chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 17-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot # 65822/0927U). Concomitant vaccination included Menactra. On approximately 19-AUG-2007 "two days after vaccination" the patient developed a rash. The patient presented with little crusty lesions on her knees and buttocks. The rash was localized to the lower area of the body. The patient went back to the doctor's office a few weeks ago and she still had some lesions. The patient's status was reported as recovering. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008. Follow up information obtained on 11-DEC-2007. The physician reported that the 12 year old female patient with asthma and a chronic allergic rhinitis weighed 131 pounds and height of 64 inches. It was reported that there were no asthma symptoms at the time of vaccination and that the allergic rhinitis is better with immunotherapy. It was reported that on 17-AUG-2007, the patient was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot # 558222/0927U), intramuscularly in the left deltoid with the first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # C2657AA) and the subcutaneously in the left deltoid with the second dose of varicella virus vaccine (lot # 658058/0837U). On 19-AUG-2007, the patient developed molluscum contagious/multiple lesions in different sites. The patient's dermatologist was consulted and gave "unspecified" topical treatment. It was reported that the patient status improved after treatment. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a female under the age of 25 who was vaccinated(date not reported) intramuscularly (site not reported) with the 1st and 2nd dose of GARDASIL (lot# not reported). Subsequently, post vaccination, the developed flu-like symptoms. At time of reporting, the patient's outcome was unknown. This is one of 2 reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a "16 year old" female with no pertinent medical history who on 13-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included MENACTRA (lot# unknown). On 13-NOV-2007 the patient fainted after receiving GARDASIL. Medical attention was sought. No additional information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history or drug reactions/allergies who on 09-NOV-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Upon leaving the practice, the patient experienced syncope at the front desk which was identified as a "vaso pagil reaction". The patient was transported to the emergency room, it was not known whether or not the patient was actually admitted to the hospital. It was unknown whether or not the patient will go on to receive the second and third doses. Unspecified medical attention was sought. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash macular
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old white female student with asthma and allergic rhinitis who on 04-MAY-2007 was vaccinated with the first dose of GARDASIL, injection. On 09-NOV-2007 the patient received the third dose of GARDASIL (lot# 659435/1265U), intramuscularly. On 10-NOV-2007 the patient experienced red blotches and red bumps over her entire face, the morning after receiving the third dose. The patient went to the urgent care for treatment and was given clindamycin gel and hydroxyzine hydrochloride 25 mg oral with good relief of symptoms. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a Medical Assistant concerning a 23 year old female with no known drug or food allergies who, on 08-NOV-2007, was vaccinated with the second dose of Gardasil (Lot #659437/1266U). Concomitant therapy included a contraceptive ring. On 08-NOV-2007, the patient experienced a pruritic rash at the injection site. The rash was approximately the size of a "silver dollar." Subsequently, the rash improved, however, a lump remained at the injection site. The Medical Assistant reported that the patient tolerated her first dose of Gardasil well. As of 17-NOV-2007, the patient was recovering from the rash and lump. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with GARDASIL, subsequently at another office. Subsequently the patient experienced a small lump at the injection site. Additional information has been requested. Information has been received from a medical assistant concerning a female who was vaccinated with HPV vaccine, subcutaneously at another office. Subsequently the patient experienced a small lump at the injection site that lasted for 2 months. No product quality complaint was involved. Additioal information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Haematochezia
