chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in July 2007, was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml). In approximately July 2007, "a couple of days after vaccine was given", the patient experienced lower back pain and tingling in the back of her legs. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. In follow-up from the patient's phyician, it was reported that per the patient's neurologist, the case deemed to have no association with the vaccine. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female who on 11-SEP-2007 at 3:30 PM was vaccinated in the deltoid with the first dose of GARDASIL (lot # 658558/1061U). On 11-SEP-2007, at 3:30, the patient developed immediate swelling and redness at the injection site. The patient was treated with BENADRYL and released. The reaction resolved the same day. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Diarrhoea, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history or illnesses at the time of the medication who on 09-JUL-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5 mL. On an unspecified date the patient experienced an adverse event after the initial injection of GARDASIL. Medical attention was sought via telephone by the patient contacting the office. The type of adverse event that occurred was not specified. Follow-up information was received. On 09-JUL-2007 the patient experienced nausea, diarrhea and lost of appetite for 2 weeks. Subsequently, the patient recovered from nausea, diarrhea and loss of appetite. On an unspecified date the patient received a second injection and the patient did not have any adverse side effects. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin negative, Cervical dysplasia, Drug hypersensitivity, Injection site discolouration, Injection site erythema
Clinical narrative: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient with cervical dysplasia, penicillin allergy and allergic reaction to erythromycin who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of Gardasil and on 18-JUN-2007, at 09:00AM she was vaccinated into the right arm with a second dose of Gardasil (lot # 655154/1210U). The nurse reported that patient developed an injection site rash after the second dose of Gardasil. The date the rash appeared was unspecified. The patient sought medical attention for the rash on 30-JUN-2007. The rash at the injection site was diagnosed as viral and not related to the injection. On 08-SEP-2007 the patient sought treatment for another condition and the physician re-evaluated the injection site rash on the right arm. The rash was described as "a hypo-pigmented area 8 centimeters in size with red papules at the periphery." The physician advised the patient not to continue with the third injection. It was reported that the patient would be evaluated on 24-SEP-2007 for the rash. At the time of this report patient had not recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/12/2007. In follow up report the reporter reported that on 29-JUN-2007 at approximately 08:00 AM "Rash on arms, stomach, thigh, back-doesn't itch. Red, pen tip size to small pen cap. Raised, darker spot in middle of Rash spots. Arm swelling and scabbed area of inj site, area is sore." The patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site papule, Injection site rash, Injection site scab, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient with cervical dysplasia, penicillin allergy and allergic reaction to erythromycin who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of Gardasil and on 18-JUN-2007, at 09:00AM she was vaccinated into the right arm with a second dose of Gardasil (lot # 655154/1210U). The nurse reported that patient developed an injection site rash after the second dose of Gardasil. The date the rash appeared was unspecified. The patient sought medical attention for the rash on 30-JUN-2007. The rash at the injection site was diagnosed as viral and not related to the injection. On 08-SEP-2007 the patient sought treatment for another condition and the physician re-evaluated the injection site rash on the right arm. The rash was described as "a hypo-pigmented area 8 centimeters in size with red papules at the periphery." The physician advised the patient not to continue with the third injection. It was reported that the patient would be evaluated on 24-SEP-2007 for the rash. At the time of this report patient had not recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/12/2007. In follow up report the reporter reported that on 29-JUN-2007 at approximately 08:00 AM "Rash on arms, stomach, thigh, back-doesn't itch. Red, pen tip size to small pen cap. Raised, darker spot in middle of Rash spots. Arm swelling and scabbed area of inj site, area is sore." The patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash generalised, Viral rash
