chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 20-something year old female who on approximately 11-MAR-2008 was vaccinated with her third dose of GARDASIL (lot number not specified). On approximately 11-MAR-2008 the patient experienced a severe rash. The patient sought unspecified medical treatment. It is not known if the patient's rash persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received form a health professional concerning a 14 year old female with a viral infection and a sore throat for 2-3 days prior to injection who on 24-MAR-2008 was IM vaccinated with a pre filled syringe of GARDASIL (lot number 660387/1967U). On 25-MAR-2008 the patient fainted in the shower and bumped her head. The patient did not have a fever on 24-MAR-2008 when the vaccine was administered. The patient has had a suspected viral infection with a sore throat for the last 2-3 days. On 25-MAR-2008 the patient's temperature was 99.7 measured orally. The mother reported that the patient did not have any history of sncope, and the patient did not have any lumps following syncope and was going to be examined by the family physician. This is one of several reports from the same source. Additional information has been requested. This is one of several reports from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 19-MAR-2008 was IM vaccinated in the right deltoid with Gardasil (lot number 659964/1978U). On 24-MAR-2008 the patient experienced redness, a hive like rash and swelling from shoulder to elbow. The patient phoned the physician to report the adverse reaction on 24-Mar-2008. The patient was not seen and no treatment was recommended. There were no other symptoms reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who on 18-JUN-2007 was vaccinated with her first dose of Gardasil (lot number unspecified) and then developed Lyme disease.  The patient started treatment for the Lyme disease on "18-Aug-2008", as originally reported.  The second dose of vaccine was delayed because the patient was treated with antibiotics.  The patient's Lyme disease persisted.  Additional information has been requested. Additional information is not expected, numerous attempts to contact the physician were unsuccessful.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a female who on 05 SEP-2007 was IM vaccinated with her first dose of GARDASIL (654539/0242U). On 21-Nov-2007 the patient was IM vaccinated with her second dose of GARDASIL (lot number 654519/0742U). Subsequently the patient experienced nausea and dizziness after both doses. The patient sought unspecified medical treatment which included the patient's mother calling the physician. Subsequently, the patient recovered from nausea and dizziness. Additional information has been requested. This is in follow-up to rep(s) previously submitted on 4/14/2008.  On 01-Apr-2008 the patient reported receiving her third dose of GARDASIL (lot number 654540/1290U).  Concomitant medication included vaccination with meningococcal ACYW conj vaccine (dip toxoid) on 05-Sep-2007.  Follow up information clarified the initial discrepancy of the third dose date.  It was also reported that when the patient received her third dose, she was placed in a supine position and the patient did not feel as if she were going to pass out.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated on an unspecified date with her first dose of Gardasil.  Subsequently the patient experienced abdominal pain that lasted 3-4 days.  Subsequently, the patient recovered from the abdominal pain.  The patient received the second dose of Gardasil on an unspecified date and told the physician she had abdominal pain again.  The patient recovered on an unspecified date.  The physician was not sure if the patient really had pain or if it was psychological.  The patient had not decided yet whether or not she will received the third dose.  She sought unspecified medical attention.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a female with a history of coeliac disease who on 18-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot # 655154/1210U). Concomitant therapy included SEASONIQUE. On 17-MAR-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot # 655327/1287U). On 17-MAR-2008, the patient experienced pain in left arm after administration in her left deltoid. The patient described the pain as "shooting down her arm to her fingers". The pain initially lasted 1-2 days and resolved. Subsequently the patient experienced reoccurring pain in arm and burning sensation in arm a couple of days later. The pain gets worse when she opens and closes her fist. When she closes her fist she gets a pain in her ring finger, little finger, and top of thumb. She also is experiencing a burning sensation down her arm. She is not able to use her arm and can not lift. The patient is being referred to a neurologist. The patient sought unspecified medical treatment via a telephone call to the office The patient's reoccurring pain in arm and burning sensation in arm persisted. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information received on 02-JUN-2008. The patient called the physician's office reporting that she had pain with injection which shot down to fingers. Sore 2-3 days. Reported burning sensation on left arm from shoulder to finger tips. No fever or redness at injection site. No pain relief with ibuprofen. The patient was referred to neurology for evaluation. On 28-MAY-2008 the patient was contacted. It was reported that the pain improved within 3 to 4 days and that the patient did not see the neurologist. The patient's outcome was recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female with allergies who on 20-AUG-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot# not reported). Concomitant therapy included ORTHO TRI-CYCLEN and ALLEGRA. On 23-NOV-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil (lot# not reported). On 26-NOV-2007 the patient experienced a single hive near her eye. The patient contacted the office and was prescribed SUDAFED. Subsequently, the patient recovered from a single hive near her eye after one dose of pseudoephedrine hydrochloride. The patient did mention that she ate shrimp on 26-NOV-2007. There was no adverse reaction after the first dose of Gardasil. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Insomnia, Nausea
