chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Headache, Hypoaesthesia, Menstrual disorder
Clinical narrative: Information has been received from a consumer concerning  her 13 year old daughter with no previous medical history and no known drug allergies / reactions reported, who near the end of September 2007, was vaccinated with the first dose of GARDASIL (lot number not provided 0.5ml  . On 02-Nov-2007, the patient was vaccinated with the second dose of GARDASIL 0.5ml and on 01-Apr-2008 with the third dose of GARDASIL (lot number not provided) 0.5 ml. There was no concomitant medication. Two days after receiving her first dose of GARDASIL , on approximately 02-Oct-2007, the patient got her first menstrual period. After getting the second dose of GARDASIL, on approximately 02-Oct-2007, the the patient got her first menstrual period. After getting the second dose of GARDASIL , on approximately 02-Nov-2008, the patient experienced a headache and stomach issues. Also she experienced a rash on the back of her neck, numbness and tingling in her hands. since the third dose GARDASIL , she experienced joint and muscle pain that had yet to go away, Since she was vaccinated with the first dose of GARDASIL, she not had another menstrual period since until recently. The patient stated that some of her symptoms felt like she was "going through menopause". A blood work was performed (results not provided). The patient sought unspecified medical attention. As of 10-Nov-2008, the patient was not recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Paraesthesia, Rash
Clinical narrative: Information has been received from a consumer concerning  her 13 year old daughter with no previous medical history and no known drug allergies / reactions reported, who near the end of September 2007, was vaccinated with the first dose of GARDASIL (lot number not provided 0.5ml  . On 02-Nov-2007, the patient was vaccinated with the second dose of GARDASIL 0.5ml and on 01-Apr-2008 with the third dose of GARDASIL (lot number not provided) 0.5 ml. There was no concomitant medication. Two days after receiving her first dose of GARDASIL , on approximately 02-Oct-2007, the patient got her first menstrual period. After getting the second dose of GARDASIL, on approximately 02-Oct-2007, the the patient got her first menstrual period. After getting the second dose of GARDASIL , on approximately 02-Nov-2008, the patient experienced a headache and stomach issues. Also she experienced a rash on the back of her neck, numbness and tingling in her hands. since the third dose GARDASIL , she experienced joint and muscle pain that had yet to go away, Since she was vaccinated with the first dose of GARDASIL, she not had another menstrual period since until recently. The patient stated that some of her symptoms felt like she was "going through menopause". A blood work was performed (results not provided). The patient sought unspecified medical attention. As of 10-Nov-2008, the patient was not recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who on an unknown date was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced an anaphylactic reaction after receiving GARDASIL. The patient recovered from the reaction, but she had recurrent rash and hives. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has received from a physician concerning a 15 year old female patient with no known allergies, who on 09-SEP-2008 was vaccinated with the third dose of GARDASIL.  Concomitant therapy included ADDERALL.  On 13-SEP-2008, the patient experienced shortness of breath.  The patient experienced a second period of shortness of breath three weeks later (approximately on 04-OCT-2008).  On an unknown date, the patient recovered from shortness of breath.  The patient sought medical attention in an office visit.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female patient with no known pertinent medical history, and no known drug allergies reaction, who on 30-AUG-2007 on an unrelated office visit, was vaccinated with the first dose of GARDASIL.  On 29-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (lot No 659055/1522U), 0.5 ml, intramuscularly.  The licensed practical nurse reported that patient did not experienced an adverse reaction after her first GARDASIL.  On 29-NOV-2007, after the patient received her second dose of GARDASIL, she experienced redness and swelling at the injection site, as well as hives, after she received her second dose of GARDASIL.  The licensed practical nurse reported that the patient had elected not to receive her third GARDASIL.  On an unknown date the patient recovered without requiring medical treatment.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test, Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on unknown dates was vaccinated with a first, second and third dose of GARDASIL,   0.5 mL.  6 months ago, on approximately 10-MAY-2008, patient experienced stop menstruating between her first through third dose for GARDASIL vaccine (lot # was not provided).  