Clinical narrative: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient with cervical dysplasia, penicillin allergy and allergic reaction to erythromycin who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of Gardasil and on 18-JUN-2007, at 09:00AM she was vaccinated into the right arm with a second dose of Gardasil (lot # 655154/1210U). The nurse reported that patient developed an injection site rash after the second dose of Gardasil. The date the rash appeared was unspecified. The patient sought medical attention for the rash on 30-JUN-2007. The rash at the injection site was diagnosed as viral and not related to the injection. On 08-SEP-2007 the patient sought treatment for another condition and the physician re-evaluated the injection site rash on the right arm. The rash was described as "a hypo-pigmented area 8 centimeters in size with red papules at the periphery." The physician advised the patient not to continue with the third injection. It was reported that the patient would be evaluated on 24-SEP-2007 for the rash. At the time of this report patient had not recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/12/2007. In follow up report the reporter reported that on 29-JUN-2007 at approximately 08:00 AM "Rash on arms, stomach, thigh, back-doesn't itch. Red, pen tip size to small pen cap. Raised, darker spot in middle of Rash spots. Arm swelling and scabbed area of inj site, area is sore." The patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, Erythema nodosum, Infectious mononucleosis
Clinical narrative: This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a physician concerning a 19 year old female patient with gastroesophageal reflux disease and seasonal allergy who in May 2007, was vaccinated IM with a dose of GARDASIL (lot #655124/0069U). Concomitant therapy included hormonal contraceptives (unspecified) and HAVRIX. Patient developed Erythema Nodosum less than a month later of vaccination with GARDASIL. She also developed joint pains. She also had mononucleosis after getting the injection but prior to the rash. The patient's outcome was unknown. Additional information has been requested. In follow up it was reported that patient was treated at the emergency room (ER) on 31-MAY-2007. She recovered from erythema nodosum and mononucleosis but had not recovered from joint pains. She was taking medication for pain and being followed by a rheumatologist. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with hypothyroidism who on 10-SEP-2007 was vaccinated with a third dose of GARDASIL (Lot # 658558/1061U). Concomitant therapy included SYNTHROID, ORTHO-NOVUM, tetracycline. On approximately 10-SEP-2007 the patient developed egg-sized lump at injection site with redness and itchiness. The patient's mother called the office on 11-SEP-2007 to report the egg-sized lump at injection with redness and itchiness. It was recommended for the patient to take BENADRYL and TYLENOL. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 01-AUG-2007 was vaccinated IM with a first 0.58 ml dose of GARDASIL (lot# 658282/0929U). On 01-AUG-2007, the patient developed a purple bruise at the injection site. Subsequently, the patient recovered without requiring treatment. No diagnostic laboratory studies were performed. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Injection site pain, Syncope
Clinical narrative: Initial and follow-up information has been received from a receptionist in a physician's office and a licensed practical nurse (LPN) concerning a female (initially reported as 3 females, later confirmed to be only 1) between the ages of 11 and 13 (initially reported as "teenager age") who was vaccinated with a dose of GARDASIL. Concomitant therapy included "2 other shots the same day" (therapy unspecified). Subsequently the patient fainted when administered the first dose or shortly after and experienced pain at the injection site. Subsequently, the patient recovered later that afternoon. The LPN discussed this with the physician and neither one felt that the faint had anything to do with the GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Pruritus, Rash erythematous, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a licensed practical nurse concerning a 16 year old female student waitress (136 pounds, 63 inches) with allergy to white oak who on 08-JUN-2007 was vaccinated with her first dose of GARDASIL (Lot#657621/0387U, exp. February 2010) in the buttocks by a different physician's office than the reporting physician. There was no concomitant medication. On 16-AUG-2007, the patient was vaccinated with her second dose of GARDASIL (Lot#655849/0263U, exp. 04-AUG-2009) in the right deltoid. "Two weeks after the vaccination," on approximately 30-AUG-2007, the patient developed little white bumps (also described as little red bumps)that come and go, over and over, on her hands, knees, and wrists. The bumps appeared and disappeared 2 to 4 times a day and last about one half an hour. They were also described as hive-like bumps on her knees and elbows that appeared small, flat, round, red and itchy developing on her bony joints. The patient's hive-like bumps on hands, wrists, knees and elbows persisted. On 13-SEP-2007 the patient presented to the office to show the "hives" type red circles, raised and circular areas. No tests were performed. The patient was treated with CLARITIN. As of 18-OCT-2007 the patient was still having symptoms. The patient sought medical attention at the physician office. According to the LPN, there were no definitive connection to the GARDASIL. The LPN also provided information regarding "a couple" patients' experiences with GARDASIL (WAES# 0710USA00228) and "some" patients' experiences with GARDASIL (WAES#0710USA00229). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Fatigue, Infectious mononucleosis
