chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Called approx. 11:25 am today-had been in garage not doing anything yet, flet " woozy, like drunk" went back in house and sat down, it went away in a couple minutes. No shortness of breath.Arm sore, no redness,drainage or swelling. Encourged patient to seek immed. medical attention if it occurs again. Go to ER
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Physician diagnosed shingles
Age: 0.18
Sex: F
Vaccine: RV5, RV5, RV5
Symptoms: Intussusception
Clinical narrative: PATIENT WAS ADMITTED WITH INTUSSUSCEPTION NINE DAYS LATER, AND REDUCED SUCCESSFULLY, AT HOSPITAL  4/3/07 Received medical records from hospital which reveal patient experienced emesis for 3 daysw/decreased feeding beginning 3/5/07 & patient became increasingly lethargic.  On exam, palpable mass was felt in abdomen.  Kept over night for observation, did well & was d/c to home on 3/9/07.  No D/c summary available. FINAL DX: ileocolic intussusception, reduced by barium enema.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Malaise
Clinical narrative: MMR vaccine given 2/21/07; reported malaise 12 days later 3/5/07, then starting on day 16 joint swelling and arthralgia particularly in knees & wrists.  Treated with OTC anti-inflammatory meds.  Subsiding by 3/12, and much improved by 3/14.
Age: 0.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Within 36 hours of administration patient called complaining of site pain, reddness, swelling, headache, and fever (102'F)
Age: 12.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Patient has hives at the site of the injections and on his upper bodya nd back. Had injections at 8am  on 3-16-07 and was reported to the clinic at 4pm the same day.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 8 cm X 9cm erythematous area to Left Upper arm at injection site, and pt c/o slight pain and itchiness to area. Given Motrin for discomfort and MD advised to take Benadryl  for swelling and itchiness. Advised to return in 3 days time if unchanged or no improvement, sooner if worse.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: Marked swelling, erythema, tenderness and moderate induration appearing after administration. Symptoms resolved within 72 of onset.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Chest X-ray normal, Cyanosis, Infantile apnoeic attack, Influenza serology negative
Clinical narrative: Mom noticed low-grade fever later in afternoon of vaccination. Fever was followed by panting spells, and baby would stop breathing for 7 seconds. The apnea occurred a few times. Mom also noted perioral cyanosis with one episode and that the baby's chin and lip turned purple while baby was sleeping. Baby then brought to the ER where the apneic spells did not occur but fever reached 101.9. 4/13/07 Received medical records from hospital which reveal patient experienced apneic spells, fever, panting, perioral cyanosis. Admitted 3/15-3/16/07 for observation & no further episodes noted.  FINAL DX: acute life threatening illness; fever.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lumbar puncture normal, Pyrexia, Urine analysis normal, Virus serology test
Clinical narrative: Mom noticed low-grade fever later in afternoon of vaccination. Fever was followed by panting spells, and baby would stop breathing for 7 seconds. The apnea occurred a few times. Mom also noted perioral cyanosis with one episode and that the baby's chin and lip turned purple while baby was sleeping. Baby then brought to the ER where the apneic spells did not occur but fever reached 101.9. 4/13/07 Received medical records from hospital which reveal patient experienced apneic spells, fever, panting, perioral cyanosis. Admitted 3/15-3/16/07 for observation & no further episodes noted.  FINAL DX: acute life threatening illness; fever.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Erythema, Oedema
Clinical narrative: Erythema, edema, axillary pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Rash generalised, Similar reaction on previous exposure to drug, Swelling face, Urticaria
Clinical narrative: Received Gardasil #2, developed swelling around injection site after 2-5 minutes. That evening she developed hives on body and extemities-Mom gave Benadryl. Rash subsided but left side of face swollen but improved later in the day. 2 months ago 1st Gardasil given; she developed hives. Mom thought it was due to other allergies. Has been getting all over rash and swollen face since then.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Left arm swollen, red, warm hard. Hard red circle below site where given. Swelling started 3/14/07. Still swollen 3/16/07-worsened x 2 days.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Lip swelling
Clinical narrative: Swelling of lips, difficulty breathing.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Large erythema-itches-hot to touch-non tender-no groin nodes. Good R.O.M. First noted 3/15/07-increased size 3/16/07.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: No adverse effect