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 24-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). On 24-MAR-2008 the patient experienced stomach cramps, nausea and insomnia. Subsequently, the patient recovered on 25-MAR-2008 from the stomach cramps, nausea and insomnia. The patient sought medical attention by calling the physician's office. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: Information has been received from a health professional concerning a 12 year old female with a history of asthma who on 17-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number reported as "2405AA").  Concomitant therapy included SINGULAIR, MENINGOCOCCAL POLYSACCHARIDE VACCINE GROUPS A AND C COMBINED and ASMANEX.  On 17-JAN-2008 the patient experienced numbness in lower extremities and myalgia in lower extremities.  Subsequently, the patient recovered from numbness in lower extremities and myalgia in lower extremities at an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a female with a history of irregular menstrual cycle who was vaccinated with her first dose of Gardasil (lot number unspecified).  Subsequently the patient experienced prolonged menstrual bleeding.  The patient experienced the bleeding for two continuous weeks after receiving the dose.  It was noted that the patient had a history of irregular menstrual periods.  The patient sought medical attention by calling the office and speaking to the physician's assistant.  Subsequently, the patient recovered from prolonged menstrual bleeding.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a nurse (consumer) indicating that on an unspecified date she was vaccinated with the third dose of Gardasil (Lot number not provided).  Six weeks after receiving the third dose of Gardasil she tested HPV positive.  She was retested 4 weeks later and was HPV positive.  The physician felt that the first test was a false positive due to the administration of Gardasil.  Unknown medical attention was sought in the office.  Patient outcome was unknown.  No product quality complaint was involved.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 27-DEC-2007 was IM vaccinated with her first dose of Gardasil (lot number unspecified).  On 17-Mar-2008 the patient was IM vaccinated with her second dose of Gardasil (lot number unspecified) at another physician's office.  On 20-Mar-2008 the patient was due for her DEPO-PROVERA shot but was given Gardasil (lot number unspecified) by mistake.  The office manager reports this was a communication error not a product confusion.  The patient did not inform the office that a second dose was given on 17-Mar-2008.  The patient sought unspecified medical treatment by calling the nurse.  No adverse reactions were reported and no other information was available to the office manager.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician assistant concerning a female (age not reported) who on 25-MAR-2008 was vaccinated with the third dose of GARDASIL (lot # not reported).  On 25-MAR-2008 while in the office, the patient fainted.  On 25-MAR-2008, the patient recovered.  There was no product quality control involved.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Allergy to vaccine, Anxiety, Dizziness, Injection site bruising
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with an allergy to penicillin, latex and metals who on 17-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not specified).  Concomitant therapy included vitamins (unspecified).  On 17-MAR-2008 the patient's mother reported that the patient almost fainted in the office after receiving the 1st dose.  The next day it was reported that the patient was sent home early from school and also didn't go to school on the next day, "which is unlike her daughter."  Also, it was reported that the patient felt like she was going to faint, and experienced anxiety, vaginal rash/itching, and developed a bruise at the injection site.  The patient sought medical attention at the physician's office.  The patient was reported to be recovering.  No product quality complaint was involved. The patient's mother also reported that her daughter had a "serious" allergic reaction to the vaccine that lasted about a week and her daughter had to go to see a physician again. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Presyncope, Pruritus, Rash, Vulvovaginal pruritus
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with an allergy to penicillin, latex and metals who on 17-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not specified).  Concomitant therapy included vitamins (unspecified).  On 17-MAR-2008 the patient's mother reported that the patient almost fainted in the office after receiving the 1st dose.  The next day it was reported that the patient was sent home early from school and also didn't go to school on the next day, "which is unlike her daughter."  Also, it was reported that the patient felt like she was going to faint, and experienced anxiety, vaginal rash/itching, and developed a bruise at the injection site.  The patient sought medical attention at the physician's office.  The patient was reported to be recovering.  No product quality complaint was involved. The patient's mother also reported that her daughter had a "serious" allergic reaction to the vaccine that lasted about a week and her daughter had to go to see a physician again. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Dizziness, Fatigue, Feeling abnormal, Genital rash
