chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 13-MAY-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently the mother called the office on 04-JUN-2008 because the patient experienced cervical, groin and bilateral axillary lymphadenopathy on an unspecified date. Subsequently, the patient recovered from cervical, groin and bilateral axillary lymphadenopathy on an unspecified date. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 25-JUN-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (injection site and route not reported). Subsequently the patient broke out in hives. She sought medical attention and was treated with diphenhydramine hydrochloride (BENADRYL). Subsequently, the patient recovered from hives. The patient came in for second dose but it was not given because of the event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no relevant medical history who on 21-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). There was no concomitant medication. On approximately 21-MAY-2008, also reported as 1 month after the first dose was given, the patient experienced myalgia and arthralgia. The patient's myalgia and arthralgia persisted. No other doses have been given yet. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who in October 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no., route and site of administration were not reported). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot no. and route of administration were not reported) on her left arm. After receiving her second dose, the patient developed a "white ring" at the injection site. This "white ring" area does not tan with sun exposure. Both dosed were given at a location other than this nurse's office. The patient went to office and sought unspecified medical attention. No other information is available at this time. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Myalgia
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history or allergies who in April 2008, was vaccinated intramuscularly with a first dose of GARDASIL vaccine live (yeast) and no problems were reported. "About 2 weeks ago", in June 2008, the patient was vaccinated intramuscularly with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. The same night of the second vaccination, the patient experienced muscle pain in the legs and arms and had a general feeling of weakness all over. No laboratory or diagnostics studies were performed. The myalgia lasted 48 to 72 hours. Subsequently, the patient recovered from myalgia. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with no medical history and no allergies, who on 21-MAY-2008 was vaccinated in the left deltoid with third dose of GARDASIL vaccine (yeast) (lot # reported as "17574"). Dates and lot #s of previous two doses were not reported was no concomitant medication. It was reported that on 22-MAY-2008 at 10 am, the patient called the office with complaints of migraine. She was advised to take ibuprofen (ADVIL) and go to ER if headache get worse. It was reported that at 11:30 am on the same day, the patient felt better and subsequently recovered from the migraine. It has been determined that WAES No. 0806USA03218 is a duplicate of WAES No. 0805USA04997. Therefore, WAES No. 0806USA03218 is being deleted from our files and the reports consolidated into WAES No. 0805USA04997. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on unspecified date was vaccinated intramuscularly with 0.5ml of GARDASIL vaccine (lot# unspecified). It was reported that on unspecified date the patient developed a persistent round circle on her arm at the injection site. At the time of this report, the patient's round circle at the injection site persisted. Unspecified medical attention was sought. No other information is available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Arthritis, Culture urine negative, Haematocrit normal
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on unspecified date was vaccinated intramuscularly with first dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed arthritis. Unspecified medical attention was sought. On unspecified date erythrocyte sedimentation rate test was performed, result was reported as "elevated". At the time of this report, the outcome was unknown. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who on 21-APR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot# 659435/1265U) in the left deltoid. There was no concomitant medication. On 24-MAY-2008 the patient was seen in urgent care for questionable mononucleosis. In June 2008, the patient developed myalgias and arthralgias. On 16-JUN-2008 the patient was seen by the physician and had the following laboratory tests performed: ANA which was negative, erythrocyte sedimentation rate 30 mm/hr, rheumatoid arthritis factor which was negative and urine culture (no growth). The patient's CBC was within normal limit on 24-JUN-2008. The physician reported that the diagnosis was arthritis. The patient was referred to a rheumatologist on 02-JUL-2008 and a positive sedimentation rate was noted. The patient was again diagnosed with arthritis. The patient did not receive any more doses of GARDASIL. At the time of this report, the patient had not recovered from the events. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Lymphocyte count normal, Mean cell volume normal, Monocyte count normal, Myalgia
