chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female patient with no previous medical history reported who on 27-MAR-2009 was vaccinated with the first dose of GARDASIL vaccine (Lot number 660616/0570X). There was no concomitant medication. On 27-MAR-2009, the patient experienced hives after receiving the first dose of GARDASIL vaccine. The patient's mother gave her BENADRYL and the hives resolved in 28-MAR-2009. The patient sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning the 19 year old female patient with no known drug allergies, with a history of acute lymphocytic leukemia with a reaction to chemotherapy who on 27-MAR-2009 at 15:00 was vaccinated with the first dose of GARDASIL vaccine (Lot number 660616/0570X) in the left deltoid. Concomitant therapy included YAZ. On 27-MAR-2009, in Friday evening the patient broke in hives, the hives started on buttocks and arms, and began itching. The mother's patient stated that she put BENADRYL on the skin and administered oral BENADRYL, the patient went to the bed, sleep and woke up fine without hives. On 28-MAR-2009, the patient recovered from hives. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 13 year old female with a history of cancer who was vaccinated with a first and second dose of GARDASIL. In September 2008, the patient experienced flu like illness. The physician had not seen the patient yet so it was unknown if the patient had this flu-like illness pre or post vaccination with the 2 doses of GARDASIL. The patient sought medical attention through a phone call. The patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Diarrhoea, Laboratory test abnormal
Clinical narrative: Information has been received from a mother concerning her 14 year old daughter, with inflammatory bowel disease and not known drug reactions/allergies, no pertinent medical history and ; who on 29-SEP-2008 was vaccinated with a dose of GARDASIL and on 06-DEC-2008 was vaccinated with another dose of GARDASIL.  Concomitant therapy included NASONEX and ALBUTEROL.  The parent reported that her daughter had inflammatory bowel disorder since August 2008.  Symptoms included diarrhea and canker sores.  An unspecified test was performed which showed that inflammatory markers were abnormal.  At the time of the report, the patient had not recovered.  The patient sought medical attention and was seen by the physician.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) concerning a 20 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2009 was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (Lot # 1702X) intramuscularly. There was no concomitant medication. It was reported that on 26-MAR-2009 the patient the patient developed cervical and inguinal lymphadenopathy. It was reported that the patient also developed "pimple-like bumps" in the groin area. The patient called to the office. There were no laboratory diagnostic tests performed. It was reported that the patient was scheduled to be examined in the office on 02-APR-2009. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated in the physician's office with a second dose of GARDASIL and experienced an episode of syncope "right after the 2nd dose". It was not specified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Furuncle
Clinical narrative: Information has been received from a consumer who in January 2008, was vaccinated first dose of with GARDASIL (dose, route and lot number not provided).  The patient stated that after she received her first doseshe got a boil several of them.  It was not specified if the patient sought medical attention.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with no known drug reaction/allergies and no pertinent medical history, who on 04-NOV-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscularly and on 03-APR-2009, was vaccinated with the second dose of GARDASIL, 0.5ml, intramuscularly.  There was no concomitant medication. The registered nurse reported that the patient experienced pain at the site of GARDASIL administration. It was noted that the patient returned late for the second dose of the vaccine. The lot number of the first dose was not available. On an unspecified date, the patient recovered. The patient sought medical attention and spoke to the nurse's practice. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient with allergy to Ceclor, who on 31-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot not reported). On 01-APR-2009 the patient developed itchy ears and jaw. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female patient with no pertinent medical history or no known drug allergies who on 04-FEB-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 661766/0652X).  There was no concomitant medication.  On 07-FEB-2009 the patient developed enlarged lymph nodes on her neck.  The nurse practitioner saw the patient on 16-FEB-2009 and the lymph node was about 1 cm in diameter.  She had been taking AUGMENTIN, to treat the symptom.  Subsequently, on an unspecified date the patient recovered.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a 27 year old female with sulfonamide allergy who "about a year ago", in approximately 2008 was vaccinated with the first dose of GARDASIL vaccine injection. Concomitant therapy included EFFEXOR and ADVAIR. "After getting the vaccine", the patient experienced a lump, itchiness and warmth at the injection site that lasted about 4 months when the patient was recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on 22-DEC-2008 was vaccinated with the first dose of GARDASIL vaccine. On 18-FEB-2009, was vaccinated with the second dose of GARDASIL vaccine. On 18-FEB-2009, the patient experienced fever and joint pain after the second dose. No adverse reactions were reported after the first dose of GARDASIL vaccine. At the time of the report the patient was recovered. The patient sought medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 30-MAR-2009 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included YAZ.  On 03-APR-2009 the patient developed 102.5 degree F fever, nausea and body aches.  The outcome was not recovered.  The patient sought medical attention by phone at office.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Autoimmune disorder
