chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female who on 23-JAN-2008 was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  On 09-JUN-2008 the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient experienced pain and redness at the injection site.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Presyncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Initial and follow-up information has been received from a physician concerning a 24 year old female with needle phobic and mitral valve prolapse and no known drug allergy, who on 21-JUL-2008 was vaccinated with a first 0.5 ml dose of GARDASIL (lot number 659055/1522U) intramuscularly in the left deltoid. On 21-JUL-2008, approximate 1 minute after the vaccination, the patient became pale and nearly experienced syncope.  The physician reported that the patient experienced symptoms of syncope but did not lose consciousness.  The physician gave the patient some cold water and drink. The patient rested for approximate 10 minutes. Subsequently, the patient recovered from symptoms of syncope.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Rash
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female, who, on an unspecified date was vaccinated IM in the deltoid with a 0.5mL dose of GARDASIL. The patient was at the office for pelvic pain when she was vaccinated. Subsequently, post vaccination the patient experienced cramping in both legs and developed red spots over her face. The patient called the office. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on 10-JUL-2008 was vaccinated with the second dose of GARDASIL (lot# not reported).  Concomitant therapy included LEXAPRO and ampicillin.  The patient experienced cellulitis at the injection site.  The patient had a sore arm for about 5 days.  The patient recovered from cellulitis at the injection site.  The patient sought medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of GARDASIL 0.5 mL (lot # not reported). The patient said her next menstrual cycle was very heavy and thought it was related to the GARDASIL. Medical attention was sought by the patient. The physician also reported that the patient was vaccinated with a second dose of GARDASIL. There was no further information. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Syncope
Clinical narrative: Information has been received from a consumer concerning her 9 year old daughter with low blood pressure, low heart rate and environmental allergies to rag weed and mildew, who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL, (lot #660553/0070X), 0.5 ml, intramuscularly (IM).  There was no concomitant medication.  It was reported that following the vaccination the daughter fainted.  She was taken to the emergency room and all tests (types not specified) were negative.  She was discharged home after four hours.  No treatment or outcome information was provided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 12 or 13 year old female who approximately 2 months ago (approximately May 2008), was vaccinated with GARDASIL (lot # not reported) and developed alopecia.  There were no other concomitant medications or no other vaccines.  The patient's alopecia resolved two weeks after the onset.  The patient sought unspecified medical attention.  No other information was available.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Neck pain
Clinical narrative: Information has been received from a drug representative and her 25 year old female friend who on 21-MAY-2008 was vaccinated with a third dose of GARDASIL 0.5 ml IM.  Approximately beginning on 08-JUL-2008 the patient experienced neck pain and back (also reported as spine) pain with no cause or injury.  The patient's neck pain and back pain persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL vaccine. After receiving her first dose she experienced swollen lips. At the time of the report, on an unknown date the patient recovered from swollen lips. The physician did not provide any details of the case. The patient sought medical attention, not specified. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female patient with latex allergy who on 24-APR-2008, was vaccinated with the first dose of GARDASIL 0.5ml, I.M. There was no concomitant medication. On 25-APR-2008, the patient experienced vomiting for 2 to 3 days after administration of her first dose of GARDASIL. On 27-APR-2008, the recovered from vomiting for 2 to 3 days after administration of her first dose. The patient sought for medical attention at the time physician's office. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from an office manager on 17-JUL-2008 concerning a 9 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL and on 14-NOV-2007 was vaccinated with the second dose of GARDASIL and "is sick".  Specific symptoms unspecified.  The patient sought medical attention, by phone and was coming into the office on 18-JUL-2008.  At the time of the report the patient was not recovered.  The patient's sibling with the same initials also had an adverse experience after vaccination with GARDASIL.  (WAES # 0807USA03678).  Additional information has been requested. This is in follow-up report (s) previously mentioned on 8/14/2008. Follow-up information has been recieved from the physician, who reported that the patient, went to the office to received her third dose of GARDASIL and was "sick" per parents - left without  being seen and returned for third dose at a later date. Her second dose had runny nose and fever in July 2008 were related to the vaccine. Eight months lapsed between the second dose and illness. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a female who on 20-DEC-2007 was vaccinated with the first dose of GARDASIL (lot# 659441/1446U) IM. On 17-JUL-2008 the patient was vaccinated with the second dose of GARDASIL (lot# 659964/1978U) IM. Concomitant therapy included WELLBUTRIN and oral birth control. On 17-JUL-2008 the patient experienced pain at injection site after the vaccination. The patient sought medical attention in office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 08/14/2008 Information has been received from a certified medical assistant concerning a female patient who on 20-DEC-2007 was vaccinated with the first dose of GARDASIL (lot # 659441/1446U) IM. On 17-JUL-2008  the patient was vaccinated with the second dose of GARDASIL (lot#659964/1978U) IM. Concomitant therapy included WELLBUTRIN and oral birth control. On 17-JUL-2008 yje patient experienced pain at injection site after the vaccination. The patient sought medical attention in office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, TDAP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated IM with a 0.5 mL dose of GARDASIL (lot # not provided). Concomitant therapies included hepatitis B virus vaccine (manufacturer unknown, lot # not provided) and TDAP (manufacturer unknown, lot # not provided). Subsequently, 2-3 days after the vaccines, the patient experienced stomach pain, nausea and vomiting. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested. This is one of two reports from the same source (WAES0807USA05655).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/14/2008. Information has been received from a physician assistant concerning a 14 year old female with attention deficit/hyperactivity disorder and no known allergies, who on 30-Aug-2007 was vaccinated with the first dose of GARDASIL (Lot No. 658094/0524U) into the left deltoid, and on 13-Feb-2008 was vaccinated with second doses of GARDASIL (Lot No. 858282/0929U) into the right deltoid and on 17-JUL-2008 was vaccinated with the third dose of GARDASIL (Lot No. 660389/1968U) into the left deltoid. Concomitant therapy included FOCALIN 30 mg morning, and RESPERDAL (reported as "RESPIDERAL") 20mg morning. Unspecified medical attention was sought. Patient developed multiple warts on her hand an one on her foot after starting the GARDASIL series. It was reported that on 16-Jul-2008 (date reported as "yesterday") the patient was seen by a physician assistant and she had 15 warts on her left hand, 7 warts on her right hand and 1 wart on her left foot. It was reported that the patient had never had any warts before, and will be seen for follow up visit.  At the time of this report the patient had not recovered from her experience. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal pain, Pain, Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning a female who on 04-Oct-2008, 08-Dec-2006 and 19-Mar-2007 was vaccinated with first (lot# 653937/0637F), second (lot# 654389/0961F) and third (lot#657617/0384U) doses, respectively, of GARDASIL. Concomitant therapy included "experimental medication for plantar warts" (therapy unspecified). Physician reported that on 21-Jul-2007, the patient had reported that she had pain in the shoulder, hip, knee, and in general on and off since May 2007, 2 months after she had her 3rd dose of GARDASIL. Unspecified medical attention was sought by seeing her doctor. It was reported that on unspecified date the patient "saw her pediatrician, orthopedist, and rheumatologist. No additional information available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Initial and follow-up information has been received from a physician concerning a 19 year old female who on 04-Oct-2006, 08-Dec-2006 and 19-Mar-2007 was vaccinated with first (lot# 657617/0384D) doses, respectively, of GARDASIL by intramuscular injection.  Concomitant therapy included "experimental medication for plantar warts", also reported as chemoprophylaxis.  Physician reported that on 21-Jul-2007, the patient had reported that she had pain in the shoulder, hip, knee, and in general on an off since May 2007, 2 months after she had her 3rd dose of GARDASIL.  It was reported that on unspecified date the patient "saw her pediatrician, orthopedist, and rheumatologist.  Laboratory tests included rheumatic work up, lyme, EBV tests, which were all negative.  It was also reported that patient underwent chemoprophylaxis for warts by a dermatologist around the time of complaint.  At the time of this report, the patient's events persisted.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided), who on unspecified dates was vaccinated with first and second doses, respectively, of GARDASIL (lot# unspecified). It was reported that the patient fainted after receiving the second dose of GARDASIL. It was mentioned that the patient also fainted after the first dose as well. Unspecified medical attention was sought. It was also reported that the patient had recovered from her experience. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female, with environmental allergies and no pertinent medical history, who on 23-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine and on 16-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (Lot No. 660557/0072X). There was no concomitant medication. On 17-JUL-2008, the patient developed right and sometimes left leg pain and fever. She also had soreness and bruising at the injection site and some tingling of her hands. She had a sore throat when vaccinated. She has been prescribed ADVIL and will see her primary physician. At the time of the reporting the patient has not recovered. The patient sought medical attention, phone call. Additional information has been requested. Follow-up information was received from the registered nurse. The patient experienced joint pain and stiffness on 17-JUL-2008. Patient did have sore throat before injection. Patient was taking TYLENOL and ws given anti-inflammatory. The patient saw primary care physician. At the time of the reprting the patient had recovered. No additional information is expected. 