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on unspecified date was vaccinated intramuscularly with first dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed arthritis. Unspecified medical attention was sought. On unspecified date erythrocyte sedimentation rate test was performed, result was reported as "elevated". At the time of this report, the outcome was unknown. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who on 21-APR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot# 659435/1265U) in the left deltoid. There was no concomitant medication. On 24-MAY-2008 the patient was seen in urgent care for questionable mononucleosis. In June 2008, the patient developed myalgias and arthralgias. On 16-JUN-2008 the patient was seen by the physician and had the following laboratory tests performed: ANA which was negative, erythrocyte sedimentation rate 30 mm/hr, rheumatoid arthritis factor which was negative and urine culture (no growth). The patient's CBC was within normal limit on 24-JUN-2008. The physician reported that the diagnosis was arthritis. The patient was referred to a rheumatologist on 02-JUL-2008 and a positive sedimentation rate was noted. The patient was again diagnosed with arthritis. The patient did not receive any more doses of GARDASIL. At the time of this report, the patient had not recovered from the events. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative, White blood cell count
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on unspecified date was vaccinated intramuscularly with first dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed arthritis. Unspecified medical attention was sought. On unspecified date erythrocyte sedimentation rate test was performed, result was reported as "elevated". At the time of this report, the outcome was unknown. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who on 21-APR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot# 659435/1265U) in the left deltoid. There was no concomitant medication. On 24-MAY-2008 the patient was seen in urgent care for questionable mononucleosis. In June 2008, the patient developed myalgias and arthralgias. On 16-JUN-2008 the patient was seen by the physician and had the following laboratory tests performed: ANA which was negative, erythrocyte sedimentation rate 30 mm/hr, rheumatoid arthritis factor which was negative and urine culture (no growth). The patient's CBC was within normal limit on 24-JUN-2008. The physician reported that the diagnosis was arthritis. The patient was referred to a rheumatologist on 02-JUL-2008 and a positive sedimentation rate was noted. The patient was again diagnosed with arthritis. The patient did not receive any more doses of GARDASIL. At the time of this report, the patient had not recovered from the events. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 15-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast) (lot# 659964/1978U). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient experienced extreme dizziness for 2-3 days after the dose. The dizziness episodes lasted about 10 minutes each. The second dose has been deferred at this time. The patient sought unspecified medical attention on an unspecified date. Subsequently, the patient recovered from extreme dizziness on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown) who on an unspecified date was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (yeast) (Lot # unknown). Subsequently, on an unknown date, the patient experienced felt dizzy and light headed for over a week after 1st dose. Therapy with human papillomavirus vaccine was discontinued. Subsequently, on an unspecified date the patient recovered. Unspecified medical attention was sought. No product quality control was involved. Additional information has been requested.
Sex: F
Vaccine: HEP, HPV4
Symptoms: Angioedema, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL vaccine (yeast). Concomitant suspect vaccination included second of third dose of hepatitis B virus vaccine (unspecified). The physician reported that within 24 hours of vaccination, the patient had hives and then had angioedema of her lips. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac stress test, Electroencephalogram, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning the 16 year old daughter of his receptionist, with polycystic kidney who in August 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). In August 2007, on an unspecified date, after receiving GARDASIL vaccine (yeast) by injection, the patient experienced "passing out." She received her second dose of GARDASIL vaccine (yeast) on an unreported date in October 2007. Her hormonal contraceptives were discontinued in November 2007. The patient was not given the third dose of GARDASIL vaccine (yeast). She sought unspecified medical attention and had a stress test and an electroencephalogram (EEG) performed, no results were provided. At the time of reporting the patient was still experiencing "passing out." Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse (RN) through a Merck pregnancy registry concerning a 13 year old female with attention deficit/hyperactivity disorder and no known drug allergies and a history of being a rape victim who on 15-OCT-2007 was vaccinated intramuscularly in the right deltoid with a first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #655849/0263U). On the same day the patient also received concomitant vaccinations of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), hepatitis A virus vaccine (manufacturer unknown) and influenza virus vaccine (unspecified). The patient was in her menstrual cycle at the time of vaccination. On 15-JUN-2008 the patient had a normal live birth, female child. Unspecified medical was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a female with no known drug allergies who on 01-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no. 659962/1740U) 0.5ml via intramuscular route. Site of injection was not reported. The patient developed red ankles and feet with minor swelling after administration of her first dose. On an unspecified date the patient was recovered. The patient sought unspecified medical attention via telephone. No additional information was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Joint swelling
Clinical narrative: Information has been received from a medical assistant concerning a female with no known drug allergies who on 01-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no. 659962/1740U) 0.5ml via intramuscular route. Site of injection was not reported. The patient developed red ankles and feet with minor swelling after administration of her first dose. On an unspecified date the patient was recovered. The patient sought unspecified medical attention via telephone. No additional information was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Borrelia burgdorferi serology, Joint swelling, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with no medical history or drug allergies reported, who in February and April 2008 was vaccinated with the first and second dose of GARDASIL vaccine (yeast), respectively. There was no concomitant medication. On 09-MAY-2008 the patient developed systemic joint tenderness with mild to moderate joint swelling. The patient sought unspecified medical attention. Lyme and magnetic resonance imaging tests were performed with no results reported. The symptoms have been somewhat responsive to prednisone, but return when the prednisone was not used. At the time of this report, the patient has not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Headache, Hypotension, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no. not reported) 0.5ml via intramuscular route. Site of injection was not reported. The patient experienced syncope right after receiving initial dose of GARDASIL vaccine (yeast). The patient was placed in a wheel chair and taken to a room in office. Vital signs demonstrated hypotension and bradycardia. The patient passed out several more times during this period in office. The patient was sent to hospital ER in ambulance, but was not admitted as In-Patient. On 18-JUN-2008, the patient recovered from syncope, hypotension, bradycardia and passed out. On the same day, the patient still had a headache. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no. not reported) 0.5ml via intramuscular route. Site of injection was not reported. The patient experienced syncope right after receiving initial dose of GARDASIL vaccine (yeast). The patient was placed in a wheel chair and taken to a room in office. Vital signs demonstrated hypotension and bradycardia. The patient passed out several more times during this period in office. The patient was sent to hospital ER in ambulance, but was not admitted as In-Patient. On 18-JUN-2008, the patient recovered from syncope, hypotension, bradycardia and passed out. On the same day, the patient still had a headache. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician assistant concerning a female who was vaccinated with GARDASIL vaccine (yeast) unsure how many doses and had a positive HPV result from a PAP smear test post vaccination. The physician assistant stated the patient became sexually active at this time frame. The patient sought medical attention. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: DNA antibody positive, Human papilloma virus test positive, Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with no relevant medical history who in May 2007 and in July 2007, was vaccinated with a first and second dose of GARDASIL vaccine (yeast) respectively (lot number, injection site and route not reported). On 06-MAY-2008 the patient was vaccine with the third dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included minocycline HCl (MINOCIN). On 06-MAY-2008 the patient had an abnormal PAP test and was positive for the HPV DNA reflex group which tested the 6 high risk types. The patient was diagnosed with low grade lesions or precancer. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast). The patient fainted after she received GARDASIL vaccine (yeast). Subsequently, the patient recovered. Unspecified medical attention was sought. This is one of several reports from the same source. No further information is available.