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 12 year old female with haemorrhoids and no drug reactions/allergies who on 26-FEB-2007 was vaccinated with her first dose of GARDASIL. In 2007, "sometime in the past couple of months", the patient developed blood in her feces. The C.M.A. believes that it is the result of her hemorrhoids. On 14-NOV-2007 the patient will receive her second dose of GARDASIL. As of 14-NOV-2007 the patient had not recovered. Medical attention was sought in the office. The product quality complaint unit was not involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who in approximately October 2007 "about one month ago", was vaccinated with Gardasil, 0.5mL, intramuscularly.  Concomitant therapy included "several other vaccines given on the same day" (therapy unspecified).  Within one hour, the patient developed itching at the injection site.  The itching lasted about 12 hours, and then resolved.  No other symptoms were noted.  Medical attention was sought with a phone call to the office.  The product quality complaint unit was not involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Headache, Influenza like illness, Injected limb mobility decreased, Malaise
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who was vaccinated with her first dose of Gardasil and her arm became swollen and she could not move her arm. The patient then received the second dose of Gardasil. Between the first and second dose the patient was always feeling sick. The patient also had kidney stones after the first dose. After receiving the second dose the patient's arm swelled again and got worse each day. Her arm was swollen and fiery red and her hand was also swollen and purple looking. The patient also had a fever, headache, and nausea. Her face and arm also broke out in a rash. The patient's mother gave her BENADRYL and ADVIL to treat her symptoms. Presently the patient has flu like symptoms and has been vomiting. The patient's present status is not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Information has been received from a consumer and follow up information from the physician's office concerning her 17 year old daughter who was vaccinatedwith her first dose of GARDASIL vaccine and her arm became swollen and she could not move her arm. The patient then received the second dose of GARDASIL intramuscularly in the left arm on 03-NOV-2007 (lot # 658560/1062U). Between the first and second dose the patient was always feeling sick. The patient also had kidney stones after the first dose. After receiving the second dose the patient's arm swelled again and got worse such day. Her arm was swollen and fiery red and her hand was also swollen and purple looking. The patient also had a fever, headache, nausea, flu-like symptoms, diarrhea, vomiting and fatigue on 12-NOV-2007. The patient recovered on 13-NOV-2007 from flu-like symptoms, diarrhea, vomiting, fever, fatigue and nausea. Her face and arm also broke out in a rash. The patient's mother gave her BENADRYL and ADVIL to treat her symptoms. Presently the patient has flu-like symptoms and has been vomiting. The patient's present status is not recovered. Additional information was received from the consumer. She reported the name, address and phone number for her daughter's physician.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nephrolithiasis, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who was vaccinated with her first dose of Gardasil and her arm became swollen and she could not move her arm. The patient then received the second dose of Gardasil. Between the first and second dose the patient was always feeling sick. The patient also had kidney stones after the first dose. After receiving the second dose the patient's arm swelled again and got worse each day. Her arm was swollen and fiery red and her hand was also swollen and purple looking. The patient also had a fever, headache, and nausea. Her face and arm also broke out in a rash. The patient's mother gave her BENADRYL and ADVIL to treat her symptoms. Presently the patient has flu like symptoms and has been vomiting. The patient's present status is not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Information has been received from a consumer and follow up information from the physician's office concerning her 17 year old daughter who was vaccinatedwith her first dose of GARDASIL vaccine and her arm became swollen and she could not move her arm. The patient then received the second dose of GARDASIL intramuscularly in the left arm on 03-NOV-2007 (lot # 658560/1062U). Between the first and second dose the patient was always feeling sick. The patient also had kidney stones after the first dose. After receiving the second dose the patient's arm swelled again and got worse such day. Her arm was swollen and fiery red and her hand was also swollen and purple looking. The patient also had a fever, headache, nausea, flu-like symptoms, diarrhea, vomiting and fatigue on 12-NOV-2007. The patient recovered on 13-NOV-2007 from flu-like symptoms, diarrhea, vomiting, fever, fatigue and nausea. Her face and arm also broke out in a rash. The patient's mother gave her BENADRYL and ADVIL to treat her symptoms. Presently the patient has flu-like symptoms and has been vomiting. The patient's present status is not recovered. Additional information was received from the consumer. She reported the name, address and phone number for her daughter's physician.