chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This is in follow-up to report (s) submitted on 2/11/2009. Information has been received from a receptionist in a physician's office concerning her daughter who on 28-JAN-2009 was vaccinated with the fourth dose of GARDASIL (lot # unspecified). In addition, the patient's arm is sore at the injection site. The outcome is unknown. It was reported that the  patient was vaccinated with the first, second and third dose of GARDASIL on 18-AUG-2007, 04-JAN-2008 and 14-MAY-2008 respectively. Follow-up information was received from teh physician reported that she does not have additional information. The patient sought unspecified medical attention. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner and the mother concerning a 16 year old female with no medical history and drug allergies who on 28-JAN-2009 11:45 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 661703/0651X) IM in the left arm. On the same day the patient was also vaccinated with a dose of HAVRIX into the right arm. There was no other concomitant medication. About an hour later after the patient went to school she blanked out in class. This was after 12:30. The teacher thought the patient was sleeping because her head was down and he called her name. The kids in class shook her and she woke up. She lost consciousness for about 5 minutes. The patient said that she did not hear any of the lessons. The patient was recovered after she was shaken on the same day. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness, Dyspnoea, Wheezing
Clinical narrative: Initial information has been received from an office staff member and follow up information has been received from a nurse concerning a female patient who in approximately January 2009 was vaccinated with the first dose of GARDASIL (lot # not available). The patient became lightheaded and went to the emergency room after receiving the vaccine (approximately January 2009). The patient becoming lightheaded was considered another important medical event by the reporter because the patient went to the emergency room. Additional information has been requested.  In the follow-up the nurse stated that the vaccine was ordered by a nurse practitioner. The patient was 13 year old and was vaccinated with the first dose of GARDASIL (Lot # 659055/05060X) on 22-OCT-2008. The nurse reported that within 5 minutes of receiving the vaccination, the patient became dizzy and lightheaded. The patient complained of shortness of breath. The nurse practitioner evaluated the patient and had her transported to the emergency room. The patient was evaluated in the emergency room. The patient was wheezing and was given a breathing treatment. The patient was not admitted to the hospital. The patient had recovered and the following day returned to school. The patient becoming lightheaded was considered another important medical event by the reporter because the patient went to the emergency room. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Acrochordon, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who in July 2008 "6 months ago" was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that the patient developed skin tags under each of her arms a few days after receiving her first dose of GARDASIL. It was reported that the number of skin tags increased after receiving her second dose. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia oral, Rash pruritic, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with asthma who on 25-NOV-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 660016/0570X). Concomitant therapy included MSD, ALBUTEROL (unspecified) and influenza virus vaccine (unspecified). The patient developed a pruritic rash after administration of her first dose of GARDASIL. On 26-JAN-2009 the patient received her second dose GARDASIL (Lot # 661841/0653X). Concomitant therapy included MENACTRA. It was reported that the patient developed a pruritic rash and tingling in her tongue. She was treated with BENADRYL.  At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning 3 female patients who fainted after receiving the first dose of GARDASIL. Medical attention was sought. The patients recovered 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.