Clinical narrative: No adverse events. No adverse events occurred. MD 4/2/07.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a registered nurse, concerning a 13 year old female with multiple allergies, who on 23-JAN-2007 was vaccinated IM in the right arm, with the first dose of Gardasil (yeast) (Lot # 655165/1425F). There was no concomitant medication. Approximately five to ten minutes later, the patient developed a rash that "started at the injection site and then spread to the arm and the whole body." Treatment with ZYRTEC was immediately given in the office, and the patient was instructed to take BENADRYL at home, if needed. The nurse reported that "rash was mild and self-limiting," and remarked "it was easily treated with antihistamine and resolved soon after treatment was given." He clarified that "this was a mild reaction," and he did not feel the patients condition would have required hospitalization or threatened her safety. The mother of the patient wanted her daughter to receive the subsequent doses of the vaccine, however the nurse stated he felt the patient's system was "sensitized" and believed a second dose would be "too risky." Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, "within last week or week and a half," the patient developed a fever and was admitted to the hospital for 24 hours. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female, with no pertinent medical history with allergies to erythromycin and sulfamethoxazole (+) SEPTRA who on 06-FEB-2007 was vaccinated with Gardasil (yeast), (Lot # 654885/1424F). There was no concomitant medication. On 06-FEB-2007 the patient developed chest pain when taking deep breaths. No other symptoms. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who in December 2006, was vaccinated with Gardasil (yeast) which may have been given by the SQ route or a partial SQ route. Subsequently, the patient developed slight injection site soreness (date unknown). The nurse reported that the nurse who administered this vaccination was left handed and his technique appeared "odd" and it may have looked like a SQ injection when it was really intramuscular. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a female medical assistant who was vaccinated IM, into the arm, with a first dose of Gardasil (yeast). Subsequently the patient experienced had pain in the arm that lasted a few minutes after vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Hypoaesthesia, Injection site pain, Local reaction
Clinical narrative: Information has been received from a health professional concerning a 16 year old female with no medical history who on 06-FEB-2007 was vaccinated IM in to the right deltoid with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). There was no concomitant medication. On 06-FEB-2007 after vaccination the patient developed a local reaction. She experienced 30 seconds of dizziness. The local reaction started with pain at the injection site that radiated down her arm and her entire arm was red. After the patient subsided the arm went numb and then the patient was fine. The entire episode lasted only 5 minutes and the patient seemed fully recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second of GARDASIL. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. This is in follow-up to report(s) previously submitted on 3/14/2007.  Initial and follow-up information has been received from a physician, concerning a female patient who was vaccinated with either a first or second dose of GARDASIL (date not specified).  The physician stated the patient's father mentioned that his daughter experienced nausea after vaccination.  The physician reported that the patient recovered within a day.  The physician did not believe the nausea was caused by GARDASIL.  The patient sought unspecified medical attention.  No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Inappropriate schedule of drug administration, Loss of consciousness
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse via a company representative, concerning a 12 year old white female student, who on 06 Nov 2006 was vaccinated in the right deltoid with 0.5 ml of the first dose of Gardasil. There was no concomitant medication. There was no illness at the time of vaccination. The patient passed out in the physician's waiting room after receiving the vaccination. The patient stated she did not eat breakfast. Upon awakening, the patient was given crackers and soda, and stated she felt better. On 05 Feb 2007, three months after the first dose, the patient was vaccinated in the left deltoid with the second dose of Gardasil. After the second vaccination, the mother called and reported her daughter had passed out at home and hit her head. The patient did not receive medical attention, but her physician was informed. The patient recovered the same day, 05 Feb 2007. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Information has been received from a physician via a company representative, concerning a 19 year old female who on 07 Feb 2007 was vaccinated with an 0.5 ml dose of Gardasil. By the evening of the same day, the patient developed a "rash from head to toe and itching." The patient has not recovered at the time of this report. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection
Clinical narrative: Information has been received from a 22 year old female health professional who on 25 Jan 2006 was vaccinated with a first dose of Gardasil. The patient reported that within 24 hours of vaccination she experienced a yeast infection. It was reported that the patient sought medical attention for this event. The patient recovered after approximately 2 days. Patient would complete her vaccination series. Additional informatio has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Bacterial test negative, Blood test, Syphilis test positive
