chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Cold sweat, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on approximately 02-JUL-2007 was vaccinated with a dose of Gardasil (lot3 656050/0245U) 0.5mL IM. Concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL). On approximately 03-JUL-2007 "within 24 hours" the patient experienced fever, chills and cold sweats. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on approximately 02-JUL-2007 (also reported as 28-JUN-2007) was vaccinated with a first dose of GARDASIL (lot# 656050/0245U) 0.5mL IM in the deltoid. Concomitant medication included ADDERALL. On approximately 03-JUL-2007 (also reported as 29-JUN-2007) "within 24 hours" after the injection the patient developed a fever of 101, chills, body aches, nausea and cold sweats. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. The patient recovered on 30-JUN-2007 in "48 hours". Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Hyperhidrosis, Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 36 year old white female with no illness at time of vaccination and no medical history who on 18-JUN-2007 was vaccinated in the right deltoid with a dose of Gardasil (lot # 0210U). Concomitant therapy included "trilevelis". On 19-JUN-2007 the patient experienced mild headache post vaccination. That evening patient woke up "shaking/like chills" which woke her up from deep sleep. The patient was "sweating". Symptoms resolved after approximately 4-5 hours. Patient also had right arm swelling at injection site. It was reported that the patient recovered 24 hours after vaccination. No further information is available.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 36 year old white female with no illness at time of vaccination and no medical history who on 18-JUN-2007 was vaccinated in the right deltoid with a dose of Gardasil (lot # 0210U). Concomitant therapy included "trilevelis". On 19-JUN-2007 the patient experienced mild headache post vaccination. That evening patient woke up "shaking/like chills" which woke her up from deep sleep. The patient was "sweating". Symptoms resolved after approximately 4-5 hours. Patient also had right arm swelling at injection site. It was reported that the patient recovered 24 hours after vaccination. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown) injection. Immediately following the injection the patient experienced nausea and vomiting. Medical attention was sought. At the time reporting the patient recovered from the nausea and vomiting shortly afterwards. No additional information was provided. Additional information has been requested. This is in nfollow-up to report (s) previously submittedon 8/14/2007. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Muscle spasms, Nausea
Clinical narrative: Information has been received from a medical assistant concerning herself (demographics not provided). On 18-MAY-2007 she was vaccinated intramuscularly with the first dose of Gardasil (Lot# no provided). On 18-JUN-2007 the patient was vaccinated intramuscularly with the second dose of Gardasil (Lot# not provided). The patient reported that since the second vaccination on 18-JUN-2007 she has experienced intermittent nausea and cramping. The patient has no sought medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with her second dose of Gardasil and developed hives all over her body. The hives were not concentrated to one specific area of the body. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Abdominal pain, Blood pressure decreased, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female with irritable bowel syndrome and with no history of drug reactions/allergies, who on 06-JUL-2007 was vaccinated with the first dose of Gardasil (0.5 ml). Concomitant vaccination on 06-JUL-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and MENACTRA. Other concomitant therapy included PRILOSEC. It was reported that within a few minutes the patient experienced sharp abdominal pain, and her blood pressure dropped from 100/60 to 90/65 and she felt faint. The patient remained in the office and lied down. It was reported that she felt better. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning approximately 3 females (age not reported) on unspecified dates were vaccinated with a second dose of Gardasil. The nurse reported that the second dose hurt more after the injection than the first or third dose of Gardasil. Medical attention was sought. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil. Subsequently, one day post vaccination, the patient developed a red, slightly raised area around the injection site. Unspecified medical attention was sought. It was reported that the patient improved after two days are was doing fine. Additional information has been requested. This is one of two reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oral mucosal blistering
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 24-MAY-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot # 655620/0171U). It was reported that about a day or two after receiving the vaccination, on approximately 25-MAY-2007, the patient developed blister formations around her mouth. Unspecified medical attention was sought. Subsequently, the patient recovered on an unspecified date. The physician was unsure whether or not therapy would be discontinued. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a "teenaged" female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included MENACTRA. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patients also developed hives after vaccination with the first dose of Gardasil (lot # not provided) (WAES: 0707USA00837, 0707USA01121, and 0707USA01122). Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a physician , via a company representative, concerning a "teenaged" female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included MENACTRA. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patients also developed hives after vaccination with the first dose of Gardasil (lot # not provided (WAES: 0707USA00837, 0707USA01120, and 0707USA01122)). Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a "teenaged" female patient, who on unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included MENACTRA. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patient's also developed hives after vaccination with the first dose of Gardasil (lot # not provided (WAES 0707USA00837, 0707USA01120, and 0707USA01121). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of Gardasil (lot # not reported). Subsequently the "patient experienced syncope after vaccination." The patient sought unspecified medical attention. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female student with hyperhydrosis and acne who on 03-JUL-2007 was vaccinated in to right arm at 10:30 AM with a first dose of Gardasil lot #658094/0524U). On 03-JUL-2007, a second dose of concomitant suspect therapy included Varivax, lot # 657618/0602U, was given in to left arm at 10:30 AM. Other concomitant therapy included MENACTRA lot # 42323AA. The physician reported that "The patient fainted after receiving first dose of GARDASIL. It was reported that the patient did not eat anything that morning". In follow up it was reported that patient fainted about 10 minutes after the injection, she was caught by the nurse and layed down with legs up. On 03-JUL-2007 he patient recovered with no problem. Additional information has been requested.  Additional infromation is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown) 0.5mL injection. The physician reported that the patient passed out after receiving the first dose of Gardasil. Medical attention was sought. At the time of reporting on an unspecified date the patient had recovered. The patient is going to receive her second injection. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007.  Follow-up information was received from a healthcare worker.  On 03-JUL-2007 the patient recovered from passing out and near syncope.  The patient recovered with rest.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Feeling hot
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 20 year old female patient with no medical history or allergies who on 24-JUL-2007, was vaccinated IM into the right deltoid with a first 0.5 ml dose of Gardasil (Lot# 656371/0181U). There was no concomitant medication. Right after her first dose of the vaccine the patient started to feel really warm and dizzy. It was reported that a nurse in the office applied cold cloths to her face and neck until she felt better, which was about 15 minutes after the onset. No laboratory diagnostic studies were performed. The patient recovered and walked out of the office. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 20 year old female patient with no medical history or allergies who on 24-JUL-2007, was vaccinated IM into the right deltoid with a first 0.5 ml dose of Gardasil (Lot# 656371/0181U). There was no concomitant medication. Right after her first dose of the vaccine the patient started to feel really warm and dizzy. It was reported that a nurse in the office applied cold cloths to her face and neck until she felt better, which was about 15 minutes after the onset. No laboratory diagnostic studies were performed. The patient recovered and walked out of the office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot# unknown) injection. The nurse practitioner reported that on an unspecified date the patient developed total body hives after receiving a dose of Gardasil. Medical attention was sought. The patient was put on a high dose of steroids (unspecified therapy) to decrease the inflammation of the hives. The outcome of the hives was not reported. No further adverse event information. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Presyncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 20 year old female with allergy to pencillin, amoxicillin and sulfa, who on 08-MAY-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included unspecified "birth control" therapy. On 06-JUL-2007 the patient was vaccinated intramuscularly with a second dose of GARDASIL. "Almost immediately post vaccination the patient experienced extreme nausea, dizziness, and vomiting. Physician reported that the patient almost fainted twice. The patient was retained in the physician's office for about three hours until the symptoms subsided. There was no product quality complaint. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of "aspirin-type reaction" who on 05-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil (lot #657736/0389U). On 05-JUL-2007 the patient experienced fever and flu like symptoms. On an unspecified date the patient recovered from fever and flu like symptoms. There was no product quality complaint. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history and no known drug reactions/allergies who in January 2007, was vaccinated with a dose of 0.5 mL, IM, of  Gardasil. Thee was no concomitant medication. In January 2007, the day after receiving her first vaccine, the patient experienced nausea and vomiting. In March 2007, the patient received her second vaccination with a dose, 0.5 mL IM, of Gardasil. Subsequently, the day after the vaccination, the patient experienced nausea and vomiting. The physician noted the vomiting lasted for less than 1w hours both times. Subsequently, the patient recovered from the nausea and vomiting. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mood swings, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a female patient who was vaccinated with the first doses of Gardasil. Subsequently, the patient experienced incredible mood swings. Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced incredible mood swings. Subsequently, the patient recovered. On 07-JUL-2007, the patient was vaccinated with the third dose of Gardasil. At the time of the report, the physician was waiting to hear from the patient as to whether she had the same symptoms. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Condition aggravated, Echocardiogram normal, Electrocardiogram normal, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of fainting/syncope with every vaccination at the onset of age 4 to 5 years old, who on 29-JUN-2007 was vaccinated intramuscularly with the second dose of Gardasil (lot # 657621/0387U1). Concomitant vaccination on 29-JUN-2007 included the first dose of MENACTRA (lot # U2227AA) intramuscularly. There was illness at the time of vaccination. The patient's father also had a history of syncope during injections. It was reported that following the vaccinations, the patient passed out (unconscious) times two minutes. The patient "turned pale, the passed out, fainted". Her vital signs were good during the episode (RR=22, HR=78, oxygen saturation=98% on room air). The patient was allowed to rest with her legs elevated in an air conditioned room times 30-45 minutes. It was reported that a previous physician had sent the patient to a specialist and that an echocardiogram and EKG were within normal range. The patient subsquently recovered then went home.No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of fainting/syncope with every vaccination at the onset of age 4 to 5 years old, who on 29-JUN-2007 was vaccinated intramuscularly with the second dose of Gardasil (lot # 657621/0387U1). Concomitant vaccination on 29-JUN-2007 included the first dose of MENACTRA (lot # U2227AA) intramuscularly. There was illness at the time of vaccination. The patient's father also had a history of syncope during injections. It was reported that following the vaccinations, the patient passed out (unconscious) times two minutes. The patient "turned pale, the passed out, fainted". Her vital signs were good during the episode (RR=22, HR=78, oxygen saturation=98% on room air). The patient was allowed to rest with her legs elevated in an air conditioned room times 30-45 minutes. It was reported that a previous physician had sent the patient to a specialist and that an echocardiogram and EKG were within normal range. The patient subsquently recovered then went home.No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history and no drug allergies, who on 09-JUL-2007 in the evening was vaccinated intramuscularly with a first dose of Gardasil (Lot# 655617/1447P). There were no illness at the time of the vaccination. On 10-JUL-2007 the patient developed a nose bleed. The patient recovered on 10-JUL-2007. There were no additional reports of the bleeding continuing. It was noted thathe patient went to vollyball practice right after receiving the vaccination. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning a 17 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil. Thirty days post vaccination the patient had an abnormal Pap test and was positive for high risk HPV with a DNA HPV test. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a secretary in a physician's office concerning her daughter who on an unspecified date was vaccinated with a dose of Gardasil. On an unspecified date the patient developed a fever. Subsequently, the patient recovered from the fever. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with no drug allergies and no medical history, who on 07-JUN-2007 was vaccinated intramuscularly with a 0.54mL dose of Gardasil (Lot# 0211U) and on 90-JUL-2007 was vaccinated with a second dose. There was no concomitant medications. On 10-JUL-2007 the patient developed an egg size swollen area at the injection site. NO redness or fever was noted. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a female patient in her early 20's who in May 2007, was vaccinated IM with a first dose of Gardasil. A week later, the patient developed a rash. The patient went to see a dermatologist. It was reported that the rash was still not resolved. It was reported that the patient will not receive anymore doses of Gardasil. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history who on 10-JUL-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included MENACTRA and ADACEL. On 10-jUL-2007, after receiving Gardasil vaccination, the patient became pale and began to pass out. It was reported that the physician did not wait the recommended 15 minutes before allowing the patient to stand up and the office staff caught her before she passed out and laid her down on the table in the exam room. The patient recovered on 10-JUL-2007. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle haemorrhage, Muscle swelling, Myalgia
Clinical narrative: Information has been received from a nurse concerning her 14 year old daughter who "months ago" was vaccinated with a dose of Gardasil. Approximately two weeks after vaccination, the patient experienced a "painful lump in her deltoid muscle". The physician reported that it "appears to be a hematoma". Unspecified medical attention was sought. The patient's symptoms resolved after a few weeks. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Mouth ulceration, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no known allergies who in May 2007 was vaccinated wit a first dose of Gardasil. Concomitant therapy included clonidine, EISPERDAL, LAMICTAL, BUSPAR, trazodone, and benztropine. Within 24 hours of receiving the vaccine, the patient developed a case of hives. Within five days, the case of hives became severe with lesions in her mouth and prednisone was started. Within a couple of days after completion of the series of prednisone, her daughter developed hives. She periodically broke out with hives since the initial experience. ZYRTEC was started and initially controlled the symptoms. ZYRTEC ceased controlling the symptoms completely. The reporter indicated that a skin test would be conducted. The patient's outcome was unknown. Additional expected