Sex: F
Vaccine: HPV4
Symptoms: Erythema nodosum
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date received the first dose of GARDASIL. In September 2008, the patient was vaccinated with the second dose of GARDASIL (lot # was not available). In November 2008, the patient developed erythema nodosum on her two legs. The patient's erythema nodosum on her two legs persisted. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL and her hair started falling out. The patient's mother called the clinic. At the time of reporting, the outcome was unspecified. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL (Lot # not reported).  After patient received the vaccine experienced an unspecified side effect.  The physician who reported the adverse experience did not administer the vaccine.   Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Diarrhoea, Fatigue, Influenza like illness, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with polycystic ovarian syndrome, a history of thoracic sympathectomy for excessive sweating, and not known drug allergies, who on 27-JAN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 1423X), intramuscularly. Concomitant therapy included MIRCETTE and prenatal vitamins (unspecified). That evening the patient had episodes of diarrhea, flu like feeling, fatigue, achiness and chills. The symptoms persisted and the patient stated that she started to develop tingling in her lower legs and feet on 29-JAN-2009. The registered nurse requested that the patient took her temperature and it was 98.4 degrees F. The patient sought medical attention through a phone call. At the time of this report the patient had not recovered. Additional information has been requested.4/8/09records received-presented in ED on 2/2/09 with C/O pins and needles in legs and hands s/p  gardasil vaccine. Paresthesia and weakness lower extremities. Mild shortness of breath. PE RLE 4/5 LUE 4/5. No actual motor weakness.   DX: Mild Guillain Barre secondary to vaccination.  This is in follow-up to report (s) previously submitted on 2/13/2009.  Follow up information received on 19-FEB-2009 stated that the patient received a first dose of GARDASIL (lot # 1423X), intramuscularly into the left deltoid on 27-JAN-2009 at approximately 12:00.  The patient had a sympathectomy in 1999 for excessive sweating.  It was also reported that the patient called to the physicians office on 29-JAN-2009 complaining of fatigue, diarrhea and flu like symptoms starting a few hours after administration of GARDASIL.  The patient also complained of "tingling of feet".  On 01-FEB-2009 the patient called for increasing numbness on legs, the patient went to E.R. on 02-FEB-2009 for numbness and saw the neurologist who prescribed NEURONTIN.  Follow up information received on 27-FEB-2009 from the physician's secretary; she provided the patient's last name.  It was also stated that the patient was in contact with the physician by phone on 24-FEB-2009 and she told the physician that she was going to a rehab center for physician therapy two times a week for about a month, to "get resolution of symptoms".  The secretary could not find the name of the neurologist in the chart, nor was there any mention of recovery for the other events.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with polycystic ovarian syndrome, a history of thoracic sympathectomy for excessive sweating, and not known drug allergies, who on 27-JAN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 1423X), intramuscularly. Concomitant therapy included MIRCETTE and prenatal vitamins (unspecified). That evening the patient had episodes of diarrhea, flu like feeling, fatigue, achiness and chills. The symptoms persisted and the patient stated that she started to develop tingling in her lower legs and feet on 29-JAN-2009. The registered nurse requested that the patient took her temperature and it was 98.4 degrees F. The patient sought medical attention through a phone call. At the time of this report the patient had not recovered. Additional information has been requested.4/8/09records received-presented in ED on 2/2/09 with C/O pins and needles in legs and hands s/p  gardasil vaccine. Paresthesia and weakness lower extremities. Mild shortness of breath. PE RLE 4/5 LUE 4/5. No actual motor weakness.   DX: Mild Guillain Barre secondary to vaccination.  This is in follow-up to report (s) previously submitted on 2/13/2009.  Follow up information received on 19-FEB-2009 stated that the patient received a first dose of GARDASIL (lot # 1423X), intramuscularly into the left deltoid on 27-JAN-2009 at approximately 12:00.  The patient had a sympathectomy in 1999 for excessive sweating.  It was also reported that the patient called to the physicians office on 29-JAN-2009 complaining of fatigue, diarrhea and flu like symptoms starting a few hours after administration of GARDASIL.  The patient also complained of "tingling of feet".  On 01-FEB-2009 the patient called for increasing numbness on legs, the patient went to E.R. on 02-FEB-2009 for numbness and saw the neurologist who prescribed NEURONTIN.  Follow up information received on 27-FEB-2009 from the physician's secretary; she provided the patient's last name.  It was also stated that the patient was in contact with the physician by phone on 24-FEB-2009 and she told the physician that she was going to a rehab center for physician therapy two times a week for about a month, to "get resolution of symptoms".  