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 25-SEP-2007 was vaccinated with the first dose of GARDASIL (Lot number 0530U), on an unknown date with the second dose of GARDASIL and on 01-APR-2009 with the third dose of GARDASIL.  Within a month after received the first of GARDASIL, approximately on 25-OCT-2007, the patient experienced joint pain all over her body and an auto immune response.  The physician reported that the patient was still experienced joint pain and was given PLAQUENIL, (manufacturer unspecified) but the joint pain had not gotten worse.  At the time of reporting the patient was not recovered.  The patient sought medical attention with the physician.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 02-APR-2009, was vaccinated intramuscularly with third 0.5 mL dose of GARDASIL (lot number not reported). The physician reported that on 02-APR-2009, the patient "fainted and hit her head" after receiving the third dose of GARDASIL. The physician reported that the patient did not experience adverse events after the first and second doses of GARDASIL. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 13-NOV-2008 was vaccinated with first dose of GARDASIL (dose, route and lot number not provided). On an unspecified date after vaccination, the patient experienced amenorrhea and lighter than normal cycles. On 19-JAN-2009, the patient was vaccinated with second dose of GARDASIL (dose, route and lot number not provided). The patient was seen by her OB/GYN. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pelvic pain
Clinical narrative: Information has been received from a registered nurse, for the GARDASIL vaccine a Pregnancy Registry concerning a 17 year old female with sulfa allergy and no pertinent medical history who on 29-AUG-2008 was vaccinated with the first 0.5 mL IM dose of GARDASIL vaccine (lot # not reported). On 29-OCT-2008 received her second 0.5 mL IM dose of GARDASIL vaccine (lot# 660393/0067X) and on 30-MAR-2009 received her third GARDASIL vaccine (lot # 661531/1311X). Concomitant therapy included antibiotics (unspecified) and CLARITIN. The nurse learned that the patient was pregnant from the report that was sent by an emergency department which the patient went in due to her pelvic pain. The nurse didn't know anything about the detail of the patient's pelvic pain. LMP was not specified. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia
Clinical narrative: Information has been received from a registered pharmacist concerning her 17 year old daughter with no pertinent medical history, who on an unspecified date was vaccinated with the third dose of GARDASIL.  There was no concomitant medication.  On an unknown date, the patient developed heart arrhythmia after getting the third dose of GARDASIL lot # was not provided.  The patient sought unspecified medical attention.  At the time of reporting, the patient had not recovered.  Additional information has been requested.  7/10/09 Cardiology consult rec'd for DOS 5/12/08-6/5/09 with final dx: Wolff-Parkinson-White syndrome with supraventricular tachycardia.  Pt initially presented 5//12/08 with ~ 1wk hx of episodes of palpitations which begin and end suddenly. Also reporting joint pain in the wrists, knees and ankles.  Syncope with vomiting 7/2008.  Episode of palpitations 5/26/09 at school and RN noted HR between 200-300.  Sent to ER where the WPW dx was made.  Cardiac ablation scheduled.  7/14/09 MR recd from PCP with vax info. Several OVs 4/2008-6/2008 r/t c/o  fatigue and irregular heart rate. One episode ~2/2008. Referred to cardiologist (above). Dx: Fatigue, malaise, arthralgia, palpitation, irregular heartbeat, heart murmur..Seen 7/5/08 in f/u to sycopal episode on 7/4/08. Several month hx of fatigue, muscle aches, palpitations. Wearing a heart monitor which registered HR 32 during event. Dx: fainting.  7/15/09 ER record rec'd for 2 ER visits 6/7/08 and 5/26/09 as well as a heme/onc consult from 11/2008. Initially presented on 6/7/08 with c/o sudden onset of palpitations lasting~5 minutes. Resolved on arrival.  ..  To f/u with peds cardiology (above). Heme/onc consult 11/20/08 in f/u for von Willebrand.   Reports sensation of heart racing and fatigue, but vW in good control. ER visit 5/26/09 with dx: Wolff Parkinson-White syndrome.  SVT.   EKG abnormal-see above.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unknown date, was vaccinated with GARDASIL (lot # not reported).  Within 5 minutes after vaccination, the patient experienced vomiting.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with no drug reaction/allergies who was vaccinated with the first 0.5ml dose of GARDASIL.  After getting the first dose, the patient developed rash all over the body.  The patient recovered from rash all over the body on an unspecified date.  It was reported that the patient would not be getting the second and third dose.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a Pharm.  T.  concerning a 23 year old female with sulfonamide allergy and a history of birth control who on 16-MAR-2009 was vaccinated with the first 0.5ml dose of GARDASIL.  Concomitant therapy included YAZ.  On 21-MAR-2009 the patient developed injection site pain.  The patient was not recovered at the time of reporting.  The patient sought unspecified medical attention.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Injection site anaesthesia, Vomiting