Sex: M
Vaccine: HPV4
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 18-JUN-2008 was vaccinated with a third dose of GARDASIL vaccine (yeast) subcutaneously (lot number and injection site not reported). Subsequently the patient developed an injection site reaction. The injection site reaction went away and at the time of reporting there was a hard area at the injection site. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Diarrhoea, Malaise, Nausea, Nervousness
Clinical narrative: Information has been received from a physician and a consumer concerning the 25(also reported as 26) year old female consumer with irritable bowel syndrome who on 18-JUN-2008 was vaccinated intramuscularly with GARDASIL vaccine (yeast). The physician reported that the consumer felt "sick" all night after receiving the dose of GARDASIL vaccine (yeast). There was no concomitant medication. The consumer reported that the same night after receiving the GARDASIL vaccine (yeast), she experienced diarrhea, nausea and "I even threw up a little". The reporter also noted that she was feeling anxious and scared. The consumer sought medical attention with a call to the physician. The consumer reported that she was "feeling a little better but not fully myself." No further information was available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician and a consumer concerning the 25(also reported as 26) year old female consumer with irritable bowel syndrome who on 18-JUN-2008 was vaccinated intramuscularly with GARDASIL vaccine (yeast). The physician reported that the consumer felt "sick" all night after receiving the dose of GARDASIL vaccine (yeast). There was no concomitant medication. The consumer reported that the same night after receiving the GARDASIL vaccine (yeast), she experienced diarrhea, nausea and "I even threw up a little". The reporter also noted that she was feeling anxious and scared. The consumer sought medical attention with a call to the physician. The consumer reported that she was "feeling a little better but not fully myself." No further information was available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Breast discharge, Mastitis, Ultrasound pelvis
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 23-APR-2008 had a complete physical and was symptom free, she then was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot# not specified). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). on approximately 30-APR-2008 the patient developed mastitis (of the breasts) and discharge from her nipples. The patient sought unspecified medical attention and underwent a pelvic sonogram on an unspecified date, the results of which were negative. The physician reported that the patient was treated with unspecified antibiotics. On 27-MAY-2008, the physician reported that the patient was seen for a follow-up office visit and appeared to be fine. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a licensed practical nurse, concerning a patient who received the third dose of GARDASIL vaccine (yeast) on 18-Jun-2008 and passed out. The office reporting the adverse reaction was not the facility that administered the dose. The patient passed out after receiving the dose of GARDASIL vaccine (yeast) for a "short time". The patient received the first dose of GARDASIL vaccine (yeast) on 04-Jan-2008, the second dose on 07-Mar-2008 and the third dose on 18-Jun-2008. There was no concomitant therapies. All doses were administered at another facility. The patient recovered. No other information to report. There was no product quality complaint. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unreported) who was vaccinated on an unspecified date with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced a grief syncopal episode. The patient was reported as "fine" and no follow up was needed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Human papilloma virus test positive, Pregnancy test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse for the pregnancy registry for HPV vaccine concerning a 16 year old female who on 20-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 ml intramuscularly. Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 14-APR-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 ml intramuscularly. The nurse reported that the patient is now pregnant, on an unspecified date a pregnancy test was done. It was noted that the patient tested positive for HPV during routine PAP test. The patient is not experiencing any known symptoms. The patient's LMP was 01-APR-2008 and EDD 06-JAN-2009. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Rash, Rash papular, Skin discolouration