The secretary could not find the name of the neurologist in the chart, nor was there any mention of recovery for the other events.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who on 13-MAY-2008 was vaccinated with first dose of GARDASIL (Lot # not reported).  On 14-JUL-2008 patient received second dose of GARDASIL (Lot # not reported) 0.5ml.  After the second dose of vaccine patient developed allergic reaction.  Patient received third dose of GARDASIL (Lot # not reported) on 18-NOV-2008.  On approximately 18-NOV-2008.  The adverse event disappeared after got third dose of vaccine.  This is one of two reports from the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history who on 30-DEC-2008 was vaccinated with the third 0.5 ml dose of GARDASIL vaccine (lot# unspecified). There was no concomitant medication. On 04-JAN-2009 the patient experienced hives all over the body, itching and burning. The patient recovered on 13-JAN-2009. The first  dose was administered on 19-JUN-2008 and second dose on 19-AUG-2009. The patient sought unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information was received from a registered nurse (R.N.) concerning the 18 year old female patient with seasonal allergies who on 30-DEC-2008 at 2:30 PM was vaccinated in the left deltoid with her third dose of GARDASIL vaccine (lot# 661530/0575x). There was no illness at the time of vaccination and adverse event following prior vaccination. On 04-JAN-2009 at 3:00 AM the patient experienced hives on the whole body which burned and were pruritus. The patient saw an allergist who felt it was related to GARDASIL vaccine. Hives lasted through 13-JAN-2009 and finally disappeared. The patient was recovered on 13-JAN-2009. No relelvant diagnostic tests or laboratory data was collected. The patient sought unspecified medical attention. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning an unknown number of patients who were vaccinated with a dose of GARDASIL and experienced pain after vaccination.  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.  Follow information received on 30-JAN-2009 stated that the reporter didn't had more information to provide.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female with a history of dysmenorrhea and pelvic pain as well as no known drug allergies who was 08-FEB-2008 vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# 655327/1287U). There was no concomitant medication or lab diagnostics. On an unspecified date the patient experienced pain in the same arm she received her first dose of GARDASIL. The patient was not able to lift her arm. At the time of reporting the patient was recovered. Follow up information was received from the physician's office asked if they are required to fill out the AE form that was sent to them regarding this AE. No follow up information was provided. The patient sought medical attention by visiting the physician's office. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an approximately 14 year old female who was vaccinated with the first 0.5 ml dose of GARDASIL, VARIVAX (Merck) and hepatitis A vaccine (manufacturer unknown) a few weeks ago.  She was told to wait in the lobby for 15 minutes before she was supposed to leave.  While walking to the lobby the patient fainted.  No injuries occurred.  No lot number was provided.  The patient was recovered few weeks ago.  The patient sought medical attention.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Headache, Mood altered, Nasal congestion, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient experienced persistent headache. The patient contacted the physician regarding the persistent headache.  The outcome of the patient's experience was unknown. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow-up information has been received from the physician concerning a 16 year old female with sleep difficulty and a history of wisdom teeth extracted in September 2008 and allergy to PROACTIV, who on 13-AUG-2008 was vaccinated with a first dose of GARDASIL (lot number 0250X). On 30-OCT-2008 the patient was vaccinated with a second dose of GARDASIL (lot number 0947X) (injection site and route not reported). Concomitant therapy included topical acne medication. On 23-AUG-2008 the patient experienced severe frontal headache. The physician reported that the patient was not able to swim and experienced mood changes. The patient was examined by a dentist, neurologist and ophthalmologist. MRI was normal except for minimal paranasal sinus disease. The patient was treated with antibiotics for nasal congestion. The patient experienced syncope while swimming and was taken to the Emergency Room. The patient was not admitted. The patient started ELAVIL on 17-OCT-2008. The physician reported that the patient's symptoms resolved since starting ELAVIL. The physician stated that the patient was not going to be administered her third dose of GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Sinus disorder, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient experienced persistent headache. The patient contacted the physician regarding the persistent headache.  The outcome of the patient's experience was unknown. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow-up information has been received from the physician concerning a 16 year old female with sleep difficulty and a history of wisdom teeth extracted in September 2008 and allergy to PROACTIV, who on 13-AUG-2008 was vaccinated with a first dose of GARDASIL (lot number 0250X). On 30-OCT-2008 the patient was vaccinated with a second dose of GARDASIL (lot number 0947X) (injection site and route not reported). Concomitant therapy included topical acne medication. On 23-AUG-2008 the patient experienced severe frontal headache. The physician reported that the patient was not able to swim and experienced mood changes. The patient was examined by a dentist, neurologist and ophthalmologist. MRI was normal except for minimal paranasal sinus disease. The patient was treated with antibiotics for nasal congestion. The patient experienced syncope while swimming and was taken to the Emergency Room. The patient was not admitted. The patient started ELAVIL on 17-OCT-2008. The physician reported that the patient's symptoms resolved since starting ELAVIL. The physician stated that the patient was not going to be administered her third dose of GARDASIL. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Antibody test negative, Arthralgia, Borrelia burgdorferi serology negative, Chest pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who in November 2006, was vaccinated with GARDASIL IM for her first dose. The patient experienced flu like reactions after the first dose such as headache, fever, nausea and dizziness. The patient received the second dose of GARDASIL IM on 09-JAN-2007 and experienced sore arm (unspecified which arm). The patient received the third dose of GARDASIL IM on 24-MAY-2007. The patient was having unusual joint pain (all over but mostly in the knees), excessive fatigue, moments of shortness of breath, lots of muscle weakness, period of stomach aches, dizziness (may have been related to fluid in the ears), and chest pain on exercising. It was unspecified the time period all these symptoms occurred. The patient remembered having stomach problems but not sure as to the timing of the onset of the problem in relation to the third dose. The patient was last seen in the office on 22-JAN-2009 and was not doing any better. The patient had also sought medical attention by phone calls and office visits. Additional information has been requested.  3/6/09 Received PCP medical records of 4/12/2008-1/27/2009. FINAL DX: polyarthralgia Records reveal patient experienced feeling feverish, sore throat, fall from horse w/o LOC or injury then developed frontal HAs, LUQ pain after meals, fatigue.  RTC 10/08 w/left hip pain, dx w/greater trochanter tendinitis w/early ileatal band syndrome.  RTC 12/08 w/dry nonproductive cough x 2 wks, dx bronchitis & tx w/oral antibiotics.  RTC 1/09 w/recurrent cough, difficulty breathing, fatigue, muscle aches, HA & dizziness.  Dx w/recurrent bronchitis.  RTC 1/14 w/persisting HA, resolved dizziness & persistent muscle/joint aching.  RTC 1/27/09 & reports having flu-like s/s after initial HPV vaccine.  Referred to Neuro when CT head neg but no record available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Dyspnoea, Epstein-Barr virus antibody negative, Fatigue
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who in November 2006, was vaccinated with GARDASIL IM for her first dose. The patient experienced flu like reactions after the first dose such as headache, fever, nausea and dizziness. The patient received the second dose of GARDASIL IM on 09-JAN-2007 and experienced sore arm (unspecified which arm). The patient received the third dose of GARDASIL IM on 24-MAY-2007. The patient was having unusual joint pain (all over but mostly in the knees), excessive fatigue, moments of shortness of breath, lots of muscle weakness, period of stomach aches, dizziness (may have been related to fluid in the ears), and chest pain on exercising. It was unspecified the time period all these symptoms occurred. The patient remembered having stomach problems but not sure as to the timing of the onset of the problem in relation to the third dose. The patient was last seen in the office on 22-JAN-2009 and was not doing any better. The patient had also sought medical attention by phone calls and office visits. Additional information has been requested.  3/6/09 Received PCP medical records of 4/12/2008-1/27/2009. FINAL DX: polyarthralgia Records reveal patient experienced feeling feverish, sore throat, fall from horse w/o LOC or injury then developed frontal HAs, LUQ pain after meals, fatigue.  RTC 10/08 w/left hip pain, dx w/greater trochanter tendinitis w/early ileatal band syndrome.  RTC 12/08 w/dry nonproductive cough x 2 wks, dx bronchitis & tx w/oral antibiotics.  RTC 1/09 w/recurrent cough, difficulty breathing, fatigue, muscle aches, HA & dizziness.  Dx w/recurrent bronchitis.  RTC 1/14 w/persisting HA, resolved dizziness & persistent muscle/joint aching.  RTC 1/27/09 & reports having flu-like s/s after initial HPV vaccine.  Referred to Neuro when CT head neg but no record available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Headache, Influenza like illness, Metabolic function test normal, Middle ear effusion