9/26/08 Reviewed OB/GYN medical records of 5/23-8/11/08. FINAL DX: none provided Records reveal patient in good health on 5/23/08, day of HPV #1, Lot 1968U.  Received HPV #2, Lot 0072X on 7/16/08 & had sore throat prior to vax.  Experienced joint pain & stiffness, fever x 4 days.  Seen by PCP 7/18 & dx w/tonsillitis.  Had sore throat x 1 wk.  Joint pain & stiffness resolved.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) and her last PAP smear test came up positive for Human papillomavirus (HPV). It was unknown if the patient sought medical attention. No further information is available.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Inappropriate schedule of drug administration, Neck pain
Clinical narrative: Information has been received from a 49 year old female registered dietician who in November 2007 was vaccinated with the first dose of GARDASIL vaccine. The second and third dose of GARADSIL vaccine were administered on unknown dates. She reported the the sternoclavicular pain started after the first dose and after the third dose, the pain went into her neck. The patient spoke to a physician. At time of report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 23 year old female who in September 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot No 0250X). Concomitant therapy included (LOESTRIN). In September 2007, the patient experienced pain in arm for 4 months. The patient sought unspecified medical attention. On an unspecified date in January 2008, the patient recovered. Since she had pain for four months she did not get the second dose of GARDASIL vaccine (yeast) until 14-JUL-2008. No AE reported after the second dose. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a 25 year old female with allergies to sulfa, erythromycin and augmentin and Crohn's disease who on 30-JUN-2008 was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included (ZOFRAN), (NEXIUM) and mercaptopurine, "2 weeks after shot", on approximately 14-JUL-2008 the patient developed "a rash and intense itching" (starting around the midline and now on her chest and legs). The patient visited her doctor and dermatologist. She got cortisone (manufacturer unspecified) at the emergency room (ER) and came back for a second shot of cortisone since the rash spread. A biopsy of the rash on the stomach was taken but result was not provided yet. The patient's rash and intense itching persisted and she did not know if she would have the second dose on 03-SEP-2008. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Genital lesion, Smear cervix
Clinical narrative: Information has been received from a consumer concerning his over 18 year old daughter who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. The patient had bumps on her genitals after receiving the first dose. The patient got tests (including a pap smear) to see if the bumps on her genitals were genital warts (no results reported). The outcome was unknown. It was unknown if the patient sought medical attention or not. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Convulsion, Dermatitis contact, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 19-JUN-2008 was vaccinated with GARDASIL vaccine (yeast) and varicella virus vaccine live (MSD).Shortly thereafter the patient developed hives, contact dermatitis and pseudo-seizure activity. As of 03-JUL-2008, pseudo-seizure activity persisted. The outcome of hives and contact dermatitis was not reported. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female with epilepsy as a child (no treatment at present) and depression and no history of drug reactions/allergies, who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (Lot No. 654272/0073X) 0.5 mL, IM. Concomitant therapy included ZOLOFT. The next day, on 18-JUL-2007, the patient called to the office stating that she was having shortness of breathe and chest pain. The patient was advised to go to the local emergency room for evaluation. The medical assistant reported that the patient was never seen at the emergency room and has not returned the phone calls that the office has placed to her home. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Inappropriate schedule of drug administration, Myalgia