At the time of reporting the outcome of the event was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a female patient, with no pertinent medical history and no drug allergies/drug rections, who on 26-AUG-2008 was vaccinated with a first 0.5mL dose of GARDASIL vaccine.  There was no concomitant medication.  The patient reported that on 27-OCT-2008 she experienced injection site pain after getting her second dose of GARDASIL vaccine.  No laboratory diagnostics studies were performed.  It was noted that she did not have any events after first dose.  The patient was not recovered.  The patient unspecified sought medical attention.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a 23 year old female with no drug reaction/allergies, who on 22-OCT-2008 was vaccinated with the first dose of GARDASIL vaccine.  There was no concomitant medication.  Patient mentioned that she was supposed to have her period on 26-OCT-2008, but until now she had not had her menstrual period yet.  Patient noted that she had not done any pregnancy testing.  The patient sought medical attention.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning a her daughter who on unspecified dates was vaccinated wit ha full set of GARDASIL vaccine (reported as HPB).  The consumer reported the patient is now positive for HPV and "her family is devastated".  The outcome of the patient was not reported.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Nausea, Syncope vasovagal
Clinical narrative: Information has been received from a health professional concerning a 20 year old female patient who on 06-NOV-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 661044/0548X), intramuscularly in her right deltoid at 13:10.  The health professional reported that after the vaccine was given, at 13:13, the patient became dizzy, nauseous and her blood pressure decreased to 76/40.  At 13:15, the patient was given cold compress.  Upon discharge, the patient's blood pressure raised to 92/58.  The health professional reported that the patient experienced a vasovagal reaction.  On 06-NOV-2008, the patient recovered.  The patient sought medical attention.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 03-NOV-2008 was vaccination with a first dose of GARDASIL vaccine (lot # 659180/1758U) intramuscularly in her left arm.  The patient had irregular periods after her first dose.  The patient had regular periods for almost 1 year.  After the first dose of GARDASIL vaccine, the patient had more frequent menstruation and bleed more.  The outcome was not reported.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: The information has been received from a mother concerning her 15 year old daughter, with no pertinent medical history, or known drug allergies/drug reactions who on 18-JUL-2008 was vaccinated with her "first dose" of GARDASIL vaccine.  There was no concomitant medications.  The mother reported that approximately "3 - 4 weeks after vaccination" her daughter experienced alopecia.  It was reported that her hair was starting to slowly grow back.  "Unspecified tests" were performed (results not provided).  The patient did not plan on receiving her second or third dose.  At the time of this report, the patient was recovering.  The patient sought medical attention.  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL vaccine.  The patient experienced migraines after vaccination.  Patient went to emergency room but it was not known if the patient was admitted.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a physician concerning a 11 year old female with environmental allergies who on 06-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 658282/0929U).  The physician reported than on 07-JUL-2008 the patient received her second dose of GARDASIL vaccine (lot # 659441/1446U) and on 18-OCT-2008 the patient experienced peeling on the palms of her hands and between her fingers and the soles of her feet.  The patient was seen at an office visit.  At the time of the report the patient's peeling on the palms of her hands and between her fingers and the soles of her feet persisted.  No lab diagnostic studies were performed.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 14 year old female patient with a medical history of fainting and no known drug reaction/allergies, who on 18-AUG-2008, was vaccinated with the first dose GARDASIL, 0.5ml, intramuscularly, and on 07-NOV-2008 was vaccinated with the second dose of GARDASIL vaccine (Lot # 660557/0072X), 0.5ml, intramuscularly.  Concomitant therapy included ORTHO TRI-CYCLEN.  The nurse reported that on 07-NOV-2008, the patient received the second of GARDASIL, and fainted twice while laying in the supine position.  Additionally, the patient became nauseous and vomited once.  The nurse reported that the patient was observed in the office and then discharged home.   The patient recovered from the symptoms on the same day of the vaccination.  The nurse reported that the patient did not experience any difficulties with the first dose of the GARDASIL.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a female patient who in approximately October 2008, was vaccinated with GARDASIL vaccine.  