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who in November 2006, was vaccinated with GARDASIL IM for her first dose. The patient experienced flu like reactions after the first dose such as headache, fever, nausea and dizziness. The patient received the second dose of GARDASIL IM on 09-JAN-2007 and experienced sore arm (unspecified which arm). The patient received the third dose of GARDASIL IM on 24-MAY-2007. The patient was having unusual joint pain (all over but mostly in the knees), excessive fatigue, moments of shortness of breath, lots of muscle weakness, period of stomach aches, dizziness (may have been related to fluid in the ears), and chest pain on exercising. It was unspecified the time period all these symptoms occurred. The patient remembered having stomach problems but not sure as to the timing of the onset of the problem in relation to the third dose. The patient was last seen in the office on 22-JAN-2009 and was not doing any better. The patient had also sought medical attention by phone calls and office visits. Additional information has been requested.  3/6/09 Received PCP medical records of 4/12/2008-1/27/2009. FINAL DX: polyarthralgia Records reveal patient experienced feeling feverish, sore throat, fall from horse w/o LOC or injury then developed frontal HAs, LUQ pain after meals, fatigue.  RTC 10/08 w/left hip pain, dx w/greater trochanter tendinitis w/early ileatal band syndrome.  RTC 12/08 w/dry nonproductive cough x 2 wks, dx bronchitis & tx w/oral antibiotics.  RTC 1/09 w/recurrent cough, difficulty breathing, fatigue, muscle aches, HA & dizziness.  Dx w/recurrent bronchitis.  RTC 1/14 w/persisting HA, resolved dizziness & persistent muscle/joint aching.  RTC 1/27/09 & reports having flu-like s/s after initial HPV vaccine.  Referred to Neuro when CT head neg but no record available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who in November 2006, was vaccinated with GARDASIL IM for her first dose. The patient experienced flu like reactions after the first dose such as headache, fever, nausea and dizziness. The patient received the second dose of GARDASIL IM on 09-JAN-2007 and experienced sore arm (unspecified which arm). The patient received the third dose of GARDASIL IM on 24-MAY-2007. The patient was having unusual joint pain (all over but mostly in the knees), excessive fatigue, moments of shortness of breath, lots of muscle weakness, period of stomach aches, dizziness (may have been related to fluid in the ears), and chest pain on exercising. It was unspecified the time period all these symptoms occurred. The patient remembered having stomach problems but not sure as to the timing of the onset of the problem in relation to the third dose. The patient was last seen in the office on 22-JAN-2009 and was not doing any better. The patient had also sought medical attention by phone calls and office visits. Additional information has been requested.  3/6/09 Received PCP medical records of 4/12/2008-1/27/2009. FINAL DX: polyarthralgia Records reveal patient experienced feeling feverish, sore throat, fall from horse w/o LOC or injury then developed frontal HAs, LUQ pain after meals, fatigue.  RTC 10/08 w/left hip pain, dx w/greater trochanter tendinitis w/early ileatal band syndrome.  RTC 12/08 w/dry nonproductive cough x 2 wks, dx bronchitis & tx w/oral antibiotics.  RTC 1/09 w/recurrent cough, difficulty breathing, fatigue, muscle aches, HA & dizziness.  Dx w/recurrent bronchitis.  RTC 1/14 w/persisting HA, resolved dizziness & persistent muscle/joint aching.  RTC 1/27/09 & reports having flu-like s/s after initial HPV vaccine.  Referred to Neuro when CT head neg but no record available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information has been received from Merck Pregnancy Registry for GARDASIL vaccine from a Nurse practitioner concerning an 18 year old female with AUGMENTIN allergy and no  pertinent medical history who on 06-OCT-2-008 was vaccinated with first dose of GARDASIL vaccine (Lot # not reported). Concomitant therapy included ZOFRAN. On 08-DEC-2008 she received second dose of GARDASIL (Lot # not reported). When she received second dose of vaccine she was pregnant. Patient had last menstrual period on 13-NOV-2008. Estimated date of delivery was 29-AUG-2009. The patient received out patient IV therapy for hyperemesis. Ultrasound was performed to confirm pregnancy. Additional information has been requested.  This is in follow-up to reports (s) previously submitted on 2/13/2003.  Follow up information has been received from a nurse practitioner concerning a 18 year old female, on 15-JAN-2009 and ultrasound was made and showed that the foetus has 8 weeks and 2 days old. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 25-MAR-2008 was vaccinated with first dose of GARDASIL (Lot # not reported). On 27-MAY-2008 she received second dose of GARDASIL (Lot # not reported) 0.5ml. After the second dose of vaccine she developed serious allergic reaction. She received third dose of GARDASIL (Lot # not reported) on 28-SEP-2008. The adverse event disappeared after got third dose of vaccine. The patient sought unspecified medical attention. This is one of two reports from the same source. Upon internal review, serious allergic reaction was considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 23-Jan-2009 was vaccinated in arm with the second dose of GARDASIL vaccine. On 24-JAN-2009, the patient developed a rash all over her body. It was reported that the patient does not plan on receiving a third dose. Lot number was not available. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a 22 year old female patient with yeast hypersensitivity, no drug/reactions allergies who on 23-JAN-2009 was vaccinated with a 0.5 mL dose of GARDASIL vaccine. Concomitant therapy included hormonal contraceptives (unspecified). "Eight hours after receiving the GARDASIL vaccine", the patient experienced a rash on her legs. The patient sought unspecified medical attention. There were no laboratory or diagnostic tests performed. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 17 year old female with drug hypersensitivity and allergic reaction to AMOXICILLIN and  CODEINE who on 31-OCT-2008 was vaccinated with a first dose of GARDASIL vaccine. The patient received a second dose of GARDASIL vaccine (Lot #661046/0546X). There was no concomitant medication. 4 days after vaccination with the second dose of GARDASIL vaccine the patient developed persisting injection site pain lasting more than 5 days, the patient was vaccinated in the deltoid with a 1 inch needle. The patient was treated with hot compresses and anti inflammatory medication. After the first dose of GARDASIL vaccine she had pain, but it resolved in a few days. No laboratory studies performed. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Follow up information received on 30-JAN-2009 stated that the patient had called back the physician with injection site pain 10 days after the GARDASIL vaccine was administered. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Furuncle, Injection site pustule, Purulence
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history and no known drug allergies, who on 21-NOV-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 661530/0575X) 0.5 ml intramuscularly. There was no concomitant medication. The patient experienced puss-filled boils around the site of injection (2008). The boils "come and go" for the last eight weeks. She had had a total of 8-10 boils so far. The patient had a tattoo on her left arm (around the deltoid area) which she had had for years prior to receiving the vaccine. The patient's puss-filled boils around the site of injection persisted. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain, Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old female patient with asthma, allergies an allergies to penicillin, CECLOR, and CIPRO who was vaccinated on an unspecified date with the first and second doses of GARDASIL. Concomitant therapy included BACTRIM, Albuterol , and allergy immunotherapy and allergy medication. The patient was given GARDASIL in the gluteal area for both doses. The patient developed pain at injection site after receiving each dose and pain had not resolved. The patient also experienced fever and malaise fro several days after both doses. Malaise and fever had resolved.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Culture urine, Diarrhoea, Eosinophil count increased, Full blood count
Clinical narrative: Information has been received from a RN concerning a 16 year old female who was vaccinated with her first dose of GARDASIL on an unspecified date (injection). The patient developed "flu-like" symptoms and diarrhea the next day after receiving the first dose of GARDASIL. Lot # is not available. The patient sought medical attention by visiting the nurse's office. Additional information has been requested. Information has been received from a physician concerning a 16 year old female with nuts allergy who on 19-JAN-2009 at 12:30 was vaccinated with the third dose of GARDASIL (lot# 661841/0653X). On 12-JAN-2009 the patietn experienced vomiting (2 days), diarrhea, stomach pain and fever after the third dose of vaccine received. The patient experienced vomiting since 21-JAN-2009. Relevant diagnostic tests or laboratory tests included complete blood cell with differenctial/pltelet test, comprehensive metabolic panel test, urinalysis (routine), lipid panel test, urine culture (routine) and venipuncture test. Results indicated blood eosinophilic leukocyte count and absolute blood eosinophilic  leukocyte count were high (8 and 0.5x10H3/uL respectively, reference level: 0-4 and 0.0-0.4 x10K0/uL respectively). The apperance of urine was turbid abnormal. Occult blood test indicated trace abnormal. The outcome was unknown. The patient sought medical attention by visiting the nurse's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Lipids, Metabolic function test, Occult blood positive, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 16 year old female who was vaccinated with her first dose of GARDASIL on an unspecified date (injection). The patient developed "flu-like" symptoms and diarrhea the next day after receiving the first dose of GARDASIL. Lot # is not available. The patient sought medical attention by visiting the nurse's office. Additional information has been requested. Information has been received from a physician concerning a 16 year old female with nuts allergy who on 19-JAN-2009 at 12:30 was vaccinated with the third dose of GARDASIL (lot# 661841/0653X). On 12-JAN-2009 the patietn experienced vomiting (2 days), diarrhea, stomach pain and fever after the third dose of vaccine received. The patient experienced vomiting since 