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female with a penicillin allergy and no pertinent medical history who on 15-MAY-2007 was vaccinated with a first dose of Gardasil (lot# 653736/0014U) 0.5mL IM. Concomitant therapy included NUVARING. On 15-MAY-2007 the patient developed a fever of 101.6 degrees F shortly after the dose was administered. Medical attention was not sought. The fever subsided by the time the patient woke up the following morning on 16-MAY-2007. At the time of reporting the patient recovered. No further information is available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Dizziness, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with a history of depression who on 03-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U) 0.5mL IM. Concomitant therapy included LEXAPRO. On 03-JUL-2007 the patient experienced lightheadedness immediately after vaccination with Gardasil. the patient then fainted and hit her head. She subsequently complained of double vision. Medical attention was sought. The patient was transported to the local emergency room by ambulance. The nurse reported that she is unaware of the details of the evaluation in the emergency room but the patient was not admitted to the hospital. At the time of reporting it is unknown if the patient has recovered. No further information is available. Additional information has been requested.  Additional information was received. On an unspecified date the patient recovered and was discharged from the emergency room. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown). ON an unspecified date the patient was vaccinated with a second dose of Gardasil (lot# unknown). The nurse reported that the patient had an injection site reaction after receiving the second dose. She developed a "lump" the size of a baseball at the injection site. The patient had no reaction on her first vaccination. No further information is available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Mouth ulceration, Oral herpes, Pyrexia, Respiratory disorder
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with two doses of Gardasil at two different times. Concomitant therapy included MENACTRA. The patient had experienced two similar symptoms after each vaccination. Post dose one, the patient experienced fever for 3-4 days and joint aches. Post dose two, the patient experienced an intermittent fever for two months as well as ulcerations or blisters in her mouth. The physician had diagnosed the blisters as a form of herpes. After the second dose the patient had experienced significant respiratory issues. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mononucleosis syndrome
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on 05-JUN-2007 was vaccinated with a dose of Gardasil. On 12-JUN-2007 one week after the injection the patient developed mononucleosis. Unspecified medical attention was sought by the patient. The outcome was unknown. 2/19/2010 In followup information the pharmacist called back on 01-OCT-2007 and stated that the physician determined that the mononucleosis was not associated with th GARDISIL vaccine. No further information reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypokinesia
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Additional and follow up information has been received from a medical assistant concerning a 15 year old female who on 11-JUN-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot#656371/0181U). On 11-JUN-2007, post vaccination while still in the physician's office the patient experienced "numbing of her entire arm and she couldn't move it". The medical assistant reported that after the patient waited approximately 15 minutes in the office she was fine". Follow-up information received stated that the patient found the injection site very painful. The patient was considered to have recovered from the event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a "16 or 17" year old female who on an unknown date in May 2007, was vaccinated intramuscularly with Gardasil (Lot# not provided). Subsequently, post vaccination, on an unspecified date in May 2007, the patient experienced abdominal pain. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the abdominal pain. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a female consumer who on an unknown date was vaccinated with a dose of Gardasil. It was reported that the consumer missed her third dose of vaccine, which she was suppose to get on 22-JUN-2007, because she was taking antibiotics for an unknown reason. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received concerning a 22 year old female with no medical history or allergies who on 09-APR-2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 09-MAY-2007, a month after receiving the vaccine, the patient developed small clear blisters on top of her hands. NO medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. . In follow-up it was reported by the patient's mother, concerning her white, 22 year old, student, daughter with no illness at the time of vaccination, whose reported weight was 170 pounds and whose reported height was 71 inches, who on 09-APR-2007, was vaccinated into the left deltoid muscle with the first 0.5ml dose of Gardisil (lot # 656051/0244U). It was reported that on 11-APR-2007, the patient's mother noticed small blister-like pimples on the top of the patient's hand. On 16-APR-2007, the patient recovered.This is one of two reports from the same source.Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Facial palsy, Facial paresis