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who was vaccinated with her first dose of Gardasil and her arm became swollen and she could not move her arm. The patient then received the second dose of Gardasil. Between the first and second dose the patient was always feeling sick. The patient also had kidney stones after the first dose. After receiving the second dose the patient's arm swelled again and got worse each day. Her arm was swollen and fiery red and her hand was also swollen and purple looking. The patient also had a fever, headache, and nausea. Her face and arm also broke out in a rash. The patient's mother gave her BENADRYL and ADVIL to treat her symptoms. Presently the patient has flu like symptoms and has been vomiting. The patient's present status is not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Information has been received from a consumer and follow up information from the physician's office concerning her 17 year old daughter who was vaccinatedwith her first dose of GARDASIL vaccine and her arm became swollen and she could not move her arm. The patient then received the second dose of GARDASIL intramuscularly in the left arm on 03-NOV-2007 (lot # 658560/1062U). Between the first and second dose the patient was always feeling sick. The patient also had kidney stones after the first dose. After receiving the second dose the patient's arm swelled again and got worse such day. Her arm was swollen and fiery red and her hand was also swollen and purple looking. The patient also had a fever, headache, nausea, flu-like symptoms, diarrhea, vomiting and fatigue on 12-NOV-2007. The patient recovered on 13-NOV-2007 from flu-like symptoms, diarrhea, vomiting, fever, fatigue and nausea. Her face and arm also broke out in a rash. The patient's mother gave her BENADRYL and ADVIL to treat her symptoms. Presently the patient has flu-like symptoms and has been vomiting. The patient's present status is not recovered. Additional information was received from the consumer. She reported the name, address and phone number for her daughter's physician.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on approximately 23-OCT-2007, was vaccinated intramuscularly with a second dose of Gardasil.  On approximately 24-OCT-2007 the patient broke out in hives.  The hives were not at the injection site but rather on her body.  The patient did not seek medical attention.  Subsequently, the patient recovered.  The patient did not experience hives after receiving the first dose of Gardasil.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: No reaction on previous exposure to drug, Syncope, Tremor
Clinical narrative: Information has been received from a mother concerning her 12 year old daughter who on 09-May-2007 was vaccinated into the left arm with a first dose of Gardasil.  On 13-Nov-2007, the patient was vaccinated with a third dose of Gardasil.  Concomitant suspect vaccination on the same day included Vaqta.  On 14-Nov-2007 the patient fainted.  She "came out of it shaking or tremoring (whole body) and almost fell off the table".  She was given orange juice and was told to lie down.  The patient was in the office.  On 13-Nov-2007, the patient recovered.  The patient had no problems with the first and second dose of Gardasil.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Tuberculin test
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who was vaccinated with a dose of Gardasil (Lot #658554/0928U).  Concomitant therapy included Menactra.  Five minutes later the patient came out of the room and reported that she was dizzy and lightheaded.  The nurse had the patient lay down for 15 minutes with her legs elevated.  It was reported that she did not lose consciousness nor was she cold or clammy.  The patient also had a TB test drawn.  At the time of this report, the patient's outcome was unknown.  It was reported the patient survived the incident.  It was also reported that the patient reported to the physician that she was scared.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a first dose of Gardasil.  About one month after vaccination the patient returned to the office and complained of injection site soreness.  She was examined and was found to have a small bump at the Gardasil vaccination site.  The bump was the size of 1/2 of a pee.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Bronchitis, Drug exposure during pregnancy, Menorrhagia, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 17 year old white female with a history of depression who on 16-AUG-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of Gardasil (Lot #655617/1447F). On 25-SEP-2007 the patient was treated for Menorrhagia and was given DARVOCET and CIPRO for a urinary tract infection (UTI). On 16-OCT-2007 the patient was vaccinated intramuscularly into the left deltoid with a second dose of Gardasil (Lot #658563/1063U). On 16-OCT-2007 the patient was given a pregnancy test prior to vaccination which was negative. On 30-OCT-2007, the patient requested a pregnancy test because she was 2 weeks late. This test was positive for pregnancy. A serum quantitative test was performed, results were 3528 and positive for pregnancy. The patient was placed on unspecified prenatal vitamins. The patient's last menstrual period was on 18-SEP-2007 and the estimated date for delivery was 24-JUN-2008. On 14-NOV-2007 the patient was placed on ZITHROMAX for treatment of bronchitis. On 26-NOV-2007 the patient was to have an appointment with the obstetrician (OB). At the time of the report the patient's outcome was unknown.  