21-JAN-2009. Relevant diagnostic tests or laboratory tests included complete blood cell with differenctial/pltelet test, comprehensive metabolic panel test, urinalysis (routine), lipid panel test, urine culture (routine) and venipuncture test. Results indicated blood eosinophilic leukocyte count and absolute blood eosinophilic  leukocyte count were high (8 and 0.5x10H3/uL respectively, reference level: 0-4 and 0.0-0.4 x10K0/uL respectively). The apperance of urine was turbid abnormal. Occult blood test indicated trace abnormal. The outcome was unknown. The patient sought medical attention by visiting the nurse's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis, Vaccine positive rechallenge, Venipuncture, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a RN concerning a 16 year old female who was vaccinated with her first dose of GARDASIL on an unspecified date (injection). The patient developed "flu-like" symptoms and diarrhea the next day after receiving the first dose of GARDASIL. Lot # is not available. The patient sought medical attention by visiting the nurse's office. Additional information has been requested. Information has been received from a physician concerning a 16 year old female with nuts allergy who on 19-JAN-2009 at 12:30 was vaccinated with the third dose of GARDASIL (lot# 661841/0653X). On 12-JAN-2009 the patietn experienced vomiting (2 days), diarrhea, stomach pain and fever after the third dose of vaccine received. The patient experienced vomiting since 21-JAN-2009. Relevant diagnostic tests or laboratory tests included complete blood cell with differenctial/pltelet test, comprehensive metabolic panel test, urinalysis (routine), lipid panel test, urine culture (routine) and venipuncture test. Results indicated blood eosinophilic leukocyte count and absolute blood eosinophilic  leukocyte count were high (8 and 0.5x10H3/uL respectively, reference level: 0-4 and 0.0-0.4 x10K0/uL respectively). The apperance of urine was turbid abnormal. Occult blood test indicated trace abnormal. The outcome was unknown. The patient sought medical attention by visiting the nurse's office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Hepatitis, Infectious mononucleosis, Malaise
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female student with a slight temperature at the time of vaccination (99.9 degrees) (weight 110 pounds, height 60.5 inches) who on the morning of 09-JAN-2009 was vaccinated in the arm with a first dose of GARDASIL.  Concomitant therapy included DORYX, DIFFERIN and FEMCON.  It was reported that the patient after receiving GARDASIL began feeling ill later that evening.  The nurse stated that the patient went to pediatric physician twice and was diagnosed with mononucleosis and mononucleosis caused hepatitis.  The nurse indicated that the patient's mother believes GARDASIL caused or worsened the condition.  Patient not recovered.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a respiratory therapist concerning a 11 year old female patient with no pertinent medical history and no known drug allergies, who on 26-JAN-2009 was vaccinated with the first dose of GARDASIL (lot# 661703/0651X) 0.5 ml intramuscularly. Concomitant therapy included CLARITIN. On 26-JAN-2009, four minutes after receiving the injection, the patient experienced pain, swelling and redness at the injection site, and the area was hot to the touch. The patient applied ice to the area. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Eye irritation, Lacrimation increased
Clinical narrative: Information has been received from a physician concerning a 48 year old female licensed nurse practitioner with sulfanomide allergy who was administering GARDASIL when the needle broke and some of the vaccine splashed into her left eye. The left eye was watering a little and a tiny bit of burning. The eye was being irrigated. The needle used was not from a pre filled syringe. The patient sought medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who was vaccinated with a first dose of GARDASIL, lot number not reported. The nurse stated that one of the patient's ankles swelled after receiving the GARDASIL vaccine. The patient sought unspecified medical attention. Her outcome is unknown. Additional information has been requested. Follow-up information has been received from a nurse concerning the patient. It was reported that she did not recall the patient's name and was not able to access the information. She also did not know her date of birth, vaccine dates or the lot numbers for those vaccines. She noted that thee patient had a job which required her to be on her feet, so she felt as though the AE of joint swelling was due to her job and not to her exposure to GARDASIL vaccine. The nurse stated that the patient had not been back to see them, sho she figured she had recovered. Also she said that she was not aware that the patietn required any treatment for the swelling. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician assistant concerning a female patient who "experienced a severe headache after her first dose of GARDASIL (lot # not provided).  She recovered by experienced a severe headache again after receiving her second dose of GARDASIL (lot # not provided).  Patient sought unspecified medical attention and dose not plan on receiving a third dose.  