chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain of skin
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who "about two months ago" (in approximately March 2010), was vaccinated with a 0.5 ml first dose of GARDASIL IM (Lot number not provided). The physician reported that when the patient came for the second dose she reported that after getting her first injection it felt like "acid being purred into her skin and she could not use her arm". On an unspecified date the patient recovered. The patient did not receive her second dose. No laboratory tests were performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date, was vaccinated with the second 0.5 ml dose of GARDASIL. Subsequently the patient experienced fever and body aches for a week. The patient didn't experience an AE after the first dose. On unspecified date, the patient recovered from fever and body aches. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from Observant LLC, concerning an 18 year old female female with no concurrent conditions and no medical history who completed GARDASIL series on unspecified date. In December 2009 pap/colposcopy was performed indicating ASCUS. The patient was diagnosed with ASCUS prior to C1N1. At the time of the report, the patient was recovering. At this time, relationship of ASCUR prior to C1N1 to GARDASIL therapy was unknown. This was originally reported by a physician. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient who had on adverse effect her first dose of GARDASIL and on approximately 24-MAY-2010 was vaccinated with a second dose of GARDASIL (Lot # not provided), 0.5 mL. After vaccination, the patient waited 5 minutes before she stood up. When she stood up, she felt faint and sat down and then passed out. She fell down and hit her head on the floor and got a knot on her head. She laid down at the office. Every time she would feel fine she would stand up, but every time she stood up she would feel dizzy and laid down again. After two hours an ambulance was called and she was brought to an unspecified hospital. It was unknown if the patient was admitted. The patient now said she felt "fine", but the nurse did not know if the patient still has the "knot" on her head. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness, Syncope, Tremor
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 20 year old female with no pertinent medical history and no drug reactions/allergies who on 07-APR-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 663694/1316Y, exp 10-NOV-2011). There was no concomitant medication. The patient was empty stomach prior to vaccination. On 07-APR-2010 after vaccination, the patient experienced fainting and jerking. The patient's body shake after she passed out. The patient did not urinate. Earlier that day, the patient got her shot then went out to the waiting room. It was in the waiting room that the patient had the event. The patient went to an ER in a hospital, then returned a few hours later to the office. The patient was seen by a physician. By that time the patient had fully recovered. The physician could not say if the patient had a seizure. There were no lab diagnostics studies performed. At the time of the report, the patient had recovered on 07-APR-2010. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter who on 06-MAY-2010 was vaccinated with a dose of GARDASIL. On 06-MAY-2010 the patient developed hives on the opposite arm where blood was drawn after getting GARDASIL. The reporter believed that it was due to the latex. It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant, concerning a female patient who on an unknown date was vaccinated intramuscularly in the deltoid muscle with a first dose of GARDASIL (dose and lot number not provided). The medical assistant reported that the patient had a really sore arm in the deltoid muscle after receiving her first dose of GARDASIL. On an unknown date, a day after vaccination, the patient recovered. The patient did not seek medical attention. Follow up information has been received from a physician concerning the 22 year old female patient with no illness at the time of vaccination and no pre-existing allergies or medical conditions. Concomitant medications included AVIANE. On 24-OCT-2008 the patient's arm was very sore and achy after injection. The patient requested the second shot of GARDAIL to be given in her gluteus maximus. No laboratory or diagnostic tests were performed. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram ambulatory normal, Feeling abnormal, Palpitations, Presyncope
Clinical narrative: Information has been received from a health professional concerning a 25 year old female patient with a history of genital wart and cervical dysplasia and no known allergies who on 07-JAN-2010 was vaccinated IM with the third dose of GARDASIL (lot number 663452/0671Y, expiration 18-SEP-2011). Concomitant therapy included vitamins (unspecified) and ALDARA cream. A note on the patient's chart form from 11-JAN-2010 stated that she had been feeling lightheaded for 2 days (since 09-JAN-2010). The patient then continued to feel lightheaded, felt like she would "black out" and experienced palpitations. The patient saw her primary care physician and a Halter monitor was normal. The patient would see a cardiologist. The patient was seen in office on 06-MAY-2010 and stated that she had the same reactions after the first dose but no reaction after the second dose. The first two dosed were given at another location, dates of administration and lot numbers not available. The patient stated she was starting to feel better. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 25 year old female patient with a history of genital wart and cervical dysplasia and no known allergies who on 07-JAN-2010 was vaccinated IM with the third dose of GARDASIL (lot number 663452/0671Y, expiration 18-SEP-2011). Concomitant therapy included vitamins (unspecified) and ALDARA cream. A note on the patient's chart form from 11-JAN-2010 stated that she had been feeling lightheaded for 2 days (since 09-JAN-2010). The patient then continued to feel lightheaded, felt like she would "black out" and experienced palpitations. The patient saw her primary care physician and a Halter monitor was normal. The patient would see a cardiologist. The patient was seen in office on 06-MAY-2010 and stated that she had the same reactions after the first dose but no reaction after the second dose. The first two dosed were given at another location, dates of administration and lot numbers not available. The patient stated she was starting to feel better. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with all  3 doses of GARDASIL (lot numbers not reported). After the vaccinations the physician did a test for human papillomavirus (HPV) and on the first test she tested negative, however for the second test she tested positive for HPV type 16. Unspecified medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus infection, Epstein-Barr virus test positive, Oropharyngeal pain
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with not known medical history or drug reactions/allergies who on 01-JUL-2009 and 10-JAN-2009 was vaccinated with a first and second dose of GARDASIL respectively (expiration date on 13-JUN-2010 for both doses). There was no concomitant medication. The medical assistant reported that the patient experienced episodes of a sore throat after the first doses of GARDASIL. A blood test in February 2010 was positive for Epstein Barr Virus. No medications used to treat this but rest was required. Because of being ill, the third dose was delayed and was given in 06-MAY-2010. The patient sought unspecified medical attention. At the time of this report, the patient had recovered on an unspecified date. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from an approximately 19 year old female patient with allergy to penicillin, CECLOR, AUGMENTING and erythromycin and not other pertinent medical history, who in 2005, "when she was 15 years old", was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). There was no concomitant therapy. On unknown dates, the patient received the 2nd and 3rd doses of GARDASIL (doses, routes and lot number not provided). On an unknown date, a DNA HPV test was performed and the result was positive for HPV type 16 after receiving all 3 doses of GARDASIL. The patient's outcome was unknown at the time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with allergic reaction to CIPRO, BACTRIM, who on 04-MAY-2010 was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 665768/1354Y) in the left arm deltoid. Concomitant therapy included TRINESSA. "within 24 hours of immunization, the patient developed hives on her body. There were no labs or diagnostic tests performed. The patient made a phone call to medical attention. At time of reporting, the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female with no pertinent medical history and no drug allergies, who in March 2010, was vaccinated with her third dose of GARDASIL (lot # 663451/0216Y). There was no concomitant medication. After the vaccination, the patient missed her period. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. It was reported that the last time the reporter heard from the patient was in April 2010 so they did not know how she was doing. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Sensation of heaviness
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient with not known medical history or drug reactions/allergies who on 20-APR-2010 was vaccinated with a first dose of GARDASIL (Lot # 0702X), IM into the left arm. There was no concomitant medication. Three days later, on 23-APR-2010, the patient developed redness and itching at the injection site on the left arm. As a result, she reported to the office. The affected area was measure to be 12 cm by 6 cm, with borders that were sharply demarcated. The area was found to be mildly red/tawny, with some warmth at the upper aspect (where the injection was given). The area was not raised, painful, swollen, nor blistering. There was no shortness of breath. The patient complained of a "heavy feeling for a week". The patient did not take or receive anything for this problem. At the time of this report, she was slowly recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Joint stiffness, Pain