Clinical narrative: Information has been received from a female staff member in a physician's office but not healthcare professional concerning her 14 year old daughter who on 16-MAY-2008 was vaccinated with a first dose of GARDASIL.  The patient experienced numbness on the whole arm where she had the injection, headache and vomiting after receiving the first dose of GARDASIL.  The reporter was not sure if her daughter would received the second dose.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient with no relative medical history, drug reactions or allergies who in September 2008, was vaccinated IM with her first dose of GARDASIL (lot number and site not reported).  In December 2008, the patient was vaccinated IM with her second dose of GARDASIL (lot number and site not reported).  On 25-MAR-2009, the patient was vaccinated IM with her third dose of GARDASIL (lot number 661953/1130X), site not reported).  There was no concomitant medication.  On 27-MAR-2009 the patient developed allergic symptoms.  The patient developed shortness of breath and rash all over her body.  The event persisted at this report time.  The patient went to an emergency room to seek medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Fatigue
Clinical narrative: Information has been received from a consumer concerning her daughter, a female patient, who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, site and route not reported).  On an unspecified date, the patient experienced "auto immune disease and fatigue".  The outcome of the event was not reported.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a practice manager concerning a 22 year old female patient who on 06-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number 661766/0652X, route not reported) in her left deltoid.  The patient developed left leg soreness starting from her hip and left leg tingling beginning that first night.  She was sore for two days and then the symptoms resolved.  The patient would be seen in office on the reporting date.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a female who on 03-APR-2009 was vaccinated with the second dose of GARDASIL, IM, 0.5ml.  On 03-APR-2009 the patient developed hives.  The hives were on her left arm from the injection site down to her hand.  She took BENADRYL Saturday (04-APR-2009) morning and evening and the hives were gone by Sunday (05-APR-2009).  No problems reported with her initial dose on unspecified date.  The patient was recovered on 05-APR-2009.  The patient sought medical attention to the office.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with anemia, herpes type 1 since July 2005 and sulfa allergy who on 21-OCT-2008 was vaccinated with her first dose of GARDASIL (lot # 661044/0548X) IM.  The patient experienced "flu like" symptoms after her first vaccine.  On 22-DEC-2008 the patient was vaccinated with her second dose of GARDASIL (lot # 660616/0570X) IM.  Concomitant therapy includes VALTREX and birth control therapy.  After her second vaccine on 22-DEC-2008 the patient experienced nausea and "was flat on her back for 4 days in bed with a low grade fever".  The patient called the office in March 2009 to conceal her appointment for a third dose of GARDASIL citing the previous 2 reactions.  The patient did not call the office when she experienced the reactions.  The patient would not continue the series.  Subsequently the patient recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on an unknown date, received  her second dose of GARDASIL IM 0.5mL (lot # not reported).  On 31-MAR-2009, the patient developed an injection site soreness and pain.  The patient had no other symptoms.  No lab diagnostics studies were performed.  The patient's injection site soreness and pain persisted.  The patient sought medical attention by calling the nurse.  No further information is available.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed vocational nurse concerning a female who on 04-OCT-2007 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 657006/0188U) 0.5 mL.  The patient had pain at the injection site the same day of the injection.  On 07-APR-2009, the patient was vaccinated intramuscularly with a second dose of GARDASIL (lot # 661841/0653X).  The patient had pain at the injection site but less so than the 1st dose.  As of 07-APR-2009 the injection site was tender.  The patient was seen at the office.  The patient's recovery status was listed as not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed vocational nurse concerning a female who on 04-OCT-2007 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 657006/0188U) 0.5 mL.  The patient had pain at the injection site the same day of the injection.  On 07-APR-2009, the patient was vaccinated intramuscularly with a second dose of GARDASIL (lot # 661841/0653X).  The patient had pain at the injection site but less so than the 1st dose.  