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female with candidal vaginitis at the time of vaccination who on 26-APR-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (lot # 656050/0245U). On 15-MAY-2007 the patient noted weakness on right side of face and was diagnosed with Bell's palsy after receiving the first dose. The patient was treated expectantly, and no medications were given. There were no laboratory or diagnostic tests performed. Medical attention was sought. At the time of reporting the patient has recovered. On 29-MAY-2007 the patient recovered fully. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL third dose of Gardasil. Subsequently, five days after receiving the vaccination the patient experienced "nausea, vomiting, and fever (flu like symptoms)". The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 26 year old female patient who on 10-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # 658490/0802U). On 10-JUL-2007, within ten minutes of the vaccination, the patient fainted. Unspecified medical attention was sought. On 10-JUL-2007, the patient recovered. This report is one of two reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Mydriasis, Pallor, Syncope
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 11-JUL-2007 at 11:00, was vaccinated IM into the right buttock with a first 0.5ml of Gardasil (Lot # 657005/0314U). There was no concomitant medication. On 11-JUL-2007 the patient experienced dilated pupils and she turned white. The patient fainted for approximately 30 seconds. A minute after being conscious, she passed out again but for a shorter period of time. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. On 11-JUL-2007, the patient recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: information has been received from a nurse practitioner concerning a 13 year old female who was vaccinated with Gardasil. Subsequently the patient fainted after the vaccination. Subsequently the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient became dizzy one week later. The patient received her second dose and became dizzy one week later again.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient experienced rash. The physician thought it might be an allergic reaction. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information ahs been received from a nurse concerning a female with no prior history of drug reactions, who was vaccinated intramuscularly with the first dose of Gardasil. On approximately 09-JUL-2007 (also reported as "last 2 days"), immediately after the injection of Gardasil, the patient fainted. Subsequently, the patient recovered from the fainting. Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report. Additional information will be provided, if available. The same source provided information on another patient, WAES #0707USA05068. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a nurse concerning a female between the ages of 13 to 16 years old with no prior history of drug reactions, who was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 654741/1208F). On approximately 09-JUL-2007 (also reported as "last 2 days"), immediately after the injection of GARDASIL, the patient fainted. Subsequently, the patient recovered from the fainting. The same source provided information on another patient, WAES #0707USA05068 and WAES# 0709USA00163. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 23 year old female with hypertension and allergies who on 04-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included TOPROL XL TABLETS and ALLEGRA. On 29-JUN-2007 the laboratory data revealed elevated liver enzymes tests. The serum alanine aminotransferase (ALT) test reported 289 and serum aspartate aminotransferase (AST) test reported 102 (in August 2006 the ALT/AST tests were both reported to be in the normal range). Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted after the vaccine was administered. The patient was either sitting or standing when the vaccine was administered. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is 1 of three reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female with sulfonamide, (Omnicef), (Bactrim), and (Levaquin) allergies, who on 11-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 657868/0523U). There was no concomitant medication. Subsequently, the patient had syncope after receiving the vaccination. She lot consciousness for 15 to 20 seconds while standing in the waiting room. A nurse was able to hold her just prior to "black out." The patient's blood pressure was normal. She was kept in the office for 30 minutes for observation and then released. No laboratory diagnostics were performed. The patient recovered on 11-JUL-2007. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced syncope immediately after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient who on 13-JUN-2007, was vaccinated high into the shoulder with a third dose of Gardasil. Right after the vaccination, the patient's shoulder went numb. It was reported that the pain in her shoulder has been intermittent since she received the vaccine. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Dizziness
