chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Blood thyroid stimulating hormone normal, Clumsiness, Dizziness, Full blood count normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient who on 07-JAN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) route intramuscular (lot# 654539/0890F), on 12-MAR-2008, was vaccinated with the second dose of GARDASIL vaccine (yeast) route intramuscular (lot# 655604/0052X). Concomitant therapy included hormonal contraceptives (unspecified). On 21-APR-2008, the patient experienced dizziness, lightheadedness and clumsiness. She had blood work for a Complete Blood Count, Thyroid and glucose, which were all normal. On 23-JUL-2008, the patient called the office and stated her symptoms were continuing. She was referred to an otolaryngologist and a neurologist. The patient sought medical attention in the office. Additional information has been requested.  9/30/08 Reviewed PCP medical records of 3/12-9/23/08. FINAL DX: none provided Records reveal patient experienced vaginitis on 3/12/08.  Dizziness 7/23 & referred to ENT & Neuro.  9/23/08 doing well w/occasional dizziness.  Office does not have ENT/Neuro consult contact info.  Unable to reach patient or parent despite multiple attempts.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with no pertinent medical history who on 23-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 10-OCT-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). On 18-FEB-2008 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 25-JUN-2008 the patient experienced alopecia. At the time of this report, the patient's alopecia persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea decreased
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast) and fainted. It was mentioned that on 23-JUL-2008, after the second dose of GARDASIL vaccine (yeast), injection route, the patient faint as well. All boxes refer to second dose. The patient sought medical attention. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up information was received in the form of medical records. It was reported that the patient was a 16 year old female with a history of migraines and no known drug allergies, who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659182/1757U), IM into the deltoid. Approximately 5-10 seconds after getting the shot, the patient passed out. The office staff kept her in the office for a while but it took her 1-1/2 hours to recover sufficiently so that she could sit up and then ambulate. She was advised to go to the emergency department for further evaluation and care. This had not happened to patient before. It was reported that the day of vaccination the patient had had a bowl of cereal. She had not had anything else to eat but she did drink a large sized soft drink. The patient had not had any recent weight loss. In the emergency room on 26-JUN-2008 the patient had an EKG which showed normal sinus rhythm at 92 beats per minute with slight sinus arrhythmia, rightward axis. No other abnormalities were reported. The white count was 10.100, hemoglobin 13.6, platelet count 370.00. Normal red cell indices. White cell differential showed 75. polys, no bands, 19 lymphs, 5 monocytes, 1 eosinophil, 1 basophil. Urinalysis showed no significant abnormalities. Sodium 138, potassium 3.8, chloride 101, CO2 was 28, BUN 6, creatinine 0.6, glucose 82, calcium 9.3. Urine pregnancy test was negative. While in the emergency room, the patient had pulse and blood pressure orthostatics done with slight change from supine to standing. She was given 1 L of normal saline and her orthostatic improved. It was reporter's strong opinion this was not an allergic reaction but autonomic system dysfunction with slow reset. The clinical impression was vasovagal syncope. The patient was discharged to home from the emergency room the same day. Additional information has been requested. All medical records will be provided upon request.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Haematocrit normal, Haemoglobin normal, Laboratory test normal, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast) and fainted. It was mentioned that on 23-JUL-2008, after the second dose of GARDASIL vaccine (yeast), injection route, the patient faint as well. All boxes refer to second dose. The patient sought medical attention. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up information was received in the form of medical records. It was reported that the patient was a 16 year old female with a history of migraines and no known drug allergies, who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659182/1757U), IM into the deltoid. Approximately 5-10 seconds after getting the shot, the patient passed out. The office staff kept her in the office for a while but it took her 1-1/2 hours to recover sufficiently so that she could sit up and then ambulate. She was advised to go to the emergency department for further evaluation and care. This had not happened to patient before. It was reported that the day of vaccination the patient had had a bowl of cereal. She had not had anything else to eat but she did drink a large sized soft drink. The patient had not had any recent weight loss. In the emergency room on 26-JUN-2008 the patient had an EKG which showed normal sinus rhythm at 92 beats per minute with slight sinus arrhythmia, rightward axis. No other abnormalities were reported. The white count was 10.100, hemoglobin 13.6, platelet count 370.00. Normal red cell indices. White cell differential showed 75. polys, no bands, 19 lymphs, 5 monocytes, 1 eosinophil, 1 basophil. Urinalysis showed no significant abnormalities. Sodium 138, potassium 3.8, chloride 101, CO2 was 28, BUN 6, creatinine 0.6, glucose 82, calcium 9.3. Urine pregnancy test was negative. While in the emergency room, the patient had pulse and blood pressure orthostatics done with slight change from supine to standing. She was given 1 L of normal saline and her orthostatic improved. It was reporter's strong opinion this was not an allergic reaction but autonomic system dysfunction with slow reset. The clinical impression was vasovagal syncope. The patient was discharged to home from the emergency room the same day. Additional information has been requested. All medical records will be provided upon request.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test negative, Sinus arrhythmia, Syncope, Syncope