As of 07-APR-2009 the injection site was tender.  The patient was seen at the office.  The patient's recovery status was listed as not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female with no pertinent medical history or drug allergies who on 04-OCT-2007 was vaccinated IM in the gluteal with a 0.5 ml first dose of GARDASIL (lot# 657006/0188U). There was no concomitant medication. On 4-OCT-2007 the patient had pain at the injection site. Subsequently the patient recovered. On 07-APR-2009 the patient was vaccinated IM in the left arm with a 0.5 ml second dose of GARDASIL (lot# 661841/0653X). The patient had pain at the injection site but less than the first dose. The injection site was tender. The patient visited the office but no laboratory diagnostics tests were performed. At the time of reporting, the patient did not recover from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female with no pertinent medical history or drug allergies who on 04-OCT-2007 was vaccinated IM in the gluteal with a 0.5 ml first dose of GARDASIL (lot# 657006/0188U). There was no concomitant medication. On 4-OCT-2007 the patient had pain at the injection site. Subsequently the patient recovered. On 07-APR-2009 the patient was vaccinated IM in the left arm with a 0.5 ml second dose of GARDASIL (lot# 661841/0653X). The patient had pain at the injection site but less than the first dose. The injection site was tender. The patient visited the office but no laboratory diagnostics tests were performed. At the time of reporting, the patient did not recover from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated
Clinical narrative: Information has been received from a physician concerning a female who was already being treated for vulvar Condyloma (genital wart) and was vaccinated with GARDASIL.  Several weeks later, the patient came back to the office because her genital warts got significantly more prevalent and worse.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (R.N.) reported that in February 2009 an unknown number of patient may had received a dose of GARDASIL which was exposed to temperature below 2 centigrade multiple times. No adverse effect was reported. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Heart rate increased, Tachycardia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an 18 year old female who on 02-APR-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # 0558X).  Concomitant therapy included MENACTRA.  On 02-APR-2009 the patient experienced dizzy and an elevated heart rate (Tachycardia) beginning several hours after her initial dose of vaccine.  The patient sought unspecified medical attention.  The symptoms persisted for several hours and resolved without treatment overnight.  The patient was recovered on 03-APR-2009.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female patient who was vaccinated with her first dose of GARDASIL (lot # 661952/1129X) "a couple of weeks ago" (approximately March 2009) and then the day after receiving the vaccine the patient experienced very heavy menstrual bleeding.  There was no concomitant medication.  It was reported that the patient called the office and the patient was told if the bleeding lasted more than one week then she would have to come into the office.  The physician reported that the patient had not come back into the office and believes the patient had recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information was received from a nurse practitioner concerning a 22 year old with a needle phobia and admitted to passing out with piercings and tattoos in the past who on 21-MAR-2009 was vaccinated with a second dose of GARDASIL. The patient subsequently experienced a syncopal episode. They sent her to the emergency department to be further evaluated. This event was not felt to be caused by GARDASIL but was believed to be caused by the needle as it occurred immediately as the injections was being given. The injections was administered. The patient was discharged from the Emergency Room. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypersensitivity, Pharyngeal oedema, Swollen tongue
Clinical narrative: Information has been received from a physician concerning a 26 year old female at a high risk to allergies, with penicillin allergy and a history of hospitalization with a reaction to sulfur from ingestion of it. On 23-MAR-2009 the patient was vaccinated with one dose of GARDASIL. On 24-MAR-2009, the next day, the patient called the office stating she had a hard time breathing, her tongue and throat started to swell. The patient went to the doctor's office and the doctor diagnosed the patient with an allergic reaction. The doctor gave the patient 10 mg montelukast sodium and 4 mg cyproheptadine hydrochloride. The patient then went to the hospital and they gave her a BENADRYL shot. At the time of this report, the outcome was unknown. Upon internal review, the patient's allergic reaction treated with BENADRYL shot was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning two 17 year old female who on an unspecified date were vaccinated with a 0.5 ml second or third dose of GARDASIL. Subsequently the patients experienced muscle pain. Subsequently, the patients recovered from muscle pain. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Bronchitis, Influenza like illness, Migraine