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with an allergy to penicillin, latex and metals who on 17-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not specified).  Concomitant therapy included vitamins (unspecified).  On 17-MAR-2008 the patient's mother reported that the patient almost fainted in the office after receiving the 1st dose.  The next day it was reported that the patient was sent home early from school and also didn't go to school on the next day, "which is unlike her daughter."  Also, it was reported that the patient felt like she was going to faint, and experienced anxiety, vaginal rash/itching, and developed a bruise at the injection site.  The patient sought medical attention at the physician's office.  The patient was reported to be recovering.  No product quality complaint was involved. The patient's mother also reported that her daughter had a "serious" allergic reaction to the vaccine that lasted about a week and her daughter had to go to see a physician again. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Injection site pain, Malaise, Nausea, Vulvovaginal pruritus
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with an allergy to penicillin, latex and metals who on 17-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not specified).  Concomitant therapy included vitamins (unspecified).  On 17-MAR-2008 the patient's mother reported that the patient almost fainted in the office after receiving the 1st dose.  The next day it was reported that the patient was sent home early from school and also didn't go to school on the next day, "which is unlike her daughter."  Also, it was reported that the patient felt like she was going to faint, and experienced anxiety, vaginal rash/itching, and developed a bruise at the injection site.  The patient sought medical attention at the physician's office.  The patient was reported to be recovering.  No product quality complaint was involved. The patient's mother also reported that her daughter had a "serious" allergic reaction to the vaccine that lasted about a week and her daughter had to go to see a physician again. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female (16 or 17 years old) who on an unknown date was vaccinated (route unknown) with a first dose of Gardasil (Lot # unknown) and fainted.  The nurse indicated that she did receive 4 total vaccines (therapy unspecified) when she fainted.  Subsequently, on an unknown date, the patient recovered.  The nurse also reported that the patient had received her second dose and was fine.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old female with allergic reaction to AUGMENTIN and cephalosporin (reported as cephlosporin) who on 22-JAN-2008 was vaccinated with a first dose of Gardasil (Lot # 659657/1487U) and was vaccinated with a dose of MENACTRA.  With in hours of receiving the first dose of Gardasil, on 22-JAN-2008, the patient developed hives all over her body.  No treatment Information was provided.  It was reported that after 4 days on 26-JAN-2008, the patient recovered from her hives.  It was reported that the patient had not had previous exposure to this or related drug, and the patient is not pregnant.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis infective, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: Information has been received from a physician concerning a 14 year old female who "about a month ago" in February 2008, was vaccinated intramuscularly in the upper arm in the deltoid with a first dose of GARDASIL. The physician reported that the patient received the vaccine "in the joint." ON an unspecified date, in February 2008, the patient developed pain. (NOS) and swelling (NOS). It was reported that the patient's mother gave the patient an NSAID (type unspecified). About 12 days ago, on approximately 14-MAR-2008, the patient went to the physician's office and was found to be "infected at the joint". No treatment information was provided. No lab diagnostics studies were performed. Outcome unknown. No product quality complaint was involved. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning her 16 year old daughter with no medical history or known drug allergies who on 25-SEP-2006 was vaccinated with a first dose of Gardasil (lot # not specified). On 22-NOV-2006 the patient was vaccinated with a second dose of Gardasil (lot # not reported) and experienced fatigue and tiredness right after receiving the second dose, lasting approximately two days. On 22-MAR-2007 the patient was vaccinated with a third dose of Gardasil (lot # not specified) and experienced fatigue and tiredness right after receiving the third dose, lasting approximately two days. The patient slept all day after receiving the second and third doses. Subsequently, the patient recovered from fatigue and tiredness. The patient sought unspecified medical attention. A product quality device was not involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Pyrexia, Tremor, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 25-MAR-2008 was vaccinated intramuscularly with a third dose of GARDASIL (Lot # unknown).  Dates of the previous doses are not reported.  On 25-MAR-2008, the patient developed a fever of 101 and aching in both her arms and legs, vomiting and shaking.  No lab diagnostics studies were performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  Outcome unknown.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a nurse concerning a 17 year old female and no illnesses at the time of vaccination, who on 25-MAR-2008 was vaccinated intramuscularly with a third dose of GARDASIL (Lot # 659964/1978U). Dates of the previous doses are not reported. On 25-MAR-2008, the patient vomited 1x and on 26-MAR-2008 the patient developed a fever of 101 and aching in both her arms and legs, and shaking. No lab diagnostics studies were performed. Unspecified medical attention was sought. The patient was advised to take MOTRIN and see PCP if symptoms persisted. No product quality complaint was involved. Outcome unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Contraception