Follow up information was received, conerning a 17 year old female patient, who experienced anemia, psoitive Beta strep, yeast infecetion and UTI as complications during pregnancy. Concomitant therapy used during pregnancy included prenatal vitamins and iron. On 09-JUL-2008, the patient delivered a normal, healthy female baby weighed 8-2. 7 oz and length 21 inches.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 17 year old white female with a history of depression who on 16-AUG-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of Gardasil (Lot #655617/1447F). On 25-SEP-2007 the patient was treated for Menorrhagia and was given DARVOCET and CIPRO for a urinary tract infection (UTI). On 16-OCT-2007 the patient was vaccinated intramuscularly into the left deltoid with a second dose of Gardasil (Lot #658563/1063U). On 16-OCT-2007 the patient was given a pregnancy test prior to vaccination which was negative. On 30-OCT-2007, the patient requested a pregnancy test because she was 2 weeks late. This test was positive for pregnancy. A serum quantitative test was performed, results were 3528 and positive for pregnancy. The patient was placed on unspecified prenatal vitamins. The patient's last menstrual period was on 18-SEP-2007 and the estimated date for delivery was 24-JUN-2008. On 14-NOV-2007 the patient was placed on ZITHROMAX for treatment of bronchitis. On 26-NOV-2007 the patient was to have an appointment with the obstetrician (OB). At the time of the report the patient's outcome was unknown.  Follow up information was received, conerning a 17 year old female patient, who experienced anemia, psoitive Beta strep, yeast infecetion and UTI as complications during pregnancy. Concomitant therapy used during pregnancy included prenatal vitamins and iron. On 09-JUL-2008, the patient delivered a normal, healthy female baby weighed 8-2. 7 oz and length 21 inches.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not reported), who on an unspecified date was vaccinated IM with a dose, 0.5 ml, of Gardasil (lot # not reported). With the vaccination, the patient experienced "severe injection site pain that seemed to radiate in the arm to the wrist." The patient sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Paraesthesia
Clinical narrative: Information has been received from a 26 year old female nurse who in approximately October 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). In approximately October 2007, the patient experienced injection site pain, tingling on her breast on the same side where she received the vaccination all the way to her hip right after receiving the injection. Later that same afternoon, she became nauseous. The patient recovered from the injection site pain, tingling on her breast down to her hip and nausea the next day. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 14-NOV-2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. On 14-NOV-2007, the patient's arm hurt and then she fainted. On 14-NOV-2007, the patient recovered from fainting and her arm hurting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Amnesia, Fatigue
Clinical narrative: Information has been received from a nurse concerning an approximately 17 year old female with asthma and a history of migraines and "bad headaches" who on 26-MAR-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot # 655205/1426F). Concomitant therapy included loratadine (unspecified), FLOVENT and albuterol (unspecified). On 26-MAR-2007 the patient went to the mall after receiving her first vaccination. She came home and felt very tired and went to bed that evening. When she woke up on 27-MAR-2007, she told her mother that she couldn't remember anything that happened yesterday after the mall. The patient's mother called the office to report that the patient's friends reported that the patient was "not acting right" for approximately one week after the vaccination with Gardasil. The patient sought unspecified medical attention by calling the office. On 27-MAR-2007, the patient recovered from the tiredness and lack of memory. On approximately 02-APR-2007, the patient recovered from "not acting right". Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Back pain, Headache, Paraesthesia, Pregnancy test negative