Clinical narrative: Information has been received from a 30 year old female with no relevant medical history or allergies who in November 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On unspecified dates the patient was vaccinated with a second and third dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included hormonal contraceptives (unspecified). In May 2008, also reported as after receiving the third dose, the patient experienced muscle pain and weakness. The patient sought unspecified medical attention. The patient's muscle pain and weakness persisted. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 02-JUL-2008 was vaccinated with a dose of GARDASIL vaccine (lot not reported). On 02-JUL-2008 after vaccination, the patient experienced pain in her legs. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning her 17 year old female daughter, with no pertinent medical history and no drug reaction/allergies, who on unspecified dates was vaccinated with the first, second and third dose of GARDASIL vaccine INJ. There was no concomitant medication. After receiving the third dose of GARDASIL vaccine, in June 2008, the patient was experiencing continuous bleeding of the vagina. At the time of reporting the patient had not recovered. The patient sought medical attention unspecified. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 30-JUN-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot not reported). On 02-JUL-2008 the patient experienced blisters and itching with redness at the injection site after the second dose of GARDASIL vaccine (yeast). No reaction was reported with the first dose of GARDASIL vaccine (yeast). The patient's status was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with attention deficit/hyperactivity disorder and a history of allergic reaction to antibiotics (tetracycline) who on 01-JUL-2008 was vaccinated IM in her left deltoid muscle with the second 0.5 mL dose of GARDASIL vaccine (lot 660393/0067X). Concomitant therapy included ADDERALL TABLETS and ORTHO TRI-CYCLEN LO. On 03-Jul-2008, the patient experienced injection site blisters, itching and warmth. The patient received the first dose of GARDASIL vaccine (lot 659653/1448U) on an unspecified date. At the time of the report the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning two patients who were vaccinated with a dose of GARDASIL vaccine (lot not reported) and fainted after receiving the vaccine. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008. Follow-up information was received on 04-SEP-2008 from the physician indicating that the physician had had several girls fainted with GARDASIL vaccine. The physician had not otherwise make any reports. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 17 year old female with Turner's syndrome and attention deficit/hyperactivity disorder who on 02-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 0250X). On approximately 02-JUL-2008 the patient experienced pain in both legs and difficulty walking. The patient's mother took her daughter to the clinic because the doctor's office was closed. The clinic told the mother that her child experienced a rare reaction to the vaccine. The mother reported that her daughter was 80 % improved. Patient is recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Dizziness, Drug exposure during pregnancy, Headache
Clinical narrative: Information has been received from the Pregnancy Registry for GARDASIL vaccine from a physician concerning a 16 year old female with a history of asthma and allergic reaction to antibiotics who in April 2008, was vaccinated with the first dose of GARDASIL vaccine (lot not reported). Concomitant therapy included albuterol, ADVAIR, and TYLENOL. In April 2008, "the next day after her second dose," the patient experienced headache and dizziness. She recovered after 1-2 days. The patient found out "last Friday or Saturday" that she was "about 4 weeks pregnant (estimated LMP of 05-JUN-2008). A pregnancy test given before the administration of the vaccine did not show pregnancy. The patient's status was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning her 21 year old daughter who in July 2007, was vaccinated with GARDASIL vaccine. On February 2008, the patient had completed the GARDASIL series. Concomitant therapy included ORTHO TRI-CYCLEN LO. On 01-JUL-2008, the patient had her first abnormal PAP test. Further analysis of the sample will be available on or after 18-AUG-2008. The patient sought medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 23 year old female who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 mL, IM. On 22-JUL-2008, the patient called the office to report common cold symptoms including a high fever and sore throat. At the time of reporting, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Echocardiogram abnormal, Echocardiogram normal, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist concerning her daughter with seasonal allergies and a facial tick that has worsened over the past year who between May and June 2007 was vaccinated 0.5ml, IM with a dose of GARDASIL. In May 2008 the patient was vaccinated 0.5ml, IM with a 2nd dose of GARDASIL. There was no concomitant medication. In spring 2008, the patient began developing chest pain and shortness of breath. It first occurred after running a 400 meter race at a track meet. On an unspecified date, the patient had an Echocardiogram and Electrocardiogram and the results were inconclusive. On an unspecified date, the patient had the echocardiogram repeated and believed the results showed "some type of mitral valve or injection fraction problems. "The patient outcome was not reported. The patient sought unspecified medical attention during an office visit. 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) then fainted. The physician reported that they followed the procedure for when a patient faints and then the patient came to and was fine. The patient is not going to continue the rest of the series. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Vaccine positive rechallenge, Vaginal haemorrhage