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast) and fainted. It was mentioned that on 23-JUL-2008, after the second dose of GARDASIL vaccine (yeast), injection route, the patient faint as well. All boxes refer to second dose. The patient sought medical attention. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up information was received in the form of medical records. It was reported that the patient was a 16 year old female with a history of migraines and no known drug allergies, who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659182/1757U), IM into the deltoid. Approximately 5-10 seconds after getting the shot, the patient passed out. The office staff kept her in the office for a while but it took her 1-1/2 hours to recover sufficiently so that she could sit up and then ambulate. She was advised to go to the emergency department for further evaluation and care. This had not happened to patient before. It was reported that the day of vaccination the patient had had a bowl of cereal. She had not had anything else to eat but she did drink a large sized soft drink. The patient had not had any recent weight loss. In the emergency room on 26-JUN-2008 the patient had an EKG which showed normal sinus rhythm at 92 beats per minute with slight sinus arrhythmia, rightward axis. No other abnormalities were reported. The white count was 10.100, hemoglobin 13.6, platelet count 370.00. Normal red cell indices. White cell differential showed 75. polys, no bands, 19 lymphs, 5 monocytes, 1 eosinophil, 1 basophil. Urinalysis showed no significant abnormalities. Sodium 138, potassium 3.8, chloride 101, CO2 was 28, BUN 6, creatinine 0.6, glucose 82, calcium 9.3. Urine pregnancy test was negative. While in the emergency room, the patient had pulse and blood pressure orthostatics done with slight change from supine to standing. She was given 1 L of normal saline and her orthostatic improved. It was reporter's strong opinion this was not an allergic reaction but autonomic system dysfunction with slow reset. The clinical impression was vasovagal syncope. The patient was discharged to home from the emergency room the same day. Additional information has been requested. All medical records will be provided upon request.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with GARDASIL vaccine (yeast) 0.5 mL, intramuscular. The nurse reported that she heard that the patient developed some injection site swelling after vaccination with GARDASIL vaccine (yeast). It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Condition aggravated, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no known drug allergies and no pertinent medical history, who on 30-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 mL. On 31-JUL-2007, she received the second dose of GARDASIL vaccine (yeast) 0.5 mL. On 01-DEC-2007, she received the third dose of GARDASIL vaccine (yeast) 0.5 mL. The nurse reported that the patient developed numbness on her right arm and right leg after receiving the vaccinations. The numbness got worse each time she had the vaccinations. She also complained of headaches, so she took some ibuprofen (MOTRIN). The patient saw the physician. Labs diagnostics studies included computerized axial tomography scan and magnetic resonance imaging (MRI), with no date or information reported about the results. At time of reporting, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no known drug allergies and no pertinent medical history, who on 30-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 mL. On 31-JUL-2007, she received the second dose of GARDASIL vaccine (yeast) 0.5 mL. On 01-DEC-2007, she received the third dose of GARDASIL vaccine (yeast) 0.5 mL. The nurse reported that the patient developed numbness on her right arm and right leg after receiving the vaccinations. The numbness got worse each time she had the vaccinations. She also complained of headaches, so she took some ibuprofen (MOTRIN). The patient saw the physician. Labs diagnostics studies included computerized axial tomography scan and magnetic resonance imaging (MRI), with no date or information reported about the results. At time of reporting, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Gait disturbance, Lymphadenopathy, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning an 18 year old female no known allergies or pertinent medical history who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The physician reported that the patient was given GARDASIL vaccine (yeast) in the hip and later developed pain in her right leg. Patient also had difficulty walking and thought she had an enlarged lymph node. The patient sought unspecified medical attention. No lab diagnostics were performed. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s)  previously submitted on 08/14/2008. Information has been received from a physician concerning a 18 year old female , no known allergies or pertinent medicaledical history who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL (lot# 659655/1486U). There was no concomitant meidcation The physician reported that the patient was given GARDASIL vaccine(yeast in the hip and leter developed pain in her right hip and leg. The patient stated that it i hurts to walk and, she thought she had an enlarged lymph node. The patient sought unspecified medical attention. No lab diagnostics  were performed. There was no product quality complant. The patent called the office and she said that the pain is actually in the hip joint. The patient saw her pediatrician on 15-JUL-2008., who put her on antibiotics, do blood work and an magnetic resonance imaging of her head. The results of blood work and MRI were not available at the time of reporting. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning an 18 year old female no known allergies or pertinent medical history who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The physician reported that the patient was given GARDASIL vaccine (yeast) in the hip and later developed pain in her right leg. Patient also had difficulty walking and thought she had an enlarged lymph node. The patient sought unspecified medical attention. No lab diagnostics were performed. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s)  previously submitted on 08/14/2008. Information has been received from a physician concerning a 18 year old female , no known allergies or pertinent medicaledical history who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL (lot# 659655/1486U). There was no concomitant meidcation The physician reported that the patient was given GARDASIL vaccine(yeast in the hip and leter developed pain in her right hip and leg. The patient stated that it i hurts to walk and, she thought she had an enlarged lymph node. The patient sought unspecified medical attention. No lab diagnostics  were performed. There was no product quality complant. The patent called the office and she said that the pain is actually in the hip joint. The patient saw her pediatrician on 15-JUL-2008., who put her on antibiotics, do blood work and an magnetic resonance imaging of her head. The results of blood work and MRI were not available at the time of reporting. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on8/14/2008. Information has been received from a physician concerning a 14 year old female who "six months ago" in approximately January 2008, was vaccinated with the second dose of GARDASIL vaccine (yeast). The physician reported that "six months ago" in approximately January 2008, the patient experienced joint aches and pains persisting for the past 6 months. The patient sought medical attentions, he was seen in the physician office. There was no product quality complaint. Additional information has been requested. Follow up information has been received from a nurse in the rheumatologist office, who reported that the patient did not receive here vaccines at the office. The patient first came into theoffice in May with symptoms of joint aches and pains. The patient was given medications: MOBIC, NEURONTIN and unspecified muscle relaxers. The patient was not hospitalized at any point. As of 05-AUG-2008, the patient was in physical therapy with T.E.N.S. treatments. There has been a mild improvment in her conditions. Information has been received from a nurse from the physician's office who administered the vaccines, who reportd that the patient received the doses of GARDASIL on the following dates: first dose on 19-FEB-2008 (Lot #660387/1967U) and the second dose on 22-APR-2008 (Lot #660393/0067X). The reporter stated that the patient's mother did not want the patient to receive the third dose of GARDASIL vaccine. The reporter stated that she did not know if the patient recovered. She stated that the patient was seeing specialist. Follow-up information has been received from a nurse in the rheumatologist's office, who reported that the patient was seen by the physician, a rheumatologist on 270MAY-2008 and 17-JUN-2008. The nurse reported that that the patient had extensive testing. The physician referred the patient to the Neruologist on 17-JUN-2008. The patient was seen by the physician on 23-JUN-2008 and the patient was diagnosed with reactive arthritis. The patient was treated with SKELAXIN 800 mg 4 times a day, as needed and prednisone 6 mg daily. The patient was scheduled for a follow-up visit with rheumatologist on 20-Aug-2008. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female who on unspecified dates, was vaccinated with two doses of GARDASIL vaccine (yeast) from another unspecified provider. The nurse reported that recently the patient underwent a Papanicolaou test (PAP smear) that was positive. At the time of the report the patient had not recovered. The patient sought medical attention with an office visit. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on unspecified dates was vaccinated with 2 doses GARDASIL vaccine (yeast) and experienced upper leg ache. The patient contacted the physician. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypersensitivity, Rash pruritic, Skin burning sensation