Clinical narrative: Information had been received from a physician and a Registered Nurse concerning a 16 year old female who was sexually active. In August 2006, the patient was vaccinated with the first dose of Gardasil, at the end of November 2006 with the second dose. She received the vaccination at the pediatrician's office. The patient was tested for syphilis " a couple of days" later. The patient's Rapid Plasma Reagin (RPR) test titers were 1-256 (high), with a negative Fluorescent Antibody Absorption (FTA) test.  The patient was tested again approximately one week later and the RPR titers were still high but lower. The physician mentioned that the patient underwent other antibody tests such as serum antinuclear antibodies (ANA) test, and Lyme disease test. The results were normal for those tests. The physician stated that the patient had not been sick with the flu nor mononucleosis, and that the patient had tested negative for other sexually transmitted diseases. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Epstein-Barr virus test, Full blood count, Lethargy, Nausea
Clinical narrative: Information has been received from a health professional concerning a 15 year old female on 13 Nov 2006 was vaccinated with a first dose of Gardasil. There were no concomitant medications. On approximately 13 Nov 2006 the patient experienced nausea, lethargy and "mono like symptoms." Subsequently, the patient recovered. On 03 Feb 2007, the patient was vaccinated with a second dose of Gardasil. On 03 Feb 2007 the patient experienced nausea, marked lethargy, "mono like symptoms" and diarrhea for 2 days after the vaccination. On 05 Feb 2007, the patient returned to the doctors office and underwent a complete blood cell count and an Epstein-Barr virus antibodies screen. It was reported that "mono" was ruled out. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pseudomononucleosis
Clinical narrative: Information has been received from a health professional concerning a 15 year old female on 13 Nov 2006 was vaccinated with a first dose of Gardasil. There were no concomitant medications. On approximately 13 Nov 2006 the patient experienced nausea, lethargy and "mono like symptoms." Subsequently, the patient recovered. On 03 Feb 2007, the patient was vaccinated with a second dose of Gardasil. On 03 Feb 2007 the patient experienced nausea, marked lethargy, "mono like symptoms" and diarrhea for 2 days after the vaccination. On 05 Feb 2007, the patient returned to the doctors office and underwent a complete blood cell count and an Epstein-Barr virus antibodies screen. It was reported that "mono" was ruled out. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dizziness, Injection site pain, Sudden hearing loss
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female who on approximately 31 Jan 2007 was vaccinated with a dose of Gardasil in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient's "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old white female with no known drug allergies or illness at the time of vaccination who on 01 Jan 2007 was vaccinated in the right deltoid with a 0.5 mL first dose of Gardasil. Concomitant therapy included Yaz, Zelnorm and Miralax. On 04 Jan 2007, the patient became lightheaded and had to lie down after receiving Gardasil vaccination. The patient stated that she had gotten lightheaded after injections in the past. She also did not have much to eat that morning. The patient did not lose consciousness and remained alert and responsive. The patient was given some peanut butter crackers and coke and subsequently felt better and recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 26 Jan 2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil. On 26 Jan 2007 the patient developed a rash at her injection site. The patient sought unspecified medical attention. On 27 Jan 2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site irritation, Medical device complication, Pain in extremity, Underdose
Clinical narrative: This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a licensed visiting nurse concerning a 14 year old female with no medical history and no known drug allergies, who on 08-Feb-2007 was vaccinated IM with a dose of Gardasil.  Concomitant therapy included Ortho Tri Cyclen Lo and Synthroid. The patient inadvertently received less than the recommended dose and experienced an injection site reaction. The nurse withdrew the vaccine from a vial and the medication leaked near the hub of the syringe while administering it to the patient. The patient complained of irration on the left deltoid about a two inch radius from the injection site. She also reported that the pain "ran down" her left arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Information has been received from a licensed vocational nurse concerning a 14 year old female with a thyroid condition and irregular periods and no known drug allergies, who on 08-FEB-2007 was vaccinated IM with a dose of GARDASIL (lot# 654741/0013U). Concomitant therapy included ORTHO TRI-CYCLEN LO and SYNTHROID. The patient inadvertently received less than the recommeded dose and experienced an injection site reaction. The nurse withdrew the vaccine from a vial and the medication leaked near the hub of the syringe while administering it to the patient. The patient complained of irration on the left deltoid about a two inch radius from the injection site. She also reported that the pain "ran down" her left arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. In follow-up, the nurs reported that the patient received a partial vaccination of GARDASIL (lot# 654741/0013U) in the left deltoid due to a defective syringe: some of the medication ran down the patient's arm. The patient complained of a burning sensation and "beesting-like" reaction later that evening on 08-FEB-2007. By the morning on 09-FEB-2007, the patient's are was much better. The immunization was discontinued. Addtitional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with pertinent medical history unspecified and drug reaction/allergies unspecified who in December 2006, two months ago, was vaccinated with first dose of Gardasil 0.5 ml IM.  