right arm. On 29-JUN-2008 the patient experienced a severe headache, nausea, terrible vomiting and diarrhea for 2 days and she was not able to hold anything in her stomach. The physician mentioned that it could have been the flu that was going around. On 06-JUL-2008 the patient recovered from the stomach flu. Additional information is not expected.