Clinical narrative: Initial and follow up information has been received from a healthcare professional, concerning a 25 year old female patient, who on 11-JUL-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5ml, of Gardasil (Lot #658222/0927U). Concomitant therapy included LOESTRIN. On 11-JUL-2007, 10 to 15 minutes after the vaccination, she felt dizzy and lightheaded, and also seemed to be confused. She was observed in the physician's office for 45 minutes, examined by the nurse practitioner, and then sent home as she stated she "felt fine." On 12-JUL-2007, the patient called in the morning and complained of dizziness and lightheadedness when she arose. She was referred to the emergency room for follow up. At the time of this report, the patient had not returned to the office, and the outcome of dizziness and lightheadedness was unknown. The reporter clarified that the events of dizziness, lightheadedness and seemed confused were considered to be non-serious events. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a medical assistant (MA), concerning a 25 year old female patient, with no known drug allergies, who on 11-JUL-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5ml, of GARDASIL (Lot #658222/0927U). Concomitant therapy included LOESTRIN. On 11-JUL-2007, 10 to 15 minutes after the vaccination, she felt dizzy and lightheaded, and also seemed to be confused. She was observed in the physician's office for 45 minutes, examined by the nurse practitioner, and then went home as she stated she "felt fine". On 12-JUL-2007, the patient called in the morning and complained of dizziness and lightheadedness when she arose. She was referred to the emergency room for follow up if the symptoms continued, however the MA confirmed that the patient had recovered on 12-JUL-2007, 20 minutes after she woke up. The reporter clarified that the events of dizziness, lightheadedness and seemed confused were considered to be non-serious events. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Appendicitis
Clinical narrative: Information has been received from a physician's assistant (PA), via a company representative, regarding a 17 year old female patient, who "months ago" was vaccinated with the first dose of Gardasil (Lot # not provided). The day following the vaccination, she developed appendicitis and was hospitalized (dates and duration not reported). At the time of this report, the patient was recovering from the event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Blindness, Blood pressure decreased, Deafness, Feeling abnormal
Clinical narrative: Initial and follow up information has been received from a physician's assistant (PA), concerning a 19 year old female, patient, with no known drug allergies and a fear of needles, who was vaccinated (date unspecified) with the first dose of Gardasil without any complications, and on 09-JUL-2007, at 10:00am, was vaccinated IM in the right deltoid, with the second dose of Gardasil (Lot # 0469U). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). There was no illness at the time of vaccination. On 09-JUL-2007, immediately after receiving the second dose, she did not respond, described as, the patient couldn't see, couldn't hear, and couldn't talk. When she regained her ability to speak, she told the physician she felt "spaced out," and then went into a blank stare; she was also sweating and shaking. The patient's blood pressure was reported as 80/40mmHg, and then also reported to be "normal" (value not provided) during the events; blood glucose was 115 (units not specified). The physician applied cold compress to the patient's head, and her symptoms subsided "within one minute". She was then asked to lie on the exam table for a few minutes; after 10-15 minutes she felt better and left the office. The PA reported it was not determined if the patient will receive the third dose of Gardasil. Follow up information from the PA indicated that the patient's boyfriend accompanied her to the vaccination, and stated that the patient became nervous and "worked up" and had previous similar reactions when she received a vaccination, or had to give blood. The PA felt that the events were not related to therapy with Gardasil, and were considered to be non-serious. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Initial and follow up information has been received from a physician's assistant (PA), concerning a 19 year old female, patient, with no known drug allergies and a fear of needles, who was vaccinated (date unspecified) with the first dose of Gardasil without any complications, and on 09-JUL-2007, at 10:00am, was vaccinated IM in the right deltoid, with the second dose of Gardasil (Lot # 0469U). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). There was no illness at the time of vaccination. On 09-JUL-2007, immediately after receiving the second dose, she did not respond, described as, the patient couldn't see, couldn't hear, and couldn't talk. When she regained her ability to speak, she told the physician she felt "spaced out," and then went into a blank stare; she was also sweating and shaking. The patient's blood pressure was reported as 80/40mmHg, and then also reported to be "normal" (value not provided) during the events; blood glucose was 115 (units not specified). The physician applied cold compress to the patient's head, and her symptoms subsided "within one minute". She was then asked to lie on the exam table for a few minutes; after 10-15 minutes she felt better and left the office. The PA reported it was not determined if the patient will receive the third dose of Gardasil. Follow up information from the PA indicated that the patient's boyfriend accompanied her to the vaccination, and stated that the patient became nervous and "worked up" and had previous similar reactions when she received a vaccination, or had to give blood. The PA felt that the events were not related to therapy with Gardasil, and were considered to be non-serious. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with Gardasil (lot # unknown) 0.5mL injection and developed a rash. Medical attention was sought. At the time of reporting it was unknown if the patient has recovered. One other patient also experienced a rash. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. The same day the patient received the vaccination, the patient experienced dizziness and fainted. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.