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no known medical history, who in December 2007, was vaccinated with a third dose of Gardasil (Lot # 659055/1522U).  On unspecified dates, the patient was also vaccinated with the first and second dose of Gardasil (Lot # 657868/"523U" and 658554/"928U").  Concomitant therapy included rizatriptan benzoate (MSD) as needed (dose and indication not reported).  Other concomitant therapy included birth control (hormonal contraceptives unspecified), TOPAMAX, NASONEX and ZYRTEC.  The physician reported that on an unspecified date, 6 weeks after receiving her third dose, the patient became infected with condyloma.  The patient's condyloma persisted.  The patient sought unspecified medical attention at an office visit.  No product quality complaint was involved.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 09-JAN-2008 was vaccinated IM with a 0.5 mL dose of GARDASIL (no lot# provided).  On 10-JAN-2008 the patient developed an itchy rash under her arm in the axilla area and rash later spread over her whole body.  Subsequently, the patient recovered from itchy rash under her arm in the axilla area and over her whole body.  The patient sought medical attention via the family physician.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report previously submitted on 04/14/2008: Followup information has been received from the certified registered nurse practitioner (CRNP). It was reported that the 22 year old female, weighing 175 pounds, height of 65.75 inches, with no pre-existing allergies, birth defects or medical conditions, on 09-JAN-2008 (incorrectly reported as 19-Jan-2008) was vaccinated IM in the left deltoid with the first 0.5 mL dose of GARDASIL (no lot# provided). On 10-JAN-2008 (incorrectly reported as 20-Jan-2008) the patient developed a red, itchy rash under her arm which later became widespread. When the patient returned to the office for the second dose, she notified the physician of the rash she developed after receiving the first dose. It was reported that no treatment was tendered and "self-limited." The patient did not receive the second dose due to the rash she had developed after receiving the first dose. It was reported by the CRNP that she does not think the patient will finish the series due to the rash. No laboratory diagnostics tests were performed. It was also reported that the patient's 3 year old son had a virus and a rash a week prior to the patient receiving the first dose, so patient does not know if the rash she developed was due to the vaccine or the virus and rash her son had. The patient's son is not a patient of that office and they have no information on the son's medical history. It was reported that the patient recovered on an unspecified date (previously reported as 17-Jan-2008). No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician's wife concerning their daughter who was vaccinated with three doses of GARDASIL (lot #s not provided).  Subsequently the patient experienced headaches for approximately one month after receiving a dose.  This occurred after administration of one of the three doses.  It was not specified which of the three doses it was.  Subsequently, the patient recovered from the headaches.  The patient sought unspecified medical attention.  A product quality complaint was not involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Fatigue, Gait disturbance, Hypoaesthesia, Myalgia
Clinical narrative: Information has been received from a physician concerning a 23 year old female with Crohn's disease who on 18-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # not reported).  On approximately 20-FEB-2008, "within days of receiving the first dose of GARDASIL", the patient experienced severe joint pain, myalgia, and fever.  It was reported that "the joint pain and myalgia caused the patient to experience difficulty walking for a period of approximately two weeks.  Subsequently, the patient recovered from the severe joint pain, myalgia, fever and difficulty walking.  The patient sought unspecified medical attention in an office visit.  Additional information has been requested. 02/18/2010 On an unspecified date, the patient recovered from myalgia and fever. It was later reported that on 20-FEB-2008, the patient complained of joint pain affecting all joints, including ribs, espcially upon "inspiration". The patient experienced difficulty going from sit to stand and could not stand for extended periods, had numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness. The duration of the joint pain affecting all joints, including ribs especially upon "inspiration", difficulty going from sit to stand, inability to stand for extended periods, numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness was five days. The patient sought unspecified medical attention in an office visit twice. The patient outcome was recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain of skin, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 23 year old female with Crohn's disease who on 18-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # not reported).  On approximately 20-FEB-2008, "within days of receiving the first dose of GARDASIL", the patient experienced severe joint pain, myalgia, and fever.  It was reported that "the joint pain and myalgia caused the patient to experience difficulty walking for a period of approximately two weeks.  Subsequently, the patient recovered from the severe joint pain, myalgia, fever and difficulty walking.  The patient sought unspecified medical attention in an office visit.  Additional information has been requested. 