The patient experienced rash from waist up after receiving GARDASIL vaccine.  On an unknown date in 2008, the patient recovered from the rash.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a 21 year old female who in approximately November 2007, was vaccinated with the first dose of GARDASIL (route and site not reported). Subsequently on an unknown date, the patient was diagnosed with human papilloma virus (HPV). The patient stated she had been unable to get second and third dose of GARDASIL. At the time of report, the patient's outcome was unknown. No further information available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who "2 months ago" in September 2008 was vaccinated with her first dose of GARDASIL. The physician reported that the patient called the clinic to inform that she developed redness and pigmentation on the injection site after receiving the vaccine. Follow up information from the physician also indicated that the patient had pain at the injection site, and "crescent shaped hypo-pigmented area" at the injection site. The patient sought medical attention from the physician. At the time reporting, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Lymph node pain, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a female patient with no known drug reactions/allergies and medical history, who was vaccinated with the first dose of GARDASIL by an unspecified route in the deltoid area.  There was no concomitant medication.  The physician reported that the patient developed a swollen lymph node one week after vaccination.  The swollen lymph node was warm and tender and about 4 inches from the injections site.  The lymph node is still swollen but much less.  The patient sought medical attention.  At the time of the report it was reported that the patient was not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with allergic reaction to CECLOR who on 26-Mar-2008 was vaccinated with the first dose of GARDASIL (lot#659655/1486U). Concomitant therapy included LOESTRIN. On 02-Jun-2008. the patient was vaccinated with a second dose of GARDASIL(lot#660387/1967U. It was reported that after the patient's second dose (date not provided), the patient developed severe and prolonged diarrhea after each meal, with no abdominal pain. Subsequently, the patient recovered on Sep-2008. It was reported that the event was mentioned at the patient's next office visit. The reporter also indicate that the patient "may have experienced diarrhea after her first dose" of GARDASIL . No laboratory diagnostic studies were preformed. 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 the first dose of GARDASIL (lot number was not provided) within the last week (in October 2008).  The patient fainted in the waiting room of the physician's office after receiving her first dose of GARDASIL.  She was taken to the emergency room for x-rays of her neck, but results were not provided.  It was not known if she was admitted to the hospital.  The patient recovered on an unspecified date.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Swelling
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient female patient who on approximately 23-Oct-2008 was vaccinated with the first dose of GARDASIL. The nurse reported that on approximately 23-Oct-2008 the patient began swelling up and ended up going to the emergency room. It is unknown whether the patient was admitted to the hospital. Follow-up information has been received from a licensed practical nurse concerning a 13 year old female patient with no known allergies and no relevant medical history who on 22-OCT-2008 at 4:02 pm was vaccianted intramuscularly in her left deltoid with GARDASIL (659055/0560X) at her doctor's office. It was reported that the patient experienced dizziness less than 5 minutes after receiving the injection which progressed to complaints of shortness of breath. The patient stated "not feeling like I can catch a full breath:". An emergency room visit wa required but the patient was not hospitalized. On 22-OCT-2008 the patient recovered. No further information is available.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Cystoscopy, Pollakiuria
Clinical narrative: Information has been received from a 23 year old female medical assistant with sulfonamide allergy, who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL, HAVRIX, and meningococcal vaccine (unspecified).  On 02-SEP-2008 she started to have frequent urination.  The medical assistant reported that she did see an urologist who did a "cysto test" in which they stretched her urethra, which relieved some of the pressure, but on 03-NOV-2008 the frequent urination started again.  The medical assistant stated that she is not sure is the HPV vaccine has caused this, but she is due to receive the second dose on 11-NOV-2008.  At the time of the reporting, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a female patient, with no pertinent medical history and no known drug allergies/drug reactions, who was vaccinated with the first dose of GARDASIL intramuscularly. There was no concomitant medication. The physician reported that a couple of weeks after vaccination. The patient developed "a couple of warts" on the extremity. None laboratories diagnostics studies performed. The patient was seen by the physician. The patient's outcome was not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Injection site erythema, Injection site nodule, Injection site swelling, Pain