Clinical narrative: Information has been received from a 24 year old female health professional with a urinary tract infection who on an unspecified date was vaccinated with a 1st dose of GARDASIL vaccine (yeast) (lot# not reported). Concomitant therapy included cephalexin (KEFLEX). Subsequently the patient bled for 3 weeks after dose 1 and "was not on her period". On an unspecified date the patient was vaccinated with a 2nd dose of GARDASIL vaccine (yeast) (lot# not reported). After dose 2, the patient immediately started to bled and has been bleeding for 1 week. The patient sought unspecified medical attention. The patient has not recovered from the bleeding. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Reaction to previous exposure to any vaccine, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who in July 2008 (reported as "last week), was vaccinated 0.5 mL, IM, with GARDASIL vaccine (yeast) (lot# and dose not reported). Concomitant medication included carbetapentane tannate (+) diphenhydramine tannate (+) phenylephrine tannate (D-TANN CT). In July 2008, the patient experienced syncope after her vaccination. Subsequently, the patient recovered on the same day of the vaccination from syncope. The patient sought unspecified medical attention. It was also reported that the "patient experienced syncope after all immunizations." Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot # not provided) and fainted in their office. The reporter did not elaborate whether the patient received GARDASIL vaccine (yeast) or not. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on an unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). On an unspecified date, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast), 0.5 mL, IM, then fainted. The patient also received a laceration on head as result of her fall. The patient sought medical attention. At time of reporting, the patient had recovered. Additional information is not expected as the physician requested not to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Nausea
Clinical narrative: Information has been received from a female consumer who on 28-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot# not provided). On 23-JUN-2008 the patient received the second dose of GARDASIL vaccine (yeast) (lot# not provided). The patient reported that she continuously had nausea and dizziness a few days after the injection. She had pain in her stomach for about 15 minutes. The patient's outcome was not known. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated IM with GARDASIL vaccine (yeast) and developed arm pain with stiffness. The physician advised that symptoms resolved on their own and patient had full range of motion when she returned to her office. Additional information is not expected as the physician requested not to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on an unknown date was vaccinated with GARDASIL vaccine (yeast). On an unspecified date the patient developed hives. The physician did discontinue the series. Subsequently, the patient recovered. The patient sought medical attention. No further information is available.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Diagnostic procedure, Inappropriate schedule of drug administration, Pain, Tremor
Clinical narrative: Information has been received from a 30 year old female consumer who sometime in November 2007, was vaccinated with a third dose of GARDASIL vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). Two and a half week post vaccination of dose 3, the patient experienced shakiness and achiness especially in her legs. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from shakiness and achiness especially in legs. Additional information is not expected,
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea, Oedema peripheral, Pallor, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with a history of asthma and allergy to cefixime (SUPRAX) and cefaclor (CECLOR) who in February 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number not provided). On unspecified dates the patient receive the second and third dose of GARDASIL vaccine (yeast) (lot number not provided). Concomitant therapy included albuterol. The caller reported that her daughter's arm swelled up and she experienced severe sweating, paleness, nausea and a fever approximately 1 1/2 hours after receiving her first dose of GARDASIL vaccine (yeast). These symptoms lasted for 24-30 hours. She experienced these same symptoms after her second dose of GARDASIL vaccine (yeast) however they took less than 1 1/2 hours to appear and lasted for 24 hours. These same symptoms appeared quickly after the third dose and lasted 12-15 hours. Unspecified medical attention was sought with several physicians. On an unspecified date the patient recovered. Additional information  has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with a history of asthma and allergy to cefixime (SUPRAX) and cefaclor (CECLOR) who in February 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number not provided). On unspecified dates the patient receive the second and third dose of GARDASIL vaccine (yeast) (lot number not provided). Concomitant therapy included albuterol. The caller reported that her daughter's arm swelled up and she experienced severe sweating, paleness, nausea and a fever approximately 1 1/2 hours after receiving her first dose of GARDASIL vaccine (yeast). These symptoms lasted for 24-30 hours. She experienced these same symptoms after her second dose of GARDASIL vaccine (yeast) however they took less than 1 1/2 hours to appear and lasted for 24 hours. These same symptoms appeared quickly after the third dose and lasted 12-15 hours. Unspecified medical attention was sought with several physicians. On an unspecified date the patient recovered. Additional information  has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of female patients who on unspecified dates were vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patients experienced pain after vaccination. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this reports. Additional information will be provided if available.