02/18/2010 On an unspecified date, the patient recovered from myalgia and fever. It was later reported that on 20-FEB-2008, the patient complained of joint pain affecting all joints, including ribs, espcially upon "inspiration". The patient experienced difficulty going from sit to stand and could not stand for extended periods, had numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness. The duration of the joint pain affecting all joints, including ribs especially upon "inspiration", difficulty going from sit to stand, inability to stand for extended periods, numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness was five days. The patient sought unspecified medical attention in an office visit twice. The patient outcome was recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 23 year old female with Crohn's disease who on 18-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # not reported).  On approximately 20-FEB-2008, "within days of receiving the first dose of GARDASIL", the patient experienced severe joint pain, myalgia, and fever.  It was reported that "the joint pain and myalgia caused the patient to experience difficulty walking for a period of approximately two weeks.  Subsequently, the patient recovered from the severe joint pain, myalgia, fever and difficulty walking.  The patient sought unspecified medical attention in an office visit.  Additional information has been requested. 02/18/2010 On an unspecified date, the patient recovered from myalgia and fever. It was later reported that on 20-FEB-2008, the patient complained of joint pain affecting all joints, including ribs, espcially upon "inspiration". The patient experienced difficulty going from sit to stand and could not stand for extended periods, had numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness. The duration of the joint pain affecting all joints, including ribs especially upon "inspiration", difficulty going from sit to stand, inability to stand for extended periods, numbness/tingling in fingers and toes, pain in scalp, and extreme tiredness was five days. The patient sought unspecified medical attention in an office visit twice. The patient outcome was recovered.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Information has been received from a female consumer with genital warts and herpes virus infection who on 24-MAR-2008 was vaccinated in the left arm with a first dose of GARDASIL (lot # not reported).  The patient states that "sometimes her menstrual cycle is late and at the beginning of each menstrual cycle she has a light flow for 2 or 3 days."  The patient reported that "her menstrual cycle has stopped, she was supposed to get her menstrual period on 25-MAR-2008 and she still has not gotten it" (as of 27-Mar-2008).  The patient confirmed that she is not pregnant because she has "not been sexually active."  She stated that she would like to conceive.  Her last menstrual period was 21-FEB-2008.  Also, the patient stated that she has been experiencing some stomach pains, and some dizziness.  The patient stated she will seek medical attention in a follow-up visit with a doctor this afternoon (27-MAR-2008) and she will discuss her symptoms with her physician.  There was no concomitant medication and the patient has no known allergies.  There was no product quality complaint involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nausea
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on approximately 19-MAR-2008 was vaccinated IM with the first dose of Gardasil (lot# not provided).  Immediately after the vaccination the patient became nauseous.  That was resolved within few minutes and the patient was sent home.  The nurse was followed up with the patient the next day and the patient did not experience any other symptoms.  Unknown medical attention was sought in the office.  The patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 15 year old female who in January 2008 was vaccinated IM with the first 0.5 ml dose of Gardasil (lot not reported). While in the office and after receiving the first dose of Gardasil (lot not reported) the patient fainted. No other symptoms were noted. The patient recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from the mother of a 14.5 year old female with a history of minor asthma and no drug reactions/allergies who in approximately January 2008 (about 2 months ago), was vaccinated with the first dose of GARDASIL (lot not reported). On 26-MAR-2008, the patient was vaccinated with the second 0.5 mL dose of GARDASIL (lot not reported). There was no concomitant medication. The mother reported that after about five minutes of her daughter receiving the second dose of GARDASIL (lot not reported) she fainted while in the office. She came to in about two minutes and recovered within a few minutes. No laboratory diagnostics test were performed. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Pallor
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 28-NOV-2007 was vaccinated with a first dose of Gardasil (lot # not reported) and the patient turned pale and experienced low blood pressure after the dose. Subsequently, the patient recovered from turning pale and low blood pressure. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with a first dose of Gardasil (no lot # provided).  Subsequently the patient fainted after receiving the injection.  Subsequently, the patient recovered from fainting.  The patient sought unspecified medical attention.  No product quality complaint was involved.  This is one of the multiple reports from the same source (WAES# 0804USA00153).  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Vasculitis
Clinical narrative: Information has been received from a physician, concerning a patient whom a colleague indicated had been vaccinated with a dose of Gardasil (date, route, lot # not reported), and "in the past year" developed "medium vesicle vasculitis." No further details were reported. The outcome of the event was not specified. This is one of several reports received from the same source. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient.