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 29-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X), IM, left deltoid.  Concomitant therapy included SEASONALE-BARR.  On 29-OCT-2008 within 12 hours post vaccination, the patient experienced swelling and redness at the injection site, a rash that was painful to the touch, the area felt hot and felt like a little ball or nodule at the injection site.  At time of the reporting, the patient had not recovered.  No medical attention was sought.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 29-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X), IM, left deltoid.  Concomitant therapy included SEASONALE-BARR.  On 29-OCT-2008 within 12 hours post vaccination, the patient experienced swelling and redness at the injection site, a rash that was painful to the touch, the area felt hot and felt like a little ball or nodule at the injection site.  At time of the reporting, the patient had not recovered.  No medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a female who on an unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient "got a pain" in her arm. The outcome of the patient was not reported. The patient did not seek medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Back pain, Body temperature increased, Dyspnoea, Ear pain, Erythema
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with sulfonamide allergy, Penicillin allergy, and asthma who on 29-Oct-2008 was vaccinated at another office with GARDASIL (661766/0652X) intramuscularly in her left arm. Secondary suspected therapy included MENACTRA in her left arm and an unspecified influenza virus in her right arm. All 3 vaccines were received on the same day. The nurse stated that the patient developed a reaction after receiving the 3 vaccines. On 29-Oct-2008 the patient experienced pain bilaterally in her upper and lower back. The patient said her "mouth felt funny" but had no problem swallowing. The patient had ear pain on her right side and ear turned red. The patient also reported mild aches in thighs and knees and a fever of 101f with generalized body aches and fatigue. The patient was seen in the office of the reporter for these symptoms on 30-Oct-2008 and had a transient "hive like" rash on the underside of her left upper arm. The patient also had mild difficulty breathing (her peak flow rate was usually 500 and it dropped to 350). Subsequently, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Fatigue, Injection site reaction, Oral dysaesthesia, Pain, Peak expiratory flow rate decreased
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with sulfonamide allergy, Penicillin allergy, and asthma who on 29-Oct-2008 was vaccinated at another office with GARDASIL (661766/0652X) intramuscularly in her left arm. Secondary suspected therapy included MENACTRA in her left arm and an unspecified influenza virus in her right arm. All 3 vaccines were received on the same day. The nurse stated that the patient developed a reaction after receiving the 3 vaccines. On 29-Oct-2008 the patient experienced pain bilaterally in her upper and lower back. The patient said her "mouth felt funny" but had no problem swallowing. The patient had ear pain on her right side and ear turned red. The patient also reported mild aches in thighs and knees and a fever of 101f with generalized body aches and fatigue. The patient was seen in the office of the reporter for these symptoms on 30-Oct-2008 and had a transient "hive like" rash on the underside of her left upper arm. The patient also had mild difficulty breathing (her peak flow rate was usually 500 and it dropped to 350). Subsequently, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with sulfonamide allergy, Penicillin allergy, and asthma who on 29-Oct-2008 was vaccinated at another office with GARDASIL (661766/0652X) intramuscularly in her left arm. Secondary suspected therapy included MENACTRA in her left arm and an unspecified influenza virus in her right arm. All 3 vaccines were received on the same day. The nurse stated that the patient developed a reaction after receiving the 3 vaccines. On 29-Oct-2008 the patient experienced pain bilaterally in her upper and lower back. The patient said her "mouth felt funny" but had no problem swallowing. The patient had ear pain on her right side and ear turned red. The patient also reported mild aches in thighs and knees and a fever of 101f with generalized body aches and fatigue. The patient was seen in the office of the reporter for these symptoms on 30-Oct-2008 and had a transient "hive like" rash on the underside of her left upper arm. The patient also had mild difficulty breathing (her peak flow rate was usually 500 and it dropped to 350). Subsequently, the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Raynaud's phenomenon