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on approximately 06-MAR-2010 (two months ago) was vaccinated with a first dose of GARDASIL (Lot # 662304/1013Y, expired date 20-APR-2011). After vaccination, 8 hours later the patient experienced shortness of breath, joint stiffness and body aches. The patient went to the Emergency Department and was not treated or admitted as she recovered within few hours. Additional information has been requested. Patient went to the Emergency Department at medical center.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no known drug allergies or pertinent medical history who about two years ago (in approximately 2008) completed the vaccination with the series of GARDASIL (Lot number not provided). On 25-MAR-2010 the patient had a papanicolaou test (PAP) that was positive for human papillomavirus (HPV). At the time of the report the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician who heard from two parents about a girl who on an unspecified date was vaccinated with a dose of GARDASIL. The patient experienced neurological problems after receiving GARDASIL. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information was received from an office manager. He said that he did not remember this event being discussed and he said he "would check it out". All telephone attempts to obtain follow up information have been unsuccessful. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who were vaccinated with completed series of GARDASIL. It was reported that within 2 years after completing the vaccine series the patient came back and had cervical dysplasia. Papanicolaou smears were performed. The patient sought medical attention by going to the physician's office. At the time of report the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who were vaccinated with completed series of GARDASIL. It was reported that within 2 years after completing the vaccine series the patient came back and had cervical dysplasia. Papanicolaou smears were performed. The patient sought medical attention by going to the physician's office. At the time of report the outcome was unknown. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Rash
Clinical narrative: Information has been received from a nurse concerning a 25 year old female patient who on 27-APR-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # not provided) in her left deltoid muscle. It was reported that "3 or 4" days later the patient developed a rash on the palm of her hand. The patient also experienced pain at the injection site. At the time of the report the patient's outcome for rash on the palm on the hand and injection site were not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female with no pertinent medical history and no known drug allergies or reactions who on 19-AUG-2008 was vaccinated with a first dose of GARDASIL (lot # 660553/0070X, expiry date 22-OCT-2010), 0.5mL, intramuscularly. On 10-OCT-2008 she received second dose of GARDASIL (lot # 660612/0229X, expiry date: 30-OCT-2010) 0.5mL, intramuscularly. There was no concomitant medication. In May 2009, the patient was diagnosed with papilloma viral infection after administration of two doses of GARDASIL. In the same date HPV test was positive. The patient sought unspecified medical attention. At the time on the report the patient had not recovered from papilloma viral infection. Follow up information has been received via telephone call from a certified medical assistant who reported that on 03-JAN-2008 visit, the patient was not tested for Papilloma viral infection. GARDASIL first and second doses were given on 19-AUG-2008 and 10-OCT-2008 respectively. In May 2009, the patient was tested and found to be positive for Papilloma viral infection, although the physician felt the HPV pre-existed the administration of the vaccines (thus the reason why their office later indicated there was no adverse event). On 13-MAY-2010 third dose of GARDASIL (lot # 662299/1099Y) was administered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chills, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Registered Nurse concerning a 19 year old female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL. The nurse reported that a practice patient's daughter experienced fever, chills and abdominal pain after both the first and second dose of GARDASIL. It was reported that the mother added that the adverse symptoms were more severe after the second dose of GARDASIL. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer concerning his 17 year old daughter with no pertinent medical and no known drug allergies/drug reactions who on 20-APR-2009 was vaccinated with the third dose of GARDASIL. There was no concomitant medication. It was reported that the patient has been experiencing hair loss after receiving GARDASIL. The caller stated that his "daughter's hair was turning thin and brittle and it was falling out in clumps while taking a shower". It was also reported that "she has less than a quarter of the amount of hair that she used to have from a year ago". There were no laboratory diagnostic tests performed. The patient sought medical attention with an office visit. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with sulfonamide allergy who on 19-MAR-2007 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 655619/1427F) intramuscularly (expiration date: 29-JUN-2009). On 21-MAY-2007, the patient received the second 0.5 mL dose of GARDASIL (Lot # 660200/1886U, valid for ROTATEQ) intramuscularly (expiration date: 21-NOV-2009) and on 27-SEP-2007 the patient received the third 0.5 mL dose of GARDASIL (Lot # 658554/0928U) intramuscularly (expiration date: 12-APR-2010). There was no concomitant medication reported. It was reported that the patient received the 3 doses prior to sexual contact, and had an abnormal pap smear on 28-APR-2010. The Pap smear revealed low grade, mild dysplasia with HPV effect. The patient sought medical attention with an office visit. At the time of the report the patient had not recovered. The patient will be referred to a gynecologist for evaluation. Follow up information was received from a physician concerning an 18 year old female patient. It was reported that the patient had vaccine and was not sexually active. There were no illnesses at the time of vaccination. It was reported that she finished the vaccination a year later and had positive HPV on a PAP smear test performed on 28-APR-2010. The interpretation of result was: low grade squamous intraepithelial lesion mild dysplasia with HPV cytopathic effect. This PAP test has been evaluated with the assistance of the ThinPrep Pap, Test Imagin System. It was also reported that the patient did not require an emergency room/doctor visit (previously reported as the patient went to an office visit). No further information is available.