At the time of this report patient had recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with attention deficit disorder and depression who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (no lot# provided). In October 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (no lot# provided) 0.5 ml and has not got her menstrual cycle. Patient sought unspecified medical attention. At the time of the report the patient had not yet recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 25-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # 659962/1740U) intramuscularly. There was no concomitant medication. It was reported that on 26-JUN-2008 the patient experienced a fever and muscle aches and the symptoms resolved on approximately 30-JUN-2008. On 27-AUG-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 660555/0279X). On 28-AGU-2008 the patient developed a rash on her trunk. It was reported that the rash resolved on 30-AUG-2008. The patient called health department. This is one of several cases from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.  Follow up information was received on 13-FEB-2009 from a registered nurse concerning a 15 years old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U) intramuscularly into her right deltoid.  Concomitant vaccination included a first dose of TDAP (Lot # C2889AA) intramuscularly into her left deltoid.  ON 25-JUN-2008, The patient developed high fever and muscle aches that continued for 3-5 days.  The patient did not seek medical attention.  On 27-AUG-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660585/0279X), intramuscularly into her left deltoid.  Concomitant vaccination on 27-AUG-2008 included MENACTRA (Lot # U2638AA) intramuscularly into her right deltoid.  It was reported that on 28-AUG-2008 all over rash on trunk for 3 days.  The patient did not seek medical attention.  This is one of several cases from the same source.  Additonal information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from nurse practitioner concerning a "high school age" female patient who on unspecified date was vaccinated with two doses of GARDASIL vaccine. It was reported that the patient fainted after receiving her second dose of GARDASIL vaccine. I was reported that the patient recovered shortly after fainting. The patient sought medical attention. This is one of several cases from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Headache, Learning disorder, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a consumer concerning her daughter who on 18-Apr-2008 was vaccinated with the first 0.5ml dose of GARDASIL. After getting the first dose the patient experienced joint pain in back, hip and knees. On 16-Jul-2008 received the second dose of HPV vaccine and experienced fainting, dizziness, headache, trouble comprehending in school and joint pains. At the time of reporting the mother's patient stated that daughter still had headaches and dizziness. The patient sought unspecified medical attention. Additional information has been requested.  6/19/09 Medical records received DOS 4/4/08 to 5/08/09. Assessment: Insomnia, weight loss, otitis externa acute, depression with anxiety Patient became pale and c/o blurred vision, dizziness. Difficulty walking, lightheaded. Later otalgia, URI. Aching joints - hip, back, knee. Headache, abdominal pain, anxiety. Coughing, nose congestion with headaches, postnasal drip, sore throat. acute sinusitis, dyspnea. Hyperactivity. PTSD. ICD-9 Codes: 780.52, 783.21, 380.10, 300.4, 461.9 786.2 786.09, 784.0 789.07, 300.00, 995.20, 780.4, 388.70, V65.40, 465.9, V04.89
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter who on 18-Apr-2008 was vaccinated with the first 0.5ml dose of GARDASIL. After getting the first dose the patient experienced joint pain in back, hip and knees. On 16-Jul-2008 received the second dose of HPV vaccine and experienced fainting, dizziness, headache, trouble comprehending in school and joint pains. At the time of reporting the mother's patient stated that daughter still had headaches and dizziness. The patient sought unspecified medical attention. Additional information has been requested.  6/19/09 Medical records received DOS 4/4/08 to 5/08/09. Assessment: Insomnia, weight loss, otitis externa acute, depression with anxiety Patient became pale and c/o blurred vision, dizziness. Difficulty walking, lightheaded. Later otalgia, URI. Aching joints - hip, back, knee. Headache, abdominal pain, anxiety. Coughing, nose congestion with headaches, postnasal drip, sore throat. acute sinusitis, dyspnea. Hyperactivity. PTSD. ICD-9 Codes: 780.52, 783.21, 380.10, 300.4, 461.9 786.2 786.09, 784.0 789.07, 300.00, 995.20, 780.4, 388.70, V65.40, 465.9, V04.89
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood HIV RNA, HIV test, HIV test positive
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient who on 26-NOV-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL.  It was reported that a HIV test performed on 26-NOV-2008 showed she was IgA positive.  A western blot test had an  indeterminate result.  On 05-DEC-2008 the viral load was 0.  On 07-JAN-2009 another HIV EIA ELISA showed she was IgA positive and the Western Blot result was indeterminate.  The nurse stated that the results were the same for both dates.  Additional information has been requested.