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no drug reactions or allergies, who in September 2008 was vaccinated with a first and only dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (manufacturer unknown) and influenza virus 3v reassortant vaccine live intranasal (cold adapted Ann Arbor master strain) FLUMIST. Within 2 weeks after the vaccination, the patient developed Raynaud's Phenomenon. The physician saw the patient. "Tests for autoimmune disease" were performed. At the time of reporting, the patient's Raynaud's Phenomenon persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who in approximately September 2008, was vaccinated with a second dose GARDASIL. After received the second dose of GARDASIL the patient experienced "bumps" right next to the injection site. The patient sought medical attention and was given Benadryl, and the "bumps" went away. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a registered nurse concerning her 24 year old daughter with allergies to cephalosporins and no pertinent medical history who approximately 05-MAY-208 was vaccinated IM with the third dose of GARDASIL. There was no concomitant medication. On approximately 05-AUG-2008, "three month ago", the patient experienced joint pain three months after receiving the third dose. At the time of this report, the patient's joint pain persisted. No lab tests were performed. The patient did not seek medical attention. Follow-up call was made and the office confirmed that the patient reported was not the patient with the practice. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no drug reactions or allergies and a history of attention deficit/hyperactivity disorder (ADHD) who on 04-NOV-2008 was vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included Concerta and Buspar. On 05-NOV-2008 the patient experienced vomiting. At the time of this report, the patient's vomiting persisted. No lab test were performed. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested. Follow up information was received which reported that the physician was no longer in the practice. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 12-year-old female patient who on an unknown date was vaccinated with the second dose of GARDASIL (lot number, route and injection site unknown). Concomitant vaccinations included the first dose of MENACTRA and HAVRIX. Subsequently, in October 2008 ("sometime last month"), the patient was experiencing hair loss. She didn't sought any medical attention and her outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Head injury, Nodule, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with the second dose of GARDASIL. Concomitant medication included other unspecified vaccines. About 2 months ago, in approximately September 2008, the patient experienced fainted, hit the back of her head and got a lump. On an unspecified date in 2008, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a nurse and a physician concerning a 23-year-old female patient.  According to the physician, on 23-OCT-2008 the patient was vaccinated IM with a first dose of 0.5 ml GARDASIL (lot # 660618/0572X) in the left deltoid.  Concomitant medication included YASMIN.  About three days post vaccination, the patient experienced "swelling in the neck-top of the shoulder area".  The nurse reported that the patient received a dose of GARDASIL on 15-AUG-2008;  also reported that she developed hardening of lymph nodes in her arm 3 days after receiving her second dose of GARDASIL.  The patient sought unspecified medical attention and recovered on an unspecified date.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mood altered, Personality change
Clinical narrative: Information has been received from a physician concerning a female who "about a year ago"  in approximately 2007 was vaccinated with a dose of GARDASIL, lot number was not provided.  The physician reported that the patient's mother reported that her daughter experienced severe mood/personality changes "about a week post vaccination"  after receiving GARDASIL.  At the time of the report, the patient's outcome was unknown.  This is one of two patients concerning the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female patient who on 23-APR-2008 was vaccinated with the first dose of GARDASIL, on 23-JUN-2008 she received the second dose of GARDASIL and on 22-OCT-2008 the patient received the third dose of GARDASIL 0.5 ml, I.M. in right deltoid.  The medical assistant reported that after the third dose of HPV vaccine, the patient developed an injection site reaction.  The patient experienced pain at the injection site and massaged the area that evening.  The patient still had what was described as "BB size hard knot" at the injection site with discomfort.  At the time of the report, the patient had no recovered.  The patient sought medical attention at the office.  