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from an office medical assistant concerning a 17 year old male with psoriasis who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not specified). Concomitant therapy included antimicrobial (unspecified). It was reported that after receiving a dose of GARDASIL the patient developed a rash all over his body. The reporter stated that the patient was on an antimicrobial (name and manufacturer unspecified) for psoriasis and the reporter was not sure if the rash was from psoriasis but she does not think the rash was caused by GARDASIL. The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Dyspepsia, Flatulence
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with penicillin allergy and with no pertinent medical history, who on 26-MAY-2010 was vaccinated IM with 0.5 ml dose of GARDASIL (lot number: 663559/1178Y, expiration date: 11-NOV-2011). Concomitant therapy included acetaminophen (+) diphenhydramine citrate ("Extra strength oral pack"). The nurse reported that on 27-MAY-2010 the patient developed stomach pain, dizziness, flatulence, diarrhea, nausea and heartburn. On 03-JUN-2010, the patient was examined in the physician's office and was prescribed ranitidine. No laboratory test was performed. At the time of the report the outcome of the patient was not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with penicillin allergy and with no pertinent medical history, who on 26-MAY-2010 was vaccinated IM with 0.5 ml dose of GARDASIL (lot number: 663559/1178Y, expiration date: 11-NOV-2011). Concomitant therapy included acetaminophen (+) diphenhydramine citrate ("Extra strength oral pack"). The nurse reported that on 27-MAY-2010 the patient developed stomach pain, dizziness, flatulence, diarrhea, nausea and heartburn. On 03-JUN-2010, the patient was examined in the physician's office and was prescribed ranitidine. No laboratory test was performed. At the time of the report the outcome of the patient was not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner, concerning a 22 year old female patient who on 29-MAR-2010, was vaccinated with the first dose of GARDASIL. In the evening of 29-MAR-2010, the patient began to experience a mild generalized rash on the trunk, chest and neck. The rash was treated with BENADRYL, 50 mg, three times a day. It was reported that the patient did not report to the physician's office until 06-APR-2010. On an unknown date, the patient stopped the series of GARDASIL. The patient's outcome was unknown at the time of reporting. The patient sought medical attention via office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from a physician who saw a local news report about a female patient who on an unspecified date was vaccinated with a dose of GARDASIL and experienced an unspecified autoimmune disorder.  It was unspecified if the patient sought medical attention.  At the time of the report, the outcome of the event was unknown.  Attempts to verify the existence of an identifiable patient have been unsuccessful.  No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with sulfonamide allergy and no pertinent medical history who on 23-NOV-2009 and 29-JAN-2010 was vaccinated with the first and second doses of GARDASIL.  After receiving the second of GARDASIL, the patient developed a "knot" at the injection site.  The injection site reaction was not bruised and was about 2cm around the injection site.  The patient was seen in the doctor's office.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, 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 (lot# not reported).  Subsequently, the patient fainted after administration of GARDASIL.  She was revived with smelling salts but it took the patient a good 30 minutes to feel normal again.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from an approximately 22 year old nurse concerning a female patient who on 22-APR-2010 was vaccinated with a first 0.5 mL dose of GARDASIL. The nurse reported that on 22-APR-2010 after getting the first vaccine, the patient experienced headache. On the same date, the patient recovered from headache. Patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who three years ago, in 2007, was vaccinated with 3 doses of GARDASIL. In March 2010, the patient developed HPV and that included type 18. A laboratory diagnostic study was performed to confirm the HPV type. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a female with no pertinent medical history and no drug reactions/allergies who on 06-APR-2010 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (LOT# not reported). There was no concomitant medication. On 06-APR-2010 the patient experienced a knot at the injection site and a sore arm. There was no lab study or diagnostics performed. Unspecified medical attention was sought. At the time of reporting, the patient had not recovered. Follow-up information has been received from a nurse who reported that the 25 year old (also reported as 24 year old) female patient who on 06-APR-2010 was vaccinated intramuscularly into the left deltoid with the second 0.5 mL dose (previously reported as first dose) of GARDASIL (LOT# 1487Y). The nurse reported that the patient called to let their known that she had slight hardening around injection site and area was tender to the touch -effects subsided when called patient back on 11-APR-2010. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vision blurred, Visual impairment