Clinical narrative: Information has been received from a nurse practitioner concerning a 18 year old female who in August 2007, was vaccinated with her first dose of GARDASIL. In August 2007, the patient experienced adenopathy, fatigue, fever, sore throat and elevated liver function tests (LFTs) with an alanine aminotransferase test of 177, aspartate aminotransferase of 124 and alkaline phosphatase test of 290. the patient was diagnosed with mononucleosis. The patient's mononucleosis persisted and her LFTs were still mildly elevated. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Liver function test abnormal, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 18 year old female who in August 2007, was vaccinated with her first dose of GARDASIL. In August 2007, the patient experienced adenopathy, fatigue, fever, sore throat and elevated liver function tests (LFTs) with an alanine aminotransferase test of 177, aspartate aminotransferase of 124 and alkaline phosphatase test of 290. the patient was diagnosed with mononucleosis. The patient's mononucleosis persisted and her LFTs were still mildly elevated. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on approximately 01-SEP-2007 was vaccinated with the first dose of GARDASIL. On approximately 01-SEP-2007 the patient fainted a few minutes after being vaccinated. Subsequently, the patient recovered from fainting the same day as the vaccination. The physician considered the patient's experience to be non-serious. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning two female patients who were vaccinated with GARDASIL. The physician reported that the patients experienced abnormal pap smears after receiving all three doses of GARDASIL. The patient outcomes were not reported. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TTOX
Symptoms: Asthma, Dizziness, Presyncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female with a history of asthma and an allergy to rhinitis, who on 10-SEP-2007 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot # 658100/0525U). Concomitant therapy included vaccination on the same day in the left arm with MENACTRA and tetanus toxoid. It was reported that on 10-SEP-2007 the patient near fainted after vaccination with GARDASIL. The patient sought unspecified medical attention. Subsequently, on 10-SEP-2007, the patient recovered from near fainted. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Follow up information indicated that the patient felt dizzy and light headed about 10 minutes after receiving the vaccine. She did not sit in the office for the recommended 15 minutes after receiving the vaccine. She came back into the office with symptoms and laid down for 10 minutes. Subsequently, on 10-Sep-2007, the patient recovered.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning a female who in August 2007, was vaccinated with GARDASIL. Recently the patient experienced swollen lymph gland. It was unknown whether the patient sought medical attention. The patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 05-SEP-2007 was vaccinated with a third dose of GARDASIL. On 05-SEP-2007, five minutes after the vaccination, the patient fainted. Medical attention was sought. The patient recovered 5 minutes after fainting and left office 15 minutes after recovery. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. After the vaccination the patient fainted. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Contusion, Fall, Head injury, Loss of consciousness
Clinical narrative: Information has been received from an office manager concerning a 19 year old female with no pertinent medical history or no known drug reactions/allergies who on 11-SEP-2007 was vaccinated with GARDASIL (654539/0742U) in the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 11-SEP-2007 the patient passed out, fell off the table and hit her head. The patient was sent to the hospital via ambulance. Medical attention was sought. No further information is available. Follow-up information was received from an office manager. It was reported that the patient fell and was sent to the ER where a head computed axial tomography was performed. The scan was negative and the patient was discharged. The patient had a lump on her head with swelling and bruising. The patient is recovering at this time and has decreased swelling. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Information has been received from an office manager concerning a 19 year old female with no pertinent medical history or no known drug reactions/allergies who on 11-SEP-2007 was vaccinated with GARDASIL (654539/0742U) in the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 11-SEP-2007 the patient passed out, fell off the table and hit her head. The patient was sent to the hospital via ambulance. Medical attention was sought. No further information is available. Follow-up information was received from an office manager. It was reported that the patient fell and was sent to the ER where a head computed axial tomography was performed. The scan was negative and the patient was discharged. The patient had a lump on her head with swelling and bruising. The patient is recovering at this time and has decreased swelling. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 11-JUL-2007 was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA and TETANUS ANTITOXIN USP (manufacturer unknown). On 11-JUL-2007, five minutes after vaccination the patient fainted. Medical attention was sought. The patient was recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: DTAP, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose a GARDASIL. Suspect vaccinations administered on that day included a dose of DTAP and MENACTRA. Subsequently the patient experienced syncope. It was unknown whether medical attention was sought. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL (date of vaccination and lot number not provided). Subsequently, the patient experienced pelvic pain one day after vaccination. Subsequently, the patient recovered from pelvic pain. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure decreased, Confusional state, Disorientation, Dizziness, Heart rate decreased