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 13 year old female with no medical history and no known allergies, who on 02-JUL-2008 was vaccinated intramuscularly with 0.5 ml of a first dose of GARDASIL vaccine (yeast) (Lot # 660555/0279X). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 02-JUL-2008, the patient experienced an allergic reaction after receiving her first and only dose of GARDASIL vaccine (yeast). She developed a red, flat, itchy rash all over the body. The patient said she felt like her skin was on fire. She was taken to an emergency room and released after she was treated with steroids and BENADRYL. On 03-JUL-2008, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 22 year old female with drug allergy to levofloxacine (LEVAQUIN) and no pertinent medical history who on 28-MAY-2008 and 23-JUL-2008, was vaccinated intramuscularly with her first and second 0.5 ml doses, respectively, of GARDASIL vaccine (yeast) (Lot # of the second dose: 659964/1978U). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING) and escitalopram oxalate (LEXAPRO). On 24-JUL-2008 the patient experienced flu-like symptoms and muscle pain. At the time of the report, the patient's flu-like symptoms and muscle pain persisted. The patient sought medical attention by calling office. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently on 24-JUL-2008 the patient experienced pain at the injection site, numbness, tingling and difficulty swallowing. Outcome of the adverse event were not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Myalgia, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with asthma and mitral valve prolapse and no known drug reactions/allergies who on 01-JUL-2008 was vaccinated intramuscularly with the 0.5 ml first dose of GARDASIL vaccine (yeast) (LOT # 660389/1968U). Concomitant therapy included FLONASE, albuterol and montelukast sodium (MSD). Several hours after the vaccination, the patient developed itching on her chest and chest pain. Several hours after onset, the patient recovered from itching on her chest and chest pain. The symptoms resolved without any treatment. On 30-JUL-2008, the nurse practitioner reported that the patient saw a cardiologist and the physician felt that it was just a muscular pain. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Hypoaesthesia oral
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female who on an unspecified date was vaccinated with the second dose of GARDASIL vaccine (yeast). The nurse reported that 36 hours after receiving the second dose of GARDASIL vaccine, the patient developed flushing and numbness of the lips. The patient was given BENADRYL and the flushing and numbness went away within 30 minutes. At the time of the report, the patient had recovered. The patient sought medical attention calling the office. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Menstrual disorder
Clinical narrative: Information has been received from a registered nurse (RN) concerning her 17 year old daughter who on an unspecified date was vaccinated with 0.5 ml first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced a premature menstrual cycle and extreme pain at the injection site. Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with 0.5 ml second dose of GARDASIL vaccine (yeast). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with no known pertinent medical history or drug reactions/allergies who on 20-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 654539/0742U). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ), LEXAPRO and CONCERTA. On 24-JUL-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 660620/0571X). The patient experienced burning at the injection with the second dose of GARDASIL vaccine (yeast). The patient sought medical attention in the office. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml IM. On 23-JUL-2008 the patient experienced a temperature and body aches. The patient's temperature and body aches persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a healthy 14 year old female with no known pertinent medical history, who on 18-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (Lot # 656049/0187U). There was no concomitant medication. The physician reported that on 21-JUL-2008, the patient experienced nausea, vomiting, dizziness and fever. The patient sought medical attention at the physician's office. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with the first and second dose of GARDASIL vaccine (yeast). The mother's patient informed the physician that her daughter was more tired now than she had been in the past. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning to his r 21 year old daughter with penicillin allergy and seasonal allergy who on 04-JUN-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) 0.5 ml intramuscular. The patient did not experienced any adverse event after the first and second dose of GARDASIL vaccine (yeast) (one of the two doses was given in November 2007). On 04-JUN-2008 the patient experienced low-grade fever and headache which lasted one day. On 07-JUN-2008, the patient experienced rash maculo-papular distributed on her face, chest and upper thighs and was slightly itchy. The patient was evaluated by a dermatologist and was prescribed topical steroids cream and course of oral steroids (name unspecified). The rash improved slightly at first but then increased to include the patient's shoulders and back. The patient was scheduled for another office visit with the dermatologist the week of 28-JUL-2008. The patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with a dose of GARDASIL vaccine (yeast). Physician reported the patient had upper leg thigh aches and pains in both legs post vaccination with GARDASIL vaccine (yeast). The patient has had 2 doses of GARDASIL vaccine (yeast). The physician did not provide any other information. The patient sought unspecified medical attention. 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 patient who on 10-JUL-2008 was vaccinated with the first dose of GARDASILL vaccine (yeast) 0.5 mL, IM, and fainted twice after receiving the dose. Subsequently, the patient recovered from fainted twice after received GARDASIL vaccine (yeast). The patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter who in January 2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) and in June 2007 was vaccinated with the third dose of GARDASIL vaccine (yeast) (time of the second dose was not reported). The patient switched physicians and was told that her pap smear last year came back abnormal. Outcome of the abnormal pap smear was not reported. The patient sought medical attention with a physician office visit. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Eye disorder, Photopsia