Clinical narrative: Information has been received from a nurse concerning a 26 year old ex-smoker female with depression, anxiety, polycystic ovaries, codeine allergy and a history of headache with YASMIN, and pneumonia who on 20-SEP-2007 was vaccinated intramuscularly to the left arm with the first dose of Gardasil (lot# 0530U), 0.5mL. Concomitant therapy included YASMIN which the patient stopped taking on 11-OCT-2007 because she was experiencing headaches. The patient's last menstrual period was 04-OCT-2007. A pre-vaccination pregnancy test was administered with a negative result. After the first dose in approximately September 2007, the patient experienced pain going straight down her back (outcome not reported). On 15-NOV-2007 the patient received her second dose of Gardasil (lot#0530U) into the left arm. Immediately post vaccination, the patient experienced pain going straight down her back, tingling in the jaw and headache. The patient was being treated with TYLENOL, relaxing with a heating pad, and was being monitored. During follow up with the client, the physician in the office that day indicated to the nurse that it may have been an anxiety attack. Unspecified medical attention was sought. As of 15-NOV-2007 the patient was recovering. The product quality complaint unit was not involved. Additional information has been requested. Information has been received from a nurse concerning a 26 year old ex-smoker insurance agent female with depression, anxiety, polycystic, codeine allergy and a history of headache with YASMIN, and pneumonia who on 20-SEP-2007 was vaccinated intramuscularly to the left arm with the first dose of HPV (lot # 05300), 0.5ml. The patient's last menstrual period was 04-OCT-2007. A pre-vaccination pregnancy test was administered with a negative result. After the first dose on 20-SEP-2007, the pateint experienced pain going straight down her back. On 15-NOV-2007, the patient received her second dose of intramuscularly HPV (lot # 0530U) into the left deltoid. Immediately post vaccination, the patient experiwnced pain going straight down her back, midline upper thoracic region pain, jaw pain, tingling in the jaw, tingling in her checks, dizziness, and a headache. The patient was treated with TYLENOL, relaxing with a heating pad, and was monitored. After 20-25 minutes all symtoms resolved, except for headache, before leaving the office. During follow up with the client, the physician in the office that day indicated to the nurse that it may have been an anxiety attack. Unspecified medical attention was sought. The product quality complaint unit was not involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Arthralgia, Cytomegalovirus antibody negative, Epstein-Barr virus antibody negative, Febrile infection
Clinical narrative: Information has been received from a physician concerning a 16 year old female with oesophageal acid reflux, heartburn and peanut allergy and a history of parvovirus infection who on 01-MAY-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included naproxen and PREVACID. On 14-JUN-2007 the patient received her second dose of Gardasil. On approximately 11-JUL-2007 "around the second week of July 2007", the patient experienced a febrile illness. She had diffuse arthralgia, elevations in her liver function tests "(70's and 90's)", elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). On 26-JUL-2007 laboratory tests showed AST 97 and ALT 97. On 26-OCT-2007 AST was 237, ALT 257, and gamma-glutamyl transferase (GGTP) was 97. On 07-NOV-2007 the AST was 218, ALT was 227 and GGTP was 28. An abdominal ultrasound was performed, results not reported. The outcome for febrile illness was not reported. The elevation in liver enzymes AST and ALT was not recovered. Diffuse arthralgia was improved. Unspecified medical attention was sought with "a few doctors/specialists" that included a gastroenterologist. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Liver function test abnormal, Parvovirus B19 serology negative, Ultrasound abdomen
Clinical narrative: Information has been received from a physician concerning a 16 year old female with oesophageal acid reflux, heartburn and peanut allergy and a history of parvovirus infection who on 01-MAY-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included naproxen and PREVACID. On 14-JUN-2007 the patient received her second dose of Gardasil. On approximately 11-JUL-2007 "around the second week of July 2007", the patient experienced a febrile illness. She had diffuse arthralgia, elevations in her liver function tests "(70's and 90's)", elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). On 26-JUL-2007 laboratory tests showed AST 97 and ALT 97. On 26-OCT-2007 AST was 237, ALT 257, and gamma-glutamyl transferase (GGTP) was 97. On 07-NOV-2007 the AST was 218, ALT was 227 and GGTP was 28. An abdominal ultrasound was performed, results not reported. The outcome for febrile illness was not reported. The elevation in liver enzymes AST and ALT was not recovered. Diffuse arthralgia was improved. Unspecified medical attention was sought with "a few doctors/specialists" that included a gastroenterologist. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Blepharospasm