Clinical narrative: Information has been received from a consumer concerning her daughter, a 17 year old female patient with no relevant medical history, drug reaction or allergies, who on 10-MAR-2009 was vaccinated IM with her first 0.5 ml dose of GARDASIL (lot number and site not reported). On 27-MAR-2009, the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL (lot number and site not reported). There was no adverse event after the first dose. It was reported that the patient developed "flu like symptoms and migraines" which was diagnosed with bronchitis. The patient was brought to the hospital but not admitted after getting her second dose. Unspecified blood work was performed on an unspecified date with no result reported. The patient's mother stated that the patient was feeling better and the migraines stopped "2 or 3 days ago." The patient had sought an unspecified medical attention. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a second and third dose of GARDASIL (lot # not reported) in Oct 2007 and on 08-APR-2009, respectively. It was reported that the patient was in the office for the third dose late. The patient did not experience any known symptoms. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an unknown number of female patients with no pertinent medical history or drug allergies who were vaccinated with GARDASIL (lot # not reported). It was reported that the patients experienced injection site reactions like redness, pain, swelling and burning after getting the vaccines. At the time of reporting, the patients' outcomes were unknown. 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: Alopecia, Arthritis
Clinical narrative: Information has been received from a Registered Nurse concerning a female who on an unspecified date was vaccinated with GARDASIL and experienced arthritis and alopecia. It was unsure if it was the office patient or not. At the time of reporting the patient's outcome was unspecified. No further information is available.
Age: 46.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site rash, Paraesthesia
Clinical narrative: Information has been received from a 46 year old female with allergies to sulfa and ATARAX and no pertinent medical history who on 30-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot# not provided) injection. There was no concomitant medication. On approximately 06-APR-2009 (about a weeks after getting the vaccine), the patient started experiencing a rash at the injection site that looked like shingles. On 06-APR-2009, about 2 days ago she started experiencing excruciating pain in the arm around the injection site. The rash was still there and it was painful and tingles. The dermatologist did not think it was shingles. There was no lab and diagnostic test performed. At the time of reporting, the patient did not recover from the events. No further information is available.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old patient who on 05-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot# not reported). The physician reported that the patient had a episode of syncope within 2 minutes after the vaccination. Everything resumed as normal. There were no long term effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a patient who experienced heavy menstrual bleeding about a year ago after receiving a dose of GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no medical history and drugs allergies, who on 06-AUG-2007 was vaccinated with a first dose of GARDASIL (lot# 658558/1061U). The patient received a second dose of GARDASIL (lot#658558/1061U) on 10-NOV-2007 and a 0.5mL third dose of GARDASIL (lot # 659657/1487U) on 06-MAR-2008, intramuscularly. Concomitant therapy included NUVARING. On 21-MAR-2009 the patient tested positive for a "high risk" strain of HPV. The exact strain was not identified. The patient had a Pap smear a reflex HPV testing and a DNA HPV probe. The patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Feeling hot, Injection site pain, Lymphadenopathy, Presyncope
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old patient with no pertinent medical history and no known drug allergies who on 07-APR-2009 was vaccinated with the first dose of GARDASIL  (lot# not provided). There was no concomitant medication. Subsequently, on 07-APR-2009 the patient started feeling hot, clammy, and had blurred vision, and "had to sit down". The patient did not actually faint. She did experience some pain at the injections site and on 09-APR-2009, she called her mother and told her that her glands were swollen. No lab diagnostic studies were performed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old patient with no pertinent medical history and no known drug allergies who on 07-APR-2009 was vaccinated with the first dose of GARDASIL  (lot# not provided). There was no concomitant medication. Subsequently, on 07-APR-2009 the patient started feeling hot, clammy, and had blurred vision, and "had to sit down". The patient did not actually faint. She did experience some pain at the injections site and on 09-APR-2009, she called her mother and told her that her glands were swollen. No lab diagnostic studies were performed. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Contusion, Influenza like illness, Rash