Concomitant therapy was unspecified. In December 2006, one day after receiving the injection, the patient experienced redness, swelling, itching, and bumps on her arm at the injection site. The patient also experienced light-headedness, and dizziness. The patient sought medical attention. Subsequently, the patient recovered. No other information was available at the time of reporting. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from an office manager concerning a female (age not reported) with a history of passing out when receiving shots who on an unspecified date was vaccinated with Gardasil (lot # not reported) 0.5 ml injection. On an unspecified date, the patient passed out after the shot of Gardasil, unknown which dose. Unspecified medical attention was sought. The patient recovered later in the day. Additional information has been requested. Follow-up information was received in which it was reported that no patient had a problem with this vaccine. We have been misinformed. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female receptionist who was vaccinated with a dose of Gardasil. Subsequently the injection site became swollen after a week, "about the size of a half dollar." It was reported that there were "rings around the swelling an it was painful. "Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a physician concerning a 16 year old female with asthma who in December 2006, was vaccinated with the first dose of Gardasil. Concomitant therapy included FLOVENT, albuterol and ZYRTEC. In December 2006, a few hours following vaccination with Gardasil, the patient experienced itchiness and redness of her face. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered from itchiness and redness of her face. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 26-NOV-2006 was vaccinated with the first dose of Gardasil and on 31-JAN-2007 was vaccinated with the second dose of Gardasil. Concomitant medication was not reported. On approximately 26-NOV-2006 the patient experienced headache after the first dose of Gardasil, which lasted about one month. The outcome and causality of the headache was not reported. On 07-FEB-2007, about 7 days after the second dose of Gardasil, the patient developed a "lump," redness and pain in her arm, at the injection site. The physician reported that the injection site reaction was approximately one half centimeter which was extremely tender and painful. On an unspecified date, the patient sought unspecified medical attention. The patient's events persisted. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Contusion, Pruritus, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a physician and a healthcare professional, concerning a 26 year old female nurse, with no known allergies, who at 2:00pm, on 25-August-2006, was vaccinated IM with the first dose of GARDASIL (lot #654885/1412F). There was no illness at the time of vaccination. The physician reported that by nighttime, the patient experienced a burning sensation in her cheeks. The next morning, 26-AUG-2007, she developed an itchy rash on her cheeks; the healthcare professional added that on this date, the patient also experienced bruising on her face and pruritus. The healthcare worker confirmed the symptoms lasted for "about 1 week" and then resolved with the exception of the pruritus, which lasted for "more than 3 months." Follow up information stated that on 25-OCT-2006, the patient was vaccinated IM with the second dose of GARDASIL (Lot # 654885/1424F), and she experienced a recurrence of the itching rash on her face, pruritus, and bruising on her face. Again, the symptoms of itching rash and bruising on the face resolved in about 3 week. No further information was expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. The patient was administered Gardasil in one arm ant Tetanus vaccine in the other arm on the same day. On approximately 02-FEB-2007 the patient developed a rash on her whole body. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. no additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced dizziness and sought unspecified medical attention. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site rash, Nausea
Clinical narrative: Information has been received from a registered nurse via a company representative, concerning a 25 year old female who on approximately 22-JAN-2007 (about three weeks ago), was vaccinated with the second dose of Gardasil, 0.5 ml. Concomitant therapy included ZELNORM. On approximately 10-FEB-2007 ("within the past day or two"), the patient developed "a bump and bruise at injection site, and nausea. It was reported that the patient had "no ill effects after the first dose" (date not provided). At the time of this report, the patient had not yet recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness, Sensory disturbance