Sex: U
Vaccine: HPV4
Symptoms: Vasculitis
Clinical narrative: Information has been received from a physician, concerning 6 patients whom a colleague indicated she had read about, who had been vaccinated with a dose of GARDASIL (date, route, lot # not reported), and subsequently developed "medium vesicle vasculitis."  No further details were reported.  The outcome of the events was not specified.  This is one of several reports received from the same source.  This is a hearsay report in the absence of unidentifiable patients.  Attempts are being made to verify the existence of the individual patients.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated intramuscularly on an unspecified date with her second dose of Gardasil (lot# not reported).  On 25-MAR-2008 the patient experienced dizziness, but recovered from the dizziness.  Additional information has been requested. This is in follow-up to report previously submitted on 4/14/2008. Information has been received from a physician concerning a 14 year old female with no known drug allergies, who on 24-MAR-2008 at 11:45 was vaccinated intramusculary into the left deltoid with her second dose of GARDASIL (lot#858282/1263U). On 24-MAR-2008 (previously reported as 25-MAR-2008) at 13:50, the patient experienced dizziness, but recovered from the dizziness the same day. No further information is avaliable.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Nausea
Clinical narrative: Information has been received from a nurse concerning a 22 year old female with sulfonamide allergy who on 19-MAR-2008 was vaccinated IM with a first dose of Gardasil (lot # not provided). Concomitant therapy included NUVARING. On 22-MAR-2008, three days later, the patient experienced shortness of breath and nausea. On an unspecified date, the patient recovered from shortness of breath and nausea. It is unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated on 27-MAR-2008 with her first dose of GARDASIL (lot# 659182/1757U). Concomitant therapy included MENACTRA (U2583AA) on the same day. Subsequently the patient fainted, but was fine when she left the office. No other information was available. A call was made to the office because the report says the above occurred with 4 or 5 patients. The office could only remember one patient's information. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with no known drug allergies and no past medical history who on approximately 15-JAN-2008 was vaccinated with a dose of GARDASIL (lot# unspecified, site and route not reported). There was no concomitant medication. Subsequently the patient experienced mononucleosis "a couple of weeks ago" after receiving the vaccination. It was also noted that the patient had a cold a week before receiving the vaccine. The patient sought medical attention at her physician's office. A Laboratory diagnostic test was performed. The patient's status was not reported. No further information was provided. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her third dose of GARDASIL. Sometime during the summer 2007, the patient experienced lightheadedness and dizziness after receiving the vaccination. The patient sought medical attention at the doctors office. Subsequently, the patient recovered from lightheadedness and dizziness. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site urticaria, Syncope
Clinical narrative: Information has been received from a healthcare professional concerning a female who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 27-MAR-2008 the patient experienced fainting. Subsequently, the patient recovered from having fainted. The patient sought unspecified medical attention. No further information was reported. The nurse also reported she had heard of "few" patients that had complained their arm had gone numb at the injection site where GARDASIL was received; however, no additional AE information was provided. The nurse also reported that one patient had an "allergic reaction like hives" at the injection site where GARDASIL was received; however, no additional AE information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Informationhas been received from a healthcare professional concerning a female who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 27-MAR-2008 the patient experienced fainting. Subsequently, the patient recovered from having fainted. The patient sought unspecified medical attention. No further information was reported. The nurse also reported she had board of a "few" patients that had complained their arm had gone numb at the injection site where GARDASIL was received; however, no additional AE information was provided. The nurse also reported that one patient had an "allergic reaction like hives" at the injection site where GARDASIL was received however, no additional information was provided. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Off label use, Syncope
Clinical narrative: Information has been received from an office receptionist concerning a 15 year old male who on an unspecified date was vaccinated IM with a dose of GARDASIL (lot# unspecified, site not reported).  The receptionist stated that it was not an accident that a male probably older than 15 years, received the vaccine.  She "was told to give it to him and she did."  He has received only one dose so far.  The patient left the office and went to the hospital because his father was having major surgery that day; he fainted there, about 1 hour ago after the vaccination.  She wasn't sure if he fainted because of the vaccine or because of the stress he was under by being upset by his father's surgery.  He called the office to report the fainting.  She stated that he is fine now.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Swelling face