Clinical narrative: Information has been received from a consumer concerning his 22 year old female wife who on 16-APR-2008 was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported) and on unspecified dates was vaccinated with the second and third 0.5 mL dose of GARDASIL (lot # not reported). The reporter stated that the patient experienced a rash and bruise after her first dose of GARDASIL, and after the third dose the patient was still experiencing abdominal pain, rash, weakness, and flu like symptoms. The patient talked to physician on phone. At the time of reporting, the patient had not recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a consumer concerning his 22 year old female wife who on 16-APR-2008 was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported) and on unspecified dates was vaccinated with the second and third 0.5 mL dose of GARDASIL (lot # not reported). The reporter stated that the patient experienced a rash and bruise after her first dose of GARDASIL, and after the third dose the patient was still experiencing abdominal pain, rash, weakness, and flu like symptoms. The patient talked to physician on phone. At the time of reporting, the patient had not recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Anorexia, Dizziness, Headache, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a medical assistant concerning her 12 year old daughter with no pertinent medical history reported and no known drug allergies, who on 06-APR-2009 was vaccinated in the left arm with GARDASIL (dose and route not reported, lot number 661841/0653X). Concomitant therapy included MENACTRA (administered in the left arm) and ENGERIX-B (administered in the right arm). The medical assistant reported that six to eight hours after vaccination, the patient experienced injection site pain, injection site swelling, injection site redness and the site was ridged. The patient also experienced headache, fever, nausea, some dizziness and loss of appetite. The medical assistant stated that he has been treating the patient, and she still has not fully recovered. " No labs studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning her 12 year old daughter with no pertinent medical history reported and no known drug allergies, who on 06-APR-2009 was vaccinated in the left arm with GARDASIL (dose and route not reported, lot number 661841/0653X). Concomitant therapy included MENACTRA (administered in the left arm) and ENGERIX-B (administered in the right arm). The medical assistant reported that six to eight hours after vaccination, the patient experienced injection site pain, injection site swelling, injection site redness and the site was ridged. The patient also experienced headache, fever, nausea, some dizziness and loss of appetite. The medical assistant stated that he has been treating the patient, and she still has not fully recovered. " No labs studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information hs been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDAIL (dose, route and lot number not reported). The physician reported that she heard the patient fainted after vaccination. It was not specified if the patient sought medical attention. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chills
Clinical narrative: Information has been received from a dentist concerning her 13 year old daughter who on 08-APR-2009 was vaccinated with the first dose of GARDASIL. On 09-APR-2009 the patient experienced abdominal pain and shivering. The patient's abdominal pain and shivering persisted. The patient sought unspecified medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes simplex serology, Mononucleosis heterophile test, Vaginal ulceration
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no known drug allergies/drug reactions who on 05-FEB-2009 was vaccinated with the first dose of GARDASIL (Lot # 1423X). Concomitant therapy included hormonal contraceptives (unspecified). It was reported that on 31-MAR-2009 the patient experienced "vaginal ulcer". The patient sought unspecified medical attention. "HSV testing and Mono testing" were performed (results not provided). It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Lip disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL. On 02-APR-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 659655/1486U). On 20-AUG-2008, the patient was vaccinated with the third dose of GARDASIL (lot #: 660389/1986U). Concomitant therapy included birth control pill around August 2008 and she had 3 to 4 partners at that time. It was reported that the patient had a "colposcopy in March 2009 and a lip procedure". The patient sought medical attention form the nurse practitioner/ Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2009.  Follow-up information was received from the nurse practitioner concerning the 17 year old female with no pre-existing allergies, birth defects or medical conditions who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (lot # 658490/0802U).  On 02-APR-2008 the patient was vaccinated with the second dose (lot # 659655/1486U) and on 20-AUG-2008 was vaccinated with the third dose (lot # 660389/1968U).  There was no illness at the time of vaccination.  On approximately 17-APR-2009, cervical cone was performed.  It was reported that the specimen labeled "cervix" in formalin was an unoriented, 2.5x1.5x 1.4 cm annular portion of cervical tissue.  The exocervix was tan-pink and glistening with patent.  Slit like, less than 0.1 cm.  The margin was tan, dull and granular.  The margin was inked black.  The specimen was serially suctioned sequentially and submitted in entirely in six cassettes, two pieces each, multiple levels.  It was noted that the ectocervical and endocervical margins were free of dysplasia.  The diagnosis was mild and moderate dysplasia with CIN (carcinoma intraspithelial) I and II.  