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter who "sometime" in June 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast). "Sometime" in July 2007 she was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medications. "Sometime" in October 2007 she was vaccinated with a third dose of GARDASIL vaccine (yeast). In the beginning of October 2007, the patient started to break out in rash on the front of her body and by the end of October she started to develop little bumps on her whole stomach. In December 2007 the bumps spread to her back from her chest down to her stomach. The bumps turned into open sores that were a little larger than a pencil tip but did get to the size of an eraser on a pencil. The sores healed and the patient "has brown spots on her body where the rash had been." The patient was seen and treated by a dermatologist. The patient had a biopsy (results not reported). The patient was treated with a cream (unspecified by reporter). The cream had faded the spots a "little bit" but the patient "still has the marks." At the time of the report the patient was recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female who on 16-JAN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). The patient developed a rash, unspecified, after the second dose and went to an urgent care center but was not hospitalized. The doctor's office was notified of the rash when the patient was called by the doctor's office on 17-JUN-2008 to schedule her third vaccination. The doctor's office is awaiting records. At the time of the report, the outcome was unknown. Additional information  has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 20 female patients who on unspecified date were vaccinated intramuscularly with 0.5 ml of GARDASIL vaccine (yeast) (dose and lot # unspecified). Immediately post vaccination the patients developed stinging at the injection site. Unspecified medical attention was sought. It was reported that the stinging resolved prior to the patients leaving the office or within 1-5 minutes. No other information is available. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided when available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with no known drug reactions or allergies who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur). The patient fainted 10 minutes after receiving her first dose of GARDASIL vaccine (yeast). There were no injuries. She was walking fairly soon after fainting. She did not say if she will discontinue the series. Unknown medical attention was sought with the doctor. Patient recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: DNA antibody positive, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female with no known drug reactions or allergies who was vaccinated with a dose of GARDASIL vaccine (yeast) and now has tested positive for high risk HPV DNA and has an abnormal Pap test. The patient received at least one and possibly two vaccinations with GARDASIL vaccine (yeast) prior to the abnormal Pap and HPV DNA test on 27-MAY-2008. The vaccination with GARDASIL vaccine (yeast) were not administered at the office in the case. The patient had never had an abnormal Pap or positive HPV DNA test in the past. It was unknown whether the patient sought medical attention. Patient outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who on 13-Mar-2008 was vaccinated with first dose of GARDASIL vaccine (yeast) ( lot# 655604/0052X) and developed warts on her knees and elbows. It was reported that on 20-May-2008 the patient vaccinated with second dose of GARDASIL vaccine (yeast) (lot# 659182/1757U) and developed warts on her hands and fingers. Unspecified medical attention was sought. The physician reported that the patient will not receive the 3rd dose of GARDASIL vaccine (yeast). The therapy with GARDASIL vaccine (yeast) was determined. At the time of this report the outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rectal haemorrhage
Clinical narrative: Information has been received from a Physician concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL vaccine (yeast). Lot number was not available. Subsequently, the patient experienced rectal bleeding. The patient did seek medical attention with the physician. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: This is in follow-up to report(s): previously submitted on 7/16/2008. Information has been received from a licensed practical nurse (LPN) concerning an approximately 14 year old female student with stollosis and hypermobility syndrome, drug reactions or allergies who on 19-JUN-2007 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #657737/0522U). On the same day the patient also received secondary suspect  hepatitis A virus vaccine inactivated (MSD) (Lot #657306/0360U). it was previously reported that the patient also received a dose of varicella virus vaccine live (Merck). On 20-JUN-2007 the patient had a fever of 104F. Subsequently the patient recovered from fever. On 20-JUN-2008 the patient was in office for the second dose of GARDASIL vaccine (yeast) and hepatitis V virus vaccine inactiviated. The patient did not seek medical attention. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician and an office manager concerning an approximately 21 year old female who on an specified date was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL vaccine (yeast) (lot #659653/1448U). After receiving GARDASIL vaccine (yeast) the patient fainted. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). The patient experienced faint and injured head on floor. Subsequently, the patient recovered from faint and injured head on floor. The patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 17-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number, injection site not reported) and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacture unknown). Subsequently the patient experienced faint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported), and the patient did not experience any difficulties after that. On an unspecified date the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number and injection site not reported). The patient also received 2 other vaccines (name not known) minutes prior to GARDASIL vaccine. Within 30 seconds following the vaccination of GARDASIL vaccine, the patient "passed out". Unspecified medical attention was sought. The patient recovered after 30-40 seconds. The patient's mother stated that the patient would not receive the third dose. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a third dose of GARDASIL vaccine (yeast) 0.5 ml (lot# 0152X). Concomitant therapy included albuterol sulfate (VENTOLIN (albuterol sulfate)), "topical acne medicine" dermatologic (unspecified) and fluticasone propionate (FLOVENT). On 19-JUN-2008 the patient experienced leg edema. The patient was brought to emergency room on 20-JUN-2008 but was not admitted to the hospital. The patient's leg edema persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008.  Follow-up information was received from a physician concerning the patient developed edema of both lower legs/feet beginning on 19-JUN-2008.  The patient had had a 10-12 pound weight gain since April, 2008.  The physician mentioned in follow up that the patient was still having swelling in the legs and feet.  The patient had seen a cardiologist, gastroenterologist and had had a doppler study and CT of the abdomen.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 10-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 10-MAY-2008 the patient had an injection site reaction (local reaction with erythema) for a few days. Subsequently, the patient recovered from local reaction with erythema for a few days. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: DNA antibody positive, Human papilloma virus test positive, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female patient who in January 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). The patient was HPV positive and had an abnormal PAP since receiving GARDASIL vaccine (yeast). In May 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). The patient's HPV positive and abnormal PAP were persisted. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previosly submitted on 7/15/2008. Initial and follow-up information has been received from a licensed practical nurse and a physician concerning a 19 year old female patient, also reported as 20 years old, with allergy to amoxicillin and no relevant medical history who on 28-JUL-2007 was vaccinated with a first dose of GARDASIL (lot number 658490/0802U) intramuscularly into her right upper arm. On 28-SEP-2007 the patient was vaccinated with a second dose of GARDASIL (lot number 658560/1062U) intramuscularly into her left upper arm. On 01-JAN-2008 the patient was vaccinated with a third dose of GARDASIL (lot number 659439/1267U) intramuscularly into her upper arm. The patient was tested HPV after completion of all three doses, and the result was positive. The patient had an abnormal PAP. The patient's outcome was unknown. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a nurse concerning a 11 year old female who in November 2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) IM. Since November 2007, the patient had not gotten her period until recently after receiving her third dose of GARDASIL vaccine (yeast) in May of 2008. The date of the second vaccination was not provided. the patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Inappropriate schedule of drug administration, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning an overweight 15 year old female with anxiety and no drug reactions/allergies history reported who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18-JUN-2008 the patient became lightheaded, diaphoretic and hypotensive after her first dose of GARDASIL vaccine (yeast). The patient had a consult with a cardiologist due to these adverse experiences and was diagnosed with a vasovagal response to the immunizations. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 21-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) in the right arm (route not reported. There was no concomitant medication. On 21-JUN-2008 the patient experienced numbness and parathesias. The symptoms were a little better when the patient got home. The patient sought medical attention in the office. Additional information has been requested.  9/2/08 WCC received from PCP dated 6/21/2008 which states mother refused HPV vaccine. TDaP, Menactra and Varicella vax rec'd on that date. 9/26/2008  Per office RN pt recently in for 2nd HPV vax, no reported problems.  Case closed.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Back pain, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with penicillin allergy and allergic reaction to antibiotics who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) IM. On 20-JUN-2008, the now 25 year old patient was vaccinated with a second dose of GARDASIL vaccine (yeast) IM. Concomitant therapy included "Mercet birth control" (hormonal contraceptives (unspecified)). The patient was unable to lift her arm above shoulder level after being immunized with the second dose of GARDASIL vaccine (yeast). The patient also suffered from severe bilateral back pain after receiving the second dose of GARDASIL vaccine (yeast). The nurse practitioner reported that the patient had experienced mild symptoms after the first dose of GARDASIL vaccine (yeast), but the symptoms were much more pronounced with the second dose. The nurse practitioner reported that the patient was seen in the office on 23-JUN-2008 and was treated with acetaminophen (TYLENOL) for the pain. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a nurse practitioner concerning a 24 year old registered nurse with penicillin allergy and allergice reaction to antibiotics who on approximately 14-APR-2008 was vaccinated with a first dose of GARDASIL vaccine IM. At 6pm on 14-APR-2008 the patient experienced pain in shoulder of injection site radiating down arm and severe low back pain within 6 hours. On 20-JUN-2008, the now 25 year old patient was vaccinated with a second dose of GARDASIL vaccine (lot# 060391/0063X) IM in her right deltoid. Concomitant therapy included "MERCET birth control" (unspecified). The patient experienced pain in her shoulder of the injection site radiating down her arm and severe bilateral back pain which continued for 2 weeks. The symptoms were much more pronounced with the second dose. The patient was unable to lift her arm above shoulder level after being immunized with the second dose of GARDASIL vaccine. The nurse preactitioner reported that the patient was seen in the office on 23-JUN-2008 and was treated with TYLENOL, prednisone (manufacturer unknown), cyclobenzaprine hydrochloride (MSD) and PERCOCET for the pain. The patient recovered. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Similar reaction on previous exposure to drug, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with penicillin allergy and allergic reaction to antibiotics who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) IM. On 20-JUN-2008, the now 25 year old patient was vaccinated with a second dose of GARDASIL vaccine (yeast) IM. Concomitant therapy included "Mercet birth control" (hormonal contraceptives (unspecified)). The patient was unable to lift her arm above shoulder level after being immunized with the second dose of GARDASIL vaccine (yeast). The patient also suffered from severe bilateral back pain after receiving the second dose of GARDASIL vaccine (yeast). The nurse practitioner reported that the patient had experienced mild symptoms after the first dose of GARDASIL vaccine (yeast), but the symptoms were much more pronounced with the second dose. The nurse practitioner reported that the patient was seen in the office on 23-JUN-2008 and was treated with acetaminophen (TYLENOL) for the pain. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a nurse practitioner concerning a 24 year old registered nurse with penicillin allergy and allergice reaction to antibiotics who on approximately 14-APR-2008 was vaccinated with a first dose of GARDASIL vaccine IM. At 6pm on 14-APR-2008 the patient experienced pain in shoulder of injection site radiating down arm and severe low back pain within 6 hours. On 20-JUN-2008, the now 25 year old patient was vaccinated with a second dose of GARDASIL vaccine (lot# 060391/0063X) IM in her right deltoid. Concomitant therapy included "MERCET birth control" (unspecified). The patient experienced pain in her shoulder of the injection site radiating down her arm and severe bilateral back pain which continued for 2 weeks. The symptoms were much more pronounced with the second dose. The patient was unable to lift her arm above shoulder level after being immunized with the second dose of GARDASIL vaccine. The nurse preactitioner reported that the patient was seen in the office on 23-JUN-2008 and was treated with TYLENOL, prednisone (manufacturer unknown), cyclobenzaprine hydrochloride (MSD) and PERCOCET for the pain. The patient recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Axillary pain, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 15 year old white female student with asthma who on 13-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660391/0063X) intramuscularly into left deltoid. Suspect therapy given the same day included a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot #0063X) IM into left deltoid. On 14-JUN-2008 the patient developed left axillary adenopathy, left axillary pain and also asthma exacerbation. There was no illness at the time of vaccination. It was unknown by the reporter if the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast). The patient fainted after she received GARDASIL vaccine (yeast). She became hot and sweaty after fainting. Subsequently, the patient recovered. Unspecified medical attention was sought. This is one of several reports from the same source. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Fall, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with a history of "small septal defect" and no drug reactions/allergies who on 20-JUN-2008 was vaccinated intramuscularly in the right arm with first dose of GARDASIL vaccine (yeast) (lot # unspecified). Concomitant therapy included hormonal contraceptives (unspecified). It was reported that the patient fainted and fell off exam table seconds post vaccination. Upon further examination by physician, the patient was determined to have a concussion. Unspecified medical attention was sought. It was reported that the patient was getting worse and the physician will be scheduling CT scan if symptoms won't subside. At the time of this report the patient has not recovered from her experiences. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 23-JUN-2008 was vaccinated IM in the arm with the first dose of GARDASIL  vaccine (yeast). On 23-JUN-2008 the patient fainted and fell to ground. On 23-JUN-2008 the patient recovered from fainting. Unknown medical attention was sought. Additional information has been requested.