Clinical narrative: Information has been received from a physician concerning a female who on 25-MAR-2008 was vaccinated with the second dose of Gardasil (lot# not reported).  On 26-MAR-2008 the patient experienced a swollen face and was taken to the emergency room.  The date of the first dose was unknown and it was not specified whether or not this experience occurred with the first dose.  No additional information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Pain, Vaginal infection
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on an unspecified date was vaccinated with a third dose of Gardasil.  Subsequently, the patient developed chronic abdominal pain, vaginitis and body aches.  Outcome was not specified.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Pain in extremity, Syncope
Clinical narrative: Information has been received from a physician concerning her 19 year old daughter with no drug reactions/allergies who on 23-OCT-2007 was vaccinated with a third dose of Gardasil (lot# 658563/1063U).  Concomitant therapy on the same day included a tetanus vaccination in the same arm.  On 23-OCT-2007, the patient was standing when given the Gardasil.  The patient became faint after receiving the Gardasil but may not have lost consciousness.  The patient's arm was sore after the Gardasil injection and the patient complained of pain for 3 days post vaccination.  Unspecified medical attention was sought.  No further information was available.  At the time of reporting on an unspecified date the patient recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a 19 year old female with a history of negative PAP test for human papilloma virus who in November 2006, was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  In June or July 2007, the patient was vaccinated IM with her third, 0.5 mL dose of GARDASIL.  On approximately 24-MAR-2008 the patient's PAP test was positive for human papilloma virus.  She did not have any information on the type of human papilloma virus, only that it was "high risk".  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who in March 2008, was vaccinated with a first dose of Gardasil.  In March 2008, soon after receiving a shot of Gardasil the patient experienced chills, nausea, headache and pain from shoulder to elbow.  Subsequently, the patient recovered from chills, nausea and headache in a day or so but the patient still had the pain in her arm.  The patient works at a car wash and does manual labor.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow-up information was received from a nurse practitioner. The patient had no illness at the time of vaccination. The patient called in 24 hours after the first dose of GARDASIL with pain from shoulder to just below the vaccine injection site. The patient was instructed to apply ice and to take ADVIL and to call if symptoms persisted. On an unspecified date in March or April 2008 the patient recovered. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female with a history of depression who, on an unspecified date, was vaccinated with a 0.5 mL, second dose of Gardasil (Lot# 658219/0755U).  The physician reported that the patient experienced intense burning sensation, slight redness and pain at the injection site.  She started crying during injection.  The patient complained that the first dose hurt a little but was tolerable.  The physician also reported that the patient recovered 3-5 minutes after onset.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient (age not specified) who on 29-FEB-2008 ("one month ago"), was vaccinated with a first dose of GARDASIL.  The physician reported that the patient fainted post vaccination.  The patient recovered (unspecified date).  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a medical assistant concerning a 25 year old female who on 27-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not provided).  On 31-MAR-2008 the patient called the office and stated she had back spasms.  The patient was treated with a warm compress.  The patient's back spasms have persisted.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Followup information has been received from a nurse practitioner. It was reported that the 25 year old female, with a secretarial occupation, weighing 119 pounds, height of 5 feet 2 inches, with no illness at the time of vaccination, on 27-MAR-2008 was vaccinated IM in the left deltoid with a first 0.5mL dose of GARDASIL (lot # 659182/1757U (reported as 17570)). On the following day, 28-Mar-2008, the patient experienced back spasms lasting all day. The patient had recovered.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with no medical history and no drug reactions/allergies who on 20-MAR-2008 was vaccinated IM with a 0.5 mL first dose of GARDASIL (lot #659439/1267U). Concomitant therapy included TRI-CYCLEN. On 25-MAR-2008 the patient developed redness on her cheeks and forehead with small, red raised bumps. It was noted that the area of redness were itchy. The patient called the office for medical attention. It was reported that the patient is recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL (lot# not provided). Concomitant therapy included another vaccination (unspecified). After the vaccination the patient became "lightheaded". Unknown medical attention was sought in the office. The patient's outcome is unknown. No product quality complaint was involved. Additional information is not expected.