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient who in August 2009, was vaccinated with the second dose of GARDASIL (lot# not reported) in another health care facility. However, after the second dose was administered, the patient experienced vision problems, difficulty focusing and dizziness. Unspecified medical attention was sought. At the time of this report, all the patient's issues had resolved in 2 weeks. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a 22 year old female consumer who on 29-APR-2010 was vaccinated with a dose of GARDASIL injection (dose and lot number not reported). On 29-APR-2010, the patient stated that she experienced pain in her arm, neck and chest; she was also unable to lift her arm. At the time of reporting, the patient had not recovered from pain in her arm, neck, chest and unable to lift her arm. The patient did not seek for medical attention. No further information is available.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old female patient with urinary tract infection at the time of vaccination and no known drug allergies or pertinent medical history who on 27-APR-2010 was vaccinated with a 0.5 ml first dose of GARDASIL IM (Lot number 662299/1099Y). There was no concomitant medication. On 28-APR-2010 the patient experienced moderate vomiting. The nurse reported that the patient received BACTRIM for urinary tract infection at an emergency room just prior to coming in to the office to get the GARDASIL. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. The patient's mother called the office on 29-APR-2010. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Aphagia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter, a 16 year old patient with no pertinent medical history or drug reactions/allergies, who at the "beginning of 2010", was vaccinated with the first dose of GARDASIL. On 29-APR-2010, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. "Less than 12 hours after receiving her second dose", the patient experienced stomach pains, nausea, fever, tingling and she cannot eat. It was reported that therapy with human papillomavirus vaccine was discontinued. At the time of the report, the patient had not recovered. The patient did not seek medical attention. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Menorrhagia
Clinical narrative: Information has been received from a Registered pharmacist (R.P.) concerning a 16 year old female who on 13-APR-2010 was vaccinated with a fourth dose of GARDASIL (lot# not provided). The patient experienced a heavier than normal menses this month (May 2009). The patient sought unspecified medical attention. At the time of report the outcome was unknown. Follow up information was received from a pharmacist concerning the 15 year old female patient who on 26-AUG-2008, 29-APR-2009 and 08-JUL-2009 was vaccinated with the first, second and third doses of GARDASIL, respectively. The patient was vaccinated in left arm with the fourth dose of GARDASIL (662304/1013Y) on 13-APR-2010. It was not known what other vaccines were administered during this time frame. The patient's heavy menses this cycle were reported by her parent on 03-MAY-2010. Exact date of menses and duration were unknown. No treatment was required. At the time of the report the outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Dysplasia, Human papilloma virus test, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with a history of migraine headaches, "rapid heart beat" and no drug allergies who on 21-DEC-2006 was vaccinated with 0.5 mL IM first dose of GARDASIL (lot #653978/0955F).  On 20-FEB-2007, patient was vaccinated with 0.5 mL IM second dose of GARDASIL (lot #655619/1427F) and on 08-JUN-2007, patient was vaccinated with 0.5 mL IM third dose of GARDASIL (lot #657736/0389U).  Concomitant therapy included ORTHO TRI-CYCLEN.  In March 2010, the patient had an abnormal PAP.  The PAP result was Low grade Squamous Intraepithelial Lesion (LGSIL), mild dysplasia.  The nurse stated that an HPV test was negative for HPV 16 and 18.  Patient had a visit to the physician's office.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood test
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who was vaccinated with the series of GARDASIL vaccine (lot#s not reported) in approximately 2009 ("about a year ago"). Shortly after the last dose of GARDASIL was given, the patient developed hair loss. Unspecified blood tests were performed with no results reported. At the time of this report, the hair loss was increasing. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypomenorrhoea
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 08-OCT-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication reported. It was reported that "after October 2009" the patient has had lighter periods. The patient received the second dose of GARDASIL on 11-DEC-2009 and the third dose of GARDASIL on 04-MAY-2010. There were no laboratory diagnostic tests performed. The patient sought medical attention with a visit to the nurse. It was reported that the patient recovered on an unknown date. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain, Drug exposure during pregnancy, Generalised oedema, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with no medical history and no drug reactions or allergies who in approximately October 2009, was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Details about the vaccination were unknown because the patient was vaccinated at another health department. Two weeks post vaccination, the patient found out that she was pregnant, with last menstrual period (LMP) of 12-NOV-2009, estimated delivery date (EDD) of 19-AUG-2010. Urine pregnancy test was performed. On an unknown date, the patient experienced generalized edema and was having rapid weight gain. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer who was just reading facebook when the consumer saw a post from a friend of hers "Just say no to GARDASIL".  The patient was vaccinated with a dose of GARDASIL on an unspecified date.  It was apparently her daughter had been very sick for two years after receiving the shot.  It was unknown if the patient sought medical attention.  At the time of the report, the patient's status was unknown.  This is one of several reports received from the same source.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Fatigue, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL intramuscularly.  Concomitant therapy included MENACTRA and (unspecified) TDAP received on the same day.  The patient went to the emergency room twice.  The patient had weak muscles, fatigue and shortness of breath and difficulty breathing.  At the time of the report the patient was recovering from weak muscles, fatigue and shortness of breath and difficulty breathing.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with penicillin allergy who on 02-SEP-2009, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number not provided).  There was no concomitant medication.  On 07-APR-2010, the patient received intramuscularly on the left upper arm a second 0.5 mL dose of GARDASIL.  On 08-APR-2010, one day after receiving her second dose of GARDASIL, the patient developed redness and swelling at the injection site of the left upper arm.  On 14-APR-2010, the patient was evaluated in the office and had a fever of 101.2F.  At the time of reporting, the symptoms were increasing in severity (not recovered).  No labs or diagnostic studies were performed.  The patient sought medical attention via office visit.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter a female who was vaccinated, on unspecified dates, with the first two doses of GARDASIL (dose and lot number not reported) in the top of her hip. Concomitant therapy included ALLEGRA. The patient experienced pain in the injection site. On an unspecified date, the patient recovered from pain in the injection site. Patient's AE improve with unspecified therapy. The patient sought for unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Palpitations
Clinical narrative: Information has been received from a physician concerning a female patient who in July 2009 (day unspecified), was vaccinated with the first dose of GARDASIL.  Within the first 48 hours after the injection, the patient had heart palpitations, dizziness and light headedness, which resolved after the 48 hours.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Insulin resistance, Weight increased
Clinical narrative: Information has been received from a nurse concerning her 17 year old daughter who three years ago, in April 2007 was vaccinated with doses of GARDASIL IM.  One year after vaccination, in April 2008, the patient gained 25 lbs.  One year later, in April 2009, the patient gained another 25 lbs.  The patient sought unspecified medical attention.  She had been diagnosed with insulin resistance.  At the time of the report, the patient had not recovered.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a female consumer who on 14-APR-2010 was vaccinated with her first dose of GARDASIL (lot# not reported).  On 15-APR-2010 the consumer experienced a "rash on her face".  It was unknown if the patient sought medical attention.  At the time of the report, the outcome of the patient was unknown.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Pain, Vision blurred
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on approximately 15-APR-2010 was vaccinated with a first dose of GARDASIL (lot # not reported), 0.5mL, intramuscularly.  On approximately 15-APR-2010 after getting the first dose of vaccine the patient experienced body aches, blurred vision and upset stomach.  The patient sought unspecified medical attention.  The outcome of body aches, blurred vision and upset stomach was unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL (lot# not reported).  Subsequently the patient experienced injection site reaction after GARDASIL vaccine was given.  The patient had redness, swelling and tenderness for two days.  It was unknown if the patient sought medical attention.  At the time of the report, the outcome of the patient was unknown.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling
Clinical narrative: Information has been received from a nurse practitioner, concerning a 23 year old female patient, with a vaginal yeast infection (unspecified) who on 19-APR-2010, was vaccinated intramuscularly with a dose of GARDASIL (dose, and lot number not provided) at a clinic. It was unknown if it was the first dose of GARDASIL. Concomitant therapy included DIFLUCAN for the vaginal yeast infection. It was reported that DIFLUCAN was taken three hours after the vaccine was administered on 19-MAR-2010. On 20-APR-2010, the patient experienced groin swelling. On 23-APR-2010, the patient sought medical attention through the nurse practitioner. The nurse practitioner stated that the administration of DIFLUCAN may or may not contributed to the groin swelling and prescribed KEFLEX, BENADRYL and ibuprofen. On 26-APR-2010, the patient was seen again and the groin swelling had resolved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse in office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported).  The patient had syncopal events after vaccination.  It was unknown if medical attention was sought.  The outcome of the patient was not reported.  This is one of several reports from the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nasal congestion
Clinical narrative: Information has been received from a nurse concerning the nurse daughter's a 14 year old female with yeast allergy who was vaccinated IM with 0.5 ml a first dose of GARDASIL (lot number not reported). The patient's mother reported that the 12 hours after the patient received the first dose of GARDASIL, she experienced nasal congestion. It was reported that the patient had a yeast allergy which was not life threatening. The nurse stated that her daughter would not receive last two dosed of GARDASIL. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient with CARBATROL allergy and a history of neuralgia who was vaccinated IM with the first 0.5 mL dose of GARDASIL last Wednesday (on 14-APR-2010).  On approximately 17-APR-2010, 3 or 4 days after the injection, the patient experienced a rash under her knees and on her calves.  It was reported that the patient developed rash/hives on both legs below the knees.  Treatment recommended was BENADRYL.  Client was not pregnant.  The patient sought unspecified medical attention.  Client did not follow up with physician so patient's present status was unknown.  Physician stated that he did not think GARDASIL caused this reaction.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 16 year old female patient with "peanuts" allergy and no pertinent medical history who on 15-JUL-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 661766/0652X), intramuscularly. On 14-OCT-2009, the patient received the second 0.5 mL dose of GARDASIL (Lot # 657006/0188U), intramuscularly and on 23-MAR-2010, the patient was vaccinated with the third 0.5 mL dose of GARDASIL (Lot # 662299/1099Y), intramuscularly. There was no concomitant medication. It was reported that the patient developed non raised, non itching rash approximately 2 weeks after receiving each of GARDASIL doses, approximately on 30-JUL-2009, 29-OCT-2009 and 12-APR-2010. There were no laboratory diagnostic tests performed. The patient sought unspecified medical attention. It was reported that the patient recovered from the previous 2 incidences of rash but was still recovering form the rash that appeared 11 days ago. The rash appeared on her feet and hands. Follow-up information has been received from a registered nurse, concerning the 13 (previously reported as 16) year old female patient with sinus allergies and rash at time of vaccination, who received intramuscularly in the left deltoid the first and second doses of GARDASIL and in the right deltoid the third dose of GARDASIL. The nurse reported that on about August 2009, after receiving first dose of GARDASIL, the patient had mild rash on lower legs. No treatment and rash went away. After second inoculation, "approximately 4 weeks" after, on approximately 11-NOV-2009, the patient developed a slightly more severe rash in the same area. No treatment was required and rash went away. After third dose, the patient developed swollen lips and a more severe rash, 11 days after vaccination, on 03-APR-2010. The physician treated the patient with BENADRYL and steroids (unspecified). The nurse reported that the experiences required emergency room/doctor visit. No diagnostic tests were done at that time. The nurse reported that the rash was still present at the time of reporting. The nurse also reported the patient's outcome as recovered. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse midwife concerning a 22 year old female who on unspecified dates was vaccinated intramuscularly with the three 0.5 mL doses of GARDASIL (LOT# not reported).  The patient had an annual exam and completed series of GARDASIL.  No additional information was provided for individual doses.  Later on the patient experienced genital warts.  The Pap smear was performed.  Unspecified medical attention was sought.  The genital warts were improved; but at the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician assistant concerning a female patient who in "2007" was vaccinated with the first dose of GARDASIL.  Then the patient received the other two doses of GARDASIL and later on when she had PAP (Papanicolaou) smear test the result showed that the HPV positive was at high risk.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.