Clinical narrative: Information has been received from a office manager concerning a 22 or 23 year old female who on 20-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (route and administration site not reported). Subsequently the patient developed white blinking light syndrome which was confirmed by an ophthalmologist. On an unspecified date recently the patient was vaccinated with a second dose of GARDASIL vaccine (yeast). The patient's outcome was unknown. The patient was to follow up with the ophthalmologist. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Calcinosis, Haematoma, Injection site mass
Clinical narrative: Information has been received from a physician's assistant concerning an 18 year old female who on 23-JUL-2007 was vaccinated with a first dose of GARDASIL  0.5 ml IM. On 04-JAN-2008 the patient was vaccinated with a third dose of GARDASIL 0.5 ml IM. Concomitant therapy included hormonal contraceptives (unspecified) and metronidazole. On 23-JUL-2008 the patient developed calcified hematoma on her left arm that was discovered after her third dose of GARDASIL . The patient's calcified hematoma persisted. The patient sought unspecified medical attention. Follow-up information was received from the physician's assistant who reported that the patient was a Caucasion student who had irritable bowel syndrome and polycystic ovarian syndrome.  On 23-JUL-2007 and 04-OCT-2007 she was vaccinated with first and second doses of GARDASIL in her right deltoid respectively.  Subsequently, the patient developed a semi-solid subcutaneous mass.  On 04-JAN-2008 at approximately 3:15 PM, the patient was vaccinated with a third dose of GARDASIL i her left deltoid.  There was not illnesses ath the time of vaccination.  On 04-JAN-2008 the patient developed an apporoximately grape-sized, semi-solid subcutaneous mass under the injection site.  At the time of this report, the event persisted. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Bladder pain, Blood test, Dysuria, Hypertonic bladder, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning his daughter a 27 year old female with no pertinent medical history and no allergies who in January 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). In March 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). In early June 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. Middle to late in June 2008, the patient began to experienced a burning sensation in the area of her bladder when urinating and she had a more frequent need to urinate than usual. Originally her physician treated this as an urinary tract infection and more recently she was diagnosed as having an overactive bladder. Blood tests and urine sample tests were performed. At the time of this report there was slight improvement. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pollakiuria, Urine analysis
Clinical narrative: Information has been received from a consumer concerning his daughter a 27 year old female with no pertinent medical history and no allergies who in January 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). In March 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). In early June 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. Middle to late in June 2008, the patient began to experienced a burning sensation in the area of her bladder when urinating and she had a more frequent need to urinate than usual. Originally her physician treated this as an urinary tract infection and more recently she was diagnosed as having an overactive bladder. Blood tests and urine sample tests were performed. At the time of this report there was slight improvement. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Myalgia
Clinical narrative: Information has been received from a medical assistant concerning a 27 year old female, with unremarkable medical history and no known drug reactions/allergies, who on 06-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) and on 07-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 mL, IM. Concomitant therapy included hormonal contraceptives (unspecified). On 09-JUL-2008, the patient experienced deep muscle aches in arms and legs. Patient will not receive her final dose of GARDASIL vaccine (yeast) in future. There wasn't any adverse event after first dose of GARDASIL vaccine (yeast). Therapy with GARDASIL vaccine (yeast) was discontinued. The patient sought unspecified medical attention. The patient's deep muscle aches in arms and legs persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008. The outcome of patient's severe muscle aches in arms and legs was unknown. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Coxsackie viral infection, Mouth ulceration, Oedema mouth, Oral pain