Additional information has been requested. Follow up information has been received on 12-FEB-2009 from a health care professional who reported that the patient is a 14 year old female student who no known allergies or pertinent medical history (Weight 125 lb and heighth 62 in). On 22-OCT-2008 was vaccinated intramuscularly into her left deltoid with 0.5 ml of the third dose of GARDASIL (Lot# 660359/1968U). There was no concomitant medication. On 04-NOV-2008 the patient developed a small bb size hard knot at the injectio site. Sore to touch. On an unspecified date the patient recovered. There was no illness at the time of vaccination. In further follow-up received from the health care professional and medical records, it was reported that on 04-NOV-2008, the patient complained of a knot still on the arm. No further information is available. All available medical records will be provided upon request.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 22-OCT-2008, was vaccinated with the third dose of GARDASIL.  The nurse practitioner reported that the patient experienced small knot at the injection site after getting the third dose of GARDASIL.  The nurse stated that the patient did not experienced any AE on the first and second dose of GARDASIL.  At the time of the report the outcome was
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Hemiparesis, Syncope
Clinical narrative: Information has been received from a physician and a nurse concerning a 14 year old female patient with no drug reactions/allergies, who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL.  The physician reported that the patient fainted after receiving the GARDASIL.  The nurse reported that "the patient upon feeling weak on one side of her body, the patient did fall".  The patient recovered 15 minutes later after having the symptom. The patient sought unspecified medical attention.  Follow up information has been received from a medical assistant on 12-JAN-2009. It was reported that the patient felt faint and unable to stand on her own. The GARDASIL site of administration was the left deltoid (lot number 661046/0381X) and was given on 23-OCT-2008 at 15:42.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 24-OCT-2008 was vaccinated with the first dose of GARDASIL.  The same day she received additional vaccines VARIVAX (Oka/Merck), (duration and dose not reported), DTAP (manufacturer unknown), MENACTRA and HEP A (manufacturer unknown).  The physician reported that the patient experienced throwing up for a week, after receiving GARDASIL and VARIVAX (Oka/Merck).  The patient outcome was not reported.  The patient sought unspecified medical attention.  Additional information has been requested.  1/22/08 MR received from PCP. WCC with multiple vax 10/24/08. TC from parent 10/29/08 with report of injection site swelling and 2 days of nausea. Not seen in the office for c/o.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with irritable bowel syndrome as concurrent condition and no known drug allergies who on 30-SEP-2008 was vaccinated intramuscularly in her left arm with 0.5 mL of the first dose of GARDASIL (Lot # 660387-1967U).  Concomitant therapy included hormonal contraceptives (unspecified) and CLARITIN.  On an unspecified date the patient developed a lump at the site of injection.  The patient sought medical attention via telephone.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia, Nausea, Vomiting
Clinical narrative: Information has been received from a physician and a health care worker concerning a 13 year old female patient who on 04-SEP-2008, was vaccinated with her first dose of GARDASIL (lot # 660555/0279X).  The physician reported that after receiving GARDASIL, the  patient waited for 15 minutes and then went home.  When the patient got home, she felt numbness in her legs, severe nausea, dizziness and vomiting (also reported by the office manager as occurring 15 minutes after being vaccinated).  The physician and office manager reported that the numbness in her legs resolved in 30 minutes and the physician stated that the the severe nausea, vomiting and dizziness resolved sometime in September, 2008.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Skin nodule
Clinical narrative: Information has been received from a consumer concerning her daughter with no medical with no medical medical history and no known allergies who on approximately 17-Oct-2008 was vaccinated with the third dose of GARDASIL given on the right a cause but believe that it could be the HPV vaccine" The consumer did not want to provide any or demographics or further information until she speaks with her daughter's physician. At the time of the report the patient had not recovered. Follow-up information was received which reported that the patient received the shot on 17-Oct-2008. The "bumps" started on " the weekend of October 24th" and she saw the doctor on 31-October-2008 and again on 07-Nov-2008. The bumps "stopped getting lager" on 05-Nov-2008 and now "they are getting smaller again". When the AE started, "you could not see them but you could feel them because they were under her skin. At their largest , "her neck looked swollen on that side and you could see them. "Presently, they are not visible but they can be felt". She did not have the lot# and the doctor did not do any tests when he saw the patient about this AE. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient who on 21-AUG-2008 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (Lot # 660555/0279X) and on 27-OCT-2008 was vaccinated intramuscularly with the second 0.5 dose of GARDASIL (Lot # 660555/0279X).  Concomitant therapy included birth control pills (unspecified).  The nurse reported that after the first and second dose of GARDASIL, the patient experienced headache, vomiting and general body aches.  The patient recovered 24 hours after the symptoms started.  At the time of the report the nurse was thinking of premedicating her before her third dose of GARDASIL, with ibuprofen and PHENERGAN suppositories.  The patient did not seek medical attention.  Additional information has been requested. Follow up information has been recieved from a registered nurse on 12-JAN-2008. On 21-AUG-2008 at 15:30, the patient was vaccinated, into the right deltoid with a first dose of GARDASIL. On 21-AUG-2008, at 10:30, the patient experienced headache, nausea, vomiting and "achiness all over." The patient recovered after 24 hours. On 27-OCT-2008, at 14:00, the patient was vaccinated, into the left deltoid with a second dose of GARDASIL. On 27-OCT-2008, at 15:00, the patient experienced headache, nausea, vomiting and "achiness all  over." The patient  recovered after 24 hours. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with GARDASIL.  The physician reported that the patient experienced an adverse event.  The physician is not sure whether or not the adverse event is related to the vaccine.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mood altered, Personality change
Clinical narrative: Information has been received from a physician concerning a female who "about a year ago" in approximately 2007 was vaccinated with a dose of GARDASIL, Lot number was not provided.  The physician reported that the patient's mother reported that her daughter experienced severe mood/personality changes "about a week post vaccination" after receiving GARDASIL.  At the time of the report, the patient's outcome was unknown.  This is one of two patients concerning the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haematology test normal, Nausea, Ultrasound scan normal, Vomiting
Clinical narrative: Initial and follow-up information has been received from a registered nurse for the pregnancy registry of GARDASIL, concerning an 18 year old female who on 27-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (Lot # 658556/1060U) (Expiration date 13-APR-2010), 0.5 mL, I.M.  It was noted that on 27-FEB-2008, the patient received MENACTRA.  After vaccination the patient discovered that she was pregnant.  On an unknown date was performed a prenatal blood work with no abnormal results and an ultrasound with negative results.  In follow-up, on 21-NOV-2008, a registered nurse was reporting that the patient experienced nausea and vomiting shortly after receiving the first vaccination on 27-FEB-2008.  At the time of the initial report, the time of gestation was 32 weeks.  Estimated date of delivery was 23-OCT-2008.  In follow-up was also noted that the patient had competed her pregnancy.  The date of delivery was not available.  The patient sought medical attention at the office.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Apgar score normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with asthma, peanut allergy and 1 previous pregnancies and 1 full term delivery (no birth defects or infant complications noted) who on 05-DEC-2007 was vaccinated with the first dose of GARDASIL IM 0.5 ml.  On 05-FEB-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml.  Concomitant therapy included albuterol inhaler as needed.  Other medications used during pregnancy included ferrousSO4 and biotin (+) carbonyl iron (+) docusate sodium (+) folic acid (+) minerals (unspecified) (+) vitamins (unspecified) (PRENATE ELITE) and iron supplement for anemia (begin on 12-JUN-2008 until delivery).  The patient was pregnant with an estimated date of confinement of 30-SEP-2008.  Fetal ultrasounds and positive pregnancy test were performed.  On 09-SEP-2008 the ultrasound was performed with the result of "small gestational age".  On 23-APR-2008 serum alpha fetoprotein was performed with negative results.  The complete blood cell count was performed with the result of anemia.  On 22-SEP-2008 the patient delivered a normal male baby weighing 6 pounds 2 ounces at 38 weeks with apgar scores 9/9.  There were no congenital anomalies and no other complications or abnormalities.  There was no complication during labor/delivery.  The patient sought medical attention in the office visit.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count abnormal, Small for dates baby, Ultrasound scan abnormal