Clinical narrative: Information has been received from a nursing supervisor concerning a 20 year old female who has an allergy to penicillin and minoglycine who on 27-Dec-2008 at 12:15 was vaccinated with GARDASIL (lot# 695165/1425F). On 27-DEC-2006 at 12:15, the patient reported that "when she was given the shot she felt it go down her arm and her arm felt heavy all day long. "The next day her arm was better. No product quality complaint was involved. Subsequently, the patient reported that her arm felt dead. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 08-FEB-2007 was vaccinated with her first dose of Gardasil and experienced flu-like symptoms after the vaccination. Concomitant therapy included Menactra. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Nausea, Pain, Wrong drug administered
Clinical narrative: Information has been received from the mother of an 11 year old male with severe acid reflux and possibly a hiatal hernia, severe allergies to many different things such as pollen, dust, and various foods, mild asthma, anxiety problems and a history of seizure as an infant after DPT vaccination, who on 07-FEB-2007 was vaccinated with a dose of Gardasil by mistake. Concomitant therapy included ZYRTEC, PAXIL, PRILOSEC and different allergy shots. The report stated that her son was supposed to have received an unspecified hepatitis vaccine. On 12-FEB-2007 the patient was feeling achy, weak, tired and nauseous. She also stated that she was not sure that these symptoms were related to the vaccine. Medical attention was sought. The patient was reported as not recovered at the time of this report. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with possible allergy to penicillin and erythromycin who on 03-JAN-2007 was vaccinated with a first dose of Gardasil (yeast), lot # 653938/0954F. The patient was not on any medication. On 04-JAN-2007 the patient developed hives. The patient was examined by the physician on 05-JAN-2007. The patient was reported as completely recovered by 06-JAN-2007. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient experienced "vomited eight hours with no fever". Subsequently, the patient recovered (date unspecified). No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated with a second dose of Gardasil (yeast). In December 2006, the patient's blood pressure went up and she developed shortness of breath. After 30 minutes, the patient's blood pressure returned to normal. The patient was not pregnant. At the time of this report, the outcome of the shortness of breath was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Malaise, Muscle tightness
Clinical narrative: Information has been received from a "healthcare worker" concerning a female (patient 2 of 4), either 14 years or 17 years old, who was vaccinated with the first dose of Gardasil (yeast) 0.5 ml IM in the gluteal region. The patient experienced "knots in her neck and ill feeling" one to two weeks after receiving the vaccination. The healthcare worker noted that the patient was being treated for "something else that had absolutely nothing to do with the vaccination". This patient "had no problems". Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site discolouration, Melanocytic naevus, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 22 year old female with mild asthma and a history of CIN grade I (2003, 2005 and 2006) and a benign pigmented lesion removed from her inner thigh (2006) who on 08-FEB-2007 was vaccinated IM into the right arm with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). Concomitant therapy included oral hormonal contraceptives (unspecified). Three on 11-FEB-2007 the patient developed two raised areas of hyperpigmented skin in the area of the injection site. The areas are 4 x 4 mm and 3 x 3 mm. The areas are described as are nevus like in appearance, linear, surrounded by erythema and painful. The patient is being evaluated for a "possible skin rash." The patient had not yet recovered from her experiences. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Skin hyperpigmentation
Clinical narrative: Information has been received from a physician concerning a 22 year old female with mild asthma and a history of CIN grade I (2003, 2005 and 2006) and a benign pigmented lesion removed from her inner thigh (2006) who on 08-FEB-2007 was vaccinated IM into the right arm with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). Concomitant therapy included oral hormonal contraceptives (unspecified). Three on 11-FEB-2007 the patient developed two raised areas of hyperpigmented skin in the area of the injection site. The areas are 4 x 4 mm and 3 x 3 mm. The areas are described as are nevus like in appearance, linear, surrounded by erythema and painful. The patient is being evaluated for a "possible skin rash." The patient had not yet recovered from her experiences. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of Gardasil (yeast) (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma exercise induced
Clinical narrative: Information has been received from a certified medical assistant concerning her 11 year old daughter with no past medical history and no allergies who on 15-DEC-2006 was vaccinated with a first dose of Gardasil (yeast), IM. There was no concomitant medication. On 11-JAN-2007 the patient experienced excerise induced asthma. The patient noticed that she was short of breath during exercise during sports. The patient had recovered  without treatment on 30-JAN-2007. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician's assistant concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil (yeast) (lot # not reported) IM injection. Concomitant therapy was unspecified. The patient sought unspecified medical attention. Subsequently, the patient experienced an extreme rash across her chest and up to her neck. At the time of reporting, the patient was "fine". Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein abnormal, Drug exposure during pregnancy, Neural tube defect, Pregnancy test positive, Ultrasound scan