Clinical narrative: Information has been received from a nurse practitioner concerning a female licensed practical nurse (L.P.N.) who was splashed in the eye with Gardasil during administration. The patient receiving the vaccine had pulled her arm away during administration. Subsequently the L.P.N. was experiencing eye twitching. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 17 year old female with no known drug allergies and asthma who on 31-JUL-2007 was vaccinated with the first dose of Gardasil. On 25-SEP-2007, the patient was vaccinated in the left deltoid with the second dose of Gardasil (lot # 658563/1063U). Concomitant therapy included ADVAIR and MAXAIR. On 27-SEP-2007, the patient experienced fever for 2 days and called the physician's office. No laboratory/diagnostic tests were performed. There was no illness reported at the time of vaccination. On 29-SEP-2007, the patient recovered from fever. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant (MA), via a company representative, concerning a 25 year old female patient, who on 14-NOV-2007 was vaccinated IM with the first dose of Gardasil (lot # not specified). Following the vaccination, the patient fainted. The patient recovered, and the MA noted that she was "fine before leaving the office." Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a company representative from a physician concerning a young female who was vaccinated with a dose of Gardasil. Subsequently the patient fainted. The patient sought unspecified medical treatment while in the office. The patient recovered at an unspecified time. Additional information has been requested. Information has been received froma company representative from a physician concerning a 24 year old female who was vaccinated with her first dose of HPV vaccine in the left deltoid (lot # 658560/1062U). Immediately after the vaccine, the patient had a simple office gyn procedure. At the end of the procedure, the patient was still lying down, fainted with tonic/clonic movements of limbs lasting approx. 1 minute. The patient sought unspecified medical treatment while in the office. The patient recovered at an unspecified time. The patient has a history of similar reaction ro a morphine dose in the ER in the past. Following this vaccine, she had another episode, went to the ER, had an EEG and saw her PCP in follow up. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a mother concerning her 17 year old daughter with no pertinent medical history or drug reactions/allergies who on 13-SEP-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced a delay in her menstrual period by 7-8 weeks. Medical attention was sought with the patient's physician. The patient did get her menstrual cycle around the time of 20-NOV-2007. No further information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Colonoscopy, Laboratory test, Nausea, Vomiting, Weight decreased
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 04-SEP-2007 was vaccinated with the first dose of Gardasil (lot# 658558/1061U). On 30-OCT-2007 the patient received the second dose of Gardasil (lot# 658563/1063U). Concomitant therapy included LOESTRIN. One month after the first dose the patient experienced lots of nausea and vomiting and a 15 pound weight loss. At the time of 2nd dose of vaccination the patient still had nausea and vomiting. Unknown medical attention was sought. The patient had a lot of unspecified tests that were negative. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a nurse concerning a female patient who at an unknown dates was vaccinated with first and second dose of Gardasil. Subsequently the patient experienced heart palpitations after both doses. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 42 year old female who on 28-SEP-2007 was vaccinated with her second dose of Gardasil. There was no concomitant medication. on 29-SEP-2007 the patient experienced pain and swelling at injection site that went up into her neck. The patient sought unspecified medical treatment. No lot number was provided. No further information was provided. The patient's pain and swelling at injection site persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced redness, swelling at the injection site and low grade fever. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a company representative from a Nurse practitioner concerning a female, who in October 2007, was vaccinated by injection with the first dose of Gardasil. Concomitant therapy included DEPO-PROVERA. In October 2007, the patient experienced a 2 millimeter, hard circular area on the left posterior deltoid area which is tender occasionally. Lot number was not available. The patient sought unspecified medical attention. No further information available. Additional information has been requested. Follow-up received 04/16/2008. Information has been received from a nurse practitioner concerning a female, with no known drug allergies, who on 05-OCT-2007, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658556/1060U). Concomitant therapy included DEPU-PROVERA. In October 2007, the patient experienced a 3 millimeter, lump on left posterior deltoid, subcutaneous-occasionally tender. Medical attention was sought. Not tender on date of visit. The patient stated that she was rubbing and checking frequently since 05-OCT-2007. Advised to stop frequent daily checks. Warm soak to area daily. The patient was recovered from the lump. Arm sore after lifting. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain
Clinical narrative: Information has been received from a nurse concerning a 11 year old female who was vaccinated intramuscularly with a dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced pain and numbness immediately after vaccination. Subsequently, the patient recovered from pain and numbness. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with a dose of Gardasil. Subsequently "few weeks ago" the patient experienced dizziness, headaches and blurred vision. Subsequently, the patient recovered from dizziness, headaches and blurred vision. Additional information has been requested. Information has been received from a physician concerning a 15  year old female who was vaccinated with a dose of HPV vaccine. Subsequently "few weeks ago" the patient experienced dizziness, headaches and blurred vision. Subsequently, the patient recovered from dizziness, headaches and blurred vision. Additional informatin has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a 23 year old consumer, who on 15-NOV-2007 was vaccinated with the first dose, 0.5 ml, of Gardasil (lot # not provided). There was no concomitant medication. Following the vaccination, the consumer ingested an unspecified amount of alcohol. On 16-NOV-2007, she developed a headache and nausea. At the time of this report, the consumer had not recovered. The consumer did not seek medical attention. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Menstruation delayed, Migraine, Muscular weakness
Clinical narrative: Information has been received from a mother concerning her 13 year old daughter who on 14-SEP-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a delay in her menstrual cycle by 3 weeks. "A few weeks" after she received Gardasil estimated to be 28-SEP-2007, she also went to the emergency room with a severe headache, weakness, and numbness in her arm and scrambled speech. The hospital diagnosed it as a severe migraine. Medical attention was sought in the emergency room. Follow-up information received on 27-NOV-2007: The mother reported that her daughter did end up getting her menstrual cycle around the time of November 20, 2007. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder
Clinical narrative: Information has been received from a mother concerning her 13 year old daughter who on 14-SEP-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a delay in her menstrual cycle by 3 weeks. "A few weeks" after she received Gardasil estimated to be 28-SEP-2007, she also went to the emergency room with a severe headache, weakness, and numbness in her arm and scrambled speech. The hospital diagnosed it as a severe migraine. Medical attention was sought in the emergency room. Follow-up information received on 27-NOV-2007: The mother reported that her daughter did end up getting her menstrual cycle around the time of November 20, 2007. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Asthma, Wheezing
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with asthma who was vaccinated with her first dose of Gardasil via injection. Concomitant therapy included influenza virus vaccine (unspecified). The mother reported that two to three hours after her daughter received the vaccine she developed signs of asthma which included wheezing. The patient was treated with a nebulizer. The wheezing continued for two to three days and then ceased. The mother mentioned that her daughter had a history of asthma, however, she had not had an asthmatic episode in a while. The patient also received a flu vaccine the same day (unspecified). Additional information has been requested. This is in follow-up to report(s) previously on 12/14/2007. Information has been received from a consumer concerning her 12 year old daughter with asthma who was vaccinated with her first dose of GARDASIL (Lot #658222/0827U) intramuscularly in the left arm. Concomitant therapy included influenza virus vaccine (Lot #U2452AA) intramuscularly in the right arm. The mother reported that two to three hours after her daughter received the vaccine she developed signs of asthma which included wheezing and coughing. The patient was treated with a nebulizer, an inhaler, and 2 courses of oral steroids. The wheezing continued for two to three days and then ceased. The patient is now better but she is still coughing. The mother mentioned that her daughter had a history of asthma.However, she had not had an asthmatic episode in over 2 years. The patient also received a flu vaccine the same day (unspecified).