Clinical narrative: Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with asthma, peanut allergy and 1 previous pregnancies and 1 full term delivery (no birth defects or infant complications noted) who on 05-DEC-2007 was vaccinated with the first dose of GARDASIL IM 0.5 ml.  On 05-FEB-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml.  Concomitant therapy included albuterol inhaler as needed.  Other medications used during pregnancy included ferrousSO4 and biotin (+) carbonyl iron (+) docusate sodium (+) folic acid (+) minerals (unspecified) (+) vitamins (unspecified) (PRENATE ELITE) and iron supplement for anemia (begin on 12-JUN-2008 until delivery).  The patient was pregnant with an estimated date of confinement of 30-SEP-2008.  Fetal ultrasounds and positive pregnancy test were performed.  On 09-SEP-2008 the ultrasound was performed with the result of "small gestational age".  On 23-APR-2008 serum alpha fetoprotein was performed with negative results.  The complete blood cell count was performed with the result of anemia.  On 22-SEP-2008 the patient delivered a normal male baby weighing 6 pounds 2 ounces at 38 weeks with apgar scores 9/9.  There were no congenital anomalies and no other complications or abnormalities.  There was no complication during labor/delivery.  The patient sought medical attention in the office visit.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician, for Pregnancy Registry for GARDASIL, concerning a 15 year old female with a history of 0 pregnancies and 0 live births and no other medical history or drug allergies who on 08-OCT-2006 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL in the deltoid and on 10-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL in the deltoid (lot # 654510/0962F).  Concomitant therapy included minocycline.  The patient delivered a healthy baby on 27-FEB-2008.  Weight: 6 pounds 14 ounces, Length: 50.0cm, Apgar score: 9/9, Head circumference: 20 inches.  No adverse symptoms.  Medical attention was sought via office visit.  No product quality complaint was involved.  There were no congenital anomalies or other complication or abnormalities.  Pediatric medical records were received and reviewed and the following experiences were identified: A 06-MAR-2008 office visit noted that the male child had eye discharge and required special formula due to lactose intolerance.  The healthy male, was born on 27-FEB-2008 via normal spontaneous vaginal delivery.  On 27-FEB-2008, poly vitamin with fluoride with Iron multiple vitamins with Iron and Fluoride 0.25 50, 1 dropperful, PO, once a day and erythromycin ophthalmic ointment 0.5%, QID, were prescribed.  On 15-MAY-2008 the male child was vaccinated with PEDIARIX, PNEUMOVAX, ROTATEQ (manufacturer unknown) and HIB (manufacturer unknown).  On 25-AUG-2008 the child was vaccinated with PEDIARIX, PNEUMOVAX (manufacturer unknown) and HIB (manufacturer unknown).  Additional information is not expected.
Age: 57.0
Sex: U
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a 57 year old patient who inadvertently was vaccinated with a dose of GARDASIL by human error. No adverse effect reported. Follow-up information was received from a physician who reported that on 10-JUL-2008 the patient was given GARDASIL, IM, in the left arm instead of ADACEL inadvertently. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score abnormal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Premature labour, Ultrasound scan normal
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a 16 year old female with allergic reaction to cephlosporins and a history of 1 pre-term delivery at 36 weeks with complication of apnea of prematurity and no birth defects who on 21-JAN-2008, was vaccinated with the first dose of GARDASIL (lot#657872/0515U).  Concomitant medication included ALESSE for birth control.  The physician reported that on 24-MAR-2008, the patient was vaccinated with the second dose of GARDASIL (lot # 657872/0515U) at her primary care office.  On 09-JUN-2008, the patient had a blood test and urine test for pregnancy, and an ultrasound that confirmed the pregnancy and showed the patient was 23 weeks and 6 days pregnant and the fetus had a normal anatomy.  The patient's LMP was 25-DEC-2007 and EDD 30-SEP-2008 and her date of conception was approximately 05 to 10-JAN-2008.  The patient sought medical attention at the physician's office.  In further follow up, the physician reported that the baby delivered on 31-AUG-2008 was male and weighed 5 pounds, 2 ounces, was 18 1/2 inches, and the APGAR score was 6/9.  The infant was normal, with no congenital anomalies and there were no other complications.  The patient had complications during the pregnancy and labor/delivery because was a precipitous delivery.  She was on bed rest at 31 weeks.  On 26-AUG-2008, the patient had an ultrasound which was normal size/fluid.  Other medications were used during this pregnancy, was terbutaline 5 mg every 4 hours for pre term labor from 06-AUG-2008 to 07-AUG-2008 and MACROBID, bid, for treatment of a urinary tract infection from 06-AUG-2008 to 13-AUG-2008.  No further information is available.