Clinical narrative: Information has been received from a certified nurse midwife concerning an 18 year old female with asthma and no known drug reactions/allergies, who on 11-JAN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 mL, IM, and on 11-MAR-2008 with the second dose. Concomitant therapy included DEPO-PROVERA and an unspecified inhaler. On 12-MAR-2008, the patient was diagnosed with Coxsackie virus. The patient was evaluated and treated, by her unspecified primary care physician, with folic acid, thiamine, and unspecified steroids. The first course of treatment was completed after one month. On an unknown date, the patient experienced a recurrence of the lesions and a second course of the same treatment was prescribed. The patient sought medical attention by a phone call. The patient's Coxsackie virus persisted. Additional information has been requested. Follow up information was received from a licensed practical nurse concerning a 17 year old female who on 11-MAR-2008 was vaccinated with a second dose of HPV (lot # 0152X) intramuscularly into the left upper deltoid. On 12-MAR-2008 the patient developed ulcers in mouth, severe swelling and pain. The patient was treated by a different physician. At the time of reporting the outcome of the patient was unknown. It was not specified if there was an illness as the time of vaccination. Ulcers in mouth, sever swelling and pain resulted in persistent or significant disability/incapacity, prolonged hospitalization and required emergency room/doctor visit. Follow up information was received from a nurse who confirmed that lot number of first dose of HPV given on 11-JAN-2008 was 655327/1287U. There were no problems after the first dose. The patient had not been seen in their office since the second dose was given on 11-MAR-2008. Patient present outcome was unknown since she was treated by her primary care physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Stomatitis
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date, was vaccinated with the first dose of GARDASIL vaccine. On an unspecified date, was vaccinated with the second dose of GARDASIL vaccine 0.5 ml, IM. A day after vaccine was received, the patient experienced sores in her mouth after second dose. The patient's sores in her mouth persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 20-MAY-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) and the second dose of GARDASIL vaccine (yeast) was given on 22-JUL-2008. The patient had a lesion removed from her scalp (the lesion was present prior to starting of the HPV vaccine series). When the plastic surgeon requested to have additional margins of the lesion area of the scalp removed he performed a complete blood count on 22-JUL-2008 that showed a platelet count of 40.000. A diagnosis of thrombocytopenia was given. A repeat complete blood count was performed on 24-JUL-2008, and that showed a platelet count of 42.000. The physician mentioned that he spoke with the pathologist performing the complete blood count/manual smear review and was told that the smear was normal. The patient's thrombocytopenia persisted. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: Local reaction @ site of injection, first red then became purple in center of local reaction, 8/28/08 observation per provider noted nickel size purple area.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) in the upper left deltoid. After vaccination, she was asked to sit for 15 minutes before leaving the office, 10 minutes later, the patient experienced red blotches on her right and left thighs. She did not feel pain. The symptoms cleared and she called the office to set up an appointment for her second dose. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fatigue, Wrong drug administered
Clinical narrative: Information has been received from a patient's mother concerning a 36 month old female who on 22-JUL-2008 was vaccinated with GARDASIL vaccine (yeast) by a human mistake. Concomitant therapy also given on 22-JUL-2008, included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On 22-JUL-2008, the child seemed more tired than usual after the vaccination. The mother called the physician. At the time of reporting, the child was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of fainting when receiving injections who on 15-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). On 15-JUL-2008 the patient fainted immediately after the vaccination. No treatment required. On 15-JUL-2008 the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 22-JUN-2008 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL vaccine (yeast) (lot #658554/0928U). On 22-JUN-2008, the same office visit, the patient also received varicella virus vaccine live (Oka/Merck) in her right arm. On 22-JUN-2008, "30 minutes after leaving office", the patient experienced "shooting pain down her left arm down to her left calf all the way to her big toe". The patient called the physician and was advised to rest. At the time of the report, no outcome was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008. Follow up information was received from the physician reported that the patient with mild alopecia and attention deficit/hyperactivity disorder (ADHD) (not on medications at the time of vaccination) who on 22-JUL-2008 at 1:00 PM was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot #658554/0928U) in her left arm. On 22-JUN-2008, the same office visit, the patient also received her second dose of VARIVAX (Merck) (lot#661336/0524X) subcutaneously in her right arm. On 22-JUL-2008 at 1:00 PM, immediately after the vaccination, the patient had shooting pain in left arm. Within an hour, the patient complained pain in both legs that felt liked pressure pain was becoming shooting pain into lower leg and foot. The patient had some dizziness and no fainting. No relevant diagnostic and laboratory tests were performed. The patient was told to rest and was given ibuprofen. Pain resolved within 2-3 hours. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Mood altered