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a 17 year old female who was vaccinated with Gardasil (lot number was not reported). Concomitant therapy included TRI-SPRINTEC. Subsequently the patient fainted after receiving Gardasil. Subsequently, the patient was revived within minutes of episode. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling hot, Mass, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 10-Nov-2007 was vaccinated intramuscularly in the upper thigh with the third dose of Gardasil (lot number not provided).  On 10-Nov-2007 the patient developed a knot that was hot, red, tender to the touch, and about the size of a half dollar.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who was reported as having been vaccinated on 14-Mar-2006 with Gardasil (Lot #654389/0961F).  The patient is reported as having received her second dose of Gardasil on 04-Oct-2006.  Concomitant therapy included drospirenone (+) ethinyl estradiol (Yasmin).  On 04-Oct-2006 the patient experienced pain during administration.  The patient was given an ice pack to apply to the area.  The patient refused to come back for the third dose.  Subsequently, the patient recovered from the pain during administration on the same day.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest discomfort, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Information has been received from a company representative by a physician concerning an 18 year old female who on 13-Nov-2007 was vaccinated in the right deltoid with her first dose of Gardasil (lot #654540/0800F).  Concomitant therapy included Concerta and Zoloft.  On 13-Nov-2007, within a few hours after vaccination, the patient experienced pain in her arm at the injection site, and the pain extended down to her fingers, chest tightness, nausea and vomiting.  There was no redness at the injection site.  The physician saw the patient the next day and she was still experiencing the severe pain in her arm, but the chest tightness, nausea and vomiting had improved.  Blood tests were performed.  No further information available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been receiveed from a physician and a registered nurse concerning an 17 year old white female student who on 13-NOV-2007 at 14:30 was vaccinated in the right deltoid with her first dose of GARDASIL (lot # 654540/0800F). Concomitant therapy included CONCERTA and ZOLOFT. On 13-NOV-2007 at approximately 18:00, the patient experienced increased pain in her arm at the injection site, chest tightness, shortness of breath and severe nausea and vomiting. It was reported that the pain extended to entire arm and shoulder. There was no redness at the injection site. The physician saw the patient the next day and she was still experiencing the severe pain in her arm, but the chest tightness, nausea and vomiting had improved. Blood tests were performed. On approximately 16-NOV-2007, the patient recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a company representative by a physician concerning an 18 year old female who on 13-Nov-2007 was vaccinated in the right deltoid with her first dose of Gardasil (lot #654540/0800F).  Concomitant therapy included Concerta and Zoloft.  On 13-Nov-2007, within a few hours after vaccination, the patient experienced pain in her arm at the injection site, and the pain extended down to her fingers, chest tightness, nausea and vomiting.  There was no redness at the injection site.  The physician saw the patient the next day and she was still experiencing the severe pain in her arm, but the chest tightness, nausea and vomiting had improved.  Blood tests were performed.  No further information available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been receiveed from a physician and a registered nurse concerning an 17 year old white female student who on 13-NOV-2007 at 14:30 was vaccinated in the right deltoid with her first dose of GARDASIL (lot # 654540/0800F). Concomitant therapy included CONCERTA and ZOLOFT. On 13-NOV-2007 at approximately 18:00, the patient experienced increased pain in her arm at the injection site, chest tightness, shortness of breath and severe nausea and vomiting. It was reported that the pain extended to entire arm and shoulder. There was no redness at the injection site. The physician saw the patient the next day and she was still experiencing the severe pain in her arm, but the chest tightness, nausea and vomiting had improved. Blood tests were performed. On approximately 16-NOV-2007, the patient recovered. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with a history of papanicolaou smear abnormal and hypersensitivity to latex, peaches, blue dye, and green dye, who on 25-Oct-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot #658563/1063U).  Concomitant therapy included CLINDAMYCIN PHOSPHATE (Klindan (clindamycin phosphate)) and ethinyl estradiol/norgestimate (SPRINTEC).  On 27-Oct-2007 the patient experienced an unspecified rash.  The patient contacted the office by phone and no details about the rash were provided.  The patient was not examined in the office and no treatment was required.  No further details available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a Registered Nurse (RN) concerning a 21 (reported as "20" year old in follow up) year old white female student with a history of papanicolaou smear abnormal and hypersensitivity to latex, peaches, blue dye, and green dye, who on 25-OCT-2007 at 03:00 PM was vaccinated intramuscularly into right deltoid with her first dose of GARDASIL (Lot # 650563/1063U). Concomitant therapy included KLINDAN and SPRINTEC. On 27-OCT-2007 the patient experienced an unspecified rash. The patient contacted the office by phone and no details about the rash were  provided. The patient was not examined in the office and no treatment was required. No further details available. In follow up it was reported that on 05-NOV-2007 a follow up phone call was made to discuss how long the rash lasted. No response from patient was available at the time of this report. The outcome was unknown. Additional information is not expected.