Sex: F
Vaccine: HPV4
Symptoms: Depression, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer reading on the internet concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast). The patient was vaccinated with the second dose of GARDASIL vaccine (yeast) on an unspecified date. The patient became depressed after receiving the first dose and recovered shortly afterward. After receiving her second dose she became even more depressed. This is one of several reports from the same source. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female who on an unspecified date was vaccinated IM with the first 0.5 ml dose of GARDASIL vaccine (yeast). Concomitant therapy included varicella virus vaccine live (VARIVAX), tetanus toxoid (unspecified, manufacturer unknown) meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur). The patient experienced syncope soon after vaccination. Unspecified medical attention was sought at the office. She recovered on the same day as vaccination at the office and was released. Additional information has been requested. No further information is available.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Erythema, Inappropriate schedule of drug administration, Scar
Clinical narrative: Information has been received from a 37 year old female consumer with no medical history and an allergy to penicillin who in October 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) in her left arm "in the muscle". In December 2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) given in the same spot on her left arm. In April 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) on the back side of her right arm. There was no concomitant medication. A few days after (also reported as a few weeks after) the first dose a red mark appeared that looked like a pimple at first. The red mark was still there when she went back for her second dose. After the second dose the red spot became worse. The patient did not have any red marks after the third dose. At time of reporting, the mark on the patient's left arm was still there, looks like a scar, but has gotten fainter. Unspecified medical attention was sought. Patient outcome was recovering. No further information was available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Laboratory test, Rash
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who on an unspecified date in January 2007, was vaccinated with her first dose of GGARDASIL vaccine (yeast) (Lot #, site, and route not reported). There was no concomitant medication. On an unspecified date in May 2007, the patient was vaccinated with her third dose of GARDASIL vaccine (yeast) (Lot #, site, and route not reported). No information was provided regarding the second vaccination with GARDASIL vaccine (yeast). On an unspecified date in June 2007, the patient experienced a red rash in her hip area going up to her breast area. The patient has been having this rash on and off since June 2007. The patient has sought unspecified medical by visiting "a couple of doctors and dermatologists and no one can determine the cause." As of the time of this report, the red rash was persisted. No additional information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (Lot #, site, route and dose # not reported). On an unspecified date, the patient had "warts on her hands" after getting GARDASIL vaccine (yeast). The patient sought unspecified medical attention by calling the nurse. The patient outcome was not reported. No additional information was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a mother concerning her daughter who was vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). Subsequently the patient experienced pain at injection site and swelling at injection site. The patient's outcome was unknown. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Mood altered
Clinical narrative: Information has been received from a licensed visiting nurse that a registered nurse observed 2 patients who experienced a mood change after vaccination with GARDASIL vaccine (yeast) (Lot number not reported). The registered nurse reported that the patients had also received other vaccinations at the time of vaccination, but the specific other vaccines are unspecified. Attempts are being made to obtain additional information on a multi-patient report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on unspecified dates with all three doses of GARDASIL vaccine (yeast) (lot #'s not reported). Subsequently the patient was diagnosed with being high risk for HPV. The patient's outcome was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a mother concerning her 12 year old daughter who on 30-JUN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). There was no concomitant medication. On 04-JUL-2008 the patient experienced hair loss. The patient's hair loss persisted. Laboratory tests performed including thyroid test, joint test and autoimmune test were reported as "fine" (dates Unspecified). The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a very few patients who were vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). Subsequently the patients experienced sore arms after vaccination. The patients' outcome were unknown. No further information is available.