Clinical narrative: Information has been received from a physician (a counselor reported it to the physician) concerning unspecified number of patients who were vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently the patients experienced moodiness. The counselor stated that she felt mood problems were probably related to the vaccination as she had seen similar reactions in other clinics. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL vaccine (yeast) and MENACTRA vaccine (dip toxoid) on the same office visit and had fainting and dyskineteic movements after receiving GARDASIL vaccine (yeast) and MENACTRA vaccine (dip toxoid). "She was in the ER for 18 hours." The patient saw the doctor. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of fainting during medical procedures who on approximately 07-JUL-2008, reported as "3 weeks ago", was vaccinated 0.5mL, IM with a 1st dose of GARDASIL vaccine (yeast) (lot# not reported). It was reported that the patient fainted as soon as the needle was withdrawn from her arm and was unconscious for approximately 2 minutes. It was reported that the nurse moved the patient's feet up and eventually the patient was conscious. The patient sought medical attention from the physician in the office. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Information has been received from a registered nurse considering a 23 year old female with no known drug allergies and no previous medical history who on 28-JAN-2008 was vaccinated IM in the deltoid with her first dose of GARDASIL vaccine (yeast) (lot#659657/1487U) 0.5 ml. There was no concomitant medication. The patient received her second dose of GARDASIL vaccine (yeast) (lot# 659182/1757U, site not reported) on 28-MAR-2008. Subsequently she "passed out" and felt nauseous after the second dose. The patient did not seek treatment for her symptoms and recovered on an unspecified date. No further information was available Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no medical history or no known drug allergies, who on 02-JAN-2008 was vaccinated IM with a first dose of GARDASIL vaccine (yeast) (Lot# 660393/0067X). Concomitant therapy included ACETEXA. On 07-Jul-2008 the patient received the second dose of GARDASIL vaccine (yeast). Within a few hours of vaccination the patient experienced redness, pain and swelling at the injection site. The patient also mentioned after she received the second dose, that she did have a similar reaction after the first dose. Medical attention was not sought. On an unspecified date the patient was recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who in March 2008, was vaccinated with the third dose of GARDASIL vaccine (yeast), IM. It was reported that the patient experienced joint pain after receiving the third dose of GARDASIL vaccine (yeast). The patient sought medical attention. No additional information available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: This is in follow-up to report (s) previously submitted on 8/14/2008. Information has been received from an office secretary concerning a 23 year old female neighbor who on approximately 08-JUN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). The office secretary stated that on approximately 09-JUN-2008, the patient experienced tingling in her hands and toes, the day after receiving her first dose of HPV vaccine, postpartum 3 weeks ago. The patient's tingling in her hands and feet persisted. Additional information has been requested. In follow-up the office secretary stated that she had not seen her neighbor since the initial report but knew that her neighor did follow up with her physician and was doing well. No further information was provided.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Herpes simplex serology positive, Oedema peripheral, Oral herpes, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with a history of her first abnormal PAP Low Grade Squamous Intraepithelial Lesion (LGSIL) (18-MAR-2008) and cervical intraepithelial neoplasia (CIN 1) after colposcopy (02-MAY-2008), who on 14-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660393/0067X) IM and on 21-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 660553/0070X) IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The nurse practitioner reported that on 14-MAY-2008 and on 21-JUL-2008, the patient experienced itching, redness, swelling on left palm after received the first and second dose of HPV vaccine. On 15-MAY-2008, the patient was seen by her family physician who did not know patient had just received HPV vaccine and diagnosed patient with a cold sore and patient was treated with VALTREX 1gm for 1 dose. On 16-MAY-2008, the patient recovered from her first episode of itching, redness, swelling on left palm and swelling on left palm. On 21-JUL-2008, after the second dose of HPV vaccine, the patient developed itching, redness, and swelling of the left palm that evening. On 23-JUL-2008, antibody titers were done which showed IgM not detected IgG titer for Herpes simplex 1 was positive. On 26-JUL-2008, the patient recovered from her second episode of itching, redness, swelling on  left palm. The NP was unsure if she would give the patient the third dose of HPV vaccine. Additional information has been requested.