Mild and moderate dysplasia with CIN (carcinoma intraspithelial) I and II was considered to an Other Important Medical Event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a healthcare worker concerning a 12 or 13 year old female patient with no relative medical history, drug reactions or allergies who in January 2009, was vaccinated IM with her second dose of 0.5 ml GARDASIL (lot number, site and route not reported). The date of the first dose was not available. There was no concomitant medication. The patient became pale and dizzy after the second dose. On an unspecified date, the patient recovered from pale and dizzy. The patient had sought medical attention in physician's office. Follow-up information was received from a certified medical assistant who reported that he didn't know the patient's name or date of birth or the date that the patient received the first dose. On 22-JAN-2009 the patient was given the second dose of GARDASIL (lot number 661764/0650X). It was reported that no other vaccines were given to the patient that day. On 22-JAN-2009, after the patient was given the vaccine, she became pale and dizzy with no syncope. At this report time, the patient recovered. No further information was reported.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 25 year old female teacher with no know drug allergy who on 01-APR-2009 was vaccinated with the first dose of GARDASIL IM 0.5 ml into deltoid (lot # 661846/1312X). On 05-APR-2009 the patient started vomiting every 0.5 hour for 12 hours accompanied with a fever. The patient felt better better but still felt dehydrated. The patient was able to eat at the report time. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test, Mucous stools, Pregnancy test positive
Clinical narrative: Information has been received from a medical assistant, for GARDASIL,  a Pregnancy Registry product, concerning her daughter, an approximately 16 year old female with penicillin allergy and history of unspecified sexually transmitted disease who in February 2009, was vaccinated with the first dose of GARDASIL, IM, 0.5ml and then was determined to be pregnant. Concomitant therapy included " a nasal spray for headaches" and Zithromax. There had been no AE related to pregnancy. The medical assistant was unable to provide her daughter's physician's name and demographic information. The medical assistant added that her daughter had also noticed mucus in her stool since she received GARDASIL. The patient had pregnancy and unspecified blood work performed. At the time of the report the patient was "11 weeks" gestation. The patient sought medical attention by office visit. Follow-up information has been received from a medical assistant concerning her daughter, a 16 year old female, who was vaccinated with the first dose of GARDASIL (lot # 661841/0653X) on 26-FEB-2009. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 19 years old female patient who was vaccinated with a complete series of GARDASIL (lot no. 658219/0755U for three doses) first dose given on 12-JUN-2008, second dose on 31-AUG-2008 and third dose on 07-JAN-2009. It was reported by the nurse that in April 2008 the patient had a  PAP smear that was negative. In March 2009 a PAP smear that was positive for atypical squamous changes and Human papilloma virus. No further evaluation has been done for this patient. The nurse considered this patient had not recovered. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: DNA antibody negative, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 27 years old female patient who was vaccinated with a complete series of GARDASIL (lot no. 654510/0962). First dose given on 06-DEC-2006, second dose on 07-FEB-2007 and third dose on 13-JUN-2007. The nurse reported that on 06-DEC-2006, the patient had a negative PAP smear. On 05-DEC-2007, a PAP smear done, showed a low grade atypical squamous changes and was reported that a lesion may have been present, no HPV test was done at this time. On 25-JUN-2008 other PAP smear came back negative and on the same date a DNA test for human papilloma virus showed a low risk detected HPV but a high risk was not detected HPV. On 17-DEC-2009, the HPV test was negative. The registered nurse considered the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a complete series of GARDASIL. It was reported that the patient now tested positive from atypical squamous changes and HPV. They were negative before beginning the vaccination series. The patient's are being treated with boric acid. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Vaginal discharge
Clinical narrative: Information has been received from a 25 year old female with no medical history and drug allergy who was vaccinated with her second dose of GARDAIL (lot number not provided) on an unspecified date. There was no concomitant medication. Subsequently, the patient experienced off white discharge after having her period. She noticed that 2-3 months after she started getting a discharge along with pain in her lower abdomen. She performed laparoscopic test. Because of the experience the patient decided she would not get her third dose of the series. The patient sought unspecified medical attention. Additional information hs been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information hs been received from a consumer concerning a 10 year old female who was vaccinated with GARDASIL. Then the patient started to feel very sick and was "a completely different person". No further information is available.