Sex: M
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from an office manager within the office concerning a male who was vaccinated SQ with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced, injection site reaction. The patient also experienced swelling at the injection site which formed a hard ball. The patient sought unspecified medical attention. The patient's outcome is unknown. Additional information is not expected.
Age: 0.8
Sex: M
Vaccine: HPV4
Symptoms: Crying, Cyanosis, Rash, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 10 month old male baby with no pertinent medical history, drug reactions or allergies who on 19-JUN-2008 was accidentally vaccinated with a dose of GARDASIL vaccine (yeast). There was no concomitant medication. A nurse at the office accidently mixed up the vials and the mother received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid which was meant for her baby and her baby received the third dose of GARDASIL vaccine (yeast) that was meant for her. A couple of days later, on 21-JUN-2008 the baby broke out in a rash and had been constantly been crying. "2-3 days after receiving GARDASIL vaccine (yeast)", the baby experienced purple lips. At the time of the report, the baby had not recovered from the events. No 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 who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). On an unspecified date the patient fainted after receiving the dose of GARDASIL vaccine (yeast). The patient was seen by the physician. Patient outcome was recovered on an unspecified date. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test abnormal, Injected limb mobility decreased, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no medical history who on 06-SEP-2007 was vaccinated IM in the deltoid with the first dose of the GARDASIL vaccine (yeast). On 19-NOV-2007 the patient was vaccinated in the upper thigh with the second dose of GARDASIL vaccine (yeast). In March 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). After the first dose the patient was unable to lift her arm and had to go to the neurologist. A month later she developed a rash on her neck. A month after the second dose the patient broke out in rash on her lower body underneath the skin that looked like "bug bites". The patient has been experiencing rashes since the third dose. The rash clears out then comes back again. The patient was seen by multiple specialists and blood work was done that came back abnormal and the nurse asked the patient to call her with the outcomes of the blood work. The patient outcome was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Neuralgia, Neurological examination
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of GARDASIL vaccine (lot not reported) and who developed redness and neuralgia in her arm after vaccination. The patient's status was not reported. Additional information has been requested. In follow-up, the physician reported there was no reaction. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning one of his family friends, a teenage female who was vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced Guillain-Barre syndrome. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. Upon internal review, Guillain-Barre syndrome was determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female teenager patient who on an unknown date was vaccinated with the first dose GARDASIL vaccine (yeast). The physician reported that after the patient received the first dose GARDASIL vaccine (yeast) she contacted him to say that she hadn't had her period. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Breast haemorrhage, Nipple disorder, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who on 22-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). The same day, the patient's mother called the office to report that her daughter was experiencing vomiting and her nipples were cracked and bleeding. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (exact dose and dates of dose were not known) and three weeks after the dose, the patient developed musculoskeletal pain in her legs. The patient has been sent to two neurologists and a conclusive diagnosis has not been obtained. No additional information is available. The patient sought medical attention, office visit. Additional information has been requested.