Clinical narrative: Information has been received from a licensed practical nurse (LVN) as part of the pregnancy registry concerning a 17 year old female with penicillin allergy and drug reaction/allergy to DARVOCET, and VICODIN. She had no other concurrent medical conditions, or significant past medical history including no history or pregnancies.  On 17-OCT-2006, the patient was vaccinated with first dose of Gardasil (yeast) (lot # 654540/0800F also reported as 653937/0637F) 0.5 ml IM. There was no concomitant medication. The patient's last menstrual period was 18-OCT-2006. Medical attention was sought. On 11-DEC-2006, an ultrasound was performed that revealed pregnancy of 8 weeks and 2 days (estimated date of delivery 25-JUL-2007). On approximately 11-DEC-2006, maternal serum alpha-fetoprotein (MSAFP) test was performed that indicated the baby was at increased risk (positive) for neural tube defect (NTD). Medication taken during the pregnancy included prenatal vitamins. The patient was scheduled for follow-up testing with a perinatologist. No other information was available at the time of reporting. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Pruritus generalised
Clinical narrative: Information has been received from a consumer concerning her 18 year old old daughter with no pertinent medical history who on 26-JAN-2007 was vaccinated with her first dose of HPV. Concomitant therapy included hormonal contraceptives (unspecified). On 26-JAN-2007 the patient experienced itching at the injection site that developed into full body itching. Medical attention was sought. The patient was treated with Benadryl. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Her second dose was scheduled for 23-MAR-2007. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a physician and a consumer concerning her 18 year old daughter with no pertinent medical history who on 26-JAN-2007 was vaccinated intramuscularly, into the left arm, with her first dose of GARDASIL (lot 654540/1161F). Concomitant therapy included YASMIN. On 26-JAN-2007 the patient experienced itching at the injection site that developed into full body itching. Medical attention was sought. The patient was treated with BENADRYL. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Her second dose was scheduled for 23-MAR-2007. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site calcification, Injection site pain, Injection site pruritus, Oedema peripheral
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007 Initial and follow-up information has been received from a physician and a 35 year old female with penicillin and sulfonamide allergy with no pertinent medical history who on 22-JAN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. There was no concomitant medication. The patient reported that on 31-JAN-2007 she developed a painful itch at the injection site. The patient reported that after careful study of the site, she noted and then felt a bump at the injection site. The patient consulted with her physician who stated it was a calcification. Follow-up from the physician reported that on 08-FEB-2007 the patient developed a 1/2 cm tender firm lump at mid-humerus and was unsure if it was at the area of injection. Subsequently, the patient recovered. There were no laboratory or diagnostic tests performed. No additional information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female patient with Hyperlipidemia, polycystitis ovarian syndrome and penicillin allergy who on 31-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (lot# 654702/0011U), intramuscularly. Concomitant therapy included cholestyramine resin, atorvastatin calcium (Lipitor) and drospireneone + ethinyl estradiol (Yasmin). On 11-FEB-2007, the patient developed a maculopapular rash on her torso and bilateral upper extremities. The patient was evaluated at an urgent care facility and was prescribed a Prednisone pack. At the time of the report the patient was considered to be not recovered. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 24 year old female with hyperlipidemia, Polycystic ovarian syndrome, ovarian cyst and penicillin allergy who on 31-JAN-2007 was vaccinated with a first dose of GARDASIL, (lot # 654702/0011U), in left deltoid intramuscularly. Concomitant therapy included cholestyramine resin, LIPITOR and YASMIN. On 11-FEB-2007, the patient developed a maculopapular rash on her torso, chest, and bilateral upper extremities. The patient was evaluated at an urgent care facility and was prescribed a prednisone pack, tapered dose. As of 14-MAR-2007 the patient's outcome was unknown. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female with genital warts who in December 2006, was vaccinated with first dose of HPV (lot # not reported) 0.5 ml injection. Concomitant therapy was unspecified. The patient sought medical attention. In December 2006, after taking the first dose of vaccine, the genital warts seemed to worsen. The patient was treated with thioguanine and cytarabine (TCA). On approximately 07-FEB-2007, the patient was given the second dose of HPV (lot # not reported) 0.5 ml injection. The outcome of the worsening genital warts was not specified. No further information was provided at the time of reporting. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning her 17 year old daughter with attention deficit/hyperactivity disorder and a history of shellfish allergy (as a child: outgrew) who in 06-NOV-2006 at 1:00PM, was vaccinated in the left deltoid (previously reported as right deltoid), IM with a first dose of GARDSIL (Lot # 653650/0640F). Her second dose of GARDASIL vaccine (Lot # 653650-0640F) was administered intramuscularly into the right deltoidon 16-January-2007, at 2:00PM. Concomitant therapy included ADDERALL. There was no illness at the time of vaccination. The nurse practitioner reported that 3 days after each dose of GARDSIL vaccine, her daughter developed diarrhea, on 09-NOV-2006 and 19-JAN-2007, respectively. The diarrhea was reported to be "relatively severe and spontaneously resolved" (dates unspecified). On 20-January-2007 at 8:00AM, on the fourth day after the second dose, the patient "developed a rash on her knees and thigh that spread during the day until she was covered in a rash from her neck to her feet." In follow-up, the nurse practitioner confirmed that the patient developed a rash four days post vaccination that covered her legs, trunk, arms and neck. She was treated with BENADRYL and it resolved. The reporter noted that the decision was made to discontinue the series so a third dose would not be given. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a first dose of HPV. Subsequently the patient experienced nausea and vomiting. At the time of the report the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Crying, Pain
Clinical narrative: Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of HPV. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either left or right arm and had some pain afterwards. The licensed practical nurse further reported that the patient developed pain one hour after the injection. The patient reported that the pain had subsided, however, when the patient went to bed that evening, the pain had returned. Unspecified medical attention was sought. At the time of this report, the patient had fully recovered from the events (date unknown). Follow up information indicated that the patient had no further complaints of pain. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with no past medical history who on 04-DEC-2006 was vaccinated with HPV (lot # 654510/0962F), intramuscularly. There was no concomitant medication. On 04-DEC-2006, "five hours after vaccination", the patient felt feverish plus experienced dizziness and nausea and diaphoretic. The patient went to bed that evening and the next morning symptoms had resolved. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with established papilloma viral infection and a colposcopy was performed who on an unspecified date was vaccinated with HPV (lot# not reported). Subsequently, the patient experienced an outbreak of genital warts. Medical attention was sought. The outcome of the genital warts was not reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Fatigue, Nausea, Urticaria, Wheezing
Clinical narrative: Information has been received from  registered nurse supervisor, via a company representative, concerning a 12 year old patient who on 13-FEB-2007 was vaccinated IM in the left deltoid a 5:00 pm with the first dose of Gardasil. Three hours later (8:00pm), the patient had developed hives on the face, back and bottom. By 8:30pm, the patient began to experience wheezing, but then "slept fine through the night". Treatment was not specified. The next morning (14-FEB-2007), hives "had subsided," but the patient "felt nauseous and tired." At the time of this report, the patient had not recovered. The nurse also reported that the patient will not be given the second and third dose of the vaccine. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain in extremity, Palpitations
Clinical narrative: Initial and follow up information has been received from a physician and a registered nurse (R.N.) concerning a 16 year old female patient who on 15-JAN-2007 was vaccinated IM in left deltoid with her first dose of GARDASIL vaccine. On 19-JAN-2007 the patient developed red and swollen arm in the injection area. The physician advised patient to take TYLENOL. On 22-JAN-2007 the patient reported that her tonsils were swollen. She felt really tired and that her leg was hurting and she could not put weight on it. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow-up information indicated that on 16-JAN-2007 patient had heart palpitations and on 19-JAN-2007 in AM she had swollen throat, right leg pain (previously reported as starting on 22-JAN-2007, not site of injection), felt tired (previously reported as starting on 22-JAN-2007). The patient recovered in one week. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tonsillar hypertrophy
Clinical narrative: Initial and follow up information has been received from a physician and a registered nurse (R.N.) concerning a 16 year old female patient who on 15-JAN-2007 was vaccinated IM in left deltoid with her first dose of GARDASIL vaccine. On 19-JAN-2007 the patient developed red and swollen arm in the injection area. The physician advised patient to take TYLENOL. On 22-JAN-2007 the patient reported that her tonsils were swollen. She felt really tired and that her leg was hurting and she could not put weight on it. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow-up information indicated that on 16-JAN-2007 patient had heart palpitations and on 19-JAN-2007 in AM she had swollen throat, right leg pain (previously reported as starting on 22-JAN-2007, not site of injection), felt tired (previously reported as starting on 22-JAN-2007). The patient recovered in one week. Additional information is not expected.