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 13-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included MENACTRA. The physician reported that on 13-SEP-2007 the patient became lightheaded shortly after receiving her first dose of GARDASIL. It was reported by the physician that the patient's blood was drawn prior to receiving the vaccinations. She became disoriented, and confused. The patient reported that she felt "like her head was spinning and she was going to vomit". The child was kept quiet, observed and given juice. It was reported that her blood pressure dropped from 90/70 to 80/60, pulse slightly dropped from 88 to 76. On the 13SEP-2007 the patient recovered, while in the physician office. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Vertigo
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 13-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included MENACTRA. The physician reported that on 13-SEP-2007 the patient became lightheaded shortly after receiving her first dose of GARDASIL. It was reported by the physician that the patient's blood was drawn prior to receiving the vaccinations. She became disoriented, and confused. The patient reported that she felt "like her head was spinning and she was going to vomit". The child was kept quiet, observed and given juice. It was reported that her blood pressure dropped from 90/70 to 80/60, pulse slightly dropped from 88 to 76. On the 13SEP-2007 the patient recovered, while in the physician office. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning his niece a 14 year old female who in September 2007, was vaccinated with a second dose of GARDASIL. Subsequently the patient experienced flat brown spots all the way down the arm she was vaccinated. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a certified medical assistant concerning a female with no pertinent medical history who in September 2007, "sometime last week was vaccinated IM into the right arm with 0.5 ml of a first dose dose of GARDASIL. There was no concomitant medication. In September 2007 "3- 4 days" after vaccination the patient developed blisters under her right arm. It was reported that the patient called the office to report she developed blisters under her right arm. Subsequently, the patient recovered from the blister under her right arm. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with allergic rhinitis and AMOXIL and a history of reactive airways disease who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL, the patient was vaccinated with the second dose GARDASIL (lot # 658556/1060U) 0.5 ml IM in the left deltoid. On 24-AUG-2007, the experienced pain and tenderness in her left arm. On 11-SEP-2007, the patient sought medical attention (office visit) and at that time she had decreased range of motion, tenderness and pain of the arm. There was no masses and no redness. At the time of reporting, the patient had not recovered. The patient was scheduled to have a MRI. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Fatigue, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse at school, concerning a non-pregnant female teacher in her "early 20's," who had been under a lot of stress, and who on 12-SEP-2007 was vaccinated with the first dose of GARDASIL (lot # not provided). There was no concomitant medication. On 12-SEP-2007, "shortly" after the vaccination, the teacher developed fatigue, and by 6:30 pm, she was so exhausted she had to go to bed. The following morning (13-SEP-2007), the teacher's mother had to shake her to wake her up. In addition, she then experienced pain and achiness in the arm of vaccination, extending up to her shoulder and neck. She visited the school nurse due to her symptoms, and questioned if the stress had anything to do with her fatigue. At the time of this report. The teacher had not recovered from the events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Smear cervix normal
Clinical narrative: Information has been received from a licensed practical nurse, concerning a female patient in her "early 20's" with a prior history of a negative PAP test, who was vaccinated with all 3 doses of GARDASIL (lot # not provided). Following the vaccinations, the patient had a "positive" PAP test. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a positive PAP smear. This was the first time the patient had a PAP test conducted. The outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. The patient had not gotten her period since she received the vaccination and the patient thought that it was because of vaccination. Medical attention was sought. The patient was placed on birth control pills (manufacturer unspecified) to regulate her menstrual cycle. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who 11-SEP-2007 was vaccinated with a 0.5 ml dose of GARDASIL. Concomitant vaccination on the same day included a second dose of Varicella virus vaccine live (MSD). On 12-SEP-2007 the mother of the child called the doctor office stating the child had nausea and was vomiting. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of GARDASIL. The physician reported that the patient experienced, "prolonged injection site pain" that lasted for weeks. On an unspecified date 8 weeks after the first vaccination the patient informed the physician of the prolonged post injection site pain and she was vaccinated in the opposite arm with a second dose of GARDASIL. It was unknown at the time of reporting if the injection site pain reoccurred with the second dose. At the time of the report, the "patient is feeling better." Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing, Heart rate increased
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no pertinent medical history who on 13-SEP-2007 was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot # "1061U"). Concomitant therapy included hormonal contraceptives (unspecified). On 13-SEP-2007 about 10 minutes post vaccination the patient fainted. There were no laboratory or diagnostic tests performed. The patient was in the office. On 13-SEP-2007 the patient recovered. Additional information has been requested.  Follow-up received 10/08/2008. GARDASIL injection in the left deltoid. At apporximately 2:00 pm the patient experienced dizziness, flushing, and a rapid pulse. There was no loss of consciousness. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who in September 2007, was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot # 654741/1208F). Concomitant therapy included MENACTRA. In September 2007, the patient fainted while still in the office and hit forehead. The patient was treated with an ice pack. There were no laboratory or diagnostic tests performed. The patient was seen in the office. Subsequently, the patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 11-SEP-2007 was vaccinated with a second dose of GARDASIL. On 12-SEP-2007, 24 hours after the vaccination, the patient developed rash over her entire body. The rash was described as many red specks, that were more concentrated on her trunk and face. Medical attention was sought. The patient's rash her over entire body persisted. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 17 year old white female student who on 13-JUN-2007 was vaccinated with a first dose GARDASIL. Concomitant therapy included MENACTRA. On 13-JUN-2007 at 9:30 AM the patient experienced syncope. Medical attention was sought. Immediate recovery. Observed for 20 minutes without further adverse events. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Inappropriate schedule of drug administration, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician who is over 26 years old concerning herself who was vaccinated with GARDASIL. She was greater that the label suggests and she vaccinated herself with first and second dose. She normally had a lupus like rash.  Four days after receiving dosages one and two she experienced a butterfly rash (malar rash) and (lupus like rash) it was more intensified after the first and second dose of which she took solumederol upon getting the rash. Again, she normally had this rash of the face but it was intensified through the vaccination of first and second dose. At an unspecified date the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site induration, Injection site pain, Injection site reaction, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who on 15-MAY-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included doxycycline. Subsequently the patient experienced injection site reaction. On 16-Aug-2007 the patient received the second dose and approximately 3 weeks later noticed a hard and tender area at the site injection. Medical attention was not sought. The patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 31-AUG-2007 was vaccinated with a second dose of GARDASIL. One or two days after vaccination, the patient experienced peeling feet. Medical attention was sought. The patient's peeling feet persisted. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug hypersensitivity, Syncope, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 13-NOV-2006 was vaccinated with the first dose of GARDASIL (Lot# 653978/0955F). On 15-JAN-2007 the patient was vaccinated with the second dose of GARDASIL (Lot# 655619/1427F). On 09-JUL-2007 she was vaccinated with the third dose of GARDASIL (Lot# 657622/0388U). The patient experienced vomiting and dizziness for one day following all three doses of GARDASIL. The patient recovered from the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007; 1/7/2008. Information has been received from a registered nurse concerning a 17 year old female patient with an allergy to ROCEPHIN and BIAXIN and a history of pediatric PVC's (premature ventricular contractions) who on 13-NOV-2006 at 15:45, was vaccinated into the left arm with a first dose of GARDASIL vaccine (lot# 653978/0953F). On 15-JAN-2007 at 15:30, the patient was vaccinated into the left arm with the second dose of GARDASIL vaccine (Lot# 655619/1427F). On 09-JUL-2007 at 10:00am, she was vaccinated into the left arm with a third dose of GARDASIL vaccine (Lot# 657622/0388U). The patient experienced vomiting and dizziness for one day following all three doses of GARDASIL vaccine. Follow up information stated on 13-NOV-2006 within 15 minutes after the vaccination, the patient experienced syncope following each injection which seems to get worse each injection and she could be dizzy for several hours. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected. This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a registered nurse concerning a 16 year old female who on 13-NOV-2006, was vaccinated with a first dose of GARDASIL (Lot# 653978/0955F). On 15-JAN-2007 the patient was vaccinated with the second dose of GARDASIL (Lot# 655619/1427F). On 09-JUL-2007, she was vaccinated with the third dose of GARDASIL (Lot# 657622/0388U). The patient experienced vomiting and dizziness for one day following all three doses of GARDASIL. At the time of this report, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 24 year old female with a history of tonsillectomy and adenoidectomy who on 15-AUG-2007 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly in the left deltoid (Lot# 658282/0929U). Concomitant therapy included YASMIN. On 15-AUG-2007, after receiving the vaccination, the patient's arm became swollen and sore and she developed a hard "knot-like" lump at the site of the injection. Her whole arm was sore. The patient sought medical attention by telephone with her physician. The events persisted as of 14-SEP-2007. Additional information has been requested.  In follow-up it was reported that the patient, a 24 year old, female whose reported weight was 130 pounds and whose reported height was 66 inches with no pre-existing allergies, birth defects or medical conditions, with a history if tonsillectomy and adenoidectomy who on 15-AUG-2007 was vaccinated into the left upper arm with the first dose of GARDASIL 0.5 ml intramuscularly in the left deltoid (Lot# 65828/0929U). It was reported that the patient developed swelling, induration, redness and pain at injection site for 4 weeks.  Additional infromation has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 24 year old female with a history of tonsillectomy and adenoidectomy who on 15-AUG-2007 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly in the left deltoid (Lot# 658282/0929U). Concomitant therapy included YASMIN. On 15-AUG-2007, after receiving the vaccination, the patient's arm became swollen and sore and she developed a hard "knot-like" lump at the site of the injection. Her whole arm was sore. The patient sought medical attention by telephone with her physician. The events persisted as of 14-SEP-2007. Additional information has been requested.  In follow-up it was reported that the patient, a 24 year old, female whose reported weight was 130 pounds and whose reported height was 66 inches with no pre-existing allergies, birth defects or medical conditions, with a history if tonsillectomy and adenoidectomy who on 15-AUG-2007 was vaccinated into the left upper arm with the first dose of GARDASIL 0.5 ml intramuscularly in the left deltoid (Lot# 65828/0929U). It was reported that the patient developed swelling, induration, redness and pain at injection site for 4 weeks.  Additional infromation has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site extravasation
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 13-SEP-2007 was vaccinated with GARDASIL 0.5 ml. On 13-SEP-2007, upon leaving the office after the injection, the patient had liquid on her arm. The medication was leaking from her arm. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Induration, Mass, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly in the outer aspect of the right arm with a 0.5 ml second dose of GARDASIL. Subsequently 12 hours post vaccination the patient developed a painful bump on the upper, inner aspect of her right arm. Approximately, 48 hours post vaccination the developed a similar bump on the upper, inner aspect of her left arm. The patient was seen for an office visit. The symptoms have since resolved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Paraesthesia oral, Pruritus, Throat tightness
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2002. Initial and follow up information has been received from a registered nurse concerning a 19 year old female student with no drug reactions/allergies and a history of anorexia (Restricting and binging) and anxiety (panic attack) who 13-SEP-2007 at 14:00 PM was vaccinated with the second dose of GARDASIL 0.5 ml intramuscularly in to left deltoid (Lot# 658560/1062U).Concomitant therapy included ZOLOFT and SEASONALE. On 14-SEP-2007 at approximately 1 am the patient experienced tightening of her throat and itchy lips. The patient was seen at a 24 hour clinic. No labs were performed. She was administered Benadryl and the symptoms resolved at approximately 9 am that day. In follow up it was reported that on 14-SEP-2007 at approximately 1 am the patient experienced tightening of her throat and itchy lips. The patient was seen at a 24 hour clinic. No labs were performed. She was administered Benadryl and the symptoms resolved at approximately 9 am that day. In follow up it was reported that on 14-SEP-2007 at 00:45 AM patient began with tightness in throat and tingling lips, face flushed. She was given IM Benadryl 50 and was observed for 8 hours. She recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been from a nurse practitioner concerning a female who was vaccinated with GARDASIL. Subsequently, she fainted in the office after receiving GARDASIL. The patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Tenderness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 30-JUL-2007 was vaccinated with her first dose of 0.5 ml GARDASIL IM in the right deltoid. On 02-AUG-2007 the patient experienced area of redness and tenderness near her right clavicle. Subsequently, the patient recovered on 09-SEP-2007. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on approximately 10-SEP-2007 was vaccinated with the first dose of GARDASIL IM. The patient passed out in the elevator when she left the office. The patient's fainting lasted for 15-30 seconds. She was brought back to the office and went home after recovery that same day. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 15-JUN-2007 was vaccinated with the first dose of GARDASIL IM in the right upper arm. At that time, she also received MENACTRA in the left upper arm. Subsequently the patient developed red, itchy blisters around injection site of the right upper arm one day after GARDASIL administration. The rash spread to the patient's abdomen and lower back. The patient called the office but no therapy was required. The patient fully recovered. The physician discontinued the remaining GARDASIL. Additional information has been requested. Information has been received from a physician and a medical assistant concerning a 15 year old female with no pertinent medical history and no prior history of drug reactions who, on 15-JUN-2007, was vaccinated with the first dose of GARDASIL (Lot #657006/0188U) intramuscularly (IM) in the right upper arm. At that time, she also received MENACTRA in the left upper arm. On the morning of 14-JUN-2007 (also reported as "the morning after she received the GARDASIL injection"), a rash erupted. The rash was described as "like poison ivy" and began at the right arm injection site, then the other arm and lower body/abdomen. The rash was itchy and lasted several days (5-7 days). On approximately 21-JUN-2007, the patient recovered from the rash. The physician discontinued the remaining GARDASIL. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant (CMA) /healthcare student concerning a female with no pertinent medical history and no prior drug reactions who on 06-SEP-2007 was vaccinated subcutaneously in the right upper arm with a first dose of GARDASIL. There was no concomitant medication. The CMA reported that the patient was recently vaccinated with GARDASIL via subcutaneous (SQ) route. The patient also developed mild redness and warmth at injection site. The patient sought medical attention in the form of an office visit. No other symptoms were noted. Subsequently, the patient recovered from mild redness and warmth at injection site. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant (CMA)/healthcare student concerning a 23 year old female registered nurse with no pertinent medical history and no prior drug reactions, who on 06-SEP-2007 at 11:00, was vaccinated subcutaneously in the right upper arm with a first dose of GARDASIL vaccine (Lot # 1061). There was no concomitant medication. There were no inllnesses at the time of the vaccination. On 06-SEP-2007 the patient developed redness, warmth, and swelling at the injection site. The patient sought medical attention in the form of an office visit. No other symptoms were noted. The patient recovered on an unspecified date a few days later (also reported as recovered immediately). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on approximately 24-AUG-2007 was vaccinated with a dose GARDASIL and fainted immediately thereafter. Subsequently, the patient recovered in the office and was monitored by the nursing staff. No other symptoms or treatment reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was between her second and third vaccination with GARDASIL, 0.5ml injection. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 14-AUG-2007 the patient's pap smear was positive for high risk. The patient's pap smear was positive for high risk persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician a female patient who was vaccinated IM with a first dose of GARDASIL. Subsequently the patient fainted. The patient recovered. Patient received her second injection on an unknown day and had no complications. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a female who on approximately 17-AUG-2007, was vaccinated with a first dose of GARDASIL. On approximately 17-AUG- 2007 the patient experienced pain in her arm. There were no obvious bruise of exterior sighting of a problem; however she was unable to lay on her arm. At the time of the reporting the pain in her perisited. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on 14-AUG-2007 was vaccinated with a first dose of GARDASIL. On 18-AUG-2007 4 days later, the patient experienced "welts on face, arms, legs". The physician discontinued the plan for future injections. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Menorrhagia, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 18 year old sister with diabetes controlled by a diet and seasonal allergies who was vaccinated "about 2 1/2 months ago" with a 0.5 ml second dose of GARDASIL. There was no concomitant medication. Approximately on 03-SEP-2007 the patient was experiencing as extra heavy menstrual flow. The office did a Papanicolaou test. She was notified to come into the office because the pap smear indicated a positive human papillomavirus test. At